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# NMSS Licensee Newsletter June 1996 - July 1996

NUREG/BR-0117; No. 96-2
        - Human Performance Evaluation of Industrial Radiography Exposure Events
        - Training and Monitoring of Carrier Personnel: Comments on NRC Generic Letter 95-09
        - The Timeliness Rule May Apply to Onsite Burials
        - Business Process Re-Engineering Update
        - Meeting of the Advisory Committee on the Medical Uses of Isotopes
        - Sealed Sources and Devices Bulletin Board System
        - Reports of Atypical Radiation Levels Surrounding Packages Containing Technetium-99m/molybdenum-99 Generators
        - Selected Federal Register Notices, February 2, 1996-May 31, 1996
        Petitions for Rulemaking
Notice of Issuance of Regulatory Guides
- Final Guide
- Draft Guide
- Proposed Rules
- Final Rules
Guidance
Policy Statements

        - Significant Enforcement Actions
        Academic
Medical
Measuring Gauges
Other Materials Licensees

        - Generic Communications Issued (February 1, 1996-May 1, 1996)
        Generic Letters
Information Notices

## Human Performance Evaluation of Industrial Radiography Exposure Events

The Nuclear Material Events Database (NMED) is maintained by the Office for Analysis and Evaluation of Operational Data (AEOD) under contract with the Idaho National Engineering Laboratory (INEL) and includes radiation exposure events reported by both the U.S. Nuclear Regulatory Commission and Agreement State licensees. A review of the data in NMED shows that industrial radiography overexposures account for a significant number of overexposures reported to NRC and that most of the acute exposures have resulted in physical injury. The number of reported radiography licensee overexposures is especially significant when considering that radiography licensees account for less than 10 percent of NRC and Agreement State licensees.

To develop better information on: (1) the cause of radiography overexposures, and (2) how to minimize radiography overexposures, AEOD contracted with INEL to review the NMED data and perform a human factors review of field radiography overexposure events reported between 1987 and 1994. The scope of the effort included a review and analysis of historical and current events, categorization of the events in terms of human actions and contributing factors, and detailed modeling of a subset of 19 events. INEL-95/0387, "Human Performance Evaluation of Industrial Radiography Exposure Events," summarizes the methods, results, and conclusions drawn from the human performance evaluation. Data summaries and analysis materials are included in the appendices of this report.

In the initial analysis of the 95 events, one third were categorized as involving procedural errors (e.g., improper survey or survey not performed, camera not locked); one third were events involving equipment problems (e.g., equipment design issues, source connections/disconnections); and another third involved external factors (e.g., alarms, supervision, and area control). The data showed that there was a greater incidence of events for more recent time periods (1993-94), but this apparent rise could be caused by changes in reporting practices and more rigorous data collection efforts.

The results of the initial analysis were supported by detailed modeling of a subset of 19 acute overexposure and acute-but-less-than overexposure events, based on regulatory limits on personnel exposures. A modeling method was developed and applied to use the information on overexposures to help describe how human performance and equipment interactions were affecting industrial radiography operations. Procedural errors were involved with sixty-eight percent of the 19 events modeled. Of these, nearly half concerned failure to survey. The most common performance errors occurred in the setting up of equipment before the radiograph and in the use of survey meters throughout the process.

The report also includes suggestions related to training, equipment inspection, and equipment design, as well as a data collection guide to assist incident investigators in collecting human performance data.

Additional information about the study and copies of the INEL report can be obtained from Samuel L. Pettijohn, AEOD, at 301-415-6822.

(Contact: Diane S. Flack, NMSS, 301-415-5681 or dsf1@nrc.gov)

## Training and Monitoring of Carrier Personnel: Comments on NRC Generic Letter 95-09

The U.S. Nuclear Regulatory Commission's licensees are responsible for implementing NRC regulations and license conditions, including training and radiation monitoring requirements, for persons who enter their facilities, whether these persons are employed by licensees or by different organizations. When applied to persons who enter many licensed facilities in the course of their work, some of these requirements, --particularly the training and monitoring requirements,-- may prove burdensome. For example, carrier and shipping personnel may enter a large number of licensed facilities to pick up or deliver packages. Implementing the training and monitoring regulations for these persons would mean that many of the facilities visited by these personnel would have to provide training and radiation monitoring, in addition to the training and monitoring their employers, the carriers or shipping companies, usually provide. Such multiple training and monitoring would be mostly redundant, would not improve safety, and would burden both the NRC licensees and the carriers or shipping companies.

To try to relieve this burden, NRC issued, on November 3, 1995, Generic Letter 95-09, "Monitoring and Training of Shippers and Carriers of Radioactive Materials." The generic letter stated that NRC licensees need not provide the required training and monitoring to carrier and shipping personnel who enter their facilities, provided they were being trained and monitored under acceptable programs offered by the personnel's carriers or shipping companies. The generic letter stated that acceptable programs would include programs such as those established under Department of Transportation regulations, or other programs that, after evaluation by the licensees, are deemed to provide training and monitoring equivalent to those required under NRC regulations.

Soon after Generic Letter 95-09 was issued, NRC received complaints that some carriers and shippers were being inundated by requests from NRC licensees for letters stating that their personnel had received the appropriate training and are being appropriately monitored. NRC also received numerous telephone calls from licensees asking whether the guidance in the generic letter applied to their facilities. This response was unexpected, because NRC knew that the generic letter would be relevant to only a very small number of its licensees. Analysis of the questions and requests received from licensees showed that this unexpected response stemmed almost entirely from licensees being unaware of the most recent changes in NRC regulations affecting training. This article attempts to clarify this issue.

Up until August 14, 1995, 10 CFR 19.12 required that all persons entering a licensee's restricted area be provided with training on radiation protection and the hazards of radiation exposure. This meant that any person working for a carrier or shipping company who entered the licensee's restricted area to pick up or deliver a package had to be trained by the licensee. This rule has been changed, however, and as of August 14, 1995, the new rule states that training must be provided only to those who are occupationally exposed, and then only if the person is likely to receive, in a year, an occupational dose in excess of 1 mSv (100 mrem). In the vast majority of cases, carrier and shipping personnel who enter a licensee's facility receive, in a year, a dose in that facility that is far less than 1 mSv (100 mrem), and therefore training is not required to be provided to these personnel by the licensee. Only in the rare situation in which the carrier person is likely to receive a dose in excess of 1 mSv (100 mrem) in a year, at a specific licensee's facility, is that licensee responsible for ensuring that training is provided.

(Contact: Sami Sherbini, NMSS, 301-415-7902 or sxs2@nrc.gov)

## The Timeliness Rule May Apply to Onsite Burials

The U.S. Nuclear Regulatory Commission staff is developing guidance considering the application of the Timeliness Rule (59 FR 36026) to onsite burials of radioactive material. Sections 30.36, 40.42, 70.38, and 70.54 of the rule state that if a site contains buildings or outdoor areas that contain residual radioactivity and have not been in use for 24 months, the licensee is required to notify NRC of this situation. Within 12 months of this notification, the licensee is required to begin decommissioning, or submit a decommissioning plan for these areas if they are not suitable for release in accordance with NRC requirements.

If onsite burials are considered part of outdoor areas, this rule could include those areas that were used by licensees to dispose of radioactive materials in accordance with 10 CFR 20.304 (rescinded) and 20.302 (now Section 20.2002). If the Commission determines that the rule does apply to onsite burials, the licensees could be required to determine if the burial sites would be suitable for release under NRC requirements. This could require the licensee to characterize the burials, and submit decommissioning plans for the sites as early as August 1996. This effort could include both current and terminated licenses, as well as operational and decommissioning sites.

The staff is currently consulting with the Commission on this issue and plans to distribute a Generic Letter to the licensees describing the Commission's decision and outlining necessary future actions.

(Contact: Heather Astwood, NMSS, 301-415-5819 or hma@nrc.gov)

## Business Process Re-engineering Update

The staff's Business Process Re-engineering initiative, which is designed to enhance the overall quality of licensing reviews and associated tasks, has engaged in a set of activities designed to provide licensees, Agreement States, and members of the public the opportunity to provide feedback on the new process.

**Workshop**

On April 25, 1996, the office of Nuclear Material Safety and Safeguards (NMSS) held a public workshop to obtain suggestions and comments on the U.S. Nuclear Regulatory Commission's Business Process Redesign (BPR) of the materials licensing process.

To publicize the workshop, the staff published a Federal Register notice on March 6, 1996, and mailed a letter announcing the meeting and the agenda to each of NRC's materials licensees.

The attendees provided highly useful comments on the BPR process, as well as very specific comments on the development of the Materials Electronic Library. The licensees recommended that additional workshops be held at different locations throughout the country. They also recommended that licensees participate in some type of pilot project or Beta test before full implementation of the licensing process.

**NUREGs**

In April 1996, the staff published two NUREGs describing NRC's methodology for redesigning its processes: NUREG No. 1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," and NUREG No.1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance." For copies of these documents, you may contact: Sally L. Merchant, NMSS, Mail Stop T 8-F-5, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone 301-415- 7874; Fax: 301-415-5369; INTERNET: SLM2@NRC.GOV.

(Contact: Patricia A. Rathbun, NMSS, 301-415-7178 or par@nrc.gov)

## Meeting of the Advisory Committee on the Medical Uses of Isotopes

The U.S. Nuclear Regulatory Commission's Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on May 3, 1996. The ACMUI discussed the Advance Notice for Proposed Rulemaking for Part 33. Additionally, the ACMUI prepared for the Commission briefing on the National Academy of Sciences, Institute of Medicine, report on the medical use program. The briefing was held on May 3, 1996.

Copies of the transcripts and summary minutes for the meeting are available through the Public Document Room, 202-634-3273. Contact Torre Taylor, 301- 415-7900, with any questions.

The next meeting of the ACMUI will be noticed in the Federal Register.

(Contact: Torre Taylor, 301-415-7900 or tmt@nrc.gov)

## Sealed Sources and Devices Bulletin Board System

The Sealed Sources and Devices Bulletin Board System (SSD BBS) is offered by the Sealed Source Safety Section of the Division of Nuclear Material Safety and Safeguards. The SSD BBS will provide users access to materials and information dealing with the registration of sealed sources and devices, and you will find much of the information commonly sought from the Sealed Source Safety Section. Many of the text files can then either be viewed on screen or downloaded to your computer. In addition, the SSD BBS allows users to download copies of the RADXREF and SSD Registry programs.

The SSD BBS has been set up to facilitate easy access to needed materials, and each screen provides either on-screen directions or an "About. . ." file to give you further information on how to use the SSD BBS. Please carefully read all on-screen directions, any "About . . ." section that you come across, and choice [N] "SSD Late-Breaking News and Information" every time you log onto the SSD BBS. These sections will direct you to any new items offered in the SSD BBS, as well as alerting you to other important information dealing with Sealed Sources and Devices.

For information on using the FedWorld Systems and general commands, please contact the FedWorld help desk at (703) 487-4608. For assistance in accessing the U.S. Nuclear Regulatory Commission portion of FedWorld, please contact Arthur Davis, NRC, at (301) 415-5780. For questions about the content of the SSD BBS, please contact Michele Burgess at 301-415-5868 or Steve Baggett at 301-415-7273.

(Contacts: Michele Burgess, NMSS, 301-415-5868 or mlb5@nrc.gov; Steve Baggett, NMSS, 301-415-7273 or slb@nrc.gov)

## Reports of Atypical Radiation Levels Surrounding Packages Containing Technetium-99M/Molybdenum-99 Generators

U.S. Nuclear Regulatory Commission regulations establish the maximum allowable radiation levels on the external surfaces of packages containing licensed material. Section 71.47(a) states, in part, that each package of radioactive materials offered for transportation must be designed and prepared for shipment so that under conditions normally incident to transportation, the radiation level does not exceed 2 mSv/hour (200 mrem/hour) at any point on the external surface of the package. Region I has recently had several reports, from licensees receiving packages containing Technetium-99m/Molybdenum-99 generators, of radiation levels exceeding 2 mSv/hour (200 mrem/hour) on the external surfaces. Investigations into these reports have revealed that the increased radiation levels have resulted from a variety of factors and have failed to identify any common elements that caused these survey findings.

NRC reminds licensees of the importance of performing surveys of incoming packages that contain radioactive materials. In addition, 10 CFR 20.1906(d) requires, in part, that licensees immediately notify the appropriate NRC regional office when external radiation levels exceed 2 mSv/hour (200 mrem/hour) at any point on the external surface of the package. NRC regional offices would be interested in information on unusual radiation levels.

It would be useful if NRC regional offices were notified of cases in which generators show unusual radiation levels, even when these levels are not high enough to require reporting under 10 CFR 20.1906(d), so that NRC can gather additional information, if necessary, and possibly identify common problems with packages containing generators.

(Contact: John Kinneman, RI, 610-337-5252 or jdk@nrc.gov)

## Selected Federal Register Notices

(Full text of the listed Federal Register Notices can be viewed from the Federal Register Online via GPO Access)

February 2, 1996 - May 31,1996

**Petitions for Rulemaking**

Portland General Electric Company, PRM-72-2, "Petition to Permit Storage of Greater Than Class C Waste in Part 72 Facility," 61 FR 3619, February 1, 1996. Contact: Michael Lesar, Office of Administration, 301-415-7163 or 800-368- 5642.

National Registry of Radiation Protection Technologists (NRRPT), PRM 35-13, "Petition to Accept NRRPT Registration as Fulfilling Some Training Requirements for a Radiation Safety Officer," 61 FR 4754, February 8, 1996. Contact: Michael Lesar, Office of Administration, 301-415-7163 or 800-368- 5642.

**Notice of Issuance of Regulatory Guides**

**Final Guide**

"Instruction Concerning Risks from Occupational Radiation Exposure," RG 8.29, 61 FR 10812, March 15, 1996. Contact: Alan Roecklein, RES, 301-415-6223.

**Draft Guide**

"Perimeter Intrusion Alarm Systems," DG-5007, Proposed Revision 3 to RG 5.44, 61 FR 16016, April 10, 1996. Contact: Elizabeth Suarez, NMSS, 301-415-8094; e-mail EXS@NRC.GOV.

**Proposed Rules**

"Modifications to Fitness-for-Duty Program Requirements," 61 FR 21105, May 9, 1996. Contact: Loren L. Bush, NRR, 301-415-2944.

"Employee Protection Policies; Minor Amendments," 61 FR 6796, February 22, 1996. Contact: Mark Haisfield, RES, 301-415-6196; e-mail MFH@NRC.GOV.

**Final Rules**

"Revision of Fee Schedules; 100% Fee Recovery"; FY 1996, 61 FR 16203, April 12, 1996. Contact: C. James Holloway, OC, 301-415-6213.

"Termination or Transfer of Licensed Activities; Recordkeeping Requirements," 61 FR 24669, May 16, 1996. Contact: Mary L. Thomas, RES, 301-415-6230; e-mail MLT1@NRC.GOV.

"Employee Protection Policies; Minor Amendments," 61 FR 6762, February 22, 1996. Contact: Mark Haisfield, RES, 301-415-6196, e-mail MFH@NRC.GOV.

**Guidance**

"Request for Comments on Guidance for Radiation Protection Programs for [DOT] Hazardous Materials Regulations," 61 FR 17349, April 19, 1996. Contact: Dr. Fred D. Ferate II, Office of Hazardous Materials Technology, U.S. Department of Transportation, 202-366-4545.

"Notice of Publication of Federal Radiological Emergency Response Plan," 61 FR 20944, May 8, 1996. Contact: Thomas Antush, Federal Emergency Management Agency, 202-646-3617.

**Policy Statements**

"Freedom of Employees in the Nuclear Industry to Raise Safety Concerns without Fear of Retaliation," 61 FR 24336, May 14, 1996. Contact: James Lieberman, Director, OE, 301-415-2741.

"Protecting the Identity of Allegers and Confidential Sources," 61 FR 25924, May 23, 1996. Contact: Edward T. Baker, NRR, 301-415-8529.

(General Contact: Paul Goldberg, NMSS, 301-415-7842; e-mail pfg@nrc.gov.

## Significant Enforcement Actions

More detailed information concerning these enforcement actions will be published in NUREG-0940, "Enforcement Actions: Significant Enforcement Actions Resolved," Volume 15, No. 1, Part 3.

**Academic**

**Massachusetts Institute of Technology**, Cambridge, Massachusetts, EA 95-284. A Notice of Violation was issued for failure to maintain security or surveillance over licensed material located in several laboratories.

**Medical**

**Central Plains Clinic**, Sioux Falls, South Dakota, EA 95-249. A Notice of Violation was issued because the medical quality management program did not include adequate procedures to meet the objective that each administration of sodium iodide I-131 was in accordance with a written directive, which led to three misadministrations.

**Clara Maass Medical Center**, Belleville, New Jersey, EA 96-047. A Notice of Violation was issued after a brachytherapy misadministration because the medical quality management program did not include: (1) a clear notification procedure when a nurse observes an accidental patient displacement of a brachytherapy implant; and (2) procedures to ensure prompt evaluation of the dose consequences from a dislodged implant, in order to take timely action.

**Department of the Navy**, San Diego Naval Medical Center, EA 95-210. A $2500 civil penalty was assessed because the medical quality management program did not include adequate procedures to verify that selection of brachytherapy sources was in accordance with the written directive, which led to a misadministration.

**St. Mary's Hospital**, Norton, Virginia, EA 96-006. A Notice of Violation was issued because medical quality management procedures were not implemented for diagnostic studies involving sodium iodide I-131.

**Temple University**, Philadelphia, Pennsylvania, EA 95-243. A Notice of Violation was issued for failure to implement the medical quality management program. A teletherapy misadministration resulted because: (1) an adequate check of calculations was not performed, and (2) a technologist failed to make the proper notifications when she noticed that the written directive was not consistent with the treatment plan.

**Measuring Gauges**

**Applied Construction Technologies**, Inc., Cleveland, Ohio, EA 95-266. A Notice of Violation was issued for failure to secure a moisture/density gauge, which was subsequently stolen from the licensee's vehicle.

**Ashland Petroleum Corporation**, Canton, Ohio, EA 95-103. A $500 civil penalty was assessed for a willful violation involving removal of a fixed gauge by an unauthorized individual.

**EDP Consultants, Inc.**, Kirtland, Ohio, EA 96-010. A Notice of Violation was issued for failure to maintain surveillance over a moisture/density gauge, which was run over by a soil compactor.

**FMC Wyoming Corporation,** Green River, Wyoming, EA 95-269. A Notice of Violation was issued for removal of a fixed gauge from service by an unauthorized individual and subsequent transfer to an unlicensed contractor.

**Monsanto Chemical Company**, Soda Springs, Idaho, EA 95-280. A $2500 civil penalty was assessed for a violation involving loss of a gauge containing 50 millicuries of cesium-137.

**Testwell Craig Testing Laboratories, Inc.**, Mays Landing, New Jersey, EA 95- 254. A Notice of Violation was issued for failure to maintain security or surveillance over a moisture/density gauge located at a construction site.

**Other Materials Licensees**

**ABB-Combustion Engineering Nuclear Fuel**, Hematite, Missouri, EA 96-002. A $12,500 civil penalty was assessed for failure to provide NRC with complete and accurate information in responses related to the licensee's chemical safety program, a previous Notice of Violation, and a Demand for Information.

**Corning Clinical Laboratories**, Horsham, Pennsylvania, EA 96-008. A Notice of Violation was issued for violations indicative of a breakdown in control of licensed activities, as related to the consolidation and termination of operations at one facility.

**Stocker and Yale, Inc.**, Swampscott, Massachusetts, EA 96-036. A Notice of Violation was issued for violations indicative of a breakdown in control of licensed activities, including transfer of licensed material to an unauthorized location and failure to maintain security or surveillance over licensed material.

(Contact: Joseph DelMedico, OE, 301-415-2739 or rjd@nrc.gov)

## Generic Communications Issued (February 1, 1996 - May 1, 1996)

Note that these are only summaries of U.S. Nuclear Regulatory Commission generic communications. If one of these documents appears relevant to your needs and you have not received it, please call one of the technical contacts listed below.

**Generic Letters (GLs)**

GL 95-09, Supplement 1, "Monitoring and Training of Shippers and Carriers of Radioactive Materials," was issued on April 5, 1996. This supplement clarifies the guidance provided in the original letter on requirements for monitoring and training of shipping and carrier personnel during pickup and delivery of packaged radioactive materials at NRC-licensed facilities. Contact: Sami Sherbini, NMSS, 301-415-7902; INTERNET:SXS2@NRC.GOV.

**Information Notices (INs)**

IN 96-18, "Compliance with 10 CFR Part 20 for Airborne Thorium," was issued on March 25, 1996. This notice alerts licensees authorized to possess and use thorium in unsealed forms to radiological problems that may be encountered. NRC inspectors have discovered some licensees engaging in activities that can generate significant airborne contamination. Contacts: Sheri Arredondo, RI, 610-337-5342; INTERNET:SAA1@NRC.GOV; Sami Sherbini, NMSS, 301-415-7902; INTERNET:SXS2@NRC.GOV.

IN 96-20, "Demonstration of Associated Equipment Compliance with 10 CFR 34.20," was issued on April 4, 1996. This notice informs radiography licensees and equipment manufacturers of acceptable methods of demonstrating that their associated equipment used in radiographic operations meets the regulations in 10 CFR 34.20. Contact: Thomas W. Rich, NMSS, 301-415-7893; INTERNET:TWR@NRC.GOV.

IN 96-21, "Safety Concerns Related to the Design of the Door Interlock Circuit on Nucletron High-Dose Rate and Pulsed-Dose Rate Remote Afterloading Brachytherapy Devices," was issued on April 10, 1996. This notice alerts medical licensees authorized to use these devices to the recent discovery that the treatment room door interlocks are rendered inoperative by the failure of either the control unit, or by the loss of communications between the control and treatment units. Contacts: Robert L. Ayres, NMSS, 301-415-5746; INTERNET:RXA1@NRC.GOV; .James A. Smith, NMSS, 301-415-7904; INTERNET:JAS4@NRC.GOV.

IN 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," was issued on May 1, 1996. This notice provides all material and fuel cycle licensees with guidance relating to the development and implementation of corrective actions that should be considered after violations of NRC requirements are identified. Contacts: Nader L. Mamish, OE, 301-415-2740; INTERNET:NLM@NRC.GOV. Daniel J. Holody, RI, 610-337-5312; INTERNET:DJH@NRC.GOV. Bruno Uryc, Jr., RII, 404-331-5505; INTERNET:BXU@NRC.GOV. Bruce L. Burgess, RIII, 708-829-9666; INTERNET:BLB@NRC.GOV. Gary F. Sanborn, RIV, 817-860-8222; INTERNET:GFS@NRC.GOV. (General Contact: Kevin Ramsey, NMSS, 301-415-7887; INTERNET:kmr@nrc.gov.)

Comments, and suggestions you may have for information that is not currently being included, that might be helpful to licensees, should be sent to:

E. Kraus NMSS Licensee Newsletter Editor Office of Nuclear Material Safety and Safeguards Two White Flint North, Mail Stop 8-A-23 U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 (or send e-mail to: eek@nrc.gov

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