NMSS Licensee Newsletter September 1997 - October 1997
NUREG/BR-0117; No. 97-3
- Revision to 10 CFR Part 35
- Medical Licensee Unauthorized Use of Byproduct Materials
- Authorized Activities at Locations Identified on Industrial Radiography Licenses
- Consolidating and Updating Materials Licensing Guides
- Publication of Final Guidance on Portable Gauge Licenses
- New Draft Guidance on Industrial Radiography Licenses
- Nuclear Byproduct Material Risk Review Group
- Year-2000 Effect on Computer System Software
- Selected Federal Register Notices (June 1, 1997 - August 31, 1997)
- Generic Communications Issued (May 1, 1997 - July 31, 1997)
- Significant Enforcement Actions
Revision to 10 CFR Part 35
As indicated in the FRN, public input and suggestions may be submitted either electronically, via Internet, or in writing at the following addresses:
- Send written input and suggestions to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudication Staff.
- Hand-deliver comments to 11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on Federal workdays.
- Public input may also be submitted electronically on the Internet via NRC's Technical Conference Forum (http://techconf.llnl.gov/noframe.html).
Revision to 10 CFR Part 35
In a Federal Register notice (FRN), dated August 6, 1997 (62 FR 42219), the U.S. Nuclear Regulatory Commission published a request for public input and a description of the overall program for revising the regulations governing the medical use of byproduct material. Specifically, the FRN (a) describes NRC's rationale and program for revising the medical use regulation; (b) identifies plans for review of the 1979 Medical Policy Statement; (c) describes plans for guidance development; (d) notifies the public of the availability of documents associated with the revision process; and (e) solicits informal public input on development of proposed rule language and associated documents. Further, the program specifies Commission plans to formally propose specific rulemaking text for public comment during the summer of 1998, with the goal of beginning final Commission approval in Spring 1999.
The staff plans to solicit public input on the revision to 10 CFR Part 35, associated guidance, and the 1979 Medical Policy Statement on an informal and formal basis during the rulemaking process. The first version of the draft rule language is expected to be available for public review at the NRC Technical Conference Forum (Internet access: http://techconf.llnl.gov/noframe.html) and through the NRC Public Document Room, in Fall 1997. During the development process, the staff will make drafts publicly available, but will only be able to ensure consideration of informal public input that is received before the time beginning approximately 2 to 3 months before the draft proposed rule language and associated draft documents are provided to the Commission for approval. (Currently the draft proposed rule and associated draft documents are scheduled to be provided to the Commission in Spring 1998.) Public input received after the time indicated will be considered later, as part of the ongoing interaction process and along with the comments received during the formal public comment period on the proposed rule.
At the proposed final rule stage and on Commission approval, the proposed rule and associated draft documents will be published in the Federal Register for a public comment period of 75 days. These documents will also be made available at the NRC Technical Conference Forum and the NRC Public Document Room. Draft documents will continue to be at these locations, but the staff will not be able to consider further public input on these documents after the time beginning approximately 4 months before the submission of the draft documents for Commission approval (currently scheduled for Spring 1999).
Further, the staff plans to interact with professional societies on an ongoing basis to solicit input. The staff will conduct facilitated public meetings in Philadelphia, PA, from October 28-30, 1997, and in Chicago, IL, from November 12-14, 1997. These meetings will be used to focus discussion on specific rule text proposals. Discussions will also be held in meetings with the Advisory Committee on the Medical Uses of Isotopes and the Organization of Agreement States, in the Fall of 1997.
Medical Licensee Unauthorized Use of Byproduct Materials
Occasionally the Nuclear Regulatory Commission discovers a medical licensee using byproduct material in a manner not authorized by its NRC license. This occurs most frequently in the conduct of radiation therapy treatments. One of the most recent examples of this type of license violation occurred when an NRC licensee used its high-dose-rate (HDR) remote, afterloading brachytherapy device to perform surface treatments of superficial skin lesions, a use not authorized by its license. The typical license condition for HDR devices authorizes uses for "interstitial, intracavitary, and intraluminal uses only," and thus excludes other uses such as topical or surface treatments and intravascular treatments intended to reduce or eliminate restenosis.
Often uses not presently authorized by existing license conditions, such as the previously cited surface treatments, have been and can be authorized by licensee request for a license amendment. Other uses, such as the new intravascular brachytherapy procedures for the prevention of restenosis, can also be approved, but may require a much more complex license amendment procedure. The "Draft Guidance for Intravascular Brachytherapy Investigative Device Exemption (IDE) Applications"(1) issued by the U.S. Food and Drug Administration (FDA) on May 9, 1996, states that the FDA considers the use of intravascular brachytherapy an unproven therapy with the potential for significant risk to patients. As such, the FDA continues to require all such procedures to be conducted under an FDA-approved IDE. Thus, the NRC approval process requires the submission of proof that the required IDE has been approved by the FDA as one component of the NRC approval process. Another consideration that needs to be addressed, in some procedures, is whether the device and/or source has been evaluated and approved for the intended use and is listed for such use in the NRC "Registry of Sealed Sources and Devices."
Whenever a licensee is considering changing its services to provide a new radiation therapy service or treatment, or implementing a new or significantly revised diagnostic procedure, it should carefully examine its byproduct materials license to ensure that the new procedures do not require any new radionuclides, and that the procedures are authorized on its license. This should also include checking that the new procedure(s) do not require quantities of a given radionuclide in excess of the licensee's possession limits. If the licensee is uncertain whether a new procedure is permitted by its existing license conditions, it should contact its NRC regional office for clarification before implementing any questionable procedures that my be in violation of its existing license conditions. If a new procedure or therapy is found to be unauthorized, then the licensee must request and receive an appropriate amendment to its existing license before beginning the procedure. It should be noted that broad-scope licensees are granted much more authority to approve the adoption of new procedures and research involving the use of byproduct materials than are licensees of limited specific scope and are less likely to be limited, by license condition(s), from conducting new procedures without prior NRC approval. However, in some instances even broad-scope licensees may find license amendments are necessary.
(Contact: Robert L. Ayres, NMSS, 301-415-5746, e-mail: email@example.com.)
Authorized Activities at Locations Identified on Industrial Radiography Licenses
As previously reported in this newsletter, the final rule on the revision of 10 CFR Part 34 was published in the Federal Register on May 28, 1997 (62 FR 28948). The revision of Part 34 introduced a number of regulatory changes, affecting industrial radiography operations, of which licensees need to be aware. NRC has learned that there may be some confusion regarding changes affecting the activities licensees may conduct, under the revised regulations, at locations identified on the license.
As a result of a contentious enforcement action involving a licensee that was conducting radiography operations in a shielded cell at its place of business, the Commission directed the staff to revise Part 34 to more clearly define a "permanent radiographic installation" and to ensure that the Nuclear Regulatory Commission understands when activities are conducted in such installations, and the conditions of use at the installations. In an attempt to achieve this goal, the staff revised the definition for a permanent radiographic installation, and added new definitions for "field station" and "temporary job site." The permanent radiographic installation definition establishes that these installations are not located at temporary job sites. Section 34.13(j) requires radiography license applicants to identify the locations of and describe all field stations and permanent radiographic installations. Section 34.41(b) provides that radiographic operations conducted at locations identified on a license must be conducted in a permanent radiographic installation unless otherwise specifically authorized.
Therefore, industrial radiography licensees (and applicants) should note that they may not treat a location identified on their license as a temporary job site for purposes of conducting radiography, and that radiography at these locations may only be performed in a permanent radiographic installation that has been described in the license application, unless otherwise specifically authorized. If a location identified in an existing license was described as a storage location, but the licensee also wishes to perform radiography at that location, the licensee must submit a license amendment request that describes the conditions of use at the location.
The "Statements of Consideration" (SOC) supporting the final rule noted that the proposed rule specified that all radiographic operations conducted at locations identified on a license must be conducted in a permanent radiographic installation. The SOC further states, "The NRC has always believed that radiography performed in a fixed facility, meeting the requirements of Sec. 34.33, would provide a safer environment for workers and the public. If licensees need to perform radiography at their place of business outside of a permanent facility due to some unique circumstances, i.e., item to be radiographed is too large for the facility, Commission authorization would be required." NRC notes that no public comments were received concerning the proposed rule language.
There are several provisions in Part 34 directly applicable to permanent radiographic installations. The control devices that must be used at permanent radiographic installations are described in 10 CFR 34.33. Section 34.41(a) requires that there be at least two qualified individuals present whenever radiography is conducted, except when conducted in a permanent radiographic installation. Section 34.47(a) requires, in part, that alarm ratemeters must be worn when conducting radiography, except at permanent radiographic installations where other required warning devices are in use. Section 34.51 specifies that continuous direct visual surveillance must be maintained during radiographic operations, except at permanent radiographic installations where entryways are locked.
As noted previously, NRC believes that radiography performed in a permanent radiographic installation provides a safer environment for workers and the public; however, other conditions of use may be authorized. In addition, when conducting operations in a permanent radiographic installation, a single individual may conduct the radiography, continuous surveillance is not required provided the entrance ways are locked, and alarm ratemeters are not required.
(Contact: J. Bruce Carrico, NMSS, 301-415-7826, e-mail: firstname.lastname@example.org)
Consolidating and Updating Materials Licensing Guides
During a Business Process Re-engineering effort to evaluate and improve the materials licensing process, the Nuclear Regulatory Commission determined that much of the existing licensing guidance was very old, and in some cases duplicative, or unavailable in a current or readily accessible electronic format. As a result, the Division of Industrial and Medical Nuclear Safety is updating and consolidating all existing licensing guidance documents over the next 3 years. Thereafter, guidance documents will be updated on a 3-year revision cycle. During this initial 3-year cycle, all existing documents will be subsumed into "specific use" documents, and published as NUREGs. This effort will result in the development of approximately 22 NUREGs, each containing applicant information, review instructions, licensing checklists, sample licenses, and inspection/audit guidelines.
By January 1998, IMNS expects to have published NUREGs about portable gauges, industrial radiography, self-shielded irradiators, fixed gauges, master material licenses, and guidance on sealed source and device reviews.
The NUREGs series is numbered NUREG-1556, and is entitled: "Consolidated Guidance about Materials Licenses." Each topic has a different volume number and subtitle. For example, NUREG-1556, Volume 1, is entitled: "Consolidated Guidance about Materials Licenses," and subtitled: "Program-Specific Guidance about Portable Gauge Licenses."
Each of the NUREGs will be published in hard copy, and on NRC's Nuclear Material Safety and Safeguards Internet Homepage. The address is http://www.nrc.gov/NRC/ NUREGS/SR1556/V1/Index.html (for portable gauge). To access other guidance NUREGs, the "V1" in the address is changed to the appropriate NUREG Volume number (2,3,4, etc.).
Each of the NUREGs will be published first in draft, for a 3-month comment period, then in final. During the comment period, we would appreciate suggestions that would improve the development of this licensing guidance.
(Contact: Sally Merchant, NMSS, 301-415-7874, e-mail: email@example.com)
Publication of Final Guidance on Portable Gauge Licenses
On October 3, 1996 (61 FR 51729), the Nuclear Regulatory Commission announced the availability of draft NUREG-1556, Vol. 1, "Consolidated Guidance about Materials Licenses," subtitled, "Program-Specific Guidance about Portable Gauge Licenses," dated September 1996, and requested comments on it. This draft NUREG report is the first program-specific guidance developed to support an improved materials licensing process. On December 6, 1996 (61 FR 64768), NRC requested volunteers to participate in a January 1997 pilot test to evaluate the document's content, format, and usefulness. Most of the public comments and those of the participants in the pilot test were positive. The staff considered all the comments, including constructive suggestions to improve the document, in the preparation of the final NUREG report.
The final version of NUREG-1556, Vol. 1, is now available for use by applicants, licensees, NRC license reviewers, and other NRC staff. It supersedes the guidance for applicants and licensees previously 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.
Implementation: The performance-based approach in NUREG-1556, Vol. 1, gives portable gauge licensees greater flexibility than previously permitted under licenses based on applications prepared according to DG-0008. This permits licensees to make more changes in their radiation safety program without amending their licenses, thus reducing the regulatory burden on licenses and the staff. Accordingly, existing portable gauge licensees have the option of submitting a complete application, using NUREG-1556, Vol. 1, at the time they file an amendment request. Portable gauge licensees choosing this option should incorporate the requested change into the complete application, submit it with the appropriate amendment fee, and indicate that the complete application is an amendment request to take advantage of the new guidance. When the staff has reviewed the request and resolved any outstanding issues, it will amend the license in its entirety without changing the expiration date.
Portable gauge licensees wishing to renew their licenses should submit a complete application according to NUREG-1556, Vol. 1. The staff's action will be similar to that described for amendments, but will include an extension of the license's expiration date. By following this procedure, the staff expects all existing portable gauge licenses to be converted to the more performance-based format within a few years.
Note: NUREG-1556, Vol. 1, permits applicants to make a "generic" request for portable gauges (i.e., any source and device combination registered by NRC, according to 10 CFR 32.210, or by an Agreement State). After the publication of NUREG-1556, Vol. 1, the Office of the General Counsel examined the provisions of 10 CFR 30.32(g)(1), determined that "generic" requests do not meet its requirements, and advised that applications must contain the manufacturer's name and model number of each requested sealed source and device. Accordingly, applicants will need to provide the manufacturer's name and model number for each requested sealed source and device.
Availability: NUREG-1556, Vol. 1, is available on the Internet at the following address: http://www.nrc.gov/NRC/NUREGS/SR1556/V1/index.html. Copies of NUREG-1556, Vol. 1, may also be obtained by writing to the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9828. Copies are also available from the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia 22161.
(Contact: Patricia C. Vacca, NMSS, 301-415-7908, e-mail: firstname.lastname@example.org)
New Draft Guidance on Industrial Radiography Licenses
Draft NUREG-1556, Vol. 2, "Consolidated Guidance about Materials Licenses," subtitled, "Program-Specific Guidance about Industrial Radiography Licenses," dated August 1997, is the second program-specific guidance developed as part of this redesigned materials licensing process. This draft NUREG report is intended for use by applicants, licensees, and staff. The guidance corresponds with the revision to 10 CFR Part 34 published in May 1997. It combines and updates the guidance, for applicants and licensees, previously found in draft Regulatory Guide FC 401-4, "Guide for the Preparation of Applications for the Use of Sealed Sources and Devices for Performing Industrial Radiography (dated October 1984), and the guidance for licensing staff previously found in Policy and Guidance Directive FC 84-15, "Standard Review Plan for Applications for the Use of Sealed Sources and Devices for Performing Industrial Radiography," dated October 1994. In addition this draft report also contains information found in pertinent technical assistance requests and information notices.
The draft NUREG report has been distributed for comment to encourage public participation in its development. It represents the current position of NRC, which is subject to change after the review of public comments. Comments received will be considered in developing the final NUREG report that represents the official staff position. Until the final report is published, this draft NUREG report represents the best available guidance, and may be used when preparing requests for licensing actions. Once the final NUREG report is published, staff will use it in its review of requests for licensing actions. The draft and final NUREG reports may differ. If a license were issued or amended based on recommendations in the draft NUREG report and the final guidance is believed to be more advantageous, licensees may choose to request an amendment.
NRC sent copies of draft NUREG-1556, Vol. 2, to each of its radiography licensees. Other ways of obtaining the document are as follows: For a free single copy of draft NUREG-1556, Volume 2, write to the U.S. Nuclear Regulatory Commission, ATTN: J. Bruce Carrico, Mail Stop TWFN 8F5, Washington, DC 20555-0001. Alternatively, submit requests through the Internet by addressing electronic mail to "email@example.com." NUREG-1556, Volume 2, is also available electronically by visiting NRC's Home Page (http://www.nrc.gov) and choosing "Nuclear Materials," then "Business Process Redesign project," then "Library," and then "draft NUREG-1556, Volume 2."
Please submit comments by December 31, 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. Comments may also be submitted through the Internet by addressing electronic mail to firstname.lastname@example.org.
(Contact: J. Bruce Carrico, NMSS, 301-415-7826 e-mail: email@example.com)
Nuclear Byproduct Material Risk Review Group
As part of the Nuclear Regulatory Commission's strategic assessment and rebaselining efforts, one of the direction-setting issues (DSIs) considered was "Risk-Informed, Performance-Based Regulation." In a staff requirements memorandum (SRM) dated April 15, 1997, the Commission directed the staff, in part to reexamine the applicability of risk-informed, performance-based or risk-informed, less-prescriptive approaches, to regulation of nuclear material. Another issue considered was DSI No. 7, which addressed nuclear byproduct materials/medical oversight. The Commission's March 20, 1997, SRM, related to that issue, indicated Commission support for continuing the existing nuclear byproduct materials/medical oversight program--with improvements--and for decreased oversight of low-risk activities, and continued emphasis on high-risk activities.
A December 31, 1996, SRM, related to a staff proposal for improving NRC's control over, and licensees' accountability for, generally and specifically licensed devices, directed the staff to quantify the risks associated with unaccounted-for devices. The Commission's direction to the staff included establishing the probabilities associated with devices being lost, devices causing exposures to members of the public, devices entering the metals manufacturing stream, devices being smelted, and other incidents the staff recommended analyzing. Finally, a March 3, 1997, SRM addressed a rule-making plan for revision of prototype testing requirements for hands, dials, and pointers using Tritium. The Commission directed the staff to make rules for manufacture and distribution of generally licensed and exempt products or materials more flexible and user-friendly, while still maintaining an adequate level of safety. In response to these Commission directions, the Office of Nuclear Material Safety and Safeguards, in cooperation with the Office of State Programs, Organization of Agreement States, and State of Colorado, has formed the Nuclear Byproduct Material Risk Review Group.
The review group's activities will address byproduct materials as defined in Section 11.e(1) of the Atomic Energy Act of 1954 and Title 10 of the U.S. Code of Federal Regulations, Section 30.4. Specific areas to be addressed will include Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material"; Part 31, "General Domestic Licenses for Byproduct Material"; Part 32, "Specified Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material"; Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"; Part 34, "Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations"; Part 35, "Medical use of Byproduct Material"; Part 36, "Licenses and Radiation Safety Requirements for Irradiators"; and Part 39, "Licenses and Radiation Safety Requirements for Well Logging."
The goals of the Nuclear Byproduct Material Risk Review Group are: 1) to identify and document a technical basis for a risk-informed approach to the regulation of nuclear byproduct material; and 2) to develop plans for a graded approach to nuclear byproduct material regulation, based on risk information. The group's approach will involve systematic evaluations of "nuclear byproduct material systems." Nuclear byproduct material systems will be defined as broadly as is necessary to identify the real-world risks associated with them. A multi-dimensional characterization of risk will be used in evaluating the systems. The plans for a graded approach to regulation will be based on results of the systems evaluations and, as appropriate, will take into account societal and socio-economic factors and non-radiological risks associated with the nuclear byproduct material systems.
The review group met in June, July, August, and September 1997 and is expected to meet at approximately monthly intervals through September 1998. Meetings will be in the Washington, DC, area, or at other areas agreed on by working group members. The meetings will be announced in advance through the NRC Public Meeting Notice System and, with some exceptions, will be open for public observation. Persons attending working group meetings will be welcome to provide comments to the working group for its consideration, either in written form or orally, at times specified by the working group chair.
(Contact: Dennis I. Serig, NMSS, 301-415-7901, e-mail: firstname.lastname@example.org)
Year-2000 Effect on Computer System Software
Information Notice 96-70, "Year 2000 Effect on Computer System Software," and Information Notice 97-61, "U.S. Department of Health and Human Services Letter to Medical Device Manufacturers on the Year-2000 Problem," notified licensees that many computer systems will potentially fail to recognize the change to a new century. These systems will misread "00" or the year 2000, as 1900, and thus may cause the system to fail or generate faulty data. The Year-2000 problem may affect computer systems, software applications, and embedded microprocessors. Because dates are involved in many facets of computer systems and software, the magnitude of the Year-2000 issue poses problems to all those potentially affected.
This issue may affect Nuclear Regulatory Commission licensees in many different ways. For example, computer software used to calculate dose or to account for radioactive decay may not recognize the turn of the century, which could lead to incorrectly calculated doses or exposure times for medical treatment planning and other applications. Other examples of software that may be affected include computer-controlled design, production, quality control processes, security control, radiation monitoring, technical-specification surveillance testing, and accumulated reactor-fuel burn-up programs. Also, equipment that licensees have purchased may contain computer software or embedded microprocessors susceptible to the Year-2000 problem. The problem could occur not only in computer software or data acquired from external sources, but also in programs developed by licensees or consultants. For many licensees, this issue may not prove to be a significant health and safety concern. However, licensees are encouraged to examine their uses of computer systems and software well before the turn of the century. In assessing computer software, licensees may want to consider reviewing those programs used to meet licensing requirements or those that have safety significance.
NRC has established an Internet list server dedicated to the Year-2000 problem. The purpose of the list server is to facilitate the exchange of information among licensees, NRC, and the public. Licensees are encouraged to monitor the list server and to provide suggestions and solutions to the Year-2000 problem. To subscribe to this list, Internet e-mail may be sent to listproc@ nrc.gov with the message: subscribe year-2000 username, where the username is the first and last name of the individual making the request (e.g., John Doe). Furthermore, Year-2000 information is available on the NRC homepage (http://www.nrc.gov) under the "News and Information" option.
NRC inspectors will review the following points during all routine inspections, to draw attention to this issue:
- Confirm that the licensee has received information Notices 96-70 and 97-61.
- Confirm that the licensee is aware of the NRC list server for the Year-2000 problem and encourage its use in sharing any identified problems and solutions.
- Determine whether the licensee has identified any potential problems and, if so, taken corrective actions.
NRC intends to review this information periodically and publish additional information notices and newsletter articles to maintain awareness in the licensee community of Year-2000 issues and corrective actions that have been developed. None of the above items is a specific inspection requirement, and no specific actions are required to comply with them.
(Gary W. Purdy, NMSS, 301-415-7897, e-mail: email@example.com)
Selected Federal Register Notices (June 1, 1997 - August 31, 1997)
Note: Contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
10 CFR Parts 170 and 171, "Revision of Fee Schedules; 100% Fee Recovery, FY 1997, Correction," 62 FR 32682, June 16, 1997.
10 CFR Part 20, et al., "Radiological Criteria for License Termination," 62 FR 39057, July 21, 1997.
(Contacts: Cheryl A. Trottier, RES. 301-415-6232, e-mail: firstname.lastname@example.org; Frank Cardile, RES, 301-415-6185, e-mail: email@example.com; Dr. Carl Feldman, RES, 301-415-6194, e-mail: firstname.lastname@example.org; Christine M. Daily, RES, 301-415-6026, e-mail: email@example.com)
10 CFR Part 13, "Program Fraud Civil Remedies; Technical Amendment," 62 FR 40427, July 29, 1997. (Contact: Susan Fonner, OGC, 301-415-1634, e-mail: firstname.lastname@example.org)
10 CFR Parts 30 and 32, "Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea," 62 FR 32552, June 16, 1997. (Contact: Dr. Anthony N. Tse, RES, 301-415-6233, e-mail: email@example.com)
10 CFR Parts 20 and 40, "Radiological Criteria for License Termination: Uranium Recovery Facilities," 62 FR 39093, July 21, 1997. (Contacts: Joseph J. Holonich, NMSS, 301-415-7238, e-mail: firstname.lastname@example.org; Duane Schmidt, NMSS, 301-415-6919, e-mail: email@example.com; Frank Cardile, RES, 301-415-6185, e-mail: firstname.lastname@example.org)
10 CFR Part 35, "License Term for Medical Use Licenses," 62 FR 40975, July 31, 1997. (Contact: Torre Taylor, NMSS, 301-415-7900, e-mail: email@example.com)
10 CFR Part 35, "Medical Use of Byproduct Material: Issues and Request for Public input," 62 FR 42219," August 6, 1997. (Contacts: Catherine Haney, NMSS, 301-415-6825, e-mail: firstname.lastname@example.org; Diane Flack, NMSS, 301-415-5681, e-mail: email@example.com; Susanne Woods, NMSS, 301-415-7267, e-mail: firstname.lastname@example.org)
10 CFR Part 35, "Medical Use of Byproduct Material: Working Group for Revision," 62 FR 4270, August 8, 1997.
(Contact: Catherine Haney, NMSS, 301-415-6825, e-mail: email@example.com)
10 CFR Part 20, "Reporting Requirements for Unauthorized Use of Licensed Radioactive Material: Withdrawal," 62 FR 42948, August 11, 1997.
(Contact: Mary L. Thomas, RES, 301-415-6230, e-mail: firstname.lastname@example.org)
"Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM): Method of Announcing Working Group Meetings," 62 FR 37585, July 14, 1997. (Contact: CDR, Colleen Petullo, EPA, 702-798-2446)
(General Contact: Kevin Ramsey, NMSS, 301-415-7887, e-mail: email@example.com)
Generic Communications Issued (May 1, 1997 - July 31, 1997)
Note that these are only summaries of U.S. Nuclear Regulatory Commission generic communications. If one of these documents appears relevant to your needs and you have not received it, please call one of the technical contacts listed below. Generic Letters (GLs)
GL 97-03, "Annual Financial Surety Update Requirements for Uranium Recovery Licensees," was issued on July 9, 1997, to uranium recovery licensees and State officials. The letter documents certain procedural requirements for surety submittals. (Contact: Daniel M. Gillen, NMSS, 301-415-7295, e-mail: firstname.lastname@example.org)
Information Notices (INs)
IN 97-23, "Evaluation and Reporting of Fires and Unplanned Chemical Reaction Events at Fuel Cycle Facilities," was issued on May 7, 1997, to all fuel cycle conversion, enrichment, and fabrication facilities. The notice alerts them to requirements for notification and/or reporting of fires and unplanned chemical reaction events (e.g., explosions) at their facilities. (Contact: Garrett Smith, NMSS, 301-415-8118, e-mail: email@example.com)
IN 97-24, "Failure of Packing Nuts on One-Inch Uranium Hexafluoride Cylinder Valves," was issued on May 8, 1997, to all licensees and certificate holders authorized to handle uranium hexafluoride in 76-cm (30-inch) and 122-cm (48-inch) -diameter cylinders. This notice alerts them to incidents where valve packing nuts were found to be cracked. (Contacts: Merri Horn, NMSS, 301-415-8126, e-mail: firstname.lastname@example.org; Christopher Tripp, NMSS, 301-415-7733, e-mail: email@example.com)
IN 97-30, "Control of Licensed Material during Reorganizations, Employee- Management Disagreements and Financial Crises," was issued on June 3, 1997, to all material and fuel cycle licensees. The notice discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. (Contact: Mark A. Sitek, 301-415-6155, e-mail: firstname.lastname@example.org)
IN 97-35, "Retrofit to Industrial Nuclear Company IR100 Radiography Camera to Correct Inconsistency in 10 CFR Part 34 Compatibility," was issued on June 18, 1997, to all industrial radiography licensees. The notice informs them of a scenario where the IR100 camera would not pass the horizontal shock test required by Part 34 and alerts them to a retrofit to correct the problem. (Contacts: David Wesley, CA Dept. of Health Services, 916-445-1884; Michele Burgess, NMSS, 301-415-5868, e-mail: email@example.com)
IN 96-53, Supplement 1, "Retrofit to Amersham 660 Posilock Radiography Camera to Correct Inconsistency in 10 CFR Part 34 Compatibility," was issued on June 23, 1997, to all industrial radiography licensees. The supplement informs them that the retrofit discussed in the original notice must be completed before January 1, 1998, to maintain Part 34 compatibility. (Contact: Michele Burgess, NMSS, 301-415-5868, e-mail: firstname.lastname@example.org)
IN 97-36, "Unplanned Intakes by Worker of Transuranic Airborne Radioactive Materials and External Exposure Due to Inadequate Control of Work," was issued on June 20, 1997, to fuel cycle and power reactor licensees. The notice alerts them to incidents where inadequate controls created a substantial potential for overexposures and resulted in unplanned intakes of radioactive materials. (Contacts: Ronald L. Nimitz, RI, 610-337-5267, e-mail: email@example.com; William J. Raymond, RI, 860-267-2571, e-mail: firstname.lastname@example.org; James E. Wigginton, NRR, 301-415-1059, e-mail: email@example.com)
IN 97-39, "Inadequate 10 CFR 72.48 Safety Evaluations of Independent Spent Fuel Storage Installations," was issued on June 26, 1997, to all independent spent fuel storage licensees and all power reactor licensees. The notice alerts them to inadequate safety evaluations used to determine whether a change, test, or experiment involved an unreviewed safety question. (Contacts: M. Waters, NMSS, 301-415-3875, e-mail: firstname.lastname@example.org; V. Hodge, NRR, 301-415-1861, e-mail: email@example.com)
IN 97-42, "Management Weaknesses Resulting in Failure to Comply with Shipping Requirements for Special Nuclear Material," was issued on June 27, 1997, to all fuel cycle conversion, enrichment, and fabrication facilities. The notice alerts them to three recent events involving the inadvertent shipment of special nuclear material to or from NRC-licensed facilities. (Contacts: Charles A. Hughes, RI, 804-847-7343, e-mail: firstname.lastname@example.org; D.L. Whaley, NMSS, 301-415-8108, e-mail; email@example.com)
IN 97-47, "Inadequate Puncture Tests for Type B Packages under 10 CFR 71.73(c) (3)," was issued on June 27, 1997, to all users and fabricators of Type B transportation packages. The notice alerts them to the recent discovery that two fabricators performed puncture tests using a bar that was not "mounted" as required by the regulation. (Contacts: David Tiktinsky, NMSS, 301-415-5723, e-mail: firstname.lastname@example.org; Ross Chappell, NMSS, 301-415-8510, e-mail: email@example.com)
IN 97-51, "Problems Experienced with Loading and Unloading Spent Nuclear Fuel Transportation Casks," was issued on July 11, 1997, to independent spent fuel storage licensees, designers, and fabricators of independent spent fuel storage installations, and power reactor licensees. The notice informs them of operating experiences and problems encountered with loading and unloading casks for spent nuclear fuel. (Contacts: William D. Reckley, NRR, 301-415-1314, e-mail: firstname.lastname@example.org; Eric J. Benner, NRR, 301-415-1171, e-mail: email@example.com)
IN 97-55, "Calculation of Surface Activity for Contaminated Equipment and Materials," was issued on July 23, 1997, to all uranium recovery licensees. The notice alerts them to the correct method of calculating surface activity of contaminated materials. (Contact: Elaine Brummett, NMSS, 301-415-6606, e-mail: firstname.lastname@example.org)
IN 97-56, "Possession Limits for Special Nuclear Material at the Envirocare of Utah Low-Level Radioactive Waste Disposal Facility," was issued on July 28, 1997, to all licensees authorized to possess special nuclear material. The notice alerts them to recent violations of Envirocare's possession limit for special nuclear material and recommends that they consider actions to assure future waste shipments do not place Envirocare in violation of its license. (Contacts: Harry Felsher, NMSS, 301-415-5521, e-mail: email@example.com; Tim Harris, NMSS, 301-415-6613, e-mail: firstname.lastname@example.org)
IN 97-57, "Leak Testing of Packaging Used in the Transport of Radioactive Material," was issued on July 30, 1997, to all suppliers and users required to perform packaging leak tests. The notice informs them of shortcomings found in the performance of packaging leak tests required for certain transportation packages. (Contacts: James E. Spets, NMSS, 301-415-8553, e-mail: email@example.com); Nancy L. Osgood, NMSS, 301-415-8513, e-mail: firstname.lastname@example.org)
IN 97-58, "Mechanical Integrity of In-Situ Leach Injection Wells and Piping," was issued on July 31, 1997, to all in-situ leach facility licensees. The notice alerts them to leaks related to faulty coupling and configuration of piping. (Contact: J. Robert Tinsley, NMSS, 304-415-6251, e-mail: email@example.com)
(General Contact: Kevin Ramsey, NMSS, 301-415-7887, e-mail: firstname.lastname@example.org)
Significant Enforcement Actions
Detailed information regarding these enforcement actions can be accessed via the Nuclear Regulatory Commission homepage [http://www.nrc.gov]. Click on "Nuclear Materials," then "Enforcement Program," and finally "Enforcement Actions Issued." Cases are listed alphabetically. For details, click on the highlighted text following each case.
National Institutes of Health, Bethesda, Maryland, EA 96-027. A $2500 civil penalty was assessed for failure to secure material from unauthorized removal.
Indiana Department of Transportation, Crawfordsville, Indiana, EA 96-248. A $2500 civil penalty was assessed for two deliberate violations of license requirements.
Indianapolis Department of Capital Asset Management, Indianapolis, Indiana, EA 97-166. A $2750 civil penalty was assessed for a number of violations indicative of a breakdown in control of licensed activities.
David F. Johns, IA 97-026. An order Prohibiting Involvement in NRC-Licensed Activities was issued because the individual deliberately violated the conditions of a Commission order by continuing to use moisture density gauges.
Fairbanks Memorial Hospital, Fairbanks, Alaska, EA 96-505. A $2500 civil penalty was assessed for willful failure to obtain the physician authorized user's signature on a written directive, which led to a misadministration.
Jose L. Fernandez, M.D., San Juan, Puerto Rico, EA 97-137. An $8000 civil penalty was assessed for numerous violations indicative of a very significant breakdown in control of the licensed program.
Lower Bucks Hospital, Bristol, Pennsylvania, EA 97-005. A $2500 civil penalty was assessed for failure to follow procedures for recovering and disposing of a nuclear pacemaker.
St. Francis Hospital, Escanaba, Michigan, EA 96-491. A $2500 civil penalty was assessed for deliberately preparing inaccurate records.
Washington Hospital Center, Washington, D.C., EA 96-385. A $5000 civil penalty was assessed for failure to perform bioassays and loss of control of material.
Other Materials Licensees
Roy Sadovsky, D.V.M., Floral Park, New York, EA 97-150, IA 97-024. An Order Prohibiting Involvement in Licensed Activities was issued and a $4000 civil penalty was assessed for deliberate use of licensed material at a location not authorized on the license and numerous other violations indicative of a very significant breakdown in control of licensed activities.
(Contact: Joseph DelMedico, OE, 301-415-2739, e-mail: email@example.com)
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: firstname.lastname@example.org