U.S. Nuclear Regulatory Commission (NRC) regulations at 10 CFR Parts 30, 40, 70, and 72 require that a decommissioning plan be submitted by a licensee to support decommissioning of its facility when required by license condition, or if the procedures and activities necessary to carry out the decommissioning have not been approved by NRC and these procedures could increase the potential health and safety impacts on the workers or the public. The objective of the decommissioning plan is to describe the activities and procedures that the licensee intends to undertake to remove residual radioactive material at the facility to levels that meet NRC criteria for release of the site and termination of the radioactive materials license.
The NRC staff is currently developing a Standard Review Plan (SRP) for NRC to use in reviewing and evaluating plans and information submitted by licensees to support the decommissioning of nuclear facilities. When completed, the SRP will enable NRC staff to evaluate information submitted by licensees in a timely, efficient, and consistent manner, to determine if the decommissioning can be conducted such that the public health and safety is protected and the facility can be released in accordance with NRC's requirements.
The NRC staff has several efforts underway to obtain input from interested stakeholders on the issues that will need to be addressed in the SRP. NRC staff has scheduled a series of workshops to discuss the issues associated with reviewing and evaluating decommissioning plans and other information submitted to support decommissioning operations. Workshops have been held on December 1-2, 1998; January 21-22, 1999; March 18-19, 1999; and June 23-24, 1999. Additional workshops will be held on August 18- 19, 1999, and October 20-21, 1999. All the workshops are being held at NRC Headquarters at 11545 Rockville Pike, Rockville, Maryland.
To provide interested stakeholders with the opportunity to review and comment on the draft SRP, the NRC staff has also established a Website at: http://techconf.llnl.gov/cgi-bin/ rulemake?source= rad_cri. The Website may also be accessed by going to the NRC Homepage at: http://www.nrc.gov. Click on the "Radioactive Waste" icon. Click on "Nuclear Facilities Decommissioning." Click on "NRC Standard Review Plan for Decommissioning." This will hyperlink you to the SRP Website.
The staff has posted several draft modules (or chapters) of the SRP on the Website and will accept comments on the draft modules until December 15, 1999. Interested individuals are urged to review and provide comments to the NRC staff before the staff finalizes the SRP. Comments, or questions on the SRP, may be forwarded to Dominick A. Orlando (see below).
(Contact: Dominick A. Orlando, NMSS, 301-415-6749, e-mail: email@example.com. )
During the review of an incident involving a teletherapy unit, it was suspected that if the licensee had followed the maintenance requirements of the manufacturer, the incident might have been prevented. During a routine 5-year inspection, a service technician noted corrosion of an critical component and recommended its replacement. This part later failed, causing the source to become stuck in an unshielded position. Had the licensee replaced the part , as recommended during the last 5-year maintenance inspection, this incident might have been prevented.
In its operators' manual, the teletherapy unit manufacturer recommends weekly service to this component to prevent water vapor from getting into the unit. At this time, it is not clear whether the licensee had been performing this procedure regularly, or whether a failure to do so resulted in the corrosion of the part.
In response to this incident, NRC expects and encourages that maintenance be performed in accordance with the procedures and schedules contained in the users' manual provided by the manufacturer. Furthermore, NRC expects that licensees more closely evaluate the findings and the recommendations of service personnel.
The aforementioned manual has been carefully developed by the manufacturer, based on the manufacturer's experience and knowledge of the design of the product. The manufacturer provides specific procedures unique to a particular unit. In addition, service personnel have had a great deal of experience with the product. Ultimately, it is to the benefit of users that they observe these aforementioned maintenance requirements.
(Contact: Robert Ayres, NMSS, 301-415-5746, e-mail: firstname.lastname@example.org)
Clarification of NRC Generic Letter 99-01, "Recent NMSS Decision Concerning Bundling of Exempt Quantities"
The U.S. Nuclear Regulatory Commission (NRC) was recently asked to provide clarification to Generic Letter 99-01 (GL 99-01). It was pointed out that GL 99-01 did not mention that several companies have been specifically authorized to distribute gauging devices that use combined multiple exempt sources to general licensees. The generic letter, GL 99-01, was sent to our specific licensees to remind them of our exempt licensing requirements and it was also intended to indirectly inform persons exempt from all licensing requirements of our recommendations about devices using combined multiple exempt sources.
The following points from GL 99-01 are restated for clarity:
1) Persons exempt from licensing requirements are not authorized to combine exempt quantity sources nor are they authorized to use devices containing combined multiple exempt quantity sources; and
2) Devices intended for distribution to general or specific licensees, and designed to use combined multiple exempt quantity sources, must first be evaluated and registered with NRC or an Agreement State.
NRC and the State of Kentucky are currently the only regulatory authorities to have specifically licensed the distribution of gauges containing combined multiple exempt quantity sources to general licensees. Keep in mind that general license regulations are distinct from, and should not to be confused with, regulations concerning persons exempt from licensing.
GL 99-01 may be viewed on the NRC internet site at the following address: http://www.nrc.gov/ NRC/GENACT/GC/GL/1999/gl99001.txt
Individual copies may also be obtained from the NRC Public Document Room by writing to: NRC Public Document Room, Gelman Building, 2120 L Street, NW, Washington, DC 20037 or by calling 1-800-397-4209.
(Contact: Anthony S. Kirkwood, NMSS, 301-415-6140, e-mail: email@example.com)
Note that these are only summaries of U.S. Nuclear Regulatory Commission (NRC) 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. The Internet address for the NRC library of generic communications is-- www.nrc.gov/NRC/GENACT/GC/index.html. Please note that this address is case-sensitive and must be entered exactly as shown.
GL 99-01, "RECENT NUCLEAR MATERIAL SAFETY AND SAFEGUARDS DECISION ON BUNDLING EXEMPT QUANTITIES," was issued on May 3, 1999. This letter was issued to all materials licensees to notify them that NRC does not authorize: (a) the bundling of exempt quantities of byproduct material; (b) any program advising persons to combine exempt quantity sources; nor (c) the possession or use of bundled exempt sources, in unregistered devices, by persons exempt from licensing. Contact: Anthony S. Kirkwood, NMSS, 301-415-6140, e-mail: firstname.lastname@example.org.
IN 99-11, "INCIDENTS INVOLVING THE USE OF RADIOACTIVE IODINE-131," was issued on April 16, 1999. This notice was issued to all medical licensees to alert them to recent incidents of unintended radiation doses involving the use of iodine-131. Contact: Jamnes Cameron, RIII, 630-829-9833, e-mail: email@example.com.
IN 99-16, "FEDERAL BUREAU OF INVESTIGATION'S NUCLEAR SITE SECURITY PROGRAM," was issued on May 28, 1999. This notice was issued to all reactor and fuel cycle licensees to advise them of the FBI's Nuclear Site Security Program. Contacts: John Davidson, NMSS, 301-415-8130, e-mail: firstname.lastname@example.org; Robert Skelton, NRR, 301-415-3309, e-mail: email@example.com.
IN 99-18, "UPDATE ON NRC'S YEAR 2000 ACTIVITIES FOR MATERIALS LICENSEES AND FUEL CYCLE LICENSEES AND CERTIFICATE HOLDERS," was issued on June 14, 1999. This notice was issued to all material and fuel cycle licensees to update them regarding NRC's Year 2000 (Y2K) activities and provide sources of Y2K information. Contacts: Gary Purdy, NMSS, 301-415-7897, e-mail: firstname.lastname@example.org; Harry Felsher, NMSS, 301-415-5521, e-mail: email@example.com.
IN 99-20, "CONTINGENCY PLANNING FOR THE YEAR 2000 COMPUTER PROBLEM," was issued on June 25, 1999. This notice was issued to all material and fuel cycle licensees to encourage them to develop Year 2000 contingency plans. Contacts: Gary Purdy, NMSS, 301-415-7897, e-mail: firstname.lastname@example.org; Harry Felsher, NMSS, 301-415-5521, e-mail: email@example.com.
IN 99-22, "10 CFR 34.43(a)(1); EFFECTIVE DATE FOR RADIOGRAPHER CERTIFICATION AND PLANS FOR ENFORCEMENT DISCRETION," was issued on June 25, 1999. This notice was issued to all industrial radiography licensees to remind them of the effective date for new certification requirements, respond to industry concerns about the deadline, and advise them of the Commission's plans for enforcement action to address failures to meet the new regulation. Contacts: J. Bruce Carrico, NMSS, 301-415-7826, e-mail: firstname.lastname@example.org; Nader Mamish, OE, 301-415-2740, e-mail: email@example.com.
(General Contact: Kevin Ramsey, NMSS, 301-415-7887, e-mail: firstname.lastname@example.org)
NOTE: U.S. Nuclear Regulatory Commission (NRC) contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
"Revision of Fee Schedules; 100% Fee Recovery, FY 1999, 64 FR 31448," June 10, 1999. Contact: Glenda Jackson, 301-415-6057, e-mail: email@example.com.
"Miscellaneous Changes to Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste," 64 FR 33178, June 22, 1999. Contact: M. L. Au, 301-415-6181, e-mail: firstname.lastname@example.org.
"Disposal of High-Level Radioactive Wastes in a Proposed Geologic Repository at Yucca Mountain, Nevada, Extension of Comment Period," 64 FR 24092, May 5, 1999. Contacts: Timothy McCartin, 301-415-6681, e-mail: email@example.com; Clark Prichard, 301-415-6203, e-mail: firstname.lastname@example.org.
"Electronic Availability of NRC Public Records and Ending of NRC Local Public Document Room Program," 64 R24531, May 7, 1999. Contact: Russell A. Powell, 301-415-6527, e-mail: email@example.com.
"Receipt of Petition for Rulemaking (PRM-32-5); Metabolic Solutions Inc.," 64 FR 23796, May 4, 1999.
"Notice of Availability of Staff's Safety Evaluation on DOE's Topical Report on the Tritium Production Core (NUREG-1672)," 64 FR 28844, May 27, 1999. Contact: J. H. Wilson, 301-415-1108; e-mail: JHW1@nrc.gov.
"Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses," 64 FR 29721, June 2, 1999. Contact: Sally L. Merchant, 301-415-7874, e-mail: firstname.lastname@example.org.
"Report to Congress on Abnormal Occurrences, Fiscal Year 1998, Dissemination of Information," 64 FR 30551, June 8, 1999.
"Standard Review Plan for the Recertification of the Gaseous Diffusion Plants (NUREG-1671), Reopening of Comment Period," 64 FR 31324, June 10, 1999. Contact: Charles Cox, 301-415-6755, e-mail: email@example.com.
Issuance of Regulatory Guide 8.13, Revision 3, "Instruction Concerning Prenatal Radiation Exposure,'' 64 FR 32899, June 18, 1999.
"Release of Solid Materials at Licensed Facilities; Issues Paper Scoping Process for Environmental Issues and Notice of Public Meetings," 64 FR 35090, June 30, 1999. Contact: Frank Cardile, 301-415-6185, e-mail: FPC@nrc.gov.
(General Contact: Paul Goldberg, NMSS, 301-415-7842, e-mail: firstname.lastname@example.org)
Detailed information regarding these enforcement actions can be accessed via the U.S. Nuclear Regulatory Commission (NRC) homepage [http://www.nrc.gov/]. Click on "Nuclear Materials," then "Enforcement," then "Enforcement Actions Issued." Cases are listed alphabetically. To access the complete enforcement action, click on the highlighted text following the name of the case.
A. Abdulshafi, DAS Consult, Inc., IA 98-058. An Order prohibiting Dr. Abdulshafi's involvement in NRC-licensed activities for 1 year was issued March 31, 1999, based on deliberate transfer of gauges to a person not licensed to receive them.
DAS Consult, Inc., Columbus, Ohio, EA 98-492. A Notice of Violation and Termination of License was issued based on transfer of gauges to a person not licensed to receive them.
Mohamed El Naggar, Diversified Global Enterprise Co., IA 98-065. An Order prohibiting Dr. El Naggar's involvement in NRC-licensed activities for 1 year was issued March 31, 1999, based on deliberate possession of licensed material without an NRC license.
Special Testing Laboratories, Inc., Bethel, Connecticut, EA 98-521. An Order suspending the license was issued because untrained individuals used gauges, dosimetry was not provided, inaccurate statements were made to NRC, and licensed material was used before the NRC license was issued. The Order was subsequently replaced by a Confirmatory Order modifying the license to require that: (1) the President/Radiation Safety Officer be replaced; (2) NRC be notified if the old president attempts to influence the conduct of NRC-licensed activities; (3) the licensee fully cooperates with NRC in providing complete and accurate records; and (4) the licensee obtains independent audits of its radiation safety program.
Dale Todd, Roof Systems Design, Inc., IA 98-066. An Order prohibiting Mr. Todd's Involvement in NRC-licensed activities for 1 year was issued March 31, 1999, because he deliberately possessed licensed material without an NRC license after moving into NRC jurisdiction.
DMS Imaging, Inc., Bemidji, Minnesota, EA 97-189. A $2500 civil penalty was assessed based on: (1) a supervisor deliberately directing a newly hired technologist to conduct nuclear medicine activities before the technologist received the required personnel dosimetry; and (2) the supervisor subsequently directing two technologists to provide inaccurate information to NRC about the issue.
Lee LaRocque, Windham Community Hospital, IA 98-065. An Order prohibiting Mr. LaRocque's involvement in NRC-licensed activities for 1 year was issued February 24, 1999, because he deliberately administered a dose of iodine-131 in excess of that authorized by the hospital's NRC license and created an inaccurate record of that dose.
Washington Hospital Center, Washington, DC, EA 98-555. A $5500 civil penalty was assessed based on loss of control of a nuclear pacemaker.
Randall Allmon, March Metalfab, Inc., IA 98-061. A Confirmatory Order prohibiting Mr. Allmon's involvement in NRC-licensed activities for 5 years was issued January 27, 1999, because he deliberately made inaccurate statements to NRC and prime contractor concerning internal welding of a spent fuel cask.
March Metalfab, Inc., Hayward, California, EA 98-529. A Confirmatory Order prohibiting the company from involvement in NRC-licensed activities for 5 years was issued January 27, 1999, because company employees deliberately made inaccurate statements to NRC and prime contractor concerning internal welding of a spent fuel cask.
Brian Rogers, March Metalfab, Inc., IA 98-062. A Confirmatory Order prohibiting Mr. Rogers' involvement in NRC-licensed activities for 5 years was issued January 27, 1999, because he deliberately made inaccurate statements to NRC and prime contractor concerning internal welding of a spent fuel cask.
NDT Services, Inc., Caguas, Puerto Rico, EA 99-014. An Order was issued to require that the licensee transfer its licensed material to an authorized recipient because the material was not adequately secured.
Marshall Miller & Associates, Bluefield, Virginia, EAs 97-444 and 98-313. Civil penalties totaling $8800 were assessed based on numerous safety and training violations, including failure to secure licensed material and willful failure to maintain complete and accurate records concerning training and radiation surveys.
(Contact: Joseph DelMedico, OE, 301-415-2739; e-mail: email@example.com)
Event 1: Medical Event at Camden-Clark Memorial Hospital, in Parkersburg, West Virginia
Date and Place: September 1, 1998; Camden-Clark Memorial Hospital; Parkersburg, West Virginia.
Nature and Probable Consequences: A patient was administered 340 megabecquerel (MBq) [9.2 millicurie (mCi)] of sodium iodide-131 (I-131) in accordance with licensee procedures for the treatment of hyperthyroidism. However, after the procedure was performed, the licensee determined that the patient was pregnant.
On July 15, 1998, the patient underwent a thyroid uptake and scan study involving the administration of 7.62 MBq (0.206 mCi) of iodine-123. At that time, the patient was interviewed by the licensee's nuclear medicine technologist to ascertain her pregnancy status before the procedure. The patient indicated that she was not pregnant. On August 4, 1998, the patient was seen by one of the licensee's authorized users. As part of the examination, the patient was asked about her pregnancy status and she again indicated that she was not pregnant. The authorized user determined that the patient was a good candidate for I-131 therapy based on the results of the thyroid scan and other tests and prepared a written directive for the administration of 333 MBq (9 mCi) of I-131. The authorized user instructed the patient regarding not becoming pregnant and returning to the hospital on September 1, 1998, for the administration. At the same time, the patient signed a form acknowledging the risks associated with the procedure, as explained by the authorized user, and indicating that she would not become pregnant for 1 year after the procedure. The licensee also confirmed with the patient's referring physician a negative result of a pregnancy test performed on May 5, 1998.
The patient returned to the licensee's facility on September 1, 1998, and was administered 340 MBq (9.2 mCi) of I-131 in accordance with the written directive and other licensee procedures regarding the administration of radiopharmaceuticals. On October 5, 1998, the patient informed the licensee that she recently learned that she was approximately 5 months pregnant; she was subsequently determined to have been 14 weeks pregnant at the time of the administration.
The licensee personnel contacted a pediatric endocrinologist for assistance in calculating the whole body and thyroid dose to the fetus. Using the information provided by the licensee, the dose equivalent to the fetal thyroid and whole body were calculated to be 8800 cGy (8800 rad) and 2.3 cGy (2.3 rad), respectively. The fetus received intra-amniotic thyroid hormone therapy from high-risk pregnancy specialists at a major university hospital.
On October 8, 1998, the licensee notified the patient's referring physician of the event and potential consequences. On October 20, 1998, the licensee notified the U.S. Nuclear Regulatory Commission (NRC) of the event. The NRC medical consultant reviewed the circumstances and evaluated the effects on the fetus and concluded that the hypothyroidism developed in the fetus' thyroid is expected to be permanent. Radiation-induced severe mental retardation would be unlikely and there is no increase in the risk of thyroid carcinoma. The NRC medical consultant further concluded that the risk of leukemia and of other childhood cancers is slightly higher than normal.
Cause or Causes: The cause of the event was not knowing that the patient was pregnant at the time of the administration of the radiopharmaceutical.
Actions Taken to Prevent Recurrence:
Licensee: The licensee is considering professional standards such as the 1996 American College of Radiology's "Standard for the Performance of Therapy with Unsealed Radioactive Sources," which specifies acceptable methods for ruling out pregnancy before the administration of therapeutic doses of radiopharmaceuticals. These include a pregnancy test obtained within 48 hours before administration of the radiopharmaceutical; or documented hysterectomy or tubal ligation; or a post-menopausal condition.
NRC: An inspection was conducted to review the circumstances of the event. No violations of NRC requirements were identified.
Event 2: Therapeutic Radiopharmaceutical Misadministration at Milton Hospital in
Date and Place: July 31, 1998; Milton Hospital; Milton, Massachusetts.
Nature and Possible Consequences: A patient was prescribed and administered a diagnostic dosage of 270.1 megabecquerel (MBq) [7.3 millicurie (mCi)] of technetium-99m (Tc-99m). Later the same patient, because of identification error, was escorted to the treatment area by an authorized user and was also administered a therapy dosage of 318.2 MBq (8.6 mCi) of Iodine-131 that was intended for another patient present in the waiting room. The patient was informed of the error.
Causes or causes: Two factors combined to contribute to this event: (1) primarily, the authorized user failed to follow the established Quality Management Program (QMP) procedures requiring verification of the identity of the patient by more than one method before administering treatment; and (2) the authorized user was the primary care physician for both patients and the physician was not aware that both patients were being tested and evaluated for the same identical condition.
Actions Taken to Prevent Recurrence:
Licensee: The licensee has modified its procedures as follows: (1) the authorized user will review the chart for each therapy patient; (2) each chart will contain a photograph of the patient; (3) each patient will be identified by checking the photo in the chart; (4) before administration of radiopharmaceuticals a wrist band will be given to the identified therapy patient; (5) the authorized user and the technologist will be present during the radiopharmaceutical administration; and (6) the licensee has modified the written directive form for iodine therapy dose to include the modifications made in the procedures.
State Agency: The State investigated this event on September 10 and 11, 1998, and the licensee was issued a Notice of Violation on September 14, 1998, for not following its submitted procedures for radiopharmaceutical therapy as outlined in the QMP. The State acknowledged the action taken by the licensee to prevent recurrence of this incident.
Event 3: Radiopharmaceutical Misadministration at St. Edward Mercy Medical Center in Fort Smith, Arkansas.
Date and Place: December 7, 1998; St. Edward Mercy Medical Center; Fort Smith, Arkansas.
Nature and Probable Consequences: A patient was prescribed a thyroid scan using a 222- megabecquerel (Mbq) [6-millicurie (mCi)] dosage of technetium-99m (Tc-99m) pertecnetate. However, the patient was administered about a 148-MBq (4-mCi) dosage of iodine-131 (I-131).
The Medical Center routinely received unit dosages from a nuclear pharmacy, contained in appropriate-sized syringes ready for injection to patients. However, in this case, instead of a syringe, the dosage was in a glass vial within a large lead container. The shipping package also contained two dispensing straws. The shipping container, the lead pig, and the vial were labeled by the nuclear pharmacy as 222 MBq (6 mCi) of Tc-99m. The Center's staff performed surveys of the incoming package but nobody observed anything unusual. The change in packaging of the Tc-99m dosage, that the licensee had ordered, and the presence of the dispensing straws were attributed by the Center's staff to a mistake made by the nuclear pharmacy. Therefore, the oral solution of the I-131 dosage, mislabeled as Tc-99m, was drawn up in a syringe and was injected into the patient.
The Center's medical physicist determined that the dose to the patient's thyroid, based on the radiopharmaceutical manufacturer's package insert, was about 4800 cGy (4800 rad). The patient was notified by the licensee's Radiation Safety Officer (RSO) of the misadministration. The patient's attending physician was also notified of the circumstances and possible complications. The RSO advised the patient to continue long-term follow-up with the primary care physician.
Cause or causes: This event was a result of a mislabeled radiopharmaceutical dosage by the nuclear pharmacy. Also, it appears that the Medical Center's nuclear medicine staff did not question nor address the unusual package, on receipt.
Licensee: The licensee reported this event to the Arkansas Department of Health on December 7, 1998, and a written report was submitted on December 8, 1998. The Center's management revised the policy and procedure for the receipt of radiopharmaceuticals from the nuclear pharmacy. The revision states that only I-131 radioactive dosages will be accepted in glass vials. Any suspect or other labeled isotope received in glass vials will be questioned or returned to the pharmacy for isotope verification. The nuclear pharmacy indicated that policies and procedures for the dispensing of radiopharmaceutical therapy products have been revised to prevent recurrence of similar incidents.
State Agency: The State staff performed an onsite investigation at the Medical Center and the nuclear pharmacy on December 8, 1998. The investigation identified violations associated with license conditions and regulations for activities conducted at the nuclear pharmacy.
(Contact: Gary Purdy, NMSS, 301-415-7897, e-mail: firstname.lastname@example.org)
In January 1997 and March 1998, respectively, the Nuclear Regulatory Commission (NRC) staff issued its "Standard Review Plan (SRP) for Dry Cask Storage Systems," NUREG-1536, and the draft "Standard Review Plan for Transportation Packages for Spent Nuclear Fuel" (NUREG- 1617). These SRPs provide guidance, to the NRC staff in the Spent Fuel Storage Project Office (SFPO), for performing safety reviews of dry cask storage systems. The SRPs are intended to ensure the quality and uniformity of the staff reviews. They present a basis for the technical review scope and the staff's acceptance criteria.
As the SFPO staff has gained experience in using the SRPs in the review of dry cask storage and transportation applications, it has found areas in which the SRPs can be improved to include new methodologies that the staff find acceptable and areas that require additional clarification. In these cases, SFPO management has issued interim staff guidance (ISG) to ensure consistent staff reviews until the guidance can be incorporated into the next revision of the applicable SRP.
On May 21, 1999, SFPO issued ISGs on five new topics as well as revisions to ISG-4 and ISG-5, which were previously issued October 1998. To ease public access to the ISGs, all ISGs previously issued by SFPO were re-issued in the May memorandum. The revised and new ISGs included the following topics:
The ISGs are available in the Public Document Room as well as on the NRC/SFPO website.
(Contact: Eric Leeds, NMSS, 301-415-8540, e-mail: email@example.com)
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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