ML20087K339

NMSS Licensee Newsletter.Number 95-2

ML20087K339
Person / Time
Issue date:	07/31/1995
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N95-2, NUREG-BR-117, NUREG-BR-117-N95-2, NUDOCS 9508230219
Download: ML20087K339 (12)

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Commission and Safeguards June '95 l July '95 i

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APPOINTMENT OF COMMISSIONER NUCLEAR REGULATORY COMMISSION JACKSON MATERIALS LICENSING BUSINESS PROCESS REENGINEERING In October 1994, the NRC staff began to examine On April 6,1995, the United States Senate con.

the process used to issue materials licenses, to firmed the appointment of Dr. Shirley Ann identify ways to improve the process. The staff

)

Jackson as a member of the Commission.

was directed to develop a new bcens, g process m

Dr. Jackson succeeds Dr. Forrest J. Remick, that would-whose term as Commissioner expired on June 30, 1994. In addition, Dr. Jackson will become the 1.

Maintain or raise the level of public safety; next Nuclear Regulatory Commission Chairman J

cffective July 1.

2.

Perform licensing reviews and associated tasks an order of magnitude faster than the current process:

Dr. Jackson brings to the Commission extensive experience in research and management in the

3. Exploit modern information technology; and areas of high-energy physics, nuclear physics, and 4.

Reduce the resou:ces needed to carry out the ccadensed-matter physics, as well as high-level policy experience in business and higher educa.

heensmg program.

tion. Since 1991, she has been a Professor of The method used for tiu.s exammation is called Physics at Rutgers University, New Brunswick, Business Process Reengmeermg (BPR). BPR is New Jersey, and served as a consultant to AT&T the process of fundamentally changmg the way Bell Laboratories, where she had previously worked from 1976-1991. In the mid-1970's, she work is performed, to aclueve sigmficant improvements in speed, cost, and quality. In the was a research associate at the Fermi National first phase of this effort, a core team of people Accelerator Laboratory in Batavia, Illinois, and a who work m, licensing, admimstration, and Visiting Scientist at the European Organization inf rmation technology developed a generalized for Nuclear Research in Geneva, Switzerland.

design of a new materials licensing process. Soon Dr. Jackson carned her Bachelor's degree in the core team and others will begm the detailed 1968 and her Ph.D. degree in 1973 from the design, building, and test, g of the new process.

m i

Massachusetts institute of Technology (M. I. T),

where she became the first African-American Implementation of NRC s new bcensmg process is l

woman to receive a doctorate from M.I.T. in any scheduled to begm m 1996.

field. Dr. Jackson is a native of Washington, D.C.

The core team found that today, lictasing is being l

I accomplished by a complex process that can involve anywhere from 54 to 94 handoffs emong l

Dr. Jackson's appointment to the Commission involved individuals and computer systems during became effective on May 2,1995. She and a routine license resiew. On average. NRC tal.es members of her transition staff can be reached at 84 days to complete a licensing action. Yet only 2 (301) 415-1820.

days are actually needed to complete the technical l

safety review of a typicallicensing request. During the remaining 82 days, paper is either in transit or (Contact: Kevin Ramsey, NMSS,301-415-78S7) a queue.

9508230219 950731 PDR NUREC BR-0117 R PDR i

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j NMSS LICENSEE NEWSLE' ITER -

13. Generic Communications Issaed JUNE-JULY 1995 (General

Contact:

Kevin Ramsey, NMSS, 301-415-7887).

9 j,

14. A Samp'ing of Significant Events

1. Appointment of Commissioner Jackson Reported to NRC by NRC Material (Contact: Kevin Ramsey, NMSS.

Licensees (First Quarter CY 1995)

(301-415-7887).............

1 (Contact: Walter Lescheck AEOD,

2. Nuclear Regulatory Commission 301-415-6365)..........

.......... 9 Materials Licensing Business Process Reengineering (Contact:

15. A Sampling of Significant Enforcement Actions against Materials Licensees Donald A. Cool, NMSS 301-415-7197).. 1 (Contact: R. Joseph Delmedico. OE,

3. Status of the Enhanced Participatory 301-415-2739).

10 Rulemaking (Contact: Michael Weber, NMSS, 301-415-7297),

3

16. Formation of Interagency Steering Comm,ttee on Radiation Standards i

4.

Drachytherapy Issues Paper (Contact:

(Contact: Phyllis A. Sobel, NMSS, Patricia llolahan, NMSS, 301-415-7847).. 4 301-415-6714....

............. 11 5.

Enforcement Policy Task Force Review Comments, and suggestions you may have for (Contact: E. William 13rach, NMSS, information that is not currently being included, 301-415-7196)......

.. 4 that might be helpful to licensees, should be sent to:

E. Kraus 6.

Certification of Radiography Equipment (Contacts: Bruce Carrico, NMSS Licensec News /ctter Editor NMSS,301-415-7826 Michele Office of Nuclear Material Safety d

Burgess, NMSS, 301-415-5868)......

5 T

1t F int North, Mail Stop S-A-23

7. Transmission Source-Iloiding Devices Used U.S. Nuclear Regulatory Commission in SPECT imaging (Contact: Janet Schlueter, Washington, D.C. 20555-0001 NMSS. 301-415-7894)..

6 i

8. Semi-Annual Meeting of the Advisory Committee on the Medical Uses of Isotopes (Contact: Tone Taylor, NMSS, 301-415-7900)..

... 6 9.

Review and Inspection of Implemented Quality Management Programs (QMPs)

(Contact: Sally Merchaat. NMSS, 301-415-7874).

.7

10. NMSS Completes Regulatory Impact Survey (Contact: Paul Goldberg. NMSa, On June 16,1995, the Commission directed the 301-415-7842).

.... 7 staff:(1) to proceed with the detailed design and

11. Availability of Videotapes (Contact:

testing of the new licensing process;(2) to coor-Ilarriet Karagiannis. AEOD, dinate its efforts closely with the Agreement

... 8 States, licensees, and the public; (3) to separate 301-415-6377).

the payment of fees from the process of issuing a

12. FedemlRegister Notices (February 1, license and continue streamlining fees; and (4) on 1995-May 1,1995)(General

Contact:

a one-time basis, to extend qualified licenses for Kevin Ramsey, NMSS,301-415-7887)...

8 an additional 5 years.

2

~

Proposed New Licensing Process cnd the extension if the authorized activities pose a Coordination Efforts:

low safety risk and the results of the most recent inspection are good. Licenses that fall into one or The staff proposes to use a graded approach that more of the following categories would not be matches the safety hazards associated with a considered for license extension: (1) Any license license application. Applications for relatively that requires an emergency plan;(2) Any license simple actions would go through an automated lacking acceptable decommissioning financial review process. De automated review process assurance; (3) Any license currently listed on the uses artificial intelligence-assisted review scripts Site Decommissioning Management Plan list; to help reviewers in rapidly determining if the (4) Any license for which an environmental application conforms with established NRC assessment is needed or has been prepared; or regulations and licensing policies. Any unantic-(5) Any license subject to a significant enforce-ipated circumstance or any improper or ment action as a result of the most recent incomplete response would automatically alert the inspection (i.e., an Order, a Severity Level I, II, or reviewer and require separate action for III violation, a Confirmatory Action Letter, etc.).

resolution. This system would significantly alter NRC will publish the proposed license extension the current practice of using technical staff to criteria for comment soon.

review well-established and relatively low-risk uses oflicensed materials.

(Contact: Donald A. Cool, NMSS,301-415-7197)

Applications for more complex uses would be STATUS OF THE ENHANCED reviewed by trained technical reviewers, working PARTICIPATORY RULEMAKING either individually or in teams. The staff plans to develop a new set of tools for reviewers to The U.S. Nuclear Regulatory Commission has facilitate consistent, high-quality reviews. These been conducting an enhanced participatory tools include a single, comprehensive licensing rulemaking to establish radiological criteria for manual that consolidates all NRC regulations and decommissioning. The proposed rule was guidance in one easily accessible form. This Published in the Federal Register (59 FR 43200; licensing manual will be made available to the August 22,1994) as proposed amendments to Agreement States, the public, and licensees in 10 CFR Part 20. The rulemaking was scheduled to both hard copy and electronic media (e.g., a be completed in June 1995. However, because of bulletin board), when it is completed later this the substantial comments received on the pro-year.

Posed rule, the NRC staff now plans to submit the rulemaking package for Commission review in The staff plans to hold various meetings and December 1995. Commenters raised a variety of workshops to get input from Agreement States, concerns, including the justification for selecting licensees, and the public, and will issue 0.15 millisievert (15 millirem) per year as the dose announcements when these plans are finalized, limit for ur. restricted use, and the large costs associated with remediation of contaminated soil Streamlining Fees:

and groundwater. The staff plans to conduct a multi-day public workshop in the Washington, De staff is working on a proposal that would DC, area in early September 1995, to discuss the separate the collection of fees from the issuance issues raised by the comments, describe current of a license and would also streamline fee staff evaluations based on real-world data, and collection.

explore alternative approaches that could be used to implement the final criteria. A Federal Register One-time Extension of Qualified Licenses:

notice about the workshop should be published by July.

To provide the resources needed to develop a consistent Nuclear Material Safety and Safe-NRC staff is also cooperating with the U.S.

guards policy on the duration of licenses and Emironmental Protection Agency (EPA)in that certificates, carry out the detailed design and agency's development of residual radioactivity testing of the new process, and develop the standards. EPA circulated a preproposal draft licensing manual, the staff is proposing, on a version of its standards in May 1994. Many of the one-time basis, to extend all qualified byproduct, same issues raised in the public comments on source and some special nuclear material licenses NRC's proposed rule were also raised about by 5 years. Each extended license would include EPA's draft standards. De objective of the agency the same authorizations and limits that it does discussions is to allow EPA to find that NRC's now. Licenses would be considered qualified for requirements provide sufficient protection of the 3

[.

public and the environment. Based on such a pulsed-dose-rate brachytherapy; and mobile HDR finding, EPA would cxclude NRC and Agreement brachytherapy. This paper was discussed in detail State "censees from the scope of its standards, with the ACMUIin May 1995 and will be the basis for future discussions with professional In the interim, until NRC promulgates radio-societics and organizations.

logical criteria for decommissioning in 10 CFR Part 20, NRC will continue to use the criteria (Contact: Patricia Holahan, NMSS,301-415-7847) identified in the " Action Plan to Compel Cleanup of Site Decommissioning Management Plan ENFORCEMENT POLICY TASK FORCE Sites," which was published in the Federal Register REVIEW on April 16,1992 (57 FR 13389).

On May 13,1994, the Executive Director for (Contact: Michael Weber, NMSS, 301-415-7297)

Operations established a task force to assess the i

U.S. Nuclear Regulatory Commission enforcement BRACHYTHERAPY ISSUES PAPER program. The charter asked the task force to consider:(1) whether the defined purposes of the The U.S. Nuclear Regulatory Commission is program are appropriate; and (2) whether NRC's currently in the process of reviewing the medical enforcement practices and procedures are use of byproduct material for brachytherapy, with consistent with those purposes. Over the last year, 1

regards to the adequacy of existing regulations, meetings were held with NRC regional and i

standards, and procedures. The need for Headquarters offices, and various Federal additional regulations and guidance for brachy-agencies. Relevant documents were reviewed, therapy was discussed by the staff with NRC's including applicable statutes and regulations, Advisory Committee on Medical Uses of Isotopes NRC policies and procedures, previous 1

(ACMUI). The ACMUI advised the staff to solicit assessments, responses to requests for comment additional information from the regulated in the Federal Register, and policies of other community to sufficiently identify and evaluate Federal and State agencies.

the problems and determine what addi-tional regulations and guidance may be necessary On April 6.1995, the Enforcement Policy Task to further prevent errors. On November 3,1994, Force provided its report and recommendations NRC pubhshed a Federal Register Notice (59 FR to the Commission for review and approval. The 55068) requesting comments from the medical task force concluded that the existing NRC community on a list of issues and questions enforcement program, as implemented, is regarding those areas of medical use of byproduct appropriately directed toward supporting the material, primarily brachytherapy, that are Agency's overall safety mission. The task force currently being reviewed by NRC, to determine if also found, bewever, that the existing program, at additional or modified regulations or guidance are times, provides mixed regulatory messages to the warranted. In addition, NRC conducted symposia licensees, and room for improvement exists in at the annual meetings of the Radiological Society both the enforcement policy and its imple-of North America and the American Brachy.

mentation. The task force recommended that therapy Society.

the overall program should be clarified to:

(1) emphasize the importance of identifying The staff has developed an issues paper to problems before events occur, and of taking describe the background and issues that would be prompt, comprehensive corrective action when associated with efforts to address brachytherapy, problems are identified;(2) direct Agency either for future regulations and/or guidance. The attention to licensees with multiple enforcement issues are categorized into three major topic actions in a relatively short period; and (3) focus areas: all brachytherapy, remote afterloading on current performance of licensees. The report (RAL) brachytherapy, and manual brachytherapy.

recommends significant changes in the methods Within these broad topic areas, the issues include and processes used to determine when civil modification of the specific listing of brachy-penalties should be considered and how the therapy sources and uses in 10 CFR 35.400; amounts of civil penalties are calculated. The specific licensing guidance and license conditions following specific recommendations were made:

for high-dose-rate (HDR) RAL that are not explicitly addressed in the regulations; quality Scrcrity Lercis - NRC should continue to use a assurance checks and calibrations for RAL graduated system of enforcement actions, in a brachytherapy similar to teletherapy; computer manner that reflects the varying safety treatment planning: review of current brachy-significance of different violations, and that can therapy definitions: training and experience; be adjusted based on the circumstances of the 4

i violation. Severity Level (SL) V violations should analysis, and, given the significance and be eliminated. Formal enforcement actions should complexity of the issue, the comprehensive-1

- only be taken for violations categorized at SL I to ness of the corrective action (i.e., whether the IV. Minor violations, if documented, should be action is focused narrowly to the specific i

treated as Non-Cited Violations.

violation or broadly to the general area of concern).

Enforcement Conferences - Enforcement con-ferences should be considered when the Agency

4. Ercrcise of Discretion - De ability to exercise reasonably expects that an escalated enforcement discretion (in tailoring sanctione to the cir-j action will result, and additional information is cumstances of each case) must be preserved.

needed to make an enforcement decision.

The recomme,nded approach provides for the q

use of discretion to deviate from the normal Enforcement conferences should normally be j

public meetings held in regional offices, apr roach where necessary to ensure that the sanction reflects the sigmficance of the Civil Penalties - Applied with discretion and circumstances and conveys the appropriate judgment, civil penalties (cps) can provide an regulatory message.

effective deterrent against future violations. With As of May 23,1995, the Commission had not limited exceptions, the task force recommended taken action on these recommendations. Copies of maintaimng the existing base CP amounts. Once a the task force report," Assessment of the NRC violation has been determmed to be SL III or Enforcement Program," can be obtained free, on above, the CP assessment process should consist, written request, from the Office of Administra-a,t most, of four basic decisional pomts: (1) con-tion, Distribution and Mail Services Section, U.S.

sideration of previous escalated enforcement Nuclear Regulatory Commission, Washington, DC action, (2) credit for identification, (3) credit for 20555-0001.

corrective actions, and (4) exercise of discretion.

These four points are discussed below.

(Contact: E. William Brach, NMSS,301-415-7196)

1. Consideration of Previous Escalated Action -

CERTlFICATION OF RADIOGRAPHY i

When NRC determines that a non willful SL EQUIPMENT III violation has occurred, and the licensee Paragraphs (a) and (d) of 10 CFR 34.20 provide has not had a previous escalated action during that all newly manufactured radiographic consideration should be whether the h,e onlyexposure devices and associated equipment the past 2 years or two mspections, th eensee,s corrective actions for the present violation (manufactured after January 10,1992) acquired by U.S. Nuclear Regulatory Commission licensees may reasonably be considered prompt and must meet the requirements specified in Ameri-comprehensive (see discussion under 3, can National Standards Institute N432-1980 below).

(ANSI-N432). Paragraph (e) of 10 CFR 34.20 i

provides that all equipment in use after

2. Creditfor Identification - his decision re-January 10,19%, meet ANSI-N432 requirements.

quires considermg who identified the problem, One of the test criteria specified in ANSI-N432, whether the problem resulted m an event, the Section 8.9, is a prototype endurance test of the ease o,f discovery, the degree of heersee entire radiography system and is intended to nutiative shown, whether pnor opportunities ensure the integnty of the radiography system existed to identify the problem, and other (particularly the source assembly), and to ensure similar factors.

that the system will remain operational after 20,000 operating cycles.

3. Creditfor Corrective Actions - This factor encourages licensees to (1) take the immediate However, it has recently come to our attention actions necessary, on discovery of a violation, that this test criterion, as specified in ANSI-N432, that will restore safety and compliance with may not be reasonably attainable. Specifically, the the requirement; and (2) develop and imple-torque requirement specified in the ANSI test is ment (in a timely manner) the lasting actions not attainable for two reasons. First, it exceeds by that will not only prevent recurrence of the a considerable amount the torque that an indi-violation at issue, but also prevent occurrence vidual can likely exert on the radiography system.

of violations with similar root causes. In Second, it would require that the typically used assessing this factor, consideration will be drive cable (Type 187 teleflex cable) be operated given to the timeliness of the corrective action, beyond the working load recommended by the the adequacy of the licensee's root-cause supplier of that component.

5

Four manufacturers of radiography exposure TRANSMISSION SOURCE-HOLDING devices and/or sealed source assemblies have DEVICES USED IN SPECT IMAGING models (" newly-manufactured") approved and registered as complying with the requirement.

Recently, Ohio Imaging submitted a request to However, even though the device / source assembly the U.S. Nuclear Regulatory Commission for a manufacturers indicated that the devices / source sealed source and device review of a device used assemblies had been tested in accordance with the with SPECT imaging systems, referred to as a ANSI provisions, the manufacturers used a more

" STEP" device. ne STEP device received 501(K) attainable criterion. The staff is not aware of any approval by the Food and Drug Administration device problems occurring as a result of the use of (FDA), and NRC recently approved the STEP the alternative criterion. Nevertheless, because the device for use as described below. The source-device / source assembly models were not tested as holding device is a shutter shield affixed to the specified in ANSI-N432, these newly manufac.

rotating gantry of a tripleheaded scintillation-tured devices / source assemblies (and the licensees camera patient-imaging system and contains who use them) are not in full compliance with the either a Technetium-99m, Cobalt-57, or regulation.

Gadolinium-153 source, of various activities. The purpose of the device is to provide, during image acquisition, a photon beam of differing energy imm that administered to the patient, to improve NRC is publishing in the Fedeml Register a final resolution loss caused by non-umform absorption rule revising 10 CFR Part 34 which becomes in e pa In ey w s,jt acts as a ness compensator to improve image resolu@ tion.

effective 30 days after Publication. The amend-ment meludes language that relieves (exempts) similar device, manufactured by ADAC and licensees from the requirement to comply with referred to as " VANTAGE,"is currently under-Section 8.9.2 of ANSI N432-1980 when an going a 501(K) review by the FDA. The State of alternate and acceptable test criterion has been California is performing the sealed source and applied. The amendment also meludes a provision device review of the VANTAGE device. The that allows manufacturers to use engineermg STEP and VANTAGE devices function essentially analysis to demonstrate that,a modest change in the same; however, the VANTAGE devices use a an already approved design is acceptable without higher activity source.

the need to perform additional prototype tests.

The amendment is necessary to relieve licensees Licensees are reminded that these devices do not from comphance with an impractical and meet the definition of either a calibration or unnecessary test critenon that was required by reference source (authorized by 10 CFR 35.57) or reference to ANSI-N432. Until the effective date a sealed source for diagnosis (authorized by of the final rule, NRC staff has added a license 10 CFR 35.500). Herefore, if you are using the condition, as needed, that exempts tl e h,censee STEP or VANTAGE device, or a similar device, 3

fro.n the equipment torque tes,t requirement.

you must submit a request to amend your license Because the bcense condition is superseded by the to authorize the possession and use of such rulemaking action, the condition only remams m devices. If the device for which authorization is force until the final rulemakmg effective date.

sought has not undergone a sealed source and Licensees who are authonzed to use " newly.

device review by either NRC or an Agreement manufactured ' equipment, identified as meetmg State, either the requesting licensee or 10 CFR 34.20 requirements, can contmue to use manufacturer of the device must submit the the equipment without requesting the exemption required information, for a sealed source and license condition.

device review to occur. Once the sealed source and device review is completed and the device is registered, either by NRC or an Agreement State, Any questions regarding the exemption condition the license will be amended to authorize its or the rulemaking should be directed to Bruce possession and use.

Carrico Office of Nuclear Material Safety and Safeguards (NMSS). For questions concerning the (Contact: Janet Schlueter, NMSS,301-415-7894) applicability of 10 CFR 34.20 to a particular SEMI-ANNUAL MEETING OF Tile device, contact Michele Burgess, NMSS.

ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (Contacts: Bruce Carrico, NMSS,301-415-7826 The U.S. Nuclear Regulatory Commission's Michele Burgess, NMSS,301-415-5868)

Advisoty Committee on Medical Uses of Isotopes 6

. (ACMUI) held its regularly scheduled of recordable events that had not been previously semi annual meeting on May 11 and 12,1995, at identified by the licensees during their reviews.

the NRC Headquarters office in Rockville, Maryland. Agenda items included a discussion of:

All the inspection findings have been entered into brachytherapy issues; guidance documents for the a database to be used to evaluate the imple-i final Radiopharmacy Rule, and a petition to mentation of the Quality Management rule.

review the final Radiopharmacy Rule; prostate implant procedures; trammg and expenence of (Contact: Sally Merchant, NMSS,301-415-7874) authorized users to allow exemptions to Subpart NMSS COMPLETES REGULATORY IMPACT J; dose ranges m wntten directives; information SURVEY on Sr-90 calibration errors for eye applicators; and revisions to Regulatory Guide 10.8. 'Ihe staff The Office of Nuclear Material Safety and Safe-discussed the status of the implementation of the guards (NMSS) has completed a mail survey of Quality Management Rule; provided an update of licensees to determine the impact of NRC l

the study of the medical use program by the regulation on safety and operations. In the first National Academy of Sciences; and presented a phase of the Regulatory Impact Survey of summary of " Business Process Reengineering." In Materials Licensees, the staff interviewed repre-addition, NRC staff provided an update on sentatives of nine large licensees and reported to several rulemakings: " Medical Administration of the Commission the results of the interviews and Radiation and Radioactive Materials"; " Release of possible changes in the regulations based on those

~

Patients Containing Radiopharmaceuticals or results. The objective of the second phase of the Permanent Implants"; and " Administration of Regulatory Impact Survey is to obtain the views of Byproduct Material or Radiation from Byproduct a broader range oflicensees on the impact of Material to Patients Who May be Pregnant or NRC regulation on licensee operations. The staff Nursing."

will report to the Commission shortly on the results of this second phase.

Copies of the transcripts and summary minutes for the meeting are available through the Public With the assistance of a contractor, the staff Document Room, at 202-634-3273. The next developed a self-administered, mail-out survey meeting of the ACMUI will be held in October questionnaire based on the interview protocol 1995, and will be noticed in the Fedeml Register:

used in the first phase of the survey.'Ihe,

questionnaire covers five aspects of regulation:

(Contact: Torre Taylor, NMSS, 301-415-7900)

(1) Regulations, Policies, and Guidance;,

(2) Licensmg; (3) Inspection; (4) Reportmg; and REVIEW AND INSPECTION OF (5) Enforcement. Staff chose a stratified, random IMPLEMENTED QUALITY MANAGEMENT sample design for the survey to sample a wide PROGRAMS (QMPs) range of heensee categones wlhile givmg greater weight to certam categones (i.e., samphng a larger number within the category) based on relative S.mce August 1,1994, U.S. Nuclear Regulatory hazard, heterogeneity within categories, and Commission mspectors have been reviewmg both regulatory issues in the various categories.

the wn,tten and implemented QMPs as part of the Licensees with recent interactions with NRC (half mspection of applicable medical use programs.

for inspections and half for licensing actions) were Based on NRC m, spectors findmgs,it is apparent selected at random for the sample.

that the majonty of heensees have implemented programs that meet (or nearly meet) the require-Almost 600 questionnaires were sent to licensees.

ments described in the Quality Management A total of 371 licensees returned completed Program and Misadministration Rule (10 CFR questionnaires for a response rate of 63 percent, 35.32). However, the inspection findings indicate distributed across the licensee categories.

that a few licensees do not have procedures in Licensees were grouped into the following nine place to ensure that final plans of treatments and categories on the basis of the type of operation:

related calculations for brachytherapy, tele-therapy, and gamma stereotactic radiosurgery are Academic in accordance with the respective written directive MedicalInstitution (objective 3 of the rule), and that each adminis-Medical Other tration is in accordance with the written directive Well Logging (objective 4). Most licensees inspected are review-Gauges ing their QMP within each 12-month period.

Manufacturing / Distribution However, the inspectors have identified a number Services 7

Industrial Radiography

3. "Taking Control: Safety Procedures for Research and Development Industrial Radiography" The surveys were confidential; neither NRC nor

Contact:

the survey analysts were able to associate Harriett Karagiannis, AEOD,301-415-6377 licensees with the responses. The responses were analyzed statistically, using computer software, FEDERAL REGISTER NOTICES and responses to open-ended (write-in) qu'estions were also analyzed. The contractor's report February 1,1995 - May 1,1995 summarizes the results of these analyses, using FINAL REGULATORY GUIDES (NOTICE OF text and supportmg graphs, tables, and charts, AVAILABILITY) and suggests a number of areas m which NRC may consider changes. He results were analyzed Regulatory Guide 6.9, " Establishing Quality both in overall terms and by licensee categories.

Assurance Programs for the Manufacture and Distribution of Scaled Sources and Devices The survey yielded a number of findings signifi-Containing Byproduct Material," 60 FR 12789, cant for the materials regulatory program, March 8,1995.

involving usefulness of regulations and guidance, timeliness of licensing actions, performance of DRAFT POLICY STATEMENTS license reviewers and inspectors, and open communication with licensees. These findings

" Freedom of Employees in the Nuclear point to areas for assessment of the program and Industry to Raise Safety Concerns without for future monitoring. Staff expects to address Fear of Retaliation," 60 FR 7592, February 8, licensee concerns identified in the Regulatory 1995.

Impact Survey through existing initiatives. The staff is considering the best means, given available

Contact:

1 resources, for eliciting licensee views of NRC James Lieberman, OE,301-415-2741 regulation on a regular basis.

PETITIONS FOR RULEMAKING (All Parts are The contractor's report of the project is available fr m 10 CFR.)

as NUREG/CR.-6330. The staff's report to the Part 20, " Steve Gannis, Denial of Petition" Commission is available as SECY-93-130.

(for 0.01 millisievert (1 millirem)/ year public l

(Contact: Paul E Goldberg, NMSS,301-415-7842)

Contact:

AVAILABILITY OF VIDEOTAPES Charleen T Raddatz, RES,301-415-6215 Nuclear Regulatory Commission and Agreement Parts 170 and 171, "American Mining State licensees may obtain free videotapes that Congress; Denial of Petition"(for reduction of have been sponsored by NRC. He purpose of the fees),60 FR 20918, April 28,1995.

videotapes is to illustrate the importance of good practices and the safe use of radioactive material.

Contact:

All requests must be made in writing and Glenda C. Jackson, OC,301-415-6057 i

addressed to:

PROPOSED RULES (All Parts are from 10 Chief, Distribution and Mail Services Section CFR.)

Mailstop O-P1-37 Parts 170 and 171, " Revision of Fee Schedules; U.S. Nudear Regulatory Commission Washington, D.C. 20555-0001 100% Fee Recovery, FY 1995," 60 FR 14670, I

March 20,1995, Correction,60 FR 16589, March 31,1995.

or Faxed to 301-415-2260-Correction,60 FR 18882, April 13,1995.

The videotapes are as follows:

Contact:

1. " Good Practices in Preparing and Administering Radiopharmaceuticals" Part 2, " Petition for Rulemaking; Procedure for Submission," 60 FR 15878, March 28,

2. " Good Practices in Co-60 Teletherapy" 1995.

8

Contacts:

GENERIC COMMUNICATIONS ISSUED I Y. Chang, RES,301--415-6450, or Chris Rourk, RES,301415-5865 February 1,1995 - May 1,19" Parts 50 and 70, " Physical Security Plan Note that these are only sumuaries of U.S.

Format Changes," 60 FR 19170, April 17, Nuclear Regulatory Commission generic com-1995.

munications. If one of these documents appears relevant to your needs and you have not received

Contact:

it, please call one of the technical contacts listed Carrie Brown, NMSS,301-415-8092 below.

FINAL RULES (All Parts are from 10 CFR.)

Administrative Letters (ALs)

None.

Part 20, " Frequency of Medical Examinations for Use of Respiratory Protection Information Notices (ins)

Equipment,,60 FR 7900, February 10,1995.

Contact:

IN 94-64, Supplement 1, " Reactivity Insertion Alan K. Roecklem., RES,301-415-6223

'Itansient and Accident Limits for High Burnup Fuel," April 6,1995.

Parts 50,55, and 73, " Reduction in Reporting This supplement to IN 94-64 provides addressees Requirements Imposed on NRC Licensees,"

with additional information on high-burnup 60 FR 13615, March 14,1995.

fuel performance data acquired since the original notice, and discusses NRC and industry actions.

Naiem S. 'Ihnious, RES,301-415-6103 Contacts:

LE. Phillips, NRR,301-415-3232 Parts 20 and 61, ". Low-Level Waste Shipment S. Wu, NRR,301-415-3284 Manifest Information and Reporting," 60 FR 15649, March 27,1995.

Bulletins (BLs)

Contacts:

None.

William R. Lahs, NMSS,301-415-6756, or Mark Haisfield, RES,301-415-61%

Generic Letters (GLs)

Part 2, "NRC Size Standards; Revision" (used None.

t q i a lie se a "small entity"), 60 A SAMPLING OF SIGNIFICANT EVENTS REPORTED TO NRC BY NRC MATERIAL

Contact:

LICENSEES (FIRST QUARTER CY 1995)

Michael T. Lesar, ADM,301-415-7163 Event:

Medical Brachytherapy Misadministration Part 20, " Standards for Protection against Radiation; Clarification," 60 FR 20183, April Date Reported: November 22,1994 25,1995.

l Licensee:

Welborn Memorial Baptist I

l Contacts:

Hospital, Inc.

Evansville, Indiana l

Mary L Thomas, RES,301-415-6230, or Jayne M. McCausland, RES,301-415-6219 On November 18,1994, a 73-year-old female patient was prescribed to receive a brachytherapy Parts 2 and 72, " Interim Storage of Spent Fuel treatment dose of 600 centigray (cGy)(600 rad) at in an Independent Spent Fuel Storage the vaginal cavity using a GammaMed Ili high-Installation at a Reactor Site; Site-Specific dose-rate (HDR) afterloading unit. However, License to a Qualified Applicant," 60 FR 20879, April 28,1995.

~

because of a treatment programming error the patient received a 1250-cGy (1250-rad) dose instead of the prescribed dose. 'Ihe GammaMed l

Contact:

Ili unit contained a nominal 370-gigabecquerel C. William Reamer, OGC,301-415-1640

[10-curie] iridium-192 sealed source.

9 m

The licensee identified the misadministration A SAMPLING OF SIGNIFICANT during a quality management review on ENFORCEMENT ACTIONS AGAINST November 21,1994. The licensee reported the MATERIALS LICENSEES event to the U.S. Nuclear Regulatory Commission on November 22,1994, and followed up with a

1. Forrest L. Roudebush, IA 95-03 written report on December 6,1994. The referring physician was notified. The patient was notified An Order Prohibiting Involvement in U.S.

on November 23,1994, by the licensee s Radiation Nuclear Regulatory Commission-Licensed Safety Officer and was provided with a written Activities and Requiring Certain Notification to NRC was issued based on deliberate report of the m, eident.

violations of NRC requirements, including providing inaccurate information to NRC An NRC medical consultant was reta.med to inspectors and investigators, and untruthful evaluate the medical consequences of the mis-testimony before the Atomic Safety and admimstration. The medical consultant expressed Licensing Board. ' Die Order prohibits the concern that long-term effects such as fibrosis or individual from becoming involved in licensed loss of blood supply may occur as a result of the activities for a period of 5 years from the date 1250-cGy (1250-tad) treatment. The medical that the NRC staff issued an immediately consultant also suggested that this case be con-effective Order suspending the license of the sidered for the U.S. Department of Energy company (October 17,1991). After the 5-year (DOE), Office of Epidemiology and Health prohibition, the individual shall provide notice Surveillance long-term medical study program.

to NRC of acceptance of any employment in Information regarding the DOE program and a an NRC-licensed activity for an additional copy of the NRC medical cons,u,ltant s report were 5-year period.

provided to the referrmg physician.

2. Babcock and Wilcox Company, Lynchburg,

'ihe licensee concluded that the causes of this Virginia misadministration were as follows: (a) the Supplement VI, EA 94-169 technologist failed to activate a button that automatically corrects for the treatment time A Notice of Violation and Proposed Impo-based on soui:e decay, manually reentered the sition of Civil Penalty was issued based on two treatment time instead, and failed to notice the violations involving- (1) two examples of the error message generated; and (b) the treatment failure to conduct activities involvmg licensed software, installed to prevent treatment data entry material in accordance with established errors, failed to pievent initiation of the nuclear criticality safety limits and controls; treatment, despite mtry of erroneous data.

and (2) two examples of the failure to ade-quately consider pertinent process conditions

'Ib prevent recurren:e of the incident, the licensee and known modes of failure in establishing revised its internal irocedure for all HDRs" to these safety limits.

l require both indivic uals operating the unit t

3. Material Testing Laboratories, Inc., Norfolk, verify the displayed time factor and com-Vir 'nia pare it to the, factor supplied by the manufacturer.

Supplement VI, EAs94-244 and 95-003 Before this misadm nistration, the device oper-ators were required to verify only operator-An Order Modifying License (Effective Imme-entered data. Also, the unit was evaluated and the diately) and Notice of Violation and Proposed printed circuit board (card) with the Imposition of Civil Penalty was issued based read-only-memor/ ntegrated circuits containing on violations involving:.(1) use of NRC-i the defective so. ware program was replaced with licensed material by an unauthorized and r

a card having 'ne correct software program, unqualified individual; (2) failure to perform f

an adequate survey;(3) failure to maintain No violatims of NRC requirements were identi-direct surveillance of radiographic operations; fied. As a result of the defective software (4) failure to post the high-radiation area; and program, NRC sent a letter to all GammaMed Ili (5) failure to post a radiography vehicle as a usus to inform them of this potential problem radioactive material storage area. The Order dnd tell them how to test their software for the requires the licensee to:(1) retain and main-defect.

tain the services of a Radiation Safety Officer; (2) retain the services of an independent con-

Contact:

sultant; (3) have the consultant submit an (Walter C. Leschek AEOL,301-415-6365) assessment report and quarterly audit; 10 a

(4) submit a response to each audit report; the Department of Defense (DOD), the (5) ensure that within 30 days of returning the Department of Energy (DOE), the Department of radiographer, who was involved in the Labor's Occupational Safety and Health November 15,1994, violations, to unsuper-Administration (OSHA), and the Department of vised work, an audit be conducted by the Transportation (DOT). Representatives of the consultant quarterly for a period of 1 year:

Office of Management and Budget (OMB) and and (6) notify the regional office for a period OSTP are observers at meetings. The NRC of 1 year-each week-of the location in members are Dr. Carl Paperiello, Nuclear non-Agreement States where the radiographer Material Safety and Safeguards (NMSS) Office will be conducting radiography operations.

Director and Dr. Malcolm Knapp, NMSS Deputy Office Director.

4.

Veterans Affairs Medical Center, Memphis, Tennessee, Supplement VI, EA 94-245 Committee meetings involve pre-decisional intragovernmental discussions and, as such, are A Notice of Violation was issued based on a not open for observation by members of the violation involving a source found taped under public or media. However summary meeting the center desk drawer of a pnysician's desk notes and agendas will be made availabic to the in the nuclear medicine department. The root public and media after they have been cleared by cause of the violation was an apparent all agencies. The committee will not act as a deliberate failure to adhere to procedures for decision-making body. Instead, the control of the source by a licensee em-recommendations on specific issues will be ployee. A civil penalty was not proposed provided to the heads of member agencies, OMB, because the licensee identified the violation, and OTSP. The committee will meet took prompt and extensive corrective actions, approximately once each calendar quarter, with and had good past performance.

additional meetings held if needed for addressing specific issues. Subcomittees will meet at a FORMATION OF INTERAGENCY STEERING frequency and location determined necessary by COMMITTEE ON RADIATION STANDARDS the subcommittees.

The U.S. Nuclear Regulatory Commission and the Env,ronmental Protection Agency (EPA) have The first ISCORS meeting was held on April 5, i

formed the Interagency Streermg Committee on 1995. Representatives from Senator Glen's office, NRC, EPA, DOD, DOE, and OMB attended. The Radiation Standards (ISCORS) to expedite the committee discussed a draft charter, and future resolution and coordination of regulatory issues associated with radiatton standards. Ttus actions, including the issues that could be addressed by the committee. The committec committee was formed m, respose to October 27, 1994, letters from Senator John Glenn to NRC, agreed to increase the membership to include OSHA and DOT' EPA, and the Office of Science and Technology Policy (OSTP). ISCORS is an expanded version of the Interagency Steerirg Committee on Among the committee's first actions is finalization Radiation Cleanup Standards. It is also one of of the NRC/ EPA " Risk Harmonization White the committees recommended by OSTP to achieve Paper," which outlines the similarities and the goals of the former Committee on Interagency differences in the agencies' approaches to Radiation Research and Policy Coordination radiation risk assessment and risk management.

(CIRRPC). The objectives of the committee NRC and EPA are currently reviewing a draft of l

include the following: (1) facilitate a consensus on this paper with the other Federal agencies who acceptable levels of radiation risk to the public are members ofISCORS. Based on the findings and workers, (2) promote consistent risk in this white paper, ISCORS plans to develop a assessment and risk-management approaches in specific set of actions that will be submitted to the setting and implementing standards for EPA Administrator and the Commission for their occupational and public protection from ionizing approval by September 30,1995. Other possible radiation, (3) promote completeness and key policy areas for ISCORS review are standards coherence of Federal Standards for radiation for low-level radioactive waste disposal, protection, and (4) identify interagency issues and radioactive mixed waste, naturally-occurring and coordinate their resolution.

accelerator produced radioactive materials (NARM), and recycling criteria.

In addition to NRC and EPA, ISCORS membership also includes senior managers from (Contact Phyllis A. Sobel, NMSS,301-415-6714)

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