NMSS Licensee Newsletter September 1996 - October 1996
NUREG/BR-0117; No. 96-3
- What's New in BPR?
- Directions to NRC Offices
- Notifying NRC of Bankruptcy
- Mo-99/Tc-99m Generator Transportation Problems
- Annual Reports of Dose to Workers; 10 CFR 19.13(b)
- Major Revision of Part 34 Involving Industrial Radiography Licensing, Safety, And Operations
- Human Error During Brachytherapy
- Strontium-90 Eye Applicators
- NUREG/CR-6345 "Radiation Dose Estimates For Radiopharmaceuticals."
- Specific Domestic License of Broad Scope For Byproduct Material - Advance Notice of Proposed Rulemaking
- Transportation Requirements For Broad-Scope Licensees
- Generic Communications Issued
- Selected Communications Issued
- Significant Enforcement Actions
- Measuring Gauges
What's New in BPR?
Internet Web Site
The Business Process Redesign (BPR) team has created an internal developmental Internet Web site, for testing purposes, reachable at the following URL: http://nmss26. As written products are developed, they are made available for external access through links from the U.S. Nuclear Regulatory Commission homepage. Members of the public can access this information directly through the following URL: http://www.nrc.gov/NMSS/BPR/index.html.
These Web sites contain documents of interest (e.g., all information notices sent to Nuclear Material Safety and Safeguards licensees and applicants since 1979, draft and final NUREGs, etc.) to materials licensees and applicants, Agreement States, staff, and the public. The site also functions as a central point for the posting of guidance documents currently out for public comment. For example, NUREG-1539 ("Methodology and Findings of the NRC's Materials Licensing Process and Redesign") and draft NUREG-1541("Process and Design for Consolidating and Updating Materials Licensing Guidance"), which were published in final and draft form, respectively, are available in their entirety. The team's latest document, draft NUREG-1556, Vol. 1, is discussed in more detail below and should also be available by the time you read this.
This segment of the BPR project is subject to fairly rapid changes that parallel the changes in Internet technology. Making regular visits to the Web site should provide you with the opportunity to take advantage of the information features/content.
New Draft Guidance: Portable Gauge Licenses
Volume 1 of draft NUREG-1556, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Portable Gauge Licenses," is the first program-specific guidance developed for the new materials licensing process and may serve as a template for subsequent program-specific guidance. It is intended for use by applicants, licensees, and staff. It combines the guidance now found in Draft Regulatory Guide DG- 0008, "Applications for the Use of Sealed Sources in Portable Gauging Devices," dated May 1995, and the guidance for licensing staff now found in Policy and Guidance Directive PG 2-07, "Standard Review Plan for Applications for the Use of Sealed Sources in Portable Gauging Devices," dated September 1994. Comments received on DG-0008 were considered in the preparation of this report.
This document is strictly for public comment and NOT for use in preparation or review of applications for portable gauge licenses until the document is published in final form.
NRC is requesting comments, on this draft NUREG, such as whether a risk-informed, performance-based approach to licensing is valid, as well as comments on the information requested in support of a license application. In addition, to support NRC's efforts to streamline the materials licensing process, NRC is soliciting comments and suggestions about the document's content, format, usefulness, etc., to make the document more "user-friendly."
NRC sent copies of draft NUREG-1556, Vol. 1, to each of its portable gauge licensees. Other ways of obtaining the document are as follows. For a free single copy of draft NUREG-1556, Volume 1, write to the U.S. Nuclear Regulatory Commission, ATTN: BPR Team, Mail Stop TWFN 8F5, Washington, DC 20555-0001. For an electronic version, see the previous discussion of the Internet Web site.
Please submit comments by January 15, 1997. Comments received after that time will be considered if practicable. Address written comments on draft NUREG-1556, Volume 1, to the Chief, Rules Review and Directives Branch, U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Comments may be submitted through the Internet by addressing electronic mail to INTERNET:MTL@NRC.GOV.
BPR Pilot Test
To validate that the new licensing process and associated automated systems perform adequately, the BPR team has scheduled a small-scale pilot test to take place at NRC Headquarters November 12 through 22, 1996. It is anticipated that issues and problems will be surfaced, during the pilot test, that will be addressed after each pilot is completed. The staff is planning to invite Agreement States and volunteer licensees to participate in the pilot tests. The number of participants must be kept under nine licensees or organizations. pending receipt of Office of Management and Budget clearance (under the Paperwork Reduction Act) allowing involvement of more than nine licensees or organizations.
This pilot test will be restricted to portable gauge applications (using the current guidance in draft Regulatory Guide DG-008, "Applications for the Use of Sealed Sources in Portable Gauging Devices") and will involve knowledgeable regional technical and administrative staff, with contractor and Headquarters participation as well.
Regional pilot tests are planned for February and March 1997, and will involve processing portable gauge applications under both the existing and new systems: (a) to ensure technical accuracy both of the review (e.g., were the same deficiencies found?); and of the resulting license documents (e.g., does license contain same conditions?); (b) to test metrics associated with the new process; and (c) to determine what additional training, management systems, Information Technology systems, etc., need to be implemented to make the new process successful.
For more information on participating in the pilot test, contact: John Pelchat, RII (404) 331-5083 (e-mail JMP2); Jack Whitten, RIV (817) 860-8197 (e-mail JEW1).
(Contact: Pat Rathbun, 301-415-7178 or e-mail PAR@nrc.gov)
Directions to NRC Offices
The Office of Information Resources Management has developed a new application on the U.S. Nuclear Regulatory Commission Voice Mail System. This application provides callers with directions to Nuclear Regulatory Commission Headquarters, any of the regional offices, the Technical Training Center, or the Walnut Creek Field Office. By dialing 1-888-415-A MAP from a touch-tone telephone, one can request faxes of maps, written directions, and lists of nearby hotels.
(Contacts: Brian Brownell (BDB@NRC.GOV) on 301-415-7152 or Bryan Champion (BLC@NRC.GOV) on 301-415-7356)
Notifying NRC of Bankruptcy
Recently, there have been several cases in which licensees filed, either voluntarily or involuntarily, for bankruptcy, and notification to the U.S. Nuclear Regulatory Commission was either late or not made. The NRC requirements for licensees that file for bankruptcy can be found in 10 CFR(U.S. Code of Federal Regulations)30.34(h), 40.41(f), 61.24(k), 70.32(a)(9), and 72.44(b)(6). These regulations apply to licenses associated with byproduct material, source material, low-level waste burial sites, special nuclear material, or independent storage of spent nuclear fuel. NRC has promulgated these regulations to ensure the adequate protection of public health and safety, and to ensure that radioactive material will not be abandoned.
Specifically, any licensee who is involved in a bankruptcy proceeding, either voluntarily or involuntarily, under any chapter of the bankruptcy law (i.e., chapters 7, 11, or 13 of Title 11 of the United States Code) must notify the appropriate NRC Regional Administrator in writing immediately after the filing. The regulations further define what is meant by being involved in a bankruptcy proceeding, namely, if the filing for bankruptcy is by or against the licensee itself, an entity controlling the licensee, an entity listing the licensee as property of the estate, or an affiliate of the licensee. For example, take the case where Company A owns Company B, and Company B is an NRC licensee. Company A files to reorganize under Chapter 11 of the bankruptcy law. Company B must notify NRC immediately after such a filing.
The regulation further specifies what information must be provided to NRC at the time of notification. Specifically, the licensee must identify the bankruptcy court in which the petition was filed, and the date of the filing of the petition.
In summary, if a licensee or company that owns a licensed company files for bankruptcy, the appropriate NRC Regional Administrator must be immediately notified of the filing date and of the bankruptcy court where the filing occurred. NRC will then monitor the licensee's activities to ensure that either the facility is cleaned up and material is properly disposed of, or the company is able to exit bankruptcy and operate normally.
(Contact Monte Phillips, RIII, 630-829-9806)
Mo-99/Tc-99m Generator Transportation Problems
In the last 10 years, the U.S. Nuclear Regulatory Commission has received nine reports of excessive radiation exposure rates related to the transportation of Mo-99/Tc-99m generators. Eight of these incidents occurred within the last 3 years. Of the nine reported incidents, two involved damage to the package/generator during shipping, two had external contamination on receipt, and two had radiation levels in excess of those allowed by the stated Transportation Indexes (TIs) on receipt from the vendor. The remaining three reported incidents involved the shipment of defective generators from the customer back to the vendor, which resulted in the packages producing radiation levels in excess of the allowed TIs.
These latter incidents are of particular concern to NRC, since once a generator has been determined to be defective by the customer, it no longer qualifies as a component of a U.S. Department of Transportation (DOT) Type 7A package. This follows logically if one considers that an inoperable, or improperly functioning, generator has some internal fault and no longer meets the configuration used to test the DOT Type 7A packaging, of which it is a component. Thus, any attempt to return such a defective package to the vendor would violate NRC and DOT regulations.
If a licensee encounters a defective generator it can either: (1) decay it in storage for a minimum of 10 Mo-99 half-lives, before shipping it back to the vendor; or (2) request the vendor supply it with a salvage container, designed and tested as a DOT Type 7A container for the shipment of a severely damaged generators, and use this container to return the generator to the original vendor. The licensee may wish to consider the latter option if it cannot conveniently and safely store the defective generator.
One additional item of concern is that several of the generator vendors believe that some licensees tamper with the generators in an attempt to correct any problems that may be encountered in their operation. These devices are not intended to be worked on/opened by users. Any user who either partially or fully disassembles a generator will invalidate the criteria under which the generator was certified as a DOT Type 7A package. Should problems be encountered during the subsequent shipment of such a generator, the shipper could be in violation of both NRC and DOT regulations.
(Contact: Robert L. Ayres, 301-415-5746)
Annual Reports of Dose to Workers; 10 CFR 19.13(b)
On January 1, 1994, significant revisions were made to Title 10, U.S. Code of Federal Regulations (10 CFR) Part 20. As a result of the changes to Part 20, other Parts of 10 CFR were modified, in particular 10 CFR 19.13(b). The provisions of this paragraph state that each licensee shall advise each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106. Under the former 10 CFR 19.13 (b), licensees were only required to advise workers of their doses on specific requests from the workers.
Several recent inspections at licensee facilities have found violations of 10 CFR 19.13(b). These licensees did not advise each worker annually of the worker's dose as required by 10 CFR 19.13(b), which went into effect January 1, 1994.
Licensees are encouraged to review their reporting procedures to ensure that the program includes advising each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106. This includes internal and external doses from routine operations, and doses received during planned special exposures, accidents, and emergencies. In addition, if a worker was monitored pursuant to 10 CFR 20.1502, then a report must be submitted to the worker regardless of the dose received by the worker. The report to the individual must be in writing and must contain all of the information required in 10 CFR 19.13(a).
(Contact: Mark Sitek, 301-415-6155)
Major Revision of Part 34 Involving Industrial Radiography Licensing, Safety, And Operations
The U.S. Nuclear Regulatory Commission has revised 10 CFR Part 34 to make it more understandable to licensees and has made a number of changes designed to improve safety in all aspects of industrial radiography. Many of the changes stemmed from Agreement State, radiographic equipment manufacturer, and NRC and Agreement State licensee active participation with NRC regarding improving safety in industrial radiography. The regulations underwent several major changes that are expected to improve both the quality and safety of industrial radiography. Some of the changes are the requirement to use two persons at all non-permanent radiography sites and the requirement for all radiographers to have a minimum of 2 months of on-the-job training and to be certified by an approved certifying entity. In the case of the two-person provision, one person must be a certified radiographer and the other must, as a minimum, be a qualified radiographer's assistant. In addition, the qualified radiographer's assistant position has been upgraded to require additional training, successful completion of a written test on the subject materials covered in the training, and a demonstration of competence in the use of radiography equipment by successful completion of a practical examination in the use of such equipment.
Another major change involves the definition of the position of Radiation Safety Officer (RSO), coupled with the specification of the qualifications, training, experience, duties, and responsibilities of the RSO, including the oversight and control of operations and the ability to stop operations whenever necessary.
Other changes include a requirement for daily tests (on days of use) of the audible and visual warning signals at permanent radiographic installations, instead of the current requirement for testing every 3 months. Also the entrance controls,if used at these installations, must be tested monthly.
Crushing and kinking tests for guide tubes have been modified to require the use of forces that closely approximate the conditions likely to be encountered during use. In addition, devices that use depleted uranium (DU) shielding must be tested for DU contamination at intervals not to exceed 12 months, except when in storage or not in use.
(Contact: Don Nellis, RES, 301-415-6257 or e-mail DON@NRC.GOV)
Human Error During Brachytherapy
A misadministration occurred when a licensee performed an endometrial treatment using a high-dose-rate (HDR) remote afterloading brachytherapy device. The treatment plan specified a step size of 2.5 millimeters (mm) between source dwell positions, but an incorrect step size of 5 mm was entered into the device's control console. That resulted in delivery of radiation to an area outside the intended treatment site and constituted a misadministration as defined in 10 CFR 35.2(5)(i) Two human errors were at the root of the misadministration. The first was entry of the wrong step size into the device's control console. The second was failure to identify the first error, before treatment. Neither error, by itself, would have been sufficient to result in the misadministration. Factors contributing to the first error included: (a) the fact that, in prior years, the licensee used a 5-mm step size for endometrial treatments; (b) the extensive experience of the individual making the error with the 5-mm step size; and (c) that individual's limited experience with the 2.5-mm step size. Successful entry of step size for an endometrial treatment by that individual demanded special attention to one element of a task that was otherwise routine. A factor contributing to the second error was the attention demanded by checks of dwell position and time entries. Those demands may have led to a sharp focus on dwell positions and times and occasional lapses in attention to other parameters.
Although human errors were at the root of the misadministration, the licensee's Quality Management Program (QMP) failed to prevent or detect those errors because its procedures for ensuring that the final plans of treatment and related calculations were in accordance with the written directive were inadequate. Treatment planning involved completion of two separate worksheets that were used to implement the required procedures. One worksheet contained all the data to be entered at the control console except step size. Step size, along with other information, was on the other.
Division of the data to be entered at the control console across two worksheets produced a situation in which individuals entering those data might tend to rely more on memory than on the second worksheet for entry of step size. That division also resulted in a situation in which individuals checking for correct entry of data might fail to check step size. Inclusion of step size on the work sheet that would have contained all the other data entered at the control console would have reduced the likelihood that anyone would have entered step size incorrectly and increased the likelihood that entry of an incorrect step size would be detected.
Other licensees have experienced misadministrations caused by incorrect entry of step size and failure to detect that error. There have been similar errors in entry and checking of other parameters (e.g., treatment length). Licensees should review their procedures for meeting the objectives of the QMP and ensure that those procedures reduce the likelihood of errors in data entry and increase the likelihood that data entry errors that do occur are detected and corrected before treatment. Both the content and layout of worksheets that govern the entry of data into an HDR device's control console and checking of those data should be included in the review.
(Contacts: John Jones, RIII, 630-829-9832; Dennis Serig, NMSS, 301-415-7901)
Strontium-90 Eye Applicators
Licensees with Strontium-90 (Sr-90) eye applicators are reminded that these brachytherapy sources are subject to all of the requirements of Title 10, U.S. Code of Federal Regulations (10 CFR) 35.59, "Requirements for possession of sealed sources and brachytherapy sources." Licensees must possess and follow the radiation safety and handling instructions supplied by the manufacturer, satisfy the leak test requirements, conduct quarterly inventories, measure ambient dose rates quarterly in areas where the sources are stored, and retain required leak test and survey records. Historically, Sr-90 eye applicator licensees were required to confirm they had a properly calibrated Geiger-Mueller type survey meter on hand to use when receiving the eye applicator and make arrangements to assure continued access to a properly calibrated survey meter for other occasions (e.g., suspected leakage, detachment of the source from its holder, contamination problems, and quarterly surveys). This guidance is still appropriate. Licensees possessing Sr-90 eye applicators should review their procedures to ensure they are in compliance with all the requirements in 10 CFR 35.59.
(Contact: Donna Beth Howe, 301-415-7848)
NUREG/CR-6345 "Radiation Dose Estimates For Radiopharmaceuticals."
This NUREG was published in April 1996 and distributed to U.S. Nuclear Regulatory Commission medical use and commercial nuclear pharmacy licensees. It consists of 80 tables. Each table provides effective dose equivalent and organ radiation dose estimates for 70 radiopharmaceuticals commonly used in nuclear medicine. (Estimates are provided for multiple routes of administration or procedures for several radiopharmaceuticals.) The tables were developed by the Radiation Internal Dose Information Center at Oak Ridge Institute of Science and Education. These tables as well as specific package insert data can be used to estimate radiation doses for patients.
(Contact: Donna-Beth Howe, 301-415-7848)
Specific Domestic License of Broad Scope For Byproduct Material - Advance Notice of Proposed Rulemaking
The U.S. Nuclear Regulatory Commission will be publishing an Advance Notice of Proposed Rulemaking (ANPR) in the Federal Register. NRC is considering amending its regulations governing specific licenses of broad scope for byproduct material to clarify the regulatory and health and safety bases of current licensing practices and to provide licensees with the flexibility to make certain types of changes to their radiation safety programs. Currently, 10 CFR Part 33 does not contain a clear description of the duties and responsibilities of management, the Radiation Safety Officer (RSO), or the Radiation Safety Committee (RSC). In addition to various ongoing staff efforts regarding the possible need for clarification of requirements for broad-scope licensees, consideration of changes to Part 33 was also a recommendation of the Incident Investigation Team reviewing a recent incident involving ingestion of phosphorus-32 at a broad- scope facility. NRC is evaluating existing regulations and, for possible codification in Part 33, appropriate requirements derived from prior guidance and license standard review plans with reference to: management oversight of broad-scope licensed programs; the role of the RSO; the responsibilities of the RSC; supervision; the qualifications of the authorized user; the use of audits and inventory requirements; and security and control of licensed material. The key ANPR includes issues, questions, and discussion as well as draft rule language that was developed in partnership with the State of Illinois. The purpose of describing the preliminary issues and posing certain questions is to illustrate aspects of NRC's evaluation of Part 33 to date, and to request public comment on the completeness of the evaluation and whether the proposed changes pose any serious implementation problems. NRC is soliciting comments on the draft text, including the extent to which the text addresses the issues described and any suggestions of alternative text.
(Contact: Patricia K. Holahan, 301-415-8125)
Transportation Requirements For Broad-Scope Licensees
In 1996, U.S. Nuclear Regulatory Commission inspectors identified several examples of university broad scope licensees failing to comply with U.S. Department of Transportation (DOT) regulations as required by 10 CFR 71.5(a). Section 71.5(a) requires that each licensee who transports licensed material outside the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 CFR Parts 170 through 189 appropriate to the mode of transport. In all cases, the violations occurred while transporting NRC-licensed material on public roadways, usually from one university building to another.
Although the specific transportation violations varied, similar underlying causes were identified. Typically, licensees were unaware of the regulation or their radiation safety program lacked audit mechanisms to ensure that the university policies were being followed and met regulatory requirements.
For example, a university Radiation Safety Officer (RSO) had not observed the performance of the shipping and receiving personnel until he accompanied the NRC inspector during a routine inspection of the university's radiation safety program. During that accompaniment, the RSO realized that packages containing radioactive materials were being transported on public roads to users located on the main university campus and on remote campuses without proper shipping papers. Had a means of internally auditing the transportation program been implemented, the transportation violations could have been avoided.
The following DOT requirements are highlighted here as they are often cited in transportation violations: 49 CFR 172.200(a) requires, in part, that each person who offers a hazardous material for transportation describe the hazardous material on the shipping paper in the manner required by Subpart C of 49 CFR Part 172. Pursuant to 49 CFR 172.101, radioactive material is classified as hazardous material. Subpart C of 49 CFR Part 172 requires, in part, that the entries on the shipping papers include the following: (1) a description of the hazardous materials [172.200(a)]; (2) an emergency response telephone number [172.201(d)]; (3) a proper shipping name for the hazardous materials [172.202(a)(1)]; (4) the hazard class of the hazardous materials [172.202(a)(2)]; (5) the identification number of the hazardous materials [172.202(a)(3)]; and (6) additional descriptions [172.203(d)].
Section 177.842(d) requires that packages of Class 7 (radioactive) material on vehicles must be so blocked and braced that they cannot change position during conditions normally incident to transportation.
When implemented properly, DOT regulations help ensure that safety of NRC-licensed material is maintained during transportation. Licensees must understand and adhere to the requirements of 49 CFR Parts 170 through 189 when NRC-licensed material is transported. In addition, internal audits of the transportation program should be conducted on a frequent basis to ensure that all personnel involved with the transportation of NRC-licensed material are adequately trained and implement the necessary requirements.
(Contacts: Ronald Burrows, RIII, 630-829-9838; B. J. Holt, RIII, 630-829-9836)
Generic Communications Issued
May 1, 1996 - August 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.
Administrative Letters (ALs)
AL 94-13, Revision 2, "Access to Nuclear Regulatory Commission Bulletin Board Systems," was issued May 3, 1996. This revision serves to provide licensees updated information about the availability of the NRC bulletin board system and list server systems. (Contacts: James W. Shapaker, NRR, 301-415-1151, Internet:email@example.com; Tom Dunning, NRR, 301-415-1189, Internet:firstname.lastname@example.org; Kevin Ramsey, NMSS, 301-415-7887, Internet:email@example.com)
BL 96-04,"Chemical, Galvanic, or Other Reactions in Spent Fuel Storage and Transportation Casks," was issued on July 5, 1996. This bulletin is addressed to all parties involved with the use, construction, or sale of spent fuel storage and/or transportation casks. The potential for certain reactions is outlined along with a description of an actual incident. Actions and written responses to these actions are required by the action addressees of the bulletin. (Contacts: Marissa Bailey, NMSS, 301-415-8531, Internet:firstname.lastname@example.org; William Reckley, NRR, 301-415-1314, Internet:email@example.com)
Information Notices (INs)
IN 96-33, "Erroneous Data from Defective Thermocouple Results in a Fire," was issued on May 24, 1996. This notice serves to alert all Nuclear Material Safety and Safeguards licensees to an incident where a defective thermocouple caused an evaporator to run at an excessively high temperature, resulting in a fire.
(Contact: Kevin Ramsey, NMSS, 301-415-7887 Internet:firstname.lastname@example.org)
IN 96-34, "Hydrogen Gas Ignition during Closure Welding of a VSC-24 Multi-Assembly Sealed Basket," was issued May 31, 1996. This notice alerts independent spent fuel storage installation designers and fabricators to a hydrogen gas ignition event that occurred during the welding of the shield lid on a spent fuel storage cask at the Point Beach Nuclear Plant. (Contact: A. Hansen, NRR, 301-415-1390, Internet:email@example.com)
IN 96-35, "Failure of Safety Systems on Self-Shielded Irradiators Because of Inadequate Maintenance and Training," was issued on June 11, 1996. This notice alerts irradiator licensees and vendors to two incidents where safety interlocks on self-shielded irradiators (Category I) failed to prevent inadvertant exposure.
(Contacts: Douglas Broaddus, NMSS, 301-415-5847, Internet:firstname.lastname@example.org;Anthony Kirkwood, NMSS, 301-415-6140, Internet:email@example.com)
(General Contact: Kevin Ramsey, NMSS, 301-415-7887, Internet:firstname.lastname@example.org)
Selected Communications IssuedJune 1, 1996 - August 31, 1996
NOTE: Contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
Petitions For Rulemaking
Amersham Corporation, PRM-34-5, Petition to remove "associated equipment" from radiography equipment regulations, 61 FR 30837, June 18, 1996. Contact: Donald Nellis, 301-415-6257 or Michael Lesar, 301-415-7163 or toll-free 800-368-5642, or e-mail MTL@NRC.GOV.
University of Cincinnati, PRM-20-24, Request for amendment to regulations to allow specified visitors to radiation patients, as members of the public, to receive up to 500 mrem per year, 61 FR 31874, June 21, 1996. Contact: Michael Lesar, 301-415-7163 or toll-free 800-368-5642, or e-mail MTL@NRC.GOV.
Isostent, Inc., PRM-35-14, Petition for amendment to regulations to address intaluminal stents, including phosphorus-32 and strontium-89 radioisotope stents, permanently implanted in patients' blood vessels, and related physician training and experience requirements, 61 FR 33388, June 27, 1996. Contact: Michael Lesar, 301-415-7163 or toll-free 800-368-5642, or e-mail MTL@NRC.GOV.
Nuclear Energy Institute, Petition to allow nuclear materials licensees to monitor and maintain parts of their facilities beyond a 24-month period rather than beginning to decommission them, 61 FR 43193, August 21, 1996. Contact: Michael Lesar, 301-415-7163 or toll-free 800-368-5642, or e-mail MTL@NRC.GOV.
Regulatory GuidesDraft Guide
"Preparation of Petitions for Rulemaking under 10 CFR 2.802 and Preparation and Submission of Proposals for Regulatory Guidance Documents," 61 FR 42448, August 15, 1996. Contact: T. Y. Chang, 301-415-6450 or e-mail TYC@NRC.GOV.
"Recognition of Agreement State Licenses in Areas under Exclsive Federal Jurisdiction within an Agreement State," 61 FR 30839, June 18, 1996. Contact: Hampton Newsome, OGC, 301-415-1623, e-mail HHN@NRC.GOV or Mark Haisfield, RES, 301-415-6196, e-mail MFH@NRC.GOV.
"Access to and Protection of Classified Information," 61 FR 40555, August 5, 1996. Contact: Duane Kidd, ADM, 301-415-7403, or e-mail DGK@NRC.GOV.
Correcting Amendment to 10 CFR Part 71, "Compatibility with International Atomic Energy Agency," 61 FR 28723, June 6, 1996. Contact John R. Cook, NMSS, 301-415-8521.
"Export of Nuclear Equipment and Materials" (update), 61 FR 35600, July 8, 1996. Contact: Elaine Hemby, 301-415-2341, e-mail EOH@NRC.GOV.
Removal of 10 CFR Part 53, "Criteria and Procedures for Determining the Adequacy of Available Spent Nuclear Fuel Storage Capacity," 61 FR 35935, July 9, 1996. Contact: Gordon Gundersen, 301-415-6195.
Policy Statement, "Conversion to the Metric System," 61 FR 31169, June 19, 1996. Contact: Dr Frank Costanzi, 301-415-6250 or e-mail FAC@NRC.GOV.
Notice, "Governors' Designees Receiving Advance Notification of Transportation of Nuclear Waste (update)," 61 FR 33592, July 1, 1996. Contact: Spiros Droggitis, OSP, 301-415-2367, e-mail SCD@NRC.GOV.
"Memorandum of Understanding between Department of Labor-Nuclear Regulatory Commission with Respect to Gaseous Diffusion Plants, 61 FR 40249, August 1, 1996. Contact: John Hickey, 301-415-7192.
(General Contact: Paul Goldberg, 301-415-7842, e-mail PFG@NRC.GOV)
Significant Enforcement Actions
These selected enforcement actions (EAs) can be accessed via the U.S. Nuclear Regulatory Commission homepage by clicking on "Nuclear Materials,'' then clicking on "Enforcement Program,'' and then finally clicking on "Escalated Enforcement Actions Issued Since March 1996.'' The EAs are listed alphabetically. The details regarding these may be obtained by clicking on the highlighted text following each case.
Ashford Presbyterian Community Hospital, San Juan, Puerto Rico Supplement VI, EA 96-053
A $2500 Civil Penalty was issued March 19, 1996, to emphasize the importance of full implementation of the Quality Management Program (QMP) with respect to the administration of radiopharmaceuticals and the need for prompt identification of violations. The action was based on a problem involving the licensee's failure to fully implement its QMP as required by 10 CFR Part 35. The licensee failed on at least 10 occasions during 1994 and 1995 to properly use written directives for certain diagnostic administrations of sodium iodide I-131 or to check the patient's treatment charts for errors in dosage. The licensee also failed to adequately instruct its nuclear medicine technologists on the requirements of the QMP.
Department of the Army, Madigan Army Medical Center, Tacoma, Washington Supplement VI, EA 96-004
An $8000 Civil Penalty was issued February 22, 1996, to emphasize the licensee's responsibility to NRC to provide adequate training and to ensure that licensed requirements are being followed. The action was based on the failures to: (1) provide adequate QMP training to employees involved in the brachytherapy program, and (2) maintain and implement the QMP in a manner that ensured that patients implanted with brachytherapy sources received the doses intended by the prescribing physicians.
Diamond H Testing Company, Chubbuck, Idaho Supplement VI, EA 95-148
An $8000 Civil Penalty was issued October 25, 1995, to emphasize the licensee's responsibility to ensure that radiographers comply with NRC regulations and the licensee's operating procedures so as to ensure not only their safety but that of the public. The action was based on a problem involving: (1) an apparent willful failure to lock the sealed source in the shielded position following a radiographic exposure; (2) a failure to conduct an adequate survey of the source guide tube after a radiographic exposure; and (3) a failure to wear an alarm ratemeter.
Oncology Services Corporation, Harrisburg, Pennsylvania Supplements IV, V, and VI, EA 94-006
A Notice of Violation and Proposed Imposition of Civil Penalties in the amount of $280,000 was issued May 31, 1994, to emphasize to the licensee, in particular, and the industry in general, the importance of meticulous management oversight of the radiation safety program, so as to ensure that licensed activities are conducted safely and in accordance with requirements. The action was based on a November 1992 event in which a 4.2-Curie iridium-192 source was left inside a patient who was undergoing a brachytherapy treatment using a high-dose-rate afterloader unit. The patient received a very high radiation exposure and subsequently died. Among the violations that contributed to the event were the failure to perform a survey, failure to follow procedures regarding the wall-mounted radiation monitor and entry into the treatment room, and failure to train personnel pursuant to 10 CFR 19.12. The licensee responded on August 31, 1994 and October 4, 1994. After consideration of the licensee's responses, an Order Imposing Civil Penalties in the amount of $280,000 was issued April 24, 1995. The licensee requested a hearing on May 18, 1995, and a settlement was approved by the Commission on May 16, 1996.
Washington County Memorial Hospital, Salem, Indiana Supplement VI, EA 96-071
A Notice of Violation was issued May 2, 1996, based on violations involving the use of iodine-131. The licensee informed NRC that at the time of an administration of sodium iodine-131, the licensee did not have a physician designated as an authorized user for therapeutic dosages. A civil penalty was not proposed because the licensee had not been subject to escalated enforcement action in the past 2 years or two inspections and the licensee took prompt and comprehensive corrective action that included admonishing the individuals involved for their failure to adhere to NRC requirements, and amending the NRC license to withdraw the authority to use unsealed byproduct materials for therapeutic administrations.
Harvard University, Cambridge, Massachusetts Supplement IV, EA 96-068
A Notice of Violation was issued April 18, 1996, based on violations involving the failure to secure from unauthorized removal, or limit access to, licensed material in several laboratories at the licensee's facility and the failure of the licensee's staff to maintain control or surveillance of the licensed material. A civil penalty was not proposed because the licensee had not been subject to escalated enforcement action in the past 2 years or two inspections.
Bemis Construction, Inc., Great Bend, Kansas Supplement VI, EA 95-276
A $2500 Civil Penalty was issued March 19, 1996, to emphasize the importance of complying with NRC requirements. The action was based on a violation for using a moisture density gauge in Oklahoma, a non-Agreement State, between March 1991 and August 1992 and storing the gauge in Oklahoma between March 1991 and July 1995, all without obtaining an NRC license or filing NRC Form 241.
A. E. Staley Manufacturing Company, Lafayette, Indiana Supplements IV and VI, EA 96-042
A Notice of Violation was issued April 4, 1996, based on a violation involving the unauthorized removal of an Ohmart level gauge containing NRC-licensed material (20 millicuries of cesium-137 in a sealed source). The device was removed from service in January 1996 by individuals not authorized to remove the device from service. The device was found in a dumpster 1 day later. A civil penalty was not proposed because the licensee had not been the subject of an escalated enforcement action within the last 2 years or two inspections and the licensee took prompt and comprehensive corrective actions.
Shilts, Graves & Associates, Inc., South Bend, Indiana Supplement IV, EA 96-043
A Notice of Violation was issued April 8, 1996, based on a violation involving damage to a moisture/density gauge in November 1995. After concluding a measurement, the technicians walked 15 feet away from the gauge and the gauge was struck by a backhoe breaking the carrying handle. The technicians immediately implemented the emergency procedures and the incident did not cause any contamination nor personnel exposures. A civil penalty was not proposed because the licensee had not been the subject of an escalated enforcement action within the last 2 years or two inspections and the licensee took prompt and comprehensive corrective actions that included reviewing operating procedures with each technician and auditing employees on the use of their assigned gauges.
(Contact: Joseph DelMedico, 301-415-2730)
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
(or send e-mail to: email@example.com