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This letter responds to questions from the many individuals who received letters outlining potential deficiencies in their written quality management programs (QMPs). We wish to emphasize that the identified potential weaknesses in the QMPs do not represent a finding of fact by this Agency or our contractor. The reviewers did not visit your facility, but based their letter on a checklist review, to determine if the reader could conclude, on the basis of a paper review, alone, that the written QMPs were adequate. Such paper reviews may not reflect the situation as it actually exists.
The Office of Nuclear Material Safety and Safeguards staff agrees with a comment from a licensee that, "It is the responsibility of physicians to properly diagnose and treat patients and to ensure that they receive the correct type of radioactive material and in the proper dose." Unfortunately, our experience has shown that regulation is required to ensure that policies and procedures will be implemented to ensure that byproduct material will be administered as directed by the authorized user physician. NRC does not regulate the dose nor dosage prescribed by the physician.
The primary purpose of the review of licensees' written QMPs was to identify, to our inspectors, those areas of the QMP that should be examined in the greatest detail during site visits. However, if the contractor identified potential significant weaknesses, licensees needed to be alerted, to avoid misadministrations or violations of NRC regulations. We chose to err in the direction of identifying, rather than missing, weaknesses, because of the very serious consequences of some misadministrations. Strong language was used to warn recipients of potential serious consequences if, in fact, significant weaknesses existed in the QMP. Clearly, in retrospect, we should have more clearly qualified our concerns with some QMPs as being potential concerns rather than factual concerns arising from an actual site visit.
Some licensees from whom responses were required may find, after review of the actual policies and procedures, that only minor, if any, changes are required. However, we do expect that serious consideration will be given to all issues identified, before licensees conclude that no changes are needed.
We have received complaints from licensees that the letter reviews of their QMPs, outlining weaknesses in their programs, arrived after NRC site inspections where no QMP weaknesses were identified. Until August 1994, NRC inspectors only ensured that the licensee had developed and implemented a QMP, but did not evaluate the program. However, you should not depend on an NRC inspector to recognize and identify all weaknesses in the QMP. We recognize and acknowledge that medical licensees have more training and experience in medical procedures and practice than do NRC staff or contractors. The primary responsibility for identification of procedural deficiencies lies with each licensee.
Please consider the potential weaknesses described in our review letter as issues to revisit. If you find that some of the comments do represent significant weaknesses, take this opportunity to correct them now before any mishaps or violations occur. The majority of licensees did receive similar letters. In some cases, the actual programs will turn out to be excellent. In other cases, the significant perceived weaknesses are real. These reviews were a unique undertaking for NRC. We take comments seriously and will consider them part of our lessons learned.
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The U.S. Nuclear Regulatory Commission contracted with Lawrence Livermore National Laboratory (LLNL) to review the submitted quality management programs (QMPs). LLNL subcontracted with a major medical institution to assist with the reviews. The review of the 1709 QMPs is complete. The findings of the contractor, following NRC guidelines, were:
Thirty-five (35) of the submitted QMPs, as written, appeared to meet the objectives listed in 10 CFR 35.32;
Two-hundred and seventy-eight (278) of the submitted QMPs, as written, had weaknesses, but appeared to meet the listed objectives; and,
One-thousand, two-hundred and twenty-eight (1228) of the submitted QMPs, as written, failed to meet at least one of the listed objectives.
The remaining 168 licensees provided a negative declaration, in writing, that byproduct materials or radiation therefrom, affected by the requirements of 10 CFR 35.32, are not being administered to patients, and committed to provide a QMP before use of such material.
The 72 percent of QMPs that fell into the third category above varied in their safety significance. For example, some QMPs requiring preparation of a written directive failed to include all the necessary elements of a written directive, whereas others failed to include procedures to verify, immediately before administration, that all aspects of the administration are in accordance with the written directive.
Revised QMPs will be reviewed by NRC inspectors, in preparation for routine inspections, during which they will evaluate licensees' implementation of their QMPs. Revised QMPs may also be reviewed as part of the license renewal or amendment process.
As of August 1994, NRC began reviewing the licensee-implemented QMPs as part of a routine inspection. Before this date, the QMP review conducted by the inspectors ensured that a QMP had been developed and implemented, but did not review the program, itself, unless implementation was not apparent, or an incident had occurred.
For the next 2 years, NRC will be collecting the information from the inspections of QMPs and the findings from incident response teams, to evaluate the effectiveness of the Quality Management and Misadministrations (QM) rule (10 CFR 35.32 and 35.33). Findings of the contractor's review, results of reactive inspections to evaluate misadministrations, and results of routine inspections evaluating licensee implementation of the QM rule will ultimately be shared with the regulated community, through an informational document such as a NUREG.
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The U.S. Nuclear Regulatory Commission is seeking input from the medical community regarding the adequacy of existing standards and procedures for brachytherapy and radiopharmaceutical therapy and would like to discuss the future direction of guidelines and regulations. As one aspect of these objectives, on November 3, 1994, NRC published a list of issues and questions in the Federal Register (59 FR 55068), to allow the medical community and any other interested parties to voluntarily provide comments and responses regarding those areas of medical use of byproduct material that are currently being reviewed by NRC. The responses will be used as part of an evaluation to determine if additional or revised regulations or guidance are warranted. The list of issues focuses on high-dose-rate remote afterloading brachytherapy, manual brachytherapy, and radiopharmaceutical therapy. In particular, the issues of dose fractionation, source calibration, source placement, and training and experience are addressed. For further information, or to obtain individual copies of the list of issues and questions, please contact Patricia K. Holahan at 301-415-7847.
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On October 20, 1994, the staff briefed the Commission on the annual report on the medical use regulatory program (SECY-94-256, "Annual Report on the Medical Use Program, Including Status Reports on Implementation of the Medical Management Plan (MMP) and Quality Management (QM) Program and Misadministrations Rule," October 13, 1994). The MMP is a 5-year management plan containing over 90 action items categorized in nine major program areas. These include licensing and inspection, rulemaking, misadministration policy, enforcement, and research studies. Over one-half of the action items are considered closed, whereas others are either partially closed or not yet addressed because they depend on the closure of precursor items. The staff continues to address both short- and long-term action items to resolve policy issues and specific tasks, while adjusting program priorities in response to unforeseen events and changing needs. The annual report also discusses the staff effort to implement the QM rule since it became effective on January 27, 1992. These efforts include contractor review of licensee-submitted QM plans, inspection effort, enforcement issues, and staff recommendations. Each subsequent annual report will provide status reports on the MMP and implementation of the QM rule, until all items have been resolved.
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A notice was published in the Federal Register on November 7, 1994 (59 FR 55496) to solicit nominations for the Medical Visiting Fellows Program. The U.S. Nuclear Regulatory Commission is primarily seeking physicians who have qualifications and experience in the medical specialty of Radiation Oncology or Therapeutic Radiological Physics. Others having such qualifications are also invited to apply. Individuals participating as Fellows would join NRC for approximately 1 year, to undertake activities consistent with the interests and needs of NRC and with the individual's training and experience. Ideally, the Fellow would be available to NRC on a full-time basis; however, NRC will consider nominees who propose less than full-time availability. Appointments will be made by means of Intergovernmental Personnel Act assignment, reimbursable detail, or professional term appointment, depending on the selectee's situation. Compensation will be commensurate with the Fellow's experience, salary history and Federal pay guidelines while serving as a Fellow. The duty location is NRC Headquarters, located in Rockville, Maryland, a suburb of Washington, D.C. It is assumed that there will be some travel with this position. Candidates may be nominated by professional groups, medical societies, government agencies, or may be self-nominated. Nominations are due by January 15, 1995, and should be forwarded to: Secretary of the Commission. ATTN: Medical Visiting Fellows Program Manager, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001. For further information, contact Janet Schlueter, Medical Visiting Fellows Program Manager, at (301) 415-7894 or facsimile (301) 415-5369.
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As part of their radiation protection programs, licensees are required, by 10 CFR 20.1101(b), to use, to the extent practicable, procedures and engineering controls to achieve occupational doses, and doses to members of the public, that are as low as is reasonably achievable (ALARA). Because effluents from licensed facilities, whether airborne or liquid, contribute to the dose to members of the public, licensed facilities must meet the ALARA requirement for effluents, thus keeping doses ALARA. To ensure the application of ALARA to effluents from materials facilities, NMSS has increased the emphasis on inspection of this area of materials licensees' programs. The inspection procedure (IP) used for this purpose is IP 87102, "Maintaining Effluents from Materials Facilities As Low As Is Reasonably Achievable (ALARA)." The procedure was first issued in January 1994, and was reissued in revised form in November 1994. The U.S. Nuclear Regulatory Commission also provided guidance to licensees on the type of program it would consider acceptable in meeting the ALARA requirement for effluents. This guidance was published in July 1993, as Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities." The guide provided acceptable goals for effluents from these facilities.
In addition to being regulated by NRC, the air emissions from NRC-licensed facilities are also subject to the U.S. Environmental Protection Agency's (EPA's) 40 CFR Part 61, Subpart I, "National Emission Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory Commission and Federal Facilities Not Covered by Subpart H." NRC has agreed to provide EPA with information on air emissions obtained during its routine implementation of IP 87102. A form for that purpose, called the Inspection Referral Form, was included in the IP. This form lists the licensee's ALARA goal for effluents, if it was above the goal recommended in NRC's Regulatory Guide 8.37, which is 20 percent of the 10 CFR Part 20, Appendix B, concentrations. A section in the form also classifies the licensee's performance, with respect to its goal, by indicating whether the licensee met its ALARA goal, and also whether it exceeded the goal in Regulatory Guide 8.37. This information is relevant to EPA because the goal recommended in Regulatory Guide 8.37 is equivalent to the limit in EPA's 40 CFR Part 61, Subpart I. This form is to be filled out by the NRC inspector at the end of the inspection, and provided to the State and Government Affairs Officer for transmittal to EPA. IP 87102 also requires that a copy of the NRC inspection report, or inspection notes, be forwarded to EPA, with the Referral Form, in case of any enforcement action in the effluents area. It should be emphasized that the Referral Form does not in any way substitute for the annual compliance reporting requirements imposed on licensees by EPA's 40 CFR Part 61, Subpart I. Determination of compliance with this rule, and its enforcement, rests entirely with EPA. Copies of this IP (or any other inspection manual chapters) can be obtained electronically, through the NRC electronic bulletin board system, at 800-679-5784 or 301-504-1778 (see NRC Administrative Letter 94-13).
The Office of Nuclear Reactor Regulation, Division of Project Support, is also incorporating the Inspection Referral Form used in IP 87102 into its non-power reactor IPs, IP 80745 and IP 40750. These procedures are used in inspections of Class I and Class II research and test reactors. The reactor classifications I and II are roughly equivalent to the priority classification of material licensees.
Licensees: Please note: The article "Compliance with EPA's 40 CFR Part 61 Air Emissions Standard" (NMSS Licensee Newsletter, NUREG/BR-0117, No. 94-3, September 1994/October 1994) had a specific typographical error throughout the text. Please substitute "ÁSv" for all "mSv's." We regret this error and any problems it caused.
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U.S. Nuclear Regulatory Commission byproduct materials licenses expire 5 years after issuance. Before the expiration date, licensees must either apply for renewal of the license in accordance with 10 CFR 30.37, "Application for renewal of licenses," or comply with 10 CFR 30.36, "Expiration and termination of licenses."
In accordance with 10 CFR 30.36, unless the licensee files a renewal application, the licensed material must be properly disposed of and a certificate of disposal must be provided to NRC on or before the expiration date on the license. Once the license expires, continued possession of any byproduct material authorized on the license becomes a violation of 10 CFR 30.3, "Activities requiring license." Similar requirements exist for source material licensees under 10 CFR Part 40, and for special nuclear material licensees, under 10 CFR Part 70.
Some NRC licensees choose not to renew their license. In other cases, because a licensee has not paid an inspection fee nor annual fee, the NRC Controller has revoked the license and ordered the licensee to transfer all licensed material to an authorized recipient. In recent enforcement cases where former licensees continue to possess licensed material without a valid NRC license, the NRC staff has issued a Notice of Violation and Proposed Imposition of Civil Penalty.
In some cases, it appears that the reason for not transferring nor disposing of the material is a conscious decision not to expend the funds that would be required. In other cases, it appears that former licensees do not wish to pay the fee to renew the license until business conditions improve, but are keeping the licensed material in their possession in the meantime. Such violations are considered to be deliberate if they continue after the NRC staff has provided adequate notice to the former licensee.
A number of individuals who retained possession of radioactive sources in measuring devices after the NRC licenses expired have been assessed civil penalties of $3000 each. These individuals were also given notice that if they fail to transfer the licensed material within 30 days, the NRC staff intends to assess an additional daily civil penalty of $500 for each day until compliance is achieved. The NRC Enforcement Policy (10 CFR Part 2, Appendix C) indicates that if particularly serious violations occur, such as in cases involving willfulness, NRC may use discretion to escalate civil penalties or assess civil penalties for continuing violations on a per day basis.
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Over the past several years, many licensees have requested termination of their licenses. Many of these licensees have also held certifications, approvals, or registrations, issued by the U.S. Nuclear Regulatory Commission, that they believed would be terminated as a result of their request for license termination. However, the request for license termination did not specifically request termination of the certifications, approvals, or registrations. As a result, the certifications, approvals, or registrations remained active even though the licensees no longer possessed material. Many licensees were not aware that the aforementioned items were not terminated, until they received a bill for the materials annual fees issued under 10 CFR Part 171.
On termination of activities associated with a certification, approval, or registration issued by NRC, the holder of the certification, approval, or registration is responsible for submitting a request to the appropriate NRC office to terminate the certification, approval, or registration. Below is a list of three types of certifications, approvals, or registrations that licensees have failed to terminate once the licensees have discontinued activities associated with the aforementioned. Requests for terminations should be mailed to the appropriate address listed below.
1. Certificate of Compliance or other Package Approval --A document that is issued based on NRC's evaluation and approval of a packaging design that meets the requirements and standards for packaging and shipping fissile material and quantities of other licensed material in excess of a Type A quantity. The document is issued in accordance with 10 CFR Part 71, Subpart D.
Mailing Address for Terminations:
U.S. Nuclear Regulatory Commission
ATTN: Cask Certification Section
Mailstop T-8 F5
If you have any questions about the fee requirements for a certification, approval, or registration, please contact the License Fee and Debt Collection Branch at (301) 415-7544.
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For about 40 years, the U.S. Department of Energy (DOE) or its predecessors have owned and directed the operation of uranium enrichment plants at Paducah, Kentucky, and Portsmouth, Ohio. Working in tandem, the plants enrich uranium through the gaseous diffusion process. Information on the process was once classified in the interests of national security, but now only a few details remain classified. The enrichment process begins at the Paducah plant, which receives its feed, natural UF6, from nearby Allied Signal, a U.S. Nuclear Regulatory Commission licensee. Paducah product comprises UF6 enriched to about 2 percent, which is shipped 300 miles to Portsmouth for further enrichment.
Although its feed is mostly the Paducah 2 percent material, the Portsmouth plant can also enrich natural uranium and regularly does so for commercial customers. The plant was designed to enrich uranium up to a few points short of 100 percent, with intermediate enrichments being available. The highly enriched UF6 product was used by NRC licensees such as Nuclear Fuel Services, Babcock and Wilcox, and United Nuclear Corporation to produce fuel for the nuclear Navy. Product at 4 percent or 5 percent enrichment is also available and is used to fuel many domestic and foreign power reactors. In recent years the need for high enriched fuel has declined, and the high enriched segment of the enrichment process has been shut down, with no immediate prospect of reactivation. Production of UF6 at enrichments suitable to fuel nuclear power plants continues without interruption.
In October 1992, Congress enacted the Energy Policy Act of 1992. Among other things, the Act created the United States Enrichment Corporation and directed DOE to lease the two plants to the corporation. However, DOE is prohibited from leasing facilities for the production of high enriched uranium. The corporation is to operate the plants and market the enriched product on a profitable and efficient basis. The corporation is also directed to negotiate the purchase of high enriched uranium offered by any State of the former Soviet Union. This uranium is some of that produced in the nuclear weapons program of the former Soviet Union. Finally, the corporation is directed to assume management of new alternative technologies for the enrichment of uranium, including the atomic vapor laser isotope separation technology.
The Act directed NRC to regulate safety and safeguards at the gaseous diffusion plants operated by the corporation and specified, to some degree, how this was to be carried out. In consultation with the U.S. Environmental Protection Agency and DOE, NRC is to provide a report to Congress, at least once each year, on the status of health, safety, and environmental conditions at the plants. The report is to include a determination of whether the plants are in compliance with applicable NRC regulations, which the Act refers to as "standards." NRC was to establish a certification process to ensure that the corporation complies with the standards. The standards, including the certification process, were to be promulgated through the rulemaking process within 2 years after enactment of the act, that is, by October 1994. The corporation is to apply to NRC, annually, for a certificate of compliance with the NRC standards, and the certification process is to be in lieu of any requirement for a license. The act addresses the possibility that the corporation initially may not be in compliance with all provisions of the NRC standards. In that case, DOE is to prepare a plan for bringing the plants into compliance with the unsatisfied provisions. The plan would be submitted to NRC at the time of the corporation's initial application for certification.
For the past 2 years, the Nuclear Material Safety and Safeguards Enrichment Branch has been engaged in preparation of the regulation that would govern the plants. Dubbed Part 76, the regulation was issued in proposed form in February 1994 and in final form in September 1994, a few weeks ahead of the mandated date. The regulation applies only to the gaseous diffusion plants operated by the corporation.
The next major milestone in the certification process will be the receipt of the corporation's application, which is expected in April 1995. The Enrichment Branch staff is carrying out a pre-application evaluation of various difficult safety and safeguards issues that must be considered in the certification process. These include consideration of fire protection, accident analysis, plume modeling, criticality prevention, potential seismic and high wind damage, radiation protection, and other related issues. Evaluation of the application will take place between April and October 1995. Issuance of the initial certificate of compliance is expected shortly after conclusion of the evaluation. Until the initial certificate is issued, DOE will oversee regulation of safety and safeguards at the sites.
An important part of the certification process will be NRC verification that the plants are equipped and organized to comply with the regulations in Part 76 and to carry out the commitments made in the corporation's application. Some of the verification will be undertaken by Region III, which currently has one resident inspector at each site. A second will soon be added to each site. The remainder of the verification was undertaken by the NMSS Operations Branch, commencing in October 1994, and likely continuing until certification is complete. Current estimates for verification staffing call for over 200 staff days at the sites.
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In the NMSS Licensee Newsletter (June/August, 1994), the U.S. Nuclear Regulatory Commission provided Part III of a series of questions on low-level waste storage. The first question concerned whether generators in States denied access to LLW disposal facilities, as many now are in the United States, can dispose of their waste by shipping it to brokers in States with access. Our answer noted that compacts and States with operating disposal facilities, under the Low-Level Radioactive Waste Policy Amendments Act of 1985, can deny access for disposal to generators located in States outside the compact. It also recommended that generators consult with State and compact officials for answers to questions that pertain to disposal outside their region.
As noted by one of the States after the article was published, if a generator has already been denied access to an operating disposal facility because of the State in which it resides, shipping to a broker will not change that fact. NRC agrees with and appreciates that clarification and is providing it here for all licensees.
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The Nuclear Material Safety and Safeguards staff has recently revised the standard review plan (SRP) for the use of sealed sources in portable gauging devices. This document is used by the U.S. Nuclear Regulatory Commission's regional offices, in the review of this category of license applications. The SRP, which was recently sent to all NRC portable gauge licensees and portable gauge manufacturers, contains the text of a draft regulatory guide (RG) that will be published for comment by the Office of Nuclear Regulatory Research, and includes notes to the NRC license reviewer, which are printed in bold. The revised SRP reflects the requirements in new 10 CFR Part 20, which became effective January 1, 1994, and the NRC staff's experience with portable gauge licensees. The document contains a number of appendices that:
The SRP is NRC's most up-to-date guidance for portable gauge licensees and we suggest that portable gauge applicants and licensees use it in the preparation of applications for new licenses, major amendments, and license renewal. During this interim period before publication of the draft RG for comment, send comments to:
U.S. Nuclear Regulatory Commission
ATTN: Ms. Patricia Vacca
Mail Stop T-8 F5
Washington, DC 20555-0001
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To address Congressional concerns about radioactive contamination at sewage treatment plants, the U.S. Nuclear Regulatory Commission is currently revising the record retention requirements of 10 CFR Parts 20, 30, 40, 61, 70, and 72, to ensure the long-term availability of certain records when a licensee terminates licensed activities or when licensed activities are transferred to another licensee. The rulemaking will require that records concerning decommissioning of the facility, public dose, and waste disposal be transferred to the new licensee, when licensed activities will continue at the same location under a new or amended license, or to NRC, when all licensed activities cease and the license is terminated.
NRC regional offices have been directed that, until such time as the rulemaking is final, no transfers nor changes of ownership or license terminations are to be authorized unless all records considered important to the safe and effective decommissioning of the facility (10 CFR 30.35(g), 40.36(f), 70.25(g), and 72.30(d)) and all records concerning radiation doses to the public and waste disposal (such as releases to sewers, incineration, radioactive spills, and onsite burials) have been transferred to the person continuing the licensed activity, or to NRC, for license terminations. In addition, 10 CFR 61.30(a)(1) and 61.31(c) are being revised to clarify that records required by 10 CFR 61.80(e) and (f) must be transferred to the disposal site owner or to the party responsible for institutional control of the disposal site, and the Commission, respectively.
In support of this directive, the Office of Nuclear Material Safety and Safeguards is revising Information Notice No. 89-25, "Unauthorized Transfer of Ownership or Control of Licensed Activities," to inform licensees of their responsibility to transfer all records concerning decommissioning, and all Part 20 records for public doses and waste disposal, as well as of their liability for open inspection issues, potential enforcement actions, and decontamination and decommissioning of the site. The information notice also will provide guidance about the information to be submitted to NRC before the planned transfer of ownership or control of licensed activities. Policy and Guidance Directive PG 1-13, "Guidelines for Material Licensing Cases Involving Change of Ownership," which provides guidance to NRC license reviewers, is also being revised, to provide guidance on retention of records regarding decommissioning, public dose, and waste disposal.
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On January 31, 1991, Louisiana Energy Services (LES) submitted a license application to construct and operate a uranium enrichment facility near Homer, Louisiana, in Claiborne Parish. The facility, to be called Claiborne Enrichment Center (CEC), would enrich uranium to a maximum 5 percent uranium-235 by the gas centrifuge process, and would have a capacity of about 1.5 million separative work units (SWUs) per year. If licensed, LES would receive a combined 30-year license for construction and operation. This facility would become the first privately owned enrichment facility in the United States.
The staff has completed its review of the license application. The Safety Evaluation Report was issued in January 1994 as NUREG-1491; the Final Environmental Impact Statement was issued in August 1994 as NUREG-1484. The U.S. Nuclear Regulatory Commission staff has concluded that the CEC can be constructed and operated with small and acceptable impacts on the environment and that the facility does not pose undue risk to the public health and safety. The aforementioned documents support issuance of a combined construction/ operating license for the facility.
The organization Citizens Against Nuclear Trash (CANT) opposes licensing of the CEC. NRC's Atomic Safety and Licensing Board (ASLB) is holding a formal adjudicatory hearing in two phases: phase 1 has covered the safety issues and phase 2 will cover the environmental issues. The first phase of the hearing was held in Shreveport, LA, in July 1994. The ASLB heard testimony on emergency planning and safeguards issues. The second phase of the hearing will likely be held in early 1995 in Shreveport, LA. Issues likely to be heard include: completeness of the license application, decommissioning cost estimates, need for the facility, groundwater and surface water impacts, environmental justice, analysis of the no-action alternative, financial qualifications, and tails disposition. CANT, LES, and the NRC staff are the participants in the hearing. The ASLB will issue a decision after the hearing is complete.
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October 7 - November 28, 1994
Note that these are only summaries of U.S. Nuclear Regulatory Commission publications. If one of these publications appears relevant to your needs and you have not received it, we recommend that you obtain the notice from the NRC contact listed here and/or speak with the contact about its provisions.
A. CORRECTION: "Issues Associated with Use of Strontium-89 and other Beta-Emitting Radiopharmaceuticals," IN 94-70, September 29, 1994.
Technical Contact: Torre Taylor, NMSS, 301-504-2434
On page 3, there is an error in the conversion of two doses to SI units. In the third paragraph, 1.8 rad is 0.018 Gy, and 720 mrads is 720 x 10-3 Gy.
B. "Clarification of Criticality Reporting Criteria," IN 94-73, October 12, 1994.
Technical Contact: Jerry Roth, NMSS, 301-415-7156
This notice clarifies reporting criteria previously provided in Bulletin 91-01, Supplement 1, issued on July 27, 1993. It specifies that NRC expects immediate reports for events involving loss of criticality controls-- those to be made within 4 hours--to be made by an individual knowledgeable about the plant's operation, such as an operator or manager. It also rephrases Criterion 1 for reporting by expressing it as two separate criteria, meaning that there is a total of five criteria.
C. "Facility Management Responsibilities for Purchased or Contracted Services for Radiation Therapy Programs," IN 94-74, October 13, 1994.
Technical Contacts: Sally L. Merchant, NMSS, 301-415-7874; Patricia K. Holahan, NMSS, 301-415-7847
This notice reminds licensees that when they contract for patient services, they remain responsible for regulatory compliance and for implementation of the radiation safety program and Quality Management Plan; responsibility is not transferred to the contractor. Licensee management should ensure that adequate mechanisms are in place. The notice discusses two incidents in which licensees contracted for radiation therapy services and failed to maintain management oversight of the contracted program.
D. "Accuracy of Bioassay and Environmental Sampling Results," IN 94-81, November 25, 1994.
Contact: Scott W. Moore, NMSS, 301-415-7875
This notice alerts licensees to the issuance of a November 8, 1994, press release (attached to the notice) from the Department of Energy (DOE), which states that DOE is cooperating with other Federal authorities who executed a search warrant for the records of Controls for Environmental Pollution (CEP), a bioassay and environmental sampling contractor that analyzed samples for the bioassay program at Sandia National Laboratory. Quality control testing raised questions about the reliability of CEP's reports. Licensees may wish to determine whether they have used CEP services, how the results were used, and whether inaccurate results would have any safety significance. If inaccurate results could cause significant safety concerns, licensees may wish to consider what actions would be appropriate to confirm their sample results.
"Corrosion Problems in Certain Stainless Steel Packagings Used to Transport Uranium Hexafluoride," Bulletin 94-02, November 14, 1994.
Contacts: Ross Chappell, NMSS, 301-415-7276; Nancy Osgood, NMSS, 301-415-7879
This bulletin: (1) notifies registered users of Model Nos. NCI-21PF-l and GE-21PF-1 uranium hexafluoride transportation packages that some packages manufactured with a phenolic foam high in chlorides have exhibited pitting and corrosion problems; (2) advises addressees that these packages do not conform to the applicable NRC Certificate of Compliance; (3) reminds addressees that packagings that are not in accordance with the NRC Certificate of Compliance, or that are in an impaired physical condition, are not authorized for transport under the general license provisions of 10 CFR 71.12; and (4) requires addressees to reply in writing whether they intend to discontinue use of the packagings with the high-chloride foam that are not in accordance with the NRC Certificate of Compliance.
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October 1 - November 1, 1994
"Draft Policy Statement on Agreement States Program: Extension of Comment Period," 59 FR 52316
1. Published: October, 17, 1994
2. Contact: Maria Lopez-Otin, OSP, 301-504-2598
"Final Memorandum of Understanding between the U.S. Nuclear Regulatory Commission and the State of New Hampshire," 59 FR 52321
1. Published: October 17, 1994
2. Contact: John R. Jolicoeur, AEOD, 301-415-6383
Eric Weinstein, AEOD, 301-415-7559
"Land Ownership Requirements for Low-Level Waste Sites; Extension of Comment Period," 59 FR 52941
1. Published: October 20, 1994
2. Contact: Mark Haisfield, RES, 301-415-6196
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One way to avoid regulatory problems is to be aware of enforcement problems others have faced.
1. Paul A. Bauman, IA 94-020
An Order Requiring Notification to the U.S. Nuclear Regulatory Commission Prior to Involvement in NRC-Licensed Activities (Effective Immediately) was issued August 26, 1994, to the above individual. The action was based on the failure to train and certify personnel, creation of false records, and providing false information to NRC. The Order requires, for a period of 3 years, that the individual provide notice to NRC of his acceptance of each employment offer in NRC-licensed activities.
2. Oncology Services Corporation (OSC), Hershey, Pennsylvania, EA 93-006
An Order Suspending License (Effective Immediately) was issued January 20, 1993, based on the completion of ongoing NRC investigations and licensee corrective actions after a November 16, 1992, incident in which an iridium-192 source broke off of the metal drive wire of a high-dose-rate (HDR) remote afterloader brachytherapy machine and remained lodged in a catheter that had been placed in a patient to accommodate the treatment. An Order Modifying the License was issued May 21, 1993, which corrected a statement in the original order. The licensee requested a hearing in February 1993. The proceeding was dismissed August 31, 1994, because, in response to OSC requests, the staff: (1) recently issued individual byproduct materials licenses for five of the facilities that authorize HDR brachytherapy treatments at each facility; and (2) terminated the single OSC license that was suspended pursuant to the order at issue.
3. Chesapeake Imaging Center, Inc., San Diego, California, Supplements IV and VI, EA 93-214
A Notice of Violation and License Termination was issued July 14, 1994, based on violations involving the failure to notify NRC when licensed activities were begun and the failure to conduct weekly radiation surveys for removable contamination. A civil penalty was not issued because the licensee requested termination of the license and an Order Prohibiting Involvement in NRC-Licensed Activities was issued to the owner of the company.
4. Indiana University School of Medicine, Indianapolis, Indiana, Supplement VI, EA 93-111
A Notice of Violation and Proposed Imposition of Civil Penalty was issued October 7, 1993, to emphasize the importance of adequate implementation of the quality management program for teletherapy administrations. The action was based on a violation involving the failure of the quality management program (QMP) to ensure that a written directive contained the total dose, dose per fraction, treatment site, and the overall treatment period, as required by 10 CFR 35.2. Additionally, the QMP did not have a procedure to verify dose calculations in cases where the prescribed dose is three fractions or less. The licensee responded in a letter dated October 29, 1993. After consideration of the response, an Order Imposing Civil Monetary Penalty was issued January 18, 1994. The licensee requested a hearing on February 15, 1994. A Settlement Agreement was issued August 29, 1994.
5. Jones Inspection Services, Alderson, Oklahoma, EA 94-138
An Order to Cease and Desist Use and Possession of Regulated Byproduct Material in NRC Jurisdiction was issued July 26, 1994. The Order was based on the possession of at least three radiographic exposure devices containing sealed sources of radioactive material and the use of these devices in Oklahoma without either obtaining an NRC license, as required by 10 CFR 30.3, or authorization from NRC, as required by 10 CFR 150.20 of NRC's regulations. The Order required: (1) that the licensee immediately cease and desist the use of all regulated byproduct material; (2) placement of all such material in safe, locked storage pending transfer; (3) within 5 days, transfer of the material to an authorized recipient; (4) notification of NRC 1 day before the transfer; and (5) within 10 days of the Order, certification that the material was transferred.
6. St. Vincent Hospital and Health Center, Billings, Montana, Supplement VI, EA 94-078
A Notice of Violation and Proposed Imposition of Civil Penalty was issued August 23, 1994, to emphasize the need for rigorous compliance with NRC's quality management regulations. The action was based on failures in the implementation of the licensee's medical QMP, one of which contributed to administrations of radiation to patients that were 21 to 30 percent greater than intended by the prescribing physician.
7. Richardson X-Ray, Inc., Rancho Dominguez, California, Supplement VI, EAs 93-201 and 93-273
A Notice of Violation and Proposed Imposition of Civil Penalties and Demand for Information were issued November 5, 1993, to emphasize the need for effective management oversight of the licensee's radiation safety program. The actions were based on failures to perform adequate surveys, to properly post radiation areas, to provide training to an assistant radiographer, to block and brace material during transport, and failure of an assistant radiographer to wear an alarm ratemeter.
8. The Curators of the University of Missouri, Columbia, Missouri, EA 94-113
A Confirmatory Order Modifying License (Effective Immediately) was issued July 13, 1994. The action was based on numerous violations that were identified during an inspection that indicated that: (1) the radiation safety staff and radioactive material users had insufficient knowledge of license conditions and NRC requirements and an inadequate sense of accountability regarding compliance with radiation safety requirements; and (2) licensee management was ineffective in completing self- assessments that ensured safe program implementation. The Confirmatory Order provided: (1) a complete and thorough evaluation of the radiation safety practices and program, to determine the licensee's compliance with NRC requirements; (2) a compilation of radiation safety deficiencies from that effort; (3) a complete root-cause analysis of those deficiencies; and (4) a description of corrective actions to accomplish the improvements necessary for lasting correction of the deficiencies.
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|Event:||Teletherapy Misadministration at Triangle Radiation Oncology Associates in Pittsburgh, Pennsylvania|
|Date Reported:||December 20, 1993|
|Licensee:||Triangle Radiation Oncology Associates, Pittsburgh, Pennsylvania|
On December 20, 1993, Triangle Radiation Oncology Associates in Beaver, Pennsylvania, notified the U.S. Nuclear Regulatory Commission of two potential teletherapy misadministrations that occurred between December 13 and 17, 1993, at the licensee's Pittsburgh, Pennsylvania, facility. The potential misadministrations were identified during a review of patient records on December 17, 1993, when the licensee observed calculation errors involving the depth of the dose given to each of the two patients.
Both cases involved breast cancer treatments where the original treatment plan prescribed 28 treatments of 180 centigray (cGy) (180 rad) from a cobalt-60 teletherapy source for a total absorbed dose of 5040 cGy (5040 rad). The primary breast cancer treatments were concluded on December 10, 1993. The physician wrote separate written directives for each patient to receive an additional 1000 cGy (1000 rad) to the scar in five treatments of 200 cGy (200 rad) per day. One of the written directives indicated that the absorbed dose was to be delivered at dmax, the maximum extension of the teletherapy unit, which, as stated by the physicist, is typically a depth of 0.5 centimeter (cm) (0.2 inch). The other written directive did not indicate a depth; however, the physician stated that the intended depth was dmax.
As described above, such a treatment plan would typically have been calculated by the teletherapy technologist at the Pittsburgh facility and communicated by telephone to the teletherapy physicist at the Beaver facility, to be checked. However, this procedure changed when the computer at the Pittsburgh facility was taken out of service on December 1, 1993.
On December 9, 1993, the teletherapy technologist hand-wrote a paraphrased request of the written directive for the two breast-cancer-treatment patients needing scar booster dose calculations. Rather than writing dmax, the technologist indicated a tumor dose depth of 5 cm (2 inches) and sent the request, via facsimile transmission, to the teletherapy physicist at the Beaver facility. Hand calculations were performed for 200 cGy (200 rad) treatments at a 5-cm (2-inch) depth, checked by a certified physicist, and sent back to the technologist, via facsimile transmission, on December 9, 1993.
The patients were treated from December 13 to 17, 1993, and received doses of 1300 and 1320 cGy (1300 and 1320 rad) respectively, rather than the 1000 cGy (1000 rad) intended. This resulted in misadministrations of 30 and 32 percent greater than the intended doses. The licensee's physician stated that no adverse clinical effects were expected as a result of the overexposures.
After the initial report, the licensee told NRC, in subsequent telephone conversations, that a recalculation of the dose averaged over the entire tumor volume did not exceed 30 percent and, therefore, the licensee no longer thought the definition of a misadministration applied in this case.
NRC performed a special inspection on December 28 and 29, 1993, to review the potential misadministrations. Information gathered during this inspection, including the calculations of the administered doses, was given to an NRC scientific consultant to evaluate. The scientific consultant, in his report to NRC, stated that "The dose prescription was to dmax (i.e., 0.5-cm [0.2-inch] depth on the central axis) and a misadministration can only be judged by considering the dose given to this point....clearly, in both cases, a misadministration has taken place." On March 25, 1994, the licensee was informed that the doses to both patients were deemed to be misadministrations. The licensee submitted its report of misadministrations in a letter dated April 7, 1994.
After receiving the scientific consultant's report, an NRC medical consultant was retained to perform a clinical evaluation of the patients.
The technologist incorrectly transposed the treatment depth on the facsimile used to prepare the treatment plan. The technologist failed to make reference to dmax and entered the depth value incorrectly as 5.0 cm (2 inches) instead of the intended 0.5 cm (0.2 inch).
The licensee implemented a requirement for a stamp to be placed on all written directives that prompts a clear documentation of key treatment parameters such as site, method, daily dose, fractions, total dose, depth of calculation, spinal blocks, other blocks, and date. Previously, key parameters had been informal handwritten directives on patients' treatment charts. The licensee also formalized its requirement to include the written directive for all dosimetry calculation requests from the Beaver facility, and revised its "weekly chart check" procedure to increase chart reviews from once a week to twice a week, as was the practice before December 1, 1993.
|Event:||Medical Brachytherapy Misadministration at the University of Cincinnati, Cincinnati, Ohio|
|Date Reported:||January 14, 1994|
|Licensee:||University of Cincinnati, Cincinnati, Ohio|
On January 14, 1994, NRC was notified by telephone of a misadministration involving a leaking iodine-125 (I-125) brachytherapy implant seed. On January 7, 1994, 16 I-125 seeds, each ranging from 370 to 1110 megabecquerel (MBq) (10 to 30 millicurie [mCi]) activity, were implanted in the brain of a 30-year-old male patient. After the explant procedure on January 14, 1994, the licensee identified radioactive contamination in the surgical room and bathroom used by the patient. Personnel from the licensee's radiation safety office identified the contamination to be I-125 and confirmed that at least one seed was leaking. Further analysis by the licensee determined that one seed was damaged, during the implant procedure, by a surgical staple. The seed originally contained 758 MBq (20.5 mCi) of I-125 and, based on an assay of the explanted source, the licensee estimated that the loss was approximately 74 MBq (2.0 mCi).
Thyroid monitoring of the patient's visitors and hospital employees involved in the care of the patient was performed by the licensee. One of the licensee's employees was determined to have received a committed dose equivalent, to the thyroid, of 50 microsievert (ÁSv) (5 millirem [mrem]). In addition, a visitor was determined to have received a committed dose equivalent, to the thyroid, of 540 ÁSv (54 mrem), or a total effective dose equivalent of 160 ÁSv (16 mrem), which is less than the annual limit, for members of the general public, of 1000 ÁSv (100 mrem).
Through patient monitoring, the licensee estimates that approximately 5 percent of the free I-125 was taken up in the patient's thyroid. (In a normally functioning, unblocked thyroid, approximately 25 percent of the free iodine would be taken up in an individual's thyroid.) The licensee estimated that the uptake would result in a radiation dose to the thyroid of approximately 300 centigray (300 rad). The licensee did not expect any adverse medical effects to the patient as a result of the misadministration. An NRC medical consultant concluded that the non-radioactive iodinated contrast agent used during an imaging procedure performed on the patient before the implant blocked the absorption of the I-125. He also concluded that exposure to the radiation levels described will result in an increased probability of developing thyroid tumor(s) in the future.
The licensee notified the referring physician, patient, and patient's family of the misadministration.
The seed leaked after being inadvertently crushed by a surgical staple used to secure the catheters during the implant procedure. For future procedures, the licensee plans to ensure that the implanted seeds are located farther down the catheter, to reduce the likelihood of seed damage from surgical staples. The licensee also plans to examine each I-125 seed for leakage, after each explant procedure.
|Event 5:||Medical Brachytherapy Misadministration at Keesler Medical Center at Keesler Air Force Base in Biloxi, Mississippi|
|Date Reported:||January 13, 1994|
|Licensee:||Keesler Medical Center, Keesler Air Force Base, in Biloxi, Mississippi|
A patient was prescribed a lung brachytherapy treatment delivered by an Omnitron 2000 high-dose- rate (HDR) remote afterloader system. The prescribed tumor treatment plan included 1000-centigray (cGy) (1000-rad) absorbed doses at five treatment positions, using a 144.3-gigabecquerel (3.9-curie) iridium-192 source within a special needle. At the end of the fifth and last treatment, the source wire retracted 0.5 centimeter (cm) (0.2 in.) and stopped. Alarms immediately alerted Keesler staff that the source remained inside the patient's body. Licensee personnel followed emergency procedures, entered the therapy room, and removed the needle from the patient. Once outside the patient's body, the radioactive source retracted to the stored position.
The licensee determined that the source remained stuck at 0.5 cm (0.2 in.) above the fifth position, for approximately 2-1/2 minutes. The treatment plan called for the delivery of 1000 centigray (cGy) (1000 rad) at 1 cm (.39 in.) from each of the five treatment positions. As a result of the additional 2-1/2-minutes exposure, the last treatment position received 1732-cGy (1732-rad) absorbed dose, or 73.2 percent over the prescribed dose. The treatment plan also predicted an 800-cGy (800-rad) absorbed dose at 0.5 cm (0.2 in.) from each of the five treatment positions. The point 0.5 cm (0.2 in.) above the last treatment position, where the movement of the source stopped, received approximately 1400 cGy (1400 rad), or 75 percent greater than the absorbed dose stipulated in the prescribed treatment plan. The failure of the source to retract resulted in a single overexposure, causing an overall absorbed dose of 75 percent greater than that prescribed, for all the tissue surrounding the position 0.5 cm (0.2 in.) above the last treatment site.
The licensee reported that no adverse health effects to the patient are expected. The patient was immediately notified of the misadministration.
The patient had made a sudden move near the end of the treatment, causing the special needle to bend at the point where it extended beyond the biopsy needle. The bend prevented the radioactive source from retracting to the stored position, causing the misadministration.
The licensee immediately stopped the use of the HDR device, pending a complete check of the system by the manufacturer. The licensee also evaluated the practice of extending special needles, beyond biopsy needles, and the probability of patient movement causing damage, and decided to discontinue this practice.
NRC conducted a special inspection to review the circumstances surrounding the misadministration and the licensee's Quality Management program. A representative of the U.S. Food and Drug Administration (FDA) also participated in this inspection. No violations of regulatory requirements were identified during the inspection, but NRC initiated the following actions: (1) a Confirmatory Action Letter was issued to the licensee on January 18, 1994, which prohibited the use of the HDR unit until serviced by the manufacturer; (2) a medical consultant was contracted to evaluate the clinical effects and to assess the events that led to this misadministration; (3) the manufacturer was asked to analyze the source wire involved in the misadministration for damage as a result of the stresses experienced during this event; (4) Southwest Research Institute was contracted to analyze the special needle for mechanical failure; (5) a generic communication is being developed to notify other HDR users of the results of the inspection and related research; and (6) NRC is coordinating, with FDA, an evaluation of the generic implications surrounding this event.
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