NMSS Licensee Newsletter December 1997 - January 1998
NUREG/BR-0117; No. 97-4 Draft Guidance on Sealed Source and Device Safety Evaluations Draft Guidance on Fixed Gauge Licenses Draft Guidance on Self-Shielded Irradiators Final Rules Proposed Rules Other Notices Measuring Gauges Medical Other Materials Licensees Radiography
DOE/NRC November 21, 1997, Memorandum of Understanding
On November 21, 1997, a Memorandum of Understanding was signed between the U.S. Department of Energy (DOE) and the U.S. Nuclear Regulatory Commission, establishing a framework for a pilot program, to support a joint recommendation, by DOE and NRC, to Congress, on whether NRC should be given statutory authority to regulate nuclear safety at certain DOE nuclear facilities. During this pilot program, NRC will "simulate regulation" at between 6 and 10 DOE facilities over the next 2 years, to gain experience and provide a better opportunity to develop actual costs of external regulation. The first three pilot sites to be completed over the next year are:
- E.O. Lawrence Berkeley National Laboratory,
- Oak Ridge National Laboratory Radiochemical Engineering Development Center, and
- Savannah River Site Spent Fuel Facility.
This simulated regulation will allow NRC to test regulatory concepts and evaluate a facility and its standards, requirements, procedures, practices, and activities against standards that NRC believes would be appropriate to ensure safety. Simulated regulation will include NRC inspections of each pilot facility, to identify issues related to implementation. The inspections will review coverage by NRC and State regulations, to assess radiological operations, including accelerators, waste management, environmental monitoring, and decontamination and decommissioning. The NRC inspections will not result in enforcement actions to compel compliance with particular standards or requirements. DOE will retain responsibility for the safety of the facilities. Significant inspection findings that impact health and safety will be forwarded to the appropriate DOE organization for review.
Implementation details for each pilot facility are being negotiated by NRC, DOE, and the facility contractors, through the development of a site-specific work plan. The Berkeley work plan has been completed and on-site reviews have begun on that pilot project. The MOU also provides for involving the public and other stakeholders in the pilot program and in the decision on whether to seek external regulation. At the end of the 2 years, DOE and NRC will determine whether to seek legislation to give NRC authority to regulate individuals or classes of DOE nuclear facilities.
(Contact: Linda Suttora, NMSS, 301-415-6858)
Revision to 10 CFR PART 35
In the Federal Register notice dated October 14, 1997 (62 FR 53249), the U.S. Nuclear Regulatory Commission published a notice of facilitated public workshops on the comprehensive revision of NRC regulations governing the medical use of byproduct material in 10 CFR Part 35. The workshops focused primarily on alternatives for significant regulatory issues developed by the Part 35 Working and Steering Groups. Public workshops were held in Philadelphia, Pennsylvania, on October 28, 29, and 30, 1997, and in Chicago, Illinois, on November 12, 13, and 14, 1997.
Invited participants from a broad spectrum of areas affected by the proposed revision were present. These areas included nuclear medicine, endocrinology, radiology, radiopharmacy, medical education, medical physics, radiation technology, nursing, hospital administration, patients' rights, and State government. After an overview of the current regulatory framework and the Commission's directions for revising Part 35, Dr. Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards, led an introductory discussion on risk assessment. The rest of the meeting focused on discussions of the 1979 NRC Medical Policy Statement and the cross-cutting regulatory issues: the Radiation Safety Committee, the Quality Management Program, the Threshold for Reportable Events, Patient Notification, and Training and Experience. Currently, the staff is drafting the proposed rule text and guidance, as well as other documents associated with the rulemaking. The complete rulemaking package, associated documents, and recommendations on the Medical Policy Statement are scheduled to be forwarded for Commission review in May 1998.
The NRC Web site contains a wide variety of information, including news releases, transcripts of Commission meetings, issues affecting the different NRC program offices, and recently published office documents. In addition, a specific site (http://techconf.llnl. gov/noframe.html) has been established on NRC's technical conference forum, to facilitate public input on the cross-cutting issues and the draft proposed rule. Background material and transcripts of the Part 35 workshops are also available on this site.
Public input is solicited during the development of the proposed rule, but, to be most helpful, should be received by March 1, 1998. Comments received after this date will be considered if it is practical to do so, but the Commission only is able to ensure consideration of comments received on or before this date. Written input and suggestions can be sent to Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Hand-deliver comments to 11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on Federal workdays.
(Contact: Catherine Haney, NMSS, 301-415-6825)
Consolidating and Updating Materials Licensing Guidance (Update)
As part of its project to consolidate and update materials licensing guidance, the Nuclear Regulatory Commission has issued the following three draft documents for comment:
Draft Guidance on Sealed Source and Device Safety Evaluations
On November 6, 1997 (62 FR 60111), the Nuclear Regulatory Commission announced the availability of and requested comment on draft NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration," dated September 1997.
The guidance NUREG is intended for use by applicants, licensees, registration certificate holders, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in draft Regulatory Guides 10.10, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material," and Regulatory Guide 10.11, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material," and guidance for persons reviewing such applications found in NUREG-1550, "Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations." In addition, this draft report also contains information found in pertinent Policy and Guidance Directives, Technical Assistance Requests, and Information Notices.
Please submit comments by December 17, 1997. Comments received after that time will be considered if practicable. Address written comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand-deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to firstname.lastname@example.org.
A free single copy of draft NUREG-1556, Volume 3, may be obtained by writing to the U.S. Nuclear Regulatory Commission, ATTN: John W. Lubinski, Mail Stop TWFN 8F5, Washington, DC 20555-0001. Alternatively, submit requests through the Internet by addressing electronic mail to email@example.com. A copy of draft NUREG-1556, Volume 3, is also available for inspection and/or copying for a fee in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. The document is also available electronically by visiting NRC's Home Page.
(Contact: John W. Lubinski, NMSS, 301-415-7868; e-mail: firstname.lastname@example.org)
Draft Guidance on Fixed Gauge Licenses
In December 1997, NRC announced the availability of and requested comment on draft NUREG-1556, Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauge Licenses," dated October 1997.
The guidance NUREG is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in Draft Regulatory Guide and Value/Impact Statement, FC 404-4, "Guide for the Preparation of Applications for Licenses for the Use of Sealed Sources in Nonportable Gauging Devices," dated January 1985, and the guidance for licensing staff previously found in Policy and Guidance Directive, FC 85-4, "Standard Review Plan for Applications for the Use of Sealed Sources in Nonportable Gauging Devices," dated February 6, 1985, and Policy and Guidance Directive, FC 85-8, Revision 1, "Licensing of Fixed Gauges and Similar Devices," dated June 29, 1988. In addition, this draft report also contains pertinent information found in Technical Assistance Requests and Information Notices.
Please submit comments by March 20, 1998. Comments received after that time will be considered if practicable. Address written comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand-deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to email@example.com.
A free single copy of draft NUREG-1556, Volume 4, may be obtained by writing to the U.S. Nuclear Regulatory Commission, ATTN: Sally L. Merchant, Mail Stop TWFN 8F5, Washington, DC 20555-0001. Alternatively, submit requests through the Internet by addressing electronic mail to firstname.lastname@example.org. A copy of draft NUREG-1556, Volume 4, is also available for inspection and/or copying for a fee in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
(Contact: Sally L. Merchant, NMSS, 301-415-7874; e-mail: email@example.com)
Draft Guidance on Self-Shielded Irradiators
In December 1997, NRC announced the availability of and requested comment on draft NUREG-1556, Vol. 5, "Program-Specific Guidance about Self-Shielded Irradiator Licenses," dated October 1997.
The guidance NUREG is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in Regulatory Guide 10.9, "Guide for the Preparation of Applications for Licenses for the Use of Self-Contained Dry Source-Storage Gamma Irradiators," dated December 1988, and the guidance for licensing staff previously found in Policy and Guidance Directive, FC 84-16, Revision 1, "Standard Review Plan for Applications for Use of Self-Contained Dry Source-Storage Gamma Irradiators," dated January 26, 1989. In addition, this draft report also contains information found in pertinent Technical Assistance Requests and Information Notices.
Please submit comments by March 20, 1998. Comments received after that time will be considered, if practicable. Address written comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Hand-deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 7:15 a.m. and 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to firstname.lastname@example.org.
A free single copy of draft NUREG-1556, Volume 5, may be obtained by writing to the U.S. Nuclear Regulatory Commission, ATTN: Patricia C. Vacca, Mail Stop TWFN 8F5, Washington, DC 20555-0001. Alternatively, submit requests through the Internet by addressing electronic mail to email@example.com. A copy of draft NUREG-1556, Volume 5, is also available for inspection and/or copying for a fee in the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
(Contact: Pat C. Vacca, NMSS, 301-415-7908; e-mail: firstname.lastname@example.org.)
NRC And EPA Publish Joint Guidance on Mixed Waste Testing
On November 20, 1997, the U.S. Nuclear Regulatory Commission and the Environmental Protection Agency (EPA) published final guidance on the testing requirements for mixed radioactive and hazardous waste (mixed waste) in the Federal Register (62 FR 62079, November 20, 1997). Mixed waste is defined as hazardous waste that also contains source, special nuclear, or byproduct material. Because mixed waste contains both hazardous waste and radioactive material subject to regulation under the Atomic Energy Act, it is regulated by NRC, or an NRC Agreement State, as well as EPA, or an EPA authorized State. In the past, mixed waste generators have expressed concerns that EPA's testing requirements for the hazardous component of mixed waste could result in increased radiation exposures.
Publication of the guidance is the culmination of a multi-year effort by the agencies to provide mixed waste managers with practical methods for complying with the regulatory requirements of NRC and EPA. The guidance emphasizes the use of process knowledge, whenever possible, to determine if a waste is hazardous, as a way to avoid unnecessary exposures to radioactivity. The guidance also provides guidelines for generators wishing to rely on process knowledge as the basis for evaluating their waste.
The guidance offers two strategies for helping to maintain radiation exposures as low as is reasonably achievable, if testing is required. These strategies are the use of a sample size of less than 100 grams, as long as the resulting test is sufficiently sensitive to measure the constituents of interest at the regulatory levels prescribed in the TCLP, and the use of surrogate materials, as long as they are chemically identical to the mixed waste and faithfully represent the hazardous constituents in the waste mixture.
The guidance also discusses other allowable sampling and testing procedures, such as representative drum sampling, or sampling from drums containing lower concentrations of radioactive material, as long as the chemical contents are identical to those found in the drums with higher concentrations of radioactive material.
(Contacts: Dominick A. Orlando, NMSS, NRC, 301-415-6749; or Newman Smith, Permits and State Programs Division, Office of Solid Waste, EPA, 703-308-8757)
NRC Posts Strategic Plan on Internet Home Page
The U.S. Nuclear Regulatory Commission has posted its strategic plan on the Agency's Internet home page.
The plan contains goals to carry out NRC's mission, and strategies to meet those goals. It will serve as a comprehensive blueprint for the Agency's program and budget planning and a guide to daily management and decision- making. The plan was provided to Congress and the Office of Management and Budget in September 1997.
The assessment and rebaselining process provides a foundation for the Agency's direction and decision-making for the rest of this decade and into the future. During the process of strategic assessment, the staff developed direction-setting issues for Commission consideration. Before reaching final decisions on those issues, the Commission had the benefit of comments from members of the public and other stakeholders--those who would be most affected by those decisions--elicited at conferences around the country and from reactions to what was posted on NRC's web site.
In addition to its availability on the web page, and at the Agency's Public Document Room, 2120 L Street, NW., Washington, DC, copies of the strategic plan (NUREG-1614, Vol. 1), are available for purchase from the Government Printing Office, at 202-512-1800.
(Contact: Paul Goldberg, NMSS, 301-415-7842)
Selected Federal Register Notices
September 1, 1997--November 30, 1997
Note: Contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
"Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea," 62 FR 63634, December 2, 1997.
(Contact: Dr. Anthony N. Tse, 301-415-6233)
"License Applications for Certain Items Containing Byproduct Material," 62 FR 49173, September 19, 1997.
(Contact: Mary L. Thomas, 301-415-6230)
"License Applications for Certain Items Containing Byproduct Material: Correction," 62 FR 51817, October 3, 1997.
(Contact: Mary L. Thomas, 301-415-6230)
"Procedures Applicable to Proceedings for the Issuance of Licenses for the Receipt of High-Level Radioactive Wastes at a Geologic Repository," 62 FR 60789, November 13, 1997.
(Contact: Kathryn L. Winsberg, 301-415-1641: e-mail email@example.com)
"Statement of Principles and Policy for the Agreement State Program: Policy Statement on Adequacy and Compatibility of Agreement State Programs," 62 FR 46517, September 3, 1997.
(Contact: Cardelia Maupin, Office of State Programs, 301-415-2312)
Availability of NUREG-1601, "Chemical Process Safety at Fuel Cycle Facilities," 62 FR 46525, September 3, 1997.
(Contact: Dr. Lidia Roche, 301-415-7830)
Issuance and Availability of Regulatory Guide 3.70, "Use of Fixed Neutron Absorbers at Fuel and Materials Facilities," 62 FR 47232, September 8, 1997.
"Policy and Procedure for Enforcement Actions; Enforcement Conference Procedures" (NUREG-1600), 62 FR 52577, October 8, 1997.
(Contact: James Lieberman, 301-415-2741)
Issuance and Availability of Draft Regulatory Guide DG-3010, "Spent Fuel Heat Generation in an Independent Spent Fuel Storage Installation," 62 FR 52599, October 8, 1997.
Evaluation of Agreement State Radiation Control Programs, 62 FR 53839, October 16, 1997.
(Contact: Kathleen N. Schneider, 301-415-2320)
Availability of "Draft Standard Review Plan for In-Situ Uranium Extraction License Applications" (NUREG-1569), 62 FR 54885, October 22, 1997.
(Contact: Joseph J. Holonich, 301-415-7238)
Issuance and Availability of Regulatory Guide 5.44, Rev. 3, "Perimeter Intrusion Alarm Systems," 62 FR 55659, October 27, 1997.
"Memorandum of Understanding Between the Nuclear Regulatory Commission and the Department of Energy on Cooperation Regarding the Gaseous Diffusion Plants," 62 FR 59910, November 5, 1997.
(Contact: Robert Pierson, 301-415-7192)
"Consolidated Guidance About Materials Licensees: Applications for Sealed Source and Device Evaluation and Registration," Availability of Draft NUREG-1556, Vol. 3, 62 FR 60111, November 6, 1997.
(Contact: John Lubinski, 301-415-7868, e-mail: firstname.lastname@example.org)
"Joint NRC/EPA Guidance on Testing Requirements for Mixed Radioactive and Hazardous Waste," 62 FR 62079, November 20, 1997.
(Contacts: Dominick Orlando, 301-415-6749 or Newman Smith [EPA] 703-308-8757)
"Management of Radioactive Material Safety Programs at Medical Facilities," Availability of NUREG-1516, 62 FR 62648, November 24, 1997.
(Contact: Suzanne Woods, 301-415-7267)
"Chromalloy, Tallahassee; Receipt of Petition for Rulemaking to Exempt Nickel-Thorium Components from Licensing," 62 FR 65039, December 10, 1997.
(Contact: David L. Meyer, 301-415-7162, or Toll-Free: 800-368-5642)
"Standard Review Plan for Transportation Packages for Radioactive Material; Notice of Issuance and Availability," 62 FR 65825, December 16, 1997.
(Contact: Cass R. Chappell, 301-415-8510)
"State of New Mexico Relinquishment of Sealed Source and Device Evaluation and Approval Authority and Reassumption by the Commission," 62 FR 66702, December 19, 1997. (Contact: Cardelia Maupin, 301-415-2312, Internet: email@example.com)
"Issuance and Availability of NUREG-1556, Vols. 4 and 5," 62 FR 67100, December 23, 1997. (See article on Guidance Consolidation above.)
(General Contact: Paul Goldberg, 301-415-7842, e-mail firstname.lastname@example.org)
Significant Enforcement Actions
Detailed information regarding these enforcement actions can be accessed via the Nuclear Regulatory Commission homepage. Click on "Nuclear Materials," "Enforcement," and finally "Enforcement Actions Issued." Cases are listed alphabetically. For details, click on the highlighted text following each case.
H. H. Holmes Testing Laboratories, Wheeling, IL, EA 97-237. A $2500 civil penalty was assessed for willful failure to file NRC Form-241 before conducting work in non-Agreement States.
Grand View Hospital, Sellersville, PA, EA 97-309. A $4400 civil penalty was assessed for shipment of a package with excess removable radioactive contamination.
Overlook Hospital, Summit, New Jersey, EA 97-246. A $2750 civil penalty was assessed for failure to prepare a written directive and failure to provide instruction in the medical quality management program.
St. Mary's Hospital of Blue Springs, Blue Springs, MO, EA 97-234. A $2500 civil penalty was assessed for careless disregard in failing to perform surveys and dose calibrator tests.
Other Materials Licensees
Apgee Corporation, Alquippa, Pennsylvania, EA 96-246. A Confirmatory Order Modifying License was issued because Apgee had distributed several devices that did not conform to the NRC Sealed Source and Device Registry Certificate.
Cartier, Inc., Shelton, CT, EA 97-145. A $7500 civil penalty was assessed for distribution of timepieces containing tritium, without an NRC license.
Envirocare of Utah, Inc., Salt Lake City, Utah, EA 97-303. A Confirmatory Order was issued because Envirocare possessed special nuclear material in excess of the NRC-exempt limit.
U.S. Army Tank--Automotive and Armaments Command, Rock Island, Illinois, EA 97-059. A confirmatory Order Modifying License was issued based on extensive loss of control of licensed material and other issues.
Krishna Kumar, IA 97-011. An Order Prohibiting Involvement in NRC-Licensed Activities for 10 years was issued based on deliberate inaccurate information and deliberate misconduct.
James Mulkey, IA 97-012. An Order Prohibiting Involvement in NRC-Licensed Activities for 5 years was issued based on deliberate inaccurate information.
Derek Stephens, IA 97-008. A Confirmatory Order Prohibiting Involvement in NRC- Licensed Activities for 3 years was issued based on deliberate failures to wear dosimetry and supervise an assistant.
(Contact: Joseph DelMedico, OE, 301-415-2739: e-mail: email@example.com)
1. Nuclear Regulatory Commission Licensees
97-3 Overexposure of a Worker at Mallinckrodt, Inc., in Maryland Heights, Missouri
Date and Place--May 14-15, 1997; Mallinckrodt, Inc.; Maryland Heights, Missouri.
Nature and Probable Consequences--On May 14, 1997, an employee was removing radioactive waste from the hot cell where rhenium-186 (Re-186) was used. The employee was performing this task manually, using gloves, instead of remotely. When he left the area, he attempted to perform a personal contamination survey, but the survey meter immediately went off the scale. He assumed that the high count rate was caused by background radiation from an adjacent radioactive material transport cart and, subsequently, forgot to resurvey himself in a low background area before he left the facility that evening. On arrival at work the next day, he was told that his urine sample, which he had submitted before going home the previous night, indicated radiation contamination, and that he was restricted from working with radioactive material. At that time, he performed a personal contamination survey and detected significant levels of contamination on his left thumb.
The licensee estimates that the individual received a shallow-dose equivalent of 6090 millisievert (609 rems) to an area of about 0.75 square centimeters (0.12 square inches) on the palm side of the thumb of his left hand. Lower levels of contamination were found on the back of his right hand and fingers. On May 15, 1997, the employee had undergone decontamination to the extent that only approximately 4 percent of the activity remained.
The licensee surveyed the offsite locations where the employee had been after leaving work on May 14, 1997. Low levels of Re-186 contamination were found on three locations inside the employee's vehicle and on various items in the bathroom and kitchen of his home. The employee's vehicle and home were decontaminated. The employee was examined by a physician who identified no immediate health effects. However, according to a report from an NRC consultant, a small possibility exists that localized skin cancer may develop.
Cause or Causes--The cause of the event was a procedural deficiency in handling waste from the Re-186 hot cell. Normally, radioactive waste in other hot cells at the facility was handled with remote tools. However, in this case, procedural controls did not require remote handling of the waste. Once the employee completed the work, poor radiation work practices were exhibited as he cross- contaminated his hands when he removed his gloves. In addition, the worker did not investigate the detection of high count rates during his first attempt to perform a contamination survey.
Actions Taken to Prevent Recurrence
Licensee--The staff was instructed on the importance of conducting proper personal contamination surveys and the proper use of protective clothing. The use of Re-186 was suspended until improvements to existing waste disposal procedures could be evaluated and implemented. Plans were made: (1) to compile all existing contamination protection procedures into one contamination-protection procedure; (2) to evaluate the use of a portal-type monitoring system; and (3) to post personal-monitoring reminder signs at all laboratory exits.
NRC--NRC conducted a special safety inspection, and appropriate enforcement action will be taken.
2. Agreement State Licensees
1. AS 97-1 Multiple Transuranic Overexposures to a Worker at Isotope Products Laboratories in Burbank, California
Date and Place--Between January 1 and December 31, 1995; Isotope Products Laboratories; Burbank, California.
Nature and Probable Consequences--A radiochemist was assigned to make transuranic and other types of sources. The transuranics used included the isotopes of plutonium-238 (Pu-238); Pu-239; Pu-240; americium-241 (Am-241); and curium-244 (Cm-244). During January 1995, while making a Cm-244 source, it was discovered that the exhaust fan of the fume hood where the source was being fabricated was not working. An analysis of room air samples confirmed the loss of Cm-244 into the working area.
Bioassay results disclosed that the fecal and urine samples provided by the radiochemist contained Cm-244 and Am-241. The licensee hired dosimetry and radiation protection consultants as directed by the State Agency. Careful analysis of the bioassay data by these consultants, which included dose summation and retrospective time correction for various intakes, suggested that during 1995 the radiochemist received a total effective dose equivalent of 383.20 mSv (38.32 rems) and a committed dose equivalent of 6900 mSv (690 rems) to the bone surfaces. The specific exposures were as follows: (1) committed effective dose equivalent of 271.8 mSv (27.18 rems) from Cm-244; (2) committed effective dose equivalent of 80 mSv (8 rems) from Am-241; (3) committed effective dose equivalent of 4.4 mSv (0.44 rems) from Pu-238, Pu-239, and Pu-240; and (4) deep dose equivalent of 27.0 mSv (2.70 rems) from external radiation.
The State Agency discovered this incident during a routine inspection on December 5, 1995. During a follow-up inspection, the State Agency learned that another Cm-244 incident took place and was significant. The State Agency also learned of other exposure incidents that indicated the licensee had a deficient contamination control program, an inability to conduct internal dose assessments, and inadequate management oversight.
Cause or Causes--The licensee's radiation protection program was inadequate and lacked important elements needed to ensure the radiation safety of its workers. Some of these inadequacies were the lacks of: (1) work permits; (2) glove boxes for certain types of work; and (3) radiation procedural controls.
Actions Taken to Prevent Recurrence
Licensee--After the licensee's consultants conducted their review and comprehensive audit of the existing radiation protection program, they made recommendations to ensure future compliance with the license and regulations. The licensee hired a competent radiation safety officer, and the radiochemist was assigned duties that did not involve the handling nor processing of radioactive materials.
State Agency--The State Agency completed its investigation and is committed to closely tracking the licensee's radiation protection program to ensure continued compliance.
2. AS 97-2 Overexposure of a Radiographer and an Untrained Technician at Wolf Creek Mine in Walker County, Alabama
Date and Place--July 1, 1996; Wolf Creek Mine; Walker County, Alabama
Nature and Probable Consequences--A radiographer employed by Certified Testing and Inspection of Cottondale, Alabama, and a technician employed by Ultron, Inc., of Mt. Vernon, Illinois, were performing industrial radiography at the Wolf Creek Mine in Walker County, Alabama, when they became so distracted by problems with excessively exposed film that they forgot they had an exposure in progress and entered the high radiation area without making a survey and changed the film with the source in the unshielded exposed position. The radiographer had received prior radiation safety training: however, the technician, an employee of Ultron, Inc., had not received prior radiation safety training. The radiography film and the device used to support the source and the film during exposures were being supplied to the radiographer by Ultron, Inc.
Consequently, both individuals received unintended radiation exposure. The State Agency estimated that the radiographer received a dose of 530 millisievert (mSv) (53 rems) to his head and 48 mSv (4.8 rems) to the center of his body. The Ultron, Inc., technician received a dose of 110 mSv (11 rems) to his head and 28 mSv (2.8 rems) to the center of his body. Neither individual reported any acute radiation symptoms.
The radiography film supplied by Ultron, Inc., had faster and different exposure characteristics than the film usually used by Certified Testing and thus was being overexposed during processing in the darkroom. The darkroom, which was supplied by Certified Testing, used a homemade "safe light," which had been made a safe light by the application of red spray paint. The radiographer did not realize beforehand that the light would not be "safe" for the film supplied by Ultron, Inc.
Cause or Causes--The radiographer entered a designated high radiation area with his alarm ratemeter turned off and without following his normal practice of cranking in the source and surveying the guide tube and camera. The radiographer interpreted the silence from the alarm ratemeter as an indication of safe conditions. Unfortunately, when turned off, the alarm ratemeter gives the same indication as it does when indicating safe conditions. In addition, the radiographer did not use a collimator to reduce the exposure to himself and the Ultron, Inc., technician.
Actions Taken to Prevent Recurrence
Licensee--The licensee stated that the radiographer did not develop any symptom of acute radiation exposure and that its personnel were reinstructed in the importance of performing surveys and using a collimator. The licensee committed to the State Agency to verify the training of all technicians, including those of the company that hires the licensee to perform radiography.
State Agency--The State Agency cited the licensee for the following four violations: (1) excessive exposure to a radiation worker; (2) excessive exposure to a member of the public (the Ultron, Inc., technician representative); (3) failure to prevent unauthorized entry into the High Radiation Area; and (4) failure to exercise the philosophy of as low as is reasonable achievable, by using a collimator. A civil penalty was considered, but not imposed. The State Agency recommended that both individuals contact the State and seek medical attention if any symptoms of acute exposure should appear.
3. AS 97-3 Radiopharmaceutical Misadministration at Mad River Community Hospital in Arcata, California
Date and Place--February 28, 1996; Mad River Community Hospital; Arcata, California.
Nature and Probable Consequences--A patient was prescribed a dosage of 3.7 megabecquerel (MBq) (0.1 millicurie [mCi]) of iodine-131 (I-131) for a thyroid scan and uptake procedure. However, the patient was administered a dosage of 262.7 MBq (7.1 mCi) of I-131. As a result, the patient's thyroid received a dose of about 9100 centigray (cGy) (9100 rads), instead of the prescribed dose of 130 cGy (130 rads).
The licensee stated that such a dose may induce a hypothyroid state requiring the patient to take thyroid hormone.
Cause or Causes--The wrong dosage was administered on the assumption that the patient was prescribed a whole body thyroid scan for a cancer metastatic disease evaluation.
Actions Taken to Prevent Recurrence
Licensee--Procedures for scheduling a whole body scan for thyroid cancer metastases were revised to include a detailed patient preparation and history. The revised procedures required that the approving radiologist sign the I-131 administration policy before ordering a radiopharmaceutical. In addition, the nuclear medicine technologist attended a continuing education program at San Francisco General Hospital, which included a segment on the effects of studies involving therapy dosages.
State Agency--The State Agency conducted numerous follow-up inspections to ensure that the licensee's actions taken to prevent recurrence had been implemented.
4. AS 97-4 Radiopharmaceutical Misadministration at Tuomey Regional Medical Center in Sumter, South Carolina
Date and Place--December 11, 1996; Tuomey Regional Medical Center; Sumter, South Carolina.
Nature and Probable Consequences--A patient was prescribed a dosage of 74 megabecquerel (MBq) (2.0 millicurie [mCi]) of iodine-131 (I-131) for a treatment of Graves disease. However, the patient was administered a 388.5 MBq (10.5 mCi) dosage of I-131. As a result, the patient's thyroid received a dose of 40,400 centigray (cGy) (40,400 rads) instead of the prescribed dose of 7700 cGy (7700 rads).
The licensee stated that the administered dose of I-131 to the patient's thyroid is not expected to have major health effects.
Cause or Causes--The wrong dosage was administered to the patient because the written order for the I-131 procedure was misread by the administering technologist.
Actions Taken to Prevent Recurrence
Licensee--The licensee will have the written order on hand before ordering radiopharmaceuticals from the pharmacy and will have a second person verify the dosage before administration to the patient.
State Agency--The State Agency accepted the licensee's report and corrective action as appropriate. No further action was requested.
(General Contact: Harriet Karagiannis, 301-415-6377)
Comments, and suggestions you may have for information that is not currently being included, that might be helpful to licensees, should be sent to:
NMSS Licensee Newsletter Editor
Office of Nuclear Material Safety
Two White Flint North, Mail Stop 8-A-23
U.S. Nuclear Regulatory Commission
Washington, D.C. 20555-0001
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