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| {{#Wiki_filter:e f*" %4 e-UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 e | | {{#Wiki_filter:}} |
| / December 6, 1996 k .* *
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| CHAIRMAN l
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| l The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, D.C. 20510-6175
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| ==Dear Mr. Chairman:==
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| I am responding to your {{letter dated|date=October 8, 1996|text=letter dated October 8,1996}}, concerning the National Academy of Sciences, Institute of Medicine (IOM) report entitled, " Radiation in Medicine: A Need for Regulatory Reform." The Commission's responses to your specific questions are enclosed (Enclosure 1).
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| t The NRC intends to respond to the IOM recommendations through a deliberate process. The NRC is currently completing an agency-wide Strategic Assessment I and Rebaselining initiative. As part of the Strategic Assessment initiative, the Commission continues to review carefully the 10M report. A general ,
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| discussion, categorization, and summary of the broad range of comments I received on the report are enclosed (Enclosures 2 and 3). l The Steering Committee for the NRC's Strategic Assessment initiative i identified five options on NRC's future role in the medical program. These options ranged frem expanding the program, to retaining and revising the existing program, to entirely eliminating the medical regulatory program. The specific options considered were (1) increase NRC's regulatory responsibility with the addition of X-ray, accelerators, and naturally occurring and accelerator-produced radioactive materials; (2) continue with the current program with improvements; (3) decrease oversight of low-risk activities with continued emphasis on high-risk activities; (4) discontinue regulation of all medical activities except for NRC oversight of devices and manufacturers; and (5) discontinue the NRC's medical program.
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| On September 16, 1996, the Commission published for comment its preliminary views on 16 strategic program areas, including medical use. The Commission's preliminary view and current consensus is that the NRC would retain its regulatory authority for the medical use of byproduct material, but should make modifications to the current program utilizing a risk-informed, performance-based approach while protecting public health and safety, e.g.,
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| focusing on high-risk procedures (Option 2). Where regulations can be relaxed or eliminated without undue increases in risk, it would be our intent to amend our regulations (0ption 3). Such modifications would require rulemaking that (M.
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| likely would be initiated in 1997. The opportunity for input will be afforded 9612170124 961206 P g PDR COMMS NRCC g CORRESPONDENCE PDR fGO'7 '
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| c//k j y [);; 7; ///Jde
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| 4 2
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| to the regulated community, professional organizations, the Agreement States, the public, and others. The public comment period closed December 2,1996.
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| The Commission expects to make a final decision on the specific direction of the medical use program after consideration of public comments in early 1997.
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| Regarding the IOM report, the Commission has been concerned that the report's
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| ; conclusions were not substantiated. The report recommends removing NRC's authority and relying more on the States and the Conference of Radiation Control Program Directors (CRCPD) to increase uniformity. It should be noted that the CRCPD commented that the absence of Federal authority in medical use may have immediate and undesirable consequences. Further, the CRCPD stated that it does not support automatic selection of the Department of Health and Human Services (DHHS) as the lead Federal agency, as recommended in the IOM report. The Organization of Agreement States (OAS) and others highlighted the need for Federal oversight. Some States identified the NRC as the Federal agency of choice. Some non-Agreement States expressed significant concern regarding the lack of State resources to assume more regulatory responsibility. The DHHS commented that the IOM report does not make a compelling health and safety argument for the DHHS to take on such a substantial new role, and that it is unlikely that the DHHS would have adequate resources made available to assume such responsibility. A copy of the DHHS letter is enclosed (Enclosure 4),
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| i Particularly noteworthy in the IOM report is the dissenting opinion of Mr.
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| Robert S. Adler, a University of North Carolina law professor. Mr. Adler strongly disagrees that a case was made to repeal Federal authority over medical uses of ionizing radiation and states that the IOM Committee's recommendations lack supporting evidence and constitute unwise public policy.
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| Also worthy of mention is that during the public Strategic Assessment meeting conducted in Washington, D.C., the American College of Nuclear Physicians and Society of Nuclear Medicine indicated that they have modified their previous support for the IOM position and now support the Commission's preliminary 1
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| views on its medical use regulatory program.
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| Such comments, combined with acknowledgement in the report that the extent of State regulatory programs varies, that the CRCPD guidelines are adopted to varying degrees by individual States, and that the lack of data for comparing the risks associated with different types of ionizing radiation limited the scientific basis of the IOM Committee's findings, have caused the NRC to question the report's conclusions and recommendations.
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| Like the IOM, the NRC recognizes the benefits derived from the t.se of ionizing radiation in medicine, its potential for harm, and the need to achieve the appropriate balance between the costs and benefits of regulation in this area.
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| Most importantly, the NRC takes very seriously its responsibility to protect patients, workers, and the public as described in the agency's 1979 Medical Use Policy Statement (Enclosure 5). In adhering to the policy statement and
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| ; recognizing the unique hazards and benefits associated with the deliberate administration of byproduct material for medical use, the NRC regulates this area very differently from others. Since 1992, the NRC has made three revisions to its medical use regulations using a performance-based approach to provide greater flexibility to its licensees in the areas of reportable
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| I 4
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| l 3
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| 1 misadministrations, the practice of radiopharmacy, and criteria for the release of patients from confinement post-treatment. As a result, members of the general public could receive a dose of up to five times that allowed from i other types of licensed operations. l Regarding the safety risks associated with accelerator-produced versus .
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| byproduct material, there is nothing unique about radioactive materials l originating from a nuclear reactor (byproduct material). Generally, the same safe handling and use techniques apply to both. However, under its Atomic Energy Act (AEA) authority and responsibility, the NRC develops regulations and associated guidance for the safe medical use of byproduct material only.
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| ; While the IOM has stated that the NRC only regulates approximately 10 percent of medical use, that percentage includes virtually all of the high risk procedures, with the exception of linear accelerator therapy. In addition, l the NRC's regulatory program impacts significant portions of the remaining non-NRC regulated medical use. For example, the CRCPD and some States have used NRC's regulatory products for their own programs.
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| Regarding the effectiveness of State radiation control programs, the NRC conducts periodic reviews of Agreement State materials programs in the 29 Agreement States, including byproduct medical use programs. The NRC does not review the effectiveness of State radiation control programs as they relate to the non-Atomic Energy Act areas in any State. Therefore, the NRC is not aware of specific problems or deficiencies in how the States have handled the regulation of ionizing radiation, other than byproduct material, in medicine.
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| l The NRC reviews reported events and maintains an event database to identify root cause and generic implications and determine whether modifications to its i regulatory program are needed to further reduce errors. Neither the IOM nor the NRC is aware of a similar event database, maintained by the States, for events involving non-AEA material.
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| I will continue to keep you informed about significant Commission decisions concerning this issue. If I can be of further alsistance to you on this i
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| issue, please contact me.
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| Sincerely, b
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| Shirley Ann Jackson
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| ==Enclosures:==
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| : 1. Responses to Questions
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| : 2. General discussion of comments on IOM report
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| : 3. Specific Comments on IOM report
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| : 4. DHHS letter i
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| : 5. 1979 Medical Use Policy Statement cc: Senator Bob Graham
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| i i 3
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| 4 l
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| 1 RESPONSES TO OVESTIONS 1
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| J OVESTION 1. Regarding the use of radiopharmaceuticals for diagnostic ;
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| . treatments for the period that such records are available:
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| ! How many associated Unusual Incidents have been noted? How ,
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| l 4 many of these were only administrative in nature and how l
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| i i many involved actual misapplications? Of the latter, how many resulted in patients, occupational workers, or members of the general public receiving harmful levels of diagnostic f
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| i or therapeutic radiopharmaceuticals? And of those receiving 4
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| l harmful levels, how many actually have displayed symptoms of i I
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| , radiation sickness? l 1
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| l l After providing specific numerical responses for the above f
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| ! categories, please provide any other quantifiable 1
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| information that is available and may help to put the data j 3
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| into proper perspective.
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| {
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| i ANSWER.
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| The NRC has required reporting of misadministrations involving j radiopharmaceuticals since 1980. For the period between 1980 and 1991, i
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| diagnostic misadministrations of radiopharmaceuticals averaged approximately 1 400 per year, while therapeutic misadministrations (involving radiopharmaceuticals and sealed sources) averaged approximately 30-40 per l! year. In January 1992, the NRC revised its misadministration definitions and has not required reporting of unusual incidents involving the administration of diaanostic radiopharmaceuticals, with the exception of the use of greater Enclosure 1
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| ]
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| [ 4 I OVESTION 1. (Continued) than 30 microcuries of sodium iodide. The 30 microcurie reporting threshold i for sodium iodide was selected because it result's in a dose to the thyroid gland (approximately 50 Rem) consistent with other NRC regulatory limits for 1
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| l an individual organ dose. The 1992 revision was based on the relatively low j risk to public health and safety associated with the administration of most i
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| l radiopharmaceuticals used for diagnostic purposes. As a result of the revised misadministration definitions, from 1992 through 1995, misadministrations involving radiopharmaceuticals have averaged approximately 7 per year. The i.
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| ! IOM report estimates that over 8 million diagnostic radiopharmaceutical i
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| procedures are performed annually, and references an NRC estimate of 60,000
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| ! therapeutic radiopharmaceutical procedures annually. It is important to note
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| ! that the cited 8 million diagnostic procedures annually consists primarily of administrations of technetium-99m, which is rarely subject to misadministration because of the higher dose threshold associated with
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| , reporting of diagnostic misadministrations.
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| J j Regarding the administrative nature of some misadministrations, the NRC ,
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| l
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| '; revised its misadministration definitions and associated record keeping, !
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| l reporting, and notification requirements based on potential harm to a patient rather than root cause. As a result, the NRC receives reports of events that meet the misadministration definitions and associated requirements, but could
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| : be considered by some to be administrative in nature (e.g., correct dosage delivered in the absence of a complete written prescription). Such events
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| . tend to be in the minority.
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| j i
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| ==Reference:==
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| NUREG-1272 - AE00 annual report for calendar years 1992, 1993, and fiscal years 1994 and 1995. Data for 1996 is not yet published.
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| i i
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| 4 OVESTION 1. (Continued) Very few of the reported misadministrations involving radiopharmaceuticals resulted in harm to an individual. However, there are isolated examples, such as a 1991 event involving the administration of a diagnostic dosage of sodium iodide for whole body scanning to a nursing female patient occurred at Tripler Army Hospital in Hawaii. As a result, the nursing infant received an unintended radiation dose that destroyed the function of her thyroid gland.
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| Events such as the Tripler incident, or other cases resulting in harm to individuals from the medical use of byproduct material, are reported as Abnormal Occurrences (AO) to Congress on an annual basis. From May 1990 to May 1995, there have been 20 A0s involving radiopharmaceuticals reported to Congress. Although some A0s resulted in unintended or increased radiation doses to an individual or organs such as the thyroid or bladder, in most cases, a medical consultant determined that no harmful effects to the patient were anticipated as a result. Selected portions of the A0 reports involving radiopharmaceuticals, from 1990 to present, are included in Attachment 1.
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| The NRC is aware of misadministrations involving sealed sources administered for therapeutic purposes that have resulted in harm or potential harm to a patient. For example, in November 1992, a patient undergoing a sealed source implant for the treatment of cancer subsequently died after receiving a significant radiation overdose due to the failure of a sealed source device.
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| Currently, the NRC is reviewing the circumstances and potential patient harm associated with approximately 100 misadministrations involving a sealed source used to treat an eye disease referred to as pterygium. Each misadministration i 1
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| l OVESTION 1. (Continued) l event is reviewed by the NRC to determine whether modifications to its 1
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| existing regulatory program are needed to further reduce the likelihood of similar events.
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| l
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| OVESTION 2. What studies or any other work has the NRC performed or had performed to compare either the cost of compliance of its
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| : regulatory program with the benefits of the medical use of 1
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| ! byproduct material, or to compare other statistical evidence
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| }
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| ; associated with the use of radiopharmaceuticals with similar u .
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| types of statistical evidence associated with the success or )
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| i failure of medical procedures not involving radioactive i
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| material? I i
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| ANSWER.
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| l The NRC has not conducted studies specifically to compare the cost of regulatory compliance with the societal benefit of a given technology. The benefits of the technology are assumed to be the same with or without regulatory oversight. However, the costs associated with every rulemaking are analyzed. The cost data are summarized and submitted to the Office of Management and Budget (0MB) as part of the clearance process associated with information collection rulemaking. The most recent NRC submittals to the OMB for 10 CFR Part 35 are provided in Attachment 2. Although it is difficult I to make precise quantitative comparisons regarding costs versus benefit given the general lack of availability of statistical evidence in this and other medical areas, the NRC believes that the costs associated with compliance are commensurate with the benefits to public health and safety by ensuring the safe use of byproduct material and reducing the likelihood of misadministrations.
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| 6 OVESTION 3. What is +he range of costs that medical facilities must incur for compliance, inspection, and licensing? Has NRC done a cost versus risk assessment to form an opinion as to whether the costs are reasonable? If so, what is that opinion?
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| MSWEE.
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| l
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| . The NRC developed a fee structure, which is set forth in 10 CFR Parts 170 and l 171, to facilitate 100 percent recovery of its budget as required by the l Omnibus Budget Reconciliation Act of 1990. These parts set forth the schedule !
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| 1 of annual fees charged for licensing and other forms of registration or I certification, and inspections. Fees are set annually by rulemaking.
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| Attachment 3 provides a copy of 10 CFR Parts 170 and 171.
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| I The NRC charges a fee for a license application, amendment and renewal. These costs range from $400 to $6,000, depending on the scope of tha program. The annual fee for facilities subject to Part 35 ranges in cost from $5,000 to l
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| $25,000 depending on the scope of the program. According to the estimate submitted to the OMB for the information collections requirements in Part 35, the annual cost of compliance averages $25,000 per licensee.
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| The NRC performs a regulatory impact analysis, including a cost benefit analysis, with each rulemaking, including medical use. The NRC estimates costs associated with implementation of its regulations and submits these estimates for 0MB review. The costs to individual medical facilities vary due to the significant variations in the scope of licensee programs and their
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| * l l
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| OVESTION 3. (Continued) efficiency at achieving cost reduction. Also, it is difficult to separate the ;
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| l costs that would be incurred regardless of NRC involvement. However, the NRC i l
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| believes that the costs associated with compliance are commensurate with the 1
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| 1 benefits to public health and safety by ensuring the safe use of byproduct j material and reducing the likelihood of misadministrations. )
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| 1 l
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| QUESTION 4. What views has the Commission formed on any of the recommendations on page 22 of the report? If the Commission has not yet reached a consensus on any particular recommendation, what positions have any of the individual Commissioners formed? What information is the Commission awaiting that is imperative for determining a complete response to this report's recommendations?
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| ANSWER.
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| The Commission has considered the IOM recommendations within the framework of the agency's Strategic Assessment and Rebaselining initiative, which began in August 1995. As a result, on September 16, 1996, the Commission made its preliminary views on the medical use regulatory program publicly available for comment. The current consensus of the Commission is that the NRC would maintain its current regulatory program for the medical use of byproduct material, but should make modifications to the current program, utilizing a l
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| risk-informed, performance-based approach with opportunity for input from the l regulated industry, professional organizations, the Agreement States, the l 1
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| public and others. The Strategic Assessment public comment period closes l Shortly thereafter, the staff will review, collate, and
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| ~
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| December 2, 1996. l summarize the public comments. The staff expects to provide a summary of the public comments to the Commissicn and the public in early 1997, after which a final Commission decision on the specific direction of the medical use program will be made. For your information, Strategic Assessment Direction-Setting 1
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| I l
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| OVESTION 4. (Continued) Issues paper number 7, " Materials / Medical Oversight," and number 12, " Risk-Informed, Performance-Based Regulation," are attached (Attachment 4 and 5, respectively).
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| I l
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| - - . . . . - - ~-. . - - - . _ - .- . _ - _ . .
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| I OVESTION 5. With regard to the individual public opinions on NRC l
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| oversight in the nuclear medicine field that may be received l
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| ! from the Strategic Assessment Rebaselining process, do you expect those additional public opinioas to reflect new, l
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| ~
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| important views outside the range of comments that have
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| ! already been received? )
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| ! l l ANSWER. ,
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| As mentioned previously, the-Strategic Assessment public comment period closes l i
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| December 2, 1996. It would be premature for the Commission to prejudge what )
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| i l opinions public commenters might express. After careful review of the public l comments received, the Commission expects to make a final decision on the )
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| specific direction on the medical use regulatory program and provide direction to the' staff.
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| l Attachments:
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| A. Selected portions of A0 reports B. Supporting Statement for 10 CFR Part 35 C. 10 CFR Parts 170 and 171 D. DSI No. 7, " Materials / Medical Oversight" l E. DSI No. 12, " Risk-Informed, Performance-Based Regulation" l
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| ,, h gg Uet of AOs 10/3106 l
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| i B -- --- " CfrY ISTATE EVTDATE f NJ 5/14/90 900313 OVERLOOK HOSFjTAL SUMMIT MERCY-MEMORIAL MED4 CAL CENTER. INC. S AINT JOSEPH MI 6/5/90 I *0^!47 TRIPLER AMC HI 6/19/90 900388 TRIPLER ARMY MEDICAL CENTER MORRISVILLE VT 8/7/90
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| *J^^78 COPLEY HOSPITAL WEST SHORE HOSPITAL MANISTEE M1 9/22/90
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| ''#E'""
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| *J^^97 WILLIAM 8EAUMONT HOSPfTAL ROYAL OAK Mt 10/15/90 SAN DIEGO CA 11/26/90 900787 V.A. MEDICALCENTER DETROIT MI 1/16/91 910181 HUTZEL HOSPITAL RFt LEVILLE NJ 3/28/91 910413 CLARA MAASS MEDICAL CENTER 910706 l. GONZ_Al F7 MARTINEZ ONCOLOGIC HOSPIT HATO REY PR 6/1741 WILLLAM BEAL *WM ARMY WMAL CENT EL PASO TX 8/30/91 910946 ggg wrWAL CENTER CORP. LANSING MI 5/11/92 92 nam 7 SPRINGFIELD MA 5/18/92 920488 BAYSTATE MED6 CAL CENTER. INC.
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| PAPASTAVROS' ASSOCIATES MMAL IMA WILM6NGTON DE 1/14/93 940005 OSTEOPATHIC HOSPITAL FOL*n8RS ASSOC TULSA OK 7/27/03 940000 EVANSVILLE IN 3/9/94 941413 WELBORN CANCER CENTER STA6fjMD HOSMTAL STAMFORD CT 5/16/94 941356 PONTIAC MI 7/26/94 941s70 SAINJ_dQ1EPH MERCY HOSPITAL LONG BEACH CA 8/9/94 941719 V.A. ME06 CAL CENTER MAfiS ACHUSETTS GENERAL HOSPfTAL BOSTGN MA 5/9/95 960645 l
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| Attachment A Page 1
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| implemented pending the licensee's Radiation Safety Officer's full l investigation and review.
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| ffE - An NRC Region IV inspector conducted a special safety inspection on October 3 and 5, 1990, of the circumstances associated with the misadministration, and identified violations of NRC requirements as well as deviations from the licensee's documented procedures (Ref.1). A Confirmatory Action Letter (CAL) was issued on October 10, 1990, to confirm commitments made by the licensee during this inspection (Ref. 2). These commitments include conducting a retrospective review of patient treatments to determine if similar errors had been made. A decision regarding enforcement action is currently under consideration.
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| Future reports will be made as appropriate.
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| 90-17 Medical Diaanostic Misadministration The following information pertaining to this event is also being reported I concurrently in the federal Register. Appendix A (see the overall criterion) of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
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| Date and Place - May 14, 1990; Overlook Hospital; Summit, New Jersey.
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| Nature and Probable Conseauences - On June 1, 1990, N;C Region I was notified by the licensee in writing that a diagnostic misadministration involving iodine-131 (I-131) had occurred at the hospital.
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| An outpatient was scheduled for a nuclear medicine study by the referring physician's office by telephone. The nuclear medicine department understood the doctor's office to request an appointment for an iodine-131 scan. The patient brought the written prescription to the outpatient department and then proceeded to the nuclear medicine department for the scheduled study. The written prescription was not received by the nuclear medicine department until after the study was completed. When the nuclear medicine department received the written prescription, it was noted that the referring physician's written prescription requested a thyroid scan, not an iodine-131 scan. (A thyroid scan typically means a study using approximately 100-500 microcuries of iodine-123 as the imaging radionuclide. An iodine-131 scan usually refers to a whole body scan, utilizing a dose of approximately 1 to 5 millicuries.)
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| The patient involved in the misadministration had a benign tumor removed from a lobe of the thyroid in June 1989. Subsequent thyroid scans of the individual (an uptake study was performed in November 1989, after the thyroid lobectomy) indicated that the patient had a normally functioning thyroid.
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| The intended dose to the patient's thyroid was approximately 4 rads from 300 microcuries of iodine-123. The administered dose to the patient's thyroid, as a result of the misunderstanding of the physician's request, was approximately 3
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| l 1820 rads from 1.4 millicuries of iodine-131. The licensee does not expect any significant consequences to the patient.
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| [ause or Causes - The cause of the event is attributed to inadequate l procedures. The verbal request for the nuclear medicine study had not been !
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| l verified by a written prescription prior to the study being performed. !
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| Actions Taken to Prevent Recurrenc.g Licensee - After a telephone call on September 21, 1990, from NRC Region I i staff to the licensee in regard to the incident, the licensee convened a Radiation Safety Committee meeting on October 2, 1990, to review the cause of the misadministration and to determine the corrective actions required to prevent a recurrence. The licensee established a procedure requiring receipt of a written prescription by the nuclear medicine department prior to administering any iodine for studies. This information was communicated to NRC Region I by telephone on October 3, 1990.
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| NRC - NRC Region I inspectors will review the incident during the next routine inspection at this facility. The timeliness of the licensee's response (reviewing the cause and determining corrective actions following the May 14, 1990 incident) will also be reviewed.
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| Unless new, significant information becomes available, this item is considered closed for the purposes of this report.
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| 90-18 Sianificant Breakdown in Manaaement and Procedural Controls at a Medical Facility The following information pertaining to this event is also being reported concurrently in the Federal Register. Appendix A (see the overall criterion) of this report notes that an event involving a moderate or more severe inpact on the public health or safety can be considered an abnormal occurrence. In addition, the third general criterion in Appendix A notes that major deficiencies in management controls for licensed facilities or material can be considered an abnormal occurrence.
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| Date and Place - July 19-27, 1990; North Detroit General Hospital; Detroit, Michigan.
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| Nature and Probable Conseauences - This event involved the apparent use of fraudulent films from 30 diagnostic nuclear medicine studies that rendered all but one of them invalid. Such an event could have potentially resulted in significant adverse health effects to patients (e.g., a serious disease may not be diagnosed, or a correct diagnosis could be significantly delayed). The details of the event are as follows:
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| On August 14, 1990, the licensee reported to NRC Region III that films from diagnostic nuclear medicine studies were apparently fraudulent. The films involved 30 studies performed on 27 patients during the time period July 19-4
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| I L- .
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| 90-13 Medical Diacnostic Misadministration The following information pertaining to this event is also being repor concurrently in the federal Register.
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| of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
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| Date and Place - June 5,1990; Mercy Memorial Medical Center; St. Joseph, 1 Michigan.
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| Nature and Probable Conseauences - A 79-year-old female patient was scheduled i V to undergo a diagnostic evaluation to determine whether she was suffering from l an enlarged thyroid gland (substernal thyroid). No prescribed dose was indicated.
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| The technologist, in attempting The scan was scheduled for the following day. i to order the proper amount of radioactive material, noted that her standard '
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| dose chart (created by authorized users) did not list dosage for a substernal thyroid gland study.
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| l She then referred to the department's procedures manual, which indicated that the proper dose for a substernal thyroid gland study was 3-5 millicuries ofThe iodine-131, or 100-200 microcuries of iodine-123.
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| an authorized user which isotope to use. He instructed her to orderOna June 5, ,
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| sufficient quantity of iodine-131 to visualize the thyroid gland. I 1990, the patient was given 4.3 millicuries of iodine-131, which conformed to i the procedures manual. The dosage listed in the procedure, however, was wrong. The standard dose for a substernal thyroid scan should have been 50 to 100 microcuries of iodine-131, or approximately one-fiftieth of the l noted in the manual.
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| ' Medicine Department on June 6 and reported as a misadministration to the NRC on June 8, 1990.
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| The licensee estimated thatThethe NRC'smisadministration resulted in a mean medical consultant investigated the thyroid gland of 5,752 rads. Based on certain assumptions, the consultant e the case.
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| be 3,400 rads to the thyroid gland which, according to the Theconsultant, licensee is would yield a 10 percent chance of hypothyroidism over five years.
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| monitoring the patient's condition.
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| Cause or Causes - The Nuclear Medicine Department's The procedures dosage wasmanual not listed the wrong iodine-131 dosage for a substernal thyroid scan.
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| reviewed by an authorized user prior to its administration.
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| Actions Taken to Prevent Recurrence I Licensee - The license has been amended to incorporate the following changes in iodine-131 procedures: (1) Two nuclear medicine technologists will l
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| l independently verify the prescribed dosage and check the dose calibrator assay; (2) A written prescription by an authorized user will be required before the procedure is carried out; and (3) TwoThe signatures or initials will licensee also be required on all documents involving iodine-131.
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| 6 l
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| 4 corrected the department's procedures manual to reflect the proper dosage for a substernal thyroid scan. Dosage for a substernal thyroid scan also was added to the department's Standard Dose Chart.
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| NRC - An NRC inspection was conducted on June 19, 1990 (Ref. 6). Seven The violations of NRC requirements (unrelated to this event) were identified.
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| licensee's corrective actions to prevent recurrence were found to be satisfactory. The NRC notified its medical consultant who reviewed the circumstances. He made certain procedural recommendations for consideration by the licensee.
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| This item is considered closed for the purposes of this report.
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| 90-14 Administration of Iodine-131 to a Lactatina Female With Votake by Her Infant The following information pertaining to this event is also being reported concurrently in the Federal Register. Appendix A (see the general criterion)
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| V of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
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| Date and Place - June 19, 1990; Tripler Army Medical Center; Honolulu, Hawaii.
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| Nature and Probable Consecuences - A nursing mother was given a 4.89 millicurie dose of iodine-131 at an NRC licensed medical facility that resulted in an unintentional radiation dose to her infant's thyroid gland estimated at 30,000 rads and a dose to the infant's whole body of 17 rads.
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| The error was detected on June 21, 1990, when the patient returned to the medical center for a whole body scan. The scan indicated an unusually high breast up;ake of iodine-131. In the opinion of the patient's physician and an NRC medical consultant, the infant's thyroid function will be completely lost.
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| The infant will require artificial thyroid hormone medication for life to ensure normal growth and development.
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| Cause or Causes - The physician and nuclear medicine technologist failed to confirm that the patient was not breast feeding. The patient arrived at the medical center from a remote South Pacific island. Communication between the island physician and the Army physicians was poor and the Tripler physicians were not aware that the mother had given birth on June 1, 1990.
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| Actions Taken to Prevent Recurrence Licensee - Immediately following discovery of the error the licensee began using a new questionnaire that more clearly requires the collection and documentation of information concerning patient pregnancy and braast feeding.
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| The Commanding Officer has ordered a special investigation to define the cause and appropriate corrective actions. The licensee has contacted the patient
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| - and the patient's physician and is finalizing arrangements for long term follow-up medical care.
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| 7
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| 1 I
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| i These violations were indicative of a breakdown of management control of the licensee's nuclear medicine program.
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| Actions Taken to Prevent Recurrence I
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| licensee - As a result of this occurrence, the licensee has strengthened its l screening procedures for prospective employees, both temporary andbe There will permanent.
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| Training procedures have also been broadened and intensified.
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| more ongoing supervision and review of work by new employees.
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| l fif[G - The NRC conducted a special inspection August 15 through September 7, A number l 1990, to review the circumstances surrounding the fraudulent films.
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| of violations were identified. On October 29, 1990, the NRC issued a Notice of Violation and proposed a civil penalty of $2,500 (Ref. 3), which was paid by the licensee on November 26, 1990. l This item is considered closed for the purposes of this report. l
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| ******** l l
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| 90-19 Medical Diaanostic Misadministration l The following information pertaining to this event is also being report concurrently in the federal Register.
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| of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
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| j Date and Place - August 7, 1990; Copley Hospital; Morrisville, Vermont.
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| l 14, 1990, NRC Region I was Nature and Probable Conseauences - On August '
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| notified by the licensee in writing that a diagnostic misadministration ,
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| involving iodine-131 (I-131) had occurred at the hospital on August 7,1990. l Further information was obtained in a follow-up phone call to the licensee on September 24, 1990.
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| A 63-year-old woman patient, undergoing I-131 treatment for primary hypothyroidism, was administered 112 microcuries instead o routinely prescribed 10 microcuries.
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| results of an uptake scan, was calculated at 3.9% uptake, resulting in anThe lice estimated actual dose to the thyroid of 29 rads.
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| any adverse consequences to the patient.
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| The hospital reported that aInstead supplyofofordering I-131 capsules had been ordered with 5 capsules with a total incorrect amounts of I-131.
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| activity each.
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| of 100 microcuries, the 5 capsules were ordered a dose calibrator prior to admin;stration and incorrectly interpreted thewas The error dose calibrator reading of 112 microcuries as 11.2 microcuries.
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| identified by another technologist measuring the uptake by the patient's thyroid the following day.
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| Cause or Causes_ - The causes of the event were attributed to human error The wrong I-131 capsules had been ordered, and the technologist incorrectly interpreted the dose calibrator reading.
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| 6
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| 4 Actions Taken to Prevent Recurrence Licensee - The licensee reviewed the policies and procedures for assaying doses with all nuclear medicine technologists. In addition, the licensee's procedure was revised to require that only the technologist who orders the iodine capsules is allowed to administer them to patients.
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| NRC - NRC Region I inspectors will review the incident during the next routine inspection at this facility.
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| Unless new, significant information becomes available, this item is considered closed for the purposes of this report.
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| 90-20 Medical Diaanostic Misadministration The following information pertaining to this event is also being reported concurrently in the Federal Register. Appendix A (see the overall criterion) of this report notes than an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
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| Date and Place - September 22, 1990; West Shore Hospital; Manistee, Michigan Nature and Probable Consecuences - On September 24, 1990, the licensee's consultant informed Region Ill that an 84-year-old female cancer patient received a 175 millicurie dose of a technetium-99m (Tc-99m) labeled radiopharmaceutical for an imaging scan of her gall bladder instead of the 8 millicurie dose prescribed in the Nuclear Medicine Department's procedures manual.
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| The misadministration occurred on Saturday, September 22, 1990, when the patient's physician ordered a hepatobiliary (liver and gall bladder) scan.
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| The radiopharmaceutical was prepared and administered by a part-time technician who was on weekend call. The technician had received only two weeks of training in Nuclear Medicine Department procedures the previous February and had performed only two nuclear medicine procedures since then (during one procedure, she was directly supervised by the Radiology Manager; during the other, the Radiology Manager " coached" her through the procedure by telephone). After receiving the order on September 22, the technician telephoned the Radiology Manager at home for guidance. She was told to prepare the dose according to the Department's procedures manual, which stated that an 8 millicurie (mci) dose of Tc-99m mebrofenin was needed for hepatobiliary scans. Tc-99m mebrofenin is prepared by adding free Tc-99m to a reagent kit containing the mebrofenin.
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| According to the technician, she eluted 392 mci from the molybdenum-technetium generator, and then took 4 milliliters of the eluate and injected it into the reagent kit. After mixing, she withdrew 1 milliliter of the solution, put it on a dose calibrator, which she claimed read 8 mci, and then injected the radiopharmaceutical into the patient. When she saw a " bright spot" forming on 7
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| S 4
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| j l
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| 4 the scanning screen where the sharp image of the gall bladder should have been, she telephoned the Radiology Manager and informed him that something wrong.
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| A reconstruction of the event by NRC and licensee consultants indicated that !
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| The amount the dose to the patient was 175 mci instead of the intended 8 mci.
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| of Tc-99m mixed with the mebrofenin was probably The around 440 mci, instead o NRC consultant the manufacturer's maximum recommendation of 100 mci. con The medical consultant the dose calibrator prior to injecting the patient.also It isevaluated th biological effects should be expected from the misadminist were about 36 rads and 26 rads, respectively.
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| l Cause or Causes - The cause of the event was the licensee's failurel '
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| properly train and supervise an inexperienced technician.eithe in carrying out the procedure.
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| Actions Taken To prevent Recurrence licensee - The licensee's corrective action includes more orientation an ;
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| training of new employees; additions to the computer and additional oversight of the licensee's program by manage Radiation Safety Officer.
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| hospital.
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| 27, 1990, and EG - NRC Region III conducted a special inspection on SeptemberSeven of the identified 10 violations of NRC requirements.
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| pertained to this incident, including failure The Region contactedtoa instruc kit in accordance with manufacturer's instructions.
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| On November 16, 1990, the NRC medical consultant who reviewed the case. issued a Notice of Viola The licensee has paid the civil penalty. The corrective actions will be further reviewed during a future routine NRC inspection.
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| This item is considered closed for the purposes of this report.
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| AGREEMENT STATE LICENSEES Procedures have been developed for the Agreement States to screen u incidents or events using the same criteria as the NRC (see Appendix A) report the events to the NRC for inclusion in this report.th occurrence.
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| 8
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| Abnormal Occurrences, 4th Qtr CY90 sent the radiographer to a physician for examination tion, the licensee also received a second vial contain-and blood tests. No clinical manifestations of the ing 140 millicuries of iodine-131.This vial is a weekly overexposure were evident. standing-order for the hospital and is used as needed Cause or Causes-The radiographer failed to con-duct a radiation survey of the exposure device after The two vials were assayed by a technologist. The one
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| < the exposure. Without a radiation survey, the radiog- vial contained 180 millicuries, and this amount was rapher was not aware that the source was discon- later approved by the authorized physician for the pa-nected and had not returned to the shielded position. tient's treatment. The standing-order vial contained His willfui removal of dosimetry devices complicated 140 millicuries. After the assay, the technologist subsequent dose calculations. placed both vials side by side in the fume hood 10-cated in the nuclear pharmacy. Both were still in their j
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| original leaded shields and labeled as to their con-Actions Taken to Prevent Recurrence tents.
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| Licensee-The licensee's proposed corrective ac-At 10.30 a.m., the authorized physician-user was l tions include temporarily removing the radiographer from radiography duties, doubling the number of ready to administer the iodine-131 to the patient, and l cr.!!ed for the material. Since the technologist who management audits and safety meetings, revising company policy on the number of hours worked, and had prepared the dosage was not readily available, increasing safety training from 16 hours peryear to 32 another technologist went to the pharmacy to obtain l hours per year, the radiopharmaceutical. The technologist who had j prepared the dosage did not indicate to the admini- l NRC-NRC Region IV transmitted its inspection re- stering technologist how many vials were to be ad-ministered. De administering technologist picked port on December 9,1990 (Ref. 2), and conducted an up both vials, assuming they were to be administered Enforcement Conference with the licensee on De-cember 7,1990, to discuss the event. Escalated en- to the patient.1 he technologist did not review the la-bels on t!w containers, assuming they were the forcement action is pending. NRC issued an immedi-ately effective order on January 28,1991 (Ref. 3), proper doses. The technologist also did not consider prohibiting the radiographer from engaging in NRC- the administration of more than one vial to be un-usual since this was a common occurrence at this fa- j licensed activities on behalf of the licensee for a '
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| period of 1 year. cility.
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| After reviewing the dosage record, the authorized Future reports will be made as appropriate. I physician instructed the technologist to administer the dose to the patient. ne technologist then pro-90-23 Medical Therapy Misadrainistra- ceeded with the a&nuustration of both vials contain-tion ing 320 millicuries.The physician did not review the labeling on the containers, believing that since the De following information pertaining to this event is patient's unit dose record was complete and indicated also being reported concurrently in the federal Regis- a dosage of 180 millicuries, the two vials were the ter. Appendix A(see the overallcriterion)of this re- proper ones for administration.
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| port notes that an event involving a moderate or more severe impact on public health or safety can be On October 16, the nuclear pharmacist received a re-considered an abnormal occurrence. quest for 25 millicuries of iodine-131, but could not find the standing-order vial. The resulting investiga-Date and Place-October 15, 1990; William tion determined that the vial had been erroneously Beaumont Hospital; Royal Oak, Michigan, administered the previous day. De patient and her doctor were subsequently informed of the misad-Nature and Probable Consequences-On October muustration. De licensee's radiation safety officer
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| / 10,1990, a 60-year-old female patient was referred also was notified.
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| ,/ to the nuclear medicme department for iodine-131 i thyroid ablation therapy after undergoing a NRC Region III contracted with a medical consultant thyroidectomy for cancer. After reviewing the clinical to evaluate the potential medical effects on the pa-data on the patient, the authorized physician-user tient as a result of the misadmuustration. The con-prescribed 175 millicuries of iodine-131 to be ad- sultant's evaluation indicated that the misadministra-ministered orally on October 15. tior, should not have any significant medical effects on the patient; the estimated bone marrow dose re-On October 15, the licensee received the patienfs ceived by the patient was between 40 and 50 rads, which should be well tolerated by the patient.
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| oral iodine-131 solution from a distributor. In addi-
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| . ....m,, annn uin w. 4
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| l .
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| Abnormal Occurrences,4th Qtr CY90 tion overexposure occuaed at a temporary jobsite in l Cause or Causes-De three primary causes were:
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| Burns Flat, Oklahoma. j
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| , (1) the stock solution of iodine-131 was stored in the same location as the patient's dose, (2) the admini-stering technologist was never informed by the tech.
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| Nature and Probable Consequences-On November l 26,1990, the licensee notified the NRC that on No-nologist who actually prepared the dose that only one vember 12,1990, a radiographer's assistant may have vial was to be used, and (3) the administering tech.
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| sustained a possible radiation overexposure to his nologist and physician did not review the labels on the right hand. The licensee stated that it was not tn-I container. formed of the incident by the radiographer until the l
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| morning of November 25,1990, because the radiog-Actions Taken to Prevent Recurrence rapher did not think an overexposure had occurred l until the assistant radiographer's right hand became l Licensee-On October 18, 1990, the hospital re- red and his fingers began to swell. On the day of the I quested that its NRC license be amended to include mcident, the radiographer and his assistant were per- (
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| the following modifications to its iodine-131 admini-fgrming radiographic operations at a temporary job-stration procedures: (1) on all iodine-131 therapy site with a radiography device that contatned a 49-cu-doses, the person administering the dose must either ne iridium-192 sealed source. NRC Region IV sent be present in the radiopharmacy when the dose is as- ,
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| an mspectgr to investigate the mcident; based on m-sayed, or the person must personally assay the dose terviews with the radiographer, the assistant, and the before it is taken out of the radiopharmacy; (2) the owner of the company, the circumstances associated dose sheeting must indicate the number of vials that with the radiatton overexposure are described below.
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| comprise the dose; (3) just prior to the administra-tion, the physician will verify the assay dose activity The radiographer and his assistant were performing with the prescribed dose and mitial the dose shect; radiographic exposures of welds on a 48-inch diam-and (4) the standing order of therapeutic iodine-131 eter tank at a fabrication shop. After the sixth expo-will be stored in the hot locker and will be placed in sure, the radiographer left the immediate area to the fume hood only when needed for dispensing. On load film in a belt. While the radiographer was away, October 29,1990, these new procedures were incor- the assistant set up the seventh exposure and cranked porated mto the hospital's NRC license via an out the source. De assistant had turned the crank amendment. about two or three turns when he saw that the mag- !
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| netically mounted stand, that held the guide tube NRC-NRC Region !!! conducted an inspection at near the exterior of the tank, had fallen.
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| the facility on October 17,1990 (Ref.4). Although no violations of NRC requirementswere identified, con- De assistant radiographer's alarming personnel do-cerns were expressed over the storage of stock io- simeter (chirper) had alarmed loudly when the guide dine-131 with the patient's intended dose and the tube had fallen.The assistant stated that he froze for lack of communication between the technologist who about 5 seconds, then he cranked the source back to prepared the dose and the technologist who admini- the shielded position.The assistant's chirper had quit stered the dose. The NRC medical consultant indi- alarming, so he thought the source was in the l cated that the licensee's corrective action program shielded position in the radiography device. The as-was appropriate. Corrective actions will be examined sistant radiographer then stated that he failed to pick by the NRC Region 111 during future inspections. up and use his survey instrument to perform a survey of the radiography device and the source guide tube, This item is considered closed for the purposes of this because his chirper was not alarming. (The licensee report. later reported that the chirper had been dropped a couple of times that night and upon subsequent test-in8 was found to be malfunctioning due to a shorted 90-24 Radiation Overexposure of a Radi- ground wire.)Instead, he walked over to the tank and ographer repositioned the magnetic stand and source guide tube. After the assistant radiographer correctly posi-The following information pertaining to this event is tioned the guide tube with his right hand, he returned I also being reported concurrently in the FederalRegis- to the crank handle to proceed with the exposure.
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| ter. Appendix A (see Example 1 of "For All Licen-
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| ! sees") of this report notes that an exposure of the When he performed this exposure, he noted that his feet, ankles, hands or forearms of any individual to chirper did not alarm when the source was cranked j out. Because of this, after the exposure was com-375 rem or more of radiatien can be considered an ab-normal occurrence. pleted, he looked at his p(x ket dosimeter and noticed I
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| that it was off scale (greater than 200 millirem). At Date and Place-November 12,1990; Tumbleweed about the same time, the radiographer returned and the assistant told him what had happened and that his X-Ray Company; Greenwood, Arkansas; the radia-NUREG-0090, Vol13, No.4 4 i
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| Abnormal Occurrences, 4th Qtr CY90 I
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| l Region IV issued an inspection report to the licensee j pocket dosimeter had gone off scale. The assistant ;
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| told the radiographer that he did not think that he on February 5,1991 (Ref. 6) and plans to conduct an had received an overexposure, but that he thought his enforcement conference with the licensee.
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| pocket dosimeter was off scale because he had Future reports will be made as appropriate.
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| bumped it earlier.The radiographer and his assistant continued to work and did not inform the Radiation 90-25 Medical Diagnostic Misadmin-Safety Officer of the incident until after the assis-tant's hand showed clinical signs of a radiation injury, istration U ,
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| He assistant radiographer stated that he grasped the The following information pertammg to this event is l also being reported concurrently in the rederalRegis- l guide tube with his right hand just below where the l guide tube was taped to the magnetic stand.The ra- ter. Appendix A(see the general criterion)of this re-diation injuries that the assistant radiographer sus- port notes that an event involving a moderate or tained to his hand indicated that he grasped the guide more severe impact on public health or safety can be tube with the thumb, index, and middle fingers, and considered an abnormal occurrence.
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| that the source had to be directly beneath the point Date and Place-November 26,1990; Veterans Ad-grasped.This information may indicate that the assis. ministration Medical Center; San Diego, California.
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| tant radiographer mistakenly cranked the source out, instead of in, when the incident first occurred. From Nature and Probable Consequences-On November reenactments. clinical observations, and calculations, 26,1990, a patient scheduled for the administration the dose to the assistant radiographer s hand was esti- of 5 millicuries of indium-111 labeled anti CEA mated by the NRC to be between 1500 to 3000 rem. monoclonal antibody for diagnostic imaging of De whole body dose to the assistant, as measured by colorectal cancer was mistakenly administered 168 his thermoluminescent dosimeter, was 365 millirem. millicuries of technetium-99m pertechnetate.
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| Blood samples were taken from the assistant for cytogenetic tests; the results indicated an equivalent Prior to the administration, a nuclear medicine physi-whole body exposure of less than 10 rem. cian instructed his technical assistant to obtain the in-dium-111 from the Nuclear Medicine Preparation On November 29,1990, the NRC inspector noted 12b. However, the assistant erroneously picked up a that the assistant's thumb,index, and middle fingers syringe containing the technetium-99m pertech-were severely blistered and swollen. On this date the netate.The physician failed to positively identify the assistant was admitted to a burn center in Oklahoma label on the syringe before injecting the contents of City, Oklahoma, for medical care. The assistant re- the syringe into the patient.
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| mained in the hospital for approximately two weeks, The error was discovered by the licensee within min-and during that period had a skin graft performed on utes after the misadministration and the patient was his index finger. On January 22,1991, the physician administered 10 drops of iodide and 1 gram of contacted NRC and stated that the assistant's middle finger and thumb appeared to be healing and that the perchlorate to block and flush the thyroid gland re-index finger was graf ted due to lesions that were not spectively, healing. The physician also stated that the assistant The patient was placed in an isolated room normally would remain under his care, and he would supply used for therapy for two days. The patient was NRC with periodic repons. scanned approximately thirty hours after the misad-ministration and the thyroid gland showed no ele-Cause or Causes-The radiographer failed to super. vated radioactivity. A small residual amount of tech-vise the assistant properly, and the assistant failed to netium-99m was detected in the bladder. Following conduct a radiation survey of the exposure device. the scan, the patient was noted to be ch,mcally un-changed and was discharged from the licensce's Actions Taken to Prevent Recurrence medical center.
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| l Licensee-The assistant radiographer is no longer Had the blocking and flushing agents not been ad-l ministered, the organ receiving the highest exposure employed by the licensee. Additional actions to be would have been the stomach wall, receiving an esti-taken by the licensee will be discussed at an upcoming enforcement conference with the NRC.
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| mated 42 rem compared to about 5 rem for in-dium-111. Administration of the blocking and flush-i NRC-During the investigation of this event, an Or- ing agents reduced the radiation exposure to all der modifying the license was issued on December 4, organs except the bladder wall. It is estimated the 1990, prohibiting the radiographer and the assistant bladder wall received about 17 rem from the technc-l tium-99m compared to about 3 rem for indium-111.
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| from participating in licensed activities (Ref. 5). N RC l
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| l
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| ..-,-,,,,e .
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| 1 Abnormal Occurrences,4th Qtr CY90 tions of a licensee internal quality assurance investi-Cause or Causes-The main cause of the gation board are currently being considered.
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| misadministration was the failure of the nuclear medicine physician and his technical assistant to read NRC-A special NRC team inspection was con-the label on :he technetium-99m syringe at the time ducted at the licensee's facility following the misad-of the injection. A contributing cause of the ministration. An inspection report was issued on misadministration was inadequate training of the January 3,1991 (Ref.7) and an Enforcement Confer-physician's technical assistant who was provided a de.ence was held with the licensee on January 10,1991.
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| l!
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| scription of the radiopharmaceutical based only on On March 13,1991, a Notice of Violation was issued the color and shape of a container and not the label. to the licensee for violations identified during the in-spection (Ref. 8). None of the violations pertained to the misadministration and no civil penalty was pro-Actions Taken to Prevent Recurrence posed.
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| Unless new, significant information becomes avail- l Weensee 'Ihe physician's privilege to inject patients j able, this item is considered closed for the purposes has been temporarily revoked. Additional training of l of this report. .
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| the nuclear medicine staff is planned. Recommenda-Agreement State Licensees and report the events to the NRC for inclusion in this Procedures have been developed for the Agreement report. For this period, the Agreement States re-States to screen unscheduled incidents or events us- ported no events as abnormal occurrences.
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| ing the same criteria as the NRC (see Appendix A) 6 !
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| NUREG-0090, Vol.13 No.4_. _ ' - -
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| . . Abnormal Occurrenccs,1st Otr.CY91 1
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| Cause er Causes-ne Ecensee ider.tified the prob- was initiated to identify the nuclear safety features
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| ; able causesof the November 28 event to be (1)less and controls for each unfavorable geometry vessel. A
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| : than adequate piping layout that allowed uranium Nuclear Criticality Safety Performance Improve-solastians to flow into the unfavorable geometry tank ment: Program (PIP), that had been instituted prior to and,(2) personnel-related inadequacies in that opera- the incident, was. accelerated and expanded to ad-
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| , tors had no knowledge of the potential for crossover dress the root causer. Training was also given to fuel
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| , of highly concentrated uranium solutions into recow:ry personnel to make them aware of the prob-unfavorable tanks as a result of open valves or other lem.
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| anomalses in the piping systems.
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| NRC-The special NRC team inspection (Ref. 2) l Followag a review of the incadent, the NRC con- identified two violations dealing with (1) failure to
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| ; cluded that these appeared to be other root causes in perform an adequate evaluation of equipment joined
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| ; addition to those given by the Hee ==ea Rese root by piping for the possibility of siphoning and (2) fail-j causes M
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| * ure to adiere to the administrative criticality safety
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| ! limit of 350 grams of uranium-235 in unfavorable ge-
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| : 1. The safety basis for the plant was less than ometry tankc-adequate because a documented safety analysis was not WE The NRC inspected the actions taken and, following the licensee's identsra tion of the sadetyfeatures and
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| : 2. As a result of the lack of a detailed safety analy-controls, issued a letter authorizing resumption of so-sis, equipment important to safety, such as lution transfers on December 18,1990 (Ref. 3). An valves, were not properly identified, protected, Enforcement Conference with the licensee was held emphasized in plant control documents and on January 18,1991. On March 20,199L the NRC j training sessions, tested and maintained appro-Priate to their safety function, and did not pos- I rwarded a Notace of Violation (for the violataons j identified during the special NRC team inspection) sess positive closure m. dication.
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| and proposed a civil penalty of $10,000 (Ref. 4).De )
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| ewo violations were classdied as Severity level 11 on a 1
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| : 3. .The design b. . asis of the plant was less than scale in which Severity Levels I and V are the most adequate. De system drawings lacked adequate and least significant, respectively. The licensee has i paid the civil penalty.
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| The licensee missed an opportunity to preclude the problems several years earlier when modifications In early 1991, the NRC prepared an action plan for were made to the piping system. The licensee's the licensee's facility. His pian is updated quarterly reviews of the modifications failed to identify the and tracks the completion of the licensee's PIP items, significant potential for uranium solutions to flow quarterly NRC and licensee management meetings into unfavorable geometry vessels. on the PIP status, and NRC technical reviews of PIP.
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| Other items addressed in the plan include license re-new I milestones and management meetings on de-Actions Taken to Prevent Recurrence ,
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| commissioning activities. A full-time resident inspec-tor started at the facility on April 22,1991.
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| Licensee-Corrective actions included modification of the piping system to prevent highly concentrated uranium solutions from flowing into the unfavorable his item is considered closed for the purposes of this geometry tanks. A review of the fuel recovery facility report.
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| Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
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| nere are currently over 8000 NRC nudcar material 91-2 Medical Diagnostic Misadmin-licenses in effect in the United States, principally for istration at Hutzel Hospital in use of radioisotopes in the medical, industrial, and Y Detroit, Michigan academic fields. Incidents were reported in this cate-gory from licensees such as radiographers, medical institutions, and byproduct material users.De NRC The following information pertaining to this event is is reviewing events reported by these licensees. For also being reported concurrently in the Federal this report, the NRC has determined that four events Register. Appendix A(see the overallcriterion)of this were abnormal occurrences. report notes that an event involving a moderate or NUREG-0090, Vol.14, No.1 2
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| . ~ .
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| ~
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| - Abnormal Occurrences,1st Qtr CY91 i
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| only a 30-minute period because of the mother's more severe impact on public health or safety can be medical problems. After the misadministration was considered an abnormal occurrence. discovered, contact between the mother and baby was restricted for two days to avoid further radiation Date and Place-January 17,1991; liutzel Hospital; exposure to the infant.
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| Detroit, Michigan, l The NRC retained a medical consultant to evaluate Nature and Probable Consequences-On January the circumstances of this case.He consultant estp 24,1991, the Ecensee notified NRC Region III that a mated that the patient received a dose of approx 2-medical diapostic misadministration had occurred at mately 6500 rads to her thyroid. This exposure would its facility on January 17,1991, when a patient was ad- carry a slightly increased risk of developing hypothy-ministered a dosage of iodine-131 that was 100 times roidism or thyroid cancer. Because the patient was greater than prescribed. A written report was re- lactating, thus concentrating the radioactive sodine m ceived by Region III on February 1,1991. the breasts, there would also be an increase in the patient's risk of breast cancer.The consultant recom-On January 16,1991, a 37-year-old iemale patient mended periodic monitoring of the patient for hypo-(who had given birth to a baby 2 days earlier) was thyroidism and for breast and thyroid cancer.
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| scheduled to have a thyroid scan to determine if she had a substernal goiter (beneath the breastbone). Cause or Causes-This misadministr, tion was The licensee s normal procedure for such a thyroid caused by the modification of the intended diagnostic scan usually mvolves administration of a procedure as a result of the discussion between the 50-microcurie dosage of iodine-131. hts would typi- physician's assistant and the nuclear medicine tech-cally result in a thyroid dose m the range of 50-70 nologist. His modtfication, which involved substan-rads. The prescription for the procedure was pre- tially increasing the dosage of radioactive iodine-131, pared by a physictan,s assistant at the direction of the was not reviewed by or approved by the patient's phy-referrmg physictan. The nuclear medicine technolo- sician.The physician, in fact, desired the thyroid scan gist subsequently discussed the procedure with the procedure using the lower dosage.
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| physician's assistant and questioned whether or not the thyroid scan was the appropriate procedure.The An NRC inspection to review the circumstances of technologtst mdicated a whole body scan to identify the misadministration (Ref. 5) also determined that thyroid tissue throughout the body would be the ap' the hospital had not provided training in the proper propriate test. The physician's assistant agreed and ordering and administration of radiopharmaceuticals submitted a new order for the whole body 3can.The to individuals working under the supervision of a phy-todme-131 was administered to the patient on sician designated on the NRC license.
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| January 17, 1991, with the whole body som per-formed on January 18,1991. De procedure consti- Actions Taken to Prevent Recurrence tutes a misadministration because the referring Licensee-The hospital adopted new procedures re-physician had not intended to perform a whole body scan usmg aodme-131. qu ring specific approval by an authorized physician prior to the oral administration of more than 50 De whole body scan involved a dosage of 5 microcuries of iodine-131.This authorization is to be obtained immediately prior to the planned admini-millicuries of iodine-131 instead of 50 microcuries, stration. He hospital also reaffirmed that the tech-which would have been used for the diagnostic proce-dure actually prescribed by the referring physician.
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| nologist and physician's assistants are not permitted to change an order given by an attending physician, Althnugh the whole body scan is a diagnostic test-intended for patients who have had their thyroid re-The hospital recommended that the patient be moved-the 5-millicurie dosage is in the range that placed on a thyroid hormone to inhibit the growth of may be used for treatment of thyroid disorders. thyroid nodules and that she be monitored for possi-ble development of hypothyroidism or other compli-Prior to administering the iodine-131, the technolo-cations.
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| gist determined that the patient was not breast-feeding her baby and did not intend to breast feed. NRC- A special inspection was conducted February (Breast-feeding a baby is a concern because the ra- 19, 1991, to review the circumstances surroundmg dioactive iodine can be passed to the baby through the misadmmistration (Ref. 5).ne inspection identi-the milk.) Some direct radiation exposure was re- fled two apparent violations associated with the inci-ceived by the baby due to the presence of the io- dent: (1) failure to instruct supervised individuals on dine-131 in the mother's body. This exposure, how- the principles of radiation safety, and (2) use of NRC-ever, was mmunal (estimated to be approxiniately 0.5 licensed material by unauthorized individuals.These nuihrads) because the baby was with the mother for NUREG-0090, Vol.14, No.1 3
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| Abnormal Occurrences,1st Qtr CY91 1
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| f Nature and Probable Consequences-On March 28. f beginning of the treatment, resulting in a total treat- 1991, the licensee informed NRC Region I that a ment dose of about 59,000 rads to the base of the tu-therapeutic misadministration, involving administra-mor and 19,500 rads to the apex of the tumor. The tion of iodine-131 to the wrong patient, had occurred licensee stated that the cose received by the turr or earlier that day.
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| was within acceptable medical treatment prutocols for that type of tumor,and that no acute effects were A radiotherapy physician prescribed a therapeutic observed in the patient. dosage of 10 millicuries of iodine-131 to a patient for the treatment of hyperthyroidism.The physician that NRC Region I contacted an NRC medical consultant was famihar with the patient was not able to admmi-to review the event.ne consultant stated that there s}er the therapeutic dosage and asked another physi-was an increased risk of long term adverse effects, cian to admmister it. In the meantime, a transporter, (e.g., cataract, tissue damage). while reviewing the patient transport requests, noted that the patient was listed in a bed that she believed Cause or Causes-The causes are attributed to hu- was occupied by another patient.ne transporter no-man error on the part of the licensee's staff physicist, tified the nuclear medicine secretary to check into lack of written procedures, and lack of dual verifica- the discrepancy.ne secretary referred to a patient tion of dose calculations prior to administration. list for the patient's name, noted the area of the hos-l pital where the patient's room was, and changed the request form.The secretary did not know that there Actions Taken to Prevent Recunence were two patients in the hospital with the exact same Licensee-The licensee's planned corrective actions names. (Ihe second patient was in the hospital for a include establishing written protocol for this proce- lung condition.) Also, the secretary did not know the dure, including a second verification of the treatment computer program that generated the patient list did calculations prior to administration of dosages to pa- not print duplicate entries. The patient's name who was to undergo treatment for hyperthyroidism was trents.
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| not printed on the list.
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| NRC- An NRC Region Iinspector conc. acted a spe- The physician who administered the dose picked up cial inspection of the circumstances surrounding this the request form and the iodine 131 dosage from the misadministration on February 25,1991. The inspec- Nuclear Medicine Department and went to the nurs-tion report was forwarded to the licensee on March ing station on the floor of the patient with the lung 11,1991 (Ref. 6).ne report notes that the inspector problem.The physician did not inform the nursing suggested that the licensee establish a written proto- staff that he was about to administer a therapeutic col for the procedure and the licensee agreed. He dosage to one of their patients and went to the lung report also identified one violation of NRC require- patient's room.There, he asked the patient his name ments,i.e., failure to notify the NRC of the therapy misadministration within 24 hours of discovery. A and verified the name on the wrist band but did not cross check the patient number on the wrist band management meeting between NRC Region I and with the patient number on the request form. The licensee management was conducted on March 21, physician completed the request form and returned 1991, to review the licensee's actions to prevent re- the patient folder to the nurses' station. Within five currence, minutes of the administration of the radiopharmac-eutical, the nurses discovered the error and informed His item is considered closed for the purposes of this the physician and the Radiation Safety Officer.The report. licensee decided to administer a thyroid blocking agent of 1000 milligrams of potassium iodide immedi-Medical Therapy Misadministra- ately, with three subsequent doses of 1000 milligrams 91-5 each given at four hour intervals.
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| tion at Clara Maass MedicalCenter in Belleville, New Jersey The licensee determined that the thyroid of the patient received an uptake of between 80 and 100 The following inform' tion pertaining to this event is microcuries of iodine-131 which would give a dose of also bemg reported concurrently m the Federal between 112 and 140 rads. An NRC medical consult.
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| Register. Appendix A(seetheoveralleriterion)of this ant, who reviewed the event, concurred with these report notes that an event involving a moderate or figures. He licensee advised the NRC that no ad-more severe impact on public health or safety can be verse effects were anticipated during the lifetime of considered an abnormal occurrence. the patient as a result of the misadministration.
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| Date and Place-March 28, 1991; Clara Maass Cause or Causes-The causes were attributed to fai ure to follow the hospital protocol of checking the Medical Center; Belleville, New Jersey.
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| 1 NUREG-0090, Vol.14, No. I 5
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| l Abnormal Occurrences,1st Otr CY91 i
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| patient identification number, and failure to inform ing radiopharmaceutical therapy. Other actions in-the head nurse of the floor of the therapeutic proce- clude changing the computer program so that all of dure, prior to administration. the information is printed out on the patient list, and reinstruction to personnel regarding patient verifica-Actions Taken to Prevent Recurrence 1Jcensee-He licensee's planned corrective action NRC-On April 1,1991, a Region I inspector con.
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| ducted a specialinspection of the circumstances sur-includes establishing a check list that must be com-rounding this misadministration. %e inspection re-pleted by individuals administering therapeutic dos-port was forwarded to the licensee on April 17,1991 ages. The check list will require that the person ad-ministering the dosage to check, as a minimum, the (Ref. 7). No vio ations of regulatory requirements type of radiopharmaceutical to be administered, the were identified.The licensee's corrective actions are considered satisfactory.
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| activity of the dosage, the name of the patient, and the patient number; it will also require notification of This item is considered closed for the purposes of this the nursing staff that one of theirpatientsis undergo- report.
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| Agreement State Licensees Procedures have been developed for the Agreement consulting physicist and being told that a wedge fac-States to screen unscheduled incidents or events us- tor would be required.
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| ing the same criteria as the NRC (see Appendix A) and report the events to the NRC forinclusion in this While preparing to treat a fifth patient assigned the report. The Agreement State of Arizona reported same treatment protocol, a point hand calculation in.
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| the following event as an abnormal occurrence. The dicated a wide discrepancy when compared to the writeup is based on information provided to the NRC computer generated treatment time. His discrep-during late 1990. ancy led to a comprehensive search of past cases which revealed the three overexposures out of four AS91-1 Medical Therapy Misadministra- "
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| tion at Good Samaritan Medical All three patients showed signs of skin crythema Centerin Phoenix, Arizona (reddening) and tl e first two patients (who had re-ceived radiation to the larynx region) reported Appendix A (see the overall eriterion) of this report hoarseness and pain on swa!!owing. The licensee notes that an event involving a moderate or more se- stated that these symptoms are not unusual for pa-vere impact on public health or safety can be consid- tients undergomg radiotherapy, and in fact, these ered an abnormal occurrence. same symptoms were mentioned to the patients as possible side effects of the treatment.
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| Date and Place-February-June 1989; Good Samari-tan Medical Center; Phoenix, Arizona. Cause or Causes-A consulting physicist was re-tained to review patient records and the hospital's handling of this case. Among the findings were:
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| Nature and Probable Consequences-On July 26, 1989, the licensee reported to the Arizona Radiation a. He hospital staffing level was inadequate for the Regulatory Agency (State Agency)a series of three patient load.
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| misadministrations involving the use of a cobalt-60 teletherapy unit in the licensee's Radiation Oncology b. Here was a loss of continuity in physics services Department.
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| with the departure of one physicist and the hiring of another phpicist. l De three patients received exposures of approxi-mately 14%,11%, and 12% greater than the pre-
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| : c. Here was pcor communication (documenta-scribed doses of 6200 rads,6480 rads, and 5000 rads, tion) regarding the use of the computer gener-respectively, from an AECLheratron-80 unit con- ated treatment plans.
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| taining 5529 curies of cobalt-60 assayed on Septem- Actions Taken to Prevent Recurrence l
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| l ber 16,1988. A beam correcting wedge had been used along with a treatment planning computer. Although IJcensee-Re licensee has hired a full time quali-
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| , the computer already contained a wedge correction fied therapy physicist and a technical administrator.
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| ( factor, the technologist and dosimetrist added a sec- Dese individuals will not have responsibilities out-ond wedge correction factor after checking with the side of the therapy department.
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| l NUREG-0090, Vol.14, No.1 6
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| Abnormal Occurrences,3rd Otr CY91 in addition, the bed of the truck, from which the ship- port notes that an event involving a moderate or more severe impact on public health or safety can be ping container fell, was a flat steel deck with no obstructions at the rear of the truck except for a can- considered an abnormal occurrence.
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| vas cover held in place with four elastic straps. During transportation, several shipping containers were fas-Date and Place-September 9,1991: St. John's tened on the truck bed by locks attached to the con- Mercy Medical Center in St. Louis, Missouri.
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| j tainers and to the 3/8-inch diameter links of a slack steel chain, which was attached to structural mem- Nature and Probable Consequences-A bone scan ,
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| diagnostic study was scheduled for September 9, l bers of the truck. The chain did not surround the shipping containers, freeing them to move on the 1991, for a 15-month-old male child with possible os-truck bed. Apparently, the slack allowcd the shipping teomyelitis (bone inflammation) of the ankle. De containers to accelerate when the vehicle turned cor- child was given an adult dose of technetium-99m ners, breaking a lock and allowing the subject ship- MDP, the radioactive pharmaceutical used for a bone scan.The normal dose for a child of his weight would ping container to fall off the back of the truck.
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| be 1.91 millicuries. He standard adult dosage used The police officer who held the source received an es- for the diagnostic study was about 21.96 millicuries, more than 10 times the intended dosage to the child.
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| timated exposure of approximately 5 rem to his fin-gers. He individual who retrieved the source re-ceived an estimated exposure of approximately 150 The licensee uses a computer system as an aid to de-I millirem to his fingers. termine the appropriate amounts of the radio-pharmaceutical to use in the bone scan. For adult pa-
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| ! tients, there are standardized dosages; for patients l Cause or Causes-The event was attributed to hu-I man error. Licensee personnel did not follow the li- under 18 years old, the dosages are calculated on the censee's procedures or management instructions in basis of body weight.The pediatric patients are iden.
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| correcting shipping container deficiencies and in tified on the licensee's treatment list with an asterisk.
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| properly securing the shipping containers to the accompanied by a handwritten notation of the pa- l transporting vehicle. tient's body weight. l The radiopharmacist who prepared the techne-Actions Taken to Prevent Recurrence tium-99m MDP for the bone scan failed to note the l asterisk and handwritten body weight on the com-Licensee-On September 6,1991, the day after the incident, the licensee issued a memorandum to all puter printout of scheduled diagnostic studies. As a result, he prepared the standard adult dosage, their North American facilities. This memorandum concerned corrective measures that were effective immediately. Subsequently, the licensee took addi- The nuclear medicine technician did not detect the tional corrective actions to prevent such losses. error prior to administering the radiopharmaceutical to the patient.De technician checked the patient's name on the dose ticket accompanying the syringe, NRC-On September 6, 7, and 11,1991, NRC but did not verify the radiopharmaceutical and Region IV inspectors conducted a special, an-nounced radiation safety inspection of the licensee's dosage, as required by hospital policy. After the ad-ministration, the technician noted the volume of the l byproduct material program (Ref.1). The inspection technetium-99m MDP was greater than expected, re-included the review of organization, management, i checked the dose ticket, and discovered the error. l training, radiation protection, independent measure-l ments, notification, and transportation activities. !
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| The error did not negate the results of the diagnostic Seven apparent violations of NRC regulations were I study and the bone scan was completed. Although identified. Escalated enforcement action is under consideration. the amount of radiation the child received was greater than intended, the licensee determined the increased risk of biologic effects was not significant.
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| Future reports will be made as appropriate, The calculated radiation dose for the study was about 4.4 rads to the bone and 1.3 rads to the total body.
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| 91-9 Medical Diagnostic M.isadm. .inis- His compares to about 0.38 rads to the bone and 0.11 tration at St. John's Mercy Medi- rads to the whole body had the correct dosage been
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| /! cal Center in St. Louis, Missouri administered.
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| /V The following information pertaining to this event is Cause or Causes-The cause is attributed to human also being reponed concurrently in the Federal Regis-error on the part of the radiopharmacist and the nu- )
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| ter. Appendix A(see the overall criterion) of this re- clear medicine technician. 1 OA 0 $5 UA k b
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| ^
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| Abnormal Occurrences,3rd Otr CY91 i
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| ers and to point out the need to follow department Actions Taken to Prevent Recurrence policies.
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| N RC-The NRC staff has reviewed the circumstance 1.icensee-The hospital has counseled the two em- of the misadministration and will evaluate the licen-ployees involved in the error. Hospital management sce's correcttve actions in a routtne mspectmn to be met with the nuclear medicme department staff on conducted in the next several months.
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| September l7,1991, to review the impact of the er-This item is considered closed for the purposes of this rors in this incident, to stress the importance of checking one's own work as well as the work of oth- report.
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| Agreement State Licensees these quarterly reports to Congress. For this period.
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| Procedures have been developed for the Agreement the Agreement States reported no events as abnor-States to screen unscheduled incidents or events us-mal occurrences.
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| ing the same criteria as the NRC (see Appendix A) and report the events to the NRC for inclusion in l
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| 3 NURl!G-0090. Vol.14. No. 3
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| Abnormal Occurrences,4th Qtr CY91 of the drum. Rather than question why he did not reg- Other-Therapeutic Nuclides has redesigned their ister any reading, he assumed that all items inside the container to prevent this type of spillin the future.
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| i package had been properly secured and he allowed it Unless new, significant information becomes avail-to continue on to its destination.
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| able, this item is considered closed for the purposes tb mpoa
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| ! The package arrived at Therapeutic Nuclides on hionday, November 5,1990, but it was not opened AS91-7 Medical TheraEy Misadministra-until the followmg day. When the package was opened and discovered empty, the Radiation Safety tion at Northridge Hosp,tal i Officer for Therapeutic Nuclides immediately noti- Medical Center in Northridge, fied the Los Angeles County Radiation Control of- California fice (Agency) and an investigation was begun. An Agency inspector contacted Federal Express in an at- Appendix A(see the overall criterion)of this report tempt to backtrack the route the package took from notes that an event involving a modcrate or more se-the time it was picked up at the hospital. She was able vere impact on public health and safety can be consid-to focus her search on the Hub facility at LAX and ered an abnormal occurrence.
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| discovered the sources there as soon as she entered the facility. This writeup is based on information provided to the NRC in December 1991 by the Agreement State of All seven sources were located in various places
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| ; throughout the facility by the inspector. Federal Ex- Date and Place-hfay 3,1991; Northridge Hospital press personnel who came in contact or worked near hiedical Center in Northridge, California.
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| : where the sources were found were interviewed.
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| ! Those ir dividuals who came in close contact with the Nature and Probable Consequences-On hiay 3.
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| sources were sent for medical evaluation and fol- 1991,15 mci of iodine-131 intended for patient "A" lowup. Dose estimates were established for all work- was administered in error to patient "B" who had the ers and all were notified of their estimated doses. In- same first and last names as patient " A." The admini-dividual dose estimates for the 24 employees stration was made by the hospital's Certified Nuclear involved ranged from 10 mrem to 1810 mrem whole Medicine Technologist without the responsible phy-
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| ! body. Also, three individuals who said they touched sician present, which is a violation of the California the sources had estimated extremity doses that Radiation Control Regulations. Patient "B" had re-
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| : ranged from 90 to 260 rem. ported to the hospital's Outpatient Department for a preoperational chest x. ray instead of reporting to her doctor's private office as she was instructed. Patient
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| ! The U.S. Department of Transportation (DOT)in, "A" was scheduled to receive a hyperthyroidism vestigated whether the package of sources was prop.
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| treatment that same mornmg.
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| erly secured prior to pick-up by Federal Express.
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| There is strong evidence that the package was not When her name was called, patient "B" answered q properly scaled; therefore, when it fell down the con-
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| , and signed the consent form. She asked questions of veyor belt it easily spilled open. The hospital staff her technologist about thyroid disorders and was l
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| ; supplied sworn statements to Radiation Control Pro- g ven answers.The dose of 15 mCiwas administered.
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| ; gram staff that they had followed all procedures 1 when they packaged the sources; however, DOT has later that same day, patient "A" presented herself 4 run extensive tests on the container and has con- for the treatment it was then that the hospital dis-cluded that if it had been sealed properly, it would covered that they had administered the dose to the not have spilled its contents. wrong patient. Patient "B's" doctor was contacted and consulted with the Chief Nuclear Medicine phy-sician.They decided to give patient "B" 15 drops of a i
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| Actions Taken to Prevent Recurrence potassium todme solution three times daily for three days plus forced fluids to reduce the uptake of the ra-Hospital- After long delays, the hospital complied dioactive iodine. She underwent the previously with the dose notification requirements. scheduled surgical procedure three days after the i
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| dose was administered without any regard for the
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| ! State Agency-A Notice of Violation was issued to possible exposure of surgical room staff from the pa-the hospital for failure to report the incident and also tient.
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| for the exposures to personnel in excess of permissi-ble levels. The case was closed on November 13, 'Ihis incident was reported to the wrong unit of 1991. California's Department of Health Services by the
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| ' 7 NUREG-0090. Vol.14. No. 4
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| I I Abnormal Occurrences,4th Otr CY91 l
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| I l
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| Cause or Causes-The administration was made by hospital five days after it occurred. Not realizing the the hospital's Certified Nuclear MedicineTechnolo-significance of the error, Radiologic Health was not contacted until May 31, 1991, 28 days after it oc- gist without the responsible physician present.
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| cuned. An investigation was begun by the Radiologic Health Unit of the les Angeles County Health De- Actions Taken to Prevent Recurrence partment, the inspection agency for this licensee.
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| Licensee-An enforcement conference was held at The inspector discovered that the hospital had origi- the los Angeles County Health Department be-nally estimated the patient's thyroid dose to be much tween members of the hospital administrative staff lower than it actually was.*Ihe agency retained a con.
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| and representatives of the County and State Radia-sultant who performed a complete workup of the pa- tion Control Program staff.The hospital presented tient. The patient's dose was established at 3000 rem an extensive corrective action plan and explained to the thyroid and she was informed of this in writing new controls that would be put in place.
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| by the hospital. She was placed into a treatment fol.
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| l Iowup program. Agency-Representatives of the Radiologic Health Branch accepted the plan and the case was referred to the city attorney's office for determination if An evaluation of exposures to the surgical room staff charges should be filed.
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| was also made by the consultant. Their exposures This item is considered closed for the purposes of this were determined to be minimal and they were also notified by the hospital. report.
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| l l
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| l l
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| l r
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| , , e
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| Abnormal Occurrences. 4th Qtr CY91 I
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| l i
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| i REPORT TO CONGRESS ON ABNORMAL OCCURRENCES I OCTOBER-DECEMBER 1991 J l
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| )
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| Nuclear Power Plants NRC has not determined that any events were abnor-He NRC is reviewing events reported at the nuclear mal occurrences.
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| power plants licensed to operate. For this report, the Fuel Cycle Facilities (Other Than Nuclear Power Plants)
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| De NRC is reviewing events reported by these licensees. For this report, the NRC has not determined events were abnormal occurrences.
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| Other NRC Licensees (Inditstrial Radiographers, Medical Institutions, Industrial Users, etc.)
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| The technologist realized the error nine minutes af-There are currently over 8000 NRC nuclear material ter the dose was administered when the printed dose licenses in effect in the United States. principally for use of radioisotopes in the medical. industrial, and label from the dose calibrator was checked. The i academic fields. Incidents were reported in this cate-physician-in-charge promptly administered potas- l sium iodide solution to the patient to reduce the up-gory from licensees such as radiographers, medical institutions, and byproduct material users. ne NRC take of the radioactive iodine. The licensee esti-mated, based on 24-hour uptake measurements, that is reviewing events reported by these licensees. For the uptake of radioactive iodine in the thyroid was ap-this report, tae NRC has determined that the follow- proximately five percent resulting in an estimated ing events were abnormal occurrences. dose to the thyroid of 1612 rem. The misadmin-istration was promptly reported to the NRC.
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| 91-10 Medical Diagnostic M.isadm. .inis-The licensee continues to follow the patient's condi-tration at I. Gonzalez Martinez tion and has advised the NRC that the patient has not Oncologic Hospital in Hato Rey, experienced any adverse effects because of the Puerto Rico misadministration.
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| / The following information pertaining to this event is Cause or Causes-Be cause is attributed to human also being reported concurrently in the Federal Regis- crror by the nuclear medicine technologist.%e tech-ter. Appendix A(see the overall criterion)of this re- nologist did not verify the dose by reviewing the port notes that an event involving a moderate or printed dose label before administering the dose.
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| more severe impact on public health or safety can be considered an abnormal occurrence.
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| Actions Taken to Prevent Recurrence Date and Place-June 17, 1991; 1. Gonzalez Mar-IJcensee-The licensee's corrective actions included tinez Oncologic Hospital: Hato Rey, Puerto Rico. takingdisciplinary action against the technologist and requiring that the nuclear medicine supervisor check Nature and Probable Consequences-On June 17, each dose before the dose is administered to a pa-1991, a patient scheduled to receive a diagnostic dose of iodine-131 (1-131), was mistakenly administered a tient.
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| dose of I-131 in the therapeutic range. The misad- NRC-NRC Region 11 conducted an inspection to re-ministration occurred when a nuclear medicine tech- view the circumstances associated with the mis-nologist misread the dose calibrator and admini- administration, and to review the licensee's correc stered 6.2 millicuries rather than 6.2 microcuries.
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| ' NI iR FG-0090. Vol.14. No. 4
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| O Abnormal Occurrences 4th Otr CY91 tive actions. No violations of NRC requirements Cause or Causes-The event was attributed to hu-man error as a result of the radiopharmacist's and were identified during the inspection.
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| consulting nuclear medicine physician's inattentive-ness and short experience at this facility. Ahhough This item is considered closed for the purposes of this the prescribing physician s written request was avail-able at the time the dosage was ordered and admmi-reE rt' stered, both individuals failed to compare the pre-l scribed dosage with the dose calibrator assay result or 91-11 Medical Tlierapy Misadministra- the radiopharmaceutical package label. Additionally, tion at William Bedumont Army both the radiopharmacist and consulting nuclear medicine physician had only been working at the fa-Medical Center in El Paso, Texas cility for a short time and were unfamiliar with the j
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| use of radioiodine dosages as low as 15 millicuries for De following information pertaining to this event is the treatment of Graves, disease. The physician,s I also being reported concurrently in the Federa/ Regis- previous experience and personal preference in-ter. Appendix A (see the overall criterion)of this re- volved a routine dosage of 25-30 milhcunes for a hy- l l
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| port notes that an event involving a moderate or perthyroid disorder,and the radiopharmacist had dis-more severe impact on public health or safety can be Pensed only a few therapeutic radiciodine dosages. l considered an abnormal occurrence, involving higher dosages, prior to this particular case. j l
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| De licensee also acknowledged that the con 3uhmp l
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| Date and Place-August 30. 1991: William Beau- nuclear medicine physician may not have reali/eJ ]
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| mont Army Medical Center: El Paso. Texas. , hat the patient was receiving treatment for GraseJ disease rather than a multinodular toue goiter at the l time the dosage was administered.
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| Nature and Probable Consequences-On August 30.
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| 1991, a patient referred to the Medical Center for i Actions Taken to Present Recurrence therapeutic radiciodine treatment of Graves' dis- i case, mistakenly received a 28.6 millieu rie (mci) oral Licensee-The radiopharmacist and consulting nu-dosage of iodine-131 (I-131) instead of the pre. clear medicine physician were counseled and scribed oral dosage of 15.0 mCiI-131. As a result, the reinstructed as to the proper dose verification tech-patient's thyroid received about 31,900 rads mstead niques and safeguards. For future therapies using of the 16,700 rads intended, radiopharmaceuticals, the counseling nucicar medi-cine physician must visually check the activity of the Prior to the administration, the radiopharmacist in- radiopharmaceutical dosage, as measured by the rad-volved was mformed that a rad,otodine t treatment for iopharmacist or technologist, with the written physi-Graves disease had been requested. He assumed cian prescription. The licensee also intends to re-that it was a 29 mCt treatment rather than a 15 mC quire that the consulting nuclear medicine physician treatment. [ At the Medical Center, a 15.0 mci dose is be familiar with the patient's case history prior to ad- .
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| routinely used for Graves' disease while a 29.0 mC' ministering a therapeutic radiopharmaceutical dos- i dosage is used for thyroid disorders such as multi- age nodular toxic goiters.) lie then requested a 29.0 mci dose from Syncor, the commercial radiopharmacy. Also, the licensee's Radiation Safety Officer will con-The actual dose received from Syncor was 28.6 mCt, duct a training session in which all nuclear medicine and was labeled as such. When the radiopharmacist personnel will be required to review the videotape logged the dosage into the computer, after it had entitled," Good Practices in Preparing and Admini-been measured by the dose calibrator, he fJled to stenng Radiopharmaceuticals," prepared by the take note of the tntended therapy dose as ref'ected in NRC's Office for Analysis and Evaluation of Opera-the referring physician's prescription. In addition, the tional Data, counselmg nuclear medicine physician did not verify l the dosage to be administered with the intended dos. NRC-NRC Region IV conducted an inspection to age.ne 28.6 mCiincorrect dosage was then adm_ m i- review the circumstances associated with this l
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| l stered to the patient. misadministration and the licensee's corrective ac-tions as described above (Ref.1). The inspection ,
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| revealed no violations of regulatory requirements l The referrtng physician was nottfied on the day of the l regarding this misadministration, and the licensee's l misadministration. The licensee stated that no ad- determination of the cause of the event was consid-verse effects on the patient were noted.De patient's cred accurate based upon interviews of the indi-i condition will be appropriately followed in 'he licen- viduals involved. The licensee had implemented f I
| |
| see's Endocrine Clinic.
| |
| | |
| Abnormti Occurrenczs, 2nd Qtr CY92 i
| |
| rads based on an uptake of 66 percent and the dose to the 92-8 Medical Therapy Misadntinistration whole body to be approximately 6.25 rads. at The Christ Hospital in Cincinnati, Ohio Cause or Causes-It was determined that one of the causes of the misadministratic,n was a miscommunication The following information pertaining to this event as also between staff at both the referring endocrine clinic and being reported concurrently in the federal Register. Ap- [
| |
| 1 Baystate. Other causes were failure of the staff at Bay- pendix A(see Event'Iype 5 in Table A-1)of this report state to follow regulatory procedures involving notes that a therapeutic dose that is less then 0.5 times the radioiodine doses greater than 30 microcuries which re- prescribed dose can be considered an abnormal octor- ,
| |
| l rence. In addition, some tissue received considerably quire that an authorized user prepare a written directive ;
| |
| prior to the administration. Nuclear Medicine Depart- more radiation than it would have had the treatment been l
| |
| mental procedures also require that when an order for a as prescribed.
| |
| requested study is unclear or illegible, the referring physi- Date and Place-May 29,1992;The Christ Hospital; Cin-cian be contacted prior to the performance of the study.
| |
| cinnati, Ohio.
| |
| Nature and Probable Consequences-On May 29,1992, i Actions Taken to Prevent Recurrence the licensee performed an implant of radiation seeds for l Licensee-The licensee's corrective actions included: treatment of a patient's prostate cancer.The patient had (1) instruction of nuclear medicine staff in the depart- previously received radiation treatment to the prostate ment procedures and regulatory requirements for using a linear accelerator. The implant treatment plan radioiodine studies; (2) preparation, prior to the admini- called for placement of 58 seeds, each containing 0.31 millicuries of iodine-125. The seeds were to be implanted ;
| |
| stration, of a written directive by the Director of Endo-crine (an authorized user), or a designated authorized in the prostate using needles guided by an ultrasound user before any iodine study using greater than 30 image. He implanted seeds were to deliver a dose of l l
| |
| microcuries is performed;(3) prompt transmittal of writ- 12,000 rads to the prostate.
| |
| l ten requests for nuclear medicine studies from the clinics to the Baystate Medical Center, Nuclear Medicine Divi- The 58 seeds were implanted, but a subsequent comput-I sion, in order to compare the request to the computer erized tomographic scan showed that 21 seeds were im-planted in tissue surrounding the prostate rather than the l entry prior to the administration; and (4) review of this l patient's progress once every six weeks for three months. intended sites. Two seeds were eliminated with the j
| |
| patient's urine. The licensee calculated that the mispositioning of the seeds resulted in the patient receiv-NRC- An NRC Region 1 inspector conducted an inspec.
| |
| ing a 5,000 rad dose to the prostate rather than the in-tion on May 27 and 28,1992, to determine the circum. tended 12,000 rad dose.
| |
| stances associated with the misadministration (Ref.9). An I NRC medical consultant worked with the licensee to pro- The principal consequence of this misadm. .tmstration is j vide a clinical assessment of the misadministration. Al. the potential effects of the underdosage to the prostate. l though the medical consultant calculated the thyroid dose in addition, tissue surroundmg the prostate received a to be considerably less than the licensee's estimate, his greater radiation dose than mtended. The prescribing evaluation of the event and consequences to the patient Phystetan concluded that the delivered dose from the I
| |
| were similar to the licensee's evaluation. They were in implanted seeds and from the previous linear accelerator agreement that because the patient was diagnosed as treatment was sufficient. An NRC medical consultant, l having Graves' disease, the ultimate therapy would be retained to evaluate the circumstances and response to, treatment with about 10 millicuries of iodine-131 (com. the misadministration, noted: "l'umor recurrence ts the pared to about 4 millicuries that were mistakenly admini- greatest risk, and it will be monitored closely." The con-stered). Therefore, the patient did not suffer adverse sultant also concluded that there was not a high probabil-health effects from the misadministration worse than ity of radiation damage to the rectum, which would be the those normally associated with treatment of Graves' dis- area of principal concern.
| |
| case.
| |
| Cause or Causes-ne misadministration resulted from The NRC inspection identified two apparent violations of the difficulties in the ultrasound placement technique.
| |
| NRC requirements:(1) failure of authorized user to pre- He ultrasound image is difficult to interpret in guiding pare a written directive, and (2) failure to follow proce- the placement of the seeds with the implanting needles.
| |
| dures. An enforcement conference was held on June 23, Re prescribing physician, who is the Authorized User in 1992. Enforcement action is pending. the NRC license, had been trained and certified in the ultrasound guided implant technique, but had not actu-Future reports will be made as appropriate. ally performed the procedure.
| |
| 6 NWEG-0090. Vol.15. No. 2
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| | |
| l ,
| |
| Abnormal Occurrences, 2nd Otr CY92 I
| |
| are the most significant and least significant, respectively.
| |
| brachytherapy applicator and administered to the patient. Each violation was assessed a proposed civil penalty of Because all the sources were smaller in diameter than ihe $ 1,250. Six other violations (including the failure to notify intended sources, they slipped from the prescribed posi- the NRC within 24 hours after discovery of a therapy tion and irradiated normal tissue not intended to be irra- misadministration) were also cited at either Severity diated.He applicator was loaded by a technologist who Level IV or V and involved the licensee's radiation safety had never performed the procedure. The technologist program.
| |
| was supervised by a technologist who had not performed l the procedure in eight years, when the incorrect sources Unless new, sigmficant information becomes available, were in active use.ne incorrect sources were discovered the item is considered closed for the purposes of this I at the midpoint of the treatment by the licensee's medical report.
| |
| physicist during an unplanned training session for a new physicist, ne incorrect sources were promptly removed from the patient and the treatment restarted and com- 92-7 Medical Diagnostic Misadministra-pleted as directed by the authorized user. t,on i at Baystate Medical Center, Incorporated,in Springfield, Massa-The licensee estimated the dose to normal tissue was l/ chusells approximately 400-500 rads. The licensee advised the l
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| NRC that no adverse effects to the patient are anticipated The followmg information pertaining to this event is also as a result of the misadministration. being reported concurrently m the federa/ Regrsrer. Ap-pendix A (see Event Type 4 m Table A-1)of this report Cause or Causes-The causes are attributed to the licen- notes that admmistering a diagnostic dose of a radiophar-see's failure to: (1) properly train individuals handling maceutical that is greater than five times the prescnbed <
| |
| brachytherapy sources (2) adequately implement a Qual, dose can be considered an abnormal occurrence.
| |
| ity Management Program (QMP),(3) develop and imple.
| |
| ment adequate QMP procedures, and (4) properly label Date and Place-May 19,1992: Baystate Medical Center, the storage vault for the brachytherapy sources. Incorporated (Baystate); Springfield, Massachusetts. l Nature and Probable Consequences-On May 20,1992, Actions Taken to Prevent Recurrence the licensee notified the NRC by telephone that a medi-cal misadministration involving iodine-131 (1-131) radio-Licensee-The licensee's corrective actions included re-vision of the QMP policies and procedures, training all pharmaceuticais had occurred at the hcensee's facility the supervised individuals on brachytherapy procedures and previous day. A diagnostic dose was intended; howeJ m the revised QMP, arrangmg safe storage for the sources therapeutic dose was administered. The details of the l
| |
| no longer in use, posting a map of tne source storage vault event are desenbed below.
| |
| indicating the type of source at each storage point, and A nurse from the referring endocrine clinic called Bay-enhancing source accountabihty practices. state to make an appointment for a patient for a thyroid scan and 1-131 uptake study. Baystate's departmental NRC-Region 11 reviewed the circumstances associated procedure for a thyroid scan and 1-131 uptake is to per-with the misadministration and the licensee's immediate on form the study using 16 microcuries of I-131 and 10 mil-corrective actions during a reactive inspection licuries of technetium 99m. A whole body scan requires April 10,1992, and a follow-up inspection on April 22 and that approximately 4 millicuries of I-131 be given to the 23,1992, which included NRC consultants in the areas of patient. Apparently, the order was entered in the pa-medical physics, oncology, and risk assessment (Ref. 6). tient's scheduling chart as a whole body scan rather than NRC Region 11 conducted an Enforcement Conference the thyroid scan and 1-131 uptake study which was in-with the licensee on May 20,1992, to discuss the event tended. Questions were raised on several occasions by (Ref. 7). A notice of Violation and Proposed Irnposition licensee personnel because the patient was diagnosed of Civil Penalty in the amount of $2,500 was issued on with an enlarged thyroid and generally an 1-131 whole June 26,1992 (Ref. 8). body scan is not indicated for this diagnosis. Also, an authorized user was not consulted to review the study and This action was based on two violations that contributed prepare a written directive prior to the administration of to the brachytherapy misadministration:(1) failure of the greater than 30 mictocuries of I-131 as required by 10 QMP to include written policies and procedures to verify CFR 35.32. A nuclear medicine technologist admini-the use of correct brachytherapy sources and identify any stered 4.1 millicuries of I-131 for a whole body scan with-unintended deviations, and (2) failure to instruct super- out following the department's procedures for admini-vised individuals in the principles of radiation safety and the QMP. Each violation was categonzed at Severity stration of 1-125 or 1-131. The licensee evaluated the dose to the patient's thyroid to be approximately 14,300 Level 111 on a scale in which Severity I evels I through V 1
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| 5 NURl!G-0090. Vol.15 No. 2
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| | |
| Abnormal Occurrences 4th Qtr CY93 l
| |
| I MBq (5 mci) of P-32, as an outpatient receiving radiation AS 93-8 Medical Sodium Iodide therapy treatment. The patient was discharged in stable Misadmimstrat. ion at Inland condition. De mistake was caught when the Chief Tbchnologist was reviewing the records of doses Imaging in Spokane, prescribed and comparing these to the doses Washington admmistered. Immediate action was taken to follow-up l
| |
| on the discrepancy.He attending physician and patient R s abnormal occurrence was originally reported in were notified of the misadministration. The patient's NUREG-0090, Vol.16, No. 3, " Report to Congress on blood count monitoring frequency was changed from Abnormal Occurrences," July-1:ptember 1993. The monthly to bl. weekly and the patient was monitored for abnormal occurrence is updated as follows:
| |
| potential infections. Six weeks after the admuustration of P-32, the patient's blood count was normal except for a Date and Place-December 14, 1992; Inland Imaging:
| |
| decrease m the platelet count, which remained within the Spokane, Washington.
| |
| range of safety and represented the expected therapeutic l response.
| |
| Nature and Probable Consequences-On December 14, 1992, a patient diagnosed as hyperthyroid was referred to the licensee by the Fairchild Air Force Base Hospital for a Cause or Causes-The licensee's account of the cause is thyroid uptake scan of .26 megabecquerel (MBq) to 3.7 microcus) of duM NM De as follows: De stated package dose was 185 MBq (5 mci), q calibrated to a date 10 days after the date on which the p tpt was mis &nly admhprd a W Eq @3 technologist drew the dose. He technologist failed to milhcun,e) dose of I-131, sodium iodide for a whole body take notice of the calibration date and assumed that the scan. As a result, the patient s thyroid received a dose of stated package dose of 185 MBq (5 mci) was drawn for approximately 7950 centigray (7950 rad).
| |
| administration. Although the dose calibrator measurement of the prepared (drawn) dose indicated a The nuclear medicine technologist misinterpreted the significant discrepancy between the prescribed dose and orally requested procedure and failed to verify the the measured dose, the technologist failed to mvestigate requested procedure through review of the referring the cause of this discrepancy and did not notify the physician's written requisition.The patient's physician, an endocrinologist, was notified and did inform the patient.
| |
| physician m regard to the discrepancy. A dose of 303.4 MBq (8.2 mci) was admuustered to the patient by the physician, a Board Certified Radiologist. The licensee reported that both a whole body scan and the requested thyroid uptake study were performed three days after the misadmmistration "with no patient Actions Taken to Prevent Recurrence complaints or immediate side effects." The licensee has noted that the patient will most probably be hypothyroid for the rest of his life and that future litigation remains a Licensee-He corrective actions reported by the possibility. No NRC or State medical consultant has been licensee included the implementation of a modified contracted to review this event.
| |
| radiopharmaceutical therapy protocol for P-32 and iodine-131 administrations, and traming for the Cause or Causes-Dis event was attributed to human technologists. In addition, a work sheet and check list, error as a result of the technologist's inattentiveness and designed with several checks for technologists and relatively short , experience at this facility. Although the physicians prior to administration of the dose, were referrmg physician's written request was available at the developed for P-32 therapy.ne physician involved in the time the dosage was prepared and administered, the procedure was counselled and the technologist was technologist failed to reconcile the dose and study suspended from administration of therapy doses for a Prescribed with the dose and study given, minimum period of six months. De Chief 1bchnologist and Nuclear Medicine Physician will evaluate the Actions Taken to Prevent Recurrence technologist prior to allowing him or her to begin administering therapeutic doses again. Licensee-The technologist and the lead technologist (who was not present)were counseled and reinstructed by the authorized physician user / radiation safety officer. A State Agency-The State required the licensee to submit review by the licensee of all such administrations for the a plan of corrective action designed to prevent Prior 6 months revealed that the technologists were recurrence.The corrective actions reported by the facility inconsistent in verifying written referrals with the study appear to be satisfactory. given, prior to administration.ne licensee stated that all iodine studies are required to be verified against the his item is considered closed for pt.. pose of this report, written request slips prior to any iodine administration.
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| 23 NUREG-0090. Vol.16. No. 4
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| | |
| - - _. , _ _ _ _=-.. _ _ ,
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| )
| |
| Abnormal Occurrences,4th Qtr CY93 This abnormal occurrence was reopened because the where the dosimetrist performed treatment planning. All three facilities were notified and had independent physics following new significant information concerning enforcement action and the status of the affected patients reviews of treatment plans. At one of the hospitals, mistakes were found in two treatments involving a wedge; became available.
| |
| however, the totaldose delivered was within 10 percent of Enforcement action was initiated by the New York State
| |
| * that prescribed. At that same hospital, a mistake in the Department of Health which included provisions that the calibration of an orthovoltage unit was discovered which hospital take the following actions: commit to
| |
| ; resulted in 22 patients receiving doses in excess of 10 comprehensive quality assurance reviews for radiation percent of those prescribed. That calibration was therapy, submit quarterly progress reports for each ,
| |
| performed by the senior member of the physics consulting component of the stipulation, order of the enforcement l group. Rose patients were followed up and no adverse action, implement quality assurance reviews, mandatory i
| |
| outcomes were reported. periodic in-service training, testing of physics staff, and perform a periodic follow-up of the affected patients for l
| |
| Cause or Causes-ne dosimetrist involved lacked 1-year.
| |
| understanding of the computer treatment planmng 1 software and other basic methods in determining Reports of the patient follow-up were submitted to the l
| |
| treatment times. Quality assurance of treatment plannmg State of New York, Department of Health. As of was inadequate and no second checks of treatment plans December 1990, the reported status of the patient s were performed. condition involved in the misadministration is as follows:
| |
| two patients had laryngectomies; one patient had necrosis Actions Taken to Prevent Recurrence of the larynx; three patients had discomfort m the treatment area; one patient had a rib fracture; four Licensee-Insufficient Stformation is available on the patients had skin changes; three patients had atrophy m action (s) taken by the Ecensee to prevent recurrence. the breast; one patient had a radiation ulcer, one patient NRC has asked the Stat. of New York to provide had radiation proctitis, and nme patients died from additional information regarding the licensee action (s). complications not related to the misadmmistration.
| |
| State Agency-Ucense conditions concerning the The State radiation control regulations have been revised to include requirements of Quality Assurance programs, qualifications of physicists, treatment prescriptions,
| |
| < second checks, and misadministrations were added to all audits of therapy programs, misadministration reporting teletherapy licenses in 1988. Since that time, the State and training and experience requirements for therapy Sanitary Code has been revised to include specific physicists.
| |
| requirements for quality assurance in radiation therapy The item is comidered closed for the purposes of this for a11 therapy modalities.ne State of New Yorkbelieves that the dosimetrist involved no longer performs report.
| |
| treatment plannmg in New York State. Ihe senior physicist in the consulting group did not perform any AS 93-7 Medical .
| |
| therapy functions in New York State after the incident. Radiopharmaceutical nis report will be further evaluated when additional Misadministration by information becomes avatlable. " Unspecified Licensee" .m Albany, New York AS 88-4 Multiple Medical Therapy nis abwrmal occurrence was originally reponed in Misadministrations by NUREG-0090, Vol.16, No. 3, " Report to Congress on Rochester General Abnormal Occurrences," July-September 1993. ne abnormal occurrence report is updated as follows:
| |
| Hospitalin Monroe County, New York Date and Place-October 5,1992.
| |
| ne name of the licensee has been withheld by the State l His abnormal occurrence was originally reported in I of New York due to provisions in New York State Public NUREG-@90, Vol.11, No. 4, " Report to Congress on Abnormal Occurrences," October-December 1988 and Health law.
| |
| closed out at that time. It was reported that 19 patients Natun and Probable Consequences-A patient was received cobalt teletherapy micMministrations at admmistered 303.4 megabecquerel (MBq) (8.2 millicurie Rochester General Hospital in Monroe County, New
| |
| [ mci])of phosphorus (P-32),instead of the prescribed 18 York, between January 1988 and Atigust 1988.
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| NUREG-0090, Vol.16, No. 4 22
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| | |
| Abnormal Occurrences,4th Qtr CY93 Following the staff's review of the second occurrence on to her rectum when the physician mistakenly inserted the April 26,1993, NRC issued a Civil Penalty in the amount HDR applicator into the rectum instead of the vagina.
| |
| of $10,000 and Confirmatory Order Modifying License (Effective immediately), which confirmed the licensee's NRC Region I conducted a specialinspection on January 26 and 27,1993. The licensee was given the option of proposal to have a program assessment performed by independent experts. He program assessment was participating in an enforcement conference but declined, completed on May 10 and 11,1993. On August 24,1993, A medical consultant was retained to review the the licensee submitted their Program Assessment Report misadministration. On April 26,1993, NRC proposed a and Program Improvement Plan which was formulated in Civil Penalty in the amount of $10,000 and Confirmatory response to the program assessment. On November 16, Order Modifying License (Effective Immediately) which ,
| |
| 1993, the licensee submitted the first of the required confirmed the licensee's proposal to have a Program i quarterly reports on the implementation of the Program Assessment performed by independent experts. The Improvement Plan and stated that all actions were Program Assessment was completed on May 10 and 11, completed. NRC Region I has reviewed the Program 1993. On August 24, 1993, the licensee submitted the Assessment Report and Program Improvement Plan and report of the Program Assessment and their Program is currently preparing a response. Improvement Plan which was formulated in response to the Progrtm Assessment. On November 16,1993, the On June 10,1993, the licensee responded to the Notice of licensee submitted the first of the required quarterly Violation and Proposed Imposition of $10,000 Civil reports on the implementation of the Improvement Plan Penalty. In this response, the licensee denied one and stated that all actions were completed. NRC Region I violation, took issue with the manner in which the civd has reviewed the Program Assessment Report and penalty was determined, and requested mitigation of the Program improvement Plan and is currently preparing a
| |
| ' civil penalty based on minimal safety significance and lack response.
| |
| I of programmatic implications. On December 27, 1993, On June 10,1993, the licensee responded to the Notice of NRC responded to the licensee's request with an Order Imposing Civil Penalties in the amount of $10,000.De Violation and Proposed Imposition of $10,000 Civil licensee responded to the Order by letter dated January Penalty. In this response, the licensee denied one violation, took issue with the manner in which the civil 26,1994, and paid the Civil Penalty of $10,000.
| |
| penalty was determined, and requested mitigation of the A routine inspection was conducted of the licensee's civil penalty based on minimal safety significance and lack program from September 28 through 30,1993. One minor of programmatic implications. On December 27, 1993, violation of regulatory requirements was identified by the NRC responded to the licensee's request with an Order inspector. This violation has since been corrected by the Imposing Civil Penalties in the amount of $10,000. He licensee. Licensee responded to the Order by {{letter dated|date=January 26, 1994|text=letter dated January 26,1994}}, and paid the Civil Penalty of $10,000. l This report will be updated when additional information becomes avadable.
| |
| A routine inspection was conducted of the licensee's program from September 28 through 30,1993. One minor violation of regulatory requirements was identified by the 93-3 Med.ical Therapy mspector. This violation has since been corrected by the Misadministration Involving ticensee.
| |
| the Use of a High Dose-Rate nis report witibe updated when additionalinformation Remote Afterloader becomes avadabte.
| |
| Brachytherapy Device at Yale-New Haven Hospital in 93-10 Medical Sodium Iodide New Haven, Connecticut Misadministration at Osteopathic Hospital This abnor'ual occurrence was originally reported m.
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| V .
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| NUREG-0090, Vol.16, No.1, " Report to Congress on Founders Association DBA Abnormal Occurrences," January-March 1993. De (doing business as) hlsa abnormal occurrence report is updated as follows: Regional Medical Center in On January 21,1993, NRC was notified by the licensee Alsa, Oklahoma that a female patient received a 50 percent This abnormal occurrence was original'y reported m, undertreatment dunng a brachytherapy procedure to the NUREG-0090, Vol.16, No. 3, " Report to Congress on vagina and an unplanned 700 centigray (700 rad) exposure NUREG-0090, Vol.16, No. 4 20
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| | |
| Abnormal Occurrences,4th Qtr CY93 Abnormal Occurrences: July-September 1993." He On January 11, 1994, the NRC issued a Notice of Violation to the licensee. The licensee was cited for failing abnormal occurrence report is updated as follows:
| |
| to require individuals working under the supervision of In July 1993 the wrong patient was administered 0.21 authorized users to follow the instructions of the gigabecquerel (GBq) (5.7 millicuries [mCip of iodine-131 supervising authorized user and the written radiation safety and quality management procedures established by (I-131). De misedministration occurred because the the licensee. Because the misadministration was the licensee failed to verify patient identity.
| |
| result of an isolated failure to follow the quality The NRC staff retained a medicalconsultant to evaluate management procedures and was of limited consequence the potential medical effects to the patient as a result of to the patient, no escalated enforcement action was taken the mkadministration.He consultant provided a report by the NRC.
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| in October 1993, which stated that the impact of the incident on the status of the patient's health should be His item is considered closed for the purpose of this ;
| |
| neghgible, with no expected long. term disability as a report.
| |
| result of this misadministration. l Agreement State Licensees teletherapy unit recalibrated. Twenty two patients were AS 87-5 Therapeutic Medical identined as having mived inconcureatments ranging Misadministrations At from 50 percent underdose to approximately 100 percent overdose (total dose). All of the associated plans were Northern Westchester prepared by the same dosimetrist.
| |
| Hospital Center, Westchester An outside radiological physicist reviewed about 250 County, New York heatment plans including those of affected patients.ne His abnormal occurrence was originally reported in conclusion was that the dosimetrist made somewhat random mistakes, that is, plans were done with the correct NUREG-0090, Vol.10, No. 3., " Report to Congress on methods in some cases and incorrectly at other times.
| |
| Abnormal Occurrences," July-September 1987, and Overall, the cases indicated a lack of understanding of the closed out at that time. It was reported that 22 patients computer program used for treatment planning and the received cobalt teletherapy misadministrations at methods of calculation of 'imer settings from the l Northern Westchester Hospital in Westchester County, computer output. Furthermore, there were no second New York, between 1982 and 1987. checks performed which may have caught these mistakes.
| |
| His abnormal occurrence was reopened because the Northern Westchester Hospital Center was directed by origmal report contained several incorrect statements. the State Health Department to follow-up on the affected ne followmg report was prepared by the State of New patients for at least 1 year and to provide status reports to CU"*#* * * " '*' the department. At the time of the last report (May 1988),
| |
| 11 of the 22 patients had died. Some of the deaths may 4
| |
| Date and Place-On August 5,1987, the New York State have been from complications related to the misadministration in question. Other patients returned Department of Health Bureau of Environmental Radiation Protection was notified that mistakes m for further treatment. All treatment records for the treatment planning had been discovered and that some affected patients were requested for review by the State's cobalt teletherapy patients had received excess radiation Radiological Health Advuory Committee. He at Northern Westchester Hospital Center, committee did not have any comments that would counter the assertions by the hospital. He New York State Nature and Probable Cr:;:: aces-ne hospital had Department of Health notified the NRC that the dosimetrist involved is no longer working at the hospital contracted with a physics consulting group (Radiological or any other facility in New York State. The physicist in Physics Associates, Elmsford, New York) to provide charge of the consulting group stopped providing therapy physics services. A dosunettist from the group, who services in New York State after the incident and only normally prepared treatment plans, was not available and performed diagnostic x. ray and nuclear medicine upon review of one plan by another physicist from the consulting services.
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| group, it was discovered that the dosimetrist had made errors in his calculations. He State Health Department He State requested the names of other facilities where was notified of the mistakes and the hospital was directed physics services were performed by the same dosimetrist.
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| to discontinue therapy until treatment plans had been TWo other hospitals and a private office were identified reviewed and verified as correct and the cobalt NUREG-0090, Vol.16, No. 4 21
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| t i
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| Abnormal Occurrences,3rd Otr CY93 I
| |
| REPORT TO CONGRESS ON ABNORMAL OCCURRENCES j
| |
| JULY-SEPTEMBER 1993 j l
| |
| Nuclear Power Plants l l
| |
| NRC is reviewing events reported at the nuclear power determined that no events were abnormal occurrences.
| |
| plants licensed to operate. For this report, NRC has Fuel Cycle Facilities l
| |
| ! (Other than Nuclear Power Plants) i NRC is reviewing events reported by these licensees. For abnormaloccurrences.
| |
| this report, NRC has determined that no events were Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
| |
| than five times the intended dose to that body part, should There are currently over 7,500 NRC nuclear material licenses in effect in the United States, principally for the be considered an abnormal occurrence.'
| |
| use of radioisotopes in the medral, industrial, and Date and Place-July 27, 1993; Osteopathic Hospital academic fields. Incidents were reported in this category Founders Association DBA (doing business as) 'nitsa by licensees such as radiographers, medical institutions, Regional Medral Center; hlsa, Oklahoma.
| |
| academic institutions, and byproduct material users. NRC is reviewing events reported by these licensees. For this Nature and Probable Consequences-The licensee .
| |
| (
| |
| report, using the criteria and guidelines given in Appendix reported that on July 27,1993, a wrong patient was A, NRC has identified the following events as abnormal admimstered 0.21 gigabecquerel (GBq) (5.7 millicuries occurrences. As noted in the Preface to this report, the [ mci]) of iodine-131 (1-131). On July 27,1993, diagnostic guidelines for identifying medcal rniudministrations as Procedures were prescribed for two outpatients, patients abnormal occurrences are currently being revised A and B, usmg technetium-99m (Ib-99m) for patient A and I-131 for patient B. Prior to the admimstration, the technologist involved in the procedure believed that patient A was the one prescribed to receive I-131 and addressed patient Aby name and requested a second form of identification. Patient A responded positively and 93-9 Medical Sodium Iodide Presented a social security card as the second means of Misadministration at identifration.He technologist copied the social security Osteopattu,c Hosp, ital Founders number and attached it to patient As chart. However, tne written directive was not checked for verification of the Association DBA (doing business patient's name. As a result patient Awas admuustered a as) %1sa Regional Med, i cal 0.21 GBq (5.7 mci) dosage of 1-131 intended for patient Center in Lisa, Oklahoma B.
| |
| i i
| |
| i % definition of a ==admmatration was revned in 10 CFR 35.2 and De following information pertauung to this event is also tmme emeine on Janwy 27,1992. Ite nmoon defines a new being reported concurrently in the Federal Register. 'M I""'d"""'*i* W ""*d"""
| |
| 'di"" * * ''i'%d" Appendix A(see Event'1)pe 1in'Ihble A-1)of this report ""'I """"" #
| |
| notes that a diagnostic dose of a radsopharmaceutical to a part of the body receiving radiation improperly, if greater en under
| |
| ..,,--,,-,uw,
| |
| | |
| =
| |
| l
| |
| ~.
| |
| Abnormal Occurrences,2nd Qtr CY93 l
| |
| l l
| |
| gist immediately discovered the error and notified the Actions Taken to Prevent Recurrence physician (authorized user). Vomiting was induced within Licensee-He licensee requested that DOE (the source 5 minutes of administering the I-131 capsule. De patient manufacturer and the source lessor) manage the effort to was also administered a thyroid blocking agent,1.2 millili-I identify the leaking capsule, develop a plan for its safe re- ters (ml) (0.04 fluid ounces [fl. oz.]) of potassium iodide.
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| moval, manage its removal, and oversee the cleanup and ne patient was also instructed to take additional thyroid recovery activities at RSL blocking agent,0.3 ml (0.01 fl. oz.) of potassium iodide, once a day for 14 days. A thyroid uptake and scan were NRC-Following the .meldent, NRC reevaluated the performed 24 hours after the incident.ne thyroid uptake WESF sources and determined in early 1991 that WESF was 0.3 percent. He referring physician and the patient sources were not appropriate for long-term use in com- were mformed of the misadministration.
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| mercialirradiator facilities and ensured that the remain-ing commercial users were so notified and advised to Cause or Causes-The misadnnnistration occurred be-cause the nuclear medicine technologist failed to identify cooperate with DOE in scheduling removal of WESF sources from their facilities. As of the date of this report, the patient prior to the administration of the radiophar-WESF capsules remain in place in two licensed irradia- maceutical.
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| tors, one in Virginia and one in Colorado (licensed by the State of Colorado). According to DOE staff, if certain Actions Taken to Prevent Recurrence technical matters are resolved, DOE plans to begin re-moving the remaining WESF sources from these facilities Licensee-ne Radiation Safety Officer has implem-by the end of 1993, ented new procedures for verification of patient identifi-cation and has committed to improve the supervision of State Agency-The State of Georgia secured the services personne!.Re licensee also stated that patients who are of an mdependent consultant to verify the results of de- prescribed radiation therapeutic procedures will no long-contamination efforts by the DOE contractor. Once it was er be included in the same schedule with patients who are verified that the facility met Federal and State regulatory prescribed diagnostic procedures. ;
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| standards for decontamination, the State terminated RS1's materiallicense and returned control of the facility State Agency-The state agency staff has reviewed the cir-to its owner. Georgia will no longer license highly soluble cumstances of the misadministration and will evaluate the cesium for this application. I censee's corrective actions during the next inspection to be conducted in the near future.
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| Future reports will be made as appropriate.
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| '11 tis item is considered closed for the purposes of this re-port.
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| AS 93-2 Medical " Sodium Iodide" Misadministration at AS 93-3 Medical Brachytherapy l Grenada Lake Medical Misadministration at Maine Center in Grenada, Medical Center in Portland, Mississippi Maine Appendix A(see EventType 4 in Thble A1)of this report notes that administering a diagnostic dose of a radiophar- Appendix A(see EventType 3 in*Ihble A 1)of this report notes that a therapeutic exposure to a part of the body not maceutical that is greater than five times the prescribed scheduled to receive radiation should be considered an dose should be considered an abnormal occurrenm.
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| abnormal occurrence.
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| This report is based on information provided to the State Date and Place-November 11, 1992: Maine Medical of Mississippi on April 3,1992. Center; Portland, Maine.
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| Date and Place-April 1,1992; Grenada Lake Medical Nature and Probable Consequences-A patient was pre-Center; Grenada, Mississippi. scribed a brachytherapy treatment using 13 seeds of iridi-l um-192 in a nylon ribbon.The catheter used for the treat-Nature and Probable Consequences-On April 1,1992,a l ment developed a kink and stopped 26 centimeters (cm) patient scheduled to receive 3.7 megabecquerel (MBq) (10.24 inches [in.]) from the prescribed treatment area.
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| l (100 microcuries [Ci]) of iodine-131 (I-131) for a thyroid This resulted in a dose to the patient's hypopharynx area uptake study was administered 218.3 MBq (5.9 millicuries of 3500 centigrays (cGy) (3500 rad), which was the pre-
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| [ mci]) of 1 131. ne 218.3 MBq (5.9 mci) dosag; of I 131 scribed dose to the lung.He intended treatment area of was to be administered to another patient. ne technolo-NUREG-0090, Vol.16, No. 2 7
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| I Abnormal Occurrences,1st Otr CY93 i
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| 1 l
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| The written QM Program was received by the NRC on was held on March 1,1993, to discuss the inspection l February 11,1993. findings and actions taken by the licensee in response to i the CAL. On March 18,1993, NRC Region I issued a NRC-NRC Region I conducted an inspection on Notice of Violation with a Severity Level Ill (Severity February 3,1993 (Ref. 6). Because the misadministration Levels I through V range from the most significant to the resulted in an underdose to the patient and the therapy least significant) violation and $250 Civil Penalty (Ref. 8).
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| could be completed, the NRC did not contact a medical The licensee paid the Civil Penalty. The licensee's consultant to review this misadministration. A corrective and preventive actions will be reviewed during -
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| Confirmatory Action Letter (CAL)(Ref. 7)was issued to the next NRC inspection of the licensed program.
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| the licensee on February 5,1993, which described the commitments made by the licensee to establish and This item is considered closed for the purposes of this implement a QM Program. An Enforcement Conference report.
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| Agreement State Licensees Procedures have been developed for the Agreement quarterly reports to Congress. For this period, the States to screen unscheduled incidents or events using Agreement States reported no events as abnormal the same criteria as the NRC (see Appendix A) and occurrences.
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| report the events to the NRC for inclusion in these 1
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| i i
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| 1
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| *''""" ^^^^ ' '' '
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| .-_ _ -- __- _ _- . _ _ -. -- . _ - - - . _ ~
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| l
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| . Abnormal Occurrences,1st Qtr CY93 Cause or Causes-The licensee did not confirm the gigabscquerel (GBq) (30 millicurie [ mci]) of iodine-131 treatment site before the treatment was given as required be administered. On January 13,1993, the technologist by its Quality Management (QM) Program. ordered a 1.11 GBq (30 mci) dose from the radiopharmacy. De dose was received on January 14, 1993. The technologist noted that the label on the lead Action Taken to Prevent Recurrence container indicated 1.07 GBq (29 mci) of iodine-131, but 1 Licensee-ne licensee adJed a procedure requiring did not note that the label indicated that two capsules physicians to visually insert applicators. In addition, the were present in the vial. A second technologist who l removed the vial from the lead container and placed it in l
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| licensee committed to a complete program assessment by an outside expert. This commitment was formalized by the dose calibrator for assay also failed to note that labels l
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| i the NRC in a Confirmatory Order Modifying License on both the lead container and the vial indicated the l issued on April 26,1993 (Ref. 5). presence of two capsules. He assayed dose was i l
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| consistent with the activity noted on the label. De )
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| l NRC-NRC Region I conducted a special inspection at technologist transferred the dose from the supplier's vial the facility on January 22,1993 (Ref. 3). An NRC medical to a glass vial for administration to the patient. Only one consultant was contacted to provide a clinical assessment of the capsules came out of the vial.Re presumed empty of the effects of this misadministration.The licensee was lead container that still contained the plastic vial and offered the opportunity to participate in an Enforcement remaining capsule was placed in the nuclear medicine hot Conference but declined, believing that it would not be laboratory for storage. The licensee discovered the able to provide the NRC with any additionalinformation. remaining capsule on February 1.1993, when the NRC recommended an enforcement action. A Notice of technologist was preparing lead containers for disposal.
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| Violation and Proposed imposition of Civil Penalties. and The patient was administered 0.56 GBq (15.1 mci) of Confirmatory Order Modifying License were issued on iodine-131, instead of the intended dose of 1.11 GBq (30 Apnl 26,1993 (Ref. 5). (License modtfication required mci).ne misadministration was reported as required on that the licensee's radiation safety program be improved February 1,1993.Re patient and the patient's physician as recommended by an outside expert.)Thc enforcement were notified of the error and the patient was scheduled action was based on this event and AO 92-19, which is for follow-up therapy on February 10,1993. De discussed in Appendix B. The cumulative amount of licensee's physician expected no adverse effects as a
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| $10,000 for the violations was based on the combined result of the misadministration. While the therapeutic events. dose administered was actually about 0.5 times the prescribed dose, the staff believes that this Future reports will be made as appropriate- misadministration should still be considered an abnormal I occurrence. l 93-4 Medical Therapy Cause or Causes-ne misadministradon was caused by Misadministration at failure of the licensee to establish and unplement a Papastavros' Associates Quality Management (QM) Program as required by 10 CFR 35.32(a). In particular, failure of the licensee to Medical Imaging in establish procedures to ensure that each therapy
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| / .
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| Wilnlington, Delaware administration is in accordance with the written directive contributed to the misadministration.
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| The following information pertaming to this event is also being reported concurrently in the Fedeml Register.
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| Actions Taken to Prevent Recurrence Appendix A(seeEventType SinTable A-1)of thisreport notes that a therapeutic dose that is less than 0.5 times the Licensee-ne licensee's plan for preventing recurrence prescribed dose can be considered an abnormal of the misadministration includes three steps: (1) to occurrence.
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| prepare and implement a written QM Program and Date and Place-January 14, 1993; Papastavros' provide training; (2) to have the radiopharmaceutical Associates Medical Imaging; Wilmington, Delaware, supplier indicate the number of capsules in each vial on the packing slip provided with iodine 131 therapy doses; Nature and Probable Consequences-On February 1, and (3) to require the nuclear medicine technologists to 1993 NRC Region I was notified by telephone that a read the label on the vials and lead containers to determine the number of capsules present in the vial, and therapeutic misadministration of iodine-131 occurred at the licensce's facility. In early January, the nuclear then verify that the required number of capsules are l administered to the patient. In addition, the vial into
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| ' medicine technologist received a telephone call from the referring physician requesting that a patient be scheduled which the capsules are transferred after initial assay will for a third treatment for hyperthyroidism and that 1.11 be reassayed to ensure that all capsules are transferred.
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| NUREG-0090, Vol.16, No.1 - 4
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| . l I
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| l Abnormal Occurrences,1st Qtr CY93 1
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| l On March 2,1993, NRC Region 111 issued a Confirmatory Region til about the incident after reading about a similar Action Letter to the licensee documenting its agreement case in an NRC Office of Nuclear Material Safety and to provide training to the nuclear medicine staff on the Safeguards newsletter. A licensee consultant reviewed requirements of the QM Program, NRC regulations,and i
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| the case with NRC Region til on February 19, 1993. NRC licensee requirements (Ref. 3). No procedures I
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| Following that discussion, the consultant reported the using more than 1.11 MBq (30 pCi) of iodine-131 were to incident as a misadministration because the procedure j be performed before the training was completed. The requested by the patient's physician, a thyroid scan, would licensee also agreed to make certain that its procedures i normally use a different radiopharmaceutical, fot iodine.131 studies are consistent with the QM technetium-99m. Program.
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| Cause or Causes-ne basic causes of this misadmin. Future repcrts will be made as appropriate.
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| istration were a miscommunication between the referring physician's office and the licensee, and a failure of the Medical Therapy licensee to follow its Quality Management (QM) Program 93-3 for procedures using radioactive pharmaceuticals. Misadministration Involving the Use of a High Dose-Rate The licensee's QM Program, which was implemented in January 1992, requires that a written directive be Remote Afterloader I
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| prepared for procedures using more than 1.11 MBq (30 &M) therapy Device at microcurie (nCi]) of iodine-131. However, no written Yale-New Haven Hospitalin directive was prepared for this procedure. i New Haven, Connecticut }
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| The licensee's procedure for a whole body .iodine-131 The following information pertaining to this event is also scan required that the patient's thyroid had been removed being reported concurrently in the Federal Register.
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| previously. The licensee's procedures were not effective in determining if the patient had an intact thyroid. Appendix A(see EventType3inTable A-1)of thisreport notes that for a therapeutic exposure,if parts of the body The nuclear medicine department staff had not received receiving radiation improperly would have normally received radiatio i anyway, had the proper administration training on the requirements of the licensee's QM been used, and the actual dose is greater than 1.5 times Program which included the provision that a written that intended to the above described body part, the event directive had to be issued for a whole body scan (using more than 1.11 MBq [30 Ci] of iodine-131). can be considered an abnormal occurrence.
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| Dak and Place-January 21, 1993; Yale-New Haven Actions Taken to Prevent a Recurrence Hospital; New Haven, Connecticut.
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| Licensee-ne licensee has revised the procedures for Nature and Prohnble Consequences-A patient was thyroid cancer studies and provided traming for nuclear prescribed to receive three treatments of 700 centigray medictne personnel in the QM Program requirements. (cGy) (700 rad) per treatment to the vagina using a Gamma Med high dose-rate remote afterloader NRC- A special inspection was conducted from brachytherapy device (HDR). During the first treatment February 25 to 26,1993, to review the circumstances on January 21,1993, the physician mistakenly inserted the surround,mg the todine-131 misadmmistration (Ref. 2). HDR applicator into the patient's rectum instead of the ne NRC has also retained a medicalconsultant to review vagina, as prescribed. The licensee discovered the error immediately after the treatment was completed and the the case.
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| patient wasimmediately notified.The licensee estimated The NRC consultant concluded that the most probable that the patient receiv ed approximately 350 cGy (350 rad) effect of the misadministration would be permanent to the vagina and 700 cGy (700 rad) to the rectum. At the time of the NRC inspection on January 22,1993, the hypothyro,dism, i and he noted that evidence suggested that this condition had already occurred. No other health licensee had planned 'to make up the dose to the vagina during the remaining two treatments and to add shielding effects ,would, be expected as a result of the to the applicator to prevent significant additional dose to misadmmistration.
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| the rectum.
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| Several violations of NRC requirements were identified The patient's physician, the physician who delivered the in the inspection. D ese violations and the therapy, and an NRC Medical Consultant are presently implementation of the licensee's QM Program are still evaluating the probable consequences of this under review by the NRC for possible enforcement misadministration.
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| action.
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| _ ~. - _-
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| 1 i ,
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| . Abnormal Occurrences,1st Otr CY93 1 l
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| Future reports will be made as appropriate.
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| NRC-The event is still under staff review.The NRC will review the AIT's findings and those of the licensee, and will take appropriate actions.
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| Fuel Cycle Facilities (Other than Nuclear Power Plants) i The NRC is reviewing events reported by these licensees.
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| For this report, the NRC has determined that no events were abnormal occurrences.
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| Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial Users, etc.)
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| There are currently over 7,500 NRC nuclear material thyroid scan to detect or rule out thyroid cancer. Here licenses in effect in the United States, principally for the was a miscommunication between members of the use of radioisotopes in the medical, industrial, and support staff. The technologist who received the call academic fields. Incidents were reported in this category understood that the referring physician wanted a whole l from licensees such as radiographers, medical body scan to rule out thyroid metastasis and to look at a institutions, and byproduct material users. The NRC is thyroid nodule.The medical technologist entered a whole reviewing events reported by these licensees. For this body scan into the scheduling record.
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| report, the NRC has determined that the following On May 11,1992, a 47-year old patient received 366.3 events were abnormal occurrences using the criteria and megabecquerel (MBq) (9.9 millicurie [ mci)) of guidelines given in Appendix A. As noted in the Preface iodine-131 in capsule form as preparation for a whole to this report, the guidelines for identifying medical body scan. This procedure is normally used after a patient misadministrations as abnormal occurrences are with thyroid cancer has had the thyroid removed or currenuy being revised, ablated to determine if the cancer originating in the thyroid has spread elsewhere in the patient's body.The 93-2 Med.ical " Sodium Iodide" patient still had an active thyroid and the patient's physician intended that the patient receive a thyroid scan Misadministration at Ingham to help determine if a thyroid nodule was cancerous.He Med.ical Center .in Lans.ing' thyroid scan is a different procedure from a whole body V scan and as performed at the licensee's facility uses 370 Michigan MBq (10 mci) technetium-99m, a different radio-i pharmaceutical than iodine-131.
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| The following information pertaining to this event s also being reported cor. currently in the Fedeml Register.
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| On May 12,1992, the patient returned to the licensee's Appendix A(see EventType 4 inTable A-1)of this report nuclear medicine department for the scan.He image of notes that a diagnostic dose of a radiopharmaceutical that the intiial scan showed that the patient's thyroid was is greater than five times the prescribed dose can be intact and that an error had been made.The technologist considered an abnormal occurrence. performing the scan immediately reported the situation Date and Place-May 11,1992; Ingham Medical Center; to the supervising physicians. The licensee's procedures for an iodine 131 whole body scan specified that this Lansing, Michigan.
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| diagnostic procedure be used only on individuals whose Nature and Probable Consequences-The referring thyroid had been removed.
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| physician's staff telephoned the licensee's nuclear The referring physician and the patient were notified of medicine department on May 5,1992, to schedule a the misadministration.The licensee has been monitoring the patient and has observed decreased thyroid function.
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| I
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| ( 1De definition of misadministration was revised. De revision 10 CFR 35.2 became effective on January 27,1992. De revision de- Initially, the licensee determined that the incident was
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| ; fines a new type of misadminstration" Sodium lodule."De current not a misadministration and did not report it to the NRC.
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| l abnormal occurrence guidelines for misadministrations do not in. This was because the correct dosage and procedure were clude specific examples for sodium iodide misadministrations. For used for the study, as understood by the technologist to these types of misadministrations the staff is currently using the ab-normal occurrence guidelines (currently under revision) have been requested. The licensee contacted NRC NUREG-0090, Vol.16, No. I 2
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| Abnormal Occurrences. 4th Otr CY91 This item event is considered closed for the rhis item is considered closed for the purpose of purpose of this report.
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| ldus report.
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| i 94-12 Medical Sodium Iodide Medical Brachytherapy Misadministration at Stamford l94-11 Misadministraiion at ihe IIospital in Stamford, l
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| Queen's Medical Center in " Connecticut Ilonolulu, IIawaii ;
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| This AO was originally reported as AO 94-12 in ;
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| NUREG-0090, Vol.17, No. 2. " Report to Ihis AO was originally reported in NUREG-0090. Vol.17, No.2, " Report to Congress Congress on Abnormal Occurrences. April-June 1994.,
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| l m Abnormal Occurrence, April-June 1994."
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| The AO criterion used was Event Type 1 m. Table l
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| , lhe AO criterion used was Event Type 1 inA-1 Table of Appendix A of this report-Admimstermy
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| ' bl of Appendix A of this-Administering a di gnostic radiopharmaceuncal other than the
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| .herapeutic dose greater than 1.5 times the one prescribed that result in a wrong part of the
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| '3rescribed dose can be consideredbody an AO. receiving five times the upper limit of the normal range of exposure prescribed for
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| , At that time,it was reported that on May 2,1994,
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| , diagnostic procedures involving that body part i a patient received 1778 centigray (cGy)(1778 can be considered an AO.
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| > rads) to the right eye durmg the second of a 17, 1994, two-part treatment, rather than the prescribed At the time, it was reported that on May 1000 cGy (1000 rads), because of an error in timing a strontium-90 (Sr-90) eye treatment. a patient was administered 37 megab a whole body scan when no such study was The AO report is updated and closed out as prescribed. It was estimated that the patient follows:
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| received a whole body dose equivalent of 4.7 millisievert (470 millirems) and a thyroid ;
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| An NRC inspection was conducted from Mayabsorbed 1 to dose of 800 centigray (800 rads).
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| Consequently it was concluded that 1 July 13,1994.
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| the licensee's Quality Management Program 'Ihe AO report is updated and closed out as l (QMP) lacked appropriate procedures for use of follows.
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| Sr-90 eye applicators, as required by Title 10 of 17,1994, l l
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| the Code of Federal Regidations, Part 35.32, In a letter (Ref.11) dated November i
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| " Quality Management Program." However, NRC rescinded the proposed civil penalty based based on additional information provided by the on a reconsideration of the licensee's good licensee during an Enforcement Conference on performance on previous NRC inspections.
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| August 4,1994 NRC concluded that the licensee's This item is considered closed for the purpose of l
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| OMP, although marginal, wasthisadequate report. and thatthe OMP was vi the involved physician. Accordingly, a Severity Level IV violation with no civil penalty was issued Medical Brachytherapy on August 11,1994.
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| 94-14 i
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| Misadministration that i Required Medical Intervent,on The licensee responded to the violation on August i
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| 22,1994, by identifying several corrective actions at The William W. Backus to preclude recurrence. This included additionalllospitalin Nonvich, I
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| clarification of the OMP and Sr-90 procedure, Connecticut additional training of nurses and physicians, and i
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| additionalindependent auditing of Sr-90 This AO was originally reported as AO 94-14 in i
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| NUREG-0090, Vol.17, No. 2. " Report to .
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| procedures. !
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| Congress on Abnormal Occurrences April-June NRC accepted the licensee's 16, 1994.
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| response to this item 1994."
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| in a letter dated September NU REG-0090, Vol.17, No. 4 21 I
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| I _.
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| Abnormal Occurrences,4th Qtr C Y94 l
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| ' APPENDIX B l
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| l
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| ' UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURR discussed below contain a summary of I Durint July through September 1994, NRC information presented in previous reports and any licensees, Agreement States. Agreement State subsequent updated information provided during licensees, and other involved parties, such as the reporting period. Those updated events which l
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| reactor vendors and architect-engineering firms, still require additional information will be J continued with the implementation of actions discussed in future reports.
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| necessary to prevent recurrence of previously l l
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| reported abnormal occurrences (AO). The AOs f Other NRC Licensees .
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| deficiencies in the licensee's written Quality l 92-17 Medical Therapy Management Program; resolution by the licensee f the deficiencies; and retention by the bcensee Misadministration at Indiana of an mdependent contractor to audit the
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| ! University M . edical Center in Ind.ianapohs, Indiana implementation of its Quality Management Program.
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| This AO was originally reported in NUREG-0090 This item is considered closed for the purpose of Vol.15, No.4. " Report to Congress on Abnormal this report.
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| Occurrences October-December 1992" l Med.ical Brachytherapy l The AO criterion used was Event Type 5 in Table 94-07 !
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| A-1 of Appendix A of this report-Administering Misadnunistration at a therapeutic dose greater than 1.5 times the Alexandria Hospital in prescribed dose. Alexandria, Virginia At the time, it was reported that a 31-month-old This AO was originally reported in patient was prescribed two cobalt-60 teletherapy NUREG-0090, Vol.17, No.1, " Report to I treatments of 150 centigray (cGy)(150 rads) each Congress on Abnormal Occurrences, l to treat a brain tumor. Due to an error by the January-March 1994."
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| dosimetrist, two treatments of 300 cGy (300 rads)
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| The AO criterion used was Event Type 3 in Table cach were delivered. A-1 of Appendix A of this report - A The AO report is updated and closed out as therapeutic exposure to a part of the body not follows: scheduled to receive radiation.
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| At the time, it was reported that a patient was On October 7,1993, NRC issued to the licensee a scheduled to receive a 500 centigray (cGy)(500 Notice of Violanon and Proposed Imposition of rads) brachytherapy treatment to the trachea Civil Penalty for $5,000 (Ref.1). On January 18' using a Nucletron high-dose-rate (HDR) remote 1994, an Order imposmg Civil Monetary Penalty afterloader system. Because the HDR was not was issued to the licensee.The licensee requestep properly programmed for the correct treatment (Ref. 2) a hearing on the' Order and demed that site, it the prescribed 500 cGy (500 rads) dose was had violated the NRC, s requirements as stated in delivered to the left lung instead of the trachea the Order. target site.
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| On September 29,1994, a settlement agreement The AO report is updated and closed out as between the NRC and the licensee was approved follows:
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| i by the Atomic Safety and Licensing Board. The settlement agreement provisions included: NRC held an Enforcement Conference on July 2 1994, to discuss the inspection findings with the payment of $2,500 by the licensee to NRC: submission by NRC to l
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| l NUREG-0090, Vol.17, No. 4 19
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| t _ . .
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| h.. _tw,m. 4 p A 4.. 2 & _ 4 _ _ _ _ - -- 4-.9 =-. Ai+
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| Abnormal Occurrences 4th Qtr CY94 procedures for verifying a radiopharmaceutical therefore he continued the treatment. The dose prior to administration to a patient. He iridium-192 seeds were removed on August 4 as violation was categorized as a Severity level IV planned. On August 4,1994, a staff radiologist i violation. read the portable x-ray film taken on August 3, 1994, and indicated that the iridium implant was l not seen.
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| TI(is item is considered closed for the purpose of tlu,s report. Due to catheter displacement, the tumor dose was significantly reduced and estimated to be 620 cGy 94-23 Medical Brachytherapy (620 rads) or 31 percent of the intended dose. The remaining dose of 1380 cGy (1380 rads) was Misadministration at North delivered to an unintended site.
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| l Memorial Medical Center in Robbinsdale, Minnesota The patient was notified of the event by the treating physician on August 4,1994, and again by
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| .the followmg mformation pertaining to th.is event is another physician on August 17,1994. The also being reported concurrently m the federal Register. referring physician was informed by the treating Appendix A (see Event Tv,pe 5 in Table A-1) of this physician on August 4,1994.
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| l report indicates that a therapeutic exposure to any part of a tmdy not scheduled to receive radiation can be An NRC medical consultant was retained to considered an AO. perform a clinical assessment of this rnisadministration. The medical consultant Date and Place- August 3,1994; North Memorial concluded that it is improbable that the patient Medical Center; Robbinsdale, Minnesota. will experience any long term consequences as a result of the exposure to the unintended treatment Nature and Probable Consequences-On August site.
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| 15,1994, a licensee informed NRC that a patient received 13SO centigray (cGy)(1380 rads) to a Cause or Causes-The licensee has determined that the catheter movement caused a wrong treatment site during a brachytherapy treatment for metastatic lung cancer. misadministration of the intended dose. Two possible explanations for the catheter movement could be the following:(1) failure to properly On August 3,1994, a catheter was inserted into secure the catheter in place with tape; or (2) nasal the patient's t,ronchus and a ribbon containing 20 seeds of iridium-192 having a total activity of discharge decreasing the adhesive capability of the tape.
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| 673.4 megabecquerel(18.2 millicuries) was then inserted into the catheter and moved to the Ach,on Taken To Prevent Recurrence proper treatment location. The treatment plan was intended to deliver a prescribed dose of 2000 Licensee-The licensee's corrective actions cGy (2000 rads) to the intended target The include: amending the nursing staff procedure so treatment began at 11:15 a.m. on August 3,1994, that the attending physician will be contacted if and continued until its scheduled completion at there are further questions; directing nurses to 10:15 a.m. on August 4,1994. follow the standing protocol for obtaining an administrative consult: providing additional At about 7:00 p.m. on August 3,1994, a nurse inservice training; documenting the final length of informed the physician that the visible portion of the catheter in the patient chart; and documentmg the catheter appeared to be protruding the catheter position on each visit to the patienJs approximately 25.4 to 30.5 centimeters (10 to 12 room.
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| inches) from the patient's nose. This was a NRC - NRC conducted a safety inspection from significantly greater protrusion than previously observed, indicating that the catheter had moved August 15 through September 7,1994 (Ref.16), to from its initial placement. The nurse secured the review the circumstances of the catheter in place with additional tape. The misadministration. One apparent violation and
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| ! physician stated that, based on the information une area of concern were identified. An I available to him at that time, he determined that Enforcement Conference was held with the the catheter and ribbon had moved; but that the licensee on October 11,1994. Enforcement action tumor was receiving some radiation dose and is pending. NRC is continuing its review.
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| 7 NUREG-0090 Vol.17, No. 4
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| Manorma uccurrences, an ur m r e 4
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| administering technologist's failure to verify the 94-22 Medical Therapy isotope as well as dosage (by reading the label on Misadministration at Veterans the syringe) prior to injection.
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| Affairs Medical Center in Long 1
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| g Beach, California Actions Taken To Present Recurrence l Licensee-Corrective actions initially proposed by The following information pertaining to this event i
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| the licensee included the following: ('l) physically ''
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| is also being reported in the Fedeml Register.
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| Appendix A (see Event Type 3 in Table A-1) of separating diagnostic unit dosages from '
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| this report notes that a therapeutic exposure to therapeutic radiopharmaceutical dosages in the licensee's hot lab;(2) packaging unit dosages any part of the body not scheduled to receive received from a local radiopharmacy in different radiation can be considered an AO. containers, according to isotopes; and (3) 1 Date and Place-August 9,1994: Veterans Affa.irs retraining technologists in requirements for l identifying radiopharmaceuticals prior to Medical Center; Long Beach, California.
| |
| injection.
| |
| Nature and Probable Consequence-On August l NRC -Two NRC inspectors conducted a special 9.1994, the licensee's radiation safety officer safety inspection on August 10-12 and 17-19, (RSO) notified NRC of a misadministration 1994, to review the circumstances associated with involving a therapeutic dose of strontium-89 :
| |
| the misadministration and to review the licensee's (Sr-89) (Ref.12). corrective actions (Ref.14). In addition, NRC The RSO reported that a patient scheduled to contracted a medical physician consultant to I receive 185 megabecquerel(MBq)(5 millicurie assist in its evaluation of the potential !
| |
| consequences of the patient's radiation exposure. j
| |
| [ mci]) of thallium-201 (a radiopharmaceutical not l The consultant stated that there were no adverse regulated by NRC) for a myocardial perfusion health effects to the patient.
| |
| study was mistakenly administered 148 MBq (4
| |
| * mci) of Sr-89 (which is regulated by NRC).
| |
| Based on the misadministration of the Sr-89, the An Enforcement Conference was held with the 4 licensee on November 30,1994, to discuss aa licensee estimated that the patient received 250 apparent violation involving the failure of an centigray (250 rads) to the surface of the bone. individual working under tne supervision of an The RSO reported that no action was taken to authorized user physician to follow the licensee's j
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| mitigate the consequences of the dose (i.e., written radiation safety procedures. Additional administration of calcium as a blocking agent) concerns discussed during the conference because the patient had a preexisting heart included the licensee's use of an informal labeling condition which could have been exacerbated by system for unit radiopharmaceuticals which was administering calcium. The licensee also stated identified as a potential programmatic weakness.
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| that medical experts were contacted to assist in an The licensee presented information during the
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| ; assessment of potential health effects to the conference which supported its view that the error l i patient. In addition, the licensee reported that which led to the August 9,1994, l with the exception of emergency procedures,it l had voluntarily suspended all nuclear medicine misadministration was an isolated failure rather i
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| 4 than a programmatic problem.
| |
| procedures involving the intravenous j l administration of radiopharmaceuticals and had Based on its review of information developed initiated an internal review of the during the inspection and information provided misadmhistration, during the Enforcement Conference, NRC i
| |
| concluded that the misadministration was the-On August 10,1994 NRC issued a Confirmatory result of an isolated failure. A Notice of Violation Action Letter (Ref.13) to confirm the licensee's (Ref.15) was issued on December 29,1994, for a actions as stated above. violation involving the failure of an individual
| |
| ! working urder the supervision of a physician Cause or Causes-The cause of the authorized user to follow the licensee's written misadministration was attributed to the
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| ! NUREG-0090. Vol.17, No. 4 6 e- w
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| | |
| Abnormal Occurrences,4th Qtr CV94 activities. Subsequently, the licensee terminated that a serious deficiency in management or one of the two individuals and the other procedural controls in a major area can be individual was allowed to continue to perform considered an AO. duties that do not involve NRC-licensed activities.
| |
| Due to the nature of this occurrence, NRC performed an extensive review requiring De licensee also committed to a number of interviews and an historical review of licensee corrective actions. Some of the corrective actions records. This detailed review resulted in a delay include: assigning a pharmacist or a radiologist to in the prompt reporting of this information. verify all radioisotope dosages; implementing a unit dose system; obtaining the services of an assistant radiation safety officer; and conducting Date and Place-October 1988 through June 1993; Ball Memorial Hospital: Muncie, Indiana. monthly and quarterly audits of the Nuclear Medicine Section for at least one year.
| |
| Nature and Probable Consequences-On July 19, 1993, NRC was notified that nuclear medicine NRC-A special safety inspection was conducted technologists employed by the licensee had by NRC from July 21 to August 9,1993. ;
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| mereased the dosages of radiopharmaceuticals Subsequent to that inspection. NRC conducted a ;
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| used m diagnostic studies. NRC was als followup review .
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| mformed that the technologists had falsified the required records of the dosages administered. NRC issued a Confirmatory Action Letter (Ref. 9)
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| "l"I 26,1993, Y
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| and Confirmatory Order On July 21 through August 9,1993, NRC M difym.g License (Ref.10) on October 20,1993.
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| l conducted an inspection of the licensed facility. .rhese documented specific procedures and ,
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| The inspection revealed that since 1988, nucleittverifications to prevent any further unauthorized medicine technologists employed by the licensee increases in patient doses.
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| have been administering radiopharmaceutical dosages above the approved dose ranges for On May 23,1994, NRC issued an Order against a-diagnostic image studies by as much as 40 former nuclear medicine technologist of the percent. The in.;pection also verified that licensee. The Order required the following:(1) subsequent to administering high doses, the prohibited the technologist from involvement in technologists entered false information in NRC-licensed activities for a period of one year; '
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| NRC-required records. The doses were increased (2) required the technologist to provide a copy of for imaging studies of the lung, liver, bone, and the Order to any prospective employer who gastrointestinal tract using technetium-99m and engages in NRC-licensed activities for a xenon-133. three-year period; and (3) required the technologist to notify NRC within 20 days of NRC inspectors did not identify any medical accepting employment involving NRC-licensed misadministrations, as defined in 10 CFR 312, as ,
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| activities.
| |
| a result of this practice of administering higher than approved doses for diagnostic imaging. On May 27,1994, the technologist requested a hearing and on September 26,1994, a settlement Cause or Causes-According to the licensee, one agreement was reached. The settlement was technologist told licensee officials that dosages reviewed and approved by the Atomic Safety and were increased to minimize patient discomfort, to Licensing Board on October 3,1994 (Ref.11).
| |
| reduce imaging time for critically ill patients and The agreement resulted in the withdrawal of the to enhance the clarity of images for studies requirement for the technologist to provide a copy performed on obese patients. of the Order to any prospective employer who engages in NRC-licensed activities. The Action Taken To Prevent Recurrence settlement retained provisions (1) and (3) of the Order.
| |
| 1.icensee-The licensee conducted an internal review. Based on the findings from this review, This item is considered closed for the purpose of the licensee initially suspended two nuclear this report.
| |
| medicine technologists from all NRC-licensed 5
| |
| NUREG-0090. Vol. D. No. 4
| |
| | |
| \ . l
| |
| .m . . l Aonomm %. .
| |
| l i
| |
| remains low, NRC concluded that it is Due to the location and the extent of the cracking appropriate for BWR licensees to implement recently found, NRC and the BWROG agreed timely inspections and/or repairs, as appropria that additional attention to this issue was at their plants. To implement this position. NR warranted. BWROG met with NRC on June issued 28.GL 94-03 (Ju y 25,1994) which requeste 1994, to announce the formation of BWRVIP, BWR licensees to insps et their core shrouds by which is headed by several high level utility the next outage and to justify continued safe executives to direct its efforts. BWRVIPoperation hasbeen have since until all appropriate corrective acti implemented.
| |
| submitted documents (Ref. 5 and Ref. 6) which addressed an integrated safety assessment of the issue, inspection plans for the reactor internals, This item is considered closed for the purpose o and generic criteria for repairs and flaw this report.
| |
| acceptance.
| |
| l There are 41 active licenses for the milling, i NRC has reviewed these documents (Ref. 7 and Ref. 8) and concurs with the BWRVIP processing, and fabrication of nuclear fueli recommended generic repair criteria and flaw U.S. NRC has reviewed allincident and e assessment methodology. Inspection scope and reports received from these licensees throu methodology are still under consideration. fourth quarter of 1994. Using the criteria and in addition to the above actions,in order to verify guidelines in Appendix A of th compliance with the structural integrity were determined to be significant enough to be requirements of 10 CFR 50.55a and to assurereported that as an AO.
| |
| the risk associated with core shroud cracking f Fuel Cycle Facilities ;
| |
| (Other than Nuclear Power Plants)
| |
| Dere are 41 active licenses for milling, guidelines in Appendix A of thi processing, and fabrication of nuclear fuelin the were determined to be significant enough to be U.S. NRC has reviewed all incident and eventreported as an AO.
| |
| reports received from these licensees through the fourth quarter of 1994. Using criteria and Other NRC Licensees (Industrial Radiographers, Medical Institutions, Industrial U determined to be significant enough to be There are approximately 22,000 active material reported as AOs.
| |
| licenses for the use of byproduct materials in industrial, medical, and academic applications in Recurring Incidents of the U.S. Twenty-nine States, known as 94-21 AdministerinE Iligher Doses Agreement States, have entered into agreements than Procedurally Allowed for with NRC to assume regulatory authority for approximately 15,000 of these licensees within Diagnostic Imaging at Ball their States. 'NRC is responsible for regulating Memorial Hospital in Muncie, approximately 7000 licensees located in the Indiana
| |
| * l
| |
| ' remaining 21 States, the District of Columbia, and all U.S. territories. NRC has reviewed all incident The following information pertaining to this event and event reports received from NRC licensees is also being reported concurrently in the Fed through the fourth quarter of 1994. Using the Reghter. Appendix A (see Event Type 1I from criteria and guidelines in Appendix A of this Examples For All Licensees) of this report notes report. the following occurrences have been 4
| |
| NUREG-D090. Vol.17, No. 4
| |
| | |
| Abnormal Occurrences. 3rd Qtr CY94 De AO criterion used was EventType 5 in Table A-t- A On May 16,1994 NRC Region !!! issued a Notice of Vio- therapeutic dose that is greater than 1.5 times the pre-lation (Ref. 3) to the hospital. citing it for failing to provide scribed dose.
| |
| written notification to the patient of the misadministra-tion within l5' days, as required.The patient was informed At the time, it was reported that on June 21,1994, a pa-orally of the misadministration at the time it was discov- tient was implan ted with 112 iodine-125 (1-125) seeds hav-cred, but was not provided with written notification until ing an activity of 166 megabecquerel(MBq)(4.49 millicu-April 27,1994. No fine was assessed. rie [ mci]) each, rather than the presenbed 112 1-125 seeds having an activity of between 15.9 and 17.0 MBq This event is closed for the purpose of this report. (0.43 and 0.46 mci) each.
| |
| The AO report is updated as follows:
| |
| 94-12 Medical Sodium Iodide ne license submitted its 15-day report on the misadmi-Misadministration at Stamford nistration by {{letter dated|date=July 6, 1994|text=letter dated July 6,1994}} (Ref. 4).ne report Hospitalin Stamford, stated that in addition to the prostatectomy performed i
| |
| during the initial surgery on June 21,1994, the patient's Connect.icut bowel was diverted via a colostomy. The initial dose was intended to deliver a peripheral target dose of 16,000cen-This abnormal occu rrence ( AO) was originally reported in tigray (cGy)(16,000 rad). A conservative estimate of the NUREG-0090, Vol.17, No. 2, " Report to Congress on final dose is 55.137 cGy (55,137 rad) based on the remain-Abnormal Occurrences." April-June 1994. mg residual seeds. The NRC medical consultant's final report was in agreement with the licensee's report. The The AO cnterica used was Event Type 1 in 'lable A consultant indicated that the misadministration, and sub-Administering a radiopharmaceutical other than the one sequent multiple surgical procedures to remove the iso-intended which results in any part of the body receiving tope, predisposes the patient to a variety of future medical unscheduled diagnostic radiation, and the actual dose to problems. The licensee agreed to provide monthly up-the wrong body part is five times the upper limit of the dates on the patient's condition to NRC for at least one normal range of exposures presenbed for diagnostic pro. year.
| |
| cedures involving that body part, At the Enforcement Conference held on August 24,1994, At the time,it was reported that on May 17,1994,a patient the licensce presented corrective actions that included:
| |
| O ) '*9 " E " ". r medicme technologtsts to venfy all was administered 37 megabecquerel(MBq)(1 millicurie j inf rm tion contamed in the packing slip, certificate of l (mci]) of sodium iodide iodine-131 (I-131) activity, for a wholevial label, and written directive at the time the :
| |
| bcdy scan when no such study was presenbed.
| |
| package is received, as well as requinng the Radiation Safety Officer to be notified if any discrepancy is identi- f He AO report is updated as follows: fied; (2) confirming all orders in writing with the supplier .
| |
| prior to implantation;(3) providing training to the nuclear The licensee responded to the NRC's Notice of Violation medicine staff;(4) revising procedures to require venfica.
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| and Proposed imposition of Civil Penalties in a letter tion in accordance with the written directive prior to ad-dated August 10,1994, contesting a number of the viola- ministration of doses;(5) revising the Quality Manage-tions and the civil penalty. NRC is evaluating the licens- ment program; and (6) creating the staff position of ee's response. Brachytherapy Safety Nurse Coordinator to provide in-etcased control over these activities.
| |
| This event wtll be updated when additional information NRC is evaluating the licensee's corrective actions, and is becomes available.
| |
| reviewing its enforcement options as a result of the En-f reement C nference held on August 24,1994.
| |
| 94-14 Medical Brachytherapy 19, 1994, NRC performed an inspection on September Misadministration at The and observed that all of the corrective actions had not yet William W. Backus Hospital in been fully implemented. De licensee agreed to notify N RC Region Iin writin8 when implementation of the cor-Norwich, Connect.icut rective actions was completed.
| |
| This abnormal occurrence (AO) was originally reported in This event will be updated when additional information NUREG-0090. Vol.17, No. 2, " Report to Congress on becomes available.
| |
| Abnormal Occurrences," April June 19' 15 NU REG-0W0. Vol.17. No. 3
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| | |
| without incident. However, on the 21st treatm NRC-NRC Region 111 conducted an inspection on gust Au-3, the teletherapy unit was position d wrong treatment angle. This resulted in a ra gust 1,1994, to review the misadministration of 100 cGy (100 rad)being (Ref. 3). AConf received by the righ censee on August 2,1994, which desenbed the commit- instead of the right shoulder area.
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| ments made by the hcensee as to which actions will be tak-An N that RCnomedical consultant review en prior to the administration of cluded I-131. An EnforcementConfe significant adverse side effects Jury are expected.
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| mspection findings and actions taken by the licensee in re.
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| sponse to the CAL. am r ams4 cam of Nth misadmimstrata was human errors by several of the licens In October 1994, N RC proposed an $8,000 fine against the to My tk Munaw angk licensee for violations of NRC requirements involved e
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| in erap a
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| wedge settmg. and the treatment site bef diagnostic procedure using radioactive iodineing atthe theteletherapy hos. dose to the patients.
| |
| pital. The violations involve: (1) failure to have signed written directives by an authorized user prior to admmis- Action Taken To Prevent Recurrence tration of I-131 in quantities greater than 1.11 N111g (0.03 mci) on July 26, and in two previous instances where Licensee-The the corrective actions ta 1-131 was the intended radiopharmaceutical;(2) failure pendmg to all teletherapy treatments pendi have a clinical procedure for the proper admmistration investigation,andidentification of of appropriate 1-131 for whole body scans; and (3) failure to provide actions prior to re start of the teletherapy trea proper mstruction to the nuclear medicine staff. (2) developing procedures which The li-of proper treatment parameters require verification censee paid the civil penalty.
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| tient set-up; and (3)instalhng a record-an 1his event is closed for the purpose of this report. on the teletherapy unit to ensure that all ma parameters are checked pnor to a treatm NRC-NRC Region W conducted an insp 94-18 Multiple Teletherapy 12,1994, to review the ctrcumstances Misadministrations at Sinai through Augustroundmg the wo misadm Hospitalin Detroit, Michigan retamed a medical consultan: t forcement conference was held on Se The following information pertaming to this discuss event is the censee.
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| inspection findings and a alsoSeptember On 21.1994 NRC being reported concurrently in the Federal Register.
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| Notice Ap- with a Seventy Le of Violation pendtx A of this report notes that da therapeutic Levels I throughdose that V range from the mos resultsinanypartof thebody receivingunscheduledra i.
| |
| least signtftctmt) violation with no civil p ation can be considered an abnormal occurrence. The licensee's corrective and presentis reviewed dunng the next NRC mspe Date and Place-July 2S and August 3,1994; Smai Hospi.
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| program.
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| tal: Detroit, hiichigan, 28, 1994, As required by 10 CFR 35.33(a). the Nature and Probable Consequences-On July m sadministration. nottfied the refernn and August 3,1994, misadmtmstrations occurred on two separate patients when the bcensee's to patient therapistsafter fatted the to discove il will be verify correct teletherapy machine parameters pnor submitted to NRC Region t the report treatment. available upon request.
| |
| 19.1994, a patient was to receive 4500 This event is closed for the purpose o Beginning on July centigray (cGy)(4500 rad)in a series mof 25 treatments to the left neck area.The first seven treatments Brachy, were therapy.
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| co - ,
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| 94-19 pleted without incident. Ilowever, d f 90 on the eighth trea Misadministration Invo treatment angle. This resulted in a radiation ose o the Use of a Strontium nnersit; 4 M 5 = i w & " * =1hishoulder "d neck Applicator at the l. .
| |
| rea cread of :he lei necx am.
| |
| Massachusetts Medic me.inene;=,g W)TCesler. a ! Ma55aC mnmemnm !2 t m :=e w w um eere ::~<eiv im ano e: S 2:n "e'm :.
| |
| g
| |
| ,o ,
| |
| s
| |
| | |
| l
| |
| * l Abnormal Occurrences,3rd Qtr CY94 l
| |
| I Conference. The causes appeared to be the following: Ihe normal range of exposures presenbed for the diagnos-tte procedure can be considered an abnormal occurrence.
| |
| (1) written procedures were not developed to address l
| |
| gantry angle conversions;(2) the technologists did not Date and Place-July 26.1994:St. Joseph Mercy llospital; have an adequate understanding of the informal gantry Pontiac, Michigan. ;
| |
| angle conversion procedures; (3) the informal gantry j angle conversion procedure was not part of the licensee's Nature and Probable Consequences-On July 27,1994, (
| |
| annual refresher training program; (4) technologists did the licensee reported to NRC that a misadministration oc.
| |
| not fully understand their responsibilities to resolve dis- curred involving a patient receiving the wrong radiophar-crepancies in a treatment plan: and (5) gantry angle con- maceutical for a diagnostic procedure.
| |
| version factors were not included in the licensee's treat-ment chart checks conducted by the technologists.
| |
| The patient's referring physician requested a thyroid scan which involves administration of a standard prescription Action Taken To Prevent Recurrence at St. Joseph Mercy llospital of a 9.25 megabecquerel (Milq) (0.25 millicurie [ mci)) sodium iodide-123 (I-123) !
| |
| Licensee-The licensee's corrective actions included: capsule. Ilowever, the licensee administered a 92.5 Mllq (1) revising the simulation data form to include a spectfic (2.5 mci)1-131 capsule.The amount of activity that was location to document the converted gantry angles: (2)ini. admmistered is normally used following removal of the tialmg all angle conversions by the person performing the thyroid to examine a patient for the spread of cance r from conversion, and havmg a second individual independently the thyroid through the body.
| |
| verify the conversions prior to treatment;(3) instructing I the technologists to review all treatment information and NRC retained a medical consultant to review the case.
| |
| to resolve any discrepancy prior to continuing treatment: 'Ihe medical consultant concluded that the resultant un-(4) performing all future gantry angle conversions by the
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| ~
| |
| necessary dose to the patient's thyroid would result in a licensee rather than by the licensee's simulation contrac, low, but finite, probability of hypothyroidism developing tor; and (5) conducting a review of past treatment plans in the future. Also, there is a lifettme probability of devel-back to 1988, with emphasis on those which did not identi- oping radiation. induced thyroid cancer of 10 percent, in-fy any additional errors. cluding a risk of fatal thyroid carcinoma of approximately I percentflhe licensee has arranged for the pattent to be NRC-NRC Region !!! conducted an inspection on Au- seen by a endocrinologist, and for repeat thyroid imaging gust 1,1994, to review the circumstances surrounding the with I-123 to be performed several months after the mis-misadministration (Ref. 2). NRC aise retained a medical administration.
| |
| consultant to review the case. An Enforcement Confer, ence was held on September 1,1994, to discuss the inspec- 'Ihe patient was notified in person by the Radiation Safety tion findings and actions taken by the bcensee. On Sep- Officer on July 27,1994. Subsequently, the patient was tember 20, 1994, NRC Region !!I tssued a Notice of also given a written report that was dated August 5,1994.
| |
| Violation with a Severity Level III (Severity Levels I through V range from the most significant to the least sig- Cause or Causes-Part of the cause of the misadministra-ntficant) violation with no civil penalty assessed. The li- tion was the lack of the treating physician's involveme nt in censee s corrective and preventive actions will be re- the patient's examination prior to the 1-131 administra-viewed during the next NRC inspection of the licensed tion.The administrative staff and technologists failed to have the examination clarified by a treating physician with E'UE'**'
| |
| the referring physician prior to administration of the
| |
| .this event is closed for the purpose of this report. 1-131. Causal factors for this event also included the fatl-ure of licensee management to ensure implementation of the hcensee3 wnuen Wahty Management Pmgram.
| |
| 94-17 Sodium Iodide Contributing factors also appear to include deficiencies in trainmg, and a failure to follow through on matters.
| |
| Misadministration at St.
| |
| g joseph Merey Hospita1 in g, 7,p,,,,,,g,,,,,,,,,
| |
| Pontiac, Michigan Licensee /lhe licensee took the following corrective ac-tions:(1) held a training session which included the Radi-The following information pertaining to this event is also ation Safety Officer, treating physicians and technolo-being reported concurrently in the federal Register. Ap-gists;(2)insututed a limit on the number of individuals pendix A of this report notes that administering a diagnos- w he wtll be involved in the use of I-131; and (3) required a tic dose of a radiopharmaceutical dtffering from the pre- written dtrective to be filled out and signed oy a treating senbed dose by more than 50 percent in which the event results in adverse health effects worse than expected for physician.
| |
| ,, , - nenn . . . , ,, v ,
| |
| | |
| t Abnormal Occurrences. 3rd Qtr CY94 i
| |
| Teletherapy Misadininistration 55 94-]6 at Medical Center Hospital in fetal whole body dose was calculated a range ignif,- t as 0.55 cGy (0.
| |
| Chill,icothe, Oh.io rad). Based on the calculated Radiation Oak he fetal dose followmg therepertaining information areof i t r AP- po i also to cant harm to the fetus. At NRC request, the he eing reported concurrently in the Fed dose that Emergency Assistance Centerffraining pendix A of this report Site notes resultsin any part of thebody receiving un inRidge, h duled radi- that a dose assessment and potential fetal cffects.
| |
| ftl ation can be considered Medical an Centerabn On May 10.1994, a physician specializingin h Dat<= and Place--July maternal e a21 and 22,1994:
| |
| medicine, not affiliated with the licensee, discussed t f ed of Hospital: Chillicothe, Ohio. 94 incident with the licensee. The patient t the fetus by was Nature in ormand Probable Consequenc i ed a radiation the exposure and possible consequences o the licemce reported that a patient rece d)to anv the maternal fetal specialist. 0 l therap) dose of approximately 300 f licensee rehance on fthe partent umt.
| |
| s assurance o non-C A patient was scheduled tohap d
| |
| recei pregnancy. Licensee proceduresado seriesnot ofrequire determi, for cancer seven treatments nation of pregnancy status through l serum testing, ct other appropnately documented means, l un-Each for all fema ofe pa- the treatments Fb w l
| |
| tients of chtidbearing age.Theangles.The patient was first apparent treatmenI yaware isten-istration on March 9,1994. i treatment on July 22, the technologist i foun Action Taken To Prevent Recurrence cies in the angles of treatm ngtreat- '
| |
| ther review, the licensee dete Licensee -The licensee is in the process y of developing part of the secondin. treatment.
| |
| ternal policies which will address As a optionsresult of the forincorrect pregnancstatuangles of d e ofment site received only part of the pre l
| |
| l or suitable written proof, such as evidence f a hysterecto-l my.The legal implications and optionsjacent tissue for written receiveo proof o a higher do non. pregnancy are dbeing bearing censee evaluated estimatesby the alicensedose 20-50 c0y ter pregnancy tests to all female patients of chil tended site would have received approxim age, unless appropriate proof (20-50 ofrad).non-pregnancy is ava The treatment angles were correcte te unwilling to undergo pregnancy i chart, testing, radiopharma.ceu and the radiation dose was modi will be consulted for the appropriate course of for act on. the reduced dosage d are expected.
| |
| NRC-NRC Region III conducted a safety inspection The patient was notified verbally thef from May 18 through Junet 8,1994, writingtoasreview required the by circum- 10 C l l' the hcensee s radiopharmaceutical Quality Managemen Program (Ref.1). No regulatory violations d e quences as a result associated with of the misadministr the event were identtfied. The licensee's proce ur
| |
| , appears to have been followed in this spectfic Cause lated gantry or angles case. Causes-The NRChad not been
| |
| * error con !
| |
| , regulations do not include requirements forment patient preg-unit gantry angles, and gantry t char!
| |
| 4 nancy verification prior to administration tors were notof radiopharma-c included checks conducted by the technologists.
| |
| in the licens l
| |
| regulations which will address the administration of radio-pharmaceuticals tobreast feeding and pregnant The root patients.causes of the problem wer licensee on September 1,1994, during a i
| |
| This event is closed for the purpose of this report.
| |
| .WREG-OM Vol.17. No. .* __
| |
| | |
| I Abnormal Occurrences,3rd Qtr CY94 I
| |
| REPORT TO CONGRESS ON ABNORMAL OCCUR JULY-SEPTEMBER,1994 1
| |
| 1 Nuden Pouer Phm! :ex=s; inu reyc noze ci tte er en:a rew e,: s befr: :=a the penod was determined to be signitknnt eno;;;h lhere are 109 operating nuclear poserported plantsas m an abnormal occurrence (AO).
| |
| ' United States (U.S.). NRC has reviewed all event reportshirdquarterof dix A of received from these licensees Fuel Cycle Facilities through the t1994. Using the criter (Other thanguidelines Nuclearin Power Appendix A of Plants) of the this report, none determined sing, events reviewed for this reporting period wasd as an There are 41 active licenses U.S. NRC for has re- the milling, procesenough to be reporte to be significant and fabrication of nuclear fuelinandthedcurrence, from these licensees viewed all event reports receiveduring i the third quarter of (Industrial Radiographers, Medical185 administered Inst tu o) (5 millicune megabecquerel 9 1994, as (MBq l licenses di l
| |
| [mCil)of sodium todide 131(1-131)on atment of did not Marc prescribed in the written directive f thead- for the tre There are approximately t nine States,22,000 ee-Graves'active diseasematenafor (hyperthyroidism).
| |
| know that the patient was pregnant the use The i f med at the time of bo licensee and academic applicationsin the U.S.Twen y-known as Agreement S,ates, i forhavethe entered ministration. into agr On May 10,1994, i nt was the lt licensee ments with NRC to assume regulatory ible for regu- author ty use of byproduct materials. NRCedis in 21 respons by a private practice i physician th it lating approximately 7000 of these licenseeslocat ries. the patient's fetus received an un nte ible hy-j States, the Districth heof Columbia, and all U.S. i terr oNRC the li- '
| |
| critena following The patient was referred l(11.9 microcu- to th ees through the third t enoughquarter to censee of 1994.
| |
| administered Using a 440.3tandguidelines rie)1-131 capsule to the patient h 7,1994, and kilobecquere he ensuing on Marc events have been determined to be significan i i tering be reported as AOs. measured an 82-percent thyroid theI-131 diagnostic capsuleon March treatingphysician i i tering the was questioned and informed both te 94-15 Sodium Iodide Event at and the nuclear medicine technologist adm n Welborn Memorial Baptist capsule that she was not pregnant.The hcen 1-131 therapy llospital in Evansville, Indiana sv tis also the patient's conditionh as Gravesph licensee's treatment. On March 9,1994, a 1 The followmg mformation pertaining Register. Ap.
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| rt notes to this evenwas orally administered capsule d Priortotheby one o I nuclear medicine technologists, as prescribe being reported concurrently b the Com.
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| in on treatment the MarchFedemlpendix 9,1994, the tecin informedA by (s the that a moderate exposure to, ortherematenallicensed "'
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| patient once more and was by
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| * * *" *E'#E"""'
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| aga or otherwis l lated mission can be an abnormal Memorialoccurrence.
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| Bap- Oak Ridge Institute for Science and Edu ltda Date and Place-March 9,1994; Welborn the fetal whole body and thyro tist liospital, Inc.; Evansville, Indiana. The fetal dose to the thyroid was calcu a d), and the 16, 1994, 7,000-12,000 centigray (cGy)(7,000-12,0 Nature and Probable Consequences On May~~~acan NRC
| |
| "" mrvm. thatNo.
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| Vol.17. a 3pregna
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| 1 l
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| . 1 Abnormal Occurrences 2nd Qtr CY94 )
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| 4 l
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| I Nature and Probable Consequences-On May 19, 1994, 1.11 MBq(30 Ci)which would require written directives the licensee notified the NRC Operations Center that on and failed to instruct supervised individuals m NRC re-May 17,1994, a patient was administered 37 megabec- quirements of a OMI. !
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| querel (Milq) (1 millicurie [mCil) of sodium iodide io-dine-131 (1-131) for a jvhole body scan when no such study Actions Taken to Present Recurrence was presenbed. The hcensee identified this misadmims- J l tration during review of the scan by the authorized user. Licensee-The licensee now requires that (1) all requests 1
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| ( for diagnostic or therapeutic procedures be in wnting and I A patient was scheduled by a referring physician to have a sent via facsimile transmission from the refernng physi- ,
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| i "whole blood red cell mass" test, correctly known as a " red cian's office; (2) all administrations above 1.11 MIlq (30 i blood cell volume" test.This test involves withdrawing an pCi) of I-131 be done only by written order from the AlJ/ j amount of blood from the patient, and labeling the pa- RSO or other AU's authonzed to do so; (3) all diagnostic l
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| tient's red IAood cells in vitro with the radionuclide chro. and therapy requisitions will be reviewed by a radiologist.
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| l mium-51 having a nominal activity of 1.02 to 3.7 MBq and designated as approved or not approved;(4) all tech-l (30-100 microcuric [ Cil).This is followed by reinjection nologists wtll be trained m regard to the chmcal diagnosis j of the labeled red blood cells into the patient, and mea- for v hich each test is applicable; (5) the central bookmg ;
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| surement of radioactivity in blood samples withdrawn staff will meet with the RSO and will be mformed that the 1
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| from the patient 10 to 30 minutes later.The referring phy- clinical diagnosis must match the test being requested, l sician contacted the patients's IIealth Maintenanec Orga- and that any deviation from the match or any diagnosis
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| ! nization (llMO), as the ilMO requires that it place the that they don't understand must be challenged and order with Stamford Ilospital. The limo wrongly con, brought to the attention of the radiologist; and (6) the
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| ! tacted the central booking area for Nuclear Medicine at RSO and physicist will review the QMP annually and dis-
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| ! Stamford llospital, rather than the Clinical Laboratory cuss it at the Radiation Safety Committee meetmg and
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| ! which performs this test as authonzed in Part 35.100 of with the entire nuclear medicine staff.
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| l Title 10 of the Code of Federal Regulatwns. The central bookmg secretaiy, and the llMO secretary, in an attempt NRC-NRC Region I conducted a special inspection on to fit the procedure into one of those listed under Nuclear Medicine, converted the prescribed "Whole Illood Red May 23 and 24 and June i and 6,1994, to investigate the Cell Mass" test into "Whole Body 1-131 Scan," a scan that circumstances of the misadministration. An NRCinspec-tion report (Ref. 8) was issued June 15,1994, and identi-uses 37 Mllq (1 mci) of I-131.The central booking secre-fied the following five apparent violations: (1) failure to tary then printed the name of the referring physician at establish a QMP for amounts of I-125 and 1-131 greater the bottom of the form for " Consultation for Nuclear than 1.11 M13q (30 nCi);(2) failure to conduct annual re-Medicine," and sent it to the Nuclear Medicitie Depart-views of the OMP; (3) failure to have records specifying ment where it was received on May 13, 1994. A nuclear l the methods used to verify patient identity which can be medicine technologist (N MT) looked at the form and saw audited;(4) failure to have written directives signed by the that it was for " total red cell mass " but since the NMT authorized user; and (5) failure to instruct individuals in knew the referring physician, the NMT assumed that this l
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| ' was a new test using 1-131 to determine " total red cell the QMP. An NRC medicalconsultant reviewed the infor-mass." The NMTordered the requested 37 MBq(1 mci) mation in the NRC's inspection report, the licensee's l 15-day misadministration report, and the preliminary no-1 1-131 capsule, which was administered on May 16,1994.
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| tification, and conducted telephone interviews with the The patient was scanned on May 17, 1994, and May 18, 1994, the authorized user (AU), who is also the Radiation RSO/AU.The medical eonsultant concluded that without an actual measurement of the thyroid uptake of I-131 ;
| |
| Safety Officer (RSO), read the films.The AU immediate- there was a moderate uncertamty in the estimate of the ly noticed the error and notified the referring physician, radiation dose to the thyroid, and estimated a radiation who notified the patient. absorbed dose of approximately 530-ta-1600 cGy The licensee estimated that the patient received a whole (530-to-1600 rad).The medical consultant further sta that it is unlikely that the misadministration will result in a body dose equivalent of 4.7 millisievert(470 millirem)and clinically detectable effect on the patient's thyroid. The a thyroid absorbed dose of 800 centigray [cGyl(800 rad). impact on the patient's health should be negligible, with ,
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| NRC was notified within 24 hours of the discovery of the i
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| no expected long-term disability, r misadministration.The licensee submitted a wntten re.
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| j port of the misadministration to NRC Region I on May 31, 1994- An enforcement conference was held with the licensee on i
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| ' J une 24.1994. The five violations were classified as a Se-verity Level 111 problem and a Notice of Violation and Cause or Causes-The licensee had failed to establish a Proposed Imposition of Civil Penalty (Ref. 9) for $1,250 quahty management program (QMP) for admMistenng was issued on July 11,1994.
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| quantities of I-131 and mdme-125 (1-125) greater than NUREG-0090, Vol.17 No. 2 6
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| ~
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| o -
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| Abnormal Occurrences,2nd Qtr CY94 medical consequences of the misadministration would be Queen'S Medical Center in "#8"8#*-
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| Honolulu,IIawaii 1
| |
| Cause a or Causes-Part states tt 35 of Title 10 of The following information pertaining to this eventmais also n a w nen qu y m nagement pmgram M l being reported in the hderal Register. to provide high confidence Appendix A (seeEvent'Iype that each ministering a therapeutic radiation dose greater timethanof 1.5the treatment, the licensee did not have a writte procedure to con-require that staff members confirm th times that intended from a sealed source should be l sidered an abnormal occurrence. planned administration will be as specified in the wr directive. Consequently, neither the physician nor the on Date and Place-May 2,1994,The Queen's MedicalCen- cology nurse referred Io the written d l ter: Honolulu, Hawaii. d f training given to the oncology nurses in the metho o Nature and Probable Consequences- A patient wastimmg pre- treatments was also a contributing factor.
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| l scnbed to receive two treatments of 1000 centigray (cGy) I (llG rad) to the patient's right eye using a strontium-90 Actions Taken to Prevent Recurrence (Srd)0) eye applicator.The4btreatment Licensee-The plan called licensee revisedforthethetwo treatme QMP procedures to treatment was properly delivered on April 25,199 prevent
| |
| ,y recurrence of similar misadministration keepmg the source in contact with newthe procedure patient's right spectfieseyefor that 18 prior seco!
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| for the second treatment, the same physician treated n thethe written directive. it also states that th '
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| patient, but a different oncology nurse assisted.The seek guidance phy- prior to continuing if they do not u sician did not refer to the written directive stand any aspect or to theof dose-the written directive.
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| rate information available with the eye applicator, al*
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| though he had used other applicators in the past. He also did not discuss the procedure with the nncology nurse NRC ,NRC Region IV conducted an poor to the second treatment. At the ndthe circumstances the associated end ofcause(s).
| |
| its probable desired with The NRC18-second staff the mi d is currentl at the count of "18"(as she had been trained) withoutviewmgsay. the inspection results for possible violations, ing"stop" as the physician have expected. As a result, the treat-ment con enforcement action is pending.
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| Future reports will be made as appropriate.
| |
| physician realized that the desired time mustelapsed. As a result, t rad) to the right eye during the second treatment, rather than the prescribed 1000 cGy (1000 rad).
| |
| 94-12 Medical Sodium lodide The Radiation Safety Officer reported the2misadministra.Misadministration it at tion to the NRC Operations Center atStamford 8:37 p.m.on Stamford, Hose alin Connecticut May ,1994. Th same day. The patient was notified of the event during follow-up examinations by the The i t referring being followmg physician information pertaimngon May5 reported concurrently in the federal Reg to the and even the referri:tg physician, and none is expected.
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| h The pat en pendix A(see Event'lype 1 in Ta willbe exammed during subsequent follow-upvisits to t e h bd l
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| medical center. thantheoneintendedwhich resultsinanypartof the i receiving unscheduled diagnostic radiation, and l
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| The NRC staff retained a medical the potential medical effects on thedht f consultant tual dose to patient as a result o to theevaluate wrong body part, is five times th d
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| the misadministration.The medicalconsultantstate hmit of the normal t range adosimetryof exp fo cred an abnormal occurrence.
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| bration factors, clinical factors and Date and treatment Place-Maytechnique.The 17,1994; Stamford Hospi con calibration m the near future. The medical consultant ford Connecticut.
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| stated that the increased unintended range of normal treatments. He indicated that the dose is within the NUREG-0000. Vol.17. No. 2 5
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| r Abnormal Occurrences,1st Qtr CY94 I t
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| ! l card generated by the planning computer Cause or Causes-The licensee's radiation HDR therapy rather than programming the HDR treatm staff faded to follow the licensee's normal protocol for rameters treat-manually.
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| l
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| ' ment with the HDR remote afterloader.The NRC-NRC failure to conducted a special inspection i d f administer the treatment as prescribed ary 2 to 4,1994, resultedto review from per-form the circumstance li Man-l cation m the vicinity of the HDR console, where with therethe misadministration, the licensee's Qua ty l were a number of distractions. agement program, and the25,licensce's 1994, NRC im tive actions. In addition, on February Actions Taken to Prevent Recurrence employed a medical consultant to providl of the potential chru, cal effects of this mi Licensee-The licensee's corrective mediate retraining of all personnel involved h actions inand the events brachy-included im-that led to it.
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| f therapy treatmentsand the addition of a checklist Theorinspection eac report, medical consultant's l step in the treatment process. The licensee also added I
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| steps to its Quality Management program and for HDR enforcement bra- actions for chytherapy.These steps now require tional information the use becomes of the treat-me avaibra-input parameter and the use of the treatment parameter Agreement State Licensees l
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| The 29 Agreement States have approximately ili nostic dase of thallium 201 fo 15,000 ac-tive materiallicenses for the use of byproduct mater age atos the n second patient, the technolog i
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| industrial, medical, and academic applications. error. Procc-t dures have been developed for Agreement States to screen events using the same critena and guidelines NRC, and to report those events that have been NRC deter-was notified of thiseven as referring physician and patient. An approveI l mined to be significant enough to be considered as abnor- l mal occurrences During this period, the Agreement trast agent was injected into tl l States reported one abnormal and occurrence, continued for 2and weeks.%e night fer observation. No thyroid upta informa-tion patie nt was has been included in this report.
| |
| ne Radiation Safety officer concluded that re Therapeutic Radiopharma- take data only rough estimates of the patien AS 94-1 can de made. According to the Internatio i l
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| ceutical Misadministration on Radiological Protection, publication 53 at North Carolina Baptist Dose to Patients from Radiopharmaceuti Hosp.tal i
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| in Winston Salem, cent blocking of the thyroid would result being less than 50 millisievert (mSv) l North Carolina fective dose equivalent would be appr Appendix A(see Event'Ippe2inThble (4.3 rem). A-1)ofAssuming this reportnote inco h thyroid would have significantly higher dose
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| : wrong patient should be considered an abnormal occur.
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| In addition, the National Council on Ra rence.
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| 17,1993; North Carolir.a Baptist and Measurements Report No. 80," In Date and Place-June Cancer by lonizing Radiation," states dir:t Hospital in Wmston Salem, North Carolina.
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| Nature and Probable Consequences-The nuclear increased risk of thyroid canc medi- fin :
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| cine technologist had prepared dosages for twocomplete tered to the patient. However, different thyroid blockage, the patien due to the li patients and then prepared both patients for injection.
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| monitored for signs of hypothyroidism.
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| ; The technologist was temporanly sidetracked and then returned to complete administration of the prepared dos-ages. The first patient received a 592 of Cause megabecquerel or Causes-This misadmi to personnel error during a time of heav d
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| [ mci]) therapeutic dose (MHg) (16 millicurieiodine-131 mstead of the presenbed 37 MBq (1 mci) diag-g NUREG-0090 Vol.17, No. I
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| - -. - _ - - . . . - - - _ . . - - _ _ . - - . . - ~ . . . - . . . . . . . - . .
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| e _ . . .
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| j .s Abnormal Occurrences,1st Qtr CY94 licensed activities by the North Carolina Division of Radi-Actions Taken io Prevent Recurrence ation Protection.
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| l The patient has been contacted several times for follow-Licensee- A new policy to color -code prepared dosages up observations; however, the patient lives out of town was implemented to more clearly and easily distinguish and has not been willing to cooperate.nerefore, no addi-between therapeutic and diagnostic dosages. tional actions are expected.
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| This event is considered closed for the purpose of this re-State Agency-The licensee's corrective and preventativeport. ,
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| actions will be reviewed during the next inspection of the l t
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| j l
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| l l
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| l l
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| l l
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| i NU11EG-0090, Vol.17. No. I 9
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| e
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| '' tionurlital Uccurrences, J.110 Vir Li V5 Cs-137 sources. Also, because of anatomic approximately 7000 licensees located in the remaining 21 States, the District of Columbia, and characteristics of the patient, the phycician had all U.S. territories. NRC has reviewed allincident difficulty inserting the source carrier into the and event reports received from NRC licensees applicator. The design of the afterloading device through the second quarter of 1995. Using the allows the source to slide out of the carrier if any criteria and guidelines in Appendix A of this unusual manipulation of source carrier is report, the following occurrences were determined required. The difficulty experienced by the to be significant enough to be reported as AOs. physician in inserting the source in the applicator and the design of the source carrier resulted in l
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| the source falling out of the carrier during the 95-4 Medical BrachytherapI insertion process.
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| i Misadm.inis . trat. ion at the University of Virginia, in Actions Taken to Prevent Recurrence Charlottesville, Virginia 1icensee-The licensee provided training for its The following information pertaining to this event staff, involved in brachytherapy procedures, is also being reported concurrently in the Federal concerning the precautions which must be taken Register Appendix A (see Event Type 3 in when handling an applicator such as the one used Table A-1) of this report notes that a therapeutic in the subject procedure. Also, emphasis was i
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| exposure to any part of the body not scheduled to placed on the need to be more attentive during the source insertion process in order to account i receive radiation can be considered an AO.
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| for all prescribed sources.
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| Date and Place-March 14,1995; University of l NRC-NRC conducted a specialinspection on Virginia Medical Center; Charlottesville, Virginia. March 23-24,1995, to review the circumstances ;
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| Nature and Probable Consequences-A patient surrounding the misadministration. The was prescribed a manual brachytherapy inspection report was issued on May 2,1995.
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| Enforcement action will be taken a; appropriate.
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| procedure using cesium-137 (Cs-137) sources loaded in an applicator, for a total gynecological This event is considered closed for the purpose of treatment dose of 3000 centigray (cGy)(3000 rad).
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| this report.
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| During insertion of the applicator into the patient, one of the sources fell onto the patient's bed and was unnoticed by the licensee staff involved in performing the procedure. A nurse found the 95-5 Medical Therapeutic source in the bed on March 15 and removed it. Radiopharmaceutical The source was reloaded into the applicator and Misadministration of Iodine-131 the physician revised the prescribed dose to 25m at Massachusetts General cGy (2500 rad). The licensee estimated that the llosp.tal .in Boston, source remained at approximately 10 centimeters v' i (4 inches) from the patient's foot for 18 hours and Massachusetts delivered a dose of about 13 cGy (13 rad) to the De following information pertaining to this event f001- is also being reported concurrently in the Federal Register. Appendix A (see Event Type 5 [a]in The l.icensee notified the referring phys. .ician and Table A-1) of this report notes that administering the patient of the misadministration. An NRC a therapeutic dose of a radiopharmaceutical medical consultant was obtamed who concluded differing from the prescribed dose by more than that the patient was receiving appropriate 10 percent and the actual dose is greater than 1.5 follow-up care. In addition, the h,censee and the times the prescribed dose can be considered an medical consultant concluded that the patient will AO*
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| not experience any adverse health effects as a result of the misadministration. Date and Place-May 9,1995; Massachusetts l
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| Cause or Causes-The licensce's staff involved in Nature and Probable Consequences-A patient the brachytherapy procedure were not familiar with handling of the applicator that contained the was prescribed a 296 megabecquerel(M13q)(8 l
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| NUREG-0090, Vol.18. No. 2 4 l
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| l
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| (
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| Abnormal Occurrences,2nd Otr CY95 I
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| l Violation at the Severity Level IV on June 26.
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| millicurie [ mci]) dosage of iodine-131 (1-131) for 1995.
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| hyperthyroidism; however, a dosage of 1106.3 MBq (29.9 mci) was administered. This event is considered closed for the purpose of this report.
| |
| l Representatives of the hospitalinformed the ******** l L referring physician and the patient of the l l misadmmistration. An NRC medical consultant l
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| was obtained to evaluate the event and stated that 95-6 Multiple Medical Brach)' therapy the higher dosage given to the patient will result ,,
| |
| m a more likely achievement of the mtended M.isadministrations at Madigan therapeutic goal to eliminate the patient's Army Medical Center in Fort hyperthyroidism. Additionally, the consultant Lewis, Washington determined that it is unlikely that the patient is at significant risk of experiencing long-term De following information pertaining to this event consequences from receiving the higher dosage is also being reported concurrently in the Federal J
| |
| beyond the risk associated with the prescribed Resister. Appendix A (see Event Type 5[dj in ,
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| dosage. Therefore, the impact on the patient's Table A-1) of this report notes that administering I health is expected to be negligible with no a therapeutic dose from a sealed source such that expected long-term disability. (The intent of the the treatment dose differs from the prescribed prescribed dose was to ablate the portion of the dose by more than 10 percent and the event thyroid remaining after surgery and then support (regardless of health effects) affects two or more the patient with thyroid supplement the rest of patients at the same facility can be considered an her life. This did not change with the AO.
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| administered dose.) ;
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| Date and Place-February 1994 through May l
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| Cause or Causes-The licensee stated that this 1995: Madigan Army Medical Center (MAMC); .
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| event occurred because of a human error. The F rt Lewis, Washington. I technologist involved in this procedure inadvertently switched the labeled lids on the vial Nature and Probable Consequences-Four j shields containing the 1-131 dosages prescribed p tients were prescribed brachytherapy l for different patients. Additionally, the technician Procedures, usmg indium-192 seeds of different failed to check for the correct dosage on the vial source strengths, and received doses other than label, and the wrong dose was administered to the those prescribed because of the same computer intended patient. mput error. (The same computer mput error l could cause either underdoses or overdoses l because the algorithm used was dose dependent.)
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| l Actions Taken to Prevent Recurrence Details of the misadministrations are as follows:
| |
| Licensee-The licensee instituted a procedure for Patient A: The patient was prescribed a dose of checking the vial label before giving a dose, in 2800 centigray (cGy)(2800 rad) for a ,
| |
| addition, the licensee is obtaining a second dose gynecological brachytherapy calibrator which will be used in the out-patient treatment, but received a dose of dosing nmm of the Thyroid Clinic. Each dose about 1680 cGy.(1680 rad)instead.
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| will be re-assayed immediately before the I-131 is administered to the patient, rather than relying on Patient B: Event 1 - The patient was prescribed a the assay which was performed in the Thyroid dose of 1600 cGy (1600 rad)
| |
| Lab before the dose was transported to the for lung treatment, but outpatient dosing mom. received a dose of about i 2128 cGy (2128 rad)instead.
| |
| NRC-NRC performed an inspection on May 12, l
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| 1995, to learn about the event and determined Event 2 - On another day, the same that it constituted a misadministration as defined patient was prescribed a dose of 1500 cGy (1500 rad) ;
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| in 10 CFR 35.2. NRC determined that this was an isolated violation of the licensee's Quality for lung treatment, but Management Program and issued a Notice of NUREG-0090, Vol.18, No. 2 5
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| l
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| a
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| , p SUPPORTING STATEMENT FOR 10 CFR PART 35 MEDICAL USE OF BYPRODUCT MATERIAL (3150-0010)
| |
| EXTENSIONWIkHREVISIONS DESCRIPTION OF THE INFORMATION COLLECTION Part 35 of Title 10 of the Code of Federal Regulations contains requirements that apply to the Nuclear Regulatory Commission's licensees who are authorized to administer byproduct material or its radiation to humans for medical use.
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| A. JUSTIFICATION
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| : 1. Need for and Practical Utility of the Collection of Information Part of the NRC's function is to license and regulate the use of byproduct material in order to assure protection of public health and safety. The NRC
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| ! requires licensees to perform certain tasks to ensure fulfillment of their
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| ! obligations. The records required in this part are the least burdensome way l for licensees to demonstrate compliance. Occasionally safety matters are of i
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| such significance that personnel need to be aware of the information in order to perform their jobs or work in a safe manner. In such cases, reports are 4 required.
| |
| l Sections 35.12(b) and (c) of 10 CFR Part 35 require that applicants submit a
| |
| : completed NRC Form 313. "Ap)11 cation for Materials License." The form elicits i an orderly description of t1e applicant's complete radiation safety program, l Requests for amendments and license renewals may be submitted in a letter I
| |
| ; format. This report is needed to assure the NRC that applicants' programs
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| , are adequate to protect health and minimize danger to life and property before the NRC can authorize receipt of radioactive material. NRC Form 313 has previously been cleared under 0MB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden and cost data.
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| Section 35.13 requires that licensees a> ply for and receive a license 4 amendment before using material not autlorized by the license, before adding !
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| j or changing key individuals, before receiving more material than authorized by I the license, or before changing the area or addresses of authorized places of i use. The triggering events are critical indicators of a potential for change in the licensee's abili1y to control radiation dose to workers and the public, or the NRC's ability to contact the licensee or conduct an inspection of the licensee's arogram. The information is required so that the staff can determine w1 ether the licensee has individuals with adequate training and experience to safely use radioactive material, and the facilities and equipment necessary or required to assure protection of public health and safety.
| |
| Section 35.14 requires that licensees: 1) provide certain information for each individual no later than 30 days after the date the licensee permits the individual to work as an authorized user, or as an authorized nuclear pharmacist. 2) notify the NRC within 30 days if a key worker ends his Attachment B
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| | |
| sl association with the licensee or has a name change, or 3) when the licensee's mailing address changes. The report for authorized user or authorized nuclear pharmacist is recuired in order to maintain the licensee's file with a current l record of indivicuals authorized to use or prepare radioactive material. The report for changes in " key" workers is required because if the licensee no !
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| longer has a complete staff, the collective training and experience of the :
| |
| remaining staff may no longer be sufficient to ensure the safety of all !
| |
| l licensed users. This report will trigger a check of the licensee's file to determine whether the licensee's remaining users are qualified to receive and use radioactive material safely. The NRC needs to be aware of mailing address changes to ensure that the licensee continues receiving correspondence such as information notices, bulletins, and other safety related documents.
| |
| Section 35.20 requires licensees to have a written program to kee) radiation doses as low as reasonably achievable (ALARA). The program must )e written to provide clear statements of authority, responsibility, and technical requirements. The written program is used by the licensee, the radiation safety officer, and authorized users. Its purpose is to ensure that licensees comply with the requirement to make a reasonable effort to maintain individual and collective occupational radiation doses ALARA.
| |
| Section 35.21(b)(2) requires that the licensee establish and implement the written policy and procedures that were submitted as part of the application.
| |
| The written policy and procedures are needed so that NRC can review them and make a determination that the applicant can meet the requirements of the Atomic Energy Act and the Commission's regulations. The arocedures must be implemented in order to provide for protection of public lealth and safety.
| |
| The burden is included in the burden for the application, NRC Form 313. OMB Clearance No. 3150-0120.
| |
| Sections 35.22(a)(4) and (5) require that medical institution licensees retain a copy of radiation safety comittee meeting minutes for the duration of the license, and 3rescribe the information required in the minutes. A copy of the minutes must )e provided to each member. The record is required to document continuing management oversight of the radiation safety program.
| |
| Section 35.23(b) requires that licensees provide a written statement of authority, duties, responsibilities, and radiation safety activities for the radiation safety officer and radiation safety committee. The statement is needed so that managers and key users know their responsibilities. The statement must be retained for the duration of the license.
| |
| Section 35.29(b) requires that mobile nuclear medicine service licensees keep a letter of permission signed by the management of each client. This record is necessary to show that the client's management has permitted this work.
| |
| Section 35.31(b) requires that licensees make a record of minor radiation safety program changes. This record is needed to document what radiation safety factors were considered before implementing the minor change. This permits the NRC to evaluate the nature and appropriateness of the minor changes during inspections prior to renewal and will provide the licensee with 2
| |
| | |
| a complete record of the radiation safety program until the changes are incorporated into the license when renewed.
| |
| Section 35.32 contains requirements for a quality management program.
| |
| Section 35.32(a) requires that each applicant or licensee establish and maintain a written quality management program.
| |
| Section 35.32(b) requires that the licensee develop audit procedures, revise the quality management program when necessary, and retain records of each audit and management evaluation of the quality management program for 3 years.
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| Section 35.32(c) requires that the licensee retain records of the relevant facts of recordable events for 3 years, Section 35.32(d) requires that the licensee retain records of written directives and administered radiation dose or radiopharmaceutical dosage for 3 years.
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| Section 35.32(e) allows the licensee to make modifications to the quality management program to increase the program's efficiency and requires that the modification be submitted to the NRC regional office within 30 days.
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| Section 35.32(f)(1) requires that an applicant for a new license submit a quality management program to the NRC regional office as part of the :
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| license application.
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| Sections 35.32(a). (b). (c). (d). (e). (f)(1) and (f)(2) are cleared separately under 0MB Clearance No. 3150-0171. They are described here for information purposes only. ,
| |
| Section 35.33(a) requires:
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| (1) that the licensee notify by telephone the NRC Operations Center in l case of a therapy misadministration within 24 hours after discovering the misadministration. This prompt notification is necessary because a therapy misadministration may aresent a clear and present radiation hazard to a member of the pu)lic that may be mitigated by NRC assistance.
| |
| (2) that a licensee file a written report to the NRC within 15 days after discovery of a misadministration. This report is required so that the NRC can determine whether there might be generic implications in the incident which indicate a need to notify all licensees. NRC allows the licensee 15 days to submit the report to i give the licensee adequate time to review and analyze the event and l to provide NRC with a complete history of the event. NRC requires submission of the report within 15 days so that NRC can promptly notify other licensees if it appears the precipitating event might be generic.
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| l 3
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| l (3) that the licensee notify the referring physician and the patient. or
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| : human research subject. unless the referring physician informs the licensee that he will notify the patient, or unless contraindicated l
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| ' by factors known to the referring physician. These reports are needed so that the patient can ensure adequate follow-up care, if applicable.
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| Section 35.33(a) is cleared separately under OMB Clearance No. 3150-0171. It is described here for information purposes only.
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| Section 35.33(b) requires that the licensee retain a record of each misadmini.stration for 5 years. The written records are required to determine what kinds of actions precipitate misadministrations, to provide input for enhancements and/or revisions to procedures, and provide an indicator of the licensee's management control of the radiation safety program. This section is cleared separately under 0MB Clearance No. 3150-0171. It is described here for information purposes only.
| |
| Section 35.50(b)(4) requires that licensees make a record of a geometry dependence test for the dose calibrator. This record is required to demonstrate the relationship between volume configurations of the radio-l pharmaceutical and the accuracy of the reading given by the dose calibrator, so correction factors, if applicable, can be applied.
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| Section 35.50(e) requires that licensees retain a record of checks and tests of dose calibrator performance. The record is required to show that the dose l calibrator is functioning correctly and is capable of accurately measuring radiopharmaceutical dosages, to establish trends in equipment performance, and to show compliance with regulatory requirements.
| |
| Section 35.51(a)(3) requires that the licensee note on a survey instrument the apparent exposure rate from a dedicated check source at the time of instrument calibration. This information is required so that the licensee can check the survey instrument for proper operation before making measurements. The burden is included in the burden estimate for Section 35.51(d).
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| Section 35.51(d) requires that licensees retain a record of survey instrument calibrations. This record is required to show that survey instruments were calibrated and operational.
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| Section 35.52(b) recuires that licensees have procedures for use of instrumentation usec to measure the radioactivity of alpha- or beta-emitting radionuclides for other than unit dosages. In particular. this section does l not apply to unit dosages of alpha- or beta-emitting radionuclides from a
| |
| ! manufacturer or a nuclear pharmacy licensed under 10 CFR Part 32. Part 35 licensees may use procedures provided by the manufacturer of the instrumentation. These procedures are necessary to ensure that licensees use the instrumentation correctly. Thus, an additional recordkeeping burden may be expected, although licensees who currently use alpha- or beta-emitting radionuclides already have procedures for using this instrumentation.
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| [
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| i i .
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| 4 l
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| l l
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| l l Section 35.53(c) requires that licensees retain a record of each I' l radiopharmaceutical dosage measurement. This record is recuired for licensees l to show that they are maintaining control of the use of raciopharmaceuticals.
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| Section 35.59(a) requires that licensees maintain the manufacturer's written instructions for the safe use of sealed sources and brachytherapy sources.
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| These instructions are required so that individuals who handle sources can determine the specific safety measures appropriate for each kind of source Led .
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| l Section 35.59(d) requires that licensees retain a record of sealed source leak tests. This record is required to show that the leak test was done at the l appropriate time, and that the source was not leaking.
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| Section 35.59(e)(2) requires that licensees file a report with the NRC within !
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| 5 days if leakage of a sealed source is detected. This report is needed so that NRC can make a determination as to whether other licensees who have similar sealed sources should take special precautions. NRC allows the licensee 5 days to submit the report so that the licensee can review and analyze the source and the leak test result. NRC requires submission of the report within 5 days so that NRC can promptly notify other licensees if it appears there may be a generic problem.
| |
| Section 35.59(g) requires that licensees make a record of sealed source and brachytherapy source inventory. This inventory is required to show that possession of sealed sources did not exceed the amount authorized by the license. The 5 year recordkeeping requirement will help to assure continued control over sources that are only occasionally used.
| |
| Section 35.59(i) requires that licensees make a record of radiation surveys of areas where sealed sources and brachytherapy sources are stored. This record is necessary to document that adequate radiation shielding has been provided for such sources, and that dose rates in contiguous areas are within allowed levels.
| |
| Section 35.60(b) requires that licensees label each syringe or syringe radiation shield as to its contents. This label is needed because review of misadministration reports has indicated that in many cases misadministrations are caused by inadvertent transposition of syringes.
| |
| Section 35.61(b) requires that licensees label vial radiation shields with the identity of the radiopharmaceutical contained. NRC review of several
| |
| , misadministration reports indicates that many misadministrations occur when technicians draw a dosage from the wrong vial of radioactive material. Labels will help to reduce the chance of this happening.
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| Sections 35.70(d) and (g) require that the licensee establish action levels for radiation surveys. The action levels provide the individual who makes a l radiation survey with information on what levels are expected and what levels require investigation. The sections also require that the licensee l immediately notify the radiation safety officer if excessive levels are detected during a survey. This notification is needed so that the radiation 5
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| l
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| safety officer can take appropriate remedial action. The radiation safety officer is the primary individual onsite who is qualified to determine what action is needed to ensure worker and public health and safety, and whether that action is needed immediately or can be delayed.
| |
| Section 35.70(h) recuires that licensees retain a record of radiation surveys.
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| The record .is needec to show that the required surveys were made. l l
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| Section 35.80(f) requires that mobile nuclear medicine service licensees make a record of radiation surveys. The record is needed to show that the required surveys were made.
| |
| Section 35.92(b) requires that licensees make a record of disposal of waste that was decayed in storage. The record is needed to show that the material was decayed for the required length of time, that its radioactivity cannot be j distinguished from background radiation levels, and that a proper survey of each waste container was made prior to disposal.
| |
| Section 35.204(c) requires that licensees retain a record of molybdenum-99 concentration in radiopharmaceuticals. This record is needed to show that the concentration measurement was made and that the maximum molybdenum-99 concentration level was not exceeded.
| |
| Section 35.205(d) requires that the licensee post a time period of evacuation in areas where radioactive gases are used. In case of a spill, this provides notice to workers of how much time air handling equipment needs to reduce the air concentration to permissible limits. The licensee must retain a record of the calculations used to determine the evacuation time for the duration of use of the area.
| |
| Section 35.310(b) requires that licensees retain a record of radiation safety 1 i
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| instruction given to personnel who care for radiopharmaceutical therapy patients. This record is needed to show that the training was given. !
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| Sections 35.315(a)(2) requires that the licensee post radiopharmaceutical therapy patient room doors with a " Radioactive Materials" sign. This provides i notice to hospital workers and the public that there is radioactivity in the room. The section also requires that the licensee note in the patient's chart how long visitors may stay in the patient's room. This is the most convenient way to provide this information to nurses, who are usually responsible for ;
| |
| enforcing visiting rules. l Section 35.315(a)(4) requires that licensees make a record of dose rates l around radiopharmaceutical treatment rooms after administration of the dosage. 1 This record is required to show that members of the public are not exposed to excessive levels of radiation.
| |
| Section 35.315(a)(8) requires that licensees make a record of the thyroid burden measurement of each individual who helped prepare or administer a therapeutic dosage of iodine-131. This record is required to show that the measurement was performed and that workers were not exposed to excessive levels of iodine-131.
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| 6
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| 1 l
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| . 1 1
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| i .
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| , Section 35.315(b) requires that the licensee promptly notify the radiation safety officer if the radiopharmaceutical therapy patient dies or has a medical emergency. This notification is required so that the radiation safety i officer can take whatever actions are necessary to prevent a saread of radioactive contamination or loss of brachytherapy sources. T1e radiation safety officer is the primary individual onsite who is qualified to determine
| |
| , what action is required to ensure worker and public health and safety, and whether action is needed immediately or can be delayed. l l
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| Section 35.404(b) requires that licensees retain a record of the radiation l survey of each patient who was treated with temporary implant sources. The record is required to show that the survey was performed.
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| Section 35.406(b) requires that licensees make a record of brachytherapy source use. This record is required so that, if a brachytherapy source is 4 misplaced or missing. the licensee is immediately alerted and can take appropriate action.
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| i Section 35.406(c) requires that licensees make a record of radiation surveys of patients after implanting sources. This record is required to show that I the survey was performed.
| |
| Section 35.406(d) requires that the licensee retain a record of the use of 1 brachythera)y sources and special safety surveys. This record is needed to show that t1e licensee is providing adequate control for these sources. The record burden is included in the burden estimate for Sections 35.406(b) and (c).
| |
| h Section 35.410(b) requires that licensees retain a record of training for
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| , personnel who care for implant patients. This record is required to show that the training was given.
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| Section 35.415(a)(2) requires that a licensee post the patient's door with a i
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| " Radioactive Materials" sign and note on the door or in the patient's chart where and how long visitors may stay in the patient's room. This posting is required to help protect against excessive radiation exposure to visitors.
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| Section 35.415(a)(4) requires that, after an implant of radioactive material.
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| licensees record the results of a survey of the contiguous restricted and unrestricted areas and retain the record for 3 years. The record is used to
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| : demonstrate compliance with 10 CFR Part 20 requirements and to show that members of the public are not exposed to excessive levels of radiation.
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| Section 35.415(b) requires that the licensee notify the radiation safety officer immediately if the patient dies or has a medical emergency. This notification is required so that the radiation safety officer can take whatever action is necessary to prevent a spread of radioactive contamination or loss of sources. The radiation safety officer is the primary individual
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| ; onsite who is qualified to determine what action is necessary to ensure worker public health and safety, and Vnether that action is required immediately or can be delayed.
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| 7 4
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| _. .- -. -- - -. . _ - - - .. - - - . _ ~ . .. .
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| l Section 35.606 requires that licensees apply for and receive a license l amendment before making certain changes in the teletherapy program. This license amendment process is necessary because the licensee may consider making changes that would cause radiation levels in restricted and unrestricted areas to exceed permissible levels. The burden is included in OMB Clearance No. 3150-0120.
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| l l Section 35.610(a) requires that licensees post written instructions for
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| ! individuals who operate teletherapy units. These instructions are necessary
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| ; to remind workers of proper operating procedures and to serve as a quick
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| ! reference in case of emergencies or equipment malfunction.
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| ! Section 35.610(c) requires that licensees make a record of training for individuals who operate teletherapy units. This record is needed to show that the training was given.
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| Section 35.615(d)(4) requires that licensees retain a record of the l teletherapy room radiation monitoring device function check. This record is needed to show that the check was made, and for trend analysis by the licensee.
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| ; Section 35.615(d)(5) requires that licensees retain a record of the functional check of the instrument or dosimeter used when the radiation monitor is inoperable. The burden is included in Section 35.615(d)(4) as this record is
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| : required only when the radiation monitor is inoperable.
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| Section 35.630(c) requires that licensees retain a record of each calibration.
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| intercomparison, and comparison of teletherapy dosimetry equipment. These records are needed to show that measurements of radiation teletherapy doses were made with instruments capable of making accurate measurements.
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| Section 35.632(g) requires that licensees retain a record of teletherapy unit calibration. This record is needed to show that the calibrations were done and that licensees did not inadvertently administer incorrect radiation doses to patients.
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| Section 35.634(c) requires that the qualified teletherapy physicist report the results of teletherapy unit spot-checks prom 3tly to the licensee. This assures the licensee that the results of eaci spot-check have been reviewed by an expert. The licensee must keep a copy of each report to assure that the review has been made.
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| Section 35.634(f) recuires that licensees retain a record of spot-checks.
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| This record is needet to show that the required checks were made.
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| Section 35.636(c) requires that licensees retain a record of safety checks for l teletherapy facilities. This record is needed to show that the checks were l made.
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| l l Section 35.641(c) requires that licensees retain a record of radiation l measurements after installing a source in a teletherapy unit. These records provide assurance that the source is properly installed within the teletherapy I 8 1
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| | |
| unit, and that dose rates outside the teletherapy room are within permissible limits.
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| Section 35.643(a)(3) requires that licensees include additional survey and facility description information if changes in an NRC approved installation were necessary for compliance with 10 CFR Part 20. The additional information in the report will facilitate a determination by the NRC that dose rates in restricted and unrestricted areas are within permissible limits. The 30 day submission requirement is contained in Section 35.645.
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| Section 35.643(b) requires that licensees request a license amendment if the licensee wants authorization for radiation levels in unrestricted areas which are above permitted levels. This report will trigger an in depth NRC review of safety considerations before it allows a licensee to operate the unit.
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| The burden for the license amendment is included in OMB Clearance No. 3150-0120.
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| Section 35.645 requires that licensees mail a copy of telethera)y source installation records to the NRC. These records are needed to slow that dose rates in restricted and unrestricted areas are within permissible levels. The submission must be made within 30 days after the completion of the action that initiated the record recuirement. The 30-day requirement is imposed because of the especially high cose rates that can be found around teletherapy units.
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| Section 35.647(c) requires that licensees keep a record of teletherapy unit ins)ection and servicing. This record is needed to show that the required wort was done.
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| Section 35.980(b)(2) requires an individual to obtain a written certification signed by a preceptor before the individual can be qualified as an authorized nuclear pharmacist. This is necessary to ensure that the individual has l achieved a level of competency sufficient to independently operate a nuclear pharmacy.
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| Section 35.981 requires a licensee to receive an amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear Sharmacist. Prior to January 1,1995, there was no requirement to have an autlorized nuclear pharmacist. This amendment is necessary to ensure that facilities have a qualified nuclear pharmacist on site.
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| : 2. Aaency Use of the Information l The records that 10 CFR Part 35 requires the licensees to maintain are reviewed during inspections, license renewals, and license amendment reviews to evaluate compliance with NRC radiation safety requirements for possession and use of byproduct material.
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| The records of receipt, transfer, and disposal of byproduct material are reviewed by the NRC inspectors to determine that licensees have confined their possession and use of byproduct material to the locations, purposes, receipt, and quantities authorized in their licenses.
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| 9
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| ! Reports are used by the agency in evaluating the protective actions required to avoid exposures to radiation or releases of radioactive materials that
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| : could impact public health and safety and the environment.
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| 1 .
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| ! 3. Reduction of Burden Throuah Information Technoloav i There are no current information technology applications that would reduce the burden of these information collection requirements. The NRC encourages
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| ;- applicants and licensees to use new automated information technology when it would be beneficial to them. However, because of the types of information and j the infrequency of submission, the applications and reports may not lend
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| ; themselves readily to the use of automated information technology for their j submission. Consequently, the current percentage of electronic submission is
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| ! zero.
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| !- 4. Effort to Identify Duolication and Use Similar Information i The Information Requirements Control Automated System was searched to l
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| determine duplication. None was found. In general, information required by
| |
| ! the NRC in applications, reports, or records concerning the transfer, receipt, possession, or use of byproduct material does not duplicate other Federal
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| , information collection requirements and is not available from any source other i than applicants or licensees. Portions of the needed information might also 4 be contained in other information submittals to the NRC or other Federal i agencies. However, duplication, if any, is slight and the collection of this
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| ; information by use of specified forms and other required reports and records i is the most effective and least burdensome means of obtaining the information.
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| : 5. Effort to Reduce Small Business Burden l While a number of licensees are considered small businesses, under the NRC's J
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| current definitions, the health and safety consequences of improper use of
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| ; radioactive material are the same for large and small entities. It is not
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| , possible to reduce the burden on small businesses by less frequent or less
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| ; complete reporting, recordkeeping, or accounting and control procedures while
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| : maintaining the required level of safety.
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| t
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| : 6. Conseauences to Federal Proaram or Policy Activities if the Collection Is Not Conducted or Is Conducted Less Freauently l
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| }' If the information is not collected, NRC will have no way to assess whether this category of licensee is operating within the radiation safety l requirements applicable to the possession, use, or transfer of byproduct ,
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| a material . !
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| The required reports are collected and evaluated on a continuing basis as events occur. Applications for new licenses and amendments are submitted only once. Applications for renewal of licenses are submitted every 5 years.
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| Information submitted in previous applications may be referenced without being resubmitted. The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of public health and safety.
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| 10
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| )
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| : 7. Circumstances Which Jectify Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.5(d). Section 35.14 requires that licensees notify the NRC within 30 days if a key worker ends his association with the licensee. This prompt report is required because if the licensee no I longer has a complete staff, the collective training and experience of the )
| |
| ; remaining staff may no longer be sufficient to ensure safety. This report 1 will trigger a check of the licensee's file to determine whether the remaining l q key users are qualified to receive and use material safely. !
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| : Secticn 35.20 requires licensees to retain, for the duration of the license, a !
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| ; written program to keep radiation dose as low as reasonably achievable. The written program must be retained so that it can be used by the licensee, the-
| |
| { radiation safety officer, and authorized users throughout the period of the
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| : license to ensure that a reasonable effort is made to maintain individual and l i collective occupational radiation doses as low as reasonably achievable.
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| Section 35.21(b)(2) requires that the licensee establish and implement the written policy and proc M urcs that were submitted as part of the application.
| |
| ;- It is necessary that the policy and procedures be retained for the duration of the license so that they will be available to the licensee's staff for implementation and so that the NRC staff can review them to ensure that the applicant can meet the requirements of the Atomic Energy Act and the Commission's regulations for protection of public health and safety.
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| I Sections 35.22(a)(4) and (5) require that medical institution licensees retain a copy of radiation safety committee meeting minutes for the duration of the l license, and prescribe the information required in the minutes. Retention of i
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| the records for the duration of the license is required to show continuing i management oversight of the radiation safety program. '
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| Section oS.23(b) requires that licensees retain, for the duration of the license, a written statement of authority, duties, responsibiiities, and radiation raiety activities for the radiation safety officer and radiation safety c Amittee. Retention of the statement for the period of the license is necessary so that managers and key users know their responsibilities.
| |
| Section 35.31(b) requires that licensees retain a record of minor radiation safety program changes until license renewal or termination. This record is needed to show what radiation safety factors were considered before implementing the minor change. This permits NRC to evaluate the nature and appropriateness of the minor changes during inspections prior to renewal and provides the licensee with a complete record of the radiation safety program until the changes are incorporated into the license at renewal.
| |
| Section 35.32(a) requires that each applicant or licensee establish and maintain a written quality management program for the duration of the licensed activity. Section 35.32(a) is cleared separately under OMB No. Clearance 3150-0171.
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| 11
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| | |
| Section 35.33(a) requires:
| |
| (1) that the licensee notify by telephone the NRC Operations Center in case of a therapy misadministration within 24 hours after discovering the misadministration. This prompt notification is necessary because a therapy misadministration may present a clear and present radiation hazard to a member of the pu)lic that might be mitigated by NRC assistance.
| |
| (2) that a licensee file a written report to NRC within 15 days after discovery of a misadministration. This resort is necessary so that the NRC can determine whether there might ae generic implications in the incident which indicate a need to notify all licensees. NRC allows the licensee 15 days to submit the report so that it can review and analyze what has happened and provide NRC with a complete history of the event. NRC requires submission of the report within 15 days so that it can promatly notify other licensees if it appears the precipitating event mig 1t be generic.
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| Section 35.33(b) requires that the licensee retain a record of each misadministration for 5 years. These written records are needed to determine what kinds of actions precipitate misadministrations, and also provide an indicator of the licensee's management control of the radiation safety l program, j Sections 35.33(a) and (b) are cleared separately under OMB Clearance No. 3150-0171.
| |
| Section 35.50(b)(4) requires that licensees retain a record of a geometry dependence test for the dose calibrator for the duration of use of the dose calibrator. This record is necessary throughout the duration of use of the equipment to demonstrate the relationship between volume configurations of the radiopharaaceutical and the accuracy of the reading given by the dose calibrator, and would be necessary for subsequent reconstruction in the event of an incident involving questions of dose calibration.
| |
| Section 35.50(e) requires that licensees retain a record of checks and tests of dose calibrator performance for the duration of use of the equipment. This record is needed throughout the duration of use of the equipment to show that the dose calibrator is functioning correctly and is capable of accurately measuring radiopharmaceutical dosages, and to establisi trends in equipment performance.
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| Section 35.59(a) requires that licensees maintain, for the duration of source use, the manufacturer's written instructions for the safe use of sealed i
| |
| sources and brachytherapy sources. These instructions are needed so that. at
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| : any time during the duration of use, individuals who are handling sources can determine the specific safety measures appropriate for each kind of source l
| |
| used.
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| l Section 35.59(e)(2) requires that licensees file a report with the NRC within 5 days if leakage of a sealed source is detected. This report is necessary so i 12 l
| |
| | |
| that the NRC can make a determination as to whether other licensees who have similar sealed sources should take special precautions. NRC allows the.
| |
| licensee 5 days to submit the report so that the licensee can review and analyze the source and the leak test result. NRC requires submission of the report within 5 days so that NRC can promptly notify other licensees if it appears there may be a generic problem. ;
| |
| Section 35.59(g) requires that licensees retain a record of sealed source and l brachytherapy source inventory for 5 years. This inventory is needed to show ;
| |
| ! that possession of sealed sources did not exceed the' amount authorized by the l l license. The 5 year recordkeeping requirement is necessary to assure
| |
| ! continued control over sources that are only occasionally used, and to ensure l that the records will be available for periodic inspections, which may exceed a 3 year interval.
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| Section 35.205(d) recuires that the licensee retain, for the duration of use
| |
| , of the area, a recorc of the calculations used to determine the evacuation l time for areas where radioactive gases are used. In case of a spill, the l record of the calculations, which is required to be posted, provides notice to ,
| |
| workers of how much time air handling equipment needs to reduce the air i concentration to permissible limits. This record is also needed to show that i the calculations were performed. Retention beyond 3 years is necessary to provide notice of evacuation time to workers and to ensure that records of calculations are available to the NRC for periodic inspections, which may exceed 3 year intervals.
| |
| I Section 35.315(a)(8) requires that licensees retain a record of the thyroid burden measurement of each individual who helped prepare or administer a therapeutic dosage of iodine-131 until the Commis'sion cuthorizes their disposition. This record is needed to .show that the mea:;urement was performed and that workers were not exposed to excessive levels of iodine-131.
| |
| Retention beyond 3 years is necessary to ensure that complete records of exposure of each individual are available to the individual and to the licensee so that the licensee can avoid accumulation of excessive exposures by individuals.
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| Section 35.415(b) requires that the licensee notify the radiation safety officer immediately if the patient dies or has a medical emergency. This immediate notification is necessary to permit the radiation safety officer to ensure that safety requirements are met for removal or disposal of the implanted radioactive material.
| |
| Section 35.630(c) requires that licensees retain a record of each calibration, intercomparison, and comparison of teletherapy dosimetry equipment for the duration of use of the teletherapy unit source. These records are necessary to show throughout the period of use of the equipment that measurements of radiation teletherapy doses were made with instruments capable of making accurate measurements, and for use in reconstruction in case of an incident.
| |
| Section 35.632(g) requires that licensees retain, for the duration of the license. a record of teletherapy unit calibrat M This record is required to show that the calibrations were done and that 11cencec2 did not inadvertently r
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| l 13 l
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| | |
| administer incorrect radiation doses to patients. It would also be necessary in the case of reconstruction of an incident.
| |
| Section 35.641(c) requires that licensees retain, for the duration of the license, a record of radiation measurements after installing a source in a teletherapy unit. These record: are required throughout the period of the license to provide assurance that the source was properly installed within the teletherapy unit, and that dose rates outside the teletherapy room are within permissible limits. They would also be necessary in reconstruction following ,
| |
| an incident involving the unit.
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| Section 35.645 requires that licensees mail a copy of the telethera)y source installation records to the NRC. This record is required to show tlat dose rates in restricted and unrestricted areas are within permissible levels. The submission must be made within 30 days after completion of the action that initiated the record recuirement. The 30 day requirement is imposed because of the especially high cose rates that can be found around teletherapy units.
| |
| Section 35.647(c) requires that licensees keep a record of teletherapy unit inspection and servicing for the duration of the license. This record is required throughout the period of licensed activity to show that the required work was done and to establish a service history which may be used in incident 1 investigations and evaluation of generic equipment problems.
| |
| : 8. Consultations Outside the NRC During this clearance period, there have been consultations with the Advisory Committee on the Medical Use of isotopes (ACHUI), a group which includes a number of representatives of the licensed medical community, which provides advice to the NRC staff. There have been consultations with staff members of the Food and Drug Administration *s (FDA) Center for Drug Evaluation and Research and the FDA's Center for Biologics Evaluation and Research on amendments to the rule, and on supporting recordkeeping recuirements.
| |
| Additionally, the NRC has received public comments on amencments to the rule.
| |
| An invitation to comment on the current Part 35 information collection requirements was published in the Federal Reaister on March 27, 1996 (61 FR 13519-13520). There were no comments.
| |
| : 9. Payment or Gift to Resoondents Not Applicable
| |
| : 10. Confidentiality of the Information Reports submitted are generally subject to public disclosure in accordance with 10 CFR 2.790 and 10 CFR Part 9. Section 2.790 allows the NRC to withhold certain proprietary information (information of commercial value or " trade secrets") if, at the time of submittal of the report, the requirements for withholding the information are met (refer to 10 CFR 2.790(b)). Also, there are provisions in 10 CFR Part 9 for the NRC to withhold from public disclosure 14
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| | |
| O documents such as reports of radiation exposure to individuals and other personal records.
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| : 11. Justification for Sensitive Questions No sensitive information is requested under these regulations.
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| : 12. Estimated Burden and Burden Hor Cost NRC Licensees:
| |
| These requirements will affect a) proximately 1982 licensees and applicants, of which 1348 of the licensees are lospitals, and 394 of the licensees are physicians in private practice.
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| The total annual burden is estimated to be about 376.407 hours aer year (about 190 hours per licensee) for the 1.982 licensees covered by 10 C R Part 35.
| |
| The details are shown in Tables 1 and 2. The total cost for the NRC licensees is estimated at $45.168.840 (376.407 hours x $120.00). Cost is calculated at a rate of $120 per hour, which 1s based on NRC's fee recovery rate.
| |
| Aareement State Licensees:
| |
| 10 CFR Part 35 is a Division III level of compatibility for Agreement States.
| |
| The Agreement States are encouraged to adoat similar regulations, but are not l required to have any degree of uniformity aetween the NRC regulations and the State regulations. The burden for Agreement State licensees is calculated on the basis of Agreement States having similar regulations for medical use programs.
| |
| The total annual burden is estimated to be about 942.820 hours per year (about 190 hours per licensee) for the estimated 4.955 licensees covered by equivalent regulations. The details are shown in Tables 3 and 4. The total cost for the Agreement State licensees is estimated at $113.138.400 (942.820 hours x $120.00).
| |
| l
| |
| : 13. Estimate of Other Additional Costs None For licensees under 10 CFR Part 35, it is most likely that purchases of equipment and services were made (1) prior to October 1. 1995. (2) to achieve regulatory-compliance with requirements not associated with the information collection. (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
| |
| : 14. Estimated Annualized Cost to the Federal Government Application review activities are attributable to and reported under NRC Form 313. " Application for Material Licensee," OMB Clearance No. 3150-0120.
| |
| 15
| |
| | |
| The " Quality Management Program and Misadministrations" information collection requirements are cleared under OMB Clearance No. 3150-0171.
| |
| Annual Cost of NRC staff review for activities other than application review (Professional effort is 239 hours @ $120.00 per hour) - $28,680. This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.
| |
| '15. Reasons for Chanaes in Burden and Cost NRC Licensees:
| |
| The revision is a net increase adjustment in burden as a result of an increase t
| |
| in the number of 10 CFR Part 35 licensees, and a reevaluation of the time required to perform individual activities and the number of times those activities are performed. Two new requirements were included as a result of l rulemaking since the last burden was calculated. One recuirement, which was inadvertently omitted during the last evaluation, was adced. There is an increase in the number of NRC medical use licensees, from 1.900 to 1.982. The result is a net burden increase of 46.614 hours. I Aareement State Licensees: The burden for Agreement State licensees was not addressed in the previous OMB clearance package for 10 CFR Part 35. Its inclusion in this submittal will increase the overall burden to licensees l
| |
| reflected in this clearance submittal by 942.820. l l 16. Publication for Statistical Use There is no application to statistics in the information collected. There are no plans for publication of this information.
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| : 17. Reason for Not Disolavina the Exoiration Date 1 I
| |
| The requirement will be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.
| |
| : 18. Exceotions to the Certification Statement There are no exceptions.
| |
| B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable i
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| 16 l
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| l
| |
| | |
| Table 1: Reporting Requirements - NRC Licensees Section No. of NRC Licensee Responses NRC Licensee Staff Total Ar.nual NRC Licensee Annually Hours per Submittal Staff Burden Hours 35.12(b) See OMB Clearance No. 3150-0120 35.12(c) See OMB Clearance No. 3150-0120 35.13 See OMB Clearance No. 3150-0120 35.14 471 0.5 236 35.32(f)(1) See OMB Clearance No. 3150-0171 35.32(f)(2) See OMB Clearance No. 3150-0171 35.33(a) See OMB Clearance No. 3150-0171 2 2 4 35.59(e)(2) 35.60(b) 986.000 0.02 19.720 876.200 0.02 17.524 35.61(b) 1.866 0.08 149 35.70(d) 35.70(g) 1.866 0.08 149 3.200 0.2 640 35.315(a)(2) 3.200 0.25 800 35.315(a)(6) 16 1 16 35.315(b) 8.700 0.2 1.740 35.415(a)(2) 73 1 73 35.415(b) 35.606 See OMB Clearance No. 3150-0120 89 0.5 45 35.610(a) 534 0.5 267 35.634(c) 4 4 35.643(a)(3) 1 35.643(b) See OMB Clearance No. 3150-0120 17
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| Table 2: Recordkeeping Requirements - NRC Licensees Section No. of NRC Annual Hours per Total Record Retention Period Recordkeepers Recordkeeper Recordkeeping Hours 35.20 See OMB Clearance No. 3150-0120* license duration 35.21(b)(2) See OMB Clearance No. 3150-0120* license duration 35.22(a)(4) & (5) 1561 8 12.488 license duration 35.23(b) See OMB Clearance No. 3150-0120* license duration 35.29(b) 37 20 740 3 years after last service 35.31(b) 1.982 1 1.982 license renewal or termination 35.32(a) See OMB Clearance No. 3150-0171 35.32(b) See OMB Clearance No. 3150-0171 35.32(c) See OMB Clearance No. 3150-0171 35.32(d) See OMB Clearance No. 3150-0171 35.32(e) See OMB Clearance No. 3150-0171 35.33(b) See OMB Clearance No. 3150-0171 35.50(b)(4) See 35.50(e)(4) equipment duration 35.50(e)(1) 1.866 1 1.866 3 years 35.50(e)(2) 1.866 0.3 560 3 years 35.50(e)(3) 1.866 4 7.464 3 years 35.50(e)(4) 80 1 80 equipment duration 35.51(a)(3) & (d) 1.955 0.5 978 3 years 55 0.2 11 equipment duration
| |
| _35.52(b)
| |
| *These documents are prepared as a written report and must be re".ained by the licensee for reference. The time spent making the record is included in the noted reporting section.
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| 19
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| | |
| ' * ' ~
| |
| Table 2 Recordkeeping Requirements - NRC Licensees continued Section No. of NRC Annual Hours per Total Recordkeeping Hours Record Retention Period Recordkeepers Recordkeeper 35.53(c) 1.866 47 87.002 3 years 35.59(a) 1.982 0.5 991 source duration 35.59(d) 1.982 1 1.982 3 years 35.59(g) 1.982 0.6 1.189 5 years 35.59(i) 1.982 0.2 396 3 years 35.70(h) 1.866 86 160.476 3 years 35.80(f) 37 130 4.810 3 years 35.92(b) 1.866 14 26.124 3 years 35.204(c) 674 12 8.088 3 years 35.205(d) 1.866 0.5 933 duration of use of area 35.310(b) 973 4 3.892 3 years 35.315(a)(4) 973 1.5 1.460 3 years 35.315(a)(8) 973 1 973 until disposal authorized 35.404(b) 478 2 956 3 years 35.406(b) 478 4 1.912 3 years 35.406(c) 478 1 478 3 years 35.406(d) Included in 35.406(b) and (c) 35.410(b) 478 4 1.912 3 years 35.415(a)(4) 478 4 1.912 3 years 35.610(c) 89 1 89 3 years 35.615(d)(4) 89 8 712 3 years 35.615(d)(5) Included in 35.615(d)(4) 20
| |
| | |
| ~ * '
| |
| * Table 2: Recordkeeping Requirements - NRC Licensees continued Section No. of NRC Annual Hours per Total Recordkeeping Record Retention Period Recordkeepers Recordkeeper Hours 35.630(c) 89 0.5 45 license duration 35.632(g) 89 4 356 duration of teletherapy source 35.634(c) 89 12 1.068 3 Years 12 1.068 3 years 35.634(f) 89 Included in 35.634(f) 3 years 35.636(c) _.
| |
| 35.641(c) Included in 35.634(f) license duration 35.647(c) 89 0.05 4 license duration 334,997 TOTAL:
| |
| Total NRC licensee burden hours: 376.407 21
| |
| | |
| e . .
| |
| Table 3: Reporting Requirements - Agreement State Licensees No. of Agreement State Licensee Agreement State Licensee Total Annual Agreement State Section Licensee Staff Burden Hours Responses Annually Staff Hours per Submittal 35.12(b) See OMB Clearance No. 3150-0120 35.12(c) See OMB Clearance No. 3150-0120 35.13 See OMB Clearance No. 3150-0120 35.14 1178 0.5 589 35.32(f)(1) See OMB Clearance No. 3150-0171 35.32(f)(2) See OMB Clearance No. 3150-0171 35.33(a) See OMB Clearance No. 3150-0171 4 2 8 35.59(e)(2) 2.465.000 0.02 49.300 35.60(b) 2.190.500 0.02 43.810 35.61(b) 4.665 0.08 373 35.70(d) _
| |
| 4.665 0.08 373 35.70(g) 8.000 0.2 1.600 35.315(a)(2) 8.000 0.25 2.000 35.315(a)(6) 40 1 40 35.315(b) 35.415(a)(2) 21.750 0.2 4.350 183 1 183 35.415(b) 35.606 See OMB Clearance No. 3150-0120 35.610(a) 223 0.5 112 1.335 0.5 668 35.634(c) 3 4 12 35.643(a)(3) 35.643(b) See OMB Clearance No. 3150-0120 22
| |
| | |
| Table 3: Reporting Requirements - Agreement State Licensees continued Section No. of Agreement State Licensee Agreement State Licensee Total Annual Agreement State Responses Annually Staff Hours per Submittal Licensee Staff Burden Hours 35.645 113 0.5 57 35.980(b)(2) No equivalent regulation required until 3 years after effective date of rule 35.981 No equivalent regulation required until 3 years after effective date of rule TOTAL: 4.705.652 11 103.475 23
| |
| | |
| Table 4: Recordkeeping Requirements - Agreement State Licensees Section No. of Agreement Annual Hours Total Record Retention Period State per Recordkeeping Recordkeepers (2.5 Recordkeeper Hours x No. NRC licensees) 35.20 See OMB Clearance No. 3150-0120* license duration 35.21(b)(2) See OMB Clearance No. 3150-0120* license duration 35.22(a)(4) & (5) 3.903 8 31.224 license duration 35.23(b) See OMB Clearance No. 3150-0120* license duration 5.29(b) 93 20 1.860 3 years after last service 35.31(b) 4.955 1 4.955 license renewal or termination 35.32(a) See OMB Clearance No. 3150-0171 35.32(b) See OMB Clearance No. 3150-0171 35.32(c) See OMB Clearance No. 3150-0171 35.32(d) See OMB Clearance No. 3150-0171 35.32(e) See OMB Clearance No. 3150-0171 35.33(b) See OMB Clearance No. 3150-0171 35.50(b)(4) See 35.50(e)(4) I equipment duration 35.50(e)(1) 4.665 1 4.665 3 years 35.50(e)(2) 4.665 0.3 1.400 3 years 35.50(e)(3) 4.665 4 18.660 3 years 35.50(e)(4) 200 1 200 equipment duration 35.51(a)(3) & (d) 4.888 0.5 2.444 3 years 35.52(b) 138 0.2 28 equipment duration
| |
| *These documents are prepared as a written report and must be retained by the licensee for reference. The time spent making the record is included in the noted reporting section.
| |
| 24
| |
| | |
| a- l o Table 4: Recordkeeping Requirements - A,greement State Licensees continued No. of Agreement Annual Hours per Total Recordkeeping Hours Record Retention Period Section State Recordkeeper Recordkeepers 47 219.255 3 years 35.53(c) 4.665 4.955 0.5 2.478 source duration 35.59(a) 4.955 3 years 35.59(d) 4.955 1 0.6 2.973 5 years 35.59(g) 4.955 0.2 991 3 years 35.59(i) 4.955 86 401.190 3 years 35.70(h) 4.665 93 130 12.090 3 years 35.80(f) 14 65.310 3 years 35.92(b) 4.665 12 20.220 3 years 35.204(c) 1.685 4.665 0.5 2.333 duration of use of area 35.205(d) 4 9.732 3 years 35.310(b) 2.433 1.5 3.650 3 years 35.315(a)(4) 2.433 2.433 until disposal anthorized 35.315(a)(8) 2.433 1 2 2.390 3 years 35.404(b) 1.195 4 4.780 3 years 35.406(b) 1.195 1.195 3 years 35.406(c) 1.195 1 35.406(d) Included in 35.406(b) and (c) 4 4.780 3 years 35.410(b) 1.195 4 4.780 3 years 35.415(a)(4) 1.195 1 223 3 years 35.610(c) 223 8 1.784 3 years 35.615(d)(4) 223 35.615(d)(5) Included in 35.615(d)(4)
| |
| Table 4: Recordkeeping Requirements - Agreement State Licensees continued 25
| |
| | |
| _ _ , *!o Section No. of Agreement Annual Hours Total Recordkeeping Hours Record Retention Period State per Recordkeepers Recordkeeper 35.630(c) 223 0.5 112 license duration 35.632(G) 223 4 892 duration of teletherapy source 35.634(c) 223 12 2.676 3 years 35.634(f) 223 12 2.676 3 years 35.636(c) Included in 35.634(f) 3 years 35.641(c) Included in 35.634(f) license duration 35.647(c) 223 0.05 11 license duration TOTAL: 839.345 Total Agreement State licensee burden hours: 942.820 Total NRC and Agreement State licensee burden hours: 1,319,227 26
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| | |
| h SUPPORTIM STATDIENT FOR 10 CFR 35.32 and 35.33
| |
| " QUALITY NANAGDIENT PROGRAN AM MISADMINISTRATIONS" (3150-0171)
| |
| REVISS CLEARANCE EXTENSION INTRODUCTION Am OVERVIW NRC regulations in 10 CFR Part 35 establish requirements for the medical use of byproduct material. The regulations are issued pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended. This clearance extension addresses two provisions of 10 CFR Part 35: 1 (1) a requirement that licensees establish and maintain a quality management I program (QNP)(i 35.32) and (2) requirements for notifications, records, and f reports of misadministrations (1 35.33).
| |
| On December 24, 1991, the NRC submitted an information collection requirements (
| |
| (ICR) approval request to the Office of Management and Budget (ON8) for the Quality Management (QN) and Nisadministrations rule which would be effective in January 1992. In communications with ON8, the American College of Nuclear Physicians and Society of Nuclear Medicine (ACNP/SNN) expressed strong opposition to the rule. In June 1992, ON8 disapproved the record collection requirements of the rule. The NRC Commissioners, finding that public health and safety warranted institution of the ICR, overrode the CM8 determination.
| |
| In addition, the ACNP/SM took the NRC to court, in American Collene of l Nuclear Physicians and Society of Nuclear Medicine v. U.S. Nuclear Reaulatory l Commission. Only ten days after hearing arguments in the case, the court ruled in favor of the NRC, declaring that it saw 'no need for a published opinion." 976 F.2d 45 (D.C. Cir.1992)(Table). The court stated:
| |
| On the record before us, we find no basis to overturn the QM rule; accordingly, the petition for review is hereby denied, substantially for the reasons stated by the NRC in its rulemaking. The NRC, in promulgating the QN rule, acted within the bounds of its broad statutory mandate to establish "such standards ... as the Commission may deem necessary or desirable to ... protect health or to minimize danger to life and property." 42 U.S.C. I 2201(b) (West Supp. 1992) (emphasis added). Moreover, the substantive requirements imposed by the QN Rule are not ' arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.' 5 U.S.C. i 706(A) (1988).
| |
| ; In 1993, the MC contracted with the National Academy of Sciences (NAS),
| |
| ; Institute of Medicine (ION) to conduct an external review of the NRC's medical i regulatory program. The goal of the external review was to develop an
| |
| ! assessment of the adequacy and appropriateness of the current framework for 4 the medical use of byproduct material. The quality management program (QNP) l (i 35.32) and requirements for notifications, records, and reports of 5
| |
| misadministrations (f 35.33) were included in that study.
| |
| In a letter to ON8, dated Novembcr 28, 1995, the ACNP/SNN again requested that ON8 disapprove the ICR associated with 10 CFR 35.32 and 35.33 as they relate
| |
| | |
| l..
| |
| 1 b 2 to diagnostic and therapeutic applications of byproduct material.
| |
| a l In December 1995, the 10M submitted its report to the NRC. The majority l report ( W re was a dissenting opinion as well) was highly critical of NRC regulation in the medical area, and of the QM rule in particular. The 10M findings have been and are being considered within the agency-wide Strategic i Assessment and Re-baselining initiative. The staff is awaiting the Commission's direction on the medical use regulatory program.
| |
| ) In February 1996, the OMB approved a one-year extension of the information j collection provisions of NRC's QM rule rather than the three-year approval 4 that is customary. The one-year extension necessitated that NRC begin preparation of the 1997 OMB submittal within four-months of the previous 4 approval. The elapsed time was not sufficient to resolve the issues
| |
| ) associated with the prospective changes to NRC's medical use program.
| |
| 4 The Commission is seeking 0M8 approval of a three-year clearance extension to I allow sufficient time to consider what legislative and/or regulatory changes are appropriate for NRC's medical use program, i
| |
| I DESCRIPTION OF TE IN0RMATION COLLECTION In the medical use of byproduct material, there have been instances where byproduct material was not administered as intended or administered to a wrong
| |
| ! individual which resulted in unnecessary exposures to radiation, or i inadequate, or incorrect diagnostic or therapeutic procedures. N most i frequent causes of these incidents were: insufficient supervision, deficient procedures, failure to follow procedures, and inattention to detail. In an i effort to reduce the frequency of such events, the NRC requires licensees to 2 implement a QMP (l 35.32) to provide high confidence that byproduct material
| |
| } or radiation from byproduct material will be administered as directed by an j authorized user physician. In response to cosmients, the final rulemaking that i established these new requirements, which the agency believes are essential to i adequately protect the health and safety of the public, also minimized the j reporting burden. In the rulemaking, NRC also revised the definition for
| |
| ! " misadministration" in i 35.2, " Definitions," and distinguished between the "misadministrations" and lesser " recordable events' for which reporting to NRC is not necessary. hse revisions considerably reduced the number of incidents that must be reported to the NRC or the Agreement States. When l
| |
| compared to the previous definition, the number of incidents that meet the j
| |
| revised definition of misadministration has resulted in a greater than 10 fold reduction in the reporting burden. There has been a corresponding reduction
| |
| ; in the regulatory effort.
| |
| i
| |
| ; The cost for this rule was " front loaded," in that, all affected licensees were required to submit a QMP to be reviewed by the applicable regulatory agency. This implementation burden has been completed by current NRC licensees and 19 of the 29 States who have agreements with the NRC that allow
| |
| - them to regulate the use of byproduct material as Agreement States. However, i ten Agreement States have not completed their adoption of the rule.
| |
| Therefore, this ICR cost estimate reflects the one-time cost for the i development and submission of QMPs for approximately 2000 Agreement States i
| |
| 1
| |
| | |
| I l 3 l
| |
| ] licensees in those ten Agreement States. It should be noted that the i Commission is currently reviewing the issue of compatibility relative to the j 5 rule for the Agreement States. If relief is granted to the Agreement
| |
| ; States from certain QM rule compatibility requirements, the staff will submit j a modification of the burden estimate that reflects the changes.
| |
| l
| |
| ) A. AISTIFICATION 1
| |
| : 1. Haed for and Practical Utility of the Collection of Information l
| |
| In order to obtain a license issued pursuant to 10 CFR Part 35, medical applicants, who plan to use byproduct material in certain diagnostic and therapeutic ranges, must submit a QNP to provide high confidence that j byproduct material will be administered as directed by an authorized
| |
| ; user physician (f 35.32). The rulemaking and related regulatory guide I were developed to include generally accepted good practices in the j medical uses of byproduct material for therapy, and include specific
| |
| : measures intended to prevent many of the kinds of human errors observed j and reported to the NRC over a number of years.
| |
| 1 l In comments provided during rulemaaking, members of the Society of i Nuclear Medicine and NRC's Advisory Committee on the Medical Uses of i Isotopes indicated a belief that NRC medical use licensees already had procedures in place to assure that the administration of byproduct
| |
| ! material was as directed by an au h rized user physician. However, when j reviewed, 72 percent of the licensee-submitted QNPs did not contain such
| |
| ; procedures. The unexpected number of licensees that did not submit (nor i apparently have) procedures to assure that byproduct material is i administered as directed by an authorized user is an indication of the need for a Quality Management Rule.
| |
| l I The recordkeeping and reporting requirements of the quality management ,
| |
| rule serve a number of valuable functions. First, they provide I assurance both to the licensees and to the NRC that sound safety
| |
| , practices are being followed, and that licensees are taking appropriate 1 followup actions if and when mishaps occur. Second, they provide a basis for enforcement action by the NRC to correct safety deficiencies and take appropriate action against licensees and/or individuals if public health and safety is being endangered. Third, they furnish data j that can be used to adjust NRC regulatory standards generically to
| |
| ; ensure that they are sufficient to protect health and safety, but at the
| |
| ; same time not more burdensame than necessary. Fourth, they can reveal i generic problems of which the medical community can then be made aware
| |
| ! by NRC.
| |
| For the calculations required in this justification, the staff estimates i that 30 therapeutic misadministrations per year will be reported by NRC i licensees over the next 3 years. The staff bases this on the number of I such misadministrations reported by NRC licensees for years 1993, 1994, and 1995. Assuming that Agreement State licensees and NRC licensees i
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| i
| |
| | |
| i i
| |
| i 4 1
| |
| have similar medical use programs, and the Agreement States license 2.5 times as many licensees, the staff estimates that 105 (30+75) j misadministrations per year will be reported nationwide. Information on the recordkeeping and reporting requirements is described by specific l section below. l l
| |
| l Section 35.32(a) requires that medical use licensees, who use byproduct l material for limited diagnostic and therapy procedures, establish, j implement, and maintain a @P to provide high confidence that byproduct ,
| |
| material will be administered as directed by an authorized user l l physician. The SP must include written policies and procedures which !
| |
| i require that prior to certain administrations, a written directive is l prepared, that the individual's identity is verified by more than one j method, that final treatment plans, doses, and administrations are in accordance with the written directive, and that any unintended deviation from the directive is identifled, evaluated, and acted upon. At this time, all affected MC licensees have submitted a SP which has
| |
| : undergone an initial RC review, or have provided a negative declaration i that they will not utilize byproduct materials affected by the @P l requirements prior to the submission of a SP. New licensees, subject
| |
| ' to the requirements, must submit a written WP with their application.
| |
| Additionally, 2000 Agreement State licensees are expected to submit a i @P to the appropriate Agreement State within the next 3 years.
| |
| Licensee implementation and maintenance of their S P is reviewed during an NRC or Agreement State inspection.
| |
| I section 35.32(b)(1) requires licensees to develop procedures for and
| |
| : conduct a review of the @P including, since the last review, an
| |
| ! evaluation of a representative sample of administrations, all recordable ,
| |
| i events, and all misadministrat',ons. Reviews must be conducted at l i intervals no greater than 12 months. This is necessary to evaluate the l l effectiveness of the SP and identify issues that may lead to l modifications of the @P.
| |
| section 35.32(b)(2) requires licensees to evaluate SP reviews and make modifications, if required, to ensure their effectiveness.
| |
| i j section 35.32(b)(3) requires licensees to retain records of each annual review of the @P, including the evaluations and findings of the review, in an auditable form for 3 years. The existence of these reviews is confirmed during NRC inspection.
| |
| Section 35.32(c)(3) requires licensees to evaluate and respond to each j ' recordable event" by retaining a record of the relevant facts and s corrective action, in an auditable form for 3 years. This enables the j' licensee to identify error trends. It enables the inspector to evaluate the licensee's response to such errors.
| |
| j section 35.32(d) requires licensees to retain each written directive and 4
| |
| a record of each administration for 3 years after the date of the l
| |
| administration, to ensure that each administration was in accordance 4 with the written directive. A sample of the licensee's written l
| |
| | |
| i i
| |
| i 5 i
| |
| i directives is reviewed during an NRC inspection.
| |
| L i Section 35.32fe) requires the licensee to submit any voluntary
| |
| { modifications to the QNP to NRC within 30 days after the modification is made, to ensure that the modification does not decrease the effectiveness of the program.
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| )
| |
| i section 35.32ffifli requires each applicant for a new license to submit
| |
| ! a QNP to NRC as part of a license application to ensure that the new
| |
| : licensee will implement a QNP that will provide high confidence that i byproduct material will be administered as directed by the authorized j user physician.
| |
| Section 35.32ff)(2) required licensees in existence on January 27, 1992, to submit certification that a QM' had been implemented as well as a copy of the QNP to assure NRC that a QMP had been implemented. This
| |
| ; requirement has been satisfied.
| |
| ! Section 35.33fa)(1) requires licensees to notify NRC by telephone no
| |
| ! later than the next calendar day after discovery of a misadministration.
| |
| i This will enable NRC to promptly take any necessary actions based on the
| |
| ! ciretanstances.
| |
| Section 35.33falf2) requires licensees to submit a written report to NRC
| |
| { within 15 days of the discovery of a misadministration to provide NRC a j synopsis of the event, its cause(s), and corrective actions taken, and j to assure that all notifications were made.
| |
| 1 i section 35.33falf3) requires licensees to notify the referring physician
| |
| ]
| |
| and the individual sub,1ect to the misadministration no later than i 24 hours after discovery, or as soon as possible, if the patient or the referring physician can not be reached within 24 hours. Patients and their referring physician (s) need this information to make tin =ly j decisions regarding possible health care needs.
| |
| l section 35.33faif4) requires the licensee to furnish a written report of i
| |
| the misadministration to the patient, if the patient has been notified l orally of the misadministration, within 15 days of the discovery of the misadministration. To satisfy this requirement, the licensee may
| |
| ; provide the patient with either a copy of the report that was submitted i to NRC, or a description of both the event and any consequences that may l affect him/her. The description of the event must include a statement that the report submitted to NRC can be obtained from the licensee.
| |
| j section 35.33fb) requires the licensee to retain a record of the j misadministration for 5 years to ensure that the record is available for
| |
| ' the next NRC inspection so that NRC can ascertain whether j misadministrations have been investigated by the licensee and that i corrective action has been taken.
| |
| I i
| |
| j i
| |
| | |
| 1 l
| |
| l 3 -
| |
| i 6
| |
| l 2.
| |
| * m use of Infs. tion Quality Manaaement Procram (0MP) Recuirements: The reporting and record )
| |
| ) keeping requirements related to the QMP allow license reviewers to j deters ne if licensees have developed a systematic approach to providing
| |
| ; high confidence that byproduct material or the radiation therefrom will j be administered as requested by authorized users. In addition, it 1 enables inspectors to determine compliance with the requirement to j implement the QMP.
| |
| l Notifications. Raoorts. and Records of Misadministrations: The i notification, reporting and recordkeeping requirements ensure that the NRC is notified of significant events and that the patient and referring ,
| |
| physician are notified of the event. In addition, it allows the NRC to i determine whether to take any immediate actions, such as to conduct a 4
| |
| i special inspection of a licensee's facility or to alert other medical t use licensees, to prevent similar events which may have generic j implications. The recordkeeping requirements allow NRC inspectors to review misadministrations and other events that have occurred, including j any corrective action taken by the licensee.
| |
| I \
| |
| : 3. Reduction of Burden Throuah Information Technolony l h NRC has not received any electronic submittals of QMPs. However, licensees have submitted parts of misadministration reports electronically. Wre is no legal obstacle to the use of information j technology, and the NRC is developing processes that will soon assist licensees in doing so.
| |
| i i '
| |
| l 4. Effort to Identify Dunlication and Use similar Information 4
| |
| ~! There is no source for the information other than from the medical use licensees. The Information Requirements Control Automated System has j
| |
| : been searched. There is no duplication with other collections of l l inferisation.
| |
| l j 5. Effort to Reduce h il Business Burden In 1990, prior to the rulemaking, the NRC conducted a pilot program (0MB Clearance No. 3150-0145) to determine the impact and efficacy of the
| |
| ' proposed " Basic Quality Assurance program, Records and Reports of i
| |
| Misadministrations or Events Relating to the Medical Use of Byproduct Raterial." several participants of the pilot program were licensees in
| |
| . private practices. Following the 60-day test, they indicated that, with certain modifications, they could incorporate the proposed rule into their procedures of medical practice and that the impact would be
| |
| : minimal. The NRC will re-address this issue in the planned revision of
| |
| . 10 CFR part 35.
| |
| 4
| |
| )
| |
| | |
| 7
| |
| : 8. Canseeuences to Federal Proeram or Policy Activities if the Collect'on ,
| |
| is Not Conducted er is Conducted Less Frequently l If the collection is not conducted, there would be no assurance that I circianstances resulting in misadministrations, that endanger the health '
| |
| and safety of the general public, would be corrected. Under the current requirements, less frequent reporting is not possible for the following reasons:
| |
| 10 CFR 35.32: The requirement to develop and submit a QNP is a one-time effort which has been completed by all affected NRC licensees and approximately one-half of Agreement States licensees. Additionally, once a QNP that meets the rule is submitted, the frequency that licensees' QNPs are modified is determined by the licensee's need to modify the QNP to correct deficiencies in their own QNP program.
| |
| Therefore, the stated frequencies are at the minimum level.
| |
| l 10 CFR 35.33: Licensees are required to report misadministrations, by telephone, within 24 hours after discovery, followed by a written report within 15 days after discovery. The requiramient for one telephone call followed by a written report is the minimum frequency to inform the NRC about a misadministration so that any follow-up action can be taken.
| |
| : 7. Circiastances itilch Justify Variation from OfB Guidelines Contrary to the OMR Guidelines in 5 CFR 1320.6(b), Section 35.33 requires licensees to report misadministrations, by telephone, within 24 hours after discovery, followed by a written report within 15 days
| |
| ! after discovery. Since a risadministration may have health and safety implications for patients or research subjects, the NRC believes that 24-hour notification is important to assure that appropriate follow-up action is iemediately taken. The submittal of a report within 15 days i assures that the licensee has adequately investigated the event, identified appropriate corrective actions to prevent recurrence, and met applicable notification, recordkeeping, and reporting requirements. ;
| |
| : 8. Camsultations Outside IRC The qu rule has been reviewed as part of the NRC-sponsored independent review of the NRC's medical use program by the National Academy of Sciences. Additionally, a Congressional appropriations committee recounnended that NRC reconsider the ICR associated with this regulation.
| |
| * The NRC believes this concern will be satisfied through the ongoing review of the NRC medical use program which may include a revision of l
| |
| 10 CFR Part 35, including 10 CFR 35.32 and 33. This effort is expected to begin in 1997. Censultations and meetings with the medical community j are planned as part of that rulemaking.
| |
| | |
| i
| |
| !. i i
| |
| ; I l
| |
| l
| |
| ; 8
| |
| ! 9. Pant or Gift to Res;;e,trits i Not applicable. I
| |
| \
| |
| : 10. Confidentiality of Information l l
| |
| 1 None, except for proprietary information.
| |
| l
| |
| : l
| |
| ! l i 11, Justification for Sensitive Ouesting j
| |
| ' There are no sensitive questions.
| |
| : 12. Estimated Burden and Burden Hour Cost There are two primary considerations in the calculation of this burden:
| |
| First, the current number of medical use licensees in the United States is approximately 2000 for the NRC and 5000 for the Agreement States. Of those licensees that require submission of a QMP (approximately 90 percent or 6300 licensees), all of the applicable NRC licensees (1800) and an estimated 2500 of the Agreement State licensees have submitted a QMP to the appropriate regulatory agency. Therefore, it is estimated that 2000 Agreement State licensees will submit a QMP within the next 3 years.
| |
| Second, based on findings from a pilot program and discussions with medical licensees in multiple public meetings during promulgation of W rule, it was assumed that 90 percent of licensees, who must implement a QMF, will have policies and procedures (e.g., prepared to meet professional audit programs or Joint Commission on Accreditation of Healthcare Organization requirements) that could be adjusted, prepared, and submitted to the NRC to comply with the requirements. However, based en the NRC's experience in reviewing the 1800 QMPs submitted by MRC licensees, 72 percent of the submittals did not meet W requirements, and modifications were required. The NRC has included this unexpected and additional burden in this estimate for the development of the 2000 QMPs to be submitted by the Agreement State licensees to the appropriate Agreement State.
| |
| These public burden estimates are based on NRC data, collected during the past 4 years and on staff projections of new applications and amendment requests expected to be received during the next 3 years.
| |
| The estimates assume that the Agreement States w 11 implemer.t the rule exactly as has the NRC. Differences in Agreement State adoption or implementation would result in either greater or lesser burden. The average burden is calculated at the NRC labor cost rate of $120 per hour, which includes overhead. A burden breakout is included in Tab 13s 1 through 3.
| |
| | |
| l .
| |
| i 9
| |
| ! The followine will be the estimated ICR burden and burden hour cost fg the implemented rule:
| |
| i 1
| |
| l BMDEM FOR IRC LICENSEES:
| |
| Each year, the NRC receives approximately 63 new license applications,
| |
| ! and approximately 100 applications to amend existing licenses to add a i modality, that require the establishment and submittal of a QMP. Since the modification of an existing QMP to add a modality may range from a
| |
| - minor change to a major effort, the average burden is estimated to be 10 hours. Therefore: !
| |
| 63 licensees X 40 hrs (new licensees-develop QMP) = 2,520 hrs /yr 100 licensees X 10 hrs (add sodality-modify QMP) = 1,000 hrs /yr i 63 licensees X 4 hrs (develop review procedures) = 252 hrs /yr i
| |
| 163 licensees X 72% (require modification) =
| |
| 1 117 X 3 hrs (modify) = 351 hrs /yr L
| |
| i Burden and cost for new applicants and new modalities added in Inc States = 4.123 hrs /yr X $120 = 14 M.760 f
| |
| ! An estimated 15 percent of the 1800 licensees who have previously
| |
| ! submitted QMPs, will modify their existing QMP each year to increase the
| |
| ! program's efficiency. This does not include the burden for modification of new applications and applications to add a modality to an existing license that does not meet the requirements.
| |
| 1800 submitted QMPs X 15% = 270 modifications per yr 270 modifications X 3 hrs per licensee = 810 hrs /yr i
| |
| I Burden for IRC licensees to modify Wrs = 810 hrshr X $120 = 197.200 1
| |
| 1 8urden Associated with Motifications. Ranorts. and Records of Misahinistration:
| |
| BRC licensees reported an average of 30 misadministrations per year for years 1993 through 1995. The definitions for misadministrations focus en therapy events in which NRC frequently requests the services of a medical consultant to reviet: the event, and conducts reactive inspections. In calculatirs the burden for 10 CFR 35.33, the time
| |
| .; commitment for licensees to interact with these consultants and NRC i inspectors has been censidered. Therefore, this burden has been j
| |
| estimated to avnrage 14 hours per licensee, per event. Additionally, NRC estimates 15 minutes for notification of event discovery, 30 minutes for notification of referring physician and individual who received the misadministration, and 15 minutes f)r furnishing the report.
| |
| 30 misadministrations reported /yr X 17 hrs / event = 510 hrs /yr
| |
| | |
| 1 l
| |
| I 10 4
| |
| l Licensees must retain a record of a misadministration for 5 yrs:
| |
| 1 30 misadministrations X 10 minutes (to file record) = 5 hrs /yr i
| |
| i Based upon inspections of implemented QMPs to date,15 percent of NRC 3 licensees were found to have records of " recordable events" i (l 35.32(c)(3)) during inspection. Therefore, '
| |
| i
| |
| : 1800 X 15% = 270 " recordable events'/yr X 30 minutes l (to record) = 135 hrs /yr l 1
| |
| l Each of the 1800 NRC licensees must retain the records of the annual QMP review for 3 years:
| |
| ! 1800 X 1 hr/yr = 1,800 hrs /yr i
| |
| l Burden associated with notifications, reports, and records of 9 misadministration = 2.450 hrs /vr X $120 = 1294.000 1
| |
| j TOTAL m enem FOR 1RC LIc m rF1 = 7383 hrs /vr X 1120 = 1885.960/vr i
| |
| f
| |
| : BLEDEM FOR AGREDENT STATE LICDISEES:
| |
| i In order to estimate the burden to the Agreement State licensees, the f following assumptions were made:
| |
| j 1. Ninety percent of the 2000 Agreement State licensees will have
| |
| {
| |
| existing policies and procedures that could be adjusted, prepared, and submitted to the Agreement State to comply with the requirements of the rule. An average burden of 5 hours is estimated for preparation and submittal of a modified QMP.
| |
| : 2. Ten percent of the 2000 licensees will have to develop and submit a QMP. This will be a x.e-time bur:len of approximately 40 hours for each of the 200 licensees.
| |
| [
| |
| j 3. Based on the NRC's experience, 72 percent of the 2000 QMPs initially ,
| |
| 1 submitted to the Agreement States will require modifications to meet j the requirements of the rule. This will result in a burden of i
| |
| 3 hours each to modify the QMP for approximately 1440 licensees.
| |
| i
| |
| ' time bu-den te Aeroament State Li w.m for Initial tevel---- t.
| |
| 1, 6^ ittal (States
| |
| * will adoot the rule within next 3 years 1:
| |
| i Development of QMP by 10% of 2000 licensees = 200 licensees X 40 hrs = 8000 hrs annualized over 3 yrs = 2667 hrs /yr i
| |
| i
| |
| | |
| l' i
| |
| 11 l
| |
| ! Preparation and submittal of existing procedures:
| |
| l g05 X 2000 licensees = 1800, annualized over 3 yrs =
| |
| j 600 submittals X 5 hrs each for preparation and submittal - 3,000 hrs /yr
| |
| ! Based on the imC's experience, 72 percent of the @P j submittals will require modification:
| |
| 2000 licensees X 72% (require modification) 1440 annualized l over 3 yrs = 480 QMPs/yr that require modification.
| |
| l 480 submittals/yr X 3 hrs / submittal to make modification = 1,440 hrs /yr d
| |
| l Each of the 2000 licensees must also develop procedures for an annual j review of the QMP (4 hrs).
| |
| 2000 licensees annualized over 3 yrs 667 licensees /yr
| |
| ; 667 licensees /yr X 4 hrs to develop procedures
| |
| : for QMP review - 2,668 hrs /yr i
| |
| ) Agreement State licensees' burden = 9.775 hrsivr X 1120 =
| |
| 11.173.000 l Burden te llow Applicants - Agreement State:
| |
| I j Each year, the llRC *eceives approximately 63 new license applications,
| |
| ! and approximately 100 applications to amend existing licenses to add a
| |
| ! modality, that require the establishment and submittal of a QMP.
| |
| i Because the Agreement States have 2.5 times the number of licensees as i the IRC, it is estimated that an average of 158 applications for new
| |
| ! licenses and 250 applications to add new modalities to existing licenses will be received each year. Since the modification of an existing QMP i to add a modality may range from a minor change to a major effort, the j average burden is estimated to be 10 hours. Therefore:
| |
| 158 licensees X 40 hrs (now licensees-develop QMP) = 6,320 hrs /yr 250 licensees X 10 hrs (add modality - modify QMP) = 2,500 hrs /yr
| |
| : 158 licensees X 4 hrs (now licensees-develop review procedures) = 632 hrs /yr 408 licensees X 72% require modification =
| |
| ! 294 licensees X 3 hrs (modify) = 882 hrs /yr i
| |
| i Burden for new applicants and modalities j added in Agreement States = 10.334 hrsivr X $120 = 11.240.000 I
| |
| j j Burden for makine modifications to nreviously submitted GMP:
| |
| 4 i An estimated 15 percent of the 2500 licensees who have previously i submitted QMPs, will modify their existing QMP each year to increase the
| |
| ! program's efficiency. This does not include the burden for modification of new applications and applications to add a modality to an existing 1
| |
| | |
| i
| |
| ,a i
| |
| i 12 i
| |
| l license that do not meet the requirardents.
| |
| i
| |
| ! 2500 submitted QNPs X 15% (mod./yr)= 375 modifications /yr 375 mod./yr X 3 hrs (to make modification) = 1,125 hrs /yr l
| |
| l
| |
| ! Burden for Agreement State licensees te modify QMPs = 1,125 hrs /yr i
| |
| ; Burden Associated with Ilotifications. Reports. and Records of Risadministration:
| |
| The Agreement States have approximately 2.5 times the number of licenroes as the NRC. Additionally, the RC has no information to demonstrate that the frequency of incidents at Agreement State licensees i
| |
| is different than that of the NRC licensees. Therefore, for purposes of
| |
| : estimating the burden, based on an average of 30 misadministrations per I year for NRC licensees, the MC estimates 75 misadministrations per year j
| |
| for Agreement State licensees.
| |
| l The estimated burden to report a misadministration is 16 hours per 1 event. Additionally, NRC astimates 15 minutes for notification of event i'
| |
| discovery, 30 minutes for notification of referring physician and individual who received the misadministration, and 15 minutes for furnishing the report.
| |
| 75 misadministrations reported /yr X 17 hrs / event = 1,275 hrs /yr 75 misadministrations X 10 minutes (to file record) = 13 hrs /yr To date, based on inspection of NRC licensees,15 percent of Agreement State licensees, per year, will have records of recordable events l (1 35.32(c)(3)) during inspection: l 4500 X 15% = 675 675 records /yr X 30 minutes to make the record = 338 hrs /yr Each of the 4500 Agreement State licensees must evaluate and retain records of an annual QNP review for 3 years:
| |
| 4500 X 1 hr/yr - 4,500 hrs /yr Burden associated with motifications, reports, and records of misadministration - 6,125 hrs /yr X $120 = 1735.120 TOTAL BWDEM FOR AGREDEMf STATE LICENSEES =
| |
| 27.360 hrs /vr I 1120 = 13.283.200 Additional details on the reporting and recordkeeping burden are found in Tables 1 through 3 (attached)
| |
| | |
| I I
| |
| ; l i
| |
| i i 13 1 The total compliance burden estimate, for Inc and Agreement State licensees is l
| |
| . summarized below: l
| |
| ! )
| |
| i Naber of Total Annual Cost: )
| |
| ! Licensees Burden (hrs): ($120/hr)
| |
| ! who will
| |
| ; respond:
| |
| : Reporting: 6300 24,400 hrs /yr $2,928,000 i Recordkeeping: 10,343 hrs /yr 1,241,160 j Total Burden: 34.743 hrs /yr 14.169.160 i
| |
| i
| |
| : 13. Estimate of Other Additional Costs l
| |
| ! Not applicable.
| |
| l 4
| |
| ) 14. Estimate of Annua 11 zed Cost to the Federal Ceve.- : it 4
| |
| euality Ranagement Prosram (GMP)
| |
| All initial QMPs for NRC licensees have been submitted and reviewed.
| |
| Therefore, the continuing cost will be for the review of QMPs submitted l as part of new license applications, when additional therapy modalities
| |
| ; (e.g., brachytherapy, teletherapy) are added to an existing NRC license, s
| |
| i and within 30 days of modifying existing QMPs. The QMPs are reviewed as l part of the license application for new and amended licenses, and l modifications are reviewed at the time of inspection. The NR(, receives i l
| |
| l approximately 63 new applications per year and approximately 100
| |
| ; requests to amend existing licenses to add a modality. Additionally, i based on the number of QMP modifications submitted to the NRC in the i past year, it is estimated that 15 percent of licensees will modify
| |
| . their QMPs each year.
| |
| l Assuming 3 hours would be needed for the QMP review for 63 new licenses j and 100 amendments to add therapy modalities per year:
| |
| 3 hrs X 163 licensing actions /yr = 489 hrs /yr X $120 = 1 58.680/vr Asseing 2 hours would be needed to review a modification made to a
| |
| ) previously reviewed QMP and 270 (estimated 15 percent) modifications are
| |
| ; submitted by NRC licensees per year:
| |
| i i 2 hrs X 270 modifications /yr = 540 hrs /yr X $120 = 1 64.800/vr
| |
| | |
| l 1 .
| |
| 4 i' ,
| |
| i :
| |
| 14 l l
| |
| The engeing cost to the MC for review of WPs = !
| |
| 102g hrs /yr I $120 = $123.480/vr i l I
| |
| l Ratifications. Esports. and Records of Risakinistrations ;
| |
| 1 Based on statistical data, the staff estimates that 30 )
| |
| misadministrations per year will occur in MC States over the next 3 years. Assuming that an average of 80 hours of MC staff effort will i be required to respond to each event, the cost to the MC will be l $288,000 per year.
| |
| 1 i 80 hrs /misahinistration X 30 misadministrations/yr = 2400 hrs /yr l 2400 hrs /yr X $120/hr = 1288.000/vr I j h estimate includes time for the NRC Operations Center to respond i
| |
| to the original call, for W NRC staff to follow up with the action
| |
| : appropriate to the event (e.g., if needed, conduct an inspection, secure i medical consultant services, etc.), and review the written report l (submitted 15 days after h event was reported).
| |
| l Total annualized cost to the MC for all activities is estimated to be:
| |
| 1029. hrs + 2400 hrs = 3429 hrs I 1120 = 1411.4aD/vr h se costs are fully recovered through fee assessments to NRC licensees, pursuant to 10 CFR Parts 170 and 171.
| |
| t i
| |
| ; 15. Esasons for Change im Burden er Cost The following are the reasons for the most significant changes in the
| |
| ; burden estimate:
| |
| i 1. The increase in the cost from $116/hr in the previous submission to
| |
| ! $120/hr for the 1997 submission. l i 2. This estimate includes the one-time burden of the submission and review of the QNPs submitted by the approximately 2000 Agreement
| |
| {
| |
| State licensees in the 10 States that have not yet adopted the rule.
| |
| In the initial submission, it was assumed that the Agreement States j would implement the QM rule by January 1995. However, at the time i
| |
| of the 19M submittal, 13 of the 29 Agreement States had not as yet I adopted the rule. Since the earlier submission, an additional three
| |
| ; States, representing approximately 1000 licensses, have adopted the i 5 rule.
| |
| l 3. The estimated burden on the Agreement States' regulatory agencies,
| |
| ! previously included in this ICR, is now included in OMB Clearance j 3150-0183 " Office of State Programs Requests to Agreement States for
| |
| ; Information."
| |
| i 4. At the time of the 1996 submittal, the best data the MC possessed l
| |
| 11
| |
| .-,m, .-, . -- -
| |
| | |
| i 2
| |
| ! 15
| |
| . estimated the number of licensee reported events that met the l misadministration criteria as 25 misadministrations per year. Since
| |
| ; that time, an improvement in data collection and analysis has
| |
| ; increased that number to an average of 30 misadministrations per
| |
| ; year. The Agrecuent States have approximately 2.5 times as many i
| |
| licensees. Therefore, we estimate approximately 105 i misadministrations per year nationwide.
| |
| 1 16. Publication for Statistical Use l The imC tabulates and publishes an annual summary of misadministrations t and other events.
| |
| : 17. Reason for Ilot Displayine the Exniration Date i
| |
| j The requirement will be contained in a regulation. Amending the Code of i Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too j difficult to keep current.
| |
| i i
| |
| ; 18. Excestions to the Certification Statement There are no exceptions.
| |
| B. Collection of Information r==1 ovine statistical liethods
| |
| ; Statistical methods are not used in this collection of information.
| |
| 1
| |
| }
| |
| l 4
| |
| I l
| |
| i j
| |
| 1
| |
| | |
| 1 i*
| |
| 16
| |
| . Distributioni PDR
| |
| } DOCUMEN NAME: g:QM0MB.96 4
| |
| { To receive a copy of this document, indicato in the box: "C" = copy without
| |
| ; attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy l OFFICE IMA8 IMA8* IM08 OGC IRM i NAME SMerchant LWCamper JPiccone GFehst GFCranford j DATE 9/ /96 8/09/96 9/ /96 9/ /96 9/ /96 j OFFICIAL RECORD COPY t
| |
| i i
| |
| A t
| |
| i i
| |
| l 2
| |
| I l
| |
| | |
| Tahis 1 (AnnumEzadl Resortina Reauir --ts fl 35.321: (Assuming S M O licensees)
| |
| Hours Total Per Burden Cost at Section Item Event hrs /yr $120/hr i
| |
| 35.32(a) Licensees:
| |
| }
| |
| Aare== ant State fone time):
| |
| Develop and maintain a written QMP (includes submittal),
| |
| Approximately 67 licensees 40 hrs *2,667 $320,040 (200 11censees/3 yrs)
| |
| Submission of QMP (Submit existing procedures, :
| |
| 600 (90%) licensees (1800 licensees /3 years) 5 hrs *3,000 $360,000 NRC & Aareement State:
| |
| 221 new application QMPs 40 hrs 8,840 $1,060,800 350 amending license to 10 hrs 3,500 $420,000 add modality (submit QMP) i
| |
| | |
| Table 1 2 ,
| |
| ! 35.32(e)
| |
| ' Submit modification of QMP ;
| |
| within 30 days after modification is made:
| |
| (72% initial failure rate for ,
| |
| first time submittals) t Aare - nt State Licensees fone time): :
| |
| 72% of initial submittals = 3 hrs *l,440 $172,800 480 QMPs NRC Licensees: ?
| |
| Modify 72% of new and added I modality applications -117 3 hrs 351 $42,120 15% existing QMPS- 270 3 hrs 810 $97,200 ,
| |
| Aareement State Licensees:
| |
| Modify 72% of new and added "
| |
| modality applications - 294 3 hrs 882 $105,840 15% of existing QMPs - 375 3 hrs 1125 $135,000 ,
| |
| 35.32(f)(1) Submit a QMP to appropriate Included in ,
| |
| agency f 35.32(a)
| |
| Submit written certification Requirement 35.32(f)(2) complete l t
| |
| * One time burden for Agreement States that have yet to adopt the rule: 7,107 hrs /yr ,
| |
| l t
| |
| t Reporting Burden (f 35.32) per yr: 22.615 hrslyr X $ 120 = 12.713.800 i
| |
| i
| |
| | |
| Tatda 2 (AnnumEmed)
| |
| Resortine Remuir----.ts ft 35.33): (Assuming 105 misadministrations per yr)
| |
| Hours Total Per Burden Cost Section Item Event hrs /yr at $120/hr 35.33(a)(1) Notify NRC or Agreement State 15 min 26 hrs $3,150 by phone no later than the next calendar day after
| |
| : discovery of misadministration.
| |
| 35.33(a)(2) Licensee written report to 16 hrs 1,680 hrs $201,600 regulatory agency within 15 days after discovery of misadministration.
| |
| 35.33(a)(3) Licensee notification to 30 min 53 hrs $6,300 referring physician and individual who received the misadministration no later than 24 hours after discovery.
| |
| 35.33(a)(4) Licensee written report to 15 min 26 hrs $3,150 May be same !
| |
| patient within 15 days of misadministration. report as 35.33(a)(2) t above Reporting Burden (f 35.33) per yr: 1.785 hrs /vr X $120 = 1214.200
| |
| | |
| Tatdo 3 (AnnaanRzed) k cordkeenina burden (6 35.32): (Assuming 6300 licensees)
| |
| Hours Total Per Burden Cost at ,
| |
| Section Item Event hrs /yr $120/hr 35.32(b)(1) Licensees:
| |
| Develop procedures for review: ,
| |
| Aare== ant State lone-time):
| |
| 667 initial development 4 hrs "2,668 $320,160 NRC and Aareement State:
| |
| 221 New licensees /yr 4 hrs 884 $106,080 t
| |
| 35.32(b)(2) Licensees (6300 total):
| |
| Evaluate QMP reviews and make modifications, if needed: 50 min. 5,250 $630,000 Retain records of each 10 min. 1,050 $126,000 t 35.32(b)(3) l audit and management evaluation of the QMP for 3 years.
| |
| 35.32(c)(3) Retain record of relevant i facts and corrective j action relative to recordable l event, for 3 years. (945 30 min. 473 $56,760 records /yr) ;
| |
| Retain each written directive Historically, I 35.32(d) part of patient's and a record of each administration for 3 years, medical record.
| |
| Recordkeeping burden'(f 35.32) per yr: 10.325 hrs /yr X $120 = 11.239.000
| |
| *0ne-time burden for licenses of Agreement States that have yet to adopt the rule: 2,668 hrs /yr
| |
| * O Tatdo 4 (AnnumEzed)
| |
| Recordkeenina burden (E 35.33): (Assuming 105 misadministrations per yr)
| |
| Assumed Hours Total No. of Per Burden Cost at Section Item Events /yr Event hrs /yr $120/hr
| |
| __ _- - = = - - - - - - - - - = = - _ _ _ = - = - = -. ----- -------------======- -_ __------------
| |
| _ _ . _ _ _ _=_ __ __ _
| |
| 35.33(b) Licensee shall retain 105 10 min 18 hours $2160 a record of the misadministration for 5 years.
| |
| Recordkeeping burden (1 35.33) per yr: 18 hrs /yr X $120 =12160 i
| |
| t i
| |
| 4
| |
| | |
| , 1 Q.
| |
| '. UNITED STATES NUCLEAR REGULATORY COMMISSION RULES and REGULATIONS titts 10. cHArten 1. coos or recenAt neoutAtions - amenov l PART FEES FOR FACL.lTIES, MATERIALS, IMPORT AND EXPORT j
| |
| Q LICENSES AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED Oswan.u. Paortssoas see. _
| |
| OsssaAL Paovtstoms t 70.1 Purposa 1702 Seopa Aetherley: 3t u.S.C 9701: sec. 301. Pub. g ggg,3 p.,,,,a, 170.3 Desaitions L9 ,
| |
| D I" SUI 8 8"#$
| |
| 170 4 Interpretation & k ecc.2-314. esasStat.
| |
| 201. Se Stat 1242, amended222(42 (42
| |
| . fees U.S.CW2201w): for M see" Mn-170 5 Communicadona R U.S.C $441); sec. 205. Pub. L 101-$76.104 " d*f'd DI IA' 170.8 InAmmacon conectio. requirements. C Stal 2842.(31 U'S.C 902)'
| |
| es,cs appent w ' mission as authortsed under Title V of
| |
| !?0.18 Esempuana 3
| |
| * the Independent Offices Appropria-tion Act of 1961 (48 Stat. 390; 31 170.12 Payaient of feen 170.20 Arecese eoet per protes ional statr-L UA.C. 443a) and provisions resardins '
| |
| hour- ,their payroent.
| |
| Sensset.s or Fssa 170.21 Schedule of fe.e for production 170.2 Scope.
| |
| and uulisation taeniues. revsew of k Except for persons who apply for or standard referenced design app *
| |
| * hold the permits. licensee, or approv- i
| |
| *P*eial protecta. inspections. and E als esempted in i110.11. the resula- )
| |
| import and esport hcenen g Mons in this part apply to a person- I lM,31 $chedule of fees for malettals hcenses and I other reeula.ory services, including tospec- L.w, ho Is*
| |
| tm and import and export hcenses.
| |
| 110.33 scheeule of fees for health and safety, and esteewards insowuona for 7-s (a) An appucent for or holder of a matem licenses. ;; specifle byproduct material license W e issued pursuant to Porta 30 and 32 110.41 FnDure by appheast or licensee to g through 36 and 39 of this chapter.
| |
| par presermed fees. y ;
| |
| 110.s1 sucht to rettew and essent of pow-acreed fees -
| |
| (b) An aseHa==* for or holder of a speettle seures statertal liosase issued i pursuant to Part et of this chaptert (c) An appusant for er holder of a spec 4fic speelst nuclear una4ertal 11 eense laused pursuant to Part 10 of this chapter * .
| |
| (d) An appucent for or holder of spe.
| |
| 6 eifle approval of spent fuel enska and 14 shippins sentainess lasued pursuant to
| |
| & Part11 of this chapter, E (e) An appueant for or holder of a y speedfle lleense to pensens sewer rene.
| |
| ter Seelt h6el and other radioactive saaterials asseclated with spent fuel storage in an independent spent fuel storase instaliattaa lasued pursuant to Part 13 of this chapter, (f) An appucant for or holder of a specirle approval of sealed sources and devtoes containins byproduct material.
| |
| source matettal, or special nuclear ma-tertal:
| |
| 170 1 "t 22x 29,1996 a a a , a, m t-
| |
| | |
| - = - . - - -- . _ _ _ - - .
| |
| l 170,2(g) 170,3 -
| |
| PART 170 e FEES FOR FACILITIES, MATERIALS, IMPORT - j (3) An appbcent for of holder of e (o) Requesting preapphestion/ " Byproduct material" means an>
| |
| production or utilization facihty beensing review assistance by radioactive material iexcept speaa. l
| |
| , construction permit, operating hcense, consulting with the NRC and/or by fihng nuclear material) ytelded in or man 3 or manufacturing license issued fN prehminary analyses, documents. or radioactne by exposure to the radi-g purruant to Part 50 of this chapter, or en i reports. I''ation incident to the process of pro.
| |
| early site pemut, standard design z (p) An apphcant for or a holder of a % ducing or utilizing special nuclear ma-E certificat)on, or combined license issued 8 specific import or export hcense*Eissued tertal
| |
| ' Government agency" means any
| |
| [ pursuant to Part 52 of this chapter: pursuant to 10 CFR part 110
| |
| - (q) An Agreement State licensee who $ executive riepartment commission, in-(h) Required to have examinations files for or is holder of a general hcense dependent establishment, corporation, and tests performed to qualify or re- under the reciprocity provisions of 10 wholly or partly owned by the United qualify indsviduals as Part 55 reactor CFR 150'20' States of America which !J an instru-a operators; mentality of the United States, or any 2 (i) Required to have routine and - board, bureau, division, service, office, Knon routine safety and safeguards in. r officer, authority, administration, or aspections of activities licensed pursu. e other establishment in the executive
| |
| " ant to the requirements of this chap. Eg178J Donalteses, branch of the Government.
| |
| 18f' f As used in this part:
| |
| (j) Applying for or is holder of an B approval of a standard reference " High Ennched Uranium means design for a nuclear steam supply p p* uramum ennched to 20 Percent or
| |
| , system of balance of plant; a g greater in the isotope uranium-235 O Act means the Atomic Energy Act of I. k) Applying for of already has E 6 N sp(plied for review, under 10 CTR 5Part amen (dments thereto.1954 68 Stat. 919)includmgS any h 52, Appendix Q, of a facihty site pnot to $ L E the submission of an apphcation for a L ,,
| |
| E construction permit;
| |
| '- r " Human use" means the internal (1) Applying for or already has sp. E " Advanced reactor" means any or external administration of byprod-plied for review of a standardised Knuclear reactor concept other than uct, source, or special nuclear materi-spent fuel f acility design; or f ghtli water reactors and high tempera- al, or the radiation therefrom, to ture gas cooled reactors. human beings.
| |
| (m) Applying for or has applied for g since March 23, 1973, review of an g Indson orgonnotion means any
| |
| - commercial group, associatbn.
| |
| f, projects item under in this the category chapter that the of special Com- partnership or corporation wholly misalon completes or makes whether Agreement State means any State E owned or controlled by an Indian tnbe.
| |
| E cr not in conjunction with a license with which the Commission or the g Indson tnbe means any Indian tnbe, I application on file-or that may be E Atomic Energy Commission has entered g band. nation, or other organized group flied- or community of Indians recognized as (n) An applicant for or holder of a 11E Esubaection into an effective 274b of theagreement Act. under E eligible for the services provided by the cense, approval, determination, or j " Nonagreement State" means any other Secretary of the Interior because of their other authorisat&on lasued by the State. status as Indians.
| |
| r'a==ldaa pursuant to 10 CPR Part ,, Inspections" means:
| |
| -,8I * (1) Routine inspections designed to evaluate the licensee's activities within
| |
| " Application" means any request the context of the licensee having pri- I filed with the Commission for a mary responsibility for protection of l permit, license, approvrl, exemption, the public and environment, gi certificate, other permission, or for (2) Non routine LnJpections in re-g any other service, sponse or reaction to an incident, alle-g " Balance of plant" consists of the sation, followup to inspection deficien-cles or inspections to determine imple-B nmaining systems, components, and structures that comprise a complete mentation of safety lasues. A non rou-nuclear power plant and are not in. tine or reactive inspection has the cluded in the nuclear steam supply same purpose as the routine inspec-system. tion.
| |
| c h Low Ennched Uranium means e uranium enriched below 20 percent in
| |
| { the isotope uranium-235.
| |
| September 29,1995 170 2
| |
| | |
| . ._ _ _ ._. _ _ . _ _ _ . _ _ __ . 1, I
| |
| 4 170.3 170,3 PART 170 e FEES FOR FACILITIES, MATERIALS, IMPORT -
| |
| l
| |
| '~
| |
| "Manuf acturing license" means a
| |
| " Nuclear reactor" means an ap-
| |
| ["" 12l An) facihty cesigned or used for l
| |
| i n license pursuant to Appendix M of paratus, other than an atomic weapon. $ the separation of the isotopes of l O Part 60 of this chapter to manufacture deetsned or used to sustain nuclear fis- 2 piutomurn. except laboratory scale l ;; a nuclear power reactor (s) to be oper. sion in a self supporting chain reac e facihties designed or used for l e sted at sites not identified in the 11 tion. O 0; cense application. " Nuclear Steam Supply System"
| |
| * nperimental cnh cr or anah tica! purposes l
| |
| * consists of the reactor core reactor c%lant system, and related auxiliary L systems including the emergency core cooling system; decay heat removal system; and chemical volume and con- ,,,,
| |
| trol system. (3) Any facility designed or used for Moterials Ucense means a license, "Other production or utilisation the processms of irradiated materials facility" means a facility other than a containing speela! nuclear material
| |
| $ certincate, approval. registration, nuclear orotherreactorfoemlicensed by the Com*
| |
| of permission mission under the authority of section issued by the except:
| |
| (1) Laboratory scale facilities de-M NRCPursuant to the ulations in 10 103 or 104 of the Atomic Energy Act of signed or used for experimental or an-m m CFR parts 30,32 grou 36,39,40,61, 1984. as amended (the Act), and pursu* alytical purposes
| |
| * 5 70,71 and 72. ant to the provisions of Part 60 of this (11) Pacilities in which the only spe- I R chapter, cial nuclear materials contained in the j r "Part SS Reviews" as used in this irradiated material to be processed are
| |
| .,,, y Part means those services provided bF uranium enriched in the isotope U*
| |
| w the Commission to administer requali- and plutonium produced by the irra-g fication and replacement examina- dlation. if the matettal processed con.
| |
| - tions and tests for reactor operators 11* tains not more than 10" grams of plu-Nonprofit educationo/ institution censed pursuant to 10 CFR Part SS of tonium per gram of U* and has fis-means a public or nonprofit educational the Commission's regulations and em' sion product activity not in excess of institution whose pnmary function is ployed by Part 50 licensees. These 0.25 millicurie of fission products per services also include related items such gram of U*; and education, whose programs are l accredited by a nationally recognized '', og't$e ex inat'io and t ta co[ScId suan t a lleense i e
| |
| , accrediting agency or association. who " Person" as used in this part has under Parts 30 and 70 of this chapter.
| |
| M is legally authortred to provide a the same meaning as found in Parts n or eculvalent regulations of an Agree-30, 40, 50, and 10 of Title 10 of the C: ment State, for the receipt, possession.
| |
| l 6 program of organised instruction or
| |
| $ study, who provides an educational Code of Federal Regulations. ;; use. and transfer of irradiated special 1 program for which it awards academic " Power mactor" means a nuclear g nuclear material, which authorises the J reactor designed to produos electrical -
| |
| degrees. and whose educational or heat energy lleensed by the Com E on processing of theforirradiated a batch beats material the separation of 1 programs are available to the public- mission under the authority of section selected fission products and limits the 103 or subsection 104b of the Act and process batch to not more than 100
| |
| - pursuant to the provisions of grams of uranium enriched in the iso-I 80.31(b) or i 50.23 of this chapter. tope 236 and not more than 18 grams
| |
| " Production facility" means. of any other special nuclear materlat I I
| |
| ! (1) Any nuclear reactor designed or " Reference systems concept" l used primarily for the formation of means a concept that involves the plutonium or uranium Sta; or review of an entire facility design or l l
| |
| major fraction of a 1.dity design out- !
| |
| side of the context of a license applica- i tion. The standard design would bc referenced in subsequent license appil-l cations.
| |
| "Research reactor" means s' nu-clear reactor licensed by the Commis-slon under the authority of subsection
| |
| ~
| |
| 104c of the Act and pursuant to the provisions of I 50.21(c) of this chapter for operation at a thermal power level l of 10 messwatts or less, and which is not a testing facility as defined by paragraph (m) of this section.
| |
| (
| |
| l
| |
| \
| |
| ]
| |
| i ,
| |
| 170-3 September 29,1995
| |
| | |
| _ ~ . - _ . , , _ - - - - . - - . - . - . - . _ . . . , . .. -_ - -
| |
| 170.3 .
| |
| 170.8 -
| |
| PART 170 e FEES FOR FACILITIES, MATERIALS, IMPORT -
| |
| The phrase " review ls completed" Speciolpro}ects means those requests a.s used tri this part means that the Cronium enrJchment focshty means.
| |
| revten has been brought to an end. subnutted to the Commissics for review (1) Any facihty used for separating the '
| |
| b ason of uan for which fees are not otherwise isotopes of urantun ir enriching t"u pp, eert ficate 8Pecified in thf s chepter. Examples of uranium in the isotope 231 except exemption, or other form of permis: 8P*c!81Projects include, but are not !
| |
| i ston, or whether the application is g laboratory scale facilities designed or I limited to,lopical and other report . used for experimentalor analytical denied, withdrawn, suspended. or reviews, early site reviews, waste g" purposes only; or action on the application is postponed solidification facilities, toute approvals p (2) Any equipment or device. or by the applicant for shipment of radioactive materials, o important component part especially
| |
| " Sealed source" means any oy. and services provided to certify designed for this equipment or device.
| |
| product matertal that is encased in a capsule designed to prevent leakage or licensee, vendor, or other private capable of separating the isotopes of escape of the byproduct matertal' industry personnel as Instructors for uranium or enriching uranium in the Source material means. Part 55 reactor operators. As used in this isotope 231 0 (D Uranium or thortum, or any com. g Part, special projects does not include e bination w chemicalthereof, form; orin any physical or g roguests/repons submitted to the NRC:
| |
| n)In response to a Generic 14tter or "Utilisation facility" means any S (2) Oree which contain by welght f NRC Bulletin which dose not reouk tn e nuclear reactor other than one de-one. twentieth of one percent (0.05%) $ an amendment to the license.does not g sisned or used pnmarily g the fe or more of (D uranium (10 thorium. or result in the review of an alternate E oYefeq*ulo e t o evice dete (11D any combination thereof. Source material does not include special nu. method or reanatysis to meet the e by rule of the Commlaston to be a utt-
| |
| * "# "" #'I' requirements of tne Generic Istter, or
| |
| * Itzation facility within the purview of "Special nuclear material" does not involve an unreviewed safety subsection 11cc of the Act.
| |
| lasue- -
| |
| 1 Plutonium. uransum 233 urani respese M on E N@ed M ,
| |
| um enriched m the isotope 233 or in the Associate OEco Director level or the isotope 235. and any other matert. above) to resolve an identj!!ed safety, IIU la8apewieas, r.1 which the Commisalon. pursuant to safeguards or environmental issue, of to the provtalons of section 51 of the Act.
| |
| assist NRC in developing a rule, 2, the GmmissionEmpi as specificalsy no sn. authorised by determines to be special nuclear mate-MS WE Y8 8 8 o en ersung.
| |
| rtal but does not inellade source mate. *
| |
| * O terpreisuon of the meaning of the rtal; or gener6c letter. or bulletin; or (2) Any matertal arttheially enriched g resulaimns m this part by an omcar or (3) As a means of exchanging by any of the foresomg. but does not g employe, of the commiss.on other than information between industry a ersuen interpretanon by the Generet include source matertal. organizations and the NRC for the
| |
| - Counsel will be secoydsed to be bending purpose of supporting geeric upon the Comanssion regulatory improvements or efforts. .~
| |
| * 6 tro.5 Commun cat ons.
| |
| All cor mnications conump the repuleuun, in this par'shd bc g; addwssed to the Eser tiu Daeciur for
| |
| " Testing factitty" oneens a nucle- 6 Opceanons LES Nucles Resul.lur) at reactor Hoensed by tk C-m e Commission. Washington, DC 2o5M under the authority of subsection 104c ' Communications may be perW in of the Act and pursuant to the provt. 2 person at the Commission e off ces at sions of i 60 21(c) of this chapter for 212o L Street NW.. Washington. DC. or operation at: at 11555 Rnchille pike Rockville (1) A thermal power level in emoess Star)l.and 2 of 10 megawatts; or "
| |
| (2) A thermal power level in emoess
| |
| {g f ot megawatt,if the reactor is to oon-w tain: ,
| |
| $ (i) A circulatins loop through the $175A bdennesten esflection core in which the appilcant proposes registremonsa: 0MS epproval to conduct fuel experiments; or This part contains no information 111 x ental 1lty in the o colledlon requirements and therefore is core in excess of 16 square inches in E not subject to the requirements of the cross.section. 3 Paperwork iteduction Act of 1980 (44
| |
| .C. 3501 ef seq.).
| |
| September 29,1996 170-4
| |
| | |
| .._ . - . .- . ... - . - . . . -- ~ . . . -. ~_- - _ - - . _ .
| |
| i 110.11(a) 170.11(b) l PART 170 e FEES FOR FACILITIES, MATERIALS, IMPORT -
| |
| i a
| |
| pI !?6.18 Esempelses.
| |
| , (9) State-owned sesearch reactore used i B prirnerily for educational training and
| |
| ' sondesiac resserch purposes. For
| |
| = purposes of this exemption,the tonn
| |
| ! E sweearch reactormeans e nuclear seector 4
| |
| L h-l (1)le lica1eed by the Nuclear 1 I
| |
| Regulatory r--season under section
| |
| ! I 104c. of sne Atomic Beesgr Act of1954 i i tel No u=== reen itsease fecA 3 142 U.S4. 2134(c)) for eyesetion at a
| |
| * level of 10 esegewette or y T 8"ehai-Q i 2 (ii)H solloonsed for operation et e l l 9 3 thermal powerlevel or mese than 1 l megewett, does not contain- f
| |
| . L. (A) A circulating loop through the i core in which the licensee conducts fuel j (I) [ Deleted 56 FR 31472 I experimente; (2) (Detried M FR 314721 IB) Alhpsid fuelloedlag: cr j _
| |
| ICI Aa : ; - ;- - J facility la the core in excess of to aquere tsches la
| |
| .' (3)(Reservedi cross-section.
| |
| (4) A construction permit or beenes -
| |
| 4 epphed for by. or tsoued to, e non.profil i educational 6netitution for a production r- l or ut6hsetion facihty. other then a power I l
| |
| j reacter, or for the posseesion and use of k [10) Activities of the Commission l j byproduct meterial. source meterial. or S underteken pursuant to Part 75 of this i l
| |
| g special nuclear meternet.This enemption g chapter, solely for the purpose of
| |
| :: dose not apply to these byproduct. . Implementeuos of the US/XAEA rw eeurne er special nuctor meterial
| |
| * Seleguardo Agreement. l i
| |
| 2 heenees which evthertes:
| |
| g til Human use:
| |
| { i (ul Remunerated services to other til) [ Deleted % FR 31472.] l 1 perseae -
| |
| i INII (b) <!) The Commlee6en may, upon
| |
| ; "8N 88"N' **
| |
| * 8' applicauon by art laterceted pereen er i nestar motsetet et predeces conte 6 ming upon its own inattauve, erant auch es.
| |
| ; byproduct meterial. seeres meteriet, e' empuene from the reeutremente of speciel n.caur meiertek end G this part as is determines are auther.
| |
| ! (tvl Activt*6es performed under a 3 tend by law and are otherwtee la the
| |
| ! Covemment egency contract. g public interest.
| |
| ? " 6 (29 Applications for esempuen
| |
| "' M under thee paraeraph may inetude ee-(5) A construction permit license, uviues such me, eut not limited to, the 4
| |
| use of licensed materisse for educa.
| |
| J E (artincate of compliance, or other . penal or noneemmercial public dis-y PPli oit for h, or W % e plays or actentline ontlecuene.
| |
| E ,._.,i Mi,y ,",en" *" N. p in IDensied 43 FR 72101 i Il chasessuchfase. .
| |
| i h
| |
| khh hh k h
| |
| * in [ossens se Fa ie**31 i
| |
| iciloeirna a rm3 n l l
| |
| a i
| |
| )
| |
| i l
| |
| l, I
| |
| no.s sepumber as, was
| |
| | |
| 1 L12W 170.12(e) l I
| |
| PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT. . . .
| |
| l (2) Fees for applications for renewals (e) Approval fees (1) Fees for J 170.12 Payment of fees. that are subiect to the full cost of the apphcations for matenals approvals that
| |
| >b(e) Application fees. Each application review are payable upon notification by are not subject to full cost recovery of ~
| |
| ,for which a fee is prescribed shall be the Commission. Except for those costs the review must accompany the accompanied by a remittance in the full deferred before August 9.1991, as noted application when it is filed. Fees for amount of the fee. The NRC will not g in paragraphs (d)(3) and (d)(4) of this o, applications or preapplication issue a new license or amendment prior 8 section, the NRC intends to bill each @ consultations and reviews subject to the I to the receipt of the prescribed fee. All E applicant at quarterly intervals for all ~ full cost of the review are payable upon {
| |
| applicction fees will be charged R accumulated costs for each application E notification by the Commission. The i irrespective of the Commission's
| |
| * that the applicant has on file for S NRC intends to bill each apphcant at l disposition of the application or a Commission review until the review is quarterly intervals until the review is l withdrawal of the application. completed. Each bill will identify the completed. Each bill willidentify the j
| |
| - apphcations and the costs related to apphcations and the costs related to I l
| |
| (b) License fees. each. each.
| |
| (1) Fees for applications for matenals -
| |
| l licenses not subject to full cost reviews - (3) Costs for review of an application for renewal of a standard design (2M ne fuu cost obe*w for a
| |
| ; must accompany the apphcation when it standardized design approval or
| |
| > is filed. certification which have been deferred certificati n that has been deferred prior
| |
| ~ ,
| |
| pnor to the effective date of this final t the effective date of this final rule
| |
| -l2) Fees for applications for permits rule shall be paid as follows: The full must be paid by the holder of the design and licenses that are subject to fees cost of review for a renewed standard approval. the applicant for certification.
| |
| b: sed on the full cost of the reviews are design certification must be paid by the r he ' upp yi 8 d s gn a payable upon notification by the applicant for renewal or other entity , pp(ica nst o p, ,
| |
| ,s Commission. The NRC intends to bill supplying the design to an applicant for .
| |
| c mbined license issued under 10 CFR 1 each epplicant at quarterly intervals for a construction permit. combined license part 52. or operating license, as issued under 10 CFR part 52. or
| |
| : all accumulated costs for each m appropriate, in five (5) equal perating license. as appropnate. in five installments. An installment ,s i payable I' Commission apphcation thereviewappbcant has on file for until the review is g; (5) equal installments. An installment is a- payable each of the first five times the each of the first five times the completed. Each bill will identify the approved / certified design is referenced apphcations and costs related to each' 2 renewed certification is referenced in an m an apphcation for a construction
| |
| - "' apphcation for a construction permit. .
| |
| combined license, or operating license. permit. combined license issued under The applicant for renewal shall pay the 10 CFR part 52. or operating license. In (c) Amendment fees andother the case of a standard design
| |
| * requiredopprova/s. (1) Amendment fees installment. unless another entity is supplying the design to the applicant for certification the applicant for
| |
| , for materials licenses and approvals not certification shall pay the installment, subjrct to full cost reviewsJnust the construction permit, combined license, or operating license. in which unless another entity is supplying the
| |
| , accomp:ny the application when it is design to the applicant for the
| |
| ' filed, case the entity shall pay the installment.
| |
| If the design is not referenced, or if all construction permit, combined 1 cense, Z or operating license, in which case the (2) Fe:s for applicat'ons for license costs are not recovered. within fifteen amIndments, other required approvals years after the date of renewalof the y other entity shall pay the incilment.
| |
| certification, the applicant for renewal g (ii)(A)In the case of a desien which and r:quists for dismantling, decommissioning, and termination of shall pay the costs for the application g has been approved but not certified and lic;nsid cctivities that are subject to the for renewal, or remainder of ' hose costs, g for which no application for certification at that time. is pending. If the design is not full cost cf the review are payable upon referenced, or if all costs are not notification by the Commission. The (4) Costs for the review of an application for renewal of an early site recovered, within five years after the NRC intinds to bill each applicant at permit which have been deferred prior date of the preliminary design approval qu:rterly intervals for all accumulated t the effective date of this rule will (PDA) or the final design approval 0 costs for each application the applicant continue to be deferred as follows:The (FD A), the applicant shall pay the costa, 3 h:s on file for Commission review until holder of the renewed permit shall pay or temainder of those costs, at that time; the revixw is completed except for those (B)In the case of a design which has the applicable fees for the renewed O costs r:1: ting to amendment and other been appraved and for which an permit at the time an application for a ,
| |
| tpprovals for early site permits that construction permit or combined license application for certification is pending. I w:re deferred before August 9.1991, referencing the permit is filed. lf, at the no fees are due until after the ,
| |
| Thise costs will be billed in a deferred end of the renewal period of the permit, certification is granted. lf the design is mannir consistent with that addressed no facility application referencing the not referenced, or if all costs are not in piragraph (d)(4) of this section. Each early site permit has been docketed, the recovered, within fifteen years after the l bill willidentify the applications and permit holder shall pay any outstanding date of certification, the applicant shall
| |
| ,c,,osts related to each. fees for the permit. pay the costs, or remainder of those costa, at that time.
| |
| (C)In the case of a design for which a 7 [d) Renewolfees. certification has been granted,if the 4 design is not referenced, or if all costa i I are not recovered, within fifteen years I after the date of the certification, the k
| |
| L- applicant shall pay the costs for the review of the application, or remainder of those costs, at that time.
| |
| >(1) (Reserved 61 FR 16203.] ,,
| |
| April 30,1996 170 6 1
| |
| | |
| k
| |
| - 170.21
| |
| ' ' TML12(f) PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT...
| |
| [f) Special Project fees. Fees for i 170.20 Average cost per professional staff. hour, applications for special projects such as topical reports are based on the full cost M Fees for permits, licenses.
| |
| N of the review and are payable upon amendments, renewals, special projects, 6 notification by the Commission.The Part 55 requalincation and replacement e NRC intends to bill each applicant at exammations and tests, other required SCHEDLLE OF FEES g quarterly intervals until the review is n reviews, approvals, and inspections 4
| |
| completed. Each bill will identify the g under SS 170.21 and 170.31 that are applications and the costs related to - based upon the full costs for the review -
| |
| 2 or inspection will be calculated using each' $ 170.2t Schedule of fees for production I the following app licable Professional and utmastion facmtsea, review of etendard I. - e
| |
| . staff. hour rates: redener ced design approveh, specw
| |
| - Reactor Prograr (5170.21 s128 per p,oieces, inspecnons and import and export 4 b(g) Inspection fees. Fees for all Nucfe aterials and Nu. 51 0 p r inspections subject to full cost recovery clear Waste Program hour. >^pplicants foe construction permits, will be assessed on a per inspection 15170.31 Activities).
| |
| msnufacturing licenses, operating d
| |
| basis for completed inspections and are _
| |
| licenses, import and export licenses, approvals of facility standard reference j h payable, on a quarterlybasis, upon designs, requalification and replacement notification by the Commission. l a examinations for reactor operators, and E Inspection costs irclude preparation g time, time on site, and documentation b special projects and holders of time and any associated contractual c'c construction permits, licenses, and service costs, but exclude the time " other approvals shall pay fees for the involved in the processing and issuance
| |
| * following categories of services. ,
| |
| of a notice of violation or civil penalty.
| |
| ~
| |
| SCHEDUL.E OF FACIUTY FEES
| |
| , _ [see soowwas at and of tabul (h) Method ofpayment. Fee payments , , , . , l shall be made by check, draft, money ,
| |
| l crder or electronic fund transfer made -
| |
| I Q payable to the U.S. Nuclear Reguletory
| |
| :: Commission. Where specific paynn nt A.Nesser power messeer.
| |
| " instructions are provided on the bills to 4,,s swi ser conseussen penwt_ stes.ooo E applicants or licensees, payment should tany am Pomet coneswesen Fd con Pamet, cenemies usense, opees.
| |
| 8 be made accordingly, e.g., bills of $5.000 or more will normally indicate payment g wWiep.,,,,esusenes.
| |
| Dienstenne. FJ Con by electrome fund transfer. g Dee masonWie and Temmenen, omer Apareven.
| |
| - kupeesens* FW Cost.
| |
| (i) Part $$ nrview fees. The costs for ,
| |
| Part 55 review services will be subject e. siannwn necence Deemen to fees based on NRC time spent in M*as.
| |
| cdministering the examinations and Pro 6mnary Doegn Approves. Fines FA com
| |
| " tests that are generally given at the D***" A88'*** C'*****a h reactor site and any related centractual "N"
| |
| : c. 3,,, F c.,pn ,,n p.,ci,,,,
| |
| E costs. The costs also include related crocasFecae.,
| |
| 3 temsi such as preparing. reviewing, and ,
| |
| N 86.000 grading of the examinations and tests. @ Appecanon ser Conswuc%n corowucson PwmL opermine u. pwm4 .... FW com The NRC intends to bill the costs at ****
| |
| quarterly intervals to the l'censee E FW cost cmploying the operatore. 3 Arasa*asat.
| |
| t__
| |
| **a**el 0* mea *ne '
| |
| - -3 and Termnehon.
| |
| Omer Appresena.
| |
| Inspectons '. . - -- Fd ooet D. Manuiachtte Usense Assecamen St25.0co.
| |
| Preenewr Deepi Approval. F>el FA cost Oseen Approvel.
| |
| Arnenenese, menswei, omer Ap- Fd east pressia.
| |
| Wieposeene * .Fd essL (QF Anrilift 1946
| |
| | |
| . .. . . ~ . . -. .. - .. - -_ .- - - _ . .- .- -_-
| |
| 170.21 170.21 PART 170 e FEES FOR FACILITIES, MATERIALS, IMPORT .
| |
| r F=caty ce and type Of g,,,,,
| |
| r- 1
| |
| ' k E. Vrerewm Ennenmou Pieru 5 ,
| |
| 5
| |
| :7, t.
| |
| : p. Ae.ennes messiere Ass essmen her Coneeussen Perma $136.000 Earty see Pomet Consoucean FA Cost perma, comamme usense, cowes.
| |
| Dig usarus.
| |
| Amenenent, mer==41. ceer Ap- Fw oest N
| |
| meeeno== e -- Fw assi u o. oeer proacean ens uwenon N Feeney Asahcesan for Coneeucean Pernua , 3126.000, a: coneeucean Pwea. % u-u-
| |
| rw east eense.
| |
| 3 Anunenene meas et omer Ae- Fw cost n ee emosceane . . . . . . . . . . . . . . . . re coat M Produc' son et Ushaeton Fecely Permaneney Closed Co=n v.poseenee __, Fue es L 9ut H Rene=e w one neensommon E4- rw east emne.one nor a cear opowere.
| |
| l 1
| |
| l l
| |
| l
| |
| * ;;;--Mr 29,1995 170-8
| |
| | |
| - - -- - - - - - . - - - . . ~ . - , - - - - - ~ - - - . _ - --- .
| |
| l r10.21 170.21
| |
| - PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT -
| |
| . SCHEDULE OF FACluTY FEES-Continued (See footnotes at end of tabiel Fac*fy categones and type of fees Fees' 7 J.SpeaalPr o ens W end preappicesorWeconsing acWwetes fur Cost.
| |
| e - - - _ .
| |
| Fue Cost.
| |
| g inspectorss_ . . _ . ~. _ . . .
| |
| ,n L.
| |
| >K. trnport and export licenses:
| |
| Licenses for the import and export only of production and utduation facdities or the export only of components for production and utsidate fachties issued pursuant to 10 CFR Part 110:
| |
| : 1. Apphcabon for import or export of reactors and other fachties and exports of components whch rnust be reviewed by the Commessaoners and the Executive Branch, for example, actions under 10 CFR 110.40(b):
| |
| Applicabon.new license ..
| |
| $7,800 Amendment ...- $7,800
| |
| : 2. Apphcation for export of reactor and other components requiring Executive Branch review only, for example, those ac.
| |
| g tions under 10 CFR 110.41(a)(1H8):
| |
| "- Aplication-new license . $4,800 l
| |
| * Amendment - $4,800 l
| |
| : 3. Appication for export of components requinng foregn government assurances only:
| |
| Applicatiormew license : . $3,000 Amendment _ ..
| |
| $3,000
| |
| : 4. Apphcation for export of facihty components and equipment not requiring Commissioner review. Executive Branch re-view, or foreign government assurances:
| |
| Applicabon.new heense $1.200 l 51,200 i Amendment .
| |
| : 5. Minor amendment of any export or import Icense to extend the experation date, change domestic informahon, or make other revis#ons which do not require irw$epth analysis or review:
| |
| - Arnendment 5120
| |
| ' Fees wiu not be charged for orders issued by the Commission pursuant to $2.202 of this chapter or for amendmente resulting spectically from the requirements of these types of Comtrussion orders. Fees wdl be charged for approvals issued under a specific exemobon provision of the Commmsion's regulatione under Trtle 10 of the Code of Federal Regulations (e.g., $$50.12,73.5) and any other sectione now or hereafter in eflect r*0ertSees of whether the approval is in the form of a license amendment, letter of approval, safety evaluanon report, or other form. Fees for lloenees in this schedule that are irwtially issued for less than full power are based on review through the leeuence of a fuH power license (generacy full power is concedered 100 percent of the facdity*e fuH rated power). Thus, if a licensee received a low power license or a temporary hoenee for less than fun power and receives full power authority (by way of license amendment or otherwise), the total coste for the licones wid be determned through that penod aumoney is granted for full power operation. If a shagon arises in which the Commission de-termines that full operatin0 power for a partcular facihty should be less than 100 percent of fuH rated power, the total coste for the Icones will be at that determined lower operating power level and not at the 100 poveent capacity 8 fun oost fees wel be deternned based on the professional staff time and appropriate contractual support serviose expended. For appNcations curroney on Ale and for which fees are determanen bened on the fue cost expended for the review, he professional etsu hours expended for the review of the appliceton up to the effective date of the f'mal rule will be determned at the professional rates in e9ect at the time the servloe was provided. For moea appucanano cure on ik 'or which review costs have reached an apphcable fee manaNiahed by the June 20,1984, and July 2,1990, rules but are stel was reecf*.". through January corepiehon of me rev6ew, 29,1989, wel not be bined to the appheant. Any A 74 stafHiours expended above those ced the cost incurred after any W' mgeJanuary on or 30,1989, will be as- i esseed at the mare rana roses estabhehed by 517020, as appropriate, except lor topical reports whose ooste exceed $60,000. Costs which ex- i osed $60,000 for any topical report, amendment, revision or supplement to a topical report corripleted or under review from January 30,1989, trough August 8,1991, wiu not be tweed to the apphcant. Any professione! hours empended on or after August 9,1991, w6E be assessed at the aprec=Na rate masaN=hed in 617020. In no event wel the total review costs be less than twice the hourly rate shown ln $ 17020.
| |
| 'essestepe essmed by ets solisede se tem suites ele noswomene selser ens entspares ok enesome ey NHl: ter sie pweses of seules er af a esonese esegenk espee. i ese se oestamed guenquest sie sus tenu es eis esaus e answo see sie a megese esames se I in esepesies uWe ete Aeuses el fees, as eseW ester tapestesk sepleens er esteen ene me tuum eid som of one esense, espweises esposesse met seeue essa em essgeese se set to seessa a case.
| |
| * Fees wel not be eseessed for rocpsestehoposte submdted to the NRC:
| |
| : 1. In seaponse to a Geneste Laser er NRC SWAsen tiet elsee not seendt in en amendment to the hcense, does not result in the review of an al.
| |
| temene meSted er to snest Sie respdfonisses of See Generic Later, or slees feet involve an unreviewed selety seue;
| |
| : 2. In seaponse to an stepseet let See Assoasse Olene Doeoter level er above) to seeolve an idonelted estety, seleguarde, or environmental eeue, or to asset fWtC h develophts a nde, segndetery guide, policy sentement, geneste letter, or bussen; or
| |
| : 3. As a sneers of eschanging intermegen betiseen edustry organnatone end me NRC lor fue purpose of supporang generic regulatory im-psosomeres or econs.
| |
| 4 170-9 APri(30,1996
| |
| | |
| .- - . . . ~ - .. .- . . . . . - _ . . . . .. . . . . . - . . , - . . . .. .
| |
| .31 170.31 PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT-W 1
| |
| 0 I
| |
| 1 4
| |
| i 4
| |
| 4 I
| |
| i 1
| |
| 4 3 5170.31 Schecluie of fees for meteriale flooness and other segulatory servlees,
| |
| . Insiuding inspensione, and import and
| |
| : caport usenses.
| |
| , 5 Applicants for materials licenses, import and export liconees, and other regulatory services and holders of materials 11<==, or import and export licenses shall pay fees for the following categories of services. This schedule
| |
| , includes fees for health and safety and safeguards inspections where e cpplicable.
| |
| 3
| |
| .1 i SCHEDULE OF MATERIALS FEES j [See footnote = at end of table]
| |
| Category of rnatorials licenses and type of fees' Fee 2.8
| |
| : 1. Special r*r materiet:
| |
| A. Ucenses for postsesion and use of 200 grams or more of plutonasn in unsealed form or 350 grams or rnere of contamed t)-236 in uneenied form or 200 grams or more of 1.Nt33 in unseeied form. This includes e to terminate liconees as was es lloonees eushonzmg posecesion only:
| |
| Uoense, Renewel, Amendenent _.- _. . . Ftd Cost.
| |
| Inspeceans . . _ . -
| |
| . -. fur Cost.
| |
| B. Uoeness for receipt and storage of opent fuel at an independent spent fuel storage lnstanation OSFSI):
| |
| Ucense. Renewel, Amendment Fue Cost.
| |
| IrW . . . ... . . fur Cost.
| |
| April 30,1906 170-10
| |
| | |
| 170.31 170.31 PART 170 FEES FOR FACILITIES, MATERIALS, IMPORT-SCHEDULE OF MATERIALS FEES-Continued (See footnotes at end of table]
| |
| Category of rnatenals licenses and type of fees ' l Feeu C. Ucenses for possession and use of special nuclear matenal in sealed sources contained in devices used in industnal i measunng systems, including x. ray fluorescence analyzers:* l Appicaton--New iconse . . . .
| |
| :l$550.
| |
| Amendment ~ .i $300.
| |
| D. Att other special nuclear matenal hcenses, except hcenses authonzing special nuclear matenal in ur' sealed form in com.
| |
| tanabon that would constitute a critical quantity, as defined in g 150.11 of this chapter. for which the Icensee shad pay the ,
| |
| same fees as those for Category 1 A:'
| |
| ApphcatsorWNew iconse $600.
| |
| Amendment ..
| |
| 3290.
| |
| E. Lcenses for constructen and operaton of a urarnum ennchment facAty:
| |
| Appication .-
| |
| $125.000.
| |
| Ucones.Renewel Amendment fun Cost. i inspections _ . - -. .
| |
| . Fuf Cost.
| |
| : 2. Source materiet ,
| |
| A. (1) Ucenses for possession and use of source matenal in recovery operations such as milling, in-situ leaching. heep- !
| |
| leaching. refining uranium mill concentrates to uranium hexafluoride. ore buying stations, ion exchange facilities and in I t processing of ores contairnng source material for extraction or rnetals other than uranium or thorium, including Icenses au.
| |
| l thonzing the possesson of byproduct waste matenal (taihngs) from source matenas recovery operabons, as well as li-censes authonzing the possessco and maintenance of a facihty in a stan@y mode:
| |
| License. Renewal. Amendment Full Cost.
| |
| Inspections - - . . .
| |
| -. . Full Cost.
| |
| (2) Ucenses that authorize the receipt of byproduct matenal, as defined in Section 11e(2) of the Atomic Energy Act, from other persons for possession and disposal except those hcenses subrect to fees in Category 2.A. (1):
| |
| Fun Cost.
| |
| Lcense. renewal. amendment Inspections Full Cost.
| |
| l (3) Uconses that authonze the receipt of byproduct matenal. as defined in Section 11e(2) of the Atome Energy Act. from
| |
| ; a other persons for possessaon and disposal incidental to the disposal of the urarnum waste tashngs generated by the licens.
| |
| l ee's midlng operathone, except those hcenses suoject to the fees in Category 2.A. (1):
| |
| l
| |
| @- Ucense, renewel. amendment . . Fun Cost.
| |
| Fun Cost.
| |
| l E tr=r=%s - -
| |
| - B. Ucenses which authorize the possession, use and/or instaliaton of source material for shaeiding:
| |
| * Apparahan--New license $160. l
| |
| - . . . . . . S240. I Amendment C. As other source metertallicenses:
| |
| ApphcellorWNew license . . 32.800.
| |
| S420.
| |
| Amendment .
| |
| : 3. Byprodtet material. !
| |
| j A. Uoonees of broad scope for posseseson and use of tyyproduct material issued pursuant to Parts 30 and 33 of this chapter l for processing or menulacturing of items contairung tsyproduct rnsterial for commercisa estritxAson. l l ._ 33.000.
| |
| AnneeleNew ileense . . . .
| |
| . . 3660.
| |
| Amendment _. _ _ __ _ _ _ .
| |
| B. Other licenses for possession and use of byproduct matenal issued pursuant to Part 30 of this chapter for processing or manutectaring of items containmg byproduct matenal for w,w.ede dietnbut ort
| |
| $1.200.
| |
| y L licenoe _. _ .. -
| |
| _ . 3580.
| |
| Amendment _.
| |
| C. Ucensee leeued pursuant to H32.72,32.73, and/or 32.74 of this chapter authorizing the processing or manufacturing and dietnbubon or reestreaution of redopharmaceuticals, generators, reagent Idts and/or sources and dowces contastung by.
| |
| product materiet . 54,100.
| |
| api *aharwNew Iconee l Ss20.
| |
| ! Amendment _
| |
| ! D. Ucenses and apprownia leeued pursuant to H 32.72. 32.73, and/or 32.74 of this chapter authorizing distributon or redie-tnbuton of redlopharmaceuticais, generators reagent Idts and/or sources or dowces not invoMng processang of byproduct material. 31,500.
| |
| Affar ahrwwNew leonee -- . . -
| |
| .- _. $430.
| |
| Amendment . _- . ..
| |
| E. Ucenses for possessen and use of byproduct material in sealed sources for irradletion of materials in which the source le not removed from lie ehleid (self-shielded units): _.. 51,200.
| |
| ArnicanarHNew Icense ..
| |
| 3360.
| |
| Amendment F. Ucenses lor paaaaa=ian and use of less then 10,000 curtes of byproduct material in seeied sources for irredemon of male.
| |
| l riels in which the source is exposed for irradistic1, purposes. This category also includes underwater irrarentars for irredle-tion of motortels where the source is not e=pasad for irradiabon purposes.
| |
| I
| |
| - . - 51.500.
| |
| AppilcaelorwNew lecense _ 3370.
| |
| Amendment - _ . _
| |
| G. Uoonees for paamaanian and use of 10.000 curies or more of byproduct memorial in seeied sources for irredenon of mate.
| |
| tiets in which the source is esposed for irradation purposes. This category also includes underweler irredators for irrede-I tion of meterials where the source is not evraamd for irradiaton purposes
| |
| - 36.000.
| |
| ApphcaterWNewlicense -
| |
| S780.
| |
| Amendment .
| |
| 170 11 April 30,1996 t
| |
| | |
| ~ . . - - - _ _ _ _ - - - _ _ . _ . . - .~_. . - --._ .. _ _-
| |
| .M . m .m PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT.-
| |
| SCHEDULE OF MATERIALS FEES-Continued (See footnotes at end of tabiel Category of matenais beenses and type of fees
| |
| * l Feex J H. Licenses issued pursuant to Subpart A of Part 32 of this chapter to distnbute items cornaining byproduct matenal that re.
| |
| quire device review to persorts exempt from the licensing requirements of Part 30 of this chapter, except specife licenses authonzing reestnbution of items that have been authonzed for distnbution to persons exempt from the Icensing require-rnents of Part 30 of this chapter:
| |
| ApplicatiorwNew license --
| |
| $2,400.
| |
| Amendment . . ..
| |
| - $1.000.
| |
| : l. Licenses issued pursuant to Subpart A of Part 32 of this chapter to dstnbute items containin0 byproduct material or quark titas of byproduct matenal that do not require devce evaluation to persons exempt from the licensing requirements of Part 30 of this chapter. except for specific licenses authonzing redstnbution of items that have been authorized for distribution to persons exempt from the Icensing requirements of Part 30 of this chapter ApphcatiorwNew license $4.400.
| |
| Arnendinent ._ . .
| |
| $860.
| |
| J. Licenses issued pursuant to Subpart 8 of Part 32 of this chapter to dstnbute stems containeng byproduct material that re-quire sealed source and/or devee review to persons generally licensed under Part 31 of this chapter, except specific li.
| |
| censes authonzing redstnbution of items that have been authon2ed for distnbution to persons generally licensed under Part 31 of this chapter:
| |
| ApphcatiorwNew license .. $1,600.
| |
| Arnendment ._
| |
| $290.
| |
| i K. Ucenses issued pursuant to Subpart B of Part 32 of this chapter to distribute items containing byproduct material or quark l titits of byproduct rnatenal that do not require sealed source and/or device review to persons generally licensed under Part 31 of this chapter, except specirc licenses authorizing redistnbution of items that have been authorized for distribution to persons generalty licensed under Part 31 of this chapter:
| |
| ApphcatiorwNew license .... $1,300.
| |
| Amendment . ~ _.. -
| |
| .. . S310.
| |
| L Lcenses of broad scope 'or possession and use of byproduct materialissued pesuant to Parts 30 and 33 of this chapter for research and development that do not authonte commercial distnbution:
| |
| Appicatiord-New license .. $4.300.
| |
| Arnendment -_ .. . . . _ .
| |
| $660.
| |
| ! M. Other licenses for possession and use of byproduct matenal issued pursuant to Part 30 of this chapter for research and l development that do not authorL2e commercial distnbutson: l
| |
| : l. AppicatiorwNew icense -. _ $1.500.
| |
| Amendment . 8610.
| |
| N. Licenses that authorize services for other Icensees. except:
| |
| (1) Lcenses that authorize only calibration and/or )eak teseng services are subject to the fees specined in fee Category 3P; and (2) Licenses that authorizarweste diafmaal sonnees are s$ect to the fees specified in fee Categories 4A. 48 and 4C:
| |
| Awe---h. license . _.. _ 81.900.
| |
| Amendment ~. . - . ~_ 8600.
| |
| O. Licenses for possession and use of byproduct material issued pursuant to Part 34 of this chapter for inchetnel radoorn-phy operatione:
| |
| Apf*enarWNew license -. ._ _._ _ 83.900.
| |
| Amendment .. ... -
| |
| 8720.
| |
| 3 P. All other spoorc byproduct matenal licenses, except those in Calogones 4 A through 90:
| |
| 'l ApplicatiorwNew license ._ $650.
| |
| : Amendment _ - - _. _. $300.
| |
| a 4. Wtsu deposal and processing:
| |
| l A. Licenses specifically authortzin0 the receipt of waste byproduct material, source matettal, or special nuclear material from j
| |
| other persons for the purpose of we, .v wy storage os commercial land disposal by the licensee; or licenses authorizing contingency storage of low 4evel ramaartive waste at the alte of nuclear power reactors; or licenses for receipt of weets from other persons for incineration or other treatment. packaging of resultang waste and residues, and transfer of packages i to another person authorized to receive or espose of waste motorial: 1 License. renewal amendment , . . . _ --
| |
| . Fue Cost. !
| |
| Inspections _ . .
| |
| ~. . Fui Cost. 1 B. Ucenses specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from i other persons for the purpose of packaging or repackaging the material The rcensee will depose of the material by trans-ut to another person authorized to receive or dispose of the material:
| |
| AppicatiorwNew license .... . $3.400.
| |
| Amendment .. . . - - - S410.
| |
| C. Licenses specifica9y authorizing the receipt of prepackaged waste byproduct material. source rnatorial, or special nuclear rnatorial from other persons. The licensee wiH dispose of the material oy transfer to another person authorized to receive or depoS4 of the material:
| |
| AppicatsorWNew license ... _ 81.700.
| |
| Amendment . __ . 3290.
| |
| : 5. Wzit logging:
| |
| A. Licenses for possession and use of byproduct material, source matenal, and/or special nuclear rnatorial for weR lo00ing, wed surveys, and tracer studies other than field flooding tracer studies:
| |
| Appicatsor>New license -
| |
| . 33,200.
| |
| i Amendment - --
| |
| .. $640.
| |
| B. Licenses for possession and use of byproduct material for Seid flooding tracer studies:
| |
| License, renewal, amendment . Fue Cost.
| |
| : 6. Nuclear laundnes:
| |
| l AprH 30,1996 170-12 1
| |
| | |
| _-- _ - _ _ _ ~ _ . _ _ __ _ . . _ _ _ . _ . _ _ _ __ ._.
| |
| 4 17031
| |
| : l'1031 PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT-i SCHEDULE OF MATERIALS FEES-Continued (See footnotes at end of table]
| |
| 4 Category of rnatorials licenses and type of fees i Feeu 5 A. Licenses for cornmere al collection and laundry of items contammated with byproduct matenal. source matenal, or special nuclear matenat Apphcatron-New iconse . . SS.100.
| |
| Amondment - $790
| |
| ' 7. Human use of byproduct. source or specal nuclear instenal:
| |
| A. Licentes issued pursuant to Parts 30. 35. 40 and 70 of ttns chapter for human use of byproduct matenal. source mate- l
| |
| {
| |
| nat. or special nuclear meterial in sealed sources contained in teletherapy devices:
| |
| ) $2.800.
| |
| Af.m,eucrAc license Amendment .. .- $470
| |
| }
| |
| B. Licenses of broad scope issued to medical inetstubons or two or more physicians pursuant to Parts 30. 33. 35. 40, and 70 of this chapter authorizing research and development. including human use of byproduct matenal. except licenses for by-l product meterial. source rnsterial, or special nuclear matenal in sealed sources contained in teletherapy devces:
| |
| ApphcotiorWNew license . __.
| |
| - $3.000.
| |
| ; Amendment .. _ ... .
| |
| .x $580.
| |
| C. Other Hoenees leeued pursuant to Ports 30. 35,40. and 70 of this chapter for human use of byproduct matenal, source 4 meterial. and/or special nuclear meterial, except licenses for bypro&ct meterial, source material. or special nuclear mate.
| |
| ; rial in sealed sources contamed in teletherapy devices:
| |
| S t ,400.
| |
| i Amicatior>--New Iconee _.
| |
| 4 Amendment . . . _ .
| |
| - $440.
| |
| ; 8. Civil defense:
| |
| 6 A. Licenses ir possession and use of byproduct material, source meterial, or speoal nuclear matenal for civil defense activi-l ties:
| |
| 9 Appicatiord-New license .
| |
| $760.
| |
| Amendment $350.
| |
| : 9. Device, product, or sealed source safety evaluat>on:
| |
| A. Safety evaluabon of devices or products contain ng byproduct material, source matenal. or special nuclear rnatenal, es.
| |
| cept reactor fuel devices, for commercial dstnbution:
| |
| $3.400.
| |
| 1 Appication-each device ._ . . . . . . . _
| |
| Amendment-each device $1.200.
| |
| 8 B. Safety evalustson of devees or products contaltung byproduct meterial, source material, or speoal nuclear rnatenal manu-Q factured m accordance with the unique specifica' ions of, and for use by, a single app 6 cant, except reactor fuel devices.
| |
| S t .700.
| |
| ; y AMha*>--each device - se00.
| |
| w Amendment-esch device .~
| |
| ~
| |
| E C. Safety evelueton of seeied sources contaming byproduct rnatenal. source motortel, or special nuclear rnsterial, except re-l actor fuel, tor commerclei sSetrmubon.
| |
| Appiloemor>-each sauce - __ _ _ _ . . . 8720.
| |
| Amenenere.-eech source . _ . . _ . . s240.
| |
| 1 j D. Safety eveiusson of seeied sources corneining byproduct mannel. source menries, or specisa nudear material. manufac.
| |
| . tured in accordance wlm me unique specsHeabone of, and for use by. e single appicant, except reactor fust 3360.
| |
| i U1 d. source . _- .
| |
| $120.
| |
| i Amending - 2 source _..m..
| |
| ; 10. Transportston of redoective meteriet 1 A. Evalueton of caska, pedoese, and shipping contamers:
| |
| Full Cost.
| |
| i Approval. Renswel. Amendment _ . . _ . _ . .
| |
| FuH Coet, i- Inspecuens . . ~- _
| |
| j B. Evalumuon of 10 CFR Part 71 quelley ensurance programs
| |
| ^ ^ _ . _ . . 3340.
| |
| : u # -6. . . . . .
| |
| .. s250.
| |
| ! Amendment ._ .. ..
| |
| Fun Cost.
| |
| Inspeceans _ ..
| |
| : 11. Review of standentred spent fuel facetes Full Cost.
| |
| Approval.Renswel. Amendment .
| |
| Inspections . - . - . . . .
| |
| - -- Fun Cost.
| |
| ' 12. Special projecto-o
| |
| . Full Cost.
| |
| Approvais and pr=m*=mvheenemo actrvines .
| |
| j . . . Fun Cost.
| |
| inspeceans _
| |
| : 13. A. Spent fuel storage cask Certlecolo of Comphence
| |
| . . _ . _ . . . . Full Cost.
| |
| Approvais i
| |
| Amendmente,revisons and ogpiements .
| |
| - - . . . . FudCool
| |
| .. Fuu Cost.
| |
| 4 Reapprover _
| |
| ; B. Inspectons veinted to apont fust storage comic
| |
| -. Full Cost.
| |
| ' Certilcate of CoriglGence _
| |
| .. Fun Cost.
| |
| C. Inspecdone reisted to storage of spent fuel under $72.210 of mis chapter .
| |
| j 14. Byproduct, source, or special nucteer material Boonees and omer approvels authorizing decommiseaoning, decontarninetlon.
| |
| fedemedon.or elle restoreson advtNes pursuant to 10 CFR Parte 30. 40. 70, and 72 of this chapter-
| |
| _ __ Fun Coet.
| |
| Approval.Renewel. Amendment _ __ _._
| |
| Fun Cost.
| |
| It'af=%e
| |
| . . _ ~
| |
| : 16. Irgort and Emport unenses.
| |
| 4 j
| |
| l 170 13 Apd 30,1996
| |
| | |
| D0.M 01 PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT-SCHEDULE OF MATERIALS FEES-Continued (Saa Sotnotes at end of tabiel ,
| |
| l Feel 2 l Category of matenals licenses and type of fees '
| |
| Ucanses issued pursuant to 10 CFR Part 110 of tNs chapter for the import and export only of special nuclear matenal, source material, tnbum and other byproduct malenal, heavy water, or nuclear grade grapNte:
| |
| A. Apphcation for export or irnport of Ngh enriched uranium and other matenals, including radioactive waste, which must be revewed by the Comenssioners and the Executive Branch, for example, those actions under to CFR t10.40(b). This cat-egory includes application for export or ernport of radeoactwo wastes in muttiple forms from multiple generators or brokers in the exporting country and/or going to multiple treatment, storage or disposal facihties in one or more recerwng countnes:
| |
| $7,800.
| |
| Apphcatiorwnew icense . $7,800. 1 Amendment - '
| |
| B. Apphcation for export or import of special nuclear matenal, source matenal, tntium and other byproduct . venal, heavy water, or nuclear grade graphite including radioactive waste, requinng Executwe Branch review but not Comenssoner re view. TNs category includes apphcation for the export or import of radioactive waste involving a single form of waste ' rom l a single class of generator in the exporting country to a single treatment, storage and/or disposal facility in the receiving
| |
| ? country $4,800. i Apphcau-new heense _ $4,800. J
| |
| ; Arnendment _-
| |
| C. Apphcanon for export of roubne reloads of low ennched uranium reactor fuel and exports of source materal requinng only foreign governtnent assurances under the Atornic Energy Act: $3,000.
| |
| Apphcat orsnew heense . . . . .
| |
| $3,000.
| |
| Amendment _ .
| |
| D. Appleation for export or import of other matenals including radioactwe waste. not requinng Commissioner review, Execu-trve Branch review, or foreign government assurances under the Atome Energy Act. TNs category includes app 6 cation for export or import of radioactwo waste where the NRC has previously authonzed the export or import of the same form of waste to or from the same or srmdar parties, requinng only conbrmation from the recewing facility and licensing authorities that the sh pments may proceed according to previously agreed understandings and procedures:
| |
| $1,200. i Appicatior+new heense . $1,200. I Amendment . _
| |
| E. %nor amendment of any export or irrport license to extend the expiration date, change domestic information, or make
| |
| ' other revisions which do not require in-depth analysts, review, or consultat ons with other agencies or foreign govemments:
| |
| . 3120.
| |
| Amendment
| |
| : 10. Reciprocity:
| |
| Agreement State Icensees who corwiuct activities in a non-Agreement State under the reciprocity provisione of 10 CFR t 50.20: $1,100.
| |
| Apphcahon (inibal filing of Form 2# 1) .
| |
| "" .. $200.
| |
| Revisions ,
| |
| $ Typse of Asse-Separes da.T,d, as shown in the schedule, will be assessed for preapphcahon consultatione and reviews and apptcebons for new kcensee and apprt,vels, leeuence of new licenses and approvane, amendments and certain renewebe to saletng Icensee and approvale, safety evaluations of seelec sources and devices, and certain instweans. The fullowing guidelinee apply to these charges.
| |
| (a) AaP 8e=*an Ases. Appkleotions for new materials beenees and ovals; appications to reenetste expired, termmeted or inactive hcenses and approvale exmpt thces ammet to fees assessed at fue costs, apphcations filed by Agreement State toeneses t t register under the gere oral hcense provisions of 10 CFR 15020, must be accompanied by the presenbod application fee for each , except fhet (1) Appheations for licenses covering more than one fee category of specal nuclear matenal or source must be accompanied by the preecnbod afWahan fee for the highest fee category; and (2) Appilcohone for umnees under Category 1E must be accompanied by the presenbod aff irahan fee of $125,000.
| |
| maan consultations and reviews subject J (b) L&g-;-C.t Aon. Fees for appications for new heenses and approvale and for pra to fut cost sees (fee Categories 1 A.1B,1E,2A. 4A,58,10A,11,12,13A. and 14) are due upon con by the Commission in accordance i l
| |
| wNh 9170.12(b), (e), and U).
| |
| (c) Mene al fees. Applications sub t ect to full cost fees (fee Categories 1 A,18,1E,2A,4A,58,10A,11,13A, and 14) are due upon notmcanon by the ' in accordance with $ 170.12(d).
| |
| (d) AmenenerWRevision Fees. '
| |
| (1) Applications for amendments to hcenses and apprwals and revisions to reciprocity initial apphcatione, ex those sub6ect to fees as-eessed at fun costs, rnuet be accomperwed by the presenbod amendment / revision fee for each heense/revleion . An appNce60n for an arnendment to a licones or approval cieserted in more than one fee category rnust be accormperwed by the prescribed amendment fee for the ca effected by the amendment uniese the amendment le apphcable to two or more fee categories in which case the amendment fee for the fee category would apply. For those licensee and approvais subpct to full costs (fee Categor6es 1 A,18,1E,2A,4A,58,10A,11,12, 1 , and 14), amendment fees are due upon nohflcation by tie Comm6ssion in accordance with $ 170.12(c).
| |
| I that would place the Econee or approval in a higher fee category or add a (2) An armaceman for amendment to a materials hcense or fee for the new category.
| |
| new fee category must be accorganied by the prescribed (3) An arWW for amenenent to a license or approval that would reduce the scope of a hcensee's program to a lower fee category must be accormpermed by the prescreed amendment fee for the lower fee category.
| |
| (4) Afr raHans u to terminate liconees authorizing emed meterlate programs, when no dismanthng or decontamination procedure le required, are not subject to fees.
| |
| (1) frvardan fees. Irmemedans resul6ng from invesbgebone conducted by the Office of Investigatione and nonroutine inspections that result from third party asegations are not subject to fees. The fees assessed at full cost will be determined bened on the profesesonal staff time re-quired to conduct the insparman muthphed by the rate estabhshed under 9170.20 plus any ) appl 6 cable contractuel support servic Inspechon fees are due upon notificahon by the Commession in accordance with $ 170.12(g .
| |
| a Fees wel not be charged tot ordere leeued by the Commiseson pursuant to 10 CFR 2.202 or for amendmente resultirig specificaey from the re-oments of the.le of C,,1,,,1 ' -i orders. However, fees will be charged for approvals issued under a specinc exemption provtsion of the
| |
| . . . _ " Te
| |
| - under Tlee to of the Code of Federal Regulations (e.g.,10 CFR 30.11,40.14,70.14,73.5, and any other accoone now or hereafter in regartSees of whether the approval le in the form of a hcense amendment, letter of approval, safety evolustion report, or otter form, in adtSton to the fee shown, an appHeant may be assessed an addruonal fee for sealed source and device evolustions as shown in Categortoe 9A through 90.
| |
| April 30,1996 170-14
| |
| | |
| 17031 17031 PART 170 o FEES FOR FACILITIES, MATERIALS, IMPORT-8 Full cost fees will be determined based on the professeal staff bme and apptegnate contractual support services expended For those apple cabone currenUy on file and for whch fees are determined based on the full cost expended for the review, the professional staff hours empended for the review of the app 6icabon up to the effectrve date of the hnal rule will be determined at the professional rates in effect at the tirne the serv.
| |
| ice was provided. For apphcations currentfy on file for which review costs have reached an apphcable fee ceihng estabhshed by the June 20, 1984, and July 2,1990, rules, but are still perx$ng completion of the review, the cost incurred after any appicable ceshng was reached through January 29,1989, will not be bdied to the app! cant. Any professional staff-hours expended above those ceihngs on or after January 30,1989, wil be assessed at the appicable rates estabhshed by $170.20. as appropnate, except for topcal reports whose costs exceed $50,000. Costs whsch exceed $50,000 for each topcal report, amendment, revision, or supplement to a topical report completed or under review from January 30,1989, through August 8,1991, will not be tulled to the app 6 cant. Any professonal hours expended on or after August 9,1991, will be as-sessed at the appicab6e rate estabhshed in 6170.20 The rnirumum total review cost is twice the hourty rate shown in $ 170.20,
| |
| 'Leensees paying fees under Categones 1 A,18, and IE are not subject to fees under Categones 1C and 10 for sealed sources authonzed in the sarne iconse exc4 in those instances in whch an apphcaten deals only with the sealed sources authonzed by the Icense. Appicants for new bcenses that cover th byproduct rnatenal and special nuclear matenalin sealed sources for use in gauging devices will pay the appro-pnate appicabon fee for fee Category IC only.
| |
| s Fees will not be assessed for requests / reports subtrutted to the NRC:
| |
| (a) in response to a Genere Letter or NRC Buneun that does not result in an amendment to the beense, does not result in the review of an al-temate rnethod or reanalysis to rneet the requirements of the Genenc Letter, or does not involve an unreviewed safety issue; (b) in response to an NRC request (at the Associate Offee Director level or above) to resoNo an identified safety or environtnentalissue, or to assist NRC in deve6oping a rule, regulatory guide, poicy statement, genere letter, or bunet n; or (c) As a means of exchanging informabon between industry organizabons and the NRC for the purpose of supporting generc regulatory irn.
| |
| provements or efforts.
| |
| l 170-15 April 30,1996
| |
| | |
| 17032 170.51 PART 170 e FEES FOR FACILITIES, MATERIALS, IMPORT...
| |
| I 170.33 SchedJe of fece for heetta and safety, and safeguares inepections for metenese neeceae.
| |
| g Materials licennes sha!! pay j inspection fees as set forth in 1170 31 L
| |
| DrroncensurT g 170.41 Panure by appesent er heensee to pay presorted fees.
| |
| In any case where the Commission finds that an applicant of a licensee has a failed to pay a prescribed fee required in 3 this part, the Commission will not a process any application and may f suspend or revoke any license or g approvalissued to the applicent or licensee or may issue an order with respect to licensed activities as the Commission determines to be appropnate or necessary in order tu carry out the provisions of this part.
| |
| Parts 30, 32 through 35. 40,50. 61. 70. 71.
| |
| 72, and 73 of this Chapter, and of the L Act.
| |
| ~
| |
| 1 170.51 nient es nev6ew aw w of Presermed Poes.
| |
| 3 All debtors' requests for review of the g fees sesened and appeal or a disagreement with the prescribed fee
| |
| ; (staff hours and comractual) must be
| |
| * submitted in accordance with the provisions of 10 CFR 15.31, '' Disputed Debts." of this title.
| |
| ~
| |
| September 29,1995 170-16
| |
| | |
| l 1 o UNITED STATES NUCLEAR REGULATORY COMMISSION l ~f
| |
| * l RULES and REGULATIONS TITLE 10. CHAPTER 1, CODE OF FEDERAL REGULATIONS-ENERGY l
| |
| i 171.5 ANNUAL FEES FOR REACTOR OPERATING LICENSES AND FUEL CYCLE LICENSES AND PART MATERIALS LICENSES. INCLUDING HOLDERS OF CERTIFICATES OF COMPLIANCE.
| |
| 171 REGISTRATIONS. AND QUALITY ASSURANCE PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY NRC sa 171.1 Purpose i 171.1 Purpoes
| |
| 't $ M iuont The regulations in this part set out the _
| |
| 171 7 Interpretauons annual fees charged to persons who Budget Authority means the authonty, 17 8 informauon colwcuon requiremena hold licenses. Certificates of in the form of appropriations, provided OMB appnwal. Compliance, sealed source and oevice by law and becoming available during 171 9 Communicates registrations, and quality assurance the year, to enter into obligations that ME put 171 1S Annual Feet Reactor operauns licenset program approvals issued by the United States Nuclear Regulatory Commission.
| |
| will result in immediate or future outlays involving Federal government funds.
| |
| t 71 16 Annual Feet Material Licensat including licenses. registrations. The appropriation is an authorization by Holden o(Ceru6 cates a(Comriiance approva 's and certificates issued to a an Act of Congress that permits the NRC Men o(Seakd Source and Nia Government agency, to incur obligations and to make Registrauons.Holderso(Quainy Assurance Payments out of the Treasury for Pmsram Approvals and Cxwernmerit u Asencies Lxensed tw the NRC.
| |
| O sPecified purposes. Fees assessed 171.17 Prorauon - pursuant to Public Law 101-508 are 17119 Payment. I u ts scope. E based on NRC budget authority.
| |
| The regulations in this part apply to
| |
| * 17123 Enforcement. . Ryproduct Motenal means any 171.23 Collecuan. interest. penaluet and 4 any person holding en operating license 3 radioactive material (except special administrauen E for a power reactor, test reactor or nuclear material) yielded in or made E research reactor issued under part 50 of radioactive oy exposure to the radiation 3 this chapter.These regulations also incident to the process of producing or apply to any person holding a materials stilizing special nuclear material.
| |
| hcense as defined in this part, a Certificate Holder means a person Certificate of Compliance, a sealed who holds a certificate of compliance, or source or device registration. a quality other package approvalissued by the assurance program approval, and to a Commission.
| |
| Government agency as defined in this O
| |
| Authertry:Sec. 7601. Pub. L. 99-2 72,100 -
| |
| " Commission" means the Up"ed
| |
| - I Stat.146 an amended by sec. 5601. Pub. L l Utg Deanmens. '
| |
| States Nuclear Regulatory Commission c5 100-203.101 Stat.1330. se amended by sec.
| |
| E 3201, Pub. L.101-239,103 Stat. 2106 as " Budget" means the funds ;; or its duly authorized representatives.
| |
| U amended by sec. 6101. Pub. L.101-50s.104 % appropr'.ated by Congress for the NRC = " Federal fiscal year" rneens a year a that begins on October 1 of each f Stat.1388 (42 U.S C. 2213), sec. 301. Pub L 2 for each fiscal year andif that
| |
| * 92-314. so Stat. 222 (42 U.S.C 220t(w)h sec 2 appropriation is not passed on or before l calender year and enda on September 30 l
| |
| *
| |
| * September 1 for that fiscal year, the ; of the following calendar year. Federal 201. as Stat.1242 as amended (42 U S.C 5841); sec. 2903. Pub. L 102-466.106 Stat. E funda most recently appropriated by flacal years are identified by the year in 3125 (42 U.S C. 2214 note) which they end (e.g., fiscal year 1987
| |
| { Congress for the most recent fiscal year,
| |
| - _begins in 1986 and ends in 1987).
| |
| l l
| |
| 171 1 Septomtw 29,1995
| |
| | |
| a.
| |
| 171.5 171.5
| |
| * PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND . . . ,
| |
| ~
| |
| Overheadand Genemland Quality Assumnce Program Approval Administmtive coslu means: is the document issued by the NRC to Covernment Agency means any (1) The Govemment benefits for each approve the quality assurance program executive department, comminion. employee such as leave and holidays, submitted to the NRC as meetmg the mdependent establishment. corporation. retirement and dinbility benefits, health requirements of 171.t01 of this chapter.
| |
| St., ,,g[ (own[d by the United and ufe insurance costs, and social Activities covered by the quality se H e a: assurance program may be divided into instrumentality of the United States or M C 8 8, an two mata groups: those activities board. burea u. division. service. (3) Direct overhead. e.g. supervision
| |
| . (ficer, authonty. admmistration. including design. fabncation and use of and support staff that directly support packaging and those actmties Ior use or other estabhshment in the executive the NRC safety minion areas g branch of the government. nly f packagmg (administrative support costs e g. rental Hh of space. equipment.
| |
| Registmtion Holder as used nn this
| |
| ;; ursru'8 Enriched Umnium fuelmeans pad means any manufactuur w imbal a: um ennched to 20 percent of j Jreater in the isotope uranium-235. telecommunications and supfd include.bes):
| |
| (4) Indirect costs that wou distributor andof a sealed source or device I.ow Enriched Ummum fuelmeans but not be limited to. NRC central policy contaming a sealed source that holds a uranium ennched below 20 percent in direction certificate of registration issued by the the isotope uraruum-235. E managem. legal and
| |
| ~
| |
| ent sereices for theexecutive NRC or a holder of a registration for a
| |
| ;; Comminion and special and sealed source or device manufactured m, g independent reviews, investigations, accordance with the unique specifications of, and for use by, a single F Mafarsals IJcease means alioenee, g and enforcement and appraisal of NRC programs and operetions. applicant.
| |
| l certificate, approvel, registration, or Some of the organizations included Research Reactor means a nuclear a othat form of permission issued by the are the Commissioners. Secretary. reactor licensed by the Commission E NRC pursuant to the regulatione in 10 Executive Director for Operations, under the authority of subsection 104c of 3 CFR parts 30,32 through 36,39,40,61, General Counul. Government and the Act and pursuant to the provisions Pubuc Affairs (except for international of l 50.21(c) of this chapter for operation safety and safeguards programs),
| |
| L70. 71 and 72. Inspector General. Investigations.
| |
| at a thermal power level of 10 megawatts or less and which is not a Enforcement. Small and Disadvantaged Business Utilization and Civil Rights, the testing facility as defined in this section.
| |
| Technical Training Center. Advisory Source Material means:
| |
| Nonprofit educationo/ institution Committees on Nuclear Weste and p (1) Uranium or thorium, or any means a public or nonprofit educational Reactor Safeguards. and the Atomic
| |
| * combination thereof, in any physical or institution whose primary function is Safety and IJcensing Board Panel and a chemical form: or education, whose programs are A Ppeal Panel. The Commission views u. (2) Ores which contain by weight one-these budgeted costs as support for all $ twentieth of one percent (0.05%) or more accredited by a nationally recognised Its regulatory services provided to of e, accrediting agenctor association. who
| |
| $ is legaUy authorized to provide a h hoenm W cdcak W Unh ab h and these costs must be (ii) Thorium, or p
| |
| g rogram of orgerused instruction or recovered pursuant to Pubbc law 101- (iii) Any combination thereof.
| |
| g study, who provides an educational , sos- Source material does not include program for which it awards academsc -
| |
| degrees. and whose educational -
| |
| ,p,cg,g ,,cj,,, ,,,,,,,g, Specia/NuclearMaterialmeans:
| |
| programs are available to the pubhc. Person'' means:(1) Any individual. (1) Plutonium, uranium-233. uranium corporation, partnership, firm, enriched in the isotope 233 or in the association, trust, estate. pubhc or isotope 235, and any other material private institution. smup. Govemeent which the Commission, pursuant to the
| |
| " Nuclear reactor" means an agency other than the r %==i=ua any provisions of section 51 of the Atomic apparatus, other than an atomic h state or any pohtical subdivision of, or Energy Act of1964, as amended, weapon, used to sustain flesion in a self. g any political entity within, a state; any determines to be special nuclear su,pporting chain reac, tion, g foreign Government or nation or any material, but does not include source
| |
| , ,Operetmg license means having a political subdivision of any such g license inued pursuant to I 50.57 of this a government or nation; or other entity; makdah or M chapter. It does not include licenses that and (2) any legal successor.
| |
| (2) Any makrial armauy ennched f only authorize possession of special by any of the foregoing. but does not representative, agent, or agency of the
| |
| - nuclear material after the Comminion in include source material.
| |
| * has received a request from the H-== fo$w,g' ,reactor" means a nuclear Testing Facility means a nuclear to amend its licensee to permanently reactor designed to produce electrical or reactor licensed by the Commission withdrew its authority to operate or the heat energy and heensed by the under the authority of subsection 104c of Commission has permanently revoked Commission under the authority of the Act and pursuant to the provisions
| |
| ,such authority. of I 50.21(c) of this chapter for operation uction 103 or hedon 104b of the Atomic Energy Act of 1964, as amended, at:
| |
| and pursuant to the provisions of I1I A thermal power levelin excess of l 50.21(b) or l $0.22 of this chapter. 10 megawatts; or (2) A thermal power levelin excess of 1 megawatt,if the reactor is to contain:
| |
| (i) A circulating loop through the core in which the applicant proposes to conduct fuel experiments: or (ii) Aliquid fuelloading;or (iii) An experimental facility in the core in excess of to square inches in cross-section.
| |
| " 5 h 29,1995 171 2
| |
| | |
| v
| |
| . 171.7 171.11(d)
| |
| PART 171 e ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-1 171.7 Interpretatene. 9 171.11 Esempt)ons. (b) The Commission may, upon Except as specihcally authonzed by (a) An annual fee is not required for: application by an interosted person or
| |
| , the Commission in wntmg. no (1) A construction permit or license on its own initiative, grant an a interpretation of the regulanons m this exemPtron from the requirements of this 3 part by an officer or employee of the applied for by, or issued to, a nonprofit educational tnsutution for a production Part that it determines is authorized by e Commission. other than a wntren or utthzation facility, other than a law or otherwise in the public interest.
| |
| D interpretation by the General Counsel.
| |
| * power reactor. or for the possession and Requests for exemption must be filed will be recogmzed as b ndmg on the use of byproduct matenai, source Commission with the NRC within 90 days from the A matenal, or special nuclear material effective date of the final rule
| |
| $ This exemption does not apply to those establishing the annual fees for which
| |
| ~ e byproduct, source, or special nuclear $ the exemption is sought in ordet to be Z materiallicenses which authonze-
| |
| * IM8 * * * * *
| |
| (1) Human use; g considered. Absent extraordinary "I*"****" circumstances, any exemption requests hy "This part containa no information (ii) Remunerated services to other E filed beyond that date will not be persons; E considered. The filing of an exemption
| |
| ] collection requirements and tharaforeis (iii) Dutnbution of byproduct request does not extend the date on
| |
| - not subfect to the requirements of the material, source material. or special wbech the billis payable. Only timely S Paperwork Reduction Act of 1980 (44 payment in full ensures avoidance of nuclear matenal or products containing U.S C. 3401 et seg.1 byproduct material. source material, or interest and penalty charges. If a partial special nuclear material, or or full exemption is granted, any
| |
| - (iv) Activities performed under a overpayment will be refunded. Requests Government contract for clarification of or questions relating i tr t.9 Communications. -
| |
| to an annual fee bill must also be filed All communications regarding the - within 90 days from the date of the regulanons in this part should be I" "' C* I ' ""
| |
| (2) Federally owned and State-owned g addressed to the Executive Director for ~
| |
| g Operations tLS. Nuclear Regulatory research reactors used primarily for ~
| |
| educational training and acadernic
| |
| ; Comrmssion. Washmgton. DC 20555 (c) An mmph n for mact rs under g Commumcations may be dehvered tc research purposes. For purposes of this o person to the Comnussion a Offices at exemption, the term research reactor pesi n rnay be granted h se means a nuclear mactor that- Commission taking into consideration 11555 Rockville Pike. Rochville, each of the followmg factors.
| |
| Maryland, or at 2120 L Street NW. 6)is licensed by the Nuclear R (1) Age of the reactor:
| |
| Washington, DC. Regulatory Commission under section 2 (2) Size of the reactor:
| |
| l
| |
| ,104c.of a (42 U.S.C.the Atomic 2134(c)) EnergyatAct for operation a of1954 g 2 ((3) Number of customers in rate base;
| |
| : 4) Net increase in KWh cost for each 8 thermal power level of to megawatts or e customer directly related to the annual E less; end l fee assessed under this part: and '
| |
| E (5) Any other relevant matter which (ii) If so licensed for oP' ration at a the licensee believee justifies the thermal power level of more than 1 reduction of the annual fee, megawatt, does not contain- _
| |
| (A) A circulating loop through the _.
| |
| core in which the licensee conducts fuel experiments; (d) The Commission may grant a materials licensee an exemption imm (B) A liquid fuelloading; or the annual fee if it determines that the (C) An experimental facility in the annual fee is not based on a fair and core in excess of to square inches in eguitable allocation of the NRC costs.
| |
| cross section. Tne following factors must be fulfilled
| |
| ""' as determined by the Commission for en exemption to be granted:
| |
| (1) There are data specifically
| |
| * indicating that the assessment of tne f enr.ual fee will result in a significantly e disproportionate allocation of costs to
| |
| " the licensee, or class of licensees: or 3 (2) There is clear and convincing evidence that the budgeted generic costs attributable to the class of licensees are neither directly or indirectly related to the specific class ofIIcensee not explicitly allocated to the licensee by Commission policy decisions; or (3) Any other relevant mr.tterthat the licensee believes shows that the annual fee was not based on a fair and equitable allocation of NRC costs.
| |
| 171-3 Septernber 29,1995
| |
| | |
| ...... m 13 PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND.-
| |
| 4 and inspection activities recovered 5171.13 Notos. under 10 CFR Part 170 of this chapter.
| |
| The annual fees applicable to an (2) Research activities directly related operatirg reactor and to a materials to the regulation of power reactors.
| |
| lic:nsee, including a Government (3) Generic activities required largely agency licensed by the NRC, subject to for NRC to regulate power reactors, e.g, this part and calculated in accordance with 55171.15 and 171.16, will be updating Part 50 of this chapter, or operating the incident Response Center.
| |
| published as a notice in the Federal (c) The activities comprising the FY Register as soon as is practicable but no lat:r than the third quarter of FY 1996 1995 surcharge are as follows:
| |
| thr: ugh 1998. b annual fees will (1) Activities not attributable to an become due and payable to the NRC in existing NRC licensee or class of accordance with 5171.19 except as licensees; e.g., reviews submitted by provided in 5171.17. Quarterly other government agencies (e.g., DOE) payments of the annual fees of $100.000 g that do not result in a license or are not er more will continue during the fiscal -
| |
| * assocf ated with a license; international year and be based on the applicable cooperative safety program and international safe 8uards activities: low-annual fees as shown In $$ 171.15 and level waste disposal generic activities:
| |
| 171.16 (f the regulations until a notice uranium ennchment generic activities; concerning the revised amount of the and fees for the f!acal year is published by (2) Activities not currently assessed Commisalon. under 10 CFR Part 170 licensing and
| |
| ' inspection fees based on existing Commission policy, e.g., reviews and inspections conducted of nonprofit
| |
| ~ educational institutions and costs that would not be collected from small
| |
| $ 171.15 Annual Fees: Reactor operating entities based on Commission policy in liconees. ace rdance with the Regulatory
| |
| > (*) Each person 11 censed to operate a Flexibility Act.
| |
| power, test, or research reactor shall pay ~
| |
| the annual fee for each unit for which the person holds an operating license at any time during the Federal.FY in which the fee is due,except for those ,
| |
| , test and research reactors exempted in l
| |
| ~ l f $ 171.11(a)(1) and (a)(2). I 4 (b) N FY 1996 uniform annual fee (3)b FY 1991 surcharge to be 2 for each operating power reactor which added to each operating power reactor l
| |
| : must be collected by September 30, is $266.000. 'This amount is calculated t 1996, is $2.746,000. '{his fee has been by dividing the total cost for these determined by adjusting the FY 1995 ,, activities ($29.0 million) by the number annual fee downward by approximately 6 porosat.N FY 1995 annual fee was { of oPereting power reactors (109).
| |
| comprised of a base annual fee and an E (4)The FY 1992 surcharge to be additional charge (surcharge).The g added to each operating power reector activities comprisin6 the base FY 1995 is 3281,000. This amount is calculated annual fee are as fouows: by dividing the total cost for these (1) Power reactor safety and activities ($30.6 million)by the number safeguards regulation exmpt licensing of operating power reactors (109).
| |
| 17f4 April 30,1996
| |
| | |
| 171.15(d) 171.15(f)
| |
| !s' ' PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-s M (d) [ Reserved 61 FR 16203.]
| |
| I -
| |
| > (e) The FY 1906 annual fees for licensees authorized to operate a y nonpower (test and research) reactor
| |
| <g licensed under Part 50 of this chapter, cc except for those reactors exempted from
| |
| ! fees under 5171.11(a), are as follows:
| |
| * Research reactor $52,800 Test reactor $ 52.800 l
| |
| (f) For FY 1992 through 1995 annual
| |
| , fees for operating reactors will be 4
| |
| E calculated and assessed in accordance
| |
| [ with i 171.13 of this section, j s l l
| |
| l I
| |
| i 171 5 April 30,1996
| |
| | |
| ,4. m aj i i i . 'i om PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND- .,
| |
| 4 l 171.14 .bmuel Fees: hetertel Uconeses, -
| |
| N #, *
| |
| $>(c) A licensee who is required to pay an annual fee under this section may (2) A licensee who seeks to estabiish status as a small entity for purposes of p , m g ou,,,ya ,,ne, Program Approvais and Government qualify as a small entity. If a licensee paying the annual fees required under Aeonetee Ucensed by th NRC. qualifies as a small entity and provides this section shall file a certification (s) Persan(s) who conduct activities the Commission with the proper statement with the Commitsion. The authorized under certification, the licensee may pay licensee shall file the regored (1)10 CFR part 30 for bypmduct reduced annual fees for FY 1996 as certification on NRC Form 526 for each matzrial. follows: R license under which it is billed.The (2) to CFR part 40 for source matenal. NRC shallinclude a copy of Form NRC (3) 10 CFR part 70 for special nuclear n fee pe $. h 528 with each annual fee invoice sent to censed cat- g a licensee for purposes of billing under msten:1.
| |
| '9*Y this section. A licensee who seeks to (4) to CFR part 71 for packaging and transportation of radioactive matenal- qualify as a small entity shall submit the Sinalt businesse,s not en-end gaged in trianufactunno completed NRC Form 526 with the (5) 10 CFR part 72 for independent and sm# not-for-proht or- reduced annual fee payment.
| |
| storags of spent nuclear fuel and high ganuraons (gross annual (3) For purposes of this section. the 1svel wiste: rece@s): licensee shall submit a new certification
| |
| $1,800 shall piy an annual fee for each license. g $350.000 to $5 mdfion . w th its annual fee payment each year.
| |
| Less than S350.000 400 v certifieste, approval or registration the T 5 person (s) holds on the date the annual - c Mamfactunng entWs that have an average of 500
| |
| ' fee is due. If a person holds more than 3 E one licznse, certificate, registration or m Woyees & less:
| |
| 35 to 500 employees 1.800 R approvsl. the annual fee will be the 400 Less than 35 employees ..
| |
| cumulative total of the annual fees Smau Governmental junsde applicable to the licenses. certificales. bons Unming Mich registraticos or approvals held by that
| |
| * person. For those licenses that authonze more than one activity on a single
| |
| $"n '
| |
| 20.000 to 50.000 .
| |
| ,"nf[
| |
| 1.800 license (e.g., human use and irradiator Less tnan 20.000 400 activitiss) annual fees will be assessed Educational institutions that for each category applicable to the are not State or publicly licznst. supported, and have 500 (b) The basis for the annual fee is the employees or less, sum of NRC budgeled costs for each FY 35 to 500 employees . ... 1.800 for those Less than 35 ernpioyees . 400 (1) Gene ic and other reaaarch cctivitlis directly related to the (1) A licensee qualifies ss a small regulati n of materials licenses as entity if it meets the size standards d fined in this part; and established by the NRC (See 10 CFR (2) Other safety, environmental, and sifegu:rds activities for materials 2'810)'
| |
| licenses (except costs for licensing and -
| |
| inspection activities directly associated with plint specific licensing and inspections that are recovered under part 170 of this chapter).
| |
| April 30,1996 1714
| |
| | |
| 1 171.16(c) 171.16(d) l
| |
| *;. PART 171 ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-.
| |
| d 3
| |
| i i
| |
| t a
| |
| i 1
| |
| ]
| |
| 1 i
| |
| 4 1
| |
| 4 -
| |
| J
| |
| >(4) For FY 1996, the maximum annual fee a small entity is required to pay is 31,8C0 for each category applicable to
| |
| ' the licanaals).
| |
| ' (d)The FY 1996 annual fees for materials licensees and holders of certificates, registrations or approvals g subject to fees under this section are I
| |
| 3 shown below. The FY 1996 annual fees, E which must be collected by September
| |
| ' i 30,1996, have been determined by
| |
| = adjusting downward the FY 1995 annual fees by approximately 6 percent.
| |
| The FY 1995 annual fee was comprised of a base annual fee and an additional charge (surcharge).The activities comprising the FY 1995 surcharge are shown in paragraph (e) of this section.
| |
| 1 a
| |
| 171-7 Aorfi 30.1996
| |
| | |
| 171.lMd) i 171.16W 9 l- PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND- a SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICENSED BY NRC
| |
| {~Ae footnotes at end of tab 6e]
| |
| Categor/ of metenals licenses M%
| |
| : 1. Special nuclear metenal:
| |
| A.(1) Lcenses for possessaon and use of U-235 or plutonium for fuel fabreat>on actmties.
| |
| }~
| |
| (a) Strategic Special Nuclear Matenat -
| |
| $2.403.000 nahm+ & Wilcox (SNM-42) . ..
| |
| 2.403,000 7 ,
| |
| Nuclear Fuel Sennees (SNM-124) ..... - .- ._ .. .
| |
| ' (b) Low Ennched Uranium in Dispersable Form Used for Fabncaton of Power Reactor Fuel: 1,179,000 Combustaan Engmeenng (Hematite) (SNM-33) . - .1,179,000 General Electric Company (SNM-1097) --
| |
| , 1,179.000 1 Semens Nuclear Power (SNM-1227) ..
| |
| ; 1,179,000 !
| |
| ^
| |
| Wesenghouse Electric Company (SNM-1107)
| |
| " (2) AE coher specaal nucceer materials licenses not included in Category 1 A(1) wNch are licensed for fuel cycle actMhes ;
| |
| (a) Facshnes with limited operations: -
| |
| 469.200 ;
| |
| B&W Fuel Company (SNM-1168) .-- - m (b) AN Others: -
| |
| 318,600 General Electric (SNM-960) -- _
| |
| 260,000
| |
| : 8. Ucenses for receipt and storage of apont fuel at an independent spent fuel storage instaNonon (!SFSI) .
| |
| C. Ucenses for ra===.an and use of special nuclear motorial in sea.ed sources contaaned in devices used in industrial 1 -
| |
| . 1.200 messunng systems, includm0 a. rey fluorescence snelyzers .
| |
| D. AN cther special nuclear rnatenal licenset, except licenses ausionzmg special nuclear meterial in unseeied form in com.
| |
| binsdon that would constitute a crihcal quantity, as defined in $ 150.11 of tNs chapter, for wNeh wie licensee ehet pay
| |
| . 2.000 the same fees as those for Category 1 A(2) ._
| |
| - " N/A ;
| |
| l i E. Ucenses for the opershon of a uraneum ennchment facihty ;
| |
| j 2. Source meteriel: 597,800 !
| |
| a g A.(1) Ucenses for possessen and use of source meterial for rennmg uranium rnill concentrates to uranium hexaGuoride ,
| |
| (2) Ucenses for possession and use of source material in recovery operatione such as rndlin0, in.eilu leechmg. heap.
| |
| I 3- leechng, are buying stahons, son exchange facables and in processing of ores contaming source motorial for extrec-
| |
| ' tion of metale other then urarnum or thonum,includin0 licenses authonzing the possession of byproduct weste moto.
| |
| @ rtal (talbngs) from source material recovery operemons, as well as Iscenses authorizing the W and mainte.
| |
| l g nonce of a IncAny in a stenchy rnode. 57.000 l C1ese I teeseles* .- 32.200 !
| |
| Close 18 loculdes* .
| |
| 20,800 Other aanmana* .
| |
| (3) Useness that authertze the receipt of byproduct motortel, as desned m secnon 1to.(2) of the Atomic Energy Act.
| |
| from other persone lor possessen and d=panal oncept tese licenses subject to tie fees in Colegory 2A(2) or Cat- 41,800 89ory 2A(4)
| |
| (4) Useness gist auterize sie receipt of byprothset motorial, as denned in Secton 11e(2) of the Atomic Energy Act, kom other persons for possession end disposalinsidental to the disposal of the urenlum weste tedings generated by 7,400 the Econsee's mang operemons. except tions Hoeness out:6ect to the fees in Category 2A(2) 450
| |
| : 8. Uoonees which authorize only the possession, use enger instematon of source metenal for shielding
| |
| , 8,10G C. All other source meteriallicenses . .
| |
| : 3. Byprockact material:
| |
| A. Usenses of broad scope for possessson and use of byproduct metenal rssued pursuant to Ports 30 and 33 of this chap. 15,400 ter for processin0 or manutectunng of items contaming byproduct material for commercial clotrbuhon --
| |
| : 8. Otter Econess for pamaanean and use of byproduct meterial issued pursuant to Part 30 of this chapter for proceseng or
| |
| . . .. 5.200 manufacturing of items contenung byproduct material for commercaat estnbution . .
| |
| C. Uoonees issued pursuant to $$32.72. 32.73 anWor 32.74 of ths chapter authonzing the proceeem0 or manufactunng and assetamon or ressetrbution of re ,.b... Mw= generators. reagent luts anWor sources and devices contaerung M and use of source metenal for shoeking authorized pursu.
| |
| byproduct meterial. This category ateo includes the , .. 10.400 ent to Part 40 of ins theptor when included on the some Econee D. Ucenses and approvais leeued pursuant to $$ 32.72,32.73, and/or 32.74 of this chapter authorizing distribuuan or redis-trhugon of retBapharmaeadeaan, generators, reagent Idts anWor sources or devices not involving processing of byprod.
| |
| uct motorial TNs category eleo inciados the poseeneson and use of source material for sheetcAng authorized pursuant to 4,100' Part 40 of this chapter when included on the same Boonee - .
| |
| E. Ucenses for possession and use of byproduct materialin sealed sources for irradiation of materials in which the source
| |
| - 2.900 is not removed from its sNeed (self.sNeided urvts)
| |
| F. Ucenses for possesecon and use of less then 10.000 curies of byproduct matenal in sealed sources for irradiation of ma.
| |
| terials in which tie source is exposed for irradehon purposes. TNs category also includes underwater irradiators for irra-
| |
| .~. 3.500 tSellon of meterials in which the source is not exposed for irrachatson purposes .. .
| |
| * G. Uooness for possession and use of 10.000 cunes or more of byproduct matenal in sealed sources for irraciation of me.
| |
| tortels in which the source is exposed for irradlehon purposes. TNs category also includes underwater irradiators for irra.
| |
| 18.100 cSecon of motorials in which the source is not exposed for irradataon purposes .._ -
| |
| 1 i
| |
| Apre 30, teos ms
| |
| : 171.16(d) 1 i 171.16(d)
| |
| ! . PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-.
| |
| I 1
| |
| j I
| |
| SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVER (See footnotes at end of table]
| |
| .i Category of metenals licenses g%3
| |
| ; H. Lu--. issued pursuant to S*="t A of Part 32 of tfus chapter to detnbute stoms contanng byproduct mate i
| |
| require device rewsw to persons exempt frorn the licensing requrements of Part 30 oft this chapter, except s requiremente of Part 30 of thee chapter -conoes aumortzing redstrbution of items that have been authonz L Ucenses issued pursuant to Subpert A of Part 32 of this chapter to distreuto items contairung 4.600 byprodu i quenhees of byprodJct meterial that do not requwe devce evaluebon to persons enempt from the beensing requwem of Part 30 of this chapter, except for specrec hcenses authorizing redstreuson of items that have been authori Inbuson to persone exempt from the beeneang requrements of Part 30 of this chapter .
| |
| J. Useness issued pursuant to Subpert B of Part 32 of thes chapter to detrtnde jeems contanng byproduct 8.200 mate quire seeied source and/or device review to persons genereAy Econeed under Port 31 of this chapter, eacept s conses Part 3I ofaumorizing tiis chapter redstrbullon of leems that have been authonzad for dombuton to persons generapy hcensed under 3.500byproduct m K. Uconnes leeued pwouant to S@ pert B of Part 31 of this chapter to detnbute items contanng under Part 31 of this chapter, except specific licenses authon2mg redstributio detreuton to persons generaNy licensed under Part 31 of this chapter .. .~ --
| |
| 3,000 Lter Ucenses of broad scope for possession and use of byproduct metenalissued pursuant to Parts 30 for research and developenent that do not authonte commercial dstreubon - -
| |
| 11,400 M. Other hcenses for possession and use cf byproduct matenalissued pursuant to Part 30 of oevelopment that do not authorize commercial distnbucon this chapter fo N. Ucenses that authonze serwcas for omer heense s, except: 5,100 (1) 3P;Ucenses and that authonze only cahbrabon and/or leak teshng servces are subrect to the fees specme (2) bconses that authorize waste esposal serwces t are sub ect to the fees specified in fee Cat.rgones 4A 48 and 4C O. Ucensos Ior possession and use of byproduct matenal issued pursuant to Part 34 of ttus5.600 chaplet for indu c, phy opereelone. This category also includes the possession and use of sowce mecenal for stmeiding aumortred pu to Port 40 of mis chapter when authorized on the same hcense g P. AI other speelAc byproduct material teenees, emospt those in Categories 4A mrough 90 _ -- 13,000
| |
| : 4. Weses deposal and processeig- --
| |
| 1,000
| |
| .g
| |
| * A. Unenses speelAcefy authortdng me receipt of weste byproduct meterial, sou 8torizing contigency storage of law.4evel redneceve weste et the eles of nudeer power reactors; or Econess for of weste from c#ier persono for indnereelon or omer tressment. pechageig of renuning weses and residusa, and trenefe of pochegos es enomer pereen aumortred to reserve or depose of weses menoreal __ --
| |
| E. Uoonoce speelAcefy auftertaktg Wie receipt of weses byproduct mesonel, sowoe matanal, or special e94.300nuclear meterial from etter persons for sie purpose of pedeging or repecheging the material. The soonees we depose ci the me transfer to anotter person aumortmed to recofwe or cespose of the menestal
| |
| -- -~ 13,300 C. Unenses speemessy simhortning the receipt of propeckaged weses bypraduct manertet, source meternel, or specia cieer mesertef receive or depose offrom other persons.
| |
| ete menertal The toenese we espose of the material by treneser to anomer person aumortted to
| |
| ~ -
| |
| : 5. We8 logging ~ - - . . - -
| |
| 7.100 A.wasUsenses for possession and use of bypredtzt masenal. source menettel, andfor specaal nuclear material for wel surveys, and trener enases caer men need sooeng tracer stumes __ ... 7,500 B. ucenses ser possession and use of byproeact motertei sor need nooding vacer seuses - ~ ~ - - - - -
| |
| : 6. Nuclear leunetes: - -~~ 12,200 A.del Ucenses for commercial counction and laundry of items contamineled with byproduct meterial, source material, or spo.
| |
| nucteer metonal _ .. .. _ _ _ -
| |
| : 7. Human use of byproduct, source, or specset nuclear metenal _ _ _ - .~.~ ~ - ~. - - - 13,600 A. Ucanoes issued pursuant to Parts 30,35,40, and 70 of this chapter for human use of byproduct meterial, source mate.
| |
| rtal, or special nucteer metenalin seeied sources contamed m Ws.,,y devices. This category also indudes the poo.
| |
| session and use of source meterial for erweiding when authortred on me same Ilconee
| |
| ----.-- g,500 B. Ucenses of broad scope issued to medcol inattutone or two or rnore physicians pursuant to Parte 30,33,36,40, and 70 of this chapta aumorizing reneesch and developmers, indudra human use of byproduct material except alcennes for byproduct meterial, source matenei. or specisi nudear material in sealed sources contained in 1 m.,4 devices. This category also includes the possession and use of source materias for shiekSng when authorized on the same liconee' .
| |
| 21,700 C. Other licenses issued pursuant to Parts 30,35. 40. and 70 of this chapter for human use of byproduct material, source malenal, and/or specsal nuclear matenal except hcenses for byprodnet material. source metenal, or special nucieer moto.
| |
| sialin sealed sources contamed in teletherapy .levices. This category also ireturtaa the possession and use of source material for sineidng when authorized on the same liceneo' -
| |
| : 8. Civil defense _
| |
| ~~.- - 4.300 A.IMlles Ucenses - for premamaan and use of byproduct matenal, source material, or special nuclear material for cMi detense so.
| |
| . ~ . . . . . -
| |
| : 9. Device, product, or seeied source esfoty evaluation:
| |
| -...-~~.--~~~~~ 1,600 A. Regletrebone issued for the selety evalumbon of devices or products contammg byproduct material, source matertel, or special nuclear masonal, except reactor fuel devices, for commercial detrmuson _~ .
| |
| 6.700 B. Registrebone issued for the eately evaluation of devices or products containing byproduct material. source mesertel, or spooalreactor emospt nucieerfuelmenettel devices - manufactured in mocordance vnth the urwoue speclecahone of, and for use by, a single opptcent.
| |
| . - - 3,400 gg . _ ,, a a <==a . _ .
| |
| | |
| 171,16(e) ,
| |
| 171,16(d)
| |
| PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-SCHEDULE OF MATERIALS ANNUAL FEES AND FEES FOR GOVERNMENT AGENCIES LICEN (See footnotes at end of tabiel Annual Category of matenals hcenses feesas C. Registrabons issued for tne safety evaluahon of sealed sources containing byproduct rnatenat, source rnaterial, or .
| |
| spe-1,400 c al nuclear rnaterial, except reactor fuel for commercal dstnbution .
| |
| D. Registrations issued for the safety evaluation of sealed sources contairung byproduct rnatenal, source material, or spe-cial nuclear material, manufactured in accordance with the unaque specircations of. and for use by, a single apphcant, 720 except reactor fuel n 10. Transpadation of radioactrve matenat A. Certifcates of Compliance or other package approvals issued for design of casks, packages, and shipping containers. 8N/A g
| |
| - Spent Fuel, High-Level Waste, and r atonium air packages sN/A a: Other Casks . . . . . . ..
| |
| I 8. Approvats issued of 10 CFR Part 71 quality assurance prograrns. 72,700
| |
| * Users and Fabncators . 950 Users .
| |
| eN/A
| |
| : 11. Stardardized spent fuel facabbes . . . . . .
| |
| eN/A
| |
| : 12. Special Profects . . - . . .
| |
| eN/A
| |
| : 13. A. Spent fuel storage cask Certircate of Compliance 260,900 B. General heenses for storage of spent fuel under to CFR 72.210 ...._
| |
| : 14. Byproduct, source, or special nuclear maternal heenses and other approvals authorizing decommissioning, decontamina. 7N/A tion, reciarnation, or site restoration actuties pursuant to 10 CFR Parts 30, 40, 70, and 72 . .
| |
| sN/A
| |
| : 15. Irnport and Export licenses , . . . . . . .
| |
| eN/A
| |
| : 16. Reciprocity .- ..... . . . . . . . . _ .
| |
| 388,400
| |
| : 17. Master materials hcenses of broad scope issued to Govemment agencies .
| |
| : 18. Department of Energy:. 'o1,077,000 A. Certif+ cates of Comphance . ............ ...... . . .. 1,812,000
| |
| - B. Uranium Miel Taihng Radiabon Control Act (UMTRCA) actmties
| |
| ' Annual fees will be assessed based on whether a Icensee held a vahd hconse with the NRC authorizing possession and use of radioactrve retinal dunng the fiscal year. However, the annual fee is waived for those rnatenals hcenses and holders of cerbfcates, registrates, and ap.
| |
| p ovais who either filed for termination of their kcenses or approvals or filed for possession onty/ storage hcenses prior to October 1,19 permanently ceased Icensed actmties entirely by Septerrber 30,1995. Annual fees for heensees who fded for termmation of a license, dow grade of a heense, or for a POL dunna the fiscal year and for new leenses issued during the nicinse, certfcate, registrataan, or approval held by that person. For hcenses that authorize rnore than one activity on a single license (e.g.,
| |
| human use and irradiator acthnties), annual fees wtil be assessed for each category appicable to the license. Licensees paymg annual fees under Category 1.A.(1) are not stefect to the annual fees of Category 1.C and 1.D for sealed sou Renewal applicatone anust be filed in accordance with the requirernents of Parts 30,40,70,71, or 72 of thi in the Federef Regieter for notice and commerit,
| |
| * A Class I license incluoes mill licenses issued for the extraction of uranium from uranium cra. A Clase il Rcenes includes solubon mining IL canses (irdsitu and heap leach) issued for the extraction of wanium from uranium ores indLding research ard development iconses. An *other" license indudes licenses for extracbon of metals, heavy metals, and rare earths.
| |
| 8 Two licenses have been issued by NRC for land dsposal of special nudear material. Once NRC issues a LLW disposal license for byproduct and source material, the Commissann will consider establishing an annual fee for this type of heense.
| |
| * Standardized spent fuel facihbes, Parts 71 and 72 Certircates of Comphance, and special rev6ews, such as topical reports, are not n-ad an annual fee because the genenc costs of regulating these actmbes are pnmanly attributable to the users of the designs, certficates, and toph ca! reports.
| |
| 'Ucensees in this category are not assessed an annual fee because they are charged an annual fee in other categories while they are lh censed b cperate, natwo of the Icense.
| |
| a No annual fee is charged because it is not practcal to adminsster due to the relatively short ife or also hold nuclear medcine licenses
| |
| ' Separate annual fees will not be assessed for pacemaker licenses issued to medical institutions under Categones 7B or 7C.
| |
| 4This includes Certrincates of Comphance issued to DOE that are not under the Nuclear Waste Fund.
| |
| " No annual lee has been established because there are cummity no Econsees in this particular fee category,
| |
| (:) The activities comprising the FY educationalinstitutions and Federal 1995 surcharge are as follows: agencies; activities related to (1) 11W disposal generic activities; h decommissioning and reclamation and (2) Activities not attributable to an - costs that would not be collected from existing NRC licensee or classes of E small entities based on Commission lic~ nsees; e.g., international cooperative ; policy in accordance with the l Regulatory Flexibility Act.
| |
| { safety program and international L
| |
| - safeguards activities; support for tne g Agreement State program; site
| |
| - decommissioning management plan (SDMP) activities; and (3) Activities not currently assessed under 10 CFR part 170 licensing and inspection fees based on existing law or Commission policy, e g., reviews and inspections conducted of nonprofit April 30,1996 171 10
| |
| | |
| 171.16(O 171.16(0 PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-
| |
| ~
| |
| 4 (f)To recover FY 1991 costs relating 1.u. 1.D. 2.C. 3. A. 3. B., 3.C. 31. category, the total surcharge assessed in
| |
| ~ 3.M. 3 N. 4.A. 4.B. 4.C.,5.B ,6 A.. and ~ F'Y 1991, the FY 1991 amended f" to LLWchargo additional disposal of $62.300generic has beenactivities, f 7A. andan e.n additional charge of surcharges and the amount of e added to fee Categories 1.A.(1).1.A.(2) e $21.000 has been added to fee Category overpayment resulting in a refund due
| |
| ; 17. For comparative purposes the table f or a credit given certain categones of
| |
| ; and 2.A.(1); an additional charge of
| |
| * $1.400 bas been added to fee Categories
| |
| * following shows, for each materials fee $ natenals beensees. )
| |
| l 1
| |
| 2 i
| |
| SCHEOULE OF MATERIALS ANNUAL FEE SUACHAAGES FY 1991 sur. FY 1991 Fee category ' charge .ts. amended sur.
| |
| hd sessed2 charge NM Special nuctear metenat.
| |
| 1 A(1) ... $143.500 $62.400 $81.100 1 1 AG) . 35.900 62.400 l 1.8 1.500 1,500 l 1.C . . . . 100 100 1.D 1.500 1,500 Source matenat:
| |
| 2A.(1) . - $143,500 $62.400 $81,100
| |
| ' 2A(2) .... 100 100 2B _
| |
| 100 100 2.C . . 1,500 1,500 2 Byproduct rnaterlat:
| |
| 3A . $1.500 $1,500 3.B - 1.500 1.500 3.C ..
| |
| 1,500 1.500 3.0 100 100 3.E . _ --
| |
| 100 100 3.F . 100 100 3.0 100 100 3.H 100 100
| |
| . , 3.1 . . 100 100 g 3J _
| |
| 100 100 gg 3.K 100 100
| |
| , e 3.L _ 1,500 1.500 g 3.M - 1,500 1.500 e 3.N 1,500 1,500 3.0 _ _ .. 100 100 3.P 100 100 Weste esposal and processing:
| |
| 4A _ _. . $35.900 1A00 $34.400 4.8 _ . . - 1,500 1,500 d.C -- _ . 1,500 1,500 Wes loggrrg:
| |
| SA - $100 $100 5.8 .
| |
| 1.500 1,500
| |
| .i Nucteer launeise 6A . _._ - $1.500 $1,500 Medca6-human use:
| |
| 7A $100 $100 1,500 1,500 7.8 _ - . .
| |
| 7.C - 100 100 Cave doienee SA .
| |
| $100 $100 Devw:Woesied scuros evoluetort 9A . .. - $100 $100 9.8 100 100 9.C _ - - 100 100 9.D - -
| |
| 100 100 Transportanon:
| |
| 10.8 . -. $100 $100 Spent fuel storage:
| |
| 13.B - . . $100 $100 Master toenees.
| |
| 17 $22.500 $21.000 $1.500 t A Mi descripton of the vertous fee categories la found in $ 171.16(d).
| |
| a ww:sudee $100 eurcharge to reemer costa not W by sman ensees.
| |
| 9 171 11 September 29,1995
| |
| | |
| 3 171.16(g) 171.16(g)
| |
| PART 171 o ANNUAL FEES FOR REACTOR OPERATING LICENSES AND-. .
| |
| s I (g) To recover FY 1992 costs relating I 1.B .1.D . 2.C. 3 A. 3.B.sI 3.C. materials 3.L., fee category, the total
| |
| $ to LLW disposal generic activities, an g , 3 M. 3 N., 4 N . 4.A. 4.B., 4 C. 5.B.. 8 surcharge assessed in FY 1992, the FY
| |
| : r. additional charge of 561.700 has been R 6.A.. and 7 B.. and an additional charge 14 1992 amendment surcharges and the E added to fee categories 1.A.(1) 1.A.(2). E of 523.100 has been added to fee E amount of overpayment resulting in a
| |
| $ and 2.A.(1); an additional charge of g Category 17. For comparative pu oses $ refund due or a credit iven for certain categones of materials scensees.
| |
| 31.500 has been added to fee Categories l the followmg table shows, for eac FY W2 sur. FY 1992 Amount of Fee category ' energe as. amended sur. overpayment sessed a charge Special nuclear metonal 1A.(1) 5155.250 561.850 593.400 1 A.Q) - 38.950 61.850 1.8 1.750 1.650 100 1.C . . . . 150 150 1.0 1.750 1.650 100 Source metenal 2A.(1) 155.250 61.850 93,400 2A.Q) . 150 150 2.8 - . . . . 150 150 2.C 1.750 1,650 100 Byproduct matenal.
| |
| 3A- 1,750 1.650 100 3.8 1,750 1.650 100 3.C 1.750 1.650 100 3.D 150 150 3.E - 150 150 3.F 150 150 3.G 150 150 3 64 150 150 3.1 -
| |
| 150 150 3J . . - -'
| |
| 150 150 3.X - 150 150 E 3.L - 1.750 1.650 100 g 3M -
| |
| 1.750 1.650 100
| |
| : a. 3.N .- . 1.750 1,650 100 w 3.0 _ 150 150 2 3.P 150 150 Weste deposal and procesong 4A 38.950 1.650 37.300 4.8 1.750 1.650 100 4.C - 1.750 1,650 100 Wet loggmg SA _ 150 150 5.8 - . - 1.750 1.650 100 Nucieer laundnee.
| |
| 6A . 1.750 1,650 100 Medicak-human use:
| |
| 7A . --
| |
| 150 150 7.B 1.750 1,650 100 7.C 150 150 Cml defense:
| |
| 8A 150 150 Devicefseeied source eveiustort 9A_ . . . 150 150 9.B 150 150 9.C - 150 150 9.D . . . 150 150 Transportanon.
| |
| 10.8 150 150 Spent fuel storage 13.8 150 150 Master iconees.
| |
| 17 36.150 23.250 12.900
| |
| * A fun of the venous fee categones is found 171.16(d). i einesudes Si surenerge to recover costs not pad t>y s entities.
| |
| l l
| |
| l September 29,1995 171-12 j l
| |
| 1
| |
| | |
| . - - .. _ . _ -~ . . _- ..
| |
| + 171.17 171.19(a)
| |
| PART 171 ANNUAL FEES FOR REACTOR OPERATING LICENSES AND- l 171.17 Prorsuon. the FY will be assessed or.e half the I tri.is payment.
| |
| Annual fees will be prorated for NRC annual fee for that FY. New licenses (a) Method of payment. Fee payments licensees as follows: issued on or after April 1 of the FY will shall be made by check, draft, money (a) Reactors. The annual fee for not be assessed an annual fee for that order or electronic fund transfer made l reactors (power or nonpower) that are FY. Thereafter, the full fee is due and payable to the U.S. Nuclear Regulatory l subject to fees under this part and are payable each subsequent FY. The Commission. Federal agencies may also j granted a l'canse to operate on or after annual fee will be prorated for licenses y make payment by either Standard Form -
| |
| S October 1 of a FY is prorated on the for which a termination request or s ;;; SF-t081 (Voucher and Schedule of l
| |
| @ basis of the number of days remaining request for a POL has been recaived on c Withdrawals and Credits) or by the On- l e in the FY. Thereafter. the full fee is due or afte October 1 of a FY on tie 'aasis of when the application for termination @ OPAC's). (line Payment andpayment Collection System l 3 and payable each subsequent FY. Where specific I
| |
| * Licensees who have requested or POL is received by the NRC provided mstructions are provided on the bills to amendment to withdraw operating the licenue permanently ceased applicants or licensees, payment should autho ity permanently during the FY licensed activities during the specified be made accordingly. e.g., bills of $5,000 will be prorated based on the number of period. Licenses for which appucations or more will normally indicate payment days during the FY the license was in for termination or POL are filed during by electronic fund transfer.
| |
| effect before the possession only license the period October 1 throu ,
| |
| was issued or the license was of the FY are assessed one gh March 31 half the terminated. annual fee for the applicable category (les) for that FY. Licenses for which applications for termination or POL are filed on or after April 1 of the !
| |
| (b) Matenals licenses (including fuel cycle licenses). (1) New licenses and that FY termmotions. The annual fee for a Q) . $w ded licenses. (1) The l 9 annual fee a materials license that is I g matenals license that is subject to fees subject to fees under this part and I g under this part and issued on or after downgreded on or after October 1 of a l
| |
| . October 1 of the FY is prorated on the s FY is prorated upon request by the l 8 basis of when the NRC issues the new R licensee on the basis of when the l license. New licenses issued during the " application for downgrade is received l penod October 1 through March 31 of E by the NRC provided the licensee l 8 permanently ceased the stated activities during the specified period. Requests for proration must be filed with the NRC within 90 days from the effective date of the final rule mtablishing the annual fees for which a proration is sought.
| |
| Absent extraordinary circumstances, any request for proration of the annual fee for a downgraded license filed bayond that date will not be considered. ,
| |
| (ii) Annual fees for licenses for which l applications to downgrade are filed during the period October 1 through March 31 of the FY will be prorated as follows:
| |
| (A) Licenses for which applications have been filed to reduce the scope of the license from a higher fee category (ies) to a lower fee category (ies) will be assessed one. half the annual fee for the higher fee category (ies) and one-half the annual fee for the lower fee category (ies), and. if applicable, the full annual fee for fee categones not affected by the downgrade; and (B) Licenses with multiple fee categories for which applications have been filed to downgrade by deleting a fee category will be assessed one-half the annual fee for the fee category being deleted and the full annual fee for the remaining categories.
| |
| (iii) Licenses for which applications for downgrade are Sted on or after April 1 of the FY are assessed the full fee for that FY.
| |
| 171 13 September 29,1995
| |
| | |
| l t71,19(b) 171.25 ,, l PART 171 e ANNUAL FEES FOR REACTOR OPERATING LICENSES AND- ;
| |
| 1
| |
| > (b) For FY 1996 through FY 1998, the Payment is due on the invoice date and 4 Commission will adjust the fourth interest accrues from the date of the 171.21 [ Removed] 53 FR52632 ]
| |
| quarterly bill for operating power invoice. However, interest will be reactors and certain materials licensees waived if payment is received within 30 -
| |
| to recover the full amount of the revised days from the invoice date.
| |
| annual fee. If the amounts collected in (c) For FYs 1996 through 1998, annual I
| |
| ; the first three quartars exceed the fees in the amount of $100.00J or more if any person required to pay the j amcunt of the revised annual fee, the and described in the Federal Register annual fee fails to pay when the fee is
| |
| ; overpayment will be refunded. The NRC notice pursuant to $ 171.13 must be paid due, or files a false certification with
| |
| : will rzfund any " flat" materials renewal in quarterly installments of 25 percent respect to qualifying as a small entity i 3 foss payments received for renewal as billed by the NRC. The quarters begin under the Regulatory Flexibility Criteria, 1 applications filed in FY 1996, as on October 1, January 1, April 1 and the Commission may refuse to process appropriate. All other licensees, or any application submitted by or on t
| |
| holders of a certificate, registration, or July)1 (d Forof each FYs fiscal 1996 year.
| |
| through 1998, behalf of the person with respect to any
| |
| , approval of a QA program will be sent annual fees ofless than $100,000 must license issued to the person and may
| |
| ; a bill for the full amount of the annual be paid as billed by the NRC. Beginning suspend or revoke any licenses held by fee upon publication of the final rule or in FY 1996, materials license annual the person.The filing of a false on the anniversary date of the license. fees that are less than 3100,000 will be certification to qualify as a small entity billed on the anniversary of the license. under i 171.16(c) of this part may also The materials licensees that will be result in punitive action pursuant to 18 I
| |
| billed on the anniversary date of the $ U.S.C.1001.
| |
| h license are those covered by fee E categories 1.C. and 1.D.: 2.A.(2) through E g 2.C.: 3.A. through 3.P.: 4.B.through 8 9 171.25 Comection, interest, penattles'
| |
| ; 9.D.: and 10.B. For annual fee purposes. and administrouve com
| |
| ,i the anniversary date of the license is
| |
| ] considered to be the first day of the All annual fees in li 171.15 and 171.16 month in which the original license was will be collected pursuant to the issued by the NRC. During the transition pr cedures of10 CFR part 15. Interest, I year of FY 1996, licensees with license penalties and administrative costs for l anniversary dates falling between late payments will be assessed in I
| |
| . October 1,1995, and the effective date accordance with 10 CFR part 15, of this a
| |
| of the FY 1996 final rule will receive an chapter,4 CFR part 102, and nther
| |
| , annual fee bill payable on the effective relevant regulations of the (!aited States s
| |
| date of the final mie, and licensees with Government, as appropriate. In the event a quarterly installment is not
| |
| ~
| |
| license anniversary dates that fall on or after the effective date of the final rule made by the appropriate due date will be billed on the anniversary of their specified in i 171.19, the full fee license. Starting with the effective date becomes due and payable, with interest.
| |
| of the FY 1990 final rule, licensecs t ., Penalties, and administrative costs of l 3
| |
| are billed on the license anniversary collection calculated from the date that l
| |
| ; date will be assessed the annual fee in quarterly installment was due.
| |
| effect on the anniversary date of the _
| |
| license.
| |
| I l
| |
| 1 1
| |
| April 30,1906 171 14
| |
| | |
| i l
| |
| l l
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| I i
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| 1 i
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| i I
| |
| l l
| |
| l Attachment D DSI No. 7, " Materials / Medical Oversight"
| |
| \
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| , i l
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| l l
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| l 1
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| l l
| |
| i t
| |
| s i
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| 1 1
| |
| | |
| + l I
| |
| k.t .
| |
| STRATEGIC ASSESSMENT ISSUE PAPER DSI 7: MATERIALS / MEDICAL OVERSIGHT INTRODUCTION l In August 1995, the Nuclear Regulatory Cosenission (NRC) staff initiated a j Strategic Assessment and Rebaselining Project. This project was intended to i
| |
| take a new look at the NRC by conducting a reassessment of NRC activities in order to redefine the basic nature of the work of the agency and the means by which that. work is accomplished, and to apply to these redefined activities a rigorous screening process to produce (or rebaseline) a new set of ass eptions, goals, and strategies for the NRC. The results of this project are intended to provide an agency-wide Strategic Plan which can be developed and implemented to allow the NRC to meet the current and future challenges.
| |
| 1 i A key aspect of this project was the identification and classification of i issues that affect the basic nature of NRC activities and the means by which j
| |
| this work is accomplished. These issues fall into three categories. The
| |
| { first category includes broad issues defined as Direction-Setting Issues (DSIs). DSIs are issues that affect NRC management philosophy and principles.
| |
| i The second category includes subsumed issues. Subsumed issues are those that should be considered along with the DSIs. The third category includes related issues. These tre issues that shoult! be considered after the Consnission makes a dechion or the option (s) for a DSI. Also, as part of the project, other issues of an operational nature were identified. These are not strategic issues and are ap
| |
| ; the issue papers.propriately resolved by the staff, and are not discussed in i
| |
| Following the reassessment of NRC activities, issue papers were prepared to
| |
| ! provide a discussion of DSIs and subsumed issues, and to obtain a review of l these broad, high-level issues. These papers are intended to provide a brief j discussion of the options as well as suissaries of the consequences of the j options related to the DSIs. Final decisions related to the DSIs will influence the related issues which are listed, but not discussed, in each l issue paper. As part of the Strategic Assessment and Rebaselining Project, j the issue papers are being provided to interested parties and to the public.
| |
| Following distribution of the issue papers, a series of meetings are planned
| |
| ; to provide a forum to discuss and receive comment on the issue papers. After j receiving public cosament on the issue papers, the commission will make final j decisions concerning the DSIs and options. .These decisions will then be used
| |
| ! to develop a Strategic Plan for the NRC. In summary, the Strategic Assessment and Rebaselining Project will analyze where the NRC is today, including i
| |
| internal and external factors, and outline a path to provide direction to move forward in a changing environment.
| |
| ) .
| |
| i i
| |
| j RELEASE DATE: SEPTEMBER 16, 1996 DSI 7 i
| |
| i 4
| |
| a
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| | |
| o ,
| |
| o, .
| |
| i DSI 7 MATERIALS / MEDICAL OVERSIGHT I.
| |
| | |
| ==SUMMARY==
| |
| | |
| A. Direction-Setting Issue ,
| |
| The Nuclear Regulatory Commission (NRC) Byproduct Materials Program currently regulates approximately 6,400 specific and 35,000 general licenses for the possession and use of nuclear materials in medical, academic, and industrial applications. The Materials Program includes licensing and inspection activities, primarily administered by the NRC regional offices, and exempt distribution licenses and sealed source and device (SS&D) reviews, which are handled by NRC Headquarters. The various regulated products and uses rang from large quantities of radioactive materials in complex devices or in the manufacture of radiopharmaceuticals to small quantities in radioactive tracer studies or in simple devices. The NRC is evaluating the level of control and regulation needed to oversee its diverse Nuclear Materials Program. Many of the applications pose similar risks and could be regulated by other Federal and State agencies. Specifically, the NRC has been considering whether to continue to regulate or to revise its oversight of the medical uses of nuclear byproduct materials. To obtain input on the medical regulation issue, the NRC contracted with the National Academy of Sciences (NAS), Institute of Medicine (IOM), to perform an external review and to assess the adequacy and ,
| |
| appropriateness of the current regulatory framework. The IOM final report, l
| |
| " Radiation in Medicine: A Need for Regulatory Reform," provides ; I recommendations to give regulatory authority over medical uses to the States, l with a Federal agency other than the NRC providing leadership and guidance'. l A decision on the Medical Use Program may effect a rethinking of the NRC's i fundamental philosophy on the extent to which it should regulate other nuclear l materials. This issue paper provides options associated with the Direction-Setting Issue (DSI) of what should be the future role and scope of the NRC's Nuclear Materials Program, and in particular, NRC's regulation of the medical use of nuclear material. The options include expanding, retaining and revising, retaining in part, or eliminating the Nuclear Byproduct Materials Program with particular emphasis on medical use.
| |
| B. Options Option 1: Increase Regulatory Responsibility With Addition of X-Ray, Accelerators, and Naturally Occurring and Accelerator-Produced Radioactive ,
| |
| Materials This option would transfer the regulatory responsibility for non-Atomic Energy Act of 1954, as amended (AEA), sources of ionizing radiation, such as x-ray, linear accelerators, and naturally occurring and accelerator-produced
| |
| ' See Attachment, " Regulation of Radiation in Medicine - IOM Issues" SEPTEMBER 16, 1996 2 DSI 7 REl. EASE DATE:
| |
| nn -... c- - n,,
| |
| | |
| s
| |
| ~
| |
| i ~
| |
| S OSI 7 MATERIALS / MEDICAL OVERSIGHT 4
| |
| i radioactive materials (NARM),-from other Federal agencies and the States to
| |
| ! the NRC. An Agreement States Program would continue. Legislation would be required to implement this option. ,
| |
| Option 2: Continue Ongoing Program (With Improvements) i This option would maintain the current regulatory responsibility of the NRC and the States, while making continual improvements to increase efficiency and i revising regulations to be more risk-informed and performance-based rather j than prescriptive. Some of these improvements are currently ongoing (business
| |
| ; process reengineering [BPR]) or are on temporary hold (revision of Part 35 of
| |
| : Title 10 of the Code of Federal Reculations [10 CFR Part 35]). Legislation would not be required.
| |
| Option 3: Decrease Oversight of Low-Risk Activities With Continued Emphasis i
| |
| of High-Risk Activities l This option would decrease regulatory responsibility for all materials that
| |
| { pose a low risk to the workers and the public. Examples of these materials
| |
| } include diagnostic nuclear medicine, gas chromatographs, some portable gauges, t and so on. The NRC would retain oversight of SS&D reviews, manufacturers and
| |
| ; distributors, and high-risk applications, such as medical therapy,
| |
| ; radiography, and large irradiators. Specific regulations and guidance in the i high-risk area would be revised to make them more risk-informed and performance-based.
| |
| l
| |
| ! Option 4: Discontinue Regulation of All Medical Activities Except NRC i Oversight of Devices and Manufacturers (National Academy of Sciences l Recommendation)
| |
| In this option, the regulatory authority over all medical uses of byproduct
| |
| ! material would be given to the States, with a Federal agency (not NRC) in a i guidance leadership role. The NRC would retain authority for SS&D reviews, i manufacturers and distributors, and all nonnedical applications. Findings
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| ; under Section 81 of the AEA for exemption or legislation would be required to
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| ] discontinue NRC responsibilities over medical uses. Legislation would be i required to give authority to the States and to name a lead Federal agency.
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| ; Option 5: Discontinue Materials Program In this option, the regulatory authority for byproduct material applications would be given to another Federal agency or the States, with the assumption that an acceptable level of safety would be maintained. The NRC would have no remaining authority for any byproduct materials oversight. Legislation would be required.
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| II. DESCRIPTION OF ISSUES -
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| ) A. Background / Bases ,
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| The key considerations in reexamining the role 2nd scope of NRC's Byproduct Materials Program, and specifically its regulatian of the medical use of j byproduct material, are NRC's responsibilities as defined by the AEA to protect public health and safety, the cosmon defense, and the environment.
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| i Although the Byproduct Materials Program must be performed in response to the AEA, the AEA also provides NRC with broad authority regarding the standards and processes that it applies in implementing this responsibility. This issue paper addresses the extent or scope of a Byproduct Materials Oversight Program i necessary to ensure adequate protection in the use of byproduct materials.
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| Section 81 of the AEA directs the NRC to regulate the manufacture, production, transfer, receipt in interstate commerce, acquisition, ownership, possession, import, and export of byproduct material. Among other things, Section 81 authorizes the NRC "to issue general or specific licenses to applicants seeking to use byproduct material." Byproduct material is defined in Section 11e(1) of the AEA as nuclear materials created or made radioactive by exposure to the radiation during the fissioning process in a reactor. As provided under the AEA, the NRC also regulates Federal licensees in all States. The I NRC has only limited responsibility, however, for regulating uses of nuclear material by the Department of Energy or the Department of Defense.
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| The nuclear materials licensees can be categorized into several major groups covering various products and uses regulated by the NRC and the Agreement States, under either a specific license or a general license.* !
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| : 1. Specific Licensed Nuclear Materials i These groups include (1) broad-scope materials licenses; (2) manufacturers and distributors; (3) hospitals, clinics, nuclear pharmacies, and private physicians; (4) limited research and development operations; (5) measuring l systems; (6) irradiators; (7) industrial radiography; (8) wrU ogging; and (g) other material licenses. All of these licensees are regulated under applicable provisions in 10 CFR Parts 19, 20, and 30 for byproduct materials.
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| In addition, individual sections of Title 10 provide specific requirements for some activities, such as medical, radiography, and irradiators.
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| In addition, the Comission has exempted certain nuclear material uses, activities, and products from regulation. The most wideiy exempted products are residential smoke detectors that contain small quantities of americium-241.
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| l -
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| L.
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT l Presented below are descriptions of the major groups of nuclear materials licensees regulated by NRC and the Agreement States that require a specific license. ,
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| : a. Broad-Scope Materials Licenses The broad-scope licensees include universities, medical schools, large medical centers, large manufacturers, and research and development facilities that cannot operate under a more limited specific license without seriously disrupting their programs. These licensees use nuclear materials for a wide variety of activities, including research and development, laboratory testing, and medical diagnosis and therapy. Broad-scope licenses authorize the use of any byproduct material by anyone in accordance with review and approval procedures and criteria established by the radiation safety consiittee. Under the broad-scope license, the NRC places significant reliance on the organization's radiation safety committee and radiation safety officer to ensure that NRC's regulations are met. At present, the NRC regulates about l 300 broad-scope licensees.
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| l b. Manufacturers and Distributors Manufacturers and distributors of nuclear materials include those that i
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| fabricate SS&Ds (e.g., brachytherapy sources, portable gauges, radiography cameras), as well as those that make radiopharmaceuticals. The manufacturers usually use unsealed nuclear materials that must be controlled to a greater extent than sealed materials. Currently, NRC licenses 129 manufacturers and
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| ; distributors under 10 CFR Part 32. Twenty of these manufacturers also have l received broad-scope licenses from the NRC.
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| l l c. Hospitals, Medical Clinics, Nuclear Pharmacies, and Private Physicians The Medical Use Program represents approximately one-third of NRC's nuclear materials licensees and includes uses of byproduct material in medical diagnosis, therapy, and research. Currently, there are approximately 2,000 NRC licenses authorizing the medical use of byproduct material under 1 10 CFR Part 35.
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| : d. Limited Research and Development Operations l Research and development licenses are issued for possession and use of specifically designated radionuclides in academic institutions, industrial facilities, and medical institutions for nonmedical use. The NRC regulates approximately 500 limited research and development licensees under applicable sections of 10 CFR Parts 20 and 30.
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| : e. Measuring Systems Measuring system licenses are. issued for the possession and use of measuring devices and are regulated under applicable sections of 10 CFR Parts 20, 30, and 70. Measuring systems include fixed gauges for measuring or controlling parameters, such as material density, flow,' thickness, or weight; portable gauges, such as moisture-density gauges used at fixed locations; x-ray fluorescence analyzers; gas chromatographs; and others. The NRC regulates approximately 2,200 measuring system licensees,
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| : f. Irradiators Irradiator licensees use radiation for purposes such as sterilizing blood products, disposable medical supplies, and food and polymerizing compounds in wood finishes. Irradiators are also used for some research applications.
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| Approximately 40 irradiator licensees are authorized, pursuant to 10 CFR Part 36, to possess radioactive material in excess of 10,000 curies each for use in irradiation activities. Several commercial NRC-licensed irradiator licensees use more than 6 million curies to process materials in their facilities. The NRC regulates 204 irradiator licenseer.
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| : g. Industrial Radiography In industrial radiography, radiographers use sealed radiation sources to make x-ray-like pictures of metal objects such as pipes and valves. Radiography is a form of nondestructive testing that uses radiation from sealed sources (principally iridium-192 and. cobalt-60) to examine the internal structure of objects. The portable radiography devices may contain radioactive sources with as much as 200 curies of iridium-192 or 100 curies of cobalt-60. The NRC has issued about 160 industrial radiography licenses pursuant to 10 CFR Part 34.
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| : h. Well Logging In well logging, sealed nuclear sources, unsealed radioactive trace material, and radioactive markers are used for subsurface surveying to obtain geological information. The testing procedures are primarily used in oil, gas, and mineral exploration to identify subsurface geologic formations. NRC licenses
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| : about 60 firms for well logging under the provisions of 10 CFR Part 39.
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| : i. Other Material Licenses i
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| The other types of materials uses that require a specific license include such diverse activities as nuclear laundries, which clean protective clothing i contaminated with radioactive material; leak test and other service companies that provide services to other licensees to leak test sealed sources or
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT devices containing sealed sources, to analyze leak test samples, to calibrate radiation survey or monitoring equipment, or to repair devices containing sealed sources; waste disposal services; and others. The NRC
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| * has about 900 licensees performing these remaining diverse activities.
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| : 2. General Licensed Devices Although specific licensees must submit a license application to the NRC and receive a written specific license, this is not the case for most general licensees.. An NRC general license becomes effective on the basis of the general license provisions in NRC's regulations. In most cases, a general license is effective without the filing of an application with the Commission or the issuance of a licensing document to the license holder. An example would be the acceptance of a nuclear materials product at the point of sale, which would make the buyer a general licensee. l l General license provisions authorize a variety of activities, such as holding I l title to licensed material, as well as use of licensed material contained in a l
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| device. The generally licensed devices must meet regulatory standards for design and manufacture so that they may be used by persons with minimal instruction in their proper use. (As previously discussed, manufacturers and distributors of devices intended for use under a general license must be l specifically licensed for this purpose.)
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| l l Examples of these devices include static eliminators, nuclear gauges, and I l
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| self-luminous signs. An NRC database indicates that there are approximately 35,000 general licensees that use about 600,000 regulated devices. i l
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| l 3. Exempt Distribution Licenses 4
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| l In addition to specific and general license products and uses, the Cosmiission l has exempted certain nuclear material products, quantities, or concentrations l from the requirements for.a license and from the regulations. These
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| ! exemptions have been made with prior findings that such exemptions will not constitute an unreasonable risk to the common defents and security and to the health and safety of the public. Exemptions have been authorized for products such as gemstones, watches with tritium paint, and smoke detectors, once there has been an initial transfer or distribution of the product.
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| l
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| : 4. Sealed Source and Device Reviews l
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| The NRC further exercises its statutory responsibilities by the certification l or registration of SS&Ds. SS&D manufacturers submit specific information on l manufacturing techniques, prototype test results, and other data related to engineering and radiation safety to the NRC or the appropriate Agreement State. These data are evaluated and an SS&D certificate is issued after a l
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| { determination is made that the product is safe for the proposed uses. The NRC
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| ; maintains a registry of SS&Ds approved by the NRC and the Agreement States.
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| j Applicants for specific licenses can reference these apprgved products in i their applications.
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| B. External Factors i i
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| j Notwithstanding the aforementioned oversight process, the operational history and knowledge base inherent in the current nuclear materials industry allows ;
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| ; opportunit19s for streamlining NRC's Regulatory Program. The nuclear i
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| materials industry, with an operational history exceeding 40 years, has a firm
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| ! foundation in the knowledge and understanding of the properties of nuclear
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| ; materials and the applicable handling and radiation safety procedures, as well as the metallurgical and engineering requirements for fabricating SS&Ds.
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| 4 However, even with such an operational history, some factors, such as
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| [ technological advances and aging equipment, may affect streamlining 1 considerations.
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| : 1. Technological Advances
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| ; The nuclear materials industry has been and will continue to be affected by j technological advances in other fields. For example, advanced computer 1
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| technology has been combined with the use of sealed sources for new products )
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| and devices. This has been the case especially in radiation medicine with the advent of the gamma knife (used for brain radiosurgery) and remote y
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| afterloading brachytherapy devices. Technological enhancements are not limited to radiation medicine. As the SS&Ds are affected by more j sophisticated nonnuclear technology, the regulations, review process, and
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| , qualifications of NRC technical staff required to review these applications t may change. In the case of the gaisna knife, for example, there are no 4
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| specific medical use requirements in 10 CFR Part 35, although the regulations do address procedures for conventional cobalt-60 teletherapy devices.
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| : 2. Aging Equipment Additionally, with a mature industry, some licensed nuclear material devices are becoming old and/or obsolete. One result may be increased mechanical and metallurgical problems. Aging devices may warrant special consideration when and if the NRC undertakes to streamline its Regulatory Program, especially in the areas of routine inspections and guidance to licensees.
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| : 3. External Interest i Unlike the organized opposition to nuclear reactors or nuclear waste disposal, the public (in most cases) has been supportive (at times, by remaining silent)
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| , on the use of nuclear materials in medicine, industry, and commerce. There i
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| l have been . times, however, when the public has expressed concern about new uses of nuclear radiation (e.g., opposition to irradiation of fresh foods). For the most part, the external interests in the Materials Program have involved a few concerned citizens, licensees and their associations and professional societies, and the news media. The print media have published in-depth articles on issues such as radiation medicine misadministrations that have resulted in deaths; radioactively contaminated sites whose licenses have been terminated; and reconcentrated radioactive sewage sludges found at sewer treatment facilities. Additionally, Congress has shown and continues to show interest in ,the Nuclear Materials Programs of both NRC and the Agreement States.
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| An example of this external interest is found in the medical use of byproduct materials. During the past several years, the medical community, regulated by NRC and Agreement States, has been very vocal on specific requirements of Part 35. In general, this medical community, including physicians,
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| ; physicists, pharmacists, hospitals, professional associations, and others, regards the detailed prescriptive requirements of Part 35 as unnecessarily burdensome. A specific target has been the regulation on " Quality Management Program and Misadministrations" (the QM rule), which became effective on January 27, 1992. The medical comunity has asserted that. the requirements are an intrusion into medical practice, are cost-ineffective, and have no utility. The QM rule was strongl.', opposed by several professional societies, which made their views known to the Office of Management and Budget (OMB). In June 1992, OMB disapproved the record collection requirements of the QM rule on the basis that the NRC had not demonstrated that the rule would yield significant benefits. The NRC Consissioners overrode the OMB determination, citing the necessity of the information collection requirements for public health and safety. In addition, the American College of Nuclear Physicians and the Society of Nuclear Medicine took the NRC to court to overturn the QM rule. The court ruled in favor of the NRC. Shortly after, in November 1992, a patient in Indiana, Pennsylvania, died as a result of a therapy misadministration. A month later, the Cleveland Plain Dealer ran a week-long series entitled " Lethal Doses: Radiation That Kills." These events resulted in congressional hearings on NRC's Medical Radiation Program and its Agreement States Program that raised questions about the adequacy of control of the medical use of byproduct material by the Nr.C and the Agreement States. As a result of the two opposing, strongly helc' views of the regulated medical l community, and Congress and the media, the Comission directed the staff to reevaluate the Medical Use Program with the assistance and advice of the NAS.
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| To that end, the staff contracted with the Institute of Medicine of the NAS to t
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| perform the external review mentioned earlier in this issue paper. The report l of that review, " Radiation in Medicine: A Need for Regulatory Reform," is discussed in the Attachment to this paper, " Regulation of Radiation in Medicine - IOM Issues" i
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| : 4. Full Cost Recovery .
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| Another significant external factor is the Omnibus Budget , Reconciliation Act of 1990, which requires that the NRC recover almost 100 percent of its budget authority. The number of NRC licensees has declined since about 1990 due primarily to the requirement for full fee recovery. This declining trend will continue, with the number of licensees decreasing by about one third if States that are currently negotiating agreements (Massachusetts, Pennsylvania, Ohio, and Oklahoma) become Agreement States and additional States continue to pursue this status, The reduced number of NRC licensees will further compound the full-fee-recovery cost issue, even though the BPR efforts will likely reduce licensing fees for some categories of NRC licensees. Also, State interest in becoming an Agreement State may be reduced by NRC changes in funding for Agreement State training and technical assistance.
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| C. Internal Factor In addition to the described external factors, an ongoing internal initiative could affect any decision on the role and scope of the Nuclear Materials Program.
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| Business Process Reengineering In 1994, the staff began a major reevaluation of the regulatory process in NRC's oversight of licensed materials. This reevaluation is being carried out as part of a BPR effort. Phase I was completed in the spring of 1995. This phase was directed toward proposing a fundamentally new approach to materials licensing designed to (1) perform at least an order of magnitude faster than the current system; (2) be supported by clear, consistent, and timely regulatory guidance; and (3) ensure that no adverse effect on public health and safety results from its implementation. The new process will use modern information technology to streamline operations. The new approach focuses on including performance requirements in NRC's regulations, discontinuing the current practice of incorporating licensee practices and procedures in license conditions, and considering changes to the duration of materials licenses. As part of these efforts, a rulemaking has been promulgated to extend qualified materials licenses for an additional 5 years.
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| It is envisioned that the BPR will have a significant impact on the entire Nuclear Materials Program during the next several years. The number of licensing actions should signif'.cantly decrease, as should the amount of required review time. Inspections for certain materials licensees will be streamlined or eliminated. Overall, as a result of the reengineering efforts, the NRC's Materials Program should be significantly more efficient and responsive to both the public and licensees. During the past several years, the NRC's Materials Program has remained at about the same level in the use of
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| , RELEASE DATE: SEPTEMBER 16, 1996 10 DSI 7
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| I staff and resources. However, in fiscal year 1997 the program will begin to i decrease in both staff and technical assistance contractual support. This
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| : decrease is due, partially, to the increased efficiencies ,in licensing and
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| , inspection anticipated from BPR, and partially from additional Agreement j States.
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| ; III. DISCUSSIONS l A. Discussion of Direction-Setting Issue 1 .,
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| ) The key considerations in reexamining the role and scope of NRC's Byproduct
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| : Materials Program, and specifically its regulation of the medical use of
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| ! byproduct material, are NRC's responsibilities as defined by the AEA to i protect public health and safety, the common defense, and the environment.
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| Although the Byproduct Materials Program must be performed in response to the AEA, the AEA also provides NRC with broad authority regarding the standards and processes that it applies in implementing this responsibility.
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| ! Also to be considered is the interpretation that the Connission has adopted j and implemented that medical patients are included in the "public."
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| t
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| ; The options on the role and scope of the Nuclear Materials Program are the l result of management and staff review and subsequent initiatives such as the Medical Management Plan, BPR, and planned revisions to 10 CFR Parts 34 and 35.
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| j; Other factors influencing the development of options included resource
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| ; limitations, growth in the number of Agreement States, a desire for increased i efficiency and effectiveness, and the recommendations of the 10M.
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| j Although the primary focus of the Byproduct Materials Program is on protecting i public health and safety. it must also ensure that the extent of control is i tempered by the risk to the public. The focus should be on the safety-
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| { significant issues and on providing timely and consistent guidance and
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| ; licensing that will allow licensees to meet the regulations and standards in
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| ! the most efficient and economic way. In turn, these considerations need to be j viewed in terms of a broader, changing environment. For example, it is
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| ! anticipated that the number of Agreement States will increase over the next 5 years, significantly reducing the number of NRC licensees. The NRC will need
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| ; to consider what steps to take to account for the anticipated reduction in resources. Although the BPR process is a step in the right direction, i additional steps need to be initiated. The NRC may also have to consider
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| : changes in how it regulates areas of low public risk. This issue paper
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| ! addresses the extent or scope of a Byproduct Materials Oversight Program t necessary to ensure adequate protection in the use of byproduct materials.
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| B. Discussion of Subsumed Issue As a part of selecting an option on the future role and seppe of the NRC's Byproduct Materials Program, the following strategic issues should be !
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| considered and resolved as a result of this issue paper.
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| Issue: Nhat should be the role of NRC in regulating the medical use of ;
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| nuclear material?
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| Under the AEA, NRC has responsibility for two categories of radiation medicine I use. Regulation of these two broad categories represents approximately one- I third of NRC's Nuclear Materials Program. One category of radiation medicine is nuclear medicine, which employs radioactive drugs (radiopharmaceuticals).
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| These drugs usually contain only very small quantities of radioactive ;
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| material, which is used primarily for the diagnosis and followup of disease. l Nuclear medicine occasionally includes the use of larger quantities of l unsealed radioactive material for therapy, especially for diseases of the I thyroid gland. The other category of radiation medicine is radiation therapy (radiation oncology). In radiation therapy, larger quantities of radioactive material, usually in the form of sealed sources, are used primarily in cancer treatment. Sealed quantities of radioactive material are used both external to and within a patient. Sealed radiation sources regulated under the AEA are used in about 25 percent of radiotherapy treatments. Radiation produced by ) i electronic devices not regulated under the AEA, such as x-ray equipment and i 1 linear accelerators, is used in the other 75 percent of treatments. ]
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| Therapeutic radiation devices,'such as a gasmaa knife, may contain more than 6,000 curies, while diagnostic nuclear medicine procedures may be limited to i microcurie or millicurie quantities. .
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| By authority of the AEA and Commission policy, the NRC regulates the medical use of nuclear materials as necessary to provide for the radiation safety of workers and the general public. NRC also rsgulates the radiation safety of patients when justified by the risk to patients, but minimizes the agency's intrusion into medical judgments affecting patients and into other areas traditionally considered to be the practice of medicine. The NRC recognizes that physicians have primary responsibility for the protection of their patients. NRC regulations assume that authorized physician users, with appropriate training and experience, will make decisions in the best interest of their patients.
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| Over the years, the Commission has made a concerted effort to improve and strengthen the Medical Use Program. Following a 1976 report of hundreds of patient overexposures at Riverside Methodist Hospital in Columbus, Ohio, NRC took action to upgrade its regulation of radiation sources in medical use.
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| Also, in February 1979, NRC issued a policy statement to guide its Regulatory Program in the medical area. A fundamental tenet in the policy statement is 4
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| i the commitment to protect patient safety without intrusion into the practice ,
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| ! of medicine. However, there has been frequent tension with the regulated I i medical community on a number of medical use regulatory igitiatives that have i been opposed by members of the regulated community as an intrusion into the 1 i practice of medicine. This tension and opposition to NRC's regulation of the
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| ] medical uses of byproduct material have been a continuing problem.
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| t l
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| i Additional problems arise from the jurisdictioral responsibilities for the different sources of radiation. Jurisdiction over various aspects of the regulation and use of ionizing radiation in medicine is exercised by both the Federal Government, primarily through the Department of Health and Human Services, the Food and Drug Administration (FDA) and the NRC, and the States.
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| Within this regulatory framework, the NRC has jurisdiction over the medical use of byproduct and special nuclear material and regulates radiation safety associated with the actual use of these products. The FDA regulates the manufacture and distribution of radiopharmaceuticals, biologics, and medical devices for safety and efficacy. For the most part, FDA does not regulate at the user level. The States have broad regulatory authority over the general ;
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| public health and safety of their residents. This includes authority over the use of all sources of ionizing radiation, except AEA material, which is regulated by the NRC. The States control most of radiation medicine, but the degree to which they exercise control varies from State to State.
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| In Igg 2, the staff began to develop a Medical Management Plan to guide the conduct of the Medical Use Regulatory Program. Although delayed as a result of staff actions in response to a radiation therapy misadministration and the associated patient fatality, media interest, and congressional hearings, the plan was subsequently completed and initiated. In parallel, the staff was i directed by the Commission to initiate an external review of the Medical Use Regulatory Program.
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| As a result, NRC contracted with the NAS in 1994 for the ION to conduct that external review, addressing not only the role of the NRC but also the roles of the FDA and the States in this area. The IOM has completed its review and recommended that regulatory authority over medical uses of byproduct material be given to the States. The IOM also reconnended that only licensed users have access to byproduct material and identifies the Department of Health and Human Services (DHHS) as the agency that should exercise a leadership role in the radiation safety community. Further, the report suggests that DHHS assist in developing recommended State laws and regulations, act as an information clearinghouse, and distribute resources for training and research.
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| The NRC has reviewed the IOM recommendations at length and has held several public meetings on them. As of August, 1996, the NRC had received 41 comments on the subject. Althcugh some connentors supported the recommendations, the CRCPD expressed concern about the elimination of the entire medical use RELEASE DATE: SEPTEMBER 16, 1996 13 DSI 7
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| . . . - - . - - - . - . __ ..- - - -.~ - -_ -.-. - - - -.- - - .- -
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| j program and the absence of Federal authority in the medical use area. DHHS
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| ! stated that it could not support the recommendation that it provide the j leadership role suggested by ION. A more extensive summar,y of the
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| ; recommendations and comments appears in the Attachment to this paper, j '' Regulation of Radiation in Medicine - ION Issues" l IV. OPTIONS 4
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| i In this section, the five options described earlier are detailed, including, j if applicable, required regulatory or legislative changes, impacts, resource
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| ; implications, and the reaction of stakeholders.
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| ! Option I: Increase Regulatory Responsibility With Addition of X-ray,
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| : Accelerators, and Naturally Occurring and Accelerator-Produced Radioactive j Materials 1
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| j Option i
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| l Under this option, the NRC would continue with its ongoing program and improvements and seek legislation for regulatory oversight of other sources of ionizing radiation, including x-ray, accelerators, and discrete NARM. Discrete 1 sources of NARM include radium sources used in medicine and industry and the i wastes resulting from cyclotrons and linear accelerators. They do not include ,
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| j wastes from the mining and processing of radium or other radionuclides. An j Agreement States Progrks would continue. This option would significantly
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| : increase NRC's jurisdiction in the control of ionizing radiation; it would j result in responsibility being taken away from other Federal agencies and the i States. Variations of this option could include consideration of limiting
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| ; oversight to specific applications, such as industrial and camarcial uses, or j to only those applications that pose a high risk (Option 3).
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| Regulatory Changes
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| ! Legislation would be needed to remove the responsibility for the regulation of these sources of radiation from other Federal agencies and the States and to j transfer it to NRC. Coupled with this action would be new and revised policy i statements, such as the 1979 Medical Policy Statement, memoranda of i understanding with other Federal agencies, and agreements with the Agreement States. Rulemaking to expand and modify existing regulations and generation or revision of the companion guidance documents for the NRC staff and j licensees would be necessary.
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| ; Impacts .
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| This option would ensure increased uniformity and consistepey in the regulation of all sources and uses of ionizing radiation. It would avoid substantive differences in regulations and oversight between AEA and non-AEA sources of radiation. Also, it could eliminate regulatory advantage of one radiation modality over another for a given application (e.g., x-ray radiography versus gasma radiography). This option would require an expansion of IRC's technological base to include specialists in x-ray and accelerator equipment . and the medical and commercial uses of this equipment. It would result in a significant increase in the number of NRC licensees (which would ;
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| multiply 5 to 10 times), especially in the medical area. This increase would '
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| require additional personnel and physical resources, including the possibility of additional regional offices. Such wide-sweeping legislation may be ,
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| difficult to support in the absence of a compelling safety problem.
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| The resources required to develop the necessary legislation would include resources from the other Federal agencies currently providing some radiation protection or source and device oversight (e.g., FDA, the Environmental Protection Agency [ EPA)), as well as NRC. A comprehensive program that would implement such legislation, that is to regulate all discrete NARM, including promulgation of regulations, guidance development, and inspection at frequencies comparable to those of similar NRC licensees, could require several hundred full-time equivalent (FTE) positions.
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| The Advisory Coenittee on Medical Uses of Isotopes (ACMUI) would need to be expanded to include other areas of expertise such as diagnostic and interventional radiology.
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| Reaction of Stakeholders As described in more detail in Option 4, the Agreement States that now have authority for non-AEA sources support the approach for a single Federal agency to be responsible for all radiation use.
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| Option 2: Continue Ongoing Program (With Improvements)
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| Option Under this option, the current regulatory responsibility of NRC and the States would be maintained. However, there would be continual improvements to increase efficiency and revision of regulations to make them more risk-informed and performance-based rather than prescriptive. Some of these -
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| improvements are ongoing or are on temporary hold (e.g., BPR and Part 35 revisions).
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| RELEASE DATE: SEPTEMBER 16, 1996 15 DSI 7
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT The ongoing BPR of the licensing process will result in the use of modern information technology to streamline operations. The envisioned new licensing process is composed of three major concepts: (1) a Regulatory Product Design Center in which technical members of the matrials licensing and inspection community can interact face to face or b/ way of the computer, to design and prepare the regulatory products necessary to support, maintain, and enhance the new licensing process; (2) improved processing of licenses through l reviewer-performed and computer-assisted licensing, using a graded approach consensurate with the safety hazards the application poses; and (3) a new way of working in agency-wide teams. The agency-wide team concept, based on BPR j philosophy, will include such attributes as collaborative team-based decisions ;
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| and parallel concurrences.
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| In addition, NRC is identifying regulations that are obsolete, unnecessarily burdensome, too prescriptive, or that overlap or duplicate the regulations of other agencies. As part of this effort, NRC is reviewing Part 35 to evaluate whether it can be revised to reflect a more risk-informed, performance-based regulation. To this end, the staff has requested input from the ACMUI and the Agreement States on what revisions should be made to Part 35 if NRC were to retain its current statutory authority and also if NRC were to ramp down in the regulation of patient safety. Examples of staff-identified and staff-suggested requirements needing revision or possible rescission include the As Low As it Reasonably Achievable (ALARA) Program, the Quality Management program, the misadministration definitions and reporting, dose calibrator checks, surveys, calibration of devices (using industry standards where possible), and training and experience requirements. Other sections of the regulations pertaining to materials are also being reviewed for appropriate revisions.
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| Regulatory Changes l No legislative changes are needed to implement this option. However, rulemaking would have to be initiated to revise the byproduct materials i regulations, such as Part 35. In addition, internal guidance documents (e.g.,
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| inspection procedures, standard review plans, etc.) as well as several regulatory guides, including Regulatory Guide 10.8, would have to be revised to reflect the proposed changes.
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| Impacts This option would result in the development of more risk-informed, performance-based regulations and increased agency efficiencies obtained by implementation of BPR initiativas. -
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| l RELEASE DATE: SEPTEMBER 16, 1996 16 DSI 7 l
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| l l
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| ! DSI 7 MATERIALS / MEDICAL OVERSIGHT Amending the regulations and modifying guidance documents and associated i regulatory guides has already been budgeted as part of the' Medical Management j plan. No additional resources would be necessary for the joedical use area.
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| Also, an overall reduction in needed materials resources fs anticipated over l the next 5 years. This reduction is predominantly due to the increased i efficiencies anticipated with the implementation of planned BPR initiatives, ,
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| as well as anticipation that there will be an increase in the number of l Agreement States within the next 5 years. This possibility could result in a l
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| : reduction of approximately 20 FTEs by the year 2000. I i ..
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| Reaction of Stakeholders ,
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| i Based on ION interviews and comunents on the IOM report, many medical licensees
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| ; would continue to support NRC's divesting itself of responsibilities in the l medical area.
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| l Option 3: Decrease Oversight of Low-Risk Activities With Continued Emphasis of High Risk-Activities Option i
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| l This option places priority on the tenet that the regulation of byproduct
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| ! materials should be consistent with the risk involved. Although the NRC has j effectively regulated areas of high risk (e.g., manufacturers, large j irradiators, etc.), it may be overregulating areas that involve low-risk j activities or sources. Low-risk activities could include the use of devices
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| : such as gas chromatographs and certain gauges, and diagnostic nuclear i medicine. The oversight of these low-risk activities may be an unnecessary l expenditure of resources because of the limited additional protection it j provides.
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| i Under this option, the NRC would modify its existing regulatory responsibility 4
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| of low-risk activities and maintain its current responsibility (with some program modifications) for high-risk activities. This could be accomplished through policy decisions on decreasing or discontinuing oversight in certain i areas, rulemaking, or an agreed-upon definition of low risk established and
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| : coordinated with other Federal agencies, the States, and the conduct of a l public comment process. This option would encompass the overall Materials Program and would affect medical as well as nonmedical programs. The low-risk i applications could be placed in a category of licenses (such as general i licenses) that warrants minimal regulatory oversight with no formalized l inspection frequency and minimal licensing requirements. However, some audit l activity might have to be established to periodically assess the general
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| ; licensee's byproduct material possession and performance.
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| i RELEASE DATE: SEPTEMBER 16, 1996 17 DSI 7 0
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| a DSI 7 MATERIALS / MEDICAL OVERSIGHT Once low risk has been defined, this option would necessitate reevaluation of those licensees currently licensed by the general license provisions, as well as those activities previously determined to be exempt frpm regulation. A reassessment of these licensing categories may result in moving activities and uses from one category to another.
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| In this option, the NRC would probably maintain its current level of regulatory oversight for the manufacturers of radiopharmaceuticals and sealed sources because these activities would most likely be considered higher risk activities.. The NRC would also maintain its current level of regulatory oversight for other high-risk applications, such as therapeutic uses of byproduct material, large irradiators, and industrial radiography. For the high-risk applications, the existing specific regulations would be revised to be more risk-informed and performance-based, or consideration may be given to limiting oversight to Part 20 compliance only.
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| Regulatory Changes The transfer of some of the current specific licenses to general licenses or to some other category that warrants minimal regulatory oversight would not require legislative changes. .The transfer of low-risk activities to general licenses would require modifications to current general license regulations in Part 31, as well as modifications to current licensing regulatory guides, ,
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| internal standard review plans, and inspection procedures.
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| Impacts This option would result in increased efficiency and effectiveness within the agency by focusing NRC's limited resources on higher risk activities and those licensees that warrant enhanced oversight because of poor performance. This option might result in the elimination of approximately 50 percent of the NRC's current specific licensee base. For the remaining high-risk licensees, the NRC would revise the applicable regulations and guidance documents using a tisk-informed, performance-based approach.
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| It is anticipated that a few FTEs over about a year would be required to complete an analysis and recategorize licensees. If NRC completely discontinues its oversight of the low-risk activities, associated legislative efforts may also require several FTEs over several years.
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| With NRC either completely discontinuing its regulatory oversight of lower risk activities or reducing its oversight, the current specific licensee base could be decreased by about half. Allowing for some resources to track and audit general licensees, a reduction of approximately 50 FTEs from current licensing, inspection, and other materials activities might be realized. This reduction includes those FTEs eliminated by the BPR.
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| RELEASE DATE: SEPTEMBER 16, 1996 18 DSI 7
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| l1 DSI 7 MATERIALS / MEDICAL OVERSIGHT I
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| Option 4: . Discontinue Regulation of all Medical Activities Except NRC Oversight of Devices and Manufacturers (National Academy of Sciences Institute of Medicine Recommendation) ,
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| Option Under this option, the NRC would request that Congress (1) discontinue NRC's regulatory authority over all medical uses of byproduct material (including biomedical research), (2) give this regulatory authority to the States, and i l
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| (3) name another Federal agency (not NRC) to a guidance leadership role. The 10M report has recousanded that this Federal agency be the DHHS. The
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| ; leadership role would be nonregulatory and would assist in developing l recommended State laws and regulations, act as an information clearinghouse, j and distribute resources for training and research. In this option, the NRC l would retain responsibility for oversight of the manufacture and distribution l of byproduct material (including SS&Ds) used in medicine. Further, NRC would I
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| condition these licenses to require that products could only be distributed to users who were licensed by a State. Also, the Conference of Radiation Control Program Directors (CRCPD) would continue to develop its acdel regulations for adoption by the States. The CRCPD would be expected to continually reevaluate its regulations to maintain congruence with any scientific advances in L knowledge on radiation bioeffects, and benefits and risks of the medical uses
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| ! of ionizing radiation. The NRC's ongoing program for nonmedical licensees would remain as in Option 2.
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| Regulatory Changes 1
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| Legislation would be needed to remove responsibility for the regulation of the l medical uses of byproduct material from the AEA. In lieu of legislation, if NRC made the requisite findings under Section 81 of the AEA, the NRC could by
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| " exemption" eliminate this aspect of the Materials Program. Rulemaking to rescind or modify regulations in Parts 30, 33, and 35, among others, would follow. This route would require public notice and consent rulemaking.
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| Coupled with these actions would be a revision or rescission (in whole or in part) of the 1979 Medical Policy Statement, the enforcement policy, agreements with the 29 Agreement States, and the memorandum of understanding with the FDA, as well as NRC regulatory guides, manuals, and directives.
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| Impacts This option would result in the elimination of approximately one-third of the NRC's current specific licensee base. The States would be responsible for all radiation medicine applications, which would result in the potential for l increased uniformity of the regulation of all radiation medicine within a given State. However, the level of oversight may vary considerably from State to State because currently some States provide oversight (licensing and RELEASE DATE: SEPTEMBER 16, 1996 19 DSI 7 l
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT inspection) through State radiologic health personnel, and others by a simple registration process. Additionally, inconsistencies could develop between regulation of basic radiation safety in medical and nonnedical applications.
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| Finally, DHHS does not support the 10M's recommendation that DHHS be given a leadership role.
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| Some of the non-Agreement States may lack the resources, including qualified ,
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| personnel, to set up their own safety programs and decide not to regulate in !
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| this area and both the Agreement States and the non-Agreement States may view the action ps an unfunded mandate. Also, revision of the agreements with each of the 29 Agreement States would be necessary. Additionally, the event l database would no longer include misadministrations or events involving overexposures to workers or members of the public (non-patients) as a result of the medical use of byproduct material. Federal facilities would be responsible for self-regulation of the medical uses of byproduct material.
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| Proposed legislation would need to address State regulation of Federal authorities or facilities.
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| For those facilities conducting both biomedical and nonmedical research, there would continue to be a dual system of regulation.
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| Resources associated with efforts for legislation and rulemaking would entail a few FTEs for a period of about 5 years. ,
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| The Medical Use Program includes approximately 50 FTEs, which would be eliminated. The majority of these FTEs, approximately 70 percent, come from the regional materials licensing, inspection, and event evaluation activities.
| |
| Also, the number of medical consultants under contract to NRC could be reduced from app.c::i=stely 12 (current) to less than half that number. These consultaats are used on an as-needed basis in response to medical misadministrations resulting in an overe::posure, as well as nonnedical events that might require the services of a physician or a scientist consultant to assess radioactive dose estimates and possible consequences. Currently, the majority of provided services is in response to medical misadministrations.
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| Reaction of Stakeholders As of the end of August 1996, the staff had received 50 written cossnents on the 10M report. The two major categories of responses are either in support of, or opposition to, the overall recommendations of the IOM committee.
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| However, within each of these major categories, there are subsets with respect to the specific direction or focus of the consnents. None of the comments received specifically indicated that there should be no Federal involvement.
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| . RELEASE DATE: SEPTEMBER 16, 1996 20 DSI 7
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| - - . -. J
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| 4 i -
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| ; DSI 7 MATERIALS / MEDICAL OVERSIGHT l
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| 4 d
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| The Secretary of the Department of Health and Human Services (DHHS), the j Federal agency that would be most directly affected by the IOM recommendations, indicated that the report does not make a com
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| ! health agreement for DHHS to assure the recommended new roie.Furthermore, pelling public
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| ;~
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| D M raised a concern that Congress would not provide resources commensurate i
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| with the added responsibilities.
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| j The majority of comments received (32 out of 47) did not endorse the full range of recommendations put forth by the 10M cosmiittee. Four of the 15 l respondents,that supported the recommendations indicated that the i
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| recommendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in its support of the IOM report, indicated that legislative initiatives should ensure that Federal facilities are not j subject to State and local regulations.
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| i The comments that did not support all the IOM reconumendations varied i dramatically in the focus of their viewpoints and opinions. The degree of j
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| ' regulatory reform perceived to be necessary ranged from simply recognizing the merits of the issues raised by the ION comunittee to a need for a complete
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| ' restructuring of the regulatory program. The non-Agreement States that i
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| responded were particularly concerned about the substantial financial impact of the recommendations and the issue of this being, in effect, an unfunded Federal mandate. For example, as indicated in the response from Hawaii, public health and safety could be jeopardized in those States with 4
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| insufficient resources or capability to adequately implement the regulation of byproduct materials. The Department of Defense response, which summarized the i
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| responses from the three Service Medical Departments (Army, Navy, and Air
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| ! - Force), supported the need to re-evaluate the current regulatory structure but emphasized the need for a uniform regulatory authority. There were several responses that recommended the need for Federal oversight for all uses j
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| of radiation.
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| } The Organization of Agreement States response provided a summary of the j consensus of thu participants of the NRC and Agreement State technical 4
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| workshop conducted March 5-6, 1996, which included that all radiation use (medical and non-medical uses) should be consolidated under one Federal agency. The CRCPD prepared a position paper, which supported the leadership i role of a single federal agency for all forms of ionizing radiation, at their May 6 meeting. The comments of these organizations are summarized in Appendix 3 to the Attachment to this Issue Paper.
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| 4 i-i 1
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| j RELEASE DATE: SEPTEMBER 16, 1996 21 DSI 7 l
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| j j
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| i
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| { DSI 7 MATERIALS / MEDICAL OVERSIGHT i
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| j Option 5:. Discontinue Materials Program Option ,
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| 4
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| ; Under this option, the NRC would requ?st that Congress discontinue NRC's J regulatory authority over all byproduct material uses, give this regulatory authority to the States, and name a Federal agency (not NRC) to a guidance
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| : role for all sources of radiation, as discussed in Option 4. This option presumes that an acceptable level of safety would be maintained by the States.
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| ; The NRC would have no remaining authority for any byproduct materials
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| ; oversight. This option is an extension of the previous option to all materials uses.
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| Also, there would be no change in the proper disposal of byproduct materials j at low-level waste disposal sites.
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| l Regulatory Changes This might be viewed as subject to the procedures of the Unfunded Mandate i legislation. Legislation would be needed to remove responsibility for the reguistion of all uses of byproduct material from the AEA. Rulemaking would ,
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| e be needed to rescind the regulations in 10 CFR Parts 30 through 39, and 1
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| ; certain policy statements and memoranda of understanding would have to be ,
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| )
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| rescinded or drastically revised. Also, all agreements with the 29 Agreement '
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| States would have to be rescinded.
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| Impacts l
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| ; In addition to the impacts described in Option 4, this option would result in l elimination of NRC's oversight of all specific and general byproduct materials
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| ; licenses, thereby dramatically decreasing the resources of the Office of
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| : Nuclear Material Safety and Safeguards (NMSS) and the Office of State Programs. The States would be responsible for all medical, academic, and commercial applications of byproduct materials.
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| : The lead Federal agency could possibly serve as a safety backup if a State requested assistance. The lead Federal agency role could be filled by an existing Federal agency such as the EPA, DHHS, or the Occupational Safety and Health Administration, with legislation modifying its authorities and responsibilities. Alternatively, a new agency or office within an existing agency could be created, thereby consolidating activities currently vested among several agencies. Greater uniformity might be achieved by consolidating a guidance role in one federal agency. However, because each State would be
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| ; responsible for implementing its regulatory program as it deems appropriate, 1 there could potentially be quite diverse programs among the 50 States.
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| 4 RELEASE DATE: SEPTEMBER 16, 1996 22 DSI 7 1
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| 4 .
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT I Resources associated with efforts for legislation and rulemaking would entail
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| ! several FTEs over a period of 5 to 7 years.
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| ! The maber of budgeted FTEs for the Byproduct Materials Pr'ogram is
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| ! approximately 140 FTEs in Headquarters and the regions. These FTEs include
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| ; all managers and technical, administrative, and support staff. Nearly all of
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| ; these FTEs could be eliminated or redirected, in part, to other activities, l recognizing that a few FTEs would be needed to handle residual activities. In
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| ! addition, staff from other NRC offices who support the NMSS Byproduct
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| ! Materials fr.ogran could be reduced by the current number of FTEs that handle j byproduct materials issues or provide support to this NMSS Program.
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| I j Reaction of Stakeholders I Reaction from the regulated'comununity could depend on whether consensus
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| ! develops among the States to follow the guidance established by the federal
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| : agency. Manufacturers of some sources and devices could be particularly
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| : concerned about the possibility of having to comply with a multiplicity
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| { of State requirements.
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| The Agreement States might support this option to the extent they find it j consistent with their consensus view described in Option 4.
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| Federal agencies would self-regulate. Some indicated in their coments on the
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| ; ION report that they did not have the resources necessary to develop and
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| ! implement an oversight program, as indicated in the Department of Defense's
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| ; comments on that report.
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| I V. RELATED ISSUES l After the Commission has made decisions concerning the Direction-Setting and l Subsumed Issues discussed above, additional issue (s) such as those related to j implementation details will be addressed as the Strategic Plan is implemented.
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| ; The Related Issues are listed in this section to provide a more complete
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| } understanding of the higher level Direction-Setting and Subsumed Issues.
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| A. Is escalated enforcement effective in preventing future violations by l materials licensees? Would it be more effective to augment the inspection 1
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| process than to impose civil penalties?
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| l t
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| i This is a Commission issue because it involves the Commission's i reconsideration of its policy on its Enforcement Program for materials l licensees and may lead to rulemaking. It is related to the DSI because NRC's enforcement policy for materials must reflect the philosophy established by the DSI. It is a related issue rather than a subsumed issue because it will j
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| i 3
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| i RELEASE DATE: SEPTEMBER 16, 1996 23 DSI 7
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| ?
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| 2
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| i .
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT reflect the extent to which the materials licensee community follows NRC's enforcement activities and will be addressed in more detail than is appropriate for the DSI. ,
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| B. What should be the NRC's policy relative to the need for and the frequency of renewals for materials licensees?
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| l This is a Commission issue because a change to the current frequency of renewals will involve policy and perhaps rulemaking. This issue is related to the DSI because the DSI will establish how important materials license e
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| renewals will be in the future. It is a related issue rather than a subsumed issue because different classes of materials licensees may require different renewal policies. Such differentiation will lead to more detail than is appropriate for the DSI. The staff is actively engaged in addressing this issue.
| |
| C. What should be NRC's policy relative to frequency of renewals for fuel fabrication facility licenses?
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| This is a Commission issue because a change in the current frequency of renewing fuel fabrication facility licenses will involve policy and perhaps rulemaking. The issue is related to the DSI because the philosophy for
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| ; renewing fuel fabrication facility licenses should be consistent with the ;
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| a philosophy for renewing materials licenses to be developed here. It is a related issue rather than a subsumed issue because it will reflect such aspects of fuel fabrication facility regulation as criticality concerns, which are beyond the scope of this DSI.
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| ~
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| 'f D. Does NRC have an acceptable program, given that history and operating experience have required revocation of very few licenses? Is there a set of licensees that NRC should be regulating differently?
| |
| Rather than revoke licenses or reject applications, NRC generally helps bring weak licensees and applicants up to acceptable standards. Such activities are often very staff-intensive and include multiple deficiency letters, pre-licensing meetings, and site visits; confirmatory action letters; increased inspection frequencies; enforcement conferences; and imposition and monitoring of "Get Well Programs." Although such activities generally bring weak licensees up to acceptable standards, this may not be the most cost-effective use of NRC's limited materials resources.
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| This issue, originally a subsumed issue, goes beyond the question of whether NRC should regulate a certain materials area and concentrates on the "how" or the methodology of regulation. As such, this issue will be directed by the j decisions made on the Byproduct Materials Program and will require an in-depth l
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| RELEASE DATE: SEPTEMBER 16, 1996 24 DSI 7 4
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| -,r,- - - - , , - - , -,,--,a.--,=-.w , , - - - - - ,
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| - - - - - . - - - - . - .- - - . - = - . - - - . - - . - . _
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| r DSI 7 MATERIALS / MEDICAL OVERSIGHT evaluation that is beyond tha. scope of the current issue paper. For these reasons, and depending on decisions by the Commission, this subsumed issue will be addressed as a related issue. ,
| |
| E. Should a single Federal agency regulate radiation safety?
| |
| This issue is directly linked to the Agreement States' comments on the IOM recommendations in which the Agreement States technical staffs said that "All radiation use (medical and nonnedical uses) should be consolidated under 2ne Federal agency to include NARM, AEA material, and machine-produced radiation.
| |
| Consensus was not reached as to which Federal agency should have the authority, or whether it should be an existing agency."'
| |
| l It appears most appropriate to consider the issue of single agency l
| |
| j jurisdiction from several perspectives. As stated above, a single agency
| |
| ' could be responsible for radiation regardless of source, to include AEA material, NARM, and machine-produced radiation. Alternatively, a single agency could hold all authorities, to include such authorities as standard-setting (now vested in EPA), approval of medical devices and l radiopharmaceuticals (now in DHHS),and applications (now in NRC).
| |
| This is a Commission issue because it involves policy concerns that are fundamental to NRC's mission, that in fact go beyond _NRC's regulation of materials to include its regulation of nuclear reactors as well. It is clearly a related, rather than a subsumed, issue, because it is well beyond the scope of this DSI.
| |
| V. COMMISSION'S PRELIMINARY VIEWS Staff actions regarding the various options should be held in abeyance pending l
| |
| the Commission's final decision on this issue paper.
| |
| The Commission preliminarily favors a combination of Option 2 (Continue the Ongoing Program with Improvements) and Option 3 (Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities). In implementing Option 3, the NRC would utilize the risk-informed performance based approach, as discussed in DSI 12, to determine which activities in the materials area, and specifically in the medical area, are low-risk activities.
| |
| The general approach described in Option 3 of this DSI appears to be a -
| |
| reasonable starting point for identifying the types of activities that can be affected by this process.
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| l 3
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| 8eport of Joint NRC/ Agreement State technical workshop, March 5-6, 1966 j RELEASE DATE: SEPTEMBER 16, 1996 25 DSI 7 i
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| DSI 7 MATERIALS / MEDICAL OVERSIGHT In implementing these options with regard to the NRC's medical program, the NRC would consult with its Advisory Committee on the Medical Uses of Radioisotopes (ACMUI) for guidance on low-risk medical activities, revisions to 10 CFR 35, and possible implementation methods. The NRC would also evaluate the feasibility of using professional medical organizations and societies as a potential source for developing professional standards and guidance that would be adhered to by NRC medical licensees and could be adopted by the NRC as regulatory requirements.
| |
| In the publjc comeents on this issue, the NRC particularly solicits the views of other affected organizations such as the Organization of Agreement States and the CRCPD on applying a risk-informed performance based approach to NRC's oversight of medical activities. The NRC also solicits the public's views on the feasibility and desirability of NRC's striving to have the remaining non-Agreement States acquire Agreement State authority for medical-use only. In addition, the Commission solicits the public's views on whether a single agency should regulate radiation safety. Finally, the NRC specifically steks comments on the Attachment to this issue paper titled " Regulation of Radiatiin in Medicine - 10M Issues."
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| l! ,
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| i l
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| I RELEASE DATE: SEPTEMBER 16, 1996 26 DSI 7
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| l 1
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| l l 1 l DSI 7 MATERIALS / MEDICAL OVERSIGHT ACRONYMS
| |
| , 1 ACMUI Advisory Connittee on Medical Uses of Isotopes AEA Atomic Energy Act ALARA As Low as is Reasonably Achievable BPR Business Process Redesign CFR Code of Federal Reaulations CRCPD Conference of Radiation Control Program Directors DES Department of Health and Human Services DSI Direction-Setting Issue EPA Environmental Protection Agency FDA Food and Drug Administration l
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| FTE Full-Time Equivalent ION Institute of Medicine NARM Naturally Occurring and Accelerator-Produced Radioactive Materials NAS National Academy of Sciences MSS Office of Nuclear Material Safety and Safeguards NRC Nuclear Regulatory Comission OMB Office of Management and Budget QM RULE Quality Management Program and Misadministrations SS&D Sealed Source and Device l
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| ! RELEASE DATE: SEPTEMBER I6, 1996 27 DSI 7
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| . DSI 7 ATTACMENT MATERIALS / MEDICAL OVERSIGHT REGULATION OF RADIATION IN MEDICINE - lOM ISSUES' I INTRODUCTION i
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| Under the Atomic Energy Act (AEA), the Nuclear Regulatory Comission (NRC) regulates the medical use of reactor - generated radioactive materials to provide for the radiation safety of workers and the general public. It also regulates the radiation safety of patients when justified by the risk. NRC's responsibilities include the regulation of radiopharmaceuticals ~and sealed sources, but not machine-produced x-rays nor naturally occurring or accelerator produced radioisotopes.
| |
| Over the years, NRC has had a concerted effort to improve and strengthen its Medical Use Program. In these efforts, it has repeatedly addressed two difficult issues; how can it best protect patient safety without intruding into the practice of medicine; and how can it best deal with the numerous l jurisdictional responsibilities for different sources of radiation? To obtain !
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| external advice on these and other issues, in 1994 the NRC contracted with the l Institute of Medicine (IGM) of the National Academy of Sciences (NAS) to ;
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| review NRC's Medical Use Program and to address the roles of the regulatory ;
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| agencies in this area. In December, 1995, the ION provided NRC with a !
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| l propublication copy of its report, " Radiation in Medicine - A Need for Regulatory Reform." The final report was issued in March 1996.
| |
| The report documents the temittee's consideration of seven alternative I regulatory systems, ranging from no regulation (laissez-faire) to Federal control of all aspects of medical care. Between these extremes, the comittee considered a variety of Federal and State regulatory systems. The comittee concluded that the Federal government should relinquish regulation of radiation in medicine to the States, with the Department of Health and Human Services (DHHS) providing support, coordination, and guidance to them. To bring about this change, the committee made eight recomendations; two to Congress, three to the NRC, and three to the Conference of Radiation Control Program Directors and the States.
| |
| This document provides an overview of the comittee's report, including issues identified by the NRC staff about each of the recomendations, and a sumary of the public coments received to date, ;
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| ' Some of the text in this paper closely parallels text in the Institute of Medicine report which is the subject of this paper, i
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| 1 DSI 7 ATTACHMENT
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| , RELEASE DATE: SEPTEMBER 16, 1996
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| | |
| - DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT l l
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| l The second section of this report, " Background," briefly discusses the use of I radiation in medicine,.the regulatory authorities of the Federal and State ;
| |
| agencies, NRC's particular responsibilities, regulations, and activities, and a summary of the history of the NRC program which led the agency to seek a review of its Medical Use Program.
| |
| The third section of this report summarizes the ION comr.ittee's view of the present situation, and describes the seven alternative regulatory systems _
| |
| considered by the committee. It describes each alternative and presents the committee's views of the positive and negative aspects of that alternative.
| |
| It concludes with the committee's basis for selecting its preferred alternative, State Regulation with Federal Guidance.
| |
| The. fourth section of this report addresses the committee's recommendations associated with the preferred alternative. It contains a brief description of each recommendation, a summary of the committee's rationale for the recommendation, the NRC staff's principal issues, and some pertinent public comments.
| |
| The fifth section documents NRC actions on the report to date and provides a general summary of the 47 comments received so far. Lists of specific commentors and brief summaries of their comments appear in appendices.
| |
| )
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| II BACKGROUND This section contains a brief description of the ways ionizing radiation is used in medicine, followed by a discussion of the Federal and State regulatory authorities over that radiation. It then summarizes NRC's medical use program including its applicable regulations, its licensee community, and its activities. It then sketches the history of NRC's efforts to improve the program, including the events and issues that led NRC to seek a review by the NAS. Finally, the section documents NRC's goals for the study and the recommendations NRC requested from NAS.
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| Ionizing radiation is used for both diagnosis and treatment. Diagnostic uses i are classified under two basic headings; radiology and nuclear medicine. In radiology, (such as the use of x-rays) the radiation administered is external to the patient; in nuclear medicine, it is internal. Nuclear medicine employs radioactive drugs (radiopharmaceuticals). When used for diagnosis or followup, these drugs usually contain only very small quantities of radioactive material.
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| Ionizing radiation used for treatment is also typically classified into categories depending on whether the source of radiation is external or internal to the patient. These areas are called teletherapy (external RELEASE DATE: SEPTEMBER 16, 1996 2 DSI 7 ATTACHMENT
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT sources), brachytherapy (internal) and therapeutic nuclear medicine (internal). Brachytherapy and teletherapy use sealed sources; therapeutic nuclear medicine uses radiopharmaceuticals. In radiation therapy, larger quantities of radioactive material, usually in the form of sealed sources, are used primarily in cancer treatment. Sealed radiation sources regulated under the AEA are used in about 25 percent of radiotherapy treatments. Radiation produced by devices not regulated under the AEA, such as linear accelerators, is used in the other 75 percent of therapy.
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| l Regulatory authority over ionizing radiation in medicine is widely dispersed l among several government agencies at the Federal, State, and local levels.
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| l At the Federal level, by authority of the Atomic Energy Act (AEA) and Commission policy, the NRC regulates the medical use of byproduct material 2 to provide for the radiation safety of workers and the general public. NRC also regulates the radiation safety of patients when justified by the risk to patients.,NRC's regg'atory authority is limited to byproduct material (such as cobalt or irdine ), so it does not regulate naturally occurring or l accelerator produced materials (NARM), or accelerator produced radiation. For example, NRC does not regulate the use of radium or x-ray equipment in medicine.
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| The Food and Drug Administration (FDA) in the Department of Health and Human l Services (DHHS) oversees the approval of radiation-producing devices l (including x-ray equipment) and radiopharmaceuticals (including NARM). In addition to these approvals, FDA's regulatory program includes review of problem reports, enforcement actions including product removal and recall, and civil prosecution of manufacturers. The Department of Transportation (DOT) regulates the transportation of radionuclides. The Environmental Protection Agency (EPA) sets generally applicable environmental standards to protect the public from radiation, and the Occupational Health and Safety Administration (OSHA) is responsible for worker safety.
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| States have broad regulatory authority over the general public health and safety of their residents, including authority over all sources of ionizing radiation excep discussedabove}. the The authority AEA doespreempted by the Federal permit States to obtainGovernment authority toasregulate byproduct material by becoming one of NRC's Agreement States. In that case, 2
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| Byproduct material is defined as nuclear material created or made radioactive by exposure to radiation during the fissioning process in a reactor.
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| 3 Although Federal pre-emption applies to source and special nuclear material as well as byproduct material, regulation of those materials is beyond the scope of this document i
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| DSI-7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT the NRC femally relinquishes its regulatory authority to_ a State i
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| based on the NRC's determination that the State's program is adequate and compatible with NRC's. (AsprovidedundertheAEA,theNBCretainsregulatory
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| , authority over Federal licensees in all States.) Presently there are 29 Agreement States.
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| The degree to which States exercise control over all medical uses of radiation varies from State to State. The Agreement States normally apply the standards i
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| ; which they have developed for NRC materials to other sources of radiation 1 within theiLr State, although there is no requirement that they do so.
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| Likewise, there is no requirement for non Agreement States to regulate the sources of radiation for which they are responsible. This situation has led to inconsistencies in the regulation of other sources of radiation in those States.
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| NRC's (and its Agreement States') regu:ation of radiation in medicine is based principally on two parts of the Code of Federal Regulations (CFR); 10 CFR Part 20, Standards for Protection Aaainst Radiaison, and 10 CFR Part 35, Medical Use of Bvoroduct Material. These regulations limit the amount of radiation j
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| ; that a worker or member of the public may receive, establish the controls that 4 j a licensee must exercise over radioactive materials, establish training and experience requirements for users of the materials, set quality management and reporting requirements, and provide a number of technical and administrative ;
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| requirements for the possession and use of the materials.
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| NRC's medical program constitutes about one-third of its Nuclear Materials Program. Currently there are about 2,000 NRC licensees authorized for the medical use of byproduct material under 10 CFR Part 35. In addition, the 29 Agreement States have issued about 4,500 licenses authorizing the medical use of nuclear material. These medical-use licensees include hospitals, clinics, and physicians in private practice. ,
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| NRC's regulatory program consists of developing regulations and guidance, issuing new licenses, and ensuring compliance. NRC promulgates new regulations and modifies existing ones through staff-initiatives or in-response to petitions. NRC provides guidance to its staff and licensees by issuing regulatory guides for licensing and procedures for inspection. NRC's medical licensing activities include issuing about 85 new licenses a year, and approving about 1,400 amendments. NRC ensures compliance with its regulations by communicating safety issues to licensees, inspecting them to observe their performance, and exercising its enforcement authority over licensees who are l in violation.
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| Over the years, and especially since the mid 1980s, the Commission has made a concerted effort to improve and strengthen the medical use program. In 1967 the Atomic Energy Commission codified its medical regulations into 10 CFR Part
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| DSI 7 ATTACHMENT- MATERIALS / MEDICAL OVERSIGHT l 35; Following a 1976 report.of hundreds of patient overexposures at Riverside !
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| Methodist Hospital in Columbus, Ohio, NRC took action to upgrade its ;
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| regulation of radiation sources in medical use. In February 1979, NRC issued a i policy statement to guide its regulatory program in the medical area. A key issue in the policy statement is NRC's commitment to protect patient safety 1 without intrusion into the practice of medicine. NRC regulates the radiation safety of patients when justified by the risk to patients, but minimizes the agency's intrusion into medical judgments affecting patients and into other areas traditionally considered to be the practice of medicine. The NRC 4 recognizes ,that physicians have primary responsibility for the protection of j their patients. NRC regulations assume that authorized physician users, with i appropriate training and experience, will make decisions in the best interest j of their patients. Since then, the tension inherent in NRC's commitment has arisen in a number of key medical-use regulatory initiatives that have been opposed by members of the regulated community as an intrusion into the l practice of medicine. The doctor / patient relationship and NRC's regulation of
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| , medical use of nuclear material has been a continuing problem, up to the j present.
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| A second set of problems arises from the jurisdictional responsibilities for the different sources of radiation. As discussed above, jurisdiction over various aspects of the use of ionizing radiation in medicine is exercised by a number of agencies in the Federal Government and by the States. Because of the diversity of, and occasionally overlapping, responsibilities, dual regulation or gaps in regulation may occur.
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| In 1992, the staff began to develop a medical management plan to guide the i conduct of the medical use regulatory program. The plan was delayed'as a l result of staff actions in response to a radiation-therapy misadministration
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| ! and the associated patient fatality, media interest, and congressional l l hearings on administrations in both the Senate and the House. The staff )
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| subsequently completed the medical management plan, and, in parallel, was
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| ; directed by the Commission to initiate an external review of the NRC's and the l l Agreement States' medical use regulatory program. I As a result, in January 1994, NRC contracted with the 10M to conduct that
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| : external review, including a review of NRC's regulations, policies, practices, and procedures. NRC set three goals for the study; 1) examination of the overall risk associated with the use of ionizing radiation in medicine; 2) examination of the broad policy issues that underlie the regulation of the
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| , medical uses of radioisotopes; and 3) a critical assessment of the current
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| ! framework for the regulation of the medical use of byproduct material. The .
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| NRC sought specific recommendations on two major issues. First, it requested !
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| recommendations on a uniform national approach to the regulation of ionizing !
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| radiation in all medical applications, including consideration of how the regulatory authority and responsibility for medical devices sold in interstate l
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| commerce for application to human beings should be' allocated among Federal ;
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| Government agencies and between the Federal and State governments. Second, !
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| the NRC requested recommendations on appropriate criteria to measure the effectiveness of regulatory programs needed to protect public health and ;
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| safety, i III ION REPORT - ALTERNATIVES This section presents 10M alternatives and recomendations. It begins with the ION broad view of the regulation of radiation in medicine to provide insight into the basis for 10M decisions on the regulatory alternatives it considered and the recomendations it made.
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| : 1) ION committee's View of the Current Situation The IOM comittee noted that NRC regulates only 10% of all ionizing radiation found in medicine, and that public health and safety would be better served by uniform regulation of all such use. It therefore concluded that NRC's current system of regulation and enforcement should be revised and that regulation of all radiation uses in medicine should be conducted by the States. j The comittee examined the existing regulatory system and identified several problems that it concluded'needed to be addressed. In particular, it judged ,
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| the NRC's present set of regulations and its approach to regulation to be ,!
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| burdensome, costly, and unduly prescriptive. In addition, it found that actions taken by the NRC against user institutions, in its public announcements and its unrealistic paperwork demands, tended to be disproportionate to the violations.
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| The committee determined that the benefits resulting from the NRC's efforts to reduce adverse events may not be commensurate with the constraints imposed. i It stated that the NRC's regulatory policy, although seemingly effective, might have gone beyond the point where "an additional dollar spent on regulation achieves an equivalent dollar benefit to patients or the public."
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| The comittee judged that, given the strength and leadership of the Conference of Radiation Control Program Directors (CRCPD) and the Suggested State Regulations for the Control of Radiation (SSRCR) which the CRCPD promulgates, that State programs would remain intact and expand to cover byproduct use if Federal regulation were to be relaxed. The committee believed that all sources of ionizing radiation would be treated more uniformly, in that they would a77 bs subject to State regulation.
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| I DSI 7 ATTACHMENT MATERIALS / MEDICAL OVE.". SIGHT l The comittee's recomendation would eliminate NRC's medical use program, but l retain the basic structure of federal regulation and responsibility. In '
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| particular, the comittee would have Federal agencies retpin responsibility for the generation, transport, non-medical use, and disposal of radionuclides l and for the approval of radiopharmaceuticals and of equipment that generates I ionizing radiation. A Federal agency would assume a guidance role for the States. l
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| : 2) Alternative Regulatory Systems The comittee considered NRC's request for recomendations on a uniform national approach to regulation broadly. It examined a wide spectrum of alternative structures through which all ionizing radiation in medicine might be regulated. The comittee report discusses seven alternatives, which are A Continue the Existing Situation B Laissez-Faire (No Regulation)
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| C State Regulation Only D State Regulation with Federal Guidance E State Regulation with Reserve Federal Authority F Centralized Federal Regulation G Health Finance Agency After considering the alternatives, the comittee found Alternative D, State Regulation with Federal Guidance, to be its preferred choice. Brief descriptions of the seven alternatives, and the basis for the committee's choice follow.
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| A Continue the Existing Situation The comittee considered two ways to continue the existing situation, which it describes as A1, Status Quo, and A2, Status Quo Modified. Alternative A1, Status Quo, would be for the NRC to continue to operate exactly as it does today. Alternative A2, Status Quo Modified, would have the NRC eliminate, or announce that it will not enforce, its requirements for quality management programs (10 CFR Part 35.32) and for notifications and records of misadministrations (10 CFR Part 35.33). The comittee's considered this modification because NRC has received considerable criticism from the medical comunity for promulgating these requirements.
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| The comittee found no positive aspects to the Status Quo. It found a positive aspect of the Modified Status Quo in that this Alternative would not require legislative change and thus would be the easiest way to change the existing system to address the medical comunity's concern. Further, in the comittee's vi;w, the NRC could make useful changes to its work culture. The comittee found the negative aspects of the Status Quo to be that this l
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| alternative did not address .two of the committee's concerns; first, that ionizing radiation in medicine is not treated consistently - sources used regularly in the practice of medicine are treated unevenk. The comittee raised the issue of whether NRC regulation is necessary, given that NARM and machine-produced regulation has been left to the States and the FDA. Second, this alternative does not address the committee's concern that safety can be maintained at lower cost.
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| l j B Laissez-Faire (No Regulation) -
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| In this 1ternative, all forms of regulation, Federal and State, would be l
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| - eliminated and responsibilities for radiation safety would be left to medical practice, medical societies, and the marketplace.
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| I The cosmiittee found that a positive aspect of Laissez-Faire would be the cost j savings resulting from an absence of regulation. The comittee found negative aspects of this Alternative to be that not everybody is conscientious about radiation protection, and the comittee had little expectation that the marketplace, the malpractice system, and the professional societies could, by themselves, weed out incompetent practitioners and ineffective procedures.
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| Further the comittee noted that most States now regulate ionizing radiation to some degree and it seemed unlikely that they could all be convinced to follow this alternative. This approach would be unwieldy, as the existing '
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| J federal regulatory structure for radiation control of non-medical applications l would continue unchanged.- )
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| C State Regulation Only This Alternative would eliminate NRC control of medical uses of byproduct i material and would give regulatory authority to the States. Under this i alternative, byproduct materials would be regulated the same way x-ray
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| . machines, linear accelerators, pharmaceuticals and other medical devices and materials are currently regulated. Under this alternative, Federal agencies would still have a number of responsibilities; FDA would continue to regulate safety and efficacy of radiopharmaceuticals and radiation devices, DOT would continue to regulate the transportation of byproduct material, and NRC would license the manufacture of byproduct material. The comittee noted that this alternative would permit States to choose the laissez-faire approach.
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| However, the comittee expected that under this Alternative, the CRCPD would encourage States to adopt its Suggested State Regulations for Control of Radiation (SSRCR).
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| I- The connittee found the positive aspect of this Alternative to be the l assumption that all States with existing programs would continue and expand i
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| -them based on the SSRCR and thus reinforce the movement toward greater l 1 uniformity. The comittee found negative aspects to be that it had no RELEASE DATE: SEPTEMBER.16, 1996 8 DSI 7 ATTACHMENT 1
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| i i assurance that States want this responsibility, that not all States currently
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| { have strong regulatory programs in place for NARM and machine-produced
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| , radiation, and that some State legislatures might be respgnsive to strong
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| , antiregulatory interest groups. The comittee also felt that the lack of 1 Federal leadership under this Alternative would make it difficult to encourage States to adopt CRCPD guidelines and that States might abandon the radiation l t safety programs now in place without the incentive from a Federal agency to l l continue operating them. '
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| l! D State, Regulation with Federal Guidance i
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| j This Alternative modifies Alternative C by identifying a Federal Agency, other
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| ; than the NRC, to exercise a leadership role in the radiation safety comunity,
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| ; with DHHS as a suggested agency. This is the committee's preferred l j Alternative.
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| ! As the comittee has developed this Alternative, the Federal agency would assist in developing recommended State laws and regulations for all ionizing radiation in medicine. It could work with CRCPD to enhance the existing SSRCR and promote their adoption. The comittee felt that development of guidelines through a collaborative process with the Federal agency, the States, the CRCPD, and professional organizations would result in successful implementation by all participants. Additional functions of the Federal Agency could include assisting States, investigating crises, educating the public, collecting risk data, conducting research, and monitoring the effects of shifting responsibility for regulating radiation in medicine to the States.
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| Under this Alternative, States would have to establish a regulatory program that includes byproduct material. Since, under this Alternative, the NRC and Agreement States would continue to regulate the manufacture of byproduct i material, manufacturers would not be able to distribute byproduct material to their users unless the users were licensed by their States. Consequently.this requirement would provide an inducement to States to expand or revise their existing radiation control programs to include byproduct material. Federal facilities would be encouraged to either expand their existing procedures for NARM to include byproducts or adopt the SSRCR for byproduct material.
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| The committee found several positive aspects of this Alternative. It includes the advantages of Alternative C, State Regulation Only, with the additional advantage of a Federal agency to provide non-regulatory oversight and-leadership. The comittee would expect the Federal agency to assume a leadership role for the Federal government as a whole. In addition, this Alternative would ensure that a State would be required to have a regulatory program for byproduct material for that material to be used in the State. The RELEASE DATE: SEPTEMBER 16, 1996 9 DSI 7 ATTACHMENT
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| committee found negative aspects of this Alternative to be the costs of the i Federal agency, and that the agency could not guarantee either the quality of j j any State program or the safety of ionizing radiation in, medicine. J
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| ! E State Regulation with Reserve Federal Authority a
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| 2 This Alternative would go beyond Alternative D, State Regulation with Federal ,
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| Guidance, and empower the Federal agency identified in that Alternative to '
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| exercise regulatory authority over any State unwilling or unable to enact a l regulatory, structure that encompasses ionizing radiation in medicine. '
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| 1 This Alternative would be identical to Alternative D, with the exception that if a State did not have a radiation control program it would become subject to the regulations for byproduct material devised for Federal medical centers.
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| The Federal. agency would enforce its authority only if the State did not assume any responsibility to adequately protect public health and safety.
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| This authority would be analogous to the NRC's present authority to resume regulatory control over an Agreement State.
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| : The committee found this alternative to have all of the positive aspects of 1 Alternatives C and D, with the advantage that placing DHHS in the leadership i i role would, in the committee's view, yield more reasonable regulations if they l are needed. The committee found negative aspects to be the need to set j minimum standards for State programs and the need to assess those programs.
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| This would have the effect that all States would become similar to NRC's present Agreement States. The committee was also concerned about funding', and Federal authority over what it expected to be a minority of States.
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| F Centralized Federal Regulation !
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| This Alternative would make a Federal agency responsible for regulating medical uses, not only of byproduct material, but of NARM and machine-produced radiation as well. The Alternative would federalize regulation of all ionizing radiation in medicine,' including standard-setting, licensing, and inspection. If this Alternative were to be adopted, the committee would recommend centralization within DHHS rather than NRC because the committee considered it best suited to administer public health programs and because it J
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| already has various levels of authority over ionizing radiation in medicine.
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| If NRC were to be the lead federal agency, its legislative authority would need to be expanded beyond byproduct materials.
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| The committee found positive aspects of this alternative to include promotion of unifomity in regulation of radiation in medicine, provision for States who do not want responsibility for radiation control programs, and the development of national standards. The committee noted that the positive aspects of the Federal role described in Alternative D, State Regulation with Federal I
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Guidance, also apply to this. Alternative. The comittee found negative aspects to include the increased Federal costs of such a role, and the difficulty in' achieving uniformity due to the regulatory involvement of a number of Federal agencies (DOT, EPA, OSHA) in addition to the comittee's proposed DHHS. Finally, the comittee noted that since NRC would continue to be responsible for the non-medical uses of byproduct material, it would be necessary for NRC and DHHS to work very closely together to avoid inconsistencies.
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| G Health Finance Agency This Alternative would place regulatory authority for all health care into a single, centralized agency to counter _ inconsistency and inefficiency. The new agency would acquire the regulatory power now held by the medical components
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| -of the NRC and by parts of DHHS. The agency would have the power to regulate health care, broadly eliminating practices that were shown not to be effective or beneficial. The comittee considered this Alternative an extreme approach I for addressing a very specific issue and recognized that it had not been j j developed to its full logical extent. The committee considered an advantage to this approach is that it could improve minimal standards and define the ;
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| goals of safety and high quality care. However, such a centralized system would mean a large increase in bureaucracy and reduce provider incentives and responsibility.
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| : 3) Assessment of Alternatives
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| ! The committee documented its consideration of the above alternatives by examining the extremes and moving toward its preferred alternative. It rejected Alternative A, Continue the Existing Situation, because it did not
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| [ address the comittee's concern that all . ionizing radiation in medicine be
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| ! administered and regulated more consistently. It rejected Alternative B, Laissez-Faire, because many comittee members were not convinced that the marketplace, the malpractice system, and the professional societies could, by themselves, weed out incompetent practitioners and ineffective procedures. The l
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| comittee rejected Alternative G, Health Finance Agency, because it was an all-encompassing and overwhelming solution to a very specific problem. The committee rejected Alternative F, Centralized Federal Regulation, because from a cost-benefit perspective the comittee as a whole saw little reason to
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| ; pursue this alternative. Thus the committee focussed on Alternatives C, State i Regulation Only, D, State Regulation with Federal Guidance, and E, State
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| ; Regulation with Reserve Federal Authority.
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| While the comittee found Alternative C, State Regulation Only, attractive, it was concerned that State regulation evolve with technical advances, that Non-Agreement States be assisted in any trensition from NRC regulation, and that information sharing be enhanced, so it rejected this alternative. The L
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| committee found that Alternative E, State Regulation with Reserve Federal Authority, could result in a program very much like NRC's 'present Agreement State program which would not resolve the committee's conperns about that program's funding characteristics and practical drawbacks. The committee therefore arrived at its preferred choice, Alternative D, State Regulation with Federal Guidance.
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| As discussed above, Alternative D would give regulatory authority over medical uses of byproduct material to the States. The States would expand their existing radiation control programs that apply to NARM to include byproduct material as well. The committee recommends that a Federal agency, DHHS, exercise a leadership role in the radiation safety community. The leadership role would be non-regulatory and would assist ta developing recommended state laws and regulations, acting as an information clearinghouse, and distributing resources for training and research. The Federal agency would work in conjunction with the CRCPD and other professional organizations to develop recommended state laws and regulations for all ionizing radiation in medicine.
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| The NRC would retain responsibility for the manufacture and distribution of byproduct material (including sealed sources and devices) used in medicine.
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| Further, NRC would condition these licenses to require that products could only be distributed to users who were licensed by a State.
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| IV 10M REPORT - RECOMMENDATIONS i To implement its preferred alternative, the committee made a total of eight specific recommendations; two to Congress, three to the NRC, and three to the CRCPD and States. First, the committee recommended that Congress: 1) eliminate all aspects of the NRC's medical use program to include 10 CFR Part 35 and applicable activities conducted under 10 CFR Part 20; and 2) direct the Secretary of Health and Human Services to support, coordinate, and encourage activities involving regulation of all ionizing radiation in medicine including support the operation of the CRCPD, assist States in implementation of regulations, oversight of State programs, enhance training and standards for health care personnel, and investigate future significant radiation medicine incidents.
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| The recommendations to the NRC were to: 1) immediately relax enforcement of 10 CFR 35.32 and 35.33; 2) if Congress fails to act within 2 years to the committee's recommendations above, initiate formal steps under the Administrative Procedures Act to revoke 10 CFR Part 35 in its entirety; and 3) separate the costs of formulating regulations from costs of administering 1 those regulations.
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT regulatory programs; and 3) continually reevaluate regulations and procedures to ensure congruence with evolving scientific understanding of radiation bioeffects and associated risks and benefits. ,
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| The committee did not reach total unanimity on the final recommendations. A committee member stated that federal regulatory authority should be reformed, not repealed. This dissenting opinion is included as a separate Appendix to the report.
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| The following sections discuss the recommendations individually. Each section contains a brief description of the recommendation, a summary of the committee's rationale for the recommendation the NRC staff's principal concerns, and some pertinent public comments
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| & RECOMMENDATIONS TO CONGRESS A1. The committee recommends that Congress eliminate all aspects of the NRC's Medical Use Program,10 CFR Part 35, and those regulatory activities conducted under 10 CFR Part 20 that are applicable to medical uses.
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| DESCRIPTION By this action, Congress would relinquish responsibility for regulation of byproduct material used in medicine to each state. NRC would retain regulatory authority over manufacturers of byproduct material used in medicine. Other federal agencies, -such as the FDA, the DOT, and the EPA, would retain their regulatory authority over radiation.
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| IOM RATIONALE The intensity with which the byproduct area of radiation medicine is being regulated at the federal level far exceeds the rest of ionizing radiation used in medicine and most of the rest of medical practice and has little if any ,
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| justification. In fact, the concentration of resources spent to reduce adverse i events involving byproduct material, although seemingly effective, appears.to ,
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| have gone beyond the point at which the additional dollar spent on regulation '
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| achieves an equivalent dollar benefit.
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| ' A list of commentors organized by commentor affiliation, a list of commentors by general view, and a summary of specific comments appear in Appendices 1, 2 and 3, respectively.
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT All ionizing radiation, with the exception of byproduct material, is currently regulated or subject to regulation at the State level. States have the ability to regulate radiation effectively. Although the,comittee cannot guarantee that states will effectively regulate byproduct material, it believes they will. Further, States with insufficient resources could join a consortium of states for the purposes of implementation and oversight.
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| Rescission of authority at the federal level for regulation of the medical use of byproduct material has three benefits: 1) it eliminates prescriptive and costly regulations that yield marginal risk reduction; 2) it shifts responsibility, by giving state governments authority over the health and safety of their citizens; and 3) it promotes uniform treatment, in that radionuclides and machine-produced radiation are regulated by a single level of government at equal intensity, regardless of their source.
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| NRC STAFF ISSUES
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| : 1. The comittee recognizes that not all states currently have strong regulatory programs in place for NARM and machine-produced radiation.
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| In fact, not all States currently regulate ionizing radiation used in medicine. What assurance does the comittee, or Congress or the NRC, have that all States will assume the responsibility for medical use of byproduct material? )
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| : 2. This recommendation assumes that federal facilities will expand the scope of their existing regulations to cover all ionizing radiation in medicine - what existing regulations currently apply to federal facilities (other than those of the NRC)?
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| : 3. How would the goal of " uniform treatment" and regulation by a single level of government at " equal intensity" be achieved through legislation and rulemaking giving responsibility to the States.
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| PUBLIC C0lWENTS NRC has received 47 coments on the committee's report. About one third of ;
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| the comentors support this recomendation and the rest of the comittee's J recommendations as well. These comentors included the Department of Veteran's Affairs, several State agencies, four professional societies 1 associated with the use of radiation in medicine and six individuals. Several !
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| of these commentors not only supported this recommendation, but believed that !
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| NRC should discontinue all of its regulation of byproduct materials, and give ,
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| 4 DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT A second third of the commentors supported the concept of regulatory reform, l but with retention of Federal authority. These commentors included three i Federal agencies, three professional societies involved in radiation in
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| , medicine,10 States and NRC's Advisory Committee on the Medical Uses of i Isotopes (ACMUI). Nine of these commentors favored continued regulation by the NRC, eight were not specific on which Federal agency should have I authority, and two, the State of California and the ACMUI would vest authority i
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| with DHHS.
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| Four commentors, including the State of New Jersey favored regulatory reform, but only after additional analysis.
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| l Nine commentors supported the concept of uniform regulation for all j radioactive materials, including NARM, with Federal oversight.
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| 1
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| ! Several specific comments are of interest. The EPA felt that the report
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| ; reflected the concerns of the regulated community more than those of the 1 public at large. The Department of Defense indicated that the Federal
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| ; regulatory authority over medical use of byproduct material should be reevaluated and perhaps relaxed and restructured, but not abolished. The i States of Utah and Virginia were concerned that State legislatures might view t
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| this as an unfunded mandate and would need additional Federal support. The
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| !. CRCPD does not support the recommendation. "CRCPD is concerned that elimination of the entire program, as recommended, could have immediate and j undesirable consequences on citizens in non-Agreement States which cannot or i will not have developed a state program consistent with the national model i prior to Congressional action. In addition, the. absence of federal authority
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| ! in the medical use area msy also have long term consequences for Agreement j
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| States as they try to maintain a nationally consistent program in the face of budget cutbacks and a changing regulatory philosophy."5 Several non-Agreement States indicated that they had neither the resources nor the capability to develop a program to adequately protect public health and
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| : safety.
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| t A2. Congress direct the Secretary of Health and Human Services to support, i
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| coordinate, and encourage the following activities involving regulation of all ionizing radiation in medicine:
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| 1 i n. supporting the operation of the CRCPD;
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| ; b. providing a venue for the review and evaluation of Suggested State i Regulations for Control of Radiation; i
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| 5
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| . CRCPD position on the NAS report, reached at their meeting in Albuquerque, New Mexico, on May 8,1996
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| ).
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| 1 1
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| 2
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| ; RELEASE DATE: SEPTEMBER 16, 1996 15 DSI i ATTACHMENT 1
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| : c. assisting states in implementation of their regulations;
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| : d. siding in assessment of the effectiveness of state prograns through the collection and analysis of data; ,
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| : e. helping develop survey methods by which the rate of adverse events for a wide range of procedures and devices night be sensured;
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| : f. nonitoring the effects of deregulation;
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| : g. enhancing training and standants for health care personnel; and
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| : h. investigating future significant radiation medicine incidents.
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| DESCRIPTION In addition to'the above, DHHS would educate the public for the primary purpose of "... putting radiation risk in a more accurate and balanced perspective." Adverse events for investigational drugs and blood products must be reported to FDA as are adverse events involving radiation devices resulting in serious injury or death.
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| ~
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| As noted in the previous recommendation, NRC and Agreement States would continue to regulate the manufacture of byproduct material for use in radiation devices and radiopharmaceuticals; thus manufacturers would not be able to distribute radioactive byproduct material to users unless they were licensed by their states.
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| IOM RATIONALE A Federal agency, such as DHHS, would assist states to establish regulatory
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| > programs; train state radiation control personnel; build liaisons between smaller states that wish to share regulatory systems; develop survey l methodology; and monitor the success of regulatory programs. I i DHHS has an extensive history in regulating radiation in medicine. Within DHHS, FDA exercises direct authority to determine the safety and l effectiveness, and to approve the marketing, labelling, and manufacture of all ;
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| radiation products used in medicine. FDA has promulgated regulations i establishing quality control standards and a certification program for medical facilities that provide mammography services. FDA has issued guidelines and recommendations regarding public exposure to ionizing and non-ionizing ,
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| radiation. l The NRC should not regulate the education and training of health care 4
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| personnel - it should be done by professional organizations and by the states.
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| NRC STAFF ISSUES
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| ]
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| : 1. Would DHHS have any regulatory responsibility for Federal facilities other than the Public Health Service? If not, who would have authority over Federal facilities?
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| RELEASE DATE: SEPTEMBER 16, 1996 16 DSI 7 ATTACHMENT 4
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| y,_m ,. ,
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| i DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT l l
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| : 2. Current reporting requirements for FDA are not identical to those of NRC
| |
| ! - they only require reporting adverse events resulting in serious bodily i j injury (to manufacturer) or death (to FDA). There 3re no reporting l requirements for radiopharmaceuticals other than investigational drugs
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| ; except on a voluntary basis. To what extent should administration J
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| errors be reported?
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| l
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| ! 3. In view of the overall reduction in federal spending, whether DHHS would l
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| , be provided any appropriations to carry out these additional
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| ; responsibilities cannot be predicted. With the reduction in federal i spending and with the knowledge that the NRC is supported by user fees rather than taxpayer dollars, would Congress appropriate sufficient funds for even the minimal expenses of this agency?
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| : 4. How would the effects of deregulation be monitored? The report states that the comittee did not possess the requisite expertise to address the issue of appropriate criteria for measuring the effectiveness of regulatory programs.
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| ! PUBLIC COMMENTS
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| ; As mentioned above, about a third of the comentors support this i recommendation along with all the comittee's recomendations. A number of 4
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| commentors support the role of a Federal agency described in this i recomendation, but do not necessarily endorse DHHS. Many of these latter comentors believe that the Federal agency should have at least some authority i and that it should be responsible for at least NARM as well as byproduct i material. The CRCPD view is illustrative. CRCPD supports the concept of a
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| ! single federal agency with a strong leadership role, and belie /es that
| |
| ; consolidation of authority presently found in several agencies including NRC, j DHHS, OSHA, and EPA is very desirable. However, CRCPD, in addition to several i states, do not support the automatic selection of DHHS as the lead agency, but 4 consider that radiation 6 protection should be a major responsibility of the
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| : lead agency. The OAS recomended a revision to recomendation A2 to include that a single federal agency should be directed (by Congress) to support, l coordinate, and oversee specified activities involving regulation of all 3
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| ionizing radiation in medicine. The OAS did not reach consensus on which agency should have the responsibility.
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| The agency most affected by this recomendation is DHHS, who does not support it. DHHS does not find the comaittee's arguments compelling and does not
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| ! consider the legislation recomtended by the comittee likely. Further, in the i
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| i ' The OAS coment provided the recommendations of and consensus reached at a NRC and Agreement State technical workshop conducted on March 6,1996.
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| 1
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| event of such legislation, DHHS considers the probability low that it would receive funding from Congress commensurate with its additional responsibilities. ,
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| A RECOMMENDATIONS TO THE NRC
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| , 81. The NRC should famediately relax enforcement of 10 CFR 35.32 and 35.33 through its present nechanisms.
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| DESCRIPTOh NRC's 10 CFR Part 35.32, Ouality Manaaement Proaram, requires, among other things, that medical licensees have written procedures to ensure that direction for a therapeutic administration is made in writing, that the patient's identity is verified by more than one method, that unintended deviation from the written directive is evaluated, and that the licensees review this program at least once every 12 months.
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| NRC's 10 CFR Part 35.33, Notifications. Reoorts. and Records of Misadministrations, requires, in part, that medical licensees notify the NRC within one calendar day of the discovery of a misadministration, and that they submit a written report within 15 days, and that they retain a record of each ;
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| misadministration for five years.
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| The information required by 10 CFR 35.33 would not be entirely abandoned. NRC could continue to cooperate with the FDA as provided in their MOV to obtain data on devices, drugs, and biological products that relate to device malfunction, serious injury, or death.
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| 10M RATIONALE NRC's Quality Management (QM) rule lacks the basic elements of a QM program:
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| comprehensive process and outcomes data, feedback mechanisms for health care providers, education of clinicians to achieve continuous improvement, and .
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| follow-up measurement to monitor change / improvement.
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| The regulation of byproduct material greatly exceeds the regulation of l chemotherapy, surgery. anesthesia, and the use of general pharmaceuticals except for controlled substances, all of which are unregulated at the federal levei.
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| A lower rate of adverse incidents in radiation medicine is not a result of stricter regulatory oversight. The more detailed reporting and enforcement systems required for byproduct materials do not seem to result in even a marginal decrease in risk to providers, patients, or members of the public.
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| The level at which the NRC currently enforces 10 CFR 35.32 and 35.33, through detailed and voluminous documentation, reporting, and penalties, is inconsistent with the NRC's Medical Policy Statement, whiph favors minimum regulatory intrusion into the practice of medicine. l The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has )
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| l a perfomance standard which requires intensive assessment when performance !
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| varies from recognized standards, but does not specifically require reporting l of medication errors except in accordance with written procedures of the !
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| hospital. .
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| Elimination of the QM rule would not lessen the radiation protection of the public, occupational worker, or the patient.
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| l l The regulated community has expressed reservations about seeking advice from
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| ! the NRC, fearing that they might become the target of punitive reprisals.
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| When the NRC levies a fine, the agency also issues a press release describing the violation and the fine. Licensees assert that adverse economic impact of such press releases is considerable.
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| l NRC STAFF ISSUES
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| : 1. The lack of data for comparing byproduct material, NARM and machine-l produce radiation limited the scientific basis of the committee's findings. How can we achieve improved data collection on actual incidence and rates of adverse incidents and misadministrations? Is l there a need for improved databases?
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| : 2. What is the rationale or basis for the necessity for immediate action?
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| l
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| : 3. Assuming that NRC were to immediately relax enforcement, NRC would be in the position of having a regulation for which there would have been no
| |
| ; monitoring or enforcement. If NRC were to follow this recommendation, l what followup actions should NRC conduct in the event of a misadministration resulting in serious injury or death?
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| : 4. If NRC lacked statutory or regulatury authority governing the medical and biomedical research use of byproduct material, why should NRC continue to gather data on user errors, drugs, and biological products to share with FDA under the MOU (unless reimbursed by another Federal l agency)?
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| )
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| PUBLIC COPMENTS A number of commentors supported the concept that many of,NRC's requirements are overly prescriptive and burdensome. CRCPD supports relaxation of these requirements because it finds them overly prescriptive and unnecessarily burdensome. The Organization of Agreement States believes that NRC should immediately relax enforcement of these requirements, and further considers that the Quality Management Rule should not be an item of Agreement State compatibility.
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| B2. The committee reconnends that the NRC initiate formal steps under the Administrative Procedure Act to revoke Part 35 in its entirety, if Congress fails to act within two years in response to the two recommendations to Congress stated above.
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| DESCRIPTION NRC's 10 CFR Part 35, Medical Use of Byoroduct Material, contains technical and administrative requirements that apply specifically to medical applications. It sets quality management and reporting requirements, and establishes training and experience c.riteria for users of byproduct material.
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| It sets requirements including dose calibration, leak testing, source 3 inventory, patient release, instructions to nurses, and survey requirements as well as use of syringe shields and storage of waste for decay.
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| IOM RATIONALE In addition to NRC's overly stringent enforcement, the regulations themselves are excessive and duplicative. 10 CFR Part 35 covers areas that either are already regulated at the institutional level or are best left to the states, to professional societies, and to patients in consultation with their doctors.
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| States regulate the medical uses of other forms of ionizing radiation and, could easily fold byproduct material into their regulatory programs.
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| The CRCPD could add byproduct material to its suggested state regulations.
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| These additions could incorporate relevant concepts currently in Part 35.
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| Doctors have ethical obligations, codified in professional standards, for informing patients of medical errors. The relatively low misadministration i rate could be maintained by less stringent programs that are administered at the state level by professional societies, and by existing liability law.
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT The FDA collects data on adverse effects of radiopharmaceuticals and incidents of failure of radiation-emitting medical devices, and it could assume the monitoring responsibilities of the NRC. ,
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| Public safety in the medical use of ionizing radiation would yet exist in the fact that the NRC would still retain responsibility for the licensing of manufacturers and, consequently could ensure that byproduct material was withheld from any state that failed to license users and regulate the use and safety of byproduct material.
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| The comittee strongly endorses the formal route of notice and coment rulemaking, subject to the Administrative Procedure Act, to accomplish the rescission of all of Part 35.
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| NRC STAFF ISSUES
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| : 1. This recomendation presupposes Congress will not act, and therefore will not vest DHHS with a leadership role. This could result in the laissez faire or . state control regulatory structures, both of which were rejected by the comittee. How would this recomendation achieve the goal of the preferred alternative?
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| : 2. With the lack of data cited in the report, on what scientific basis might NRC make a finding that there is no unreasonable risk to public health and safety, and thereby exempt medical use of byproduct material from the requirements of a license, as set forth in Section 81 of the Atomic Energy Act?
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| PUBLIC COMMENTS Many comentors, to include professional organizations, State agencies, and individuals, were in favor of the need to revise Part 35. While CRCPD considers that a major revision to 10 CFR Part 35 is needed, it does not support this recomendation. 0AS believes that 10 CFR Part 35 should be revised significantly, but that it should not be revoked in the absence of legislation. 0AS believes that a minimum level of radiation protection must be available.
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| : 83. The comittee recommends that the NRC separate the costs of formulating regulations from the cost of administering those regulations.
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| RELEASE DATE: SEPTEMBER 16, 1996 21 DSI 7 ATTACHMENT
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT j DESCRIPTION . 1 TheOmnibusBudgetReconciliationActof1990requiresNSCtorecover100%of its budget by charging fees to NRC applicants and licensees. As a result, NRC
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| : licensees bear all of the agency's costs both of developing its regulations and of administering them. Separating these costs would enable NRC to recover development costs from its licensees differently than it recovers its administrative costs.
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| IOM RATIONALE Only NRC-licensed institutions should bear the NRC's costs of licensing and inspection, whereas the costs of developing standards should be borne by all institutions, whether or not they are located in NRC-regulated states.
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| Licensing fees charged to health care facilities to meet the cost of the existing NRC program are becoming more expensive as more states become Agreement States.
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| Several individuals interviewed during site visits voiced concern that excessive costs force laboratories to stop using radionuclides, which in turn delays or prohibits the development and implementation of new uses of radionuclides in medicine.
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| NRC STAFF ISSUE If NRC were to separate the costs of formulating regulations from the cost of administering these regulations, how would the Agreement State licensees bear the cost of developing standards?
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| PUBLIC COMMENTS CRCPD supports this recommendation and recommends that Congress provide l general funds to support development of essential regulatory standards. 0AS identified the issue of how Agreement States would bear the costs of developing standards if NRC were to accept this recommendation.
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| G RECOMMENDATIONS TO THE CRCPD AND THE STATES ,
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| C1. The committee recommends that the Conference of Radiation Control Program Directors incorporate into its Suggested State Regulations for Control of Radiation any relevant concepts from 10 CFR Part 35 that are not already integrated in those suggested regulations.
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| l RELEASE DATE: SEPTEMBER 16, 1996 22 DSI 7 ATTACHMENT
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| - - . .- - . - . - . . - - . _ . - . . . - . - - . - . _ ~ . . . . - . - -
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| i l DSI 7 ATTACHMENT MATERIALS / MEDICAL OVER51GHT )
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| ! I l
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| 10M RATIONALE 1 l All states will be able to provide regulatory oversight fgr AEA material in a l l manner similar to that provided for non-AEA material through the adoptions of l
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| . CRCPD's Suggested State Regulations for the Control of Radiation. "[T]he i committee expects that byproduct materials can be accomodated in the state i systems."
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| l Although State laws, regulations, and administrative practices vary, States can and do achieve a level of uniformity in many areas through cooperative,
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| ; voluntary, and informal arrangements.
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| 1 Although States cannot be compelled to accept the voluntary guidelines or the i SSRCR, a variety of forces can greatly influence them to do so such as a j collaborative effort, professional peer pressure, consumer groups and the i media, and State medical societies.
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| 1
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| ! CRCPD will continue to provide SSRCRs of the current level of quality without j the assistance of the NRC, but with another federal agency providing j " voluntary guidelines and model regulations for states" i
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| : NRC would continue to fund the CRCPD's efforts with respect to all nonmedical l uses of byproduct material.
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| ?
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| [
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| t NRC STAFF ISSUES I Will the states voluntarily adopt the CRCPD's SSRCR in the absence of
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| ! any real compelling mandate placed on either CRCPD or the states? For j example, in the case of the recently passed mammography law, Congress provided a compelling reason for hospitals and clinics to meet the
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| ! quality standards: i.e., in order to be reimbursed for mamography services, the hospital or clinic must be certified as ureting the
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| { standards.
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| 1
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| ! 2 The level to which the states currently adopt the SSRCR varies from state to state. Would there be greater uniformity under the proposed recomendation?
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| PUBLIC COMMENTS CRCPD considers that it already has accomplished this.
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| C2.- The comittee recomends that all state legislatures enact enabling i legislation to incorporate the regulation of reactor-generated byproducts into existing state regulatory programs.
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| RELEASE DATE: SEPTEMBER 16, 1996 23 DSI 7 ATTACHMENT 1
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| (
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| s.
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| i
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| ! DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT IOM RATIONALE States have effectively regulated naturally-occurring and NARM in the past and 2 continue to do-so. Therefore all States can regulate the medical use of byproduct material effectively.
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| j Congress will modify the AEA to revoke the NRC's authority to regulate the j medical use of byproduct material, give another Federal agency the j responsibility for providing guidance, and allow all States, at their. option,
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| ; to exercise regulatory authority over the medical use of byproduct materials.
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| i
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| ! All States will devote the additional necessary resources to provide adequate
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| ! protection of the public health and safety related to the medical use of j- byproduct materials with "little", if any, additional federal funding.
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| j The possibility of precluding users from obtaining byproduct material from j
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| manufacturers in those " states that did not include byproduct material into j their existing regulatory programs" would be acceptable to Congress and the
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| ; public. ,
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| ! NRC STAFF ISSUE l Will all States in fact have the will, the resources, and the competence to
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| : j. regulate the medical use of all sources and uses of ionizing radiation safely?
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| a i PUBLIC C0tMENTS i
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| i OAS endorses this recommendation, but as applied to all ionizing radiation.
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| CRCPD ondorses the recommendation, although it recognizes that not all States j will choose to establish comprehensive programs that include byproduct materials. However, the CRCPD continues to support consistent application of radiation protection standards nationwide and believes that this can be best l accomplished by having all radiation programs in a single state agency which j can deal comprehensively with all forms of ionizing radiation within the
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| : state.
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| C3. The coanittee reconnends that the Conference of Radiation Control Progran Directors and the states continually reevaluate their i regulations and procedures pertaining to radiation medicine to ensure l congruence with evolving scientific understanding of radiation
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| : bioeffects and to be in accord with advances in knowledge regarding -
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| i benefits and sisks related to medical and biomedical research uses of ionizing raofation in medicine.
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| RELEASE DATE: SEPTEMBER 16, 1996 24 DSI 7 ATTACHMENT
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT IOM RATIONALE Continual reevaluation and maintaining congruence is a negessary step for providing adequate protection of the public health and safety.
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| The CRCPD and all states will devote the necessary resources to maintain congruence with evolving scientific understanding of radiation bioeffects and be in accord with advances in knowledge regarding the benefits and risks of the medical use of ionizing radiation.
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| NRC STAFF ISSUE Many states have adopted regulations for non-AEA materials that are similar to those that NRC implements for AEA materials and requires Agreement States to adopt as items of compatibility (e.g., NRC's QM rule for cobalt teletherapy versus State regulations for accelerator teletherapy). Will the CRCPD be able i to effectively " ensure congruence" of the States' regulations and procedures I to "be in accord with advances in knowledge regarding benefits and risks ..."
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| by using voluntary mechanisms in the absence of the regulatory presence and resource support of NRC?
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| PUBLIC COMMENTS Both OAS and CRCPD endorse this recommendation.
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| V NRC ACTIONS AND COMMENT
| |
| | |
| ==SUMMARY==
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| A NRC Actions to Date l l
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| The IOM provided NRC with a prepublication copy of the committee's report in J December 1995. The NRC provided copies of the report to all Agreement States and non-Agreement States and Territories, appropriate Federal agencies, CRCPD, OAS, Congressional Oversight Committees and NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI). In addition, the NRC published a Federal Reaister notice (61 FR 1648) on January 22, 1996, and issued a press release acknowledging receipt of the report and requesting comments on the possible impacts of the report, to include any views on policy, legislative, rulemaking, and guidance issues. The Commission directed the staff to consider the report and comments received within its Strategic Assessment and Rebaselining efforts. While the report is being considered, the NRC is continuing to implement the ongoing medical use program.
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| . RELEASE DATE: SEPTEMBER 16, 1996 25 DSI 7 ATTACHMENT
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| i DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT j
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| i
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| ! Several public meetings have been held to discuss the report. The ACMUI met
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| : on February 21-22, 1996 and subsequently briefed the Comission on May 3,1996
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| ! to discuss their recommendations. Briefly, the ACMUI diq not recommend any of
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| ! specified alternatives. They reached consensus that the medical use regulatory program should be rebuilt, reassessing the objectives of the
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| ; regulations and encompassing all uses of ionizing radiation in medicine, and that States should be federally mandated to administer the program, with l appropriate incentives to encourage States to comply. State programs should
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| ! be monitored by a Federal agency with an overall medical use perspective i
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| (e.g.,DHHS).
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| The OAS and the members of the IOM comittee briefed the Comission on February 26 and 27, 1996,~respectively. In addition, the report was discussed at a joint NRC and Agreement State technical workshop on March 5-6, 1996. The workshop included representatives of 18 Agreement States and two non-Agreement States. More recently, the report was discussed with the Conference of i Radiation Control Program Directors on May 6,1996.
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| i B C0lHENTS ON IOM REPORT As of the end of August 1996, the staff had received 47 written comments on j l
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| the report. The two major categories of responses are either in support of, ) l 4
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| or opposition to, the overall recomendations of the IOM comittee. However, j within each of these major categories, there are subsets with respect to the 1 i specific direction or focus of the coments. None of the comments received l j specifically indicated that there should be no Federal involvement.
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| ! The Secretary of the Department of Health and Human Services (DHHS), the
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| : Federal agency that would be most directly affected by the IOM
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| ! recommendations, indicated that the report does not make a compelling public health agreement for DHHS to assure the recomended new role. Furthermore, DHHS raised a concern that Congress would not provide resources commensurate l with the added responsibilities.
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| j 4
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| The majority of coments received (32 out of 47) did not endorse the full range of recommendations put forth by the IOM comittee. Four of the 15
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| - respondents that supported the recomendations indicated that the recommendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in its support of the 10M report, indicated that legislative initiatives should ensure that Federal facilities are not
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| ' subject to State and local regulations.
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| 1j The comments that did not support all the IOM recomendations varied l
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| ' dramatically in the focus of their viewpoints and opinions. The degree of l J regulatory reform perceived to be necessary ranged from simply recognizing the t
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| A l
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| I DSI 7 ATTACHNENT l I RELEASE DATE: SEPTEMBER 16, 1996 26 3
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| l
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| = -. - - .
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT I
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| merits of the issues raised by the IOM committee to a need for a complete restructuring of the regulatory program. The non-Agreement States that responded were particularly concerned about the substantigl financial impact l of the recommendations and the issue of this being, in effect, an unfunded Federal mandate. For example, as indicated in the response from Hawaii, public health and safety could be jeopardized in those States with l insufficient resources or capability to adequately implement the regulation of g byproduct materials. The Department of Defense response, which summarized the l responses from the three Service Medical Departments (Army, Navy, and Air Force), supported the need to re-evaluate the current regulatory structure, ,
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| but emphasized the need for a uniform regulatory authority. There were l
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| several responses that recommended the need for Federal oversight for all uses of radiation. ,
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| ] The Organization of Agreement States response provided a summary of the consensus of the participants of the NRC and Agreement State technical workshop conducted March 5-6, 1996, which included that all radiation use l (medical and non-medical uses) should be consolidated under one Federal agency. The CRCPD prepared a position paper, which supported the leadership i role of a single federal agency for all forms of ionizing radiation, at their l May 6 meeting. The comments of these organizations are summarized above under the specific recommendations to which they apply.
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| The NRC will continue to evaluate comments as part of the strategic assessment and rebaselining efforts. A summary of the comments is provided in
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| : Attachments 1-3.
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| 4 i
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| j 4
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| L 4
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| RELEASE DATE: SEPTEMBER 16, 1996 27 DS1 7 ATTACHMENT
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| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Categories of Responses Received on IOM Report Federal Aaencies:
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| Department of Defense (D00) - consolidates views for three services Department of Health and Human Services (DHHS)
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| Department of Labor, Occupational Safety and Health Administration (OSHA)
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| Department of Veterans Affairs (DVA)
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| Environmental Protection Agency (EPA)
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| Aare== ant States:
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| Arkansas California l Florida (Office Radiation Control) - R Florida (State Health Office) - H l Illinois Kentucky .
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| Maryland l New Mexico New York (Dept. Environmental Conservation) - E )i New York (Dept. Health) - H New York (Dept. Labor) - L Tennessee Texas Utah '
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| Vermont Washington Non-Aareement States / Territories: )
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| Alaska American Samoa Delaware Hawaii Massachusetts New Jersey Virginia Wyoming 28 Enclosure 1 I
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| l
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| . . . .-. . . _ - ~. . - - . . . . . - _ ~ . .- - . _ - -
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| DSI 7 ATTACHMENT MATERIALS /ME01 CAL OVERSIGHT i
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| i Oraanizations /Comittees:
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| American Association of Physicists in Medicine (AAPlj) ,
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| American College of Cardiology (ACC) i American College of Medical Physics (ACMP) l
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| : American College of Nuclear Physicians / Society of Nuclear Medicine l
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| ! (ACNP/SNM)
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| American College of Nuclear Physicians - California chapter
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| : (ACNP-CA)
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| American College of Radiology (ACR)
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| American Pharmaceutical Association (APHA)
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| American Society of Nuclear Cardiology (ASNC)
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| Conference of Radiation Control Program Directors (CRCPD)
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| NRC's Advisory Comittee on Medical Us Organization of Agreement States (0AS)ps of Isotopes (ACMUI)
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| Other Resoondents:
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| CBeasley, St. John's Regional Health Center, Springfield, M0 MHafermann, Virginia Mason Cancer Center, Seattle, WA DJones, Northwest Medical Physics Center, Lynnwood, WA !
| |
| CMarcus, University of California, Los Angeles, CA CPerez, Washington University, St. Louis, M0 l GPoteat, OH JRieke, Virginia Mason Cancer Center, Seattle, WA DSchumacher, Northwest Medical Physics Center, Lynnwood, WA MSelikson, RSO, University of Pennsylvania, Philadelphia, PA St. John's Hospital, Jackson, WY 7
| |
| The OAS coment provided the recomendations of and consensus views reached at the NRC and Agreement State Technical workshop. The session on the NAS report included representatives from 18 Agreement States (CA, NY, SC, NV, IL, WA, TX, MS, TN, GA, NE, CO, KY, KS, NYC, FL, AR, AZ) and two non-Agreement States (OH, PA).
| |
| 29 Enclosure 1
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| ~ - _ _ _ . _
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| _ _ . - . . . . _ ~ . _ . . . . .- .. .
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| 1 I
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| l DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT General Comments on ION Report Respondents in favor of IOM recommandations: ,
| |
| Support 10M report /reconnendations as written: \
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| AAPM ACNP/SNM ASNC DVA ,
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| M MHafermann (Virginia Mason Cancer Ctr)
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| DJones (Northwest Medical Physics Ctr)
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| CMarcus (UCLA)
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| CPerez (Washington Univ)
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| JRieke (Virginia Mason Cancer Ctr)
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| DSchumacher (Northwest Medical Physics Ctr)
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| Support 10M report / recommendations, but as applied to all materials:
| |
| FL (R)
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| NY (H)
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| NY (L) I ACNP-CA 30 Enclosure 2
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| 2 -
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| i I .
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| ; DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT
| |
| , Resnondents not in aareement .with 10M recomendations:
| |
| Support concept of regulatory reforn* but retain Federal quthority?:
| |
| j DHHS oversight: ACMUI, CA 3 NRC oversight: EPA, ACMP, ACR, HI, KY, NY(E), UT, WA, GPoteat(OH) 1
| |
| +
| |
| Unspecified oversight: DHHS' , D0D, ACC, AK, DE, TN, VA, WY
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| ^'
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| Support concept of regulatory reform, but after additional analysis:
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| i
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| ; CBeasley (St John's Regional Health Center) l MSelikson (RSO, Univ. of Pennsylvania)
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| NJ
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| ", St. John's Hospital 1
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| ; Support concept of uniformity for all radioactive materials regulation with l
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| Federal oversight:
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| CRCPD OAS I t APHA 4
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| AR (NRC as lead agency)
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| FL (H)
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| IL '
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| MA i MD TX i
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| i i
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| It should be pointed out that the degree of regulatory reform j perceived to be necessary by different respondents varied from recognizing the l concerns raised by the IOM to a drastic change in the approach to regulation
| |
| ; of medical uses.
| |
| i
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| ! Some States (e.g., VA, WY, DE) were primarily concerned with the
| |
| . substantial financial impact of the NAS recommendations and the issue of
| |
| : unfunded Federal mandates, rather than more specific concerns on the overall approach for regulation.
| |
| '" DHHS did not address the issue of regulatory reform, Federal
| |
| : authority, or concerns raised by the IOM, but focussed on the implications of j the recomendation to DHHS.
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| 3
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| ! 31 Enclosure 2 i
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| i
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| | |
| e DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Respondents indicatina report under review ML ,
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| AS VT
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| )
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| 32 Enclosure 2
| |
| | |
| a
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| ,o OSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT Specific Conuments on 10M Report . .
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| Category of Response Respondmt Specific coments RESPOISENTS IN AGREEMENT WliN ItBI RECENgEISAfl0NS __
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| Stggert Ian report / DvA The Veterans mealth Administration gemrolly concurs with and endorses the findings reconsumdation as written and recosammdations of 10N. Principed cc-rern is lack of specifics regarding regulation of Federal entititles and atse the regulation of medical research progress.
| |
| spew Mexico Agrees with I(BI recomumendation that Congress renewe regulation of possession and use of materiet steject to AEA from IIRC8s purview. Sagsports leadership role of IHutS so long as att states maintain regulatory programs that measure comprehensive standards of performance and effectiveness.
| |
| AApes AArtt findementatty stgiports position, conclusions, and recommmdations of the 10M report. IIRC abould be removed f rase its current regulatory role for medical use.
| |
| Establish programs for laptementing States' regulations monitored by appropriate Federal health agency with assistance of user community and professional organizations.
| |
| AcesP/$ses The ActIP and 58st betteve the report proposes a somd and thoughtfut approach to the regulation of nucteer smedicine and urges IIRC to laptement the 10M recommendations, attauing for comument on specific means to achieve laptementation.
| |
| AS81C Concur with the 10N's conclusions and stgiport their recousmendations for a amifons policy to be set at Federal levet which can be enforced by the States. Dents should include medical radiation safety as part of its health care management plan.
| |
| estafenmann Endorses recommendations of 10M. Does not agree with sentiments of Robert Adler in ,
| |
| Appendis L. ,
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| I 33 Enclosure 2
| |
| | |
| t DSI 7 ATTAC MENT MATERIALS / MEDICAL OVERSIGHT i Category of Response
| |
| . "_. .; speelffe Comments REMS IN AERE9ENT MITN IG4 RECGsEMATlent i Endernes recemmendations of itpt. Does not agree with sentiments of Setsert AsRer in t Sippert itNt report / DJenes i
| |
| racememndation es written Asgendia L.
| |
| Deercus Sigperts the list report and espresses disagreement ulth statements made tsy Robert #
| |
| Adler in his eipplementet statement (Aggendia L) :
| |
| (Perez Empresses streng sapport for many of recommmandetlene. j Jaleke Endorses recommendatione of 158. Does not agree witti sentiments of Robert Adler in Appmeulls L.
| |
| Oh W Segperts recommmandations preposed tur ist comodttee.
| |
| seppert tal report / Florlds support ldme of delegating regutetten of medical tuyprediset meteriet to states in recemamendetlene, but es apptled lead. teneret) additlen to ett .: meterials, to ett e lets seu York Sigport the It3t's concluelen timet the regutetten of medical use of tsypreshact toept, meetth) unteriets should be corried out at time state lowet. Encourages the Inc to not tielt its reopense to the itNt report to the narreu medical focus of the report.
| |
| I Iseu York Siggerts the ISI's rWtlen that MC discentleuse regutetten of medical use of I toept. t.eber) byprediset noteriets, tsue ceneiders it litegical to tielt the recommandation to this I ene eree teheutd include nucteer gdiernecles, manufacturers, distritsuters, and [
| |
| leuksstriot users)
| |
| Atar-CA IRC's entire meteriets program should be glwen to the states and Federal entitles ,
| |
| ~ ,
| |
| t i
| |
| i i
| |
| 34 Enclosure 2 3j
| |
| , t l
| |
| l
| |
| | |
| ' e a
| |
| b DSI 7 ATTACl# TENT MATERIAL.S/ MEDICAL OVERSIGHT l
| |
| l Category of Response Re , . ? ^ SpectfIc Commente RESPOISENTS IIOT lli AGREEIENT WITIl ItBI REttBGEleATIONS Sepport concept of regulatory Aolut ADeut Indicated a preference for a vertent of the IcIt preferred etternettwe In editch reform but retain Federet there would be onestantlet Federet oversight of State programs with a mechenlem to authority ensure compliance of States and users. State programs should be monitored by a Federal agency ulth overett medical use perspective tgINIS).
| |
| Delets Report does not make a competting petic heetth argument for DNNS taking on e -
| |
| stestantist new role. The probability is tou that Congress would provide adspete resources. DIIIIS does not steport the recommendation.
| |
| 000 Federal regulatory authority over medical use of bypreusset meterlet should be reevetuated and perhaps retamed and restructured, but not abolished in fever of a voluntary or State-operated system.
| |
| EPA Report reflects the concerns of the regulated community smore than the ptetic at targe. There may be aspects of IIRC's program that can be leproved, but INtc should continue to esaure p etic is protected.
| |
| ACC Transfer of oversight of the medical use of isotopes to the States seesus reasonable.
| |
| Ilouever, strongly encourage Federet oversl@t of this state initiative. An obvious dranaark would be if ett States had separate rai;::tations for licensure and compt Ionce.
| |
| ACMP Sagports the need for a dreetic change in regutetler of redletion in medical use including use of Advisory Penets (comprised of users, manufacturers, and pahtic) to determine the regulatory framework to be egiptied imiformly in medical profession.
| |
| Current regutettone should be modified.
| |
| ACR In Lieu of Congressionet action to eliminate IIRC's medical use program, the ACR believes that IntC's medical use program must be rebuilt and its objectives thoroughty reessessed. .
| |
| 35 Enclosure 2
| |
| | |
| i l DSI 7 ATTACMENT MATERIALS / MEDICAL OVERSIGHT
| |
| - - ^
| |
| Category of Asapense . --- - specifle r====nts ,
| |
| aEspomENTS meF In AGREEMENT WITN IGN BECGIgEISAtIONS (centinued)
| |
| Segpert concept of regulatory Alaska This would not be a cost effective nor efflcient reform for Alaske. It Is in the reform but retain Federet best interest of the State to support the seisting method of regulating nucteer authority (continued) medicine Licensene luy a Federet agency.
| |
| Cellfornia In view of optit regutetery authority at federet towet and apparent reluctance of Inc to empend jurledictlen, agree that Congrees remswe m 's authority. SENS should be given authority to ensure that every state sointelne e redletten program that meets minleses. - _ " zive - - standerde of performance and effectiveness.
| |
| geteuere The lapact of the 10H recommandstlene would be es&stantlet in terms of our, lacreened need for fieuling, staffing, training and Infrastructure rengstrements.
| |
| usuall Does not have resources or capability to edupsetely lagdement regutetlen of bypresset meteriets. Without ecolatence (training and dewetapment) to States, the renewet of mat's authority ser significantly jeeperdlae Inddle heetth and eefety.
| |
| ! Kentucky A better approach would be to have NRC revlee its medical program to go ateng with l the recommendations the Institute has glwen in preferred etternettwe D.
| |
| i meu verk Many unforeseen ces=any==nces may eccur if AEA le modified. Comoleelen eheutd proceed (0ept. Environ. cautteusty in pursuing ten recesumendettens that may atter the present AEA.
| |
| ; Conservetten)
| |
| Tennessee uhlte the findings of the camelttee have same merit, there is no conclusive seppert provided to docessent them. Sweeping changes are not mett thought out and may reeutt in chose.
| |
| Utah State legistetures may view this es another ietfunded Federet mondete and may provide no additlenet sigport to the State program. Itedical commeanity should work with Intc, States, and other porties to remotwe the regatetten leeue.
| |
| * ar 36 Enclosure 2 -
| |
| | |
| - . - - . . . . . . ~ . - - -- . . - - - - - - . - ---. . . . . . - .. . . ~ . - - - - - - . ~ . -
| |
| . -- ~ . - _ ~ . - . . . _
| |
| b
| |
| . . i t
| |
| I e *,
| |
| DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT i
| |
| Category of Response Respondent 3peelfic Cemeente RESPOISENTS NOT IN AGREEDENT UlTN ItBI RECIBgEIBAfl0NS (centinued) -
| |
| 5tgyort concept of regulatory Virginia The C alth is in no poeltlen to eseisme any eeMittenet unfunded Federet reform but retain Federet sendetes. Could enty eastene regulatory reopenelbility If MRC prowldes funds to '
| |
| outhority (centinued) defroy cast of laptamenting the program.
| |
| Washington mRC should focus en redletion safety of warter and non-pettent leMic (oversight of preesction, distribution, and hendting of byprechset meteriets) idille protection of
| |
| * petlent is best handled through State boards of medicine and phe secy.
| |
| Wyoming The conctuelens of the report nesteet the considerable herdship to be incurred by emetter, less poputeus, and less affluent States. Only through continued Federet regulatory porticipation can the goats of tettforelty and pietic access to hefe medicat processres be achieved.
| |
| GPotest Potentist decrease in safety may result from a transfer to State regulators of IstC's euthority. stinor changes are necessary but overett NRC's reputettens betence the need to protect verkers, pottent and the piMic with the reupstrements of medical practice.
| |
| i 37 Enclosure 2
| |
| | |
| i DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT i
| |
| - ^
| |
| Spectfic Cemeents -
| |
| Category of Response -.
| |
| NEms 507 IN AMEBENT litTN IGE REtXpWEWAf ttNIS (continued) f
| |
| [
| |
| IIew Jersey If NJ cheme not to became an Agreement State, peMic may not be aneured of adequate - l Sippert concept of regulatory protectlen. If edepting the recommendations, NEC and Cenerees should not act reform, test ef ter etMitlenet precipitounty, but attou the States to prepare for assiselne regutetery progrees in enetyste orderty fashlen.
| |
| tintwersity of Defere moving in the directlen of a State-h====8 decentrellred system, a better t Penneytwente evetuetten of potentlet both for increased risk to the piMIc and increased cost to i the medical Inthsstry le necessary.
| |
| St. John's tfrges INIC to give every ceneideretten to ItNE report, particularly the rewleu of risk NeoptteL assessment. j i
| |
| Cgeestey The report missed part of its stated Intended goet to rewleic the current system of I regutetten (the leeues of uniformity among states mee not futty emptored). Preposes [
| |
| rewlew in more detelt the regutetten of non-nucteer medicine redlotegy and epsestien l of iniformity between states.
| |
| b GAS At IntC/ Agreement State Technicet 18erkshop, use rearhane that att redletten Sippert concept of imiformity une (reguteted currently under tutt, FDA, EPA, and OIAA) should be ceneetidoted teder for ett radioactive materiets a single Federet agency.
| |
| regutetton with Federet CRCPD Absence of federet authority in medical use aree may have lamedlete and undesirable canoesysences en cittrene in non- Agreement States and tens term conseepsonces for Agreement States trying to mainteln a netlenetty cenelstent program. CRCPg does not
| |
| ' enspport automatic selection of Dens es the agency to provide teedership role.
| |
| Apha Att lenlains redletten should be greigned together inder e imiform regutetten.
| |
| l Transfer reopenelbility for medical uses of any leniting redletten to the States, j Some Federet authority should remain over the medical uses of lentring redletion (NRC or a sletter federet agency). .
| |
| L 38 Enclosure 2 ; ,
| |
| e
| |
| | |
| 4' 4
| |
| e DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT I
| |
| Category of Response # , " ..; i Specific rWe RESPOISENTS NOT IN AGREE 9ENT WITR f(58 RECINgENDATIONS (continued)
| |
| * Saggort conceet of teilformity Arkanses The NRC should ceneider alternettve A2 (stetus que modified). If enjor changes are for ett radioactive meteriets to be made, centretiretten of reedtetion ulthin ene Federet agency (NRC) would be the regutetten with Federet best approech for ett uses of redletion. Congress umuld be respaired to empend the oversight (continued) role of NRC and a change in the esency would be necessary. Espend current Agreeseent State program.
| |
| Florida Sepport idee that regulatory authority of gM egreeseent materiets be turned over to (Neetth the states with consolldation of federet redletion oversight, guldence, and Office) regulatory functions into one agency, not necesserity DNNS.
| |
| Ittinois Prefer CRCPO proposed new orgenlaationet concept that recommands some conettidation of att redletion regulatory functions et federet level. Revise eII and phernacy rules. Prepare iAlte paper to use as a policy basis to cteerty detInsete the respective authority and responsibilities of verlous Federet and State esencies.
| |
| Iserytend Rather then revoke NRC's authority and repest the Federet regutetlene, such authority should be empended to incorporate IIAINe, and the Federet regutettons should be thoroughty revleued and amended to clarify regulatory responsibility. OtNIS does not have necessery eypertIse.
| |
| Slessachusetts Do not sepport ettuinetton of att espects of IIRC's medical program, but sepport retesetion of overty prescriptive and tsinecesserity coetty requireusents. Sapport intent of sinate Federet agency providing a sInste teedership rote but do not steport automatic selection of DeNIS. ,
| |
| i Texas the bests for the report's recomumendatione do not seem to be siestantleted. The .
| |
| merging of att federet radiation control oversight into a sinste regulatory program {'
| |
| should be considered. The IIRC should er6ence the partnership uith the States to jointly determine compatibility respairemente.
| |
| i f
| |
| i 39 Enclosure 2
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| | |
| ~
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| 1 Attachment E DSI No. 12, " Risk-Informed, Performance-Based Regulation" i
| |
| l 1
| |
| | |
| STRATEGIC ASSESSMENT ISSUE PAPER DSI 12: RISK-INFORMED, PERFORMANCE-BASED REGULATION INTRODUCTION l In August 1995, the Nuclear Regulatory Coenission (NRC) staff initiated a l Strategic Assessment and Rebaselining Project. This project was intended to
| |
| ' take a new look at the NRC by conducting a reassessment of NRC activities in order to redefine the basic nature of the work of the agency and the means by which that work is accomplished, and to apply to these redefined activities a rigorous screening process to produce (or rebaseline) a new set of assumptions, goals, and strategies for the NRC. The results of this project are intended to provide an agency-wide Strategic Plan which can be developed and implemented to allow the NRC to meet the current and future challenges.
| |
| A key aspect of this project was the identification and classification of issues that affect the basic nature of NRC activities and the means by which this work is accomplished. These issues fall into three categories. The first category includes broad issues defined as Direction-Setting Issues (DSIs). DSIs are issues that affect NRC management philosophy and principles.
| |
| The second category includes subsumed issues. Subsumed issues are those that should be considered along with the DSIs. The third category includes related issues. These are issues that should be considered after the Commission makes a decision on the option (s) for a DSI. Also, as part of the project, other issues of an operational nature were identified. These are not strategic issues and are appropriately resolved by the staff, and are not discussed in the issue papers.
| |
| Following the reassessment of MRC activities, issue papers were prepared to provide a discussion of DSIs and subsumed issues, and to obtain a review of these broad, high-level issues. These papers are intended to provide a brief discussion of the options as well as summaries of the consequences of the options related to the DSIs. Final decisions related to the DSIs will influence the related issues which are listed, but not discussed, in each issue paper. As part of the Strategic Assessment and Rebaselining Project, the i.: sue papers are being provided to interested parties and to the public.
| |
| Fo11oving distribution of the issue papers, a series of meetings are planned to provide a forum to discuss and receive coament on the issue papers. After receiving public comment on the issue papers, the Connission will make final doctrions cencerning the DSIs and options. These decisions will then be used to devclep a Strategic Plan for the NRC. In summary, the Strategic Assessment and Rebaselining Project will analyze where the NRC is today, including internal and external factors, and outline a path to provide direction to move forward in a changing environment.
| |
| RELEASE DATE: SEPTEMBER 16, 1996 DSI 12
| |
| | |
| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION I. SUMARY A. Direction-Setting Issue ,
| |
| The Commission has established the policy that, to the extent practical, risk insights shall be incorporated into all nuclear regulatory activities. As a result of this policy, the staff has developed a framework for applying probabilistic risk assessment (PRA) methods and techniques in reactor regulation (SECY-95-280, " Framework for Applying Probabilistic Risk Analysis in Reactor Regulation") in order to ensure consistent and appropriate application of PRA methods. The staff has also identified a number of i
| |
| regulatory applications associated with reactor regulation that appear l amenable to the expanded use of PRA - such as inservice testing of pumps and i valves, inservice inspection, technical specifications, and graded quality {
| |
| assurance. In these areas, the staff is developing PRA standards and guidance to help clarify and facilitate the use of risk-informed, performance-based ;
| |
| regulation for both the NRC and the industry, i Industry and NRC efforts to develop and apply similar approaches to nuclear materials programs are not as advanced as reactor programs. The complexity of power reactors and the potentially severe consequences of a reactor accident led to the development of analysis methods to provide better estimates of risk. The consequences of an accident in the nuclear materials area would be less severe and the event sequences would be less complex than the consequences of an accident in the reactor area. The need for a better understanding of risk for commercial power reactors resulted in detailed development of reactor risk analysis methodology before such methodology was developed for the relatively simpler, but more diverse, nuclear materials area. Also, power reactor risk analysis techniques are more developed than nuclear materials risk analysis techniques because the commercial nuclear power industry is actively seeking regulatory relief in numerous areas using risk-informed, performance-based insights to help justify the request for l
| |
| re11ef.
| |
| Considering the general direction provided by the commission and Congressional directives to various Government agencies to proceed to use risk-based and cost-benefit criteria, and recognizing the resources needed to implement risk-informed, performance-based approaches to regulation the following direction setting-issue (DSI) was identified:
| |
| What criteria should NRC use in expanding the scope in applying a risk-informed, performance-based approach to rulemaking, licensing, inspection, and enforcement?
| |
| RELEASE DATE: SEPTEMBER 16, 1996 2 DSI 12
| |
| | |
| ; i l
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| l i
| |
| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION i
| |
| l I
| |
| The Commission's decision on this issue will be used to establish the overall !
| |
| framework for "how fast" and "how far" the agency will go in expanding activities in the application of risk-informed, performan'cp-based regulatory approaches. This paper provides four options for moving toward more i risk-infomed, performance-based regulatory approaches.
| |
| l Sample criteria for expanding the scope within the context of the strategic l direction are discussed in Appendix A.
| |
| i B. Options.
| |
| Option 1: Continue Current Process l The current process for pursuing risk-informed, performance-based regulation could be characterized as an incremental process. Priority and scope in applying risk-informed, performance-based regulatory approaches are determined by balancing external and internal goals and available resources. Priority criteria (Appendix A) are applied and the scope of activities is primarily determined by considering the industry demand, the safety benefit, the ease of implementation, and available resources. This approach covers both reactor and nuclear materials areas but there is more activity associated with risk-informed regulatory approaches for reactor applications as outlined in the PRA Implementation Plan (SECY-95-079).
| |
| Option 2: More Rigorously Assess Relationship to Public Health and Safety Before pursuing risk-informed,. performance-based approaches, this option would require that for new initiatives, the NRC determine that there is the potential for a substantial increase in overall protection to public health and safety that would justify the level of resources necessary to pursue additional risk-informed, performance-based regulatory initiatives. Priority and scope in applying risk-informed, performance-based regulatory approaches are primarily determined by the projected cost of the initiative compared to benefit to the public health and safety. Many intangibles would have to be qualified before proceeding. Priority criteria are weighted toward greatest safety benefit. The scope of risk-informed, performance-based approaches would be primarily determined by considering the cost / benefit, the overall impact on the NRC and regulated industry, and available resources. This option would provide additional focus for moving toward risk-informed, performance-based regulation and potentially move more slowly toward risk-informed, performance-based regulation than the current process.
| |
| SEPTEMBER 16, 1996 3 DSI 12 RELEASE DATE:
| |
| l
| |
| | |
| t 1
| |
| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION
| |
| ! Option 3: Perform a Comprehensive Assessment of NRC Regulatory Approaches i
| |
| This is a proactive, aggressive option for moving toward r,isk-informed,
| |
| ) performance-based regulation. This option would maximize internal j
| |
| self-assessment and include exploring all regulatory areas to determine i whether risk-informed, performance-based regulation should be pursued in that l area. This approach would require a comprehensive review of our regulations and regulatory processes t, determine a:eas that could be improved through i risk-informed, performance-based regulatory approaches. Priority for
| |
| ! regulatory activities are established based on consideration of the cumulative
| |
| ! impacts on safety, burden reduction, and efficiency. The scope of j
| |
| risk-informed regulatory approaches under this option would be determined by j considering agency responsiveness to stakeholder initiatives, the safety j benefit / significance of the approach, and the effect on NRC and licensee i efficiency. Ease of implementation and available resources are secondary
| |
| ' scoping considerations (i.e., if the activity is determined to be a high priority then resources will be made available and efforts made to improve the j
| |
| state-of- the-art to the level necessary to support the desired goal).
| |
| l Option 4: Consider Risk-Informed, Performance-Based Approaches Primarily in i Response to Stakeholder Initiatives i
| |
| This option is the most responsive to industry and stakeholder initiatives.
| |
| Priority and scope in applying risk-informed, performance-bund regulatory
| |
| , approaches would be primarily determined by stakeholder demd and ease of
| |
| ; implementation. Priority would be weighted toward industry initiatives to use a
| |
| risk-informed, performance-based approaches to reduce regulatory burdens. The l scope of risk-informed regulatory approaches under this option would be
| |
| ; primarily determined by nature of the initiative. Ease of implementation and cost / benefit play a major role in defining the scope of the regulatory approach.
| |
| i II. DESCRIPTION OF ISSUES 4
| |
| { A. Background I
| |
| Since the early 1970s, the NRC has expended significant resources in the development and application of PRA technology. This included the ground-breaking work of the Reactor Safety Study (documented in WASH-1400) in 1975.
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| On January 18, 1979, the NRC issued a policy statement entitled "NRC Statement of Risk Assessment and the Reactor Safety Study Report (WASH-1400) in Light of the Risk Assessment Review Group Report" [ Risk Assessment Review Group Report, NUREG/CR-0400). In addition to addressing specific criticisms of WASH-1400, the 1979 policy statement articulated limitations in the use of PRA in the regulatory arena. Many of these limitations have been addressed, however, some still remain pertinent today. Primary among these limitations is the RELEASE DATE: SEPTEMBER 16, 1996 4 DSI 12
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| characterization of uncertainties associated with calculated probabilities of !
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| reat, tor accidents. PRA methodologies have, however, provided a better means for identifying and characterizing the range of uncertaint,y.
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| The Three Mile Island accident in 1979 substantially changed the character of the analysis of severe accidents worldwide. It led to a substantial research l program on severe accident phenomenology. In addition, both major 1 investigations of the accident (the Keme'ny and Rogovin studies) recomended that PRA techniques be used more widely to augment the traditional nonprobabilistic methods of analyzing nuclear plant safety. In 1984, the NRC completed a study (NUREG-1050) that addressed the state-of-the-art in risk analysis techniques.
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| In early 1991, the NRC published NUREG-1150, " Severe Accident Risks: An Assessment for Five U.S. Nuclear Power Plants." In NUREG-1150, the NRC used improved PRA techniques to assess the risk associated with five nuclear power plants. This study was a significant turning point in the use of risk l
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| concepts in the regulatory process and enabled the Comission to greatly
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| ! improve its methods for assessing containment performance given core damage initiation and subsequent accident progression.. The methods developed for, and results from, these studies provided a valuable foundation in quantitative
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| ! risk techniques.
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| PRA methods have been applied successfully in several regulatory activit6 and have proved to be a valuable complement to traditional deterministic engineering approaches. This application of PRA represents an extension and enhancement of traditional regulation rather than a separate and different technology. Several recent Comission policies or regulations have been based, in part, on PRA methods and insights. These include the Backfit Rule (10 CFR 50.109, "Backfitting"), the Policy Statement on " Safety Goals for the Operation of Nuclear Power Plants," (51 FR 30028; August 21,1986),the Commission's " Policy Statement on Severe Reactor Accidents Regarding Future Designs and Existing Plants" (50 FR 32138; August 8,1985), and the Comission's " Final Policy Statement on Technical Specifications Improvement for Nuclear Power Reactors" (58 FR 39132; July 22,1993). PRA methods also were used effectively during the anticipated transient without scram (ATWS) and station blackout (SBO) rulemakings, and have been used extensively in the generic issue prioritization and resolution process. Additional benefits have been found in the use of " Risk-Based Inspection Guides" to focus NRC reactor inspector efforts and make more efficient use of NRC inspection resources.
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| Probabilistic analyses were extensively used in the development of the l recently proposed rule change to reactor siting criteria in 10 CFR Part 100 (59 FR 52255; October 17,1994), especially in the area of estimating the Safe Shutdown Earthquake ground motion for a nuclear reactor site.
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| ! DSI 12 i RELEASE DATE: SEPTEMBER 16, 1996 5 i
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION Currently; the NRC is using PRA techniques to assess the safety importance of operating reactor events and as an integral part of the design certification review process for advanced reactor designs. In addition, the Individual Plant Examination (IPE) program and the Individual Plant Examination -
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| External Events (IPEEE) program (an effort resulting from the implementation of the Commission's " Policy Statement on Severe Reactor Accidents Regarding Future Designs and Existing Plants") have resulted in coomercial reactor licensees using risk- assessment methods to identify any vulnerabilities needing attention.
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| l The Commission has been developing performance assessment methods for
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| . low-level and high-level waste since the mid-1970s, and these activities intensified using performance assessment techniques in the 1980s and early 1990s. This work involved the development of conceptual models and computer codes to model the disposal of waste. Because waste disposal systems are passive, certain analysis methods used for active systems in PRA studies for power reactors had to be adapted to provide scenario analysis for the performance assessment of the potential geologic repository at Yucca Mountain, l Nevada. In regard to high- level waste, the NRC staff participates in a l variety of international activities (e.g., the Performance Assessment Advisory !
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| 1 Group of the Organization for Economic Cooperation and Development, Nuclear l Energy Agency) to ensure that consistent performance assessment methods are i used to the degree appropriate. i In mid 1994, the NRC staff proposed a PRA policy statement to the Cosmission in SECY 218, " Proposed Policy Statement on the Use of Probabilistic Risk Assessment Methods in Nuclear Regulatory Activities." In that Commission paper, the staff proposed that an overall policy on the use of probabilistic risk assessment (PRA) methods in nuclear regulatory activitier should be established and that the use of PRA technology in NRC regulatory activities should be increased. The staff also forwarded SECY-94-219, " Proposed Agency-Wide Implementation Plan for Probabilistic Risk Assessment (PRA)," to
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| . the Commission.
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| The NRC established its regulatory requirements to ensure that nuclear
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| , facilities can be operated and nuclear materials can be used without undue l risk to the health and safety of the public. These requirements are largely 4
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| based on deterministic engineering criteria, involving the use of multiple barriers and application of a defense-in-depth philosophy. Beyond its deterministic criteria, for cosnercial power reactors, the NRC has additionally formulated guidance, as in the safety goal policy statement, that utilizes quantitative, probabilistic risk measures. The safety goal policy statement establishes top-level objectives to help ensure safe operation of nuclear power plants. The safety goals provide guidance on where plant risk is sufficiently low so that further regulatory action is not necessary. Also, i
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| i as noted at>ove, the Commiission has been using PRA in performing regulatory l
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| ; analyses for backfit of cost-beneficial safety improvements at operating 3
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| reactors (as required by 10 CFR 50.109) for a number of years.
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| I
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| ; The application of PRA to nuclear regulatory activities has evolved with improvements in PRA techniques and data bases. PRA techniques can be used to l
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| derive valuable insights, perspectives, and general conclusions as a result of the integrated and comprehensive examination of the plant design and a i
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| ! structured examination of plant aid operator response to events. For a nuclear power plant, a plant-specific PRA can be used to derive plant-specific i insights and conclusions where appropriate plant-specific modeling and data are available and used appropriately. PRA sensitivity studies are particularly useful in focusing designers, operators, and regulators on important aspects of design, operation, and maintenance.
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| ! The Commission has considered recent improvements in nuclear technology and accumulated experience with risk assessment methods, and concluded that increased use of these techniques as an integral part of the regulatory decision-making process is now justified. Consequently, in its policy statement, "Use of Probabilistic Risk Assessment Methods in Nuclear Regulatory Activities" (60 FR 42622, August 16,1995), the Cosnission adopted the policy that the use of PRA should be encouraged and the scope of PRA applications in nuclear regulatory matters should be expanded to the extent supported by the state-of-the-art methods and data.
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| Bases The bases for rules and standards issued by the NRC are the Atomic Energy Act of 1954 (AEA), the Energy Reorganization Act, the Administrative Proceduras Act, and other legislation. The AEA generally requires that the NRC establish regulatory standards to govern its licensing determinations. The AEA (section 161(b)) provides NRC with broad authority regarding the standards and processes that the NRC must apply in exercising its licensing and regulatory responsibilities.
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| In the reactor area, the AEA (sections 101 and 103) requires a license for .
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| each utilization facility and requires technical specifications (section 182) to be part of the license. The AEA allows for amendments to the licenses (section 187) and includes requirements for holding hearings in the amending of licenses (section 189). Under the Energy Reorganization Act of 1974, NRC l is responsible for these licensing and regulatory functions. The procedures and requirements governing issuance and modification of these licenses are contained in the NRC's regulations (primarily in 10 CFR Parts 2 and 50).
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| SEPTEMBER 16, 1996 7 DSI 12 RELEASE DATE:
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION In the nuclear materials area, the AEA requires general or specific licensing for distribution and use of special nuclear material (section 53), source material (sections 62 and 63), and byproduct material (segtion 81). As a consequence of the statutory responsibilities for licensing the distribution and use of nuclear materials and the use of utilization and production facilities, the NRC regulates medical, industrial, academic, and other commercial uses of nuclear materials.
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| The AEA provides the broad authority for inspection to ensure compliance with the provisions of the Act. NRC inspections provide an independent verification of licensees' activities to ensure that the activities are in compliance with agency regulations. Inspections are primarily discussed in 10 CFR Parts 19, 30, and 50.
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| The AEA authorizes the NRC to undertake enforcement activities relating to violations of the licensing requirements, such as notices of violations and the imposition of civil monetary penalties. The NRC is also authorized to issue orders that may lead to the suspension, revocation, or amendment of licenses. 10 CFR Part 2 describes the procedures for issuing notices of violation and Orders, and imposing civil penalties.
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| B. External Factors
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| : 1. Executive Branch and Congress Congressional and Executive requirements regarding regulatory reform, changes in international standards, and advances in understanding risk and the biological effects of radiation may affect the regulation of the nuclear industry. As late as 1995, Congress was considering legislation concerning risk assessment (Title III of H.R. 9, the Risk Assessment and Coimmunication Act of 1995).
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| : 2. Standards-Setting Organizations International and national standards-setting committees may influence the transition toward risk- informed, performance-based regulations. Translations between dose and risk usually use international consensus factors. In the nuclear materials area, NRC has traditionally used radiological dose as the endpoint for rulemaking and compliance assessment. That is, in certain nuclear materials areas, regulatory decisions are related to the acceptability of dose as a surrogate for risk. The International Commission on Radiological Protection (ICRP) dose limits reflect ICRP recommendations for acceptable risk selections for radiation workers and the public. The NRC makes use of recommendations from the ICRP, the National Council on Radiation Protection, and the National Academy of Sciences.
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| : 3. Federal Agencies ,
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| 4 The Environmental Protection Agency (EPA) has undertaken a, number of
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| ! regulatory initiatives under its authorities that affect activities licensed i or otherwise regulated by the NRC. Substantial differences have arisen i between the two agencies and have included the underlying bases and approaches j used to develop standards. In 1995, the NRC and the EPA developed a joint
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| : paper entitled " White Paper on Risk Harmonization" to help explore ways to
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| : " harmonize" risk goals and to develop autually agreeable approaches for risk i assessment methodologies to assess radiological risk.
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| 1 As previously discussed, the Paperwork Reduction Act of 1995 is the basis for agency and OM8 activities related to information collections. It requires
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| ; controls to limit and reduce the burden on the public for collecting agency l information. In 5 CFR 1320, which implements the Paperwork Reduction Act, OMB requires agencies to submit plans for new, revised, and extended information l
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| collections to OM8 for approval. However, the NRC, as an independent
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| : regulatory agency, may override OMB decisions.
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| 1 Nuclear Industry j 4.
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| l In the reactor area, commercial nuclear power utilities and industry i organizations are using risk insights to identify and reduce unnecessary
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| : burdens. Where NRC review and approval is necessary before reducing the i burden, the industry is cetively engaging the staff to seek relief. In the
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| ; nuclear materials area, there is less demand for regulatory change based on
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| : risk insights than in the reactor area. In rose instances the nuclear j materials industry may not be supportive of risk-informed, performance-based
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| ! initiatives due to perceived high cost, impact on small number of licensees, and little perceived additional safety benefit.
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| : 5. Public The public will likely play a substantial role in the transition to risk-informed, performance-based regulation. In order to maintain public confidence, the bases for and implications associated with risk-informed, performance-based regulatory approaches should be well defined and easily understood.
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| C. Internal Factors
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| : 1. Nuclear Materials Initiatives The Commission's decision on the future role and scope of the NRC's nuclear materials program (in particular NRC's regulation of the medical use of 1 nuclear material) will potentially affect the priority and scope for pursuing j 1
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| risk-informed, performance-based regulatory approaches in nuclear materials )
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| t program areas. The National Academy of Sciences recommended that the NRC l reduce or eliminate its oversight of the medical uses of qpelear material.
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| The basis for a decision regarding NRC oversight of the medical uses of i nuclear material may affect the oversight and regulation of other material itsensc*s and, consequently, the extent to which the agency may pursue risk-info *med, performance-based approaches. The Business Process Reengineering effort is examining ways to gain efficiencies in licensing of nuclear materials and the results of this effort may affect the extent to which risk-iLnformed, performance-based approaches could improve the effectiver.ess and efficiency of the licensing process. )
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| : 2. Commission's PRA Policy Statement The Commission's PRA Policy Statement onceurages the use of PRA and seeks to expand the scope of PRA applications in all nuclear regulatory matters to the extent supported by the state- of-the-art in terms of methods and data.
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| Performance-based regulation is an implicit element of the Policy Statement.
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| Depending on the Commission's decision for procee' d ing toward risk- informed, performance-based regulatory approaches (e.g., more aggressive (Option 3) or less a.)gressive (Option 4)), activities associated with the PRA Policy Statement and the companion PRA Implementation Plan may be refocused and staff resources may be redirected.
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| )
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| : 3. Defense-in-Depth The Commission has recognized that reliance for safety should not be placed on any single element of design, construction, operation, maintenance, training or other activity associated with nuclear facilities or the use cf nuclear i I
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| materials. Our current regulations are generally deterministic and were constructed around this concept of defense-in-depth. Risk insights provide a more structured way to assess relative importance of the levels of defense-in-depth and can lead to enhanced defense-in-depth. Risk-informed, performance-based regulations may need to consider the potential adverse etsuulative effect of reducing conservatism and providing additional flexibility on defense-in-depth. Performance-based initiatives are considered for activities where failure to meet the performance criteria results in tolerable conditions for which appropriate corrective action will be taken.
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| Therefore, a key element of a transition toward risk-informed, performance-based regulation is maintaining " defense-in-depth" for risk-informed, performance-based approaches by appropriately balancing deterministic- based and performance-based requirements so that defense-in-depth is not compromised.
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| : 4. Policy and Legal Issues: Compliance with Performance-Based Regulations substantive policy and legal issues are likely to emerge aj; increased reliance is placed on probabilistic- and performance-based approaches to support regulatory requirements and licensing decisions. Issues such as using risk to j
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| 4 assess the severity level of an enforcement action or determining compliance
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| ! with performance-based regulations will need to be addressed to ensure that i there is an appropriate balance between deterministic-based and performance-based regulations so that defense-in-depth is not compromised.
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| III. DISCUSSIONS l
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| A. Discussion of Direction-Setting Issue The Cosmission's decision on this direction-setting issue will be used to establish the overall framework for expanding agency activities in applying risk-informed, performance-based regulatory approaches. After deciding on the I overall approach for pursuing risk-informed, performance-based regulation, j criteria for expanding the scope in applying a risk-informed, performance-based approach to rulemaking, licensing, inspection, and enforcement activities can be applied in the context of the overall Commission ,
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| direction. In order to provide agency focus, these criteria can be l sufficiently broad so that the criteria can be applied to both the reactor and nuclear materials areas. However, given the diverse nature of nuclear i materials applications and the differences between commercial nuclear power and other nuclear materials areas in regard to their amenability for risk-informed, performance-based regulations, these criteria may need to be applied differently for different regulatory activities. Appendix A contains sample " priority and scoping" criteria that can be applied to better focus agency activities once the Commission decides the overall approach for pursuing risk-informed, performance-based regulatory approaches.
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| B. Discussion of Subsumed Issues After the Commission decides on the overall approach for pursuing risk-informed, performance- based regulation, six subsumed strategic issues will be resolved in the context of the overall direction. Four of these subsumed issues can be directly resolved through resolution of the direction-setting issue. The resolution for the two other subsumed issues will be greatly influenced by the Commission decision on this direction setting issue.
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| The four issues most directly resolved through implementation of the Commission decision for "how fast" and "how far" the agency will go in expanding activities in the application of risk- informed, performance-based regulatory approaches are:
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| SEPTEMBER 16, 1996 11 DSI 12 RELEASE DATE:
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| 1
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| l l DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION What should be NRC's strategy and philosophy with respect to changing NRC's responsibilities and authority in areas of little public risk?
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| What approach should NRC take in modifying the materials regulations to move toward risk-informed, performance-based regulation, recognizing the requirements will vary as a result of the range of products and the divergence of the licensees that use or possess byproduct nuclear material?
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| Should NRC revise its regulations to address the uses of materials resulting from technological advances and changing human factors? If 4
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| so, to what extent should NRC articulate objectives to prevent or limit the effects of equipment failures and human factors / human performance? :
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| What should be the approach for licensing material uses with various levels of inherent risks?
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| The first two issues should be completely resolved by the Commission's decision on this direction-setting issue and the Commission's decision on the direction-setting issue concerning the future role and scope of the NRC's nuclear materials program (in particular, NRC's regulation of the medical use of nuclear material).
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| I The agency is required by the Atomic Energy Act of 1954 (AEA), as amended, to provide reasonable assurance of an adequate level of protection of the public 4
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| health and safety, as well as to promote the cosmon defense and security, in its regulatory activities. Although the scope of actions necessary to attain this level of protection from the use of AEA materials is relatively clear in areas of high risk, it is not so easily defined for those activities and types of material that generate a relatively small risk to the public from their use. Such areas include, but not limited to, the use of generally licensed devices, exempt distribution of consumer products, the definition and
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| ! regulation of source material, review of formerly licensed sites and stabilization and long-term control of uranium mill tailings. As the agency !
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| seeks to improve the efficiency and effectiveness of its regulatory programs, these low risk activities will be scrutinized in order to make informed ;
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| decisions about how the agency should proceed.
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| The Commission's philosophy for considering changes to its regulatory activities, including areas of responsibilities and authorities for areas of little public risk is, in part, contained in the Cosmission's Final Policy
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| - Statement on the use of probabilistic risk assessment in nuclear regulatory activities. In the Final Policy Statement, the Commission conveys an
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| * open-minded approach for considering strategic-type changes associated with using risk insiEhts and states that two explicit implications associated with the policy statement are:
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| ; DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION First, that the NRC staff, licensees, licensee applicants, and j Cosmiission must be prepared to consider changes to regulations, to 1 guidance documents, to the licensing process, and to,the inspection i program. Second, the NRC staff and the Commission must be committed to j a shift in the application of resources over a period of time based on
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| : risk findings.
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| 4 The current agency-wide strategy for increasing the use of risk assessment and j risk management in regulatory decision-making is captured in the agency's PRA
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| < Implementatinon Plan. Therefore, the Commission decision on "how fast" and "how far" the agency should go in expanding activities associated with the
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| ! application of risk-informed, performance-based regulatory approaches will
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| )
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| further define the approach and support the bases for considering changes to regulations, responsibilities and authorities.
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| I The third issue explicitly recognizes the diverse nature of nuclear materials applications and the differences between reactor and nuclear materials areas in regard to their amenability for risk- informed, performance-based regulations. For example, events associated with industrial and medical uses i
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| : of nuclear materials generally involve a simple system, involve radiation overexposures, and result from human error, not equipment failure. Because of j these characteristics of medical and industrial events, analysis of these events using relatively simple techniques may yield useful results. These
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| ' results may lead to the establishment of standards with broad risk-informed, performance-based objectives and criteria. Conversely, these results may lead to a conclusion that more prescriptive requirements for equipment design and procedural compliance are appropriate. In these cases, risk insights lead to l
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| ! risk-informed, deterministic regulations not risk-informed, performance-based regulations. Similar to the first subsumed issue, this subsumed issue will i also be resolved by the Commission's decision on this direction-setting issue i and the aforementioned direction-setting issue concerning regulation of nuclear materials.
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| l The fourth subsumed issue concerns licensing for nuclear materials when there is determined to be a wide range of inherent risks because of the diverse use of the materials. These risks vary from very low-risk smoke detectors to relatively high-risk irradiators. Although the Coenission must license all of i these uses in response to the AEA, the Coassission has flexibility in how it approaches the licensing. Currently, the Counission provides for three types of licensing: (1) exempt distribution, (2) general licenses, and (3) specific licenses. For exempt distribution devices (e.g., smoke detectors), the Commission oversees and controls their manufacture and distribution by issuing specific licenses to the manufacturers and distributors. The individual users
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| : of these low-risk devices are not licensed. A review of the internal and external factors and ongoing activities has not identified any strategic i
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| issues associated with exempt distribution devices.
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| : The generally licensed devices consist of radioactive material contained in
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| ! sealed sources that are designed with inherent radiation safety features.
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| 1 Approximately 1.5 million generally licensed devices are under the
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| ! jurisdiction of the Agreement States and the NRC. NRC's regulation of these j devices is essentially limited to the maintenance of a general license i database, which contains the names of the general licensees and the products j they possess. For general licenses, issues associated with control and accountability were discussed in SECY- 95-139, which reports that many general licensees are not aware of their responsibilities under the general license.
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| The staff has previously noted that there are inconsistencies in terms of risk, both among and across these three levels of activities. For example, in SECY-90-175, the staff identified certain generally licensed gauges that may be better controlled through specific licensing and also identified certain generally licensed devices that are suitable for exemption from regulation.
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| In this regard and in accordance with recossmendations contained in SECY-95-139, the staff has established a joint Agreement State-NRC working group to evaluate the current regulations concerning generally and specifically licensed devices. A report from the working group is expected in June 1996. ,
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| As previously mentioned, issues associated with determining an approach for considering risk in the licensing of material uses will also be resolved in the context of the.overall Commission decision on this direction-setting issue and the direction-setting issue concerning the future role and scope of the NRC's nuclear materials program (in particular, NRC's regulation of the medical use of nuclear material).
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| A fifth subsumed issue concerns the information necessary for developing and implementing risk-informed, performance-based regulation. The subsumed issue is stated as follows: -
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| l
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| * Given the new Government-wide goals for reducing Federal information collections, how should the agency prepare for possible reductions in its budget ceiling for information collection without compromising public health and safety?
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| The Paperwork Reduction Act of 1995 is the basis for agency and OMB activities related to information collections. It requires controls to limit and reduce the burden on the public for collecting agency information. In 5 CFR 1320, which implements the Paperwork Reduction Act, OMB requires agencies to submit plans.for new, revised, and extended information collections to OMB for approval. However, the NRC, as an independent regulatory agency, is not bound by OMB decisions. By majority vote, the Cosmission can choose not to abide by an OMB decision.
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| RELEASE DATE: SEPTEMBER 16, 1996 14 DSI 12
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| ! The new Paperwork Reduction Act sets a goal of 10-percent annual reduction in information collections for 1996 and 1997 followed by a 5-percent reduction 1 each year in 1998, 1999, 2000, and 2001. It is uncertain Aow OM8 will i implement this goal. Depending on individual agency plans to achieve the
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| ! reductions, OMB could assign specific reduction goals to each agency. NRC i could be required to reduce its information collection burden before imposing
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| } any additional burden through new or amonded collections. This could affect i
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| the rulemaking process, especially since risk-informed, performance-based .
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| regulatory approaches may well require licensees to collect more information
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| ! for the 15tc.
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| l The Counission's decision on expanding agency activities in applying j risk-informed, performance-based regulatory approaches will influence the i extent and impact of additional information requirements. In response to several consents concerning the potential data collection implications of the Commiission's PRA Policy Statement, the Commission agreed that it should make every effort to avoid any unnecessary regulatory burdens in connection with collecting reliability and availability data (60 FR 42622 at 42626). The Constission also indicated that, in the context of risk-informed regulation, this was an implementation issue and that data and information collection will be addressed in connection with proposed data collection requirements when the requirements are published for connent.
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| In a strategic sense, information collection requirements and burdens should not define the direction that the agency takes regarding risk-informed, performance-based approaches. Regardless of the option selected for proceeding toward risk-informed, performance-based regulatory approaches, the Commission could consider information collection options independently. The Commission may (1) look for efficiencies in information collection and storage methods and identify areas that could be made more efficient, (2) wait until OMB publishes its guidance to agencies for implementing the provisions of the new Paperwork Reduction Act and address any issues on a case-by-case basis with each rulemaking, or (3) report NRC's case to OM8 now and request a level or increased ceiling to accommodate future information collection needs associated with risk-informed, performance-based regulatory approaches.
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| Finally, a sixth subsumed issue concerns interagency implications associated with moving toward a more risk-informed, performance-based regulatory framework. Specifically:
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| * How should a risk-informed, performance-based regulatory philosophy influence NRC's handling of dual regulation?
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| As previously mentioned, the Environmental Protection Agency (EPA) has undertaken a number of regulatory initiatives under its authorities that affect activities licensed or otherwise regulated by the NRC. Substantial i SEPTEMBER 16, 1996 15 DSI 12 RELEASE DATE:
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| . _ _ . _ . _ _ _ . _ _ .-.__~_~ _
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| I DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION l differences have arisen between the two agencies and have included differences associated with the underlying bases and approaches used to develop regulatory standards and acceptable methods for meeting these standards. In 1995, the Mtc and the epa developed a joint paper entitled " White Paper on Risk Harmonization" to help explore ways to " harmonize" risk goals and to develop outually agreeable approaches for risk assessment methodologies to assess radiological risk.
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| As the NRC and other government agencies move toward more risk-informed, performance-based regulatory approaches, the use of risk insights should help promote a common understanding of the technical bases for regulatory approaches. The common desire for increasing the use of risk in all government agencies helps define the common goals, but there is substantial interagency work necessary to ensure that there is a systematic interrelatedness among approaches and mutual understanding and agreement on the underlying bases for the regulatory approach, including agreement on key policy issues, such as agency safety goals, and technical issues confronting the agencies. The Commission decision on "how fast" and "how far" the agency should go in expanding activities associated with the application of risk-informed, performance-based regulatory approaches will further influence the level of agency resources devoted to reconcile differences in conflicting l interagency regulatory approaches.
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| I -
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| C. Important Aspects of Risk-Informed, Performance-Based Regulation )
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| 1 Three important aspects of expanding agency activities in applying risk-informed, performance- based approaches concern establishing a common i understanding of what is meant by " risk- informed, performance-based," dealing with uncertainties in regulatory decision-making, and strategically
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| -considering how to ensure regulatory coherence during the transition from '
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| deterministic-based regulations to risk-informed, performance-based regulations.
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| )
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| : 1. Discussion of terms " Deterministic-Based," " Risk-Informed, !
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| Deterministic-Based," " Performance-Based," and " Risk-Informed, !
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| Performance-Based" Deterministic-based. The NRC has generally regulated the use of nuclear material (including nuclear materials and reactors) based on deterministic approaches. Deterministic approaches to regulation consider a set of challenges to safety and specify how those challenges should be mitigated.
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| Simply stated, the deterministic approach establishes requirements for use of I nuclear materials and for engineering margin and quality assurance in design, manufacture, construction, and operation of nuclear facilities.
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| RELEASE DATE: SEPTEMBER 16, 1996 16 DSI 12
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION The NRC established its regulatory requirements to ensure that a facility is designed, constructed, and licensed to operate without undue risk to the health and safety of the public. These requirements are 1prgely based on l
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| deterministic engineering criteria. In addition, this approach assumes that adverse conditions can exist (e.g., equipment failures and human errors) and i
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| establishes a set of design basis events. It then requires that the licensed l facility design include safety systems capable of preventing and/or mitigating the consequences of those design basis events to protect the public health and safety. The deterministic approach contains implied elements of probability.
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| For examplef reactor vessel rupture is considered too improbable to be included as an accident to be analyzed. However, the likelihood that a single l emergency core cooling system or system train would not function was considered high enough that safety train redundancy and protection against single failure where required.
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| i Risk-infonned, deterministic-based. A risk-informed, deterministic approach l
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| to regulation enhances and extends this traditional, deterministic approach,
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| ! by: (a) allowing consideration of a broader set of potential challenges to l
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| safety, (b) providing a logical means for prioritizing these challenges based l
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| on likelihood and risk significance, and (c) allowing consideration of a l
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| broader set of resources to defend against these challenges. A risk-informed approach can be used to focus deterministic regulations by considering risk in a more coherent and comprehensive manner. By considering risk insights, l
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| operating experience, and engineering judgment, the NRC and its licensees can focus regulatory approaches'and licensee activities on those items most l
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| important to public health and safety. Where appropriate, a risk-informed i regulatory approach can be used to reduce unnecessary conservatism in i
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| deterministic approaches or enn be used to identify areas with insufficient conservatism and provide the bases for additional requirements.
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| Deterministic-based regulations have been successful in protecting the public health and safety and risk insights are most valuable when they serve to focus I the deterministic- based regulations and support the defense-in-depth philosophy.
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| Performance-based. A performance-based regulatory approach requires at least four key elements:
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| a There are measurable parameters to monitor acceptable plant and licensee performance.
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| = Objective performance criteria are established to assess performance.
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| * There is licensee flexibility to determine how to meet established performance criteria.
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| J SEPTEMBER 16, 1996 17 DSI 12 RELEASE DATE:
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION i
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| 1 Failure to meet a performance criterion must not result in unacceptable consequences.
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| In theory, a performance-based approach can be implemented without the use of risk insights. This type of performance-based approach would require that objective performance criteria be based on deterministic analysis and performance history. This approach would provide additional flexibility to the licensee to determine how to meet performance criteria. However, the net impact on public health and safety would be difficult to determine.
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| Risk-informed, performance-based. Risk-informed, performance-based approaches use risk insights, together with deterministic analyses and performance history, to develop measurable parameters for monitoring plant and licensee performance, as well as for developing criteria for performance assessment, and focus on the results as the primary means of regulatory oversight. l Similar to a risk-informed, deterministic-based approach, a risk-informed, I l performance-based regulatory approach can be used to reduce unnecessary l conservatism in deterministic approaches or can be used to support additional l regulatory requirements. In addition, a risk-informed, performance-based '
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| approach can further focus performance-based approaches by defining the goal or purpose of the approach in terms of performance characteristics and safety significance and permitting the licensee additional flexibility in meeting the regulation. Performance-based initiatives can be considered for activities ; l where objective performance criteria can be established for performance !
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| monitoring. Additional evaluation of performance-based approaches may result !
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| in a determination that a number of functional areas are not amenable to performance-based treatment.
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| The 18tC Inspection Manual has tailored the concepts of " risk-informed" and
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| " performance- based" for inspections into a single definition of
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| " performance-based inspection." According to Inspection Manual Chapter 0610, performance-based inspection is inspection that focuses on issues of safety and reliability, with an emphasis on field observation rather than in-office procedural or records review. The emphasis on safety and reliability borrows from risk studies, incorporating PRA and individual plant examination insights to structure inspections that focus on systems or components most important to l Plant safety. In addition, performance-based inspection tends to focus more i
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| , on results than on process and method.
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| : 2. Uncertainties in Regulatory Decision-Making The treatment of uncertainties is an important issue for regulatory decisions.
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| Uncertainties exist in any regulatory approach and these uncertainties are derived from knowledge limitations. These uncertainties and limitations existed during the development of deterministic regulations and sttempts were made to accommodate these liaitations by imposing prescriptive, and what was RELEASE DATE: SEPTEMBER 16, 1996 18 DSI 12 l
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION hoped to be, conservative regulatory requirements. A probabilistic approach has exposed some of these limitations and provided a framework to assess their significance and assist in developing a strategy to accommpdate them in the regulatory process.
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| Human performance is an important consideration in both deterministic and probabilistic approaches. Assessing the influence of errors of consiission and organizational and management issues on human reliability is an example that illustrates where current PRA methods are not fully developed. Although this lack of knowledge contributes to the uncertainty in estimated risks, the PRA framework offers a powerful tool for logically and systematically evaluating the sensitivity and importance to risk of these uncertainties. Improved PRA techniques and models to address errors of conmiission and the influence of organizational factors on human reliability are currently being developed.
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| Given the dissimilarities in the nature and consequences of the use of nuclear materials in reactors, industrial situations, waste disposal facilities, and medical applications, the Consission has recognized that a single approach for incorporating risk analyses into the regulatory process may not be appropriate. However, PRA methods and insights will be broadly applied to ensure that the best use is made of available techniques to foster consistency in NRC risk-informed decision-making. Activities that lead to regulatory coherence will also reduce uncertainty in regulatory decision-making.
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| : 3. Regulatory Coherence Regulatory coherence is essential in order to ensure that the direction the Commiission takes in expanding agency activities in applying risk-informed, performance-based regulatory approaches promotes a stable and predictable regulatory environment. Regulatory coherence is achieved when the regulatory programs or processes are well understood and proceed in a logical and orderly fashion. In this paper " regulatory coherence" means:
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| (a) integration of risk-informed, regulatory approaches based on a consistent pattern or framework (b) implementation of risk-informed, perfonnance-based approaches in a suitable or orderly way that promotes and ensures mutual understanding (c) development of risk-informed, performance-based approaches that are governed by rational principles and that ensure systematic interrelatedness.
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| The Commiission has recognized the importance of coherence for increasing the use of PRA and the Commission's policy statement on the use of probabilistic risk assessment methods in nuclear regulatory activities (60 FR 42622)
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| RELEASE DATE: SEPTEMBER 16, 1996 19 DSI 12 l
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| i
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| ; DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION
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| ! promotes regulatory coherence. Through the "PRA Implementation Plan" the i
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| staff monitors PRA-related activities and helps ensure consistent application of PRA methods and techniques. The PRA Implementation Pign explicitly contains activities that have, as a principal goal, the achievement of regulatory coherence. Recently, the schedule for completing several activities in the PRA Implementation Plan dealing with regulatory guides and standard review plans (SRPs) for reactor pilot applications have been
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| ; accelerated to improve and promote regulatory coherence. Arguably, the increased use of PRA methods and techniques itself promotes regulatory q coherence.by integrating regulatory decisions using risk, allowing systematic comparisons of approaches, and enhancing mutual understanding of those items that are most important to safety.
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| , Another way that the Commission is promoting regulatory coherence for i operating reactors is through the safety goal policy statement. The safety
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| ! goal policy statement uses quantitative, probabilistic risk measures and establishes top-level objectives to help ensure safe operation of nuclear power plants. The safety goals provide guidance on where risk is sufficiently low that further regulatory action is not necessary. The concept 4
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| of a " safety goal" has not been firmly established for NRC licensees, other than commercial power reactor licensees.
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| ; Eventually, the Cosnission could consider rulemaking, a,1 option of a national ,
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| standard for performing PRAs, or more detailed regulatory guidance to help
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| ; ensure uniformity in the quality and application of risk-informed, performance-based regulatory approaches. The Commission and senior NRC
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| , management could define staff requirements more precisely Tor moving toward risk-informed, performance-based regulatory approaches and could more strongly articulate its expectations for industry use of risk-informed, performance-based approaches to support regulatory decision-making.
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| Finally, regulatory coherence for a risk-informed, performance-based approach
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| , may not be achieved unless there is a cohesive approach that can be used as guidance for both the NRC and the regulated industry. The Connission could l encourage industry /stakeholders to develop solutions or processes that help ensure regulatory coherence. To help ensure regulatory coherence for industry l processes or industry application of a risk-informed, performance-based approach, a part of the burden could be assumed by the regulated industry.
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| For example, if the varying levels of quality for individual PRAs contrit>ute to regulatory incoherence, the industry could develop a PRA " certification" process or develop criteria for detailed peer reviews.
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| As discussed above, regulatory coherence is essential in order to ensure that the direction the Commission takes to expand agency activities in applying risk-informed, performance-based regulatory approaches promotes a stable and predictable regulatory environment.
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| ]
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| . RELEASE DATE: SEPTEMBER 16, 1996 20 DSI 12
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| _ - . - - .. . . _ . . _ _ _ - . . ~ - -. - .. . - - - _ _ _ - - - _ - -
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| 1 .
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| i DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION
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| )
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| l IV. OPTIONS Option 1: Continue Current Process ,
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| l This option would contirxe the current process for determining priority and
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| - scope of risk- informed, performance-based activities. The Commission's final policy statement on "Use of Probabilistic Risk Assessment in Nuclear Regulatory Activities" establishes an overall policy on the use of PRA methods in nuclear regulatory activities so that the many potential applications of PRA can be implemented in a consistent eid predictable manner that would promote regulatory stability and efficiency. The priority and scope for j regulatory activities under this policy statement are captured in the agency's PRA Implementation Plan.
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| i There is flexibility associated with the PRA Implementation Plan. NRC Program Offices principally determine the priority and scope in applying
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| ; risk-informed, performance-based regulatory approaches. The PRA Implementation Plan is periodically updated to reflect progress for plan activities, to indicate areas that are determined to be not yet amenable to risk- informed approaches, or to add new areas where the staff is pursuing i risk-informed approaches. Under the current process, the priority and scope in applying risk-informed, performance-based approaches are determined by balancing external and internal goals with available resources. Priority criteria are applied and the scope of activities is primarily determined by considering the industry demand, the safety benefit, the ease of implementation, and available resources.
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| The current process is responsive to industry initiatives in reactor-related areas. In part, this is because the potential benefits for reducing unnecessary industry burden, enhancing safety decision-making, and improving staff efficiency are more readily apparent. Consequently, resources in the reactor area are focused on developing additional regulatory guidance and supplementing the Standard Review Plan to address areas such as inservice !
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| inspection, inservice testing of pumps and valves, graded quality assurance, l and technical specifications.
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| There is no widespread industry demand to consider risk-informed approaches in many of the nuclear material areas and it is not apparent whether some nuclear material areas will significantly benefit from implementation of risk-informed approaches. As a result, in the PRA Implementation Plan, there is less emphasis on incorporating risk-informed approaches in the nuclear materials areas. i A performance-based approach is an implicit element for some PRA Implementation Plan activities and a necessary element for other activities in the plan. For example, there have been several performance-based initiatives SEPTEMBER 16, 1996 21 DSI 12 RELEASE DATE:
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| 1 l
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION i
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| 1 discussed .in the PRA Implementation Plan, such as risk- informed, performance-based changes to containment leakage requirements, fire protection requirements, and maintenance rule implementation. The PR$ Implementation plan pilot applications dealing with inservice testing of pumps and valves and inservice inspection contain performance-based aspects. As data from )
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| performance monitoring of structures, systems and components are accumulated and made available to the agency, the staff evaluates the performance data, :
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| where appropriate, to determine the effectiveness of the approach. l Under this. option, the modification of rules and regulations to move toward {
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| performance-based regulation would proceed at a pace consistent with the 1 activities under the PRA Implementation Plan. As areas amenable to risk-infor1med, performance-based regulation are identified and as resources become available, the staff may initiate rulemaking. In the nuclear materials areas, technological changes and changing human factors may affect the speed and scope of risk- informed, performance-based revisions to regulations. In areas involving dual regulation, the current emphasis and level of activity i devoted to resolving issues affected by dual regulation would continue and the i pace of these activities would be consistent with the safety benefit, the ease !
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| of implementation, and available resources. l l
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| Since this option is the current process, no change in resource allocation is t necessary to implement it. The resource and programatic consequences are .
| |
| gradual and incremental, i Option 2: More Rigorously Assess Relationship to Public Health and Safety l
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| Similar to the continue Currer.t Process option discussed above, this option '
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| would primarily continue the current approach for moving toward more risk-informed, performance-based regulatory approaches. However, under this option, the relationship of new activities to public health and safety would need to be more rigorously assessed. The results of this safety assessment would determine whether the agency would pursue the activity. In other words, those activities where there could be a substantial increase in overall protection to public health and safety will be given the highest priority.
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| Underlying both this option and the Continue current Process option is the assumption that our regulations and current regulatory processes are edequate, and will continue to be adequate, to protect public health and safety. The Continue Current Process option pursues enhancement to current regulatory processes through risk-informed approaches to regulation, is exploratory in nature and applies a threshold for pursuing such activities. This option also pursues enhancements to our currant regulatory processes through risk-informed l approaches to regulation. However, this option is more narrowly focused than l Option 1 and applies a higher threshold for pursuing activities.
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| RELEASE DATE: SEPTEMBER 16, 1996 22 DSI 12 l 1 l
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| l DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION Under Option 2, priority and scope in applying risk-informed, performance-based regulatory approaches would be primarily ' determined by the projected cost of the approach compared to benefit to the public health and safety. Many intangibles would have to be analyzed, at least qualitatively, and a methodology developed in order to provide a meaningful assessment.
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| Priority criteria are weighted toward greatest safety benefit. The scope of risk-informed, performance-based approaches is primarily determined by considering the cost / benefit, the overall impact on the NRC and regulated industry, ar.d available resources.
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| For example, consider scoe of the current activities in the reactor regulation area. Several of these activities are in response to industry demand and have as a principal goal to reduce unnecessary burden. The safety benefit of these activities is not well defined. There has been an assumption that, once burden has been reduced, those resources made available through that reduction in burden would be made available to focus on activities that are of greater safety importance. However, this safety benefit is difficult to quantify.
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| In the nuclear materials area, there is less industry demand to reduce unnecessary burden through risk-informed, performance-based approaches to regulation than in the reactor area. The nature of the interaction between
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| ; the NRC and its materials licenses is different from the interaction between the NRC and connercial power reactor licensees. Material licensees often deal with simple systems and the primary contributor to risk is human error. Any safety benefit associated with a risk-informed, performance-based approach may also be difficult to quantify. Under Option 2, the current emphasis on reconciling regulatory differences arising from dual regulation may be reduced.
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| Priority criteria for new initiatives are used as a threshold but weighted toward greatest safety benefit. Scoping criteria from Appendix A most useful
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| ; in this approach are cost / benefit, safety significance, largest impact, and available resources.
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| Option 3: Perform a Comprehensive Assessment of NRC Regulatory Approaches This approach would involve a comprehensive review of our regulations and regulatory processes to determine areas that could be improved through risk-informed, performance- based regulatory approaches. The agency priority l
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| l for activities would be established based on consideration of the cumulative impacts on safety, burden reduction, and efficiency.
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| l This is the most proactive, aggressive option for moving toward risk-informed, performance- based regulation. This option would maximize internal self-assessment 1md include exploring all regulatory areas to determine 4 whether risk-informed, performance-based regulation should be pursued in that SEPTEMBER 16, 1996 23 DSI 12 RELEASE DATE:
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION i
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| i i area. The purpose for the review under Option 3 is not just to enhance our j deterministic regulations. The purpose of this assessment'is to fundamentally change, in a comprehensive manner, the bases to our regulations and process for those areas that are amenable to a risk-informed, performance-based approach.
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| l Under Option 3, priority for regulatory activities would be established based 1 4
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| on consideration of the cumulative impacts on safety, burden reduction, and ;
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| efficiency. The scope of risk-informed regulatory approaches under this '
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| . option would be determined by considering agency responsiveness to stakeholder I initiatives, the safety benefit / significance of the approach, and the effect i
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| on 15tc and licensee efficiency. Ease of implementation and available resources are secondary scoping considerations (i.e., if the activity is l determined to be a high priority then resources will be made available and l efforts made to improve the state-of-the-art to the level necessary to support the desired goal).
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| In the reactor area, the staff and industry have already identified several i
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| areas that may be conducive to risk-informed, performance-based regulatory
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| ; approaches. The Commission has already performed a systematic review of the j many current rules and regulations to identify opportunities for eliminating 4
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| unnecessary regulations. In 1993, the NRC established the Regulatory Review Group (RRG) to conduct a structured review of power reactor regulations with !
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| special attention on the opportunity to reduce unnecessary regulatory burdens.
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| The RRG recomunendations to reduce the regulatory burden included the suggestion to use more risk- based approaches in quality assurance, inservice inspection, and inservice testing. The RRG recommendations were documented in SECY-94-003. Option 3 would build on the RRG review results with a more tightly focused assessment on the bases of those regulations and on identifying and prioritizing regulations that are amenable to a risk-informed, performance-based approach.
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| In the nuclear materials area, a similar systematic assessment of rules and regulations has not been conducted. However, several recent initiatives, including an materials licensee regulatory impact study and the Business Process Reengineering initiative, may result in changes to nuclear materials regulatory approaches. Option 3 would initiate a thorough review of the bases for nuclear materials regulations and process and would identify and prioritize those areas that are amenable to a risk-informed, performance-based approach. As a result of this assessment, a framework, similar to the framework for applying PRA in reactor regulation in SECY-95-280, could be developed for other nuclear materials uses.
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| Because the purpose of Option 3 is to change the bases of our regulations and process for those areas that are amenable to a risk-informed, 4 performance-based approach, this option is the most resource intensive option.
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| f RELEASE DATE: SEPTEMBER 16, 1996 24 DSI 12 6
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION
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| ! Additional resources would be needed to train the staff, develop a strategy for review, complete the assessment, and implement rulemaking or procedural changes. ,
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| Under Option 3, the staff would likely intensify its efforts to resolve issues associated with dual regulation. The agency would more aggressively pursue a
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| -systematic interrelatedness among approaches and mutual understanding and l
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| agreement on the underlying bases for the regulatory approaches, including
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| ! agreement on key policy issues, such as agency safety goals, and technical ;
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| l issues confronting tne agencies.
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| Because it is the most resource intensive, this option would also be the most .
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| costly to licensees in the form of fees to pay for the reviews, guidance !
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| l i
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| ! development, and rulemakings to be undertaken. Their participation in and l support for such activities could well depend on the extent to which they perceived near term, concrete benefits accruing to their own operations.
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| l Option 4: Consider Risk-Informed, Performance-Based Approaches Primarily in Response to Stakeholder Initiatives l.
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| This option is the most responsive to stakeholder interests. The agency would determine for new initiatives the priority and scope in applying risk-informed, performance-based regulatory approaches through consideration of stakeholder demand and ease of implementation. The scope would be primarily established to meet the demand or request.
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| Under this option, reducing industry burden would be the primary result. The safety review for proposed risk-informed, performance-based approaches would be to ensure that the proposed approach maintains an acceptable level of safety. Staff and industry efficiency may be collateral benefits of this approach.
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| Another potential consequence of selecting this option is that the agency could be perceived to be reactive and not making the best use of available information and technology to reach decisions. The agency's expertise in l l
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| risk-informed regulatory approaches may be limited by the demand for that expertise. Therefore, in the future there might be a substantial burden associated with " ramping-up to speed" to deal with emerging safety issues.
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| V. RELATED ISSUES After the Cosmiission has made decisions concerning the Direction-Setting Issue discussed above, additional issue (s) such as those related to implementation details will be addressed as the Strategic Plan is implemented. The related ,
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| issues are listed in this section to provide a more complete understanding of j
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| the higher level Direction-Setting Issut.
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| i SEPTEMBER 16, 1996 25 DSI 12
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| . RELEASE DATE:
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| l
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| 4 DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION What is the appropriate level of resources that the NRC should devote over the next few years to reduce the number of licensing requirements no longer required for safety and to develop risk-informed, performance-based approaches in order to achieve long-term reductions in the resource burden of both the licensee and the NRC7 What levels of residual radioactivity are acceptable for decommissioning a materials licensed facility?
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| VI. C0lgtISSION'S PRELIMINARY VIEWS Staff actions regarding the various options should be held in abeyance pending the Commission's final decision on this issue paper. The Comission's preliminary views are:
| |
| The Commission recognizes that, in order to accomplish the principal mission of the NRC in an efficient and cost effective manner, it will in the future have to focus on those regulatory activities that pose the greatest risk to the public. This can be accomplished by building upon probabilistic risk assessment concepts, where applicable, or other approaches that would allow a risk-graded approach for determining high and low risk activities. In general, those activities that are of a higher risk should be the primary focus of the agency's efforts and resources. The level of staff activity
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| )
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| associated with lower risk activities should be determined based on a consideration of the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on agency and licensee efficiency.
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| 1 1
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| The staff should continue with the current efforts, in cooperation with the !
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| industry (Option 1), including pilot programs. The objective of this initiative is to obtain additional information regarding the appropriateness of a risk-informed, performance-based approach for the subject activities. ,
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| I These activities and their schedule, are presently captured in the agency's l PRA Implementation Plan. As data from performance monitoring of structures, i systems and components are accumulated, the staff should evaluate the performance data to determine the effectiveness of the approach on the subject activity.
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| The staff should proceed in the direction of enhancing the PRA Implementation Plan (i.e., moving towards implementation of elements of Option 3) by building
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| ' on the Regulatory Review Group's (RRG) results, which were initially focused on reducing the regulatory burden, with a more focused assessment of those regulations which are amenable to a risk-informed, performance-based approach.
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| In determining the priority and scope of regulatory activities to be included in moving in the direction of partial implementation of option 3, the staff should consider the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on NRC and licensee efficiency. This RELEASE DATE: SEPTEMBER 16, 1996 26 DSI 12
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| 4 f
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| l DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION t
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| l approach should result in a further focusing of resources, on the various areas that the Cossiission regulates, that is commensurate with its risk i significance, potential burden reduction and effect on eff,1ciency.
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| ! The staff should evaluate and clarify any technical and/or administrative
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| < issues associated with performance-based approaches to regulation (e.g.,
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| ! inspection activities, enforcement, etc.). The staff should also perform a thorough review of the basis for nuclear materials regulations and process, j and should identify and prioritize those areas that are either now, or can be i
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| made with minimal additional effort / resources, amenable to a risk-informed, performance-based approach. This assessment should eventually lead to the
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| ; development of a framework for apply 5g PRA to nuclear material uses, similar to the one developed for reactor regulation (SECY-95-280), where appropriate.
| |
| In the public comments on this issue, the NRC particularly solicits how NRC should deal with dual regulation when applying a risk-informed, !
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| performance-based regulatory philosophy. l i
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| 4 1
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| 1 4
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| RELEASE DATE: SEPTEMBER 16, 1996 27 DSI 12 i
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| l l
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| l
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| . . . ~ - . .-~.. .. . - - . . - - - . .. . =.
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| l DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION 4
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| Appendix A Sample Criteria for Determining the Priority And Scope Within the Context of the Strategic Direction I. Applying the criteria The weighting of criteria to determine the priority and scope associated with applying a . risk- informed, performance-based approach to rulemaking, licensing, inspection, and enforcement for new initiatives will be governed by the option.that the Comeission chooses for proceeding toward a risk-informed, performance-based regulatory framework.
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| Several sample criteria for establishing the scope and priority in applying a risk-informed, performance-based regulatory are discussed under this issue paper. Except as noted, the criteria can be applied to reactor and nuclear materials areas.
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| ' The staff notes that the expected benefit of an activity may elevate its priority. However, if the scope of the activity necessary to explore that expected benefit is resource intensive, then the priority may be lowered.
| |
| II. Priority criteria 'I Priority criteria can be broadly defined by the relationship of the activity or proposed activity to the agency's commitment to good regulation. Priority criteria also reflect a balance between the need for a revised approach and an assessment of whether the revised approach is achievable. The priority for applying a risk-informed, performance-based regulatory approach can be
| |
| : illustrated by assessing an activity or proposed activity using the following high-level criteria:
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| Safety Impact: To what extent will the activity result in enhanced safety decision- making or increase the level of public health and safety? Conversely, to what extent will the activity potentially reduce the level of public health and safety?
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| i Burden Reduction: To what extent will the activity reduce unnecessary burdens on the staff or the industry by eliminating unnecessary requirements?
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| Efficiency: To what extent will the activity promote a better use of staff or industry resources by focusing on those activities that are more important to safety?
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| . RELEASE DATE: SEPTEMBER 16, 1996 28 DSI 12 I
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| i .
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| DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION III. Scoping criteria Scoping criteria can be broadly defined by the extent and, timing of the resource commitment necessary to achieve a certain goal. The scope defines the nature and character of the activity and conveys an agency resource couaitment. The scope in applying a risk-informed, performance-based regulatory approach for new initiatives can be determined using a criterion or combinations of criteria. Sample criteria are listed below.
| |
| l Responsive to Scope is determined by the extent needed to be responsive to Stakeholders: stakeholder initiatives.
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| Safety Benefit: Scope is determined by the extent needed to achieve the desired impact on reduction in risk or positive impact on public health and safety.
| |
| Efficiency: Scope is determined by the extent needed to achieve the desired impact on staff efficiency.
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| Cost / Benefit: Scope of an activity is pursued to the extent that is supported by a cost / benefit analysis. The scope of an activity may be established to optimize the cost / benefit ratio.
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| i Public Scope of an activity is limited to those areas that the Confidence:- public is willing to support.
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| Largest Impact: Scope is determined by the extent needed to provide a large-scale programmatic or systemic impact.
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| Available Scope is determined by the extent supported by available NRC Resources: and licensee resources.
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| Ease of Scope is determined by the maturity of the technology and Implementation: how easily the technology can be incorporated into the regulatory framework.
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| l RELEASE DATE: SEPTEMBER 16, 1996 29 DSI 12
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| O i
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| l DSI 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION i l l l
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| ACRONYMS I l
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| l
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| > 1 1
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| AEA Atomic Energy Act of 1954 j ATVS anticipated transient without scram BPR business process reengineering DSI direction-setting issue EPA Environmental Protection Agency ICRP International Connission on Radiological Protection l IPE Individual Plant Examination IPEEE Individual Plant Examination-External Events OMB Office of Management and Budget
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| : PRA probabilistic risk assessment )
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| RRG Regulatory Review Group 580 station blackout SNM special nuclear material SRP standard review plan l
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| l i
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| RELEASE DATE: SEPTEMBER 16, 1996 30 DSI 12
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| 3
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| 'O L
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| General Discussion of Comments on IOM Report NRC has sought a broad range of public comments on the report. NRC provided prepublication copies of the report to all Agreement States, non-Agreement States, and U.S. Territories; appropriate Federal agencies.(U.S. Departments of Health and Human Services, Veterans Administration, Defense, Labor, and Transportation, and Environmental Protection Agency); the Conference of Radiation Control Program Directors (CRCPD); the Organization of Agreement States (0AS); Congressional Oversight Committees; and NRC's Advisory Committee on the Medical Uses of Isotopes -(ACMUI). In addition, we published a Federal
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| 'Reaister notice (61 FR 1648) on January 22, 1996, and issued a press release acknowledging receipt of the report and requesting comments on the possible impacts of the report, to include any views on policy, legislative, rulemaking, and guidance issues. The NRC staff conducted an analysis of the conclusions and data used by the IOM to support its preferred alternative regulatory structure and the eight recommendations for its implementation.
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| The staff discussed the report with the ACMUI on February 21-22, 1996, and at
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| -an NRC and Agreement State Technical Workshop conducted March 5-6, 1996. On February 27, 1996, members of the IOM committee, and on May 3, 1996, the ACMUI and Robert S. Adler (IOM committee member with dissenting view) briefed the Commission. The Commission has also directed the staff to consider the ION report and comments received within its strategic assessment and rebaselining efforts.
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| To date, the NRC has received 50 letters, containing 47 comments on the report. Three of the letters stated that they would continue to consider the issues, and provide comments at a later time. A breakdown by category of respondent is attached. The staff has reviewed all the comments received and grouped them by broad category. The two major categories of responses are i either in support of, or opposition to, the overall recommendations of the IOM l committee. However, within each of these major categories, there are subsets I with respect to the specific direction or focus of the comments. None of the j comments received specifically indicated that there should be no Federal J involvement.
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| The Department of Health and Human Services (DHHS), the Federal agency that would be most likely to assume more regulatory oversight if the IOM recommendations were implemented, indicated that the report does not make a compelling public health argument for DHHS to assume the recommended new role.
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| Furthermore, DHHS raised a concern that Congress would not provide resources commensurate with the added responsibilities.
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| The majority of comments received (32 out of 47) did not endorse the full range of recommendations put forth by the IOM committee. Specific comments are summarized in a table provided as Enciosure 3 to the letter. Four of the 14 respondents that supported the recommendations indicated that the recommendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in its support of the IOM report, indicated that legislative initiatives should ensure that Federal facilities are not subject to State and local regulations.
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| Enclosure 2 1
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| s ;
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| l 6
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| Other comments varied widely in the focus of their viewpoints and opinions.
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| The degree of regulatory reform perceived to be necessary ranged from simply recognizing the merits of the issues raised by the IOM committee to a need for a complete restructuring of the regulatory program. The non-Agreement States that responded were particularly concerned about the substantial financial impact of the recommendations and the issue of this being, in effect, an unfunded Federal mandate. For example, as indicated in the response from Hawaii, public health and safety could be jeopardized in those States with insufficient resources or capability to implement adequately the regulation of )
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| byproduct materials. The Department of Defense response, which summarized the responses from the three Service Medical Departments (Army, Navy, and Air Force), supported the need to re-evaluate the current regulatory structure, but emphasized the need for a uniform regulatory authority. There were several responses that recommended the need for Federal oversight for all uses of radiation. For example, the OAS response provided a summary of the consensus opinions of the participants at the NRC and Agreement State i technical workshop conducted March 5-6, 1996, which represented 18 Agreement States and two non-Agreement States. The CRCPD response expresses the concern that the absence of Federal authority in the medical use area may have I immediate and undesirable consequences on citizens in non-Agreement States, l l
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| and long-term consequences for Agreement States trying to maintain a nationally consistent program. CRCPD does not support automatic selection of the DHHS as the agency to provide a leadership role. The staff is continuing ;
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| to evaluate the responses as they are received, and will consider them in the broader context of its agency-wide strategic assessment and rebaselining l effort.
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| l l
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| l l
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| l l
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| l l
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| l l
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| l 4 lc Categories of Responses Received on IOM Report l
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| Federal Aaencies:
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| i Department of Defense (D00) - consolidates views for three services
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| ! Department of Health and Human Services (DHHS)
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| Department of Labor, Occupational Safety and Health Administration (OSHA)
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| Department of Veterans Affairs (DVA)
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| Environmental Protection Agency (EPA)
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| Aareement States: )
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| Arkansas California l Florida (Office Radiation Control) - R i Florida (State Health Office) - H Illinois Kentucky l 1
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| Maryland New Mexico New York (Dept. Environmental Conservation) - E New York (Dept. Health) - H New York (Dept. Labor) - L Tennessee Texas Utah i Vermont Washington Non-Aareement States / Territories:
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| Alaska l American Samoa Delaware Hawaii l Massachusetts I New Jersey Virginia Wyoming l
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| l
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| L Oraanizations/ Committees:
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| American Association of Physicists in Medicine (AAPM)
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| American College of Cardiology (ACC)
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| American College of Medical Physics (ACMP) l American College of Nuclear Physicians / Society of Nuclear Medicine (ACNP/SNM)
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| American College of Nuclear Physicians - California chapter
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| : (ACNP-CA)
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| American College of Radiology (ACR)
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| American Pharmaceutical Association (APHA) l American Society of Nuclear Cardiology (ASNC)
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| Conference of Radiation Control Program Directors (CRCPD)
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| NRC's Advisory Committee on Medical Us OrganizationofAgreementStates(0AS)psofIsotopes(ACMUI)
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| Other Respondents:
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| CBeasley, St. John's Regional Health Center, Springfield, M0 MHafermann, Virginia Mason Cancer Center, Seattle, WA DJones, Northwest Medical Physics Center, Lynnwood, WA CMarcus, University of California, Los Angeles, CA CPerez, Washington University, St. Louis, M0 GPoteat, OH JRieke, Virginia Mason Cancer Center, Seattle, WA DSchumacher, Northwest Medical Physics Center, Lynnwood, WA MSelikson, RSO, University of Pennsylvania, Philadelphia, PA l
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| St. John's Hospital, Jackson, WY I
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| I i
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| i
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| ' The OAS comment provided the recommendations of and consensus views
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| ! reached at the NRC and Agreement State Technical workshop. The session on the i
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| NAS report included representatives from 18 Agreement States (CA, NY, SC, NV, IL, WA, TX, MS, TN, GA, NE, CO, KY, KS, NYC, FL, AR, AZ) and two non-Agreement
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| ; States (OH, PA).
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| l l
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| l I
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| -- - . , - ,- . = . _ -- . .- - - - - . . . .
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| ^
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| l General Comments on ION Report Respondents in favor of ION recommendations:
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| 1 Support ION report /reconnendations as written:
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| AAPM i ACNP/SNM ASNC DVA NM
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| ! MHafermann (Virginia Mason Cancer Ctr)
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| DJones (Northwest Medical Physics Ctr)
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| CMarcus (UCLA)
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| CPerez (Washington Univ)
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| JRieke (Virginia Mason Cancer Ctr)
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| DSchumacher (Northwest Medical Physics Ctr)
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| Support ION report /reconnendations, but as applied to all materials:
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| FL (R)
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| NY (H)
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| NY (L)
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| ACNP-CA Respondents not in acreement with ION recommendations:
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| Support concept of regulatory refora l but retain Federal authority1:
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| DHHS oversight: ACMUI, CA NRC oversight: EPA,ACMP,ACR,HI,KY,NY(E),UT,WA,GPoteat(OH)
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| Unspecified oversight: DHHS', D00, ACC, AK, DE, TN, VA, WY It should be pointed out that the degree of regulatory reform perceived to be necessary by different respondents varied from recognizing the concerns raised by the 10M to a drastic change in the approach to regulation of medical uses.
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| 3 Some States (e.g., VA, WY, DE) were primarily concerned with the substantial financial impact of the NAS recommendations and the issue of unfunded Federal mandates, rather than more specific concerns on the overall approach for regulation.
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| ' DHHS did not address the issue of regulatory reform, Federal authority, or concerns raised by the 10M, but focussed on the implications of the recommendation to DHHS.
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| l .
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| l l l Support concept of regulat:ry reform, but after additional analysis:
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| ! l CBeasley (St John's Regional Health Center) 1 MSelikson (RSO, Univ. of Pennsylvania) )
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| l NJ 4 I
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| St. John's Hospital Support concept of unifornity for all radioactive materials regulation with \
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| Federal oversight:
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| CRCPD OAS APHA AR (NRC as lead agency)
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| FL (H) ;
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| IL 1 MA MD TX Respondents indicatina report under review DOL AS l VT l
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| I i
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| i i
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| a . s- una - a a - - a p4 .a,.s 1 Om
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| . 9- .
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| t S 4
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| 4 9
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| 1 i
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| i il 1
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| n l
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| Enclosure 3
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| ; 1 .. !
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| Specific Comments on ION Report -
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| Category of Response Respondent Specific Comments ,
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| RESPONDENTS IN AGREEMENT WITH ION REC 0fWtDBATIONS -
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| Support IOM report / DVA The Veterans Health Administration generally concurs with and recommendation as endorses the findings and recommendations of IOM. Principal written concern is lack of specifics regarding regulation of Federal entitities and also the regulation of medical research ,
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| programs.
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| New Mexico Agrees with IOM recommendation that Congress remove regulation of possession and use of material subject to AEA ,
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| from NRC's purview. Supports leadership role of DHHS so long as all states maintain regulatory programs that measure comprehensive standards of pertermince and effectiveness.
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| AAPM AAPM fundamentally supports position, conclusions, and recommendations of the IOM report. NRC should be removed i from its current regulatory role for medical use. Establish programs for implementing States' regulations monitored by appropriate Federal health agency with assistance of user community and professional organizations. !
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| ACNP/SNM The ACNP and SNM believe the report proposes a sound and thoughtful approach to the regulation of nuclear medicine and urges NRC to implement the IOM recommendations, allowing for i comment on specific means to achieve implementation.
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| ASNC Concur with the IOM's conclusions and support their recommendations for a uniform policy to be set at Federal r level which can be enforced by the States. DHHS should include medical radiation safety as part of its health care 4 management plan. ;
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| MHafermann Endorses recommendations of 10M. Does not agree with sentiments of Robert Adler in Appendix L. <
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| i l
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| Category of Response Respondent Specific Comments RESPONDENTS IN AGREEMENf WITM ION RECOMEWATIONS Support 10M report / DJones Endorses recommendations of 10M. Does not agree with recommendation as sentiments of Robert Adler in Appendix L. !
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| written l CMarcus Supports the IOM report and expresses disagreement with statements made by Robert Adler in his supplemental statement (Appendix L)
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| CPerez Expresses strong support for many of recommendations.
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| JRieke Endorses recommendations of IOM. Does not agree with sentiments of Robert Adler in Appendix L.
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| DSchumacher Supports recommendations proposed by IOM committee.
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| Support IOM report / Florida Support idea of delegating regulation of medical byproduct recomendations, but as (Rad. Control) material to states in addition to all agreement materials.
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| applied to all
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| * materials New York Support the 10M's conclusion that the regulation of medical (Dept. Health) use of byproduct materials should be carried out at the state level. Encourages the NRC to not limit its response to the IOM report to the narrow medical focus of the report.
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| New York Supports the IOM's recommendation that NRC discontinue (Dept. Labor) regulation of medical use of byproduct materials, but considers it illogical to limit the recomendation to this one area (should include nuclear pharmacies, manufacturers, distributors, and industrial users) ,
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| ACNP-CA NRC's entire materials program should be given to the States and Federal entities i
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| ~
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| Category of Response Respondent Specific Comments l RESP 0MENTS NOT IN AGREEMENT WITH ION RECOMDBATIONS [ i Support concept of ACMUI ACMUI indicated a preference for a variant of the IOM regulatory reform but preferred alternative in which there would be substantial i retain Federal Federal oversight of State programs with a mechanism to authority ensure compliance of States and users. State programs should be monitored by a Federal agency with overall medical use i perspective (DHHS). ;
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| DHHS Report does not make a compelling public health argument for DHHS taking on a substantial new role. The probability is !
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| low that Congress would provide adequate resources. DHHS !
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| does not support the recommendation.
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| l D0D Federal regulatory authority over medical use of byproduct I material should be reevaluated and perhaps relaxed and .
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| restructured, but not abolished in favor of a voluntary or i State-operated system.
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| EPA Report reflects the concerns of the regulated community more ;
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| than the public at large. There may be aspects of NRC's program that can be improved, but NRC should continue to '
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| assure public is protected. '
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| ACC Transfer of oversight of the medical use of isotopes to the i States seems reasonable. However, strongly encourage Federal oversight of this state initiative. An obvious drawback .
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| would be if all States had separate regulations for licensure ;
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| and compliance. !
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| ACMP Supports the need for a drastic change in regulation of !
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| radiation in medical use including use of Advisory Panels i (comprised of users, manufacturers, and public) to determine ,
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| the regulatory framework to be applied uniformly in medical profession. Current regulations should be modified. <
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| ACR In lieu of Congressional action to eliminate NRC's medical use program, the ACR believes that NRC's medical use program i must be rebuilt and its objectives thoroughly reassessed.
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| l
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| .__ __... - _._ _. ..m _ _ _ - - - - - . _ - . _ _ _ - - . _ _ _ - - _ _ - . _ - _ . - - . _ . - _ - _ - _ . _ . . .
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| Category of Response Respondent Specific Comments RESPONDENTS NOT IN AGREEMENT WITH ION RECOMEMATIONS (continued)
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| Support concept of Alaska This would not be a cost effective nor efficient refom for regulatory reform but Alaska. It is in the best interest of the State to support retain Federal the existing method of regulating nuclear medicine licensees authority (continued) by a Federal agency.
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| California In view of split regulatory authority at federal level and apparent reluctance of NRC to expand jurisdiction, agree that .i Congress remove NRC's authority. DHHS should be given authority to ensure that every state maintains a radiation program that meets minimum, comprehensive, consensus i standards of perforiaance and effectiveness.
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| Delaware The impact of the IOM recommendations would be substantial in terms of our increased need for funding, staffing, training and infrastructure requirements.
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| Hawaii ,
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| Does not have resources or capability to adequately implement
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| , regulation of byproduct materials. Without assistance (training and development) to States, the removal of NRC's authority may significantly jeopardize public health and safety. ;
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| Kentucky A better approach would be to have NRC revise its medical program to go along with the recommendations the Institute ;
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| has given in preferred alternative D.
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| New York Many unforeseen consequences may occur if AEA is modified.
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| (Dept. Environ. Commission should proceed cautiously in pursuing ION Conservation) recommendations that may alter the present AEA.
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| Tennessee While the findings of the Committee have some merit, there is no conclusive support provided to document them. Sweeping changes are not well thought out and may result in chaos. ;
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| i Utah State legislatures may view this as another unfunded Federal t mandate and may provide no additional support to the State program. Medical community should work with NRC, States, and other parties to resolve the regulation issue.
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| d' O I Category of Response Respondent Specific Comments -
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| RESPONDENTS NOT IN AGREENENT WITH ION REC 0fftDSATIONS (continued)
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| Support concept of Virginia The Commonwealth is in no position to assume any additional
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| : regulatory reform but unfunded Federal mandates. Could only assume regulatory retain Federal responsibility if NRC provides funds to defray cost of authority (continued) implementing the program.
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| Washington NRC should focus on radiation safety of worker and non-patient public (oversight of production, distribution, and handling of byproduct materials) while protection of patient is best handled through State boards of medicine and pharmacy. l Wyoming The conclusions of the report neglect the considerable hardship to be incurred by smaller, less populous, and less affluent States. Only through continued Federal regulatory participation can the goals of uniformity and public access to safe medical procedures be achieved.
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| GPoteat Potential decrease in safety may result from a transfer to State regulators of NRC's authority. Minor changes are necessary but overall NRC's regulations balance the need to protect workers, patient and the public with the requirements of medical practice. :
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| h
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| Category of Response Respondent Specific Comments
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| , RESP 0fGENTS NOT IN AGREEMENT WITH ION REC 0f9fDWATIONS (continued)
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| Support concept of New Jersey If NJ chose not to become an Agreement State, public may not regulatory reform, but be assured of adequate protection. If adopting the t after additional recommendations, NRC and Congress should not act i analysis precipitously, but allow the States to prepare for assuming regulatory programs in orderly fashion. t University of Before moving in the direction of a State-based decentralized Pennsylvania system, a better evaluation of potential both for increased risk to the public and increased cost to the medical industry ;
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| is necessary.
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| St. John's Urges NRC to give avery consideration to ION report, Hospital particularly the review of risk assessment.
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| CBeasley The report missed part of its stated intended goal to review '
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| the current system of regulation (the issues of uniformity among states was not fully explored). Proposes review in -
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| more detail the regulation of non-nuclear medicine radiology and question of uniformity between states. .
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| Support concept of OAS At NRC/ Agreement State Technical Workshop, consensus was uniformity for all reached that all radiation use (regulated currently under :
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| radioactive materials NRC, FDA, EPA, and OSHA) should be consolidated under a regulation with Federal single Federal agency.
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| "*
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| * 9 CRCPD Absence of federal authority in medical use area may have immediate and undesirable consequences on citizens in non-Agreement States and long term consequences for Agreement ,
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| States trying to maintain a nationally consistent program.
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| CRCPD does not support automatic selection of DHHS as the agency to provide leadership role.
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| APHA All ionizing radiation should be grouped together under a uniform regulation. Transfer responsibility for medical uses i of any ionizing radiation to the States. Some Federal authority should remain over the medical uses of ionizing radiation (NRC or a similar federal agency).
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| i
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| ! I l - ' [
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| Category of Response Respondent Specific Comments '
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| RESPONDENTS NOT IN AGREENENT NITH ION REC 0fflElWATIONS (continued) ;
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| Support concept of Arkansas The NRC should consider alternative A2 (status quo modified).
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| uniformity for all If major changes are to be made, centralization of regulation radioactive materials within one Federal agency (NRC) would be the best approach -
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| regulation with Federal for all uses of radiation. Congress would be required to oversight (continued) expand the role of NRC and a change in the agency would be i necessary. Expand current Agreement State program. l Florida Support idea that regulatory authority of 1]l agreement (Health materials be turned over to the states with consolidation of Office) federal radiation oversight, guidance, and regulatory functions into one agency, not necessarily DHHS.
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| Illinois Prefer CRCPD proposed new organizational concept that recommends some consolidation of all radiation regulatory !
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| functions at federal level. Revise QM and pharmacy rules. !
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| Prepare white paper to use as a policy basis to clearly ,
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| delineate the respective authority and responsibilities of various Federal and State agencies.
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| Maryland Rather than revoke NRC's authority and repeal the Federal regulations, such authority should be expanded to incorporate NARM, and the Federal regulations should be thoroughly i reviewed and amended to clarify regulatory responsibility. !
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| DHHS does not have necessary expertise.
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| Massachusetts Do not support elimination of all aspects of NRC's medical !
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| program, but support relaxation of overly prescriptive and unnecessarily costly requirements. Support intent of single :
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| Federal agency providing a single leadership role but do not support automatic selection of DHHS. ;
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| i Texas The basis for the report's recommendations do not seem to be substantiated. The merging of all federal radiation control !
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| oversight into a single regulatory program should be .
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| considered. The NRC should enhance the partnership with the States to jointly determine compatibility requirements. l t
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| j f -
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| 8242 RULES AND REGULATIONS
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| !. RTAmrney or GE?tUtAt. Pottev generally oriented toward a.ssist:ng
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| [7590-01-M] qualtfled physicians in discharc ng Title 10-Energy This NRC polley statement is in' their responsibilities to patie%s Hoa-tended to trtform NRC licertsees, other eser regulatton by AEC 'NRC has ai CHAPTIR l-NUCLEAR REGULATORY ,(' Nion gen ral "' Ll** "' "" t h " '"# " D*88'd fYhe "'*'lY 'Y "Y 83P'C' I th' d'I""F I COMM15510N tention regarding the regulation of radatsotope medical services to pa-the medical uses of radioisotopes, tients. The broadest regulation oc-PART 10-HUMAN U$ES OF It ts expected that future NRC activ, curred between 1962 and 1975. 4her, SYPRODUCT MATERIALS itles in the medical area, such as pro.
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| mulgation of new regulations and de. the Food and Drug Admintstration vC3m:nt of cooperative relationships (FDA) exempted from its req uire.
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| all
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| . Regulot.te n of the Medice! Uses of sith other Federal agencies, will ments for new drugs Rodielsetepes; Statement of Gener- follow this statement of NRC policy, radiopharmaceuticals regulated by el Policy Based on past experience and the AEC. During this period AEC regulst-comments and adytee of the public, ed the radiation safety of workers and AGENCT: Nuclear Regulatory Com- other Federal agencies, the States, and the general public and the safety and mission. NRC's Adytsory Committee on the efficacy of radioactive drugs and de-
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| ' Ma lleal Uses of Isotopes, the Commis- vlees with respect to patients. AEC ACTION: Final Polley Statement. t.fr has developed the fo!!os-ing state- regulation included production of the
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| ==SUMMARY==
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| : The Nuclear Regulatory nunt of general polletto guide its reg- radioisotope, manufacture of the final Commisalon (NRC) has the following ulation or the mecical uses of radictso- radioactive drug product or device, das
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| . polley statement regarding NRC's topea? tribution. use and disposal of the prod-
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| * future role in regulating the medical Jk 1. The NRC will continue to regulate ucts. J' 1975 the FDA terminated the uses of radiolsotopes. This NRC polley the medical uses of rad.oisotopes as exemptiott for radiopharmaceuticals.
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| I st*tement ts intended to inform NRC necessary to provide for the radiation stating that it would now regulate the Itctnsees, other Federal and State safety of workers and the general safety and efficacy of radioactis e pubile. drugs with respect to patients. t As agencies and the public of the Com s 2. The NRC will regulate the radt- noted later in this statement. FDA mtssion's general intention regarding at n sa ety of patients whm justified does not regulate the phystetan's rou-the regulation of the medical uses of by the risk to patknu and whm vo!- tine use of radiopharmaceuticatu At radiotsotopes. It is expected that future NRC activities in the medwat t es st dards s're inad o ate ' " *#
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| ' YE area, such as promulgation of new reg K 3. The NRC will minimize in' trusion e ey gt t it sould regu ate ulations and development of coopera. tnto medical judgments affecting pa- the radiation safety of the workers tive relationships sith other Federal tient.s and into other areas traditional. and the public. The 1976 Medical trencies, will follow this statement of ly considered to be a part of the prac' Device Amendments to the Food. Drug i
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| NRC poljcy. Lice of medicine. and Cosmetic Act extended FD A's au-EFFECTIVE DATE: February 9.1979. thority over med1 Cal devices (including II. H Af ton ALE devices containing radioactise materi-FOR FURTHER INFORMATION The NRC and its predecessor the als) in a way samtlar to its authority I CONTACT: Atomic Energy Commission have regu- over drugs.
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| lated the medical uses of radiotsotopes NRC's authority to regulate domes-M r. Edward Podolait. Office of since 1946. AEC recognized that physt. tically the medical uses of byproduct Standards Development. U.S. Nucl?- clans have the primary responsibility material is found in the Atomic
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| ' ar Regulatory Commission. Wksh-for the protection of their patients Energy Act of 1954, as amended. For l Inston. D.C. 20555 (Phone: 301443 and designed its regulations accorc'ing- example, sect 1< n 81 of that Act autho-
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| $860)' ly. The physicians were required to b* ttzes NRC "to issue general or specific SUPPLEMENTAL INFORMATION: lleensed by the State, and their appil- Itcertses to applicants seeking to use The NRC has developed the following cable training and expertence were byproduct material for * *
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| * medica.1 three part policy statement regarding evaluated in costsultation with the Ad' therapy *
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| * 8." Section 81 directs NRC NRC's future role in regulating the visory Committee on the Medical Uses to regulate the manufacture, produc.
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| medical uses of radiotsotopes. On of Isotopes. This regulation has been tion, transfer, receipt in interstate ,
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| March 17.19'en, the three part policy commerce, acquisition, ownership, pos- L d stttement was pubitshed in the FrDt1t- 'NRC licenses radiotsotopes in three cate- session, import and export of byprod-at RectsTEJi (43 FR 11208) for publie "sortes: byproduct, source and special nucte. uct material. Finally. Section 81 also i
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| comment. Copies of the policy state. at matertal. The NRC does not terutate nat. directa that:
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| urally occurring or acceterator produced ra-ment sere sent to all NRC medical 11 dtotsotopes. The term byprodnet material The Commission shall not permit the dis-censees. the States and 25 professional means any radtoactive matertal tescept spe. tributton of any byproduct material to any societies. Federal agencies. and indt. etal nuclear matertall ytelded in or made ra. incensee, and shall recall or order the recati siduals. The comment period expired dioactive by esposure to the radiation tnet.
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| of any d6stributed matertal from any licens-May 16.1978. Tuenty.two commenta oent to the process of productns or utthstng ". s obserse no is notsuch eautoped to observetoor safety standards fails to protect special nuclear matertal. The term source j sere received. Nine commenters f a. matertal maans til uranium. .hortum or any health as may be estabitshed by the Cor'-
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| vored all three parts of the policy combtnation thereof, in any physical or misalon or aho uses such material in viola.
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| statement. four commenters opposed chemteal form or (21 cres shich contain by tion of law or regulation of the Commisuon one part of the policy statement and wetsht one. twentieth of one percent to os%) or in a manner other than as disclosed in 4 nine commenters addressed specific or more of (t) uranium. till thortum or citi, the appitenuon therefor or approved by tne issues discussed in the March 11.1978 any cometnation thereof. Source material Comrntastors.
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| Commission regulations. for the d
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| FretnAt. Rtcastra notice. The com. does not include special nuclear matertal.
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| ments are discussed in Section .11.
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| 38'''83 ""'I'er material means (t) plutoru. most part set forth in 10 CFR Parts 30 Coples of the comments may be exam. Q,"p[*$br 'the oNo N "or (( through 35 were promulgated to carry ined in the NRC Public Document matertal arttfietally enriched by any of the out the broad regulatory scheme en-Room at 1717 H Street. N.W.. Wash- foresotns. b.it does not include source rnate. visaged by section 81. For exampic.
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| Ington. D.C. rial. Part 35 establishes regulations spectfic flottat afG15fft. VOt. 44, NO. 29 ftlDAL FtstVARY 9,1979 Enclosure 5 1
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| -l
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| ], - -
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| I RULES AND REGULATIONS 8243 i I
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| j I
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| Lo human uses of byproduct matertal. The N AS-BEIR 8 report discusses The regulatforts try to find a balance l
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| ' FDA's statutory authority ( Federal limiting the exposure cf the popula- betseen adequate controts and avoid-Food. Drug and Cosmette Act. as tion to tuedical applications of tont::.ng ance of undue interference in nied: cal amended. 21 U S C. 301 et see 1 does rsdiation. That reco-t, s hidt includes Judgments. A consequence of too not dimtnish NRC's authority. Where all rnedical uses of tortising raiauen. much regulation could be poorer NRC's and FDA's authorttles overlap, shon1 an average dose rate from health care delivery to pat:ents. A con-the respective authorities can be har. radiopharmaceuticals of 1 mrem / year sMuence of leaving to physictans the l l
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| monazed by intertgency agreement. and an average dose rate from c.ag- a1crity of he d to conee ng l The central Question is a Question of nostic ridjology of 72 mrem / year in ,
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| polley not outhortf y, namely: 1970. will make mistakes. The tightest ter.!-
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| To what extent should the protec. The following Quotation is from the lation of physicians' deetstons by Fed-
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| * ton of the patient be considered m NAS-BEIR report: eral. State and professional groups will NRC s regulation of the medical use of in the foreseeable future, the major con- not be able to prevent future incidents b e ,
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| From tl e stan point of autAortip. It tIoNrt inu$ 'to catu g in the medical uses of radioisotopes.
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| The Commission recognizes that Ls clear that NRC can regulate the ground with an aversee whole body dose of FDA regulates the manufacture and medical uses of byproduct material to about 100 mrem / rear, and med: cal apotica- interstate distribution of drugs. Lnclud- l protect the health and selety of users tions whkh now contribute comparable es. ing those that are radioactive. FDA ,
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| of this material, for in. stance. patients. posures to various tLasues cf the body. Medt. also regulates the investigational and cal uposes are not under controt or guld.
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| In licensing the possession and use of ance by twutat on or law at present. The research uses of drugs as well as the byproduct material NRC establishes use of Mntr.ing rwEstion in medicine is of specific guidance on doser and proce.
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| limits within which physicians exer. ' *' 88 dures i und La the product labeling.
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| cise professional discretton. From the ,$'o$"d"#,, stnN enn b . co FDA does not have the au-standpoint of pohey. these limits pushed without loss of benefit and at rela. UO*'V"'o thority t restrict the routine use of depend upon how NRC views the po- tively low cost. The atm is not only to drugs to procedures (described to the tential hazard to the patient's health reduce the radiation exposure to the tnds.
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| and safety in the uses of the byprod- vMust but also to have procedures carned product labeling) FDA has approved uct material. The greater the potential out atth mastroum effletency so tr.at there as safe and effective. Indeed. NRC is hazard to a patient from the byprod. canbenefits be a conunuing meresse in med. cal the only Federal Agency that Ls cur-uct matertal or its use by a physician, accompanied by a mirumum rad" rently autltorized to regulate the rou-the more NRC may elect to circum- 8"0^ "D08*- tine use of radAoactive drugs from the scribe areas that might otherwise be NRC will act to he'p ensure that ra- standpuint of reducing unnecessary ra-regarded as within the discretton of dlation exposure to patients is as low diation exposure to patients.
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| the physictan. as is reasonably achievable, conststent The Comrnission be!! eves that the The first part of NRC's policy state- with competent medical ca.re and with diagnostic use of radioactive drugs u.
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| ment indlestes that NRC sill continue minimal Lntrusion into medical judg- in most cases, clearly an area of low to regulate the medical uses of radiot- ment NRC will not exercise regula- radiation ruk to patients. Therefore, sotopes as necessary to prodde for the tory control Ln those areas s here. NRC aill not control physician's pre-radiation safety of workers and the upon careful examination, it deter- rogatives on patient selection. Instru-general public.' This is the traditional mines that there are adequate reguia- ment selection. procedure selection.
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| regulatory function of NRC for all tions by other Federal or State agen- drug selection and dose level for most uses of byproduct, source and special ctes or well administered professional diagnosuc uses of radiodomes. For nuclear matertal. It ts a regulatory standards. Wherever poss:ble. NRC all therapeutic uses of rsdioactive role that was not questioned by any of will work closely with Federst and drugs, and in certain diagnostic uses-the comrnenters but, rather. It sas State agencies and professional groups for example the use of pbosphorus 3e consistently recocnazed as a necessary in designing new voluntary twdance for localization of eye tumors-the role in the medical uses of radio so. for practitioners to limit unnecessary ruk to patients is not low. The rtsk of patient radiatjon exposure, topes.
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| NRC's regulation of the radiation The third part of NRC's policy state. tissue or organ damage (or even death' safety of workers and the general ment indicates that NRC will mini. is inherw in the use of therspeutic public in the medical uses of radioiso. mize its intrusion Lnto medical judg. levels of Mjoactive drugs. NRC wlil topes is relinquished by NRC to Agree. ments affecting the patient and into continue to restrict the uses of thera-ment States; does 110t overlap with other areas traditionally considered to peutic and certain diagnostic radios.c-FDA's activities. is in harmony with be a part of the practice of medicine, tivethat drugs havetobeen the approved indicatedby procedures FDA. The regt.lation by the Department of The stelans Commission have recognizes the primary that phy-responsib!!ity NRC will not control the physicians' Trartsportation. Social Security Ad. for the protection of their patients- prerogatives on patient selection and ministration and the Joint Comrnts. The Commission believes that basic instrument selection for therapy pro-sion on Accreditation of Ilospitals; and decisions concerro v the dias'nosts and cedures. because these procedures are dovetails with Occupational Safet y treatment of d sease ad a part of the so specialized and patient spectite.
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| and 11ealth Administration regulation phystelan patient relattoruhip and are Congress recently gave FD A authord of the work-place for the use of natu. tradttlonally considered to be a part of ty to regulate medical devices, similar rally occurring and accelerator pro. the practtee of rsedicine. 4RC regula- to FDA s authority to regulate drugs.
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| duced radioactive materials. tions are predicated on the nasumption but with additional authority to re-The second part of NRC's polley that properly tralned and adequately strict the routine use of medical de-statement indicates that NRC stil reg, formed p cia s s n;a vices as may be necessary to provide ulate the radiation safety of patients p te, g reasonable assurance of their safety shere justified by the risk to patients tients' and effectiveness, FDA has not yet and where voluntary standards, or had sufficient time to trnplement its compliance tith these standards, are 'Nauonal Academy of Sc'enees Adusory full authority to regulate medical de-inadequate. As noted before. NRC has nees containing byproduct. sourte or the authority to regulate the radiation Committee on the Bioictical E!!ects of lon' tzing Radiations (N AS BEIR) report- The ggg n,x W m W d ha d tt i safety of patients. EJ/ects on Populatsons of g:posure to Leic NRC will continue to restrict physi-i Lercis of tenutsp R o d t a tion. Act:onal clan s uses of these medical devices.
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| 8The term eeMrtl pubtle in this state A ca demy of Sewnees-Nahonal Resea rch both for diagnosis and therapy. to ment specifically excludes pallenta Co u nctl. Wa.srdngton. D C. t 1972).
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| l floteat IIGttfra, VOt. 44, 840. NtioAY. FiltV AR Y 9.19r9 -
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| )
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| RULES AND REGULATIONS 8244 Two commenters objected to NRC's As noted in the proposed pohey those procedures that NRC has det:r- regulation of patient rad!ation safety statement. NRC ts studying the var-mined (in consultation with its Adviso- because they beljeve that NRC does tous allied health certification pro-ry Committee en the Medical Uses of not have the authority to regulate pa- grams currently in effect or bemg draf ted by other Federal. State and Isotopesi to be safe and effective.
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| t!ent safety. They note that NRC's en. professfonal groups. If the coserage The Commission does not constder equipment calibration, qualifications abling legislation does not specifically provided by these progia:ns is not ade-of paramedical personnel or reporting mention the radiation safety of ps. quate to protect the patient from un.
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| to NRC misadministrations of radioac- tients. They believe that patient necessary radiation exposure. NRC tne maternal to be exclustvely the safety is the responsibility of the phy. will work with these groups to deselop practice of medicine or a part of physt. sletan a responsibility that cannot be a new NRC proposed rule for the clan pattent relationships. The Com* shared. They beueve that the Ccmmis. training of allied health personnel.
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| mission miends to regulate these areas slon is in error to equate patients with There were five comtnents on the of patient radiation safety where Justi- the public and to consider patients as specific subject of nuclear pharmacies fled by the rtsk to patients and where users rather than recipients of radio. (radiophannaclest voluntary standards, or compliance active material. One commenter urged NRC to dis- ;
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| a eith these standards, are inadequate. As noted in the analysis of the slml. tinguish between radtopharmacists l lar comment above. the NRC's overrid- working in a hospital setting and those
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| !!!. DiscusstoM or Pvstic Cowuctrrs ing congressional mandate is to pro. working in a retail environment (Com-
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| : a. cowwtrrrs oM THE PoWCY sTATEMUT teCt the health and safety of the mercial nuclear pharmacy). This com-public. The patient is a member of the menter also noted the complexity of One commenter opposed the use of public, notwithstanding the Commis, the problem of definition when the the general term " radioisotopes" in ston's recognition of physicians' prima- hospital based radiopharmacy pro-the first part of the policy statement. ry responsibility for protection of vides radiophannaceuticals to other This commenter was concerned that: thelt patients. The policy statement hospitals and practitioners in .'s area.
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| If taken out of the context of the foot and, indeed, all of the Commission's As noted in the proposed policy note. It could be interpreted to include actions in regulating the medical uses statement, the NRC will defer to the naturally occurring and accelerator of radioisotopes. acknowledge the sec- Food and Drug Administration (FDA) produced radioisotopes, ondary but necessary role of NRC in regarding a determination of those ac-The Commission oelieves that the regulating the radiation safety of ps. tivities of nuclear pharmacies that stil cGneral term " radioisotopes" is plain tients. The Commission also considers be considered manuf acture and those Engitsh and easily recognized by the public. It ws.s properly footnoted in pattents to be both users and recipi. activttles that wti! be considered the the policy statement to include the ents of radioactive material. Hosever, ordinary practice of pharmacy (com-the dLstinction .between receipt and pounding and dispensing),
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| more cumbersome but specific terms: use of radioactive mat, trials is not Four commenters objected to NRC's j byproduct.
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| material andsource and special to exclude nuclear naturally oc- meaningful in this case because NRC Ilcensing nuclear pharmacies to dis-curring and accelerator produced ra- regulates, among other thlngs, receipt. tribute only those products that they Goactive material. possession, use and transfer of byprod- have prepared from FDA approved One commenter. In opposition to uct, source and special nuclear materi- radiopharmaceuticals or reagent kus.
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| NRC's regulation of patient radiation al in protecting the health and safety One commenter etted the practice of safety, suggested that NRC limit its of the public. nuclear pharmacies supplying radio-role to the radiation safety of the hos. chemicals to resca;chers who use 8 CO M!INTs OM SPretric:ssets them on humans under their own i
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| pital staff and the general patient '
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| population. He believes that patient There were six comments on the FDA " Notice of Claimed Investigation.
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| dostmetry is a responsibility of the in. question of reportir g misadministra- al Exemg'.lon fer a New Drug" (IND).
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| dividual institution and not NRC. This tions of radioactive material. Three One commenter noted that FDA per.
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| commenter feels that NRC should commenters opposed any misadmints- mits nuclear pha-macies to operate in first require adequate staffing, includ- tration r; porting and three com- the absence of a final determination of ing a board certified physician or ra, menters offered suggestions on how their status providing they meet all diopharmacist and a radiation safety they should be reported. All of the State and local pharmaceutical regula-officer, and then essentially leave the comments will tw considered in dealing tions. The two other commenters institution alone regarding dostmetry, with NRC's newly proposed mtsadmin- charactertzed the NRC's restrictions of instrumentation calibration, drug pro- on the distribution curement or any other function con .1stration reporting requirement thatwas published in the FrotaAL Rects sidered to be the practice of medictne. for public comment on July 'f. 1978 (43Into macies as an unaarranted the practice of pharTnacyintrusion which is NRC does require the Itcensee to FR 29297).
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| staff its operation with a radiation There were six comments on the spe. regulated by the nuclear NRC licenses States. pharmacies to safety officer and a phystetan (not effic issue of paramedl cal training. distribute radioactive drugs that have necessarily board certifted) trained to Three commenters believe that it is been approved by FDA. This includes administer radioactive material of ra. unnecessary for NRC to become in. radioactive drugs subject to an FDA; dittlon to patients. However, the Com. volved in paramedical training because approved "New Drug Application mission cannot limit its regulatory role several organizations are already pro. (NDA), or " Notice of Clatmed Investi; to protecting the hospital staff and viding or develop'ng minimum stand. gations! Exemption for a New Drug the general patient population and at ards. guideltaes or certtfication. One (IND). NRC relles on FDA approval of the same time fulfill its congressiona.1 commenter believad that NRC should radioactive drugs because NRC has rnandate to protect the health and be involved in this area because the not regulated the safety and effective.
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| safety of the public as regards source. technologist, not the physician, does ness of radioa'tive drugs since 1975 byproduct and special r.uclear matert. most of the work with radioisotopes. Al80 there are not many States that al. The with nosed patient being treated radioactive or disg.
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| material, as Two commenters believe that radiolog. are equipped to regulate radioactive sell as the general public who may be leal physicists should be separated out drug safety and effectiveness, exposed to radiation as a result of that from other paramedical personnel and Dated at Washington. D.C. this 1st treatment, are all members of the one of these commenters of fered a day of February 1979.
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| pubite to be protected by NRC, definition of radiological physicist.
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| Flott At 35015f18, VOL 44, NO. 29 FttpAY, fistUatY 9,1979 .
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| l
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| 'a 8245 RULES AND REGULADONS ever. was critietzed by several commen.
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| For the Nuclear Regulatory Com- tssuers ellgible to use the form for pri-mary offerings to include those whose nies tators sho sith no noted pubiteythat heldmany vottngcamps s
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| mtssion-Swert. J. Cmtx. parents do not guarantee their se-urt may be better estabitshed than t ties as to principal and interest and Secretarv of the commtssion. also allow the use of the f orm for the with such stocL' Accordmgl in- the Re-(Dt Doc. 44148 Fded 2 8 79. 8 45 am) reg 1.stratton of equity securttles of amendinents that sere adopt Form S-sucn issuers. In adition to the general lease 33-5923 allow the use licly held requirements for the use of Form S-16 16 by issuers v.ith no puer is a ma-gg g y and the market espitalization require- voting stock t hen the ment of the parent, the eligibility cri. jortty onned subsidiar and its capital-market pare.nt le IT-Commodity and Securities teria proposed tn Release 33-5974 for meets the $50 milli and guarantees tzation requireme Entb Iu substdlaries included (1) the extstence the securttles principal and inter. .
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| of outstanding debt or equity securt. l ties held by nonaffiliates. sith an ar- est.
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| C PTER ll-$ECURITIES AND As noted Release 33 5974. subse-E HANGE COMMi$$lON gregste principal amount or market value of at least $250 tnillion the offer quent to t adoption ments, f her comrnents were re-of these amend-(Rele e Nos. 23 402o. !C 10571) or sale of which ha.s been regutered cetved the effect that several sub-pursuant to the provisto:ts of Section 6 sidiar tssuers, such as finance and l
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| PART2 -FORMS PRESCRIBED of the Securttles Act. (2) compliance uttil companies, are among the lars-UNDER THE CURITIES ACT OF 1933 with certain specified earnints to itxed est nd best established business con.
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| charges ration (varying according to c and frequently finance external-Short form fo the Registrotion of industry) for the most recent fiscaj . Substantial pubtle information is period reported, and (3) the existence vallable regarding these issuers in Se rities of at least 2.500 securtty holders who view of their prevtous issuance of secu- l AOENCY; Securit s and Exchange receive annual reports from the issuer rities and reporting history. It was fur- l Commission. containing certified financial stat ther suggested that, in view of ti.e ments. Quality of these subsidfary issuers.
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| ACTION: Final rules' This reles.se contains a general is. parent compantes generally need not );
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| ==SUMMARY==
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| : The C mission is cussion of the background an pur- and do not guarantee their securttles.
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| adopting amendments the short pose of the amendments prop in It' light of these concerns, the Com- i form S-16 in order to fur er expand Release No. 33-5974. the co ents re- mission in Release 33-5974 proposed its use for primary offering y subsid* ceived on the proposal.' and he Com- amendments to the form that sould isries of certain issuers. Th amend- mission's response to thos omments. enable substdtary issuers to use the ments will enable certain subs. tary ts. The tent of the amendme should be form for primary offerings in the ab-suers sho otherstse sati.sfy the ener- consulted for a cornple understand. sence of a parent guarantee provided al requtrements of the form to the tng of the new provisto that they meet certain criterta intend-form for primary offertnts of s u ri, Pmerosg ed to assure the satisf action of stmtlar ties if they have outstanding securt es BsczonomrD standards of information dissemina-i held by non a.fftllates with an agg On April 11.197 . the Commtssion in tion and significant interest by securi-t gate principal amount or market valu Securttles Act R ease No. 5923 (43 FR ties professionais that must be met by of at least $250 million, the offer or 16612) anno .ed the adoption of their parent companies. TheJe adde sale of which has been regtstered pur. endments aking ForTu S 16 avall- tional criterta proposed in Release 33-suant to the Securities Act of 1933' le for th trst time for primary of- 5974. the comments received thereon, and at least 1.000 security holders who fe ngs by uers under certain speci- and the Commission's response as re-receive annual reports containtng cer- fle con tions. The amendments re- flected in the final amendments are .
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| tified financtal statements of the flect part the recomtnendation of discussed immediately below. !
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| usuu, the visory Committee on Corporate
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| (" Advisory Committee") AriorfloM or RrQUtarutwT or $250 PRINCIP AL EFFECTIVE DATE: March 15.1979; Dtse s S-16 be available for the MitatoM AccascATs however, persons destring to use the th Fo AMOUNT OR MARKsT VALUE or OttT.
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| restsed form prior to that date may do r itectly trati of securities to be offered sTANDtNo SECURITIts so. provided they comply with all ap.
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| to he pub!!c by a "small top tier of com es * *
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| * which usually In addition to the general require.
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| plicable provtstons of the new form, pmide h!K quality corporate con" ments that the issuer satisfy the rules FOR FURTHER INFORMATIO mun! cati n d uments including 1934 for the use of Form S-1
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| * and that its CONTACT. Act reports. *
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| * whose corporate in. ~
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| Steven J. Paggioli. Offtee of D lo. formation is wid y disseminated * * ' 'See comments cetteeted at Fife No. S1-sure Policy and Proceeding Divf. f debt and) which are idely followed by T25.
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| and equity an ysts."' One of the I ston of Corporation Finance Securi. major condittons u imately adopted g {g "jh,*,",nN,'n,*g',7, [ ofTrm ties and Exchange Comm lon. 500 North Capitol Street. hington, in furtherance of ide if ytng a catego" 1. which requtre a.n issuer tai to twe a cia.ss ry of such issuers was e requirement of secunues rettstered under section 12 or D C. 20549. (202/376-80 L that an issuer have outs nding voting be sutocet to one reporuns recuirements of SUPPLEMENTARY I RMATION.* stock held by nonaff tltat with an ag- secuon 15<di of Lne Securtties Exchange Act On September 1.19 . the Commis- gregate market value of t least $50 of 1934.qutrements Ib> to have been subject of sections to the 12 or ISidi andre.
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| to ston authortred fo publication pro- million, the relation of tl require.
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| hase filed all applicable reports for 36 calen-posed amendmen to Form S-16 (17 ment to the issuer's vWng a k.how. dar months unor to filins tne reststration CFR 239.21), a rm for the rettstra. statement and have timely filed alt requires i tion of certain curities under the Sc. 'o SL reports f or the past 12 calendar toonths. (el
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| 'See comments collected at File L* h*'' d'I'"It to D"F"'"t* 0" D"'
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| curities Act 1933 (" Securities Act") for borrom ed (15 U.S.C.
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| * a et seq. as amended by TS4- 'Repors of the Addsory '"ommitt on ferred stocit h*d ".* Indebtedness l 19751). Secu. Corporate Disclosure to the Jacurities nd money or lons term leases durtns the past Pub.1. 36 rnonths. and idi to have had eonsoudated rities N . Release 94 29 (June No. 4'5974 (43 FR , Excha.nre commission t (~ Report 7. Ho net income of at les.st s250.000 f or 3 of the l 41052 nvited coroments on these pro- committee on interstate and Foreign Ce la.st 4 fisesi years. Including the most recent j pos amendments which would gen- merce. 9$th Cons .1st Sess. Committ fiscal year. See 11 CFR 139 26.
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| er y expand the class of substdlary Print 95 29 at 433 34. .
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| I l
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| FIDit At etCl$ tit. Vol. 44. HC. 20 Jtic AY, FittVAtY , 19r9
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| l l
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| 1 i jf* * %
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| f THE SECRE TAR Y OF HE AL TH ANO HUM AN SERVICES
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| ..s-~ m ~ m ,o,u g
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| MAY 8 S$6 I The Honorable Shirley Ann Jackson -
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| Chairman Nuclear Regulatory Commission Washington D.C. 20555-0001 l
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| ==Dear Ms. Jackson:==
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| This is in response to your lotters to me and to Commissioner Kessler requesting the Department's review of the report of the Institute of Medicine (Ior) entitled " Radiation in Medicine: A (
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| Need for Regulatory Reform." We appreciate the opportunity to I comment as your Commission assesses its Medical Use Program. l I regret the delay in responding.
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| The report examines several alternatives to your agency's current regulation of the medical use of radioactive materials generated by nuclear reactors (" byproducts"). It recommends that the states take on this obligation in addition to their current range of regulatory responsibilities for the medical use of other radiation sources. It suggests that this Department provide leadership and collaboration as the States develop new guidelines and model state regulations for this purpose.
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| We do not believe, however, that the report makes a compelling public health argument for this Department's taking on such a substantial new role. We would also comment that, in the unlikely event that new legislation for such a purpose should be enacted, the probability is low that the Congress would provide the Department with resources commensurate with such responsibilities. Therefore, we cannot support the recommendation.
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| We trust these comments are helpful and that the process of public comment and review of the IOM report will prove useful.
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| Sin ly, 1
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| I D a . alala Enclosure 4 46DS 2&22XZ -}}
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