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NMSS Licensee Newsletter December 1996 - January 1997NUREG/BR-0117; No. 96-4
NRC Expectations of Licensees That Self-Identify Violations of NRC Regulatory RequirementsThe U.S. Nuclear Regulatory Commission expects that licensees will implement prompt, effective corrective actions to prevent recurrence of self-identified violations of NRC regulatory requirements. NRC has noticed that some licensees self-identified violations of NRC regulatory requirements, but determined that they could not implement prompt, effective, corrective actions because of other priorities. As a result, the licensees either: (1) planned to implement corrective actions at a future time; or (2) implemented non-comprehensive corrective actions with plans to implement full corrective actions at a future time. NRC finds both of these courses of action unacceptable. They could result in enforcement action against such licensees. Licensees should consider the guidance in Information Notice 96-28 entitled, "Suggested Guidance Relating to Development and Implementation of Corrective Action" (May 1, 1996), when they self-identify violations of NRC regulatory requirements. If a licensee identifies a violation of regulatory requirements and determines that it cannot implement prompt, effective, corrective actions to prevent recurrence, it should immediately contact the appropriate NRC regional office and discuss the following: (1) the requirement that was violated; (2) the reasons prompt, effective, corrective actions to prevent recurrence cannot be implemented immediately; (3) compensatory actions that will be taken to ensure safe operations; and (4) a plan of action to achieve compliance and prevent recurrence (including milestone dates). In cases where a licensee is unable to comply with the regulations or its license, the licensee may need to amend its license, obtain exemptions from the regulations, or cease or restrict operations. Failure to take corrective actions on self-identified violations may be viewed as deliberate misconduct, which is defined as an intentional act or omission that a person knows would cause a violation of NRC regulatory requirements, according to the provisions of 10 CFR 30.10, 40.10, 50.5, and 70.10. Cases involving potential deliberate misconduct are subject to followup by the NRC Office of Investigation staff. In addition to potential enforcement sanctions, deliberate misconduct is subject to criminal sanctions pursuant to 10 CFR 30.64, 40.82, 50.111, and 70.72. (Contact: Bruce Mallett, Region II, 404-331-5514)
Reporting and Follow-Up for Possible Brachytherapy Misadministrations: Wrong Treatment SiteThe definition of a brachytherapy misadmini- stration (10 CFR 35.2) includes events in which a radiation dose is delivered to the wrong treatment site. However, the regulations in 10 CFR Part 35 do not state a dose threshold for such misadministrations. Therefore, licensees should report and pursue proper follow-up of events involving a brachytherapy radiation dose delivered to the wrong treatment site, regardless of whether the dose delivered is significantly different from the dose the area would have received during the normal course of treatment. Similarly, events in which a source displacement/dislodgement appears to be a result of the patient's actions (commonly referred to as "patient intervention") should be reported to the U.S. Nuclear Regulatory Commission and receive proper licensee follow-up. NRC will review the reported events, and misadministration determinations will be made on a case-by-case basis. The following exemplifies a typical licensee scenario involving incorrect use of a dose threshold comparison to evaluate a misadministration. The event occurred when Cesium-137 sources were improperly loaded in a Fletcher suite applicator. Both the written directive and the patient progress record were completed to indicate a source in the right ovoid of the applicator; however, the source was inadvertently dislodged from the ovoid carrier bucket during the insertion procedure. The source remained displaced for approximately 80 minutes, until the nurse found and properly secured the source. The radiation oncologist correctly placed the source into the right ovoid. However, the oncologist did not modify the written directive because the source was dislodged for less than 3 percent of the total treatment time, and delivered a dose, to the wrong treatment site, that was approximately 2 percent greater than the site would have received if the procedure had been completed according to the written directive. The licensee's calculations and comparisons were based on the incorrect assumption that a threshold dose existed for a misadministration involving a wrong treatment site. However, Part 35 does not specify a threshold level for doses to wrong treatment sites. Appropriate licensee follow-up for misadministrations includes compliance with the requirements of 10 CFR 35.33, "Notifications, reports, and records of misadministrations." Licensees should consider determining the root cause of the event and whether appropriate corrective actions were implemented. In addition, licensees may need to ensure that they implement applicable procedures, for incident investigation, that may exist in their written quality management programs (QMPs) (10 CFR 35.32) and review their QMPs appropriately. (Contact: Susanne Woods, NMSS, 301-415-7267)
Draft Methodology For Assessing Former 10 CFR 20.302 and 20.304 BurialsOn November 4, 1996, Nuclear Regulatory Commission staff published a draft Branch Technical Position (BTP), "Screening Methodology for Assessing Prior Land Burials of Radioactive Waste Authorized under Former 10 CFR 20.302 and 20.304" (61 FR 56716). The BTP provides a screening methodology that the staff finds acceptable for determining the need for further characterization and/or remediation of prior low-level radioactive waste disposals conducted under the provisions of former 10 CFR Parts 20.304 and 20.302. Such disposals, at facilities licensed under 10 CFR Parts 30, 40, and 70, that have been unused for licensed operations for a period of 24 months, are subject to the requirements of the "Final Rule on Timeliness in Decommissioning Nuclear Facilities." Licensees who have unused outside/outdoor areas containing elevated levels of licensed radioactive materials are required to notify NRC that they are in possession of these areas and must begin following a schedule for decommissioning these areas. The methodology is based on the total activity disposed of in the burial ground and the potential for that activity to produce a significant dose to a member of the public. Staff would require no further action on sites that pass the aforementioned screening. Those sites that do not pass the screening would require detailed pathway analyses and would be addressed on a case-by-case basis. This screening method is only intended to be used for former burials conducted pursuant to 10 CFR 20.304 and 20.302. It cannot be applied to larger decommissioning sites or for the evaluation of future burials. The BTP was issued for interim use and comment for 90 days. The comment period closes on February 4, 1997, after which staff will review the comments, revise the BTP as necessary, and issue a final BTP for implementation. NRC will not release old burials evaluated using the methodology until completion of the review of public comments. (Contact: Heather Astwood, NMSS, 301-415-5819)
Meeting of The Advisory Committee on The Medical Uses of IsotopesThe U.S. Nuclear Regulatory Commission's Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on November 14-15,1996. The major topics of discussion were: (1) discussion of Strategic Assessment and Direction Setting Issues Papers; (2) Status reports on (a) the Advance Notice for Proposed Rulemaking for Part 33, "Specific Domestic Licensees of Broad Scope for Byproduct Material," (b) Modules for Regulatory Guide 10.8, "Guide for the Preparation of Applications for Medical Use Programs," (c) Memorandum of Understanding with the U.S. Food and Drug Administration, and (d) Continuing Implementation of the Quality Management Rule; (3) discussion of regulatory authorization for intravascular brachytherapy, including the petition of IsoStent intravascular brachytherapy and the development of criteria and training and experience requirements; (4) discussion of security and control of byproduct materials in medical and university settings; (5) discussion of mobile high-dose-rate afterloader applications; and (6) discussion of inspection guidance for the final rule on patient release. The staff will also provide an update on several rulemakings and regulatory guides: (1) Petition by Tri-Med for carbon-14 use; (2) "Release of Patients" (10 CFR 35.75); (3) "Reporting Requirements for Unauthorized Use of Licensed Radioactive Material"; and (4) Regulatory Guide for the final rule, "Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use." In addition, on November 14, 1996, from 8:00 a.m. to 9:00 a.m., the ACMUI held a closed discussion to discuss ethics rules and their application. Copies of the transcripts and summary minutes for the meeting are available through the Public Document Room, 202-634-3273. The next meeting of the ACMUI will be published in the Federal Register. (Contact: Torre Taylor, 301-415-7900)
Generic Communications Issued August 1, 1996 - November 1, 1996Note 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 contacts listed below.
Information Notices (INs) IN 96-47, "Recordkeeping, Decommissioning Notifications for Disposals of Radioactive Waste by Land Burial Authorized under Former 10 CFR 20.304, 20.302, and Current 20.2002," was issued on August 19, 1996. This notice was issued to inform all NRC licensees of problems identified at several burial sites, emphasize recordkeeping requirements for such burials, and remind licensees of the submittal dates for compliance with the decommissioning timeliness rule. Contacts: David N. Fauver, NMSS, 301-415-6625, e-mail: dnf@nrc.gov; Heather M. Astwood, NMSS, 301-415-5819, e-mail: hma@nrc.gov. IN 96-51, "Residual Contamination Remaining in Krypton-85 Handling System after Venting," was issued on September 11, 1996. This notice was issued to alert all material licensees to a possible fixed contamination problem in Krypton-85 handling systems that should be addressed when decommissioning these systems. Contact: Michele Burgess, NMSS, 301-415-5868, e-mail: mlb5@nrc.gov. IN 96-52, "Cracked Insertion Rods on Troxler Model 3400 Series Portable Moisture Density Gauges," was issued on September 26, 1996. This notice was issued to alert all portable gauge licensees and vendors to the potential for cracks to develop in the insertion rod of Troxler model 3400 portable moisture density gauges. If not detected early, the cracks may propagate, eventually leading to complete failure of the rod and release of the contained radioactive material. Contact: Douglas Broaddus, NMSS, 301-415-5847, e-mail: dab@nrc.gov. IN 96-53, "Retrofit to Amersham 660 Posilock Radiography Camera to Correct Inconsistency in 10 CFR 34 Compatibility," was issued on October 15, 1996. This notice was issued to inform industrial radiography licensees of a scenario where the Amersham model 660 Posilock radiography camera would not pass the horizontal shock test required by 10 CFR Part 34, and of a retrofit to the camera to correct the problem. Contact: Michele Burgess, NMSS, 301-415-5868, e-mail: mlb5@nrc.gov. IN 96-54, "Vulnerability of Stainless Steel to Corrosion When Sensitized," was issued on October 17, 1996. This notice was issued to inform all material licensees of the vulnerability of stainless steel to corrosion when sensitized. The notice describes a recent incident where irradiator sources corroded because the stainless steel sources were heat-sensitized as a result of improper loading of the sources in a shipping container. Contacts: Michele Burgess, NMSS, 301-415-5868, e-mail: mlb5@nrc.gov; Thomas Rich, NMSS, 301-415-7893, e-mail: twr@nrc.gov. IN 96-57, "Incident Reporting Requirements Involving Intakes during a 24-hour Period That May Cause a Total Effective Dose Equivalent in Excess of 0.05 Sv (5 Rem)," was issued on October 30, 1996. This notice was issued to remind all licensees of certain notification requirements in 10 CFR 20.2202(b)(1)(I) relating to intakes received, during a 24-hour period, that may cause a reportable dose. Contacts: Cynthia G. Jones, NMSS, 301-415-7853, e-mail: cgj@nrc.gov; James E. Wigginton, NRR, 301-415-1059, e-mail: jew2@nrc.gov. (General Contact: Kevin Ramsey, NMSS, 301-415-7887, e-mail: kmr@nrc.gov) Selected Federal Register NoticesNOTE: Contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
Petitions for Rulemaking Nuclear Energy Institute, Petition for amendment to Part 70 to require fuel cycle licensees to use Integrated Safety Assessments, 61 FR 60057, November 26, 1996. Contact: Michael Lesar, 301-415-7163, or toll-free 800-368-5642, e-mail: mtl@nrc.gov.
Denial of Petition Heartland Operation to Protect the Environment, Denial of Petition to require private ownership of low-level waste disposal sites during operations, 61 FR 67501, December 23, 1996. Contact: Mark Haisfield, 301-415-6196, e-mail: mfh@nrc.gov. Regulatory GuidesIssuance of Regulatory Guide 4.20, "Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors," 61 FR 67354, December 20, 1996. Contact: Sami Sherbini, NMSS, 301-415-7902. Rules
Final Rules "Adjustment of Civil Monetary Penalties for Inflation," 61 FR 53554, October 11, 1996. Contacts: Roger Davis, 301-415-1615, e-mail: rkd@nrc.gov, or Geoffrey Cant, 301-415-3283, e-mail: gcc@nrc.gov. "Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act," 61 FR 65120, December 10, 1996. Contact: Alan Roecklein, 301-415-6223.
Proposed Rules "Deliberate Misconduct by Unlicensed Persons," 61 FR 51835, October 4, 1996. Contact: Tony DiPalo, 301-415-6191, e-mail: ajd@nrc.gov. "Minor Corrections, Clarifying Changes, and a Minor Policy Change [to Part 20 Radiation Protection Standards and Related Regulations]," 61 FR 51835, October 7, 1996. Contact: Jayne McCausland, 301-415-6219, e-mail: jmm2@nrc.gov.
Other Notices Policy Statement: "Policy and Procedure for Enforcement Actions [Adjustment of Civil Monetary Penalties for Inflation]," 61 FR 53557, October 11, 1996. Contact: James Lieberman, 301-415-2741. Notice of Availability: "LSSNet Communication Program; Licensing Support System Regulations," 61 FR 59031, November 20, 1996. Contact: John C. Vogelwede, 301-415-7415 (System URL - http:\\lssnet@llnl.gov). Policy Statement: "Policy and Procedure for Enforcement Actions," 61 FR 65088, December 10, 1996. Contact: James Lieberman, 301-415-2741. Policy Statement: "Policy and Procedure for Enforcement Actions; Radiation Protection Programs," 61 FR 65128, December 10, 1996. Contact: James Lieberman, 301-415-2741. Policy Statement: "Abnormal Occurrence Reports: Implementation of Section 208 Energy Reorganization Act of 1974," 61 FR 67072, December 19, 1996. Contact Harriet Karagiannis, 301-415-6377, e-mail: hxk@nrc.gov. "Proposed Agreement between NRC and Massachusetts for Assumption of Certain Regulatory Functions by State; NRC Staff Assessment of Agreement," 61 FR 68066, December 26, 1996. Contact: Richard Blanton, 301-415-2322, e-mail: rlb@nrc.gov. Policy Statement: "Policy and Procedure for Enforcement Actions (Correction)," 61 FR 68070, December 26, 1996. Contact: James Lieberman, 301-415-2741. (General Contact: Paul Goldberg, NMSS, 301-415-7842, e-mail: pfg@nrc.gov).
Significant Enforcement ActionsDetailed information regarding these enforcement actions can be accessed via the NRC homepage [http://www.nrc.gov/]. Click on "Nuclear Materials," then "Enforcement Program," and finally "Enforcement Actions Issued." Cases are listed alphabetically. For details, click on the highlighted text following each case.
Academic Temple University, Philadelphia, Pennsylvania, EA 95-152. An $8000 civil penalty was assessed because an individual hired to become the radiation safety officer (RSO) was terminated after raising safety concerns. University of Connecticut Health Center, Farmington, Connecticut, EA 96-454. A Notice of Violation was issued because licensed material was removed from an unlocked freezer by an unknown person.
Measuring Gauges Anderson Columbia Construction, Inc., Lake City, Florida, EA 96-314. A Notice of Violation was issued for using a moisture density gauge within U.S. Nuclear Regulatory Commission jurisdiction, without obtaining an NRC license or filing an NRC Form-241. The Dial Corporation, London, Ohio, EA 96-041. A $2500 civil penalty was assessed for loss of control of a gauge containing byproduct material .GCME, Inc., DePere, Wisconsin, EAs 96-256/96-377. A Demand for Information was issued and a $5000 civil penalty was assessed for violations involving both failures to train employees and to provide film badges, and for violations involving security and transportation of licensed material. GRD Steel Corporation, Monongahela, Pennsylvania, EA 96-302. An Order Suspending License and Requiring Transfer of Licensed Material, and a Demand for Information were issued when NRC determined that there had been a foreclosure on the licensee's facility, which still housed two gauges. Middle Monongahela Industrial Development Association, Inc., Donora, Pennsylvania, EA 96-288. A Confirmatory Order was issued because this entity had purchased a building at a foreclosure sale and had come into possession of two gauges without an NRC license. Niblock Excavating, Inc., Bristol, Indiana, EA 96-298. A Notice of Violation was issued based on numerous safety violations indicative of a breakdown in control of licensed activities. Pensacola Testing Laboratories, Inc., Pensacola, Florida, EA 96-315. A Notice of Violation was issued for using a moisture density gauge within NRC jurisdiction without obtaining an NRC license or filing an NRC Form-241.
Medical Shashi K. Agarwal, M.D., Orange, New Jersey, EA 96-152. An Order Suspending License and Demand for Information was issued because Dr. Agarwal repeatedly failed to comply with numerous NRC requirements, provided inaccurate information to NRC, and failed to appear for an enforcement conference. Community Hospital, Torrington, Wyoming, EA 96-056. A $2500 civil penalty was assessed based on two I-131 misadministrations and failure to maintain complete and accurate records pertaining to the misadministrations. Equimed, Inc., Lehighton, Pennsylvania, EA 96-247. A Notice of Violation was issued for failure to follow the Quality Management Program, which caused two patient misadministrations. Jose L. Fernandez, M.D., San Juan, Puerto Rico, EA 96-154. An Order Modifying License was issued based on numerous violations following at least 104 Strontium-90 misadministrations. New Britain General Hospital, New Britain, Connecticut, EA 96-396. A Notice of Violation was issued for false entries in the licensee's dose calibrator constancy record. New England Medical Center, Boston, Massachusetts, EA 96-398. A Notice of Violation was issued for failure to ensure that a package of radioactive material for shipment complied with transportation regulations, and failure to perform an adequate survey.
Radiography Canspec Materials Testing, Inc., Middlesex, New Jersey, EA 95-163. A $5000 civil penalty was assessed based on numerous safety violations as well as the submittal of inaccurate information to NRC. CTI Alaska, Inc., Anchorage, Alaska, EA 96-232. A $13,000 civil penalty was assessed for safety violations involving potential malfunction of a radiography device and failure to maintain complete and accurate records. Eastern Testing and Inspection, Inc., Thorofare, New Jersey, EA 96-085. An Order Suspending License was issued for willful violations of NRC requirements, including certifying an individual as a radiographer when the individual was not qualified and trained. Gamma Tech Industries, Inc., San Diego, California, EA 96-093. A $1500 civil penalty was assessed for a deliberate violation by an Agreement State Licensee that performed radiography in an area under exclusive Federal jurisdiction without obtaining an NRC license or filing NRC Form 241. Industrial Marine Testing Labs, Inc., San Diego, California, EA 96-065. A $1500 civil penalty was assessed for a deliberate violation by an Agreement State Licensee that performed radiography in an area under exclusive Federal jurisdiction without obtaining an NRC license or filing NRC Form 241. NDT Services, Inc., Caguas, Puerto Rico, EA 94-029. A $15,000 civil penalty was assessed for deliberate failures to train radiographers and to provide complete and accurate information to NRC, and failure to wear alarm ratemeters. Testco, Inc., Greensboro, North Carolina, EA 95-101. A $5000 civil penalty was assessed for deliberate failure to file an NRC Form 241 before conducting operations in NRC jurisdiction.
Other Materials Licensees Applied Health Physics, Inc., Bethel Park, Pennsylvania, EA 96-009. A Confirmatory Order was issued because the licensee possessed byproduct material and special nuclear material not authorized by its NRC license and held radioactive waste in excess of 180 days, in violation of the license. Applied Health Physics, Inc., Bethel Park, Pennsylvania, EA 96-353. A Confirmatory Order was issued because the U.S. Internal Revenue Service seized the licensee's bank accounts, thereby preventing disposal of its radioactive waste. Diagnostic Reagents, Inc., Dearborn, Michigan, EA 96-140. A $1000 civil penalty was assessed for possession of licensed material at an address not authorized on the license and alteration of the street address stated on the license. Evart Products, Evart, Michigan, EA 96-254. A Notice of Violation was issued based on the loss of three polonium-210 static elimination devices. HNU Systems, Inc., Newton Highlands, Massachusetts, EA 96-234. A Confirmatory Order Modifying License was issued based on numerous safety violations indicative of a breakdown in control of licensed activities. Lucent Technologies, Inc., Lee's Summit, Missouri, EA 96-233. A Notice of Violation was issued for providing incomplete and inaccurate information on Form-314 (Certificate of Disposition of Materials), and retaining NRC-licensed material for more than 2 years after the license had been terminated. Nuclear Fuel Services, Inc., Erwin, Tennessee, EA 96-213. A $12,500 civil penalty was assessed based on numerous safety violations indicative of a breakdown in control of licensed activities. (Contact: Joseph DelMedico, OE, 301-415-2739)
Revision to 10 CFR Part 34The revision of Part 34 referenced in the last NMSS Licensee Newsletter had not been published as of January 31, 1997. It is anticipated that the final rule will be published in the Federal Register within the next 2 months. The requirements of the rule become effective 30 days after publication in the Federal Register, but particular requirements of the final rule have been given different implementation dates, to give licensees adequate time to prepare for those changes that could have a major impact on their operations. Details of implementation follow. For use/storage locations not previously identified on the license (e.g., field stations, permanent radiographic installations, and temporary jobsites exceeding 180 days), licensees must request amendments or notify the U.S. Nuclear Regulatory Commission, as appropriate, within 60 days of the effective date of the rule. Few amendment requests are anticipated. Licensees will have 1 year from the effective date of the rule to comply with the additional training requirements specified in 10 CFR 34.43(a) and (b). They should consider combining this training with the annual refresher safety training. Licensees will have 1 year from the effective date of the rule to hire and train individuals to meet the requirements of 10 CFR 34.41(a). All current radiation safety officers (RSOs) will have 2 years to implement the additional RSO training requirements specified in 10 CFR 34.42(a), and to comply with the mandatory certification requirements in 10 CFR 34.43(a)(2). Licensees will have 2 years from the effective date of the rule to affirm that all radiographers have met the certification requirements of 10 CFR 34.43(a)(1). This will allow industrial radiography licensees operating within NRC jurisdiction 2 years to obtain certification for their employees who act as radiographers. Licensees are required within 60 days of the effective date of the rule to develop and implement revised procedures needed to implement the final rule. Procedures requiring submittal to NRC will not need to be submitted until the next license renewal. Changes to 10 CFR 71.101, "Quality assurance requirements," provide that 10 CFR Part 34 licensees are no longer required to apply for separate approval of their quality assurance (QA) program for transport packages, as long as they meet the requirements of 10 CFR 34.31(b), or equivalent Agreement State requirements. Those licensees who already have NRC approval of their QA programs are deemed to have acceptable procedures. Those licensees without prior QA program approvals must develop these procedures before using applicable transport packages. Licensees are expected to implement any necessary procedural changes into their programs within 60 days of the effective date of the rule, but will not need to amend their licenses until the next renewal. Expiration dates of any existing QA program approvals will no longer be valid. (Contact: Donald Nellis, RES, 301-415-6257)
NMSS Licensee Newsletter and Sealed Source and Device Newsletter Now Available on InternetThe NMSS Licensee Newsletter and the Sealed Source and Device Newsletter are now available through the Internet. From outside the U.S. Nuclear Regulatory Commission, the site can be reached at http://www.nrc.gov/NMSS/tc_news/ introa.htm. Alternatively, it can be reached through the NRC Homepage from either the Nuclear Materials or News and Information categories. The site includes the current issue and several preceding issues of each publication and permits a variety of text searches of one or multiple issues of the NMSS Licensee Newsletter. Eventually, all the back issues of the NMSS Licensee Newsletter will appear on the site. (Contact: Paul Goldberg, NMSS, 301-415-7842)
Region II Office MoveThe Region II office will be moving April 24-26 and will be open for business at its new location on April 27. The new address will be: Region II, U.S. Nuclear Regulatory Commission, Atlanta, Federal Center, 61 Forsyth St., S.W. (23-t-85), Atlanta, GA 30303. The new general phone number will be 404-562-4400. The Region's address until the move is 101 Marietta St., Atlanta, GA 30323-2738 and its phone number is 404-331-4503. (Contact: Janice Kirby, Region II, 404-331-6269) Comments, and suggestions you may have for information that is not currently
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