ML20203G129
| ML20203G129 | |
| Person / Time | |
|---|---|
| Issue date: | 01/04/1994 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Fletcher R MARYLAND, STATE OF |
| References | |
| NUDOCS 9803020202 | |
| Download: ML20203G129 (6) | |
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't UNITED STATES 4 .)DI E NUCLEAR REGULATORY COMMISSION
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%,,,,,8 January 4, 1994 Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway Baltimore, MD 21224
Dear Mr. Fletcher:
, This responds to your April 28 and September 8, 1993 letters to Ms. T. H.
Darden and Mr. C. Gordon, respectively, which included several questions related to the uncontrolled release of radioactive materials to the environment. These issues relate to the ongoing efforts of your Department relative to operations by Neutron Products, Inc. (NPI).
The recent inspection at NP) by the State of Maryland, with assistance by the NRC staff, focussed on this same issue of uncontrolled releases of radioactive materials to the environment. The results of that inspection and the answers to the specific questions which you asked (enclosed), should help to clarify these issues.
Please let me know if you wish to discuss these matters further.
Sincerely, n
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RichardL.Bangart,Dir]e Office of State Programs $ tor
Enclosures:
- 1. d nisters to Questions
,.,2 $ Nuclear Pharmacy, Inc. Order
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- 1. Question: Is there an acceptable criteria allowing for uncontrolled release of radioactive material? Is the regulatory limit for uncontrolled release from a licensee's facility zarn?
&natar: The basic concept regarding releases which is set forth in 10 CFR Part 20 is that the licensee will have a program for controlling releases from its facility. Section 20.106 provides the limits for release of radioactive materials in effluents to unrestricted areas through airborne and liquid pathways, while 20.303 provides for disposal to the sanitary sewer system. "'ction 20.201 requires the licensee to evaluate releases to assure the above standards are met. Part 20 does not use the term " uncontrolled release," and therefore has no specific limit related to this term. However, Section 20.201 also requires evaluations which are reasonable under the circumstances to evaluate the extent of radiation hazards that may be present. It is recognized that depending on a particular licensee operation, there may be some radioactive material which leaves the confines of a restricted area through pathways which are not continuously monitored. These pathways-should not be definable air or water effluent or waste streams, but would more likely be in the form of contamination, spread through tracking or minor leakage from enclosed systems. These must M i
i evaluated on their own merits relative to the requirements of Part 20, !
l good health physics practices, potential safety significance, and criteria for unrestricted use of buildings-and areas. -
- 2. Question: If the answer to the above question is Igrg, please give benchmark examples of NRC licansee problems and remedial actions taken by NRC. Why are the above concepts not more clearly stated in the regulations?
Answer: While the egulations clearly spell out the requirements for the licensee to control releases through waste streams from its facility, they do not address all of the potential isotopes, compounds '
and uses that may need to be addressed as related to the matter of contamination that is inadvertently released off site. These types of issues are normally addrer. sed in the licensing process. For example, licensees which have the potential for uncontrolled releases are requested to evaluate these in their license application. Typically, we would c5tain from such licensees a commitment in their application to perform surveys, as necessary, and we would then incorporate such a commitment into the license through the use of a " tie down" condition.
- 3. Question: Has NRC had any history of radioactive material licensees releasing high specific activity windborne particles into residential communities? If so what action has been pursued when located particle activity is below maximum permissible concentrations listed in Regulatory Guides.
Answer: As a matter of clarification, the NRC does not have regulatory guides which address discrete particle contamination. We have had
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' instances of radioactive materials found in residential communities, although nc6 necessarily involving high specific activity particle',. In such cases, we have conducted surveys to determine the extent of the contamination, and evaluated the results to determine safety significance, and to compare the quantities found to the values for exempt concentrations and exempt quantities as found in the regulations, and also to guidance documents or branch technical positions for cleanup of material for unrestricted use. This evaluation is used to determine whether removal of the contamination is warranted.
- 4. Question: Is it an acceptable reaulatory practice for a licensee to only monitor facility releases by residential environmental sampling?
If no, why not?
Answer: No. The regulations require that the vicene must evaluate the concentr tion of effluents released from its - jed area. (See answer to question No. 1.) Environmental samr' , not sufficient to quantify the concentrations of material re" Environmental sampling may be a part of an overall evaluan.a of material released, but cannot replace the requirement to evaluate the concer.tations of materials released from the restricted area in effluent streams or other pathways.
- 5. Question: NPI's hot cell ventilation system which is situated above the facility's restricted area, discharges effluent into the air. Is this air restricted or unrestricted?
Answer: Air, by itself, is not restricted or unrestricted. The regulations define a restricted area as "..any area access to which is controlled by the licensee for purposes of protection of individuals from exposure to radiation and radioactive materials." (See 20.3(a)(14)). Airborne radioactive material released to an unrestricted area must meet the concentration limits in 20.106. While the limits apply at the boundary of the restricted area, they are normally measured at the point of release frc.a a vent or stack.
- 6. Question: Are there any NRC licensing examples where a 500 mrem per year facility boundary dose has been mandated?
Answer: We are not aware of any examples where this limit has been mandated in a license condition. However, during the evaluation of license applications and during the conduct of routine inspections, an evaluation is made of the radiation levels in unrestricted areas. In addition to reviewing the actual dose rates, evaluations are made to determine the likelihood of exposure to any individual in an unrestricted area of greater than 500 mr in any one year. This latter value is implicit in the provisions of 20.105(a).
- 7. Question: Please give examples of NRC mandates involving the requirement that independent technical consultants be hirec by licensees, and how much review and revision are allowed by the 2
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licensee's management prior to reports being submitted to the NRC7 Answer: In cases where the NR; has mandated the involvement of an independent technical consultant, such consultant is normally required to send its reports directly to the NRC at the same time that they are sent to the licensee. Licensee management-is not allowed to review and revit: the report itself prior to its issuance to the NRC. The licensee may, of course, provide their own analysis and conclusions under separate cover to the NRC. The attached Order issued to Nuclear Pharmacy, Inc. is typical of how this requirement has been imposed.
- 8. Question: Please give examples of penalties levied against licensees who:
- a. violate license amendments, and/or b, cannot control adioisotope release, and/or
- c. fall to ship radioactive wastes at a prescribed rate and store low-level radioactive waste in unrestricted areas.
Answer: We understand part a, of the question to refer to license conditions. Many NRC Notices-of Vialation (NOV's) cite license conditions, and examples can be found in NUREG-0940. Enforcement Actions. Significant Actions Resolved. Copies of this dccument are t routinely distributed to the Agreement States. With regard to parts b.
and c. of_the question, a word search of files resulted in the listing which is shown in the Enclosure. The references are to various volumes of NUREG-0940. Please note that the dollar an.ohnts for the civil penalties are not specifically assessed for the subject violation, since these cases involve several violations. Detailed information on how the NRC addresses violations and assigns civil penalties is found in the Enforcement Policy 10 CFR Part 2, Appendix C). The Supplements to the Policy provide examp(les of various violations and the severity levels that are assigned to those violations.
- 9. Question: NPI's MD-31-025-01 radioactive material' license has been in
" timely renewal" since 1980. During this period, there has been a myriad of correspondence between this agency and NPI to resolve differences. The license has been complete for over a year, but is
" hostage" to the civil action. Is there any NRC action on record that supports withholding a license renewal untii the completion of legal action?.
Answer: There are no NRC procedures or requirements which prohibit the issuance of a license renewal while legal action is being carried out against a licensee. We have not undertaken a file review to see if we have had any cases of this type. The actions taken and the timi 3 of such action would have to be evaluated on the merits of the particular case.
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^ ENCLOSURE 2 h $ i UNITED STATES NUCLEAR REGULATORY COMMISSION in the Matter of l NUCLEAR PHARMACY, INCORPORATED License No. 12-18044-01MD i P.O. Box 25141 License No. 14-19990-01MD Albuquerque, New Mexico License No. 20-21227-01MD 87125 License No. 37-18461-01MD License No. 37-19586-01MD License No. 37-21322-01 License No. 48-17466-01MD EA 84-100 ORDERMODIFYINGLICENSES(EFFECTIVEIMMEDIATELY)
I NuclearPharmacy, Incorporated (NPI),P.O. Box 25141, Albuquerque,NewMexico 87125 (the " licensee") is the holder of specific byproduct material licenses issued by the Nuclear Regulatory Comission (the "Comission or NRC") pursuant to 10 CFR.Part 30. License No.. 12-18044-01MD states that licensed material shall be used only at 319 W. Ontario St., Chicago, Illinois 60610. License No. 14-19990-01MD states that licensed material shall be used only at 1221 Center Street, Suite 9. Des Moines, Iowa 50309. License No. 20-21227-01MD states that licensad material shall only be used at 10-N Roetsler Road, Woburn, Massachusetts. Licenses No. 37-18461-01MD and No. 37-21322-01 state that licensed material shall be used only at 31-33 North 2nd Street, Philadelphia, Pennsylvania. License No. 37-19586-01MD states thst licensed material shall be used only at 7446 Derry Street Harrisburg, Pennsylvania. License No. 48-17466-01MD states that licensed material shall be used only at 933 N.
Mayfair Road, Wauwatosa, Wisconsin. These licenses, with the exception of License No. 37-21322-01, authorize, among other things, the use of molybdenum-99/
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I O i technetium-99m (Mo-99/Tc-99m) generators for the production of technetium-99m pertechnetate. License No. 37-21322-01 authorizes performance of leak tests /
instrument calibration as a service to other licensees.
License No. 12-18044-01MD was issued on November 19, 1982 and expires on November 30, 1987. License No. 14-19990-01MD was issued on November 1, 1982 and expires on June 30, 1987. License No. 20-21227-01MD was issued on April 26, 1983 and expires on April 30, 1988. License No. 37-18461-01MD was issued on March 20, 1979 and expires on November 30, 1987. License No. 37-19586-01MD was issued on May 27, 1981 and expires on March 31, 1986. License No. 37-21322-01 was issued on July 13, 1983 and expires on December 31, 1986. License No. 48-17466-01MD was issued on November 16, 1982 and expires on November 30, l 1987.
II On May 18, 1984 NPI received at its Chicago facility what was later determined to be a defective molybdenum-99/ technetium-99m generator from Medi-Physics.
Contrary to NRC requirements, the generator was neither logged-in at the facility nor surveyed upon receipt. On May 18, 19, and 20, a Friday, Saturday, and Sunday, the defective generator was eluted and unit doses and multi-dose vials of labeled technetium-99m radiopharmaceuticals were prepared and distributed. No moiybdenum-99 breakthrough tests were performed on the elutions as required by 10 CFR 30.34(g); however, the "elution log" indicated that the tests were perfonned with normal results. On Scturday morning..May 19, 1984, a multi-dose i )
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1 vial of a technetium-99m radiopharmaceutical was surveyed and showed levels ef radiation higher than expected from technetium-99m.
The pharmacist, believing s
the high reading was due to a contaminated shield, placed the vial in a second shield, failed to survey a second time and delivered the radiopharmaceutical to the hospital.
On Monday, May 21, 1984, the faulty generator was again eluted and radio-1 pharmaceuticals were prepared but no molybdenum-99 breakthrough tests were t
performed.
A NPI drive.r/ technician noted extremely high background readings t whea performing the predelivery wipe test of tne package,. When the NPI staff I
at the Chicago facility could not determina "he cause of the high readings, the laboratory manager was contacted. He askt: c Jt the molybdenum-99 breakthrough test results. When informed that the test had not yet been done, he diracted that the test be performed. A breakthrough of about 120-150 microcuries Mo-99 per millicurie Tc-99m was reportedly found. The licensee then secured all I
radiopharmaceuticals prepared that morning, but did not identify and notify hospitals that had previously been supplied products from the defective generator.
On May 21, 1984, the licensee packaged the faulty generator and returned it to Medi-Physics for evaluation.
In a letter to NPI dated June 18, 1984, Medi-Physics confirmed that a molybdenum-99 breakthrough had o: curred.
On May 23, 1984, the laboratory manager took disciplinary action by placing an " Employee Warning Report" in the personnel files of the three pharmacists who had failed to assay each elution from the defective Mo-99/Tc-99m generator.
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4 On July 12, 1984, the NPI Director of Radiation Safety and Compliance sent a memorandum to all NPI pharmacy managers reminding them of the need to assay every generator elution for molybdenum-99 breakthrough and to record the results.
I III On June 26, 1984, NRC learned from U.S. Food and Drug Administration that NPI had receivM a defective molybdenum-99/ technetium-99m generator from Medi-Physics.
On July 6, 1984, the NRC Region III office (Region III) contacted the manager of the NPI Chit.ago facility by telephone and was told that the licensee had received a faulty generator, that molybdenum-99 breakthrough tests performed on May 21, 1984 identified the problem and that no molybdenum-99 contaminated doses of l technetium-99m were distributed to area hospitals. .The laboratory manager stated he would confirm this information in writing. On July 18, 1984, Region III received a letter dated July 12, 1984 from NPI stating, contrary to the previous verbal infonnation, that two hospitals had made reports to them regarding potential Mo-99 contamination above acceptable limits in the prepared technetium-99m products dispensed on Sun:'ay, May 20, 1984. Region III conducted an inspection of the licensee's Chicago facility on July 26, 1984. A review of computer records indicated NPI prepared 26 unit doses and 27 multi-dose vials of radiopharmaceuticals from the faulty generator and distributed them to 24 hospitals between May 18 and 20, 1984.
~ On July 27, 1984, Region III issued a Confirmatory Action Letter confiming that NPI would (a) notify all hospitals that had receive'd NPI radiopharmaceutical l products prepared from the defective generator and (b) submit a report of the 5
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I NPI analysis of the incident to the Region III office. NPI's Corporate Radiation l Safety Officer contacted Region III by telephone on. August 2, 1984, and stated t
that the list of 24 hospitais obtained during the July 26, 1984 inspection was incorrect because an NPI employee had maintained inaccurate logs and computer
- records. On August 3, 1984, HPI's Corporate Radiation Safety Officer contacted Region III by telephone and provided a revised list of hospitals that had received i
potentially contaminated NPI radiopharmaceutical products. NPI confimed the j revised list by letter dated August 3, 1984, but stated that, except for the two l initially identified hospitals, none of the contaminated radiopharmaceuticals had been administered to patients.
During the period August 8 through August 21, 1984 NRC contacted the hospitals receiving potentially contaminated radiopharmaceuticals. NRC determined that five hospitals had administered contaminated technetium-99m products received from the licensee's Chicago, Illinois facility to twelve patients during the period May 19 through May 21, 1984. On August 23, 1984, Region III conducted an inspection at the HPI Wauwatosa, Wisconsin facility, and on August 28, 1984, Region III conducted an inspection at the NPI Des Moines, Iowa facility. These inspections showed that in some cases NPI had no records to show that molybdenum-99 tests had been performed and in other cases records had been produced that did not reflect actual test results. On September 26 and October 1, 1984, Region I conducted an inspection at NPI's Philadelphia and Harrisburg, Pennsylvania facilities, respectively. These inspections resulted in identification of additional violations of NRC requirements. The results of these inspections of N'PI facilities indicate that the licensee has been conducting licensed activities in violation of Connission requirements as described in the attached Statement of Violations.
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IV As a result of the inspections described above, NRC has concluded that NPI failed to perform required tests on radiophamaceuticals to dete* aine the presence of radioactive impurities and falsified records to indicate such tests had been performed. The purpose of these tests is to prevent unnecessary exposure to patients and radiation workers. Clinical use of radiopharmaceuticals contaminated with molybdenum-99 will cause unnecessary radiation exposures to patients because of the contaminant and may cause: (a)additionalunnecessaryradiationexposures to patients because the tests must be repeated. (b) delays in obtaining diagnostic information, and (c) difficulty in interpreting the test results. Hospitals are not required to perform these tests for radioactive impurities because the pharmacies are required to perform them. Accurate records of these tests are essential to permit pharm'cy management to audit compliance with the testing requirements.
Record-keeping problems continued at the Chicago facility even after disciplinary action had been taken by NPI management. These problems also continued at other NRC-licensed NPI pharmacies even after the July 1984 notification from corporate management reminding the pharmacies of the need to do the test. The pervasiveness i of the record-keeping problems raises substantial questions about the actual 4
conduct of the molybdenum-99 breakthrough tests and the commitment of the licensee to provide reliable means for local and corporate management to verify that the tests were, in fact, being done. The importance of doing these tests was
- emphasized in an imediately effective Order issued to all users of technetium-99 generators in 1979. The Order was codified in 10 CFR 30.34(g) of the Comission's regulations. There is a clear safety purpose in doing these tests. The II,A-88 4
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. 7 I actions of NPI indicate that its management has been either incapable or i
unwilling to assure that the required tests are performed and the required records are made. ..
1 until NRC became involved in investigating the May 1984 incident, NPI did not contact all of its clients to determine whether contaminated material had actually f been used on patients. Even after HPI began investigating the matter, NPI did I
not provide the Comission with reliable information.
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I In sumary, NPI's ineffective and belated investigation of the molybdenum-99 breakthrough incident and the pervasiveness of its record-keeping problems demonstrate a lack of control of licensed activities and, at a minimum, careless disfigard for the Comission's safety requirements. I have determined that additional actions are necessary to provide the Commission with reasonable assurance that NPI will comply with Comission requirements. Therefore, I have determinen that the public health and safety require that this Order be l imediately effective.
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Accordingly, pursuant to Sections 81 and 161b of the Atomic Energy Act of 1954, as amended, and the Comission's regulations in 10 CFR Parts 2, 30, and 35, l IT IS HEREBY ORDERED EFFECTIVE IlmEDIATELY THAT:
A. NPI shall obtain the services of one or more independent organizations to perform, as a minimum, the actions indicated below. The independent II.A-89
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l organization (s)shallhavein-depthknowledgeofradiationprotectiontheory and good practice, management of radiation protection programs and radiation protection programatic quality assurance through a combination of academic training and practical experience of its staff assigned to the task. Within 60 days of the date of this Order, NPI shall submit to NRC, Region III, for approval,thename(s)oftheproposedorganization(s)includingthe qualifications of the individuals who will perform the assessment, statements from these individuals regarding the extent to which they have been previously employed by NPI, and a description of the plan to accomplish the actions described below. The organization (s) shall initiate the assessment within 1.5 days of NRC approval and complete it within 60 days -
of NRC approval.
I The indepr.ndent organization (s) shall prepare a report that assesses:
- 1. The qualifications, training and commitment of NPI's employees to perform assigned radiation protection functions.
- 2. Appropriateness of NPI employee radiation protection assignments; i.e., the prope* match of persons and responsibilities.
- 3. Adequacy of the number of NPI staff assigned to perfom licensed activities.
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- 4. Adequacy of NPI operating procedures related to assigned radiation protection functions.
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S. Adequacy of NPI records necessary to demonstrate that the radiation protection program is conducted as assigned.
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Adequacy of NPI's radiation protection quality assurance program by I which management at corporate and regional levels assures itself, l through an independent system of checks and balances, that the j radiation protection program is adequate and being conducted as I assigned.
BasedonitsfindingsinItems1-6above,theindependentorganization(s) shall, in its report, provide its views as to why the violations described in the attached Statement of Violations occurred, identify programmatic weaknesses which might lead to further violations of NRC requirements and provide recomendations for improvements necessary to assure compliance with NRC requirements. The licensee shall direct the independent organization (s) to submit to the Regional Administrator, Region III, a copy of any report and any drafts thereof, at the same time they are sent to the licensee or any of its employees.
B.
Within 30 days after receipt of the independent organization (s) report, NPI i shall submit a written response to its conclusions in a report to the Regional Administrator NRC Region III, and to the Deputy Director, Office of Inspection and Enforcement. NPI's report shall describe how NPI will i
incorporate and implement recomendations of the independent organization (s) together with a schedule for implementation. If any recomendations are not adopted, NPI shall provide in its. report justification for the exclusion.
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- C. NPI at each of its NRC-licensed facilities shall:
- 1. Require that two authorized users be present whenever licensed activities are conducted to verify that all NRC-licensed activities are conducted in accordance with regulatory requirements and the provisions of this Order.
- 2. Require that the two authorized u*ers independently verify (1) the performance of all tests, assays, and surveys of NPI radiopharmaceutical products and product packages as required by the NRC license and (2) that accurate records of the results are prepared. The authorized I
users shall, by signature, note each verification and shall complete the verification prior to any material leaving the facility.
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- 3. Require that the manager perform a weekly audit of all NRC-licensed activities. The audit shall include a record of what was audited and the results of the audit. The anlit shall verify, on a sampling basis, that required surveys, measurements, and tests were performed and that records accurately reflect the results of the surveys, measurements, and tests.
- 4. Notify NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after identification of any unusual occurrences including those identified by any internal or external
! audit involving NRC-licensed, material such as, but not limited vr I
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,, l to, molybdenum-99 breakthrough and any reports from clients that identify problems with radiopharmaceuticals supplied by NPI or with excessive radiation levels or surface contamination on packages supplied by NPI.
The reautrements of Paragraph C shall be implemented no later than 7 days after the date of issuance of this Order.
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, p. At least once every .14 days, an audit of all NRC-licensed activities shall I
be performed at ecch NRC-licensed NPI facility by an individual or organization independent of NPI. The name and qualifications of the proposed auditor shall be submitted to the Regional Administrator, Region III, for approval within 14 days of the date of this Order. The audits shall commence within 14 days of HRC approval and shall consist of unannounced visits, including during early morning hours and weekends, and shall include actual observation of NPI staff members at work. The audit shall verify that all required surveys, measurements, and tests were performed and that records accurately j
reflect the results of the surveys, measurements, and tests. Written results l of the audits shall be submitted to NPI and the Regional Administrator, NRC l Region III within two working days following completion of each audit.
These audits shall continue until the report required by Section V.B of this Order is submitted to NRC by NPI and NRC determines the acceptability l and adequacy of the proposed improvements.
E. The Regional Administrator, Region IJI, may for good cause relax or re'scind all or part of the above conditions upon written request by the licensee.
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The licensee or any other person whose interest is adversely affected by this Order mt.y request a hearing on this Order. Any request for hearing shall be submitted to the Deputy Director, Office of Inspection and Enfo) cement, U.S.
Nuclear Regulatory Comission Washington, D.C. 20555, within 25 days of the date of this Order. A copy of the request also shall be sent to the Executive Legal Director at the same address and to the Regional Administrator, Region III, 799 Roosevelt Road, Glen Ellyn, Illinois 60137. A REQUEST FOR HEARING SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS Or THIS ORDER.
If a hearing is to be held concerning this Order, the Comission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order shall be sustained.
FOR THE NUCLEAR REGULATORY COMMISSION mes M. Taylor, eputy Director ffice of Inspe tion and Enforcement Dated at Bethesda, Maryland this 4 6" day of October 1984 i h!
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Enclosure 3 A. Cases involving unplanned releases.
EA Number Licensee NUREG Vol/No 88-032 Georgia Inst. of Tech V7/N4 Atlanta, GA 88-087 Dap't. of the Air Force V8/N4 Wright Patterson AFB 89-110 Atlas Corp _
V9/N2 Grand Junction, CO 89-233 Cambridge Medical Technology V9/N4 Corp., Billerica, MA 89-257 American Radiolabeled V9/N3 Chemicals, St. Louis, MO 91-060 Chemetron Corp. V11/N2 Newburgh Heights, OH 91-096 V.A. Department V11/N2
! Houston, TX 92-100 Sequoyah Fuels Corp V11/N3 Gore, OK 92-185 University of Michigan VJ2/N1 Ann Arbor, MI 92-260 Pacific Radiopharmacy V12/N1 Oahu, HI l
93-079 Mayo Clinic copy attached Rochester, MN B. Cases with storage in an unrestricted area.
EA Number Licensee. NUREG Vol/No 88-301 Hemphill Corp. V8/N1 Tulsa, OK 89-070 St. Joseph's Hospital V8/N2 Huntingburg, IN 89-051 Hospital Center of Orange V8/N2 Orange, NJ 89-140 St. Joseph's Hospital V8/N3 St. Paul, MN
i 92-171 Aircraft Components, Inc. V12/N2 Branford, CT C. Case of a shipping violation.
EA Number Licensee NUREG Vol/No 88-193 Combustion Engineering, Inc. V7/N4 Windsor, CT 89-257 American Radiolabeled V9/N3 Chemicals, St. Louis, MO l 92-072 Diagnostic Services, Inc. copy attached l Denmark, WI Attachments:
As stated
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, !as.g\ umis) starss NUCLEAR GEOULATCQY COMMIT:13N f .... m S
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esem eLLvn. stumois .et at MAY 121992 ;
Diagnostic Services, Inc. License No. 48-20341-01 ATTN: Dave Olson Docket No. 030-18274 Operations Manager EA 92-072 12321 Cedar Creek Drive i Denmark, WI 54208 l
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Dear Mr. Olson:
SulWECT:
NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 030-18274/92-001(DRSS))
This refers to the routine inspection at Diagnostic Services. Inc., conducted from March 25 through April 9, 1992, of activities authorized by NRC License No. 48-20341-01. The report documenting this inspection was sent to you by letter dated April 22, 1992. As a result of this inspection, significant violations of NRC requirements were identified, and on May 8, 1992, an enforcement conference was held in the Region III office between Ms. Lori Olson and other members of your organization, and Mr. W. L. Axelson, Deputy Director, Division of Radiation Safety and Safeguards and other members of the NRC staff.
A copy of the Enforcement Conference Report documenting that meeting is enclosed with this letter.
I The NRC has determined that a number of violations of NRC requirements. occurred under the Byproduct Material License issued to Diagnostic Services, Inc. (DSI).
The violations, which are described in the enclosed Notice of Violation.
include, but are not Itaited to, the failure to (1) maintain on file and provide on request a complete documentation of tests and an engineering evaluation or comparative data showing that the construct 1un methods, packaging
-design, and materials of construction of its packaging for radioactive material: complied with the appropriate specifications; (2) ensure by examination or appropriate tests that external radiation and contamination levels were within the allowable limits prior to transporting a package of radioactive materials; (3) properly label packages containing radioactive materials; and (4) perform daily surveys in areas where radiopharmaceuticals were routinely prepared for use. These violations, when taken collectively, represent weakness in the oversight of the transportation aspects of DSI's radiation safety program. In accordance with the " General Statement of Policy and Proedure for NRC Enforcement Actions," (Enforcement Policy) 10 CFR Part 2 Appendix C (1992), the violations are classified as Severity Level IV violations.
The root and contributing causes of the violations and DSI's subsequent corrective actions were discussed during the May 8,1992, enforcement conference. The NRC recognizes .that significant. corrective actions have been initiated and appear. acceptable. .: ?.
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Diagnostics Services, Inc. 2 MAY 121992 I We are concerned with DSI's transoortation program, with regard to the packaging, marking, labeling, and testing of radioactive materials packages :
transported by DSL between your Denmark, Wisconsin facility and your client '
hospitals. Therefore, in addition to respending to the specific violations described in the enclosed Notice, you are requested to include any steps you have taken, or plan to take, to improve your oversight of the transportation program, including actions to periodically renitor the effectiveness of the program.
You are required to document your response to this letter and should follow the ,
instre:tions specified in the enclosed Hotice when preparing your response.
After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections 4 determine whether further enforcement action is necessary, to the NRC ensure will compliance with NRC regulatory requirements.
In accordance with 10 CFR 2.790 of the Commission's regulations, a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room.
The responses directed by thi; letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required
, by the Paperwork Reduction Act of 1980, Pub. L. No.96-511.
Sincerely,
&A $ Ne&'=
Charles E. Norelius, Director Division of Radiation Saftty and Safeguards
Enclosures:
- 1. Notice of Violation
- 2. Enforcement Conference Report No. 030-18274/92-002(DRSS) cc w/ enclosures:
DCD/DCB(RIDS)
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y e NOTICE OF VIOLAT!DN Diagnostic Services, Inc.
Denmark, Wisconsin Docket No. 030-18274 License No. 48-20341-01 EA 92-072 Daring an NRC inspection conducted from Narch 25 through April 9, 1992, violations of NRC requirements were identified. In acurdance with the
" General Statement of Policy and Procedure for NRC, Enforcement Actions " 10 CFR Part 2 Appendix C (1992), the particular violations are set forth below:
A.
10 CFR 71.5(a) requires that licensees, who transport licensed material t outside the confines of their plants or deliver licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to. the mode of transport of the Department of Transportation (DOT) in 49 CFR Part 170-189.
l 1. 49 CFR 173.415(a) requires, in part, that each shipper of a Specification 7A package must maintain on file for at least one year after the latest shipment, and shall provide on request, a complete documentation of tests and an engineering evaluation or comparative data showing that the construction methods, packaging design, and materials of construction co.nply with that specification.
Contrary to the above, as of March 25 1992, the licensee did nut maintain on file and provide on reques,t a complete documentation of tests and an engineering evaluation or comparative data showing that the construction methods, psckaging design, and materials of construction of its packaging complied with Specification 7A specifications. Specifically, on March 9, 1992, the licensee transported 1020 mil 11 curies of technetium-99m, a quantity of that material required to be transported in Type A packaging, and on March 25, 1992 the licensee did not maintain on file and provide on request the documentation of tens and an engineering evaluation or comparative data showing that the packaging used complied with Specification 7A specifications.
This is a Severity Level IV violation. (SupplementV)
- 2. 49 CFR 173.475 requires in part, that before each shi'aent of any
' radioactive materials pa,ckage, the shipper ensure by axamination or appropriate tests, that external radiation and cont'.mination levels are within the allowable limits.
Contrary to the above, as of March 25, 1992, the licensee did not ensure by examination or appropriate tests that external radiation
- and conta.aination levels were within allowable limits prior to each e shipment of.a raatsactive< material,s peckage. Specifica11W4r.4
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l Notice of Violation, 2 i
j a. from March 21, 1990 through March 9, 1992, the licensee did not i
j ensure that the external radiation level of any radioactive materials package was within the a110wable limits prior to j shipment.
i b. from March 21, 1990 through March 25, 1992, the licensee did not i
determine the external contamination level e' any radioactive
{ materials package was within the allowt' '- 4mits prior to I
shipment. !
The Itcensee routinely shipped up to 1100 at111 curies of I
technetium-99m, as an inorganic salt in solution.
, This is a severity Level 1Y violation (Supplement V).
1
! 3. 49 CFR 172.401 requires, in part, that no person offer for i-transportation and no carrier tralisport any package bearing a label j unless the label represents a hazard of the hazardous material in the
- package.
49 CFR 172.403 requires, in part, that a package exhibiting surface radiation levels less than or equal to 0.5 milliram per hour be '
- labeled with a RADIDACTIVE WHITE-! label.
Contrary to the above, from March 21, 1990 through March 9, 1992, the l licensee transported packages containing up to 1100 mil 11 curies of i
technetium-99m and exhibiting surface radiation levels less than or equal to 0.5 millires per hour and the licensee affixed a label other than a RADI0 ACTIVE liHITE-! label. Specifically, on March 9, 1992,-the licensee transported a package containing 1020 mil 11 curies of technetium-99m and exhibiting surface .adiation levels of approximately 0.05 at111res per hour and the packagt bore a RADI0 ACTIVE YELLOW-!!! label, a label that represents a hazard greater than the hazardous material in the package transported.
This is a severity Level IV violation (Supplement V).
B. 10 CFR 35.70(a) requires that a licensee survey with.a radiation detection survey instrument at the end of each day of use all arean where radiopharinaceuticals are routinely prepared for use or a< ministered.
Contrary to the above, from approximately September 1991 through March 24,
?992, the licensee did not survey with a radiation detection instrument at the end of the day in its hot lab, loctted at its facilities in Denmark, Wisconsin, where radiopharmaceuticals were r,outinely prepared for use. .
Specifically, the licassea did. net tsurvey wittes radiation detection 1.- . .v 9
- instrument' em thesscdays.when emiyethermolybdesumitechnetium.generatet wask. r .e.
eluted at..that facility.r.a . .
Thi s i s. a .5everity. Leve.l.. Irvio.1stion .(Supplement.VI'). .
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Notice ci Violation 3 Pursuant to the provisions of 10 CFR 2.201, Diagnostic Services, Inc.
(Licensee) is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, Region III, 799 Roosevelt Road, Glen Ellyn, Illinois, 60137, within 30 days of the date of the letter transmittingthisNoticeofViolation(Notice). This reply should be clearly i
marked as a " Reply to a Notice of Violation" and should include for each
- alleged violation (1) the reasons for the violation, or if contested, the i
basis for disputing the violation. (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full com>11ance will be achieve,d. If an adequate reply is not receivec within tie time specified in this Notice, an order or demand for information may be issued as to why the license thould not be modified, ruspended, or revoked or why such other action as may L. proper should not be take,1. Consideration may be given to extending the response time for good cause shown.
5-/,A Dated f4.A.f h t Charles E. Norelius, Directer Division of Radiation Safety and Safeguards G
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U. S. NUCLEAR REGULATORY COMMIS$10N REGION 111 Enforcement Conference Report No. 030-18274/92-002(DRSS)
Docket No. 030-18274 License No. 48-20341-01 Category G Priority !!
Licensee: Diagnostic Services, Inc.
Denmark, Wfsconsin I i
Enforce 5entConferenceAt: NRC Region !!! Office i Glen Ellyn, Illinois Enforcement ce ce Conducted- y 8, 1992 Inspector: Oh hn - -
//
. L. Cameron
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Date Radiation Specialist Approved By:
H. Schultz, Chief N/1[42-DN6 / /
clear Materials Inspection Section 1 Meettne Summary Enforcement Conference on May 8. 1992 (Report No. 030-18274/92-002(ORSS))
Areas Discussed: A review of the findings from the March 25 through April 9,1992 inspection, including a discussion of each apparent violation, the accuracy of the facts, causal factors, the corrective actions taken or planned by the licensee, and the NRC Enfercement Policy.
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DETAILS
- 1. Conference Attendees Otaanostic Services. Inc.
', Lort Olson, Technologist George Cassidy, M.D., Radiation Safety Officer Ronald Edwards, consultant Wuclear Regulatory Comission i
- W. L. Axelson, Deputy Director, Olvision of Radiation Safaty and Safeguards, Region !!!
R. DeFayette, Otractor. Enforcement and Investigatten Coordination Staff, Region III l t
, B. Berson, P.egional Counsel, Region !!!
J. L. Cameron, Radiation Specialist, Region !!!
T. Simmons, Radiation Specialist, Region !!!
E. Kline, Enforcement Specialist, Office of Enforcement, via telephone
- 2. Enforcement Conference Sumary
)
An Enforcement Conference was held in the NRC Region III office on May 8, 1992, between members of the NRC and Diagnostic Services, Inc. staffs.
The conference was conducted to (1) review the apparent violations identified during the March 25 through April 9, 1992 inspection; (2)discussrootandcontributingcauses;(3)discusstheaccuracyofthe inspection findings and the licensee's corrective actions; (4) determine
' whether there were any aggravating or mitigating circumstances; and (5) obtain o*.her information that would help detemine the appropriate enforcement action. NRC inspection findings are documented in inspection Report No. 030-18274/92-001(DRSS), transmitted to the licensee by letter dated April 22, 1992.
' The NRC began the meeting by explaining the purpose of an Enforcement Conference, and that this conference was he'd to discuss the findings of our inspection which identified several apparent violations and a weakness in the licensee's program for the transport of radioactive materials.
The NRC presented the apparent violations. The Itcensee did not contest the apparent violations and agreed with the accuracy of the information presented, except as follows:
- a. Provided evidence, by way of testing documentation, that the packaging used by the licensee to transport radioactive material had been tested and approved as a Specification 7A package when transported with the. cylindrical:sbield.that.theelicassee routinely .- ,. .
used. However,.the licensee agreed that the packaging:did.pottoert c . . -
the full specifications .of . testing:in that.the:.wpperfoamJnsert;- *
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designed to stabilire. the package contenty during . transport,..had not.. . 4 ..
been used_. .
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- b. Stated that although the emergency telephone number required by 49 CFR 172.201(d) was not on the shipping papers used, the number was on other documents attached to the shipping papers and carried during transport. '
- c. Clarified that daily radiation level surveys in the Denmark, Wisconsin facility had not been conducted on days when the licensee eluted the generator and did not conduct other activities associated with the preparation of radiopharmaceuticals. The licensee stated, ,
and inspection findings supported, that on all days when the licensee eluted the generator and compounded radiopharmaceuticals, daily radiation level surveys were conducted.
The licensee described its corrective actions for each of the apparent violations that were discussed during the conference. The licensee also discussed its plans for strengthening and monitoring its transportation program.
The NRC staff acknowledged the licensee's statements and indi:sted that they would be considered in our decision for enforcement action.
- 3. Concludina Statements NRC representatives summarized the NRC Enforcement Policy and process and indicated that the licensee will be notified in writing of the NRC's proposed enforcement actions.
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- 799 hoottVfLT MOAD ELAN ELLYN, KUNo88 00137+0827 June 9, 1993 Docket No. 030-02195 License No. 22-00519-03 EA 93-079 Mayo Foundation ATTN Sharon E. Dunemann Rochester, Minnesota Chief Administrative Officer 55905 Dear Ms. Dunemannt l SUBJECT NOTICE PENALTY OF- VIOLATION
$6,000 AND PROPOSED IMPOSITION OF CIVIL (NRC INSPECTION REPORT No. 030-02195/93001(DRSS))
This refers to the inspection conducted on April 2 through 7, 1993, at Mayo Foundation. The inspection included a review of the circumstances surrounding an incident on March 21-23, 1993, involving phosphorus-32 contamination. You reported the event to NRC Region III on April 1, 1993. The report documenting the inspection was sent to you by letter dated April 23, 1993.
During the inspection violations of NRC requirements were identified. An enforcement conference was held on April 30, 1993, to discuss the violations, their causes, and your corrective actions.
On March 21, 1993, a rasearcher working alone in the Guggenheim Building unknowingly contaminated his hands when he opened a new vial containing 10 mil 11 curies of phosphorus-32, and he s phosphorus-32 within the laboratory and on his clothing. pread The contamination went undetected due to the researcher'c fa;1ure to survey himself and the laboratory prior to leaving the work area.
-The researchet Indicated that the survey meter located in the laboratory had low batteries and that he was in a hurry to leave.
The researcher worked in the laboratory again that night, and again-failed to survey. On March 22, 1993, the researcher continued to work with phosphorus-32, and again, he did not survey himself and the laboratory. In all three cases, he did not take the time to have the meter batteries changed or to use a meter from an adjscent laboratory. The authorized user had CERTIFIED MAIL RETURN RECEIPT REOUESTED g : C !!b b y
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Mayo Foundation June 9,1993 trained the researcher on the survey requirement, and the researcher indicated that he was aware of the requirement.
On March 23, 1993, the researcher used a meter from an adjacent laboratory, performed a survey, and discovered that his hands were contaminated. Contamination was spread within the laboratory, to a church, and to private automobiles, clothing and homes. The contamination also caused unnecessary exposure to the researcher's hands. By-April 11, 1993, all potentially contaminated areas were surveyed, all areas were decontaminated, and all contaminated Radiation articles safety officer (RS0).were collected and secured by the L Two violations are described in section I of the enclosed Hotice of Violation and Proposed Imposition of civil Penalty The first violation involves the failure of the researc(Notice).
her to l
perform March 21contamination and 22, 1993. surveys after using phosphorus-32 on This violation is willful in nature because the researcher had been trained on the survey requirement l and was aware of the requirement, yet chose not to follow it.
The-fact that the researcher was in a hurry and the survey i
instrument had low batteries is no excuse. Clearly, the )
1 researcher-should-not have conducted the work unless he had a functional surveys. survey instrument and the time to conduct proper The researcher could have taken the time to change the :
batteries laboratory. could have used an instrument from an adjacent or l contaminationThis violation is the root cause of the event. The safety _ consequences of-the event were potentially significant in-that the phosphorus-32 contauination was w..despread,-especially in the public domain.
The second violation involves inadequate off-site surveys performed by the health physics technician to detect the extent of the off-site contamination from the event. The Radiation Safety Office was informed-of the event on-March- 23, 1993. On April 2, 1993, the RSO informed the NRC inspectors that the laboratory, homes, and vehicles had been surveyed and were either found.to be clean or were decontaminated. Subsequently, the NRC inspectors identified contaminated church pews, many items of contaminated clothing, a contaminated vehicle, and several spots
-of contamination in the laboratory. The inspectors identified contamination in locations that, according to the RSO, had been surveyed-and be clean. either had been decontaminated or had been found to The violations described above represent a significant failure to control licensed material. In accordance with the " General Statement (Enforcement of Policy Policy)and. Procedure for NRC Enforcement Actions,"
10.CFR Part 2, Appendix c, these: violations-
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j Mayo roundation June 9, 1993 4
normally would be categorized at severity Level III. However, the Enforcement Policy, section IV.C, provides that the severity i level of a violation may be increased if the circesstances j surrounding the matter involve willfulness. Therefore, the two violations are categorized in the aggregate as a severity-Level II problem.
j Your corrective actions included retraining of the r9 searcher and all other personnel who use phosphorus-32 to stress the importance of performing surveys, and identifying and cleaning up !
contaminated areas. However, as discussed at the enforcement conference, your surveys'to assess the extent of contamination, i
' in some cases, were not performed, were delayed, or were j unreliable.
! The NRC considers a willful violation of NRC requirements a very j serious matter. To emphasize the importance the NRC places on !
j the performance of.necessary surveys and the unacceptability of 4
willful violations, I have been authorized to issue the enclosed l Notice of Violation and Propcsed Imposition of Civil Penalty i
(Notice) in the amount of $6,000, assessed on the basis of Violation I.A. The base value of-a civil penalty for a severity Level 11 violation or Eroblem is $4,000.
The civil penalty adjustment factors in the Enforcement Policy 3- were considered. The base civil penalty was mitigated 50 percent
- or identification since you identified that the researcher t~ failed to perform daily surveys. The base civil penalty was not mitigated for corrective actions because we had concerns in this area,.as discussed above. The base civil penalty was escalated 100 percent for multiple occurrences in that the researcher failed to perform surveys on two consecutive days. Although-your past performance has been good, no mitigation is warranted for this factor given the willful nature of the violation. The other i adjustment-factore in the Policy were considered and ru) further adjustment to the base _ civil penalty is considered appropriate.
L Therefore, based on the above, the base civil penalty has been increased by 50 percent.
section II of the Notice contains violations which were not assessed'a civil penalty. These involve failure to perform
' -weekly surveys-for removable contamination; failure of an
- individual to use a finger dosimeter when working with millicurie quantities of phosphorus-32; failure to conduct urinalysis of a radiation worker who used 10 millicuries of a beta emitting radioisotope; failure of an individual to wear a laboratory coat when working with' phosphorus-32; and failure of-an individual to
, receive radiation safety orientation training.
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s Mayo Foundation Jrne 9, 1993 i Although you identified Violations II.B, II.C, and II.E, your corrective action to prevent recurrence of those violations was
. not fully formulated at the time of the enforcement conference.
Therefore, we did not exercise discretion to treat these violations Enforcement asPolicy.
non-cited violations the Gpecifically, under rootsection cause VII.5(2) of the three of the violations was your failure to track the researcher as a radiation worker, and your plans to ensure that all radiation 1 workers were formally tracked and audited were incomplete at the time of the enforcement conference.
You are required to respond to this letter and should follow the 1 l
instructions specified in the enclosed Notice when preparing your response.
In your response, you should document the specific actions recurrence. In taken and any additional actions yo': plan to prevent addition, in light of the willful action of the researcher involved in Violation I.A of the Notice, your response should address your basis for having confidence that thio individual will, in the future, follow Commission requirements, please ensure that your response also addresses the following concerns that were documented in the inspection report and were further discussed at the enforcement confere. ices 1 your response to and evaluation of the contamination ev(en)t was not aggressive, prompt, and thorough; (2) the authorized user failed to properly train and supervise his radiation workers; and (3) the scope and depth of quarterly laboratory audits conducted by the radiation safety staff technician appear to be inadequate.
After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's " Rules of practice,"
a copy of this letter, its enclosure, and your responses will be placed in the NRC public Document Room.
The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the office of
l Mayo roundation June - 190$
Management and Budget as required by the Paperwork Reduction Act of 1980, Public Law No.96-511.
sincerely, 1
John B. Martin
- Regionel Administrator i
Enclosure:
- Notice of Violation and Proposed Imposition of civil Penalty cc/enclosuret Richard Vetter, Ph.D., Radiation Safety Officer, Mayo Foundation t
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Mayo Foundation June 9, 1993 DISTRIBUTION SECY CA MThompson, DEDS JMartin, RIII JLieberman, OE LChandler, OGC JG ' '.dberg, OGC
-RBernero, NMSS RCunningham, NMSS Enforcament Coordinators RI, RII, RIV, RV FIngram, GPA/PA DWilliams, OIG BHayes, OI EJordan, AEOD JDelMedico, OE Day File EA File DCS State of Minnesota RAO:RIII SLO:RIII PAO:RIII IMS:RIII PDR
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- NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY Mayo Foundation Rochester, Minnesota Docket No. 030-02195 License No. 22-00519-03 EA 93-079 During an NRC inspection conducted on April 2-7, 1993, violations of NRC requirements were identified. In accordance with the
" General-Statement of-Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C, the Nuclear Regulatory Commission proposes to impose a civil penalty pursuant to Section 234 of the 10 2282,_and Atomic Energy Act of 1954, as amended (Act), 42 U.S.C.
CFR 2.205.
civil penalty are set forth below:The particular violations and associated I. Violations Assessed a Civil Penalty A.
License 43 datedCondition June 4, 1992, No. 30 as contained in Amendment No.
states, in part, that the
! licensee shall conduct its program in accordance with the statements, representations cnd procedures contained letter dated in July an application 11, 1991. dated March 31, 1991, and a I
I The letter dated July 11, 1991, states, in part, in Item 6.b, " Phosphorus-32 Sofety Instructions," that a daily meter survey is required if the laboratory possesses greater than 10 times the Annual Limit of Intake (ALI) (ten times 900 microcuries).or uses more than 10 microcuries of phosphorus-32 on that day.
Contrary to the above, on March 21 and 22, 1993, a daily meter survey was not performed and the laboratory (Guggenheim Building Room 319) possessed 10 millicuries of phosphorus-32, a quantity greater than 10 ALI and used more than 10 microcuries on those days.
B.
License 43 datedCondition June 4, 1992, No. 30 as contained in Amendment No.
states, in part, that the licensee shall conduct its program in accordance with the statements, representations and procedures containsd in an application dated March 31, 1991, and a letter dated July 11, 1991.
The application dated March 31, 1991, states, in part, in Attachment 10.12, " Procedure for-Area Surveys," that if major contamination.(equal to or greater than 220 dpm/100 cm*) is found of a beta emitter in an unrestricted area, decontamination by laboratory __
personnel-and resurvey by Radiation Safety Office personnel within two working days are required.
1 4
Notice of Violation June 9, 1993 10 CFR 20.201(b) requires that each licensee make such surveys as may be hecessary to comply with the requirements of Part 20 and which are reasonable under the circumstances hazards that may beto evaluate the extent of radiation present. As defined in 10 CFR 20.201(a), " survey" means an evaluation of the radiation hazards incident to the production, use, release, disposal or presence of radioactive materials or other sources o,f radiation under a specific set of )
conditions.
Contrary to the abovat
- 1. From March 23, 1993, through April 3, 1993, the licensee did not perform adequate surveys to determine the presence of phosphorus-32 contamination in unrestricted areas including individuala' clothing, vehicles, homes, and a church, to assure that contamination limits in these unrestricted areas were not exceeded.
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- 2. On March 25, 1993, major contamination fapproximately 3,300 dpm) of phosphorus-32 (a beta emitter) was found by a laboratory person in his home (an unrestricted area) and a resurvey was not performed by Radiation Safety Office personnel until April 2, 1993, a period exceeding two days.
These violations represent a Severity Level II problem (Supplements IV and VI).
Civil Penalty - $6,000 (assessed for Violation I.A).
II. Violations Not Assessed a Civil Penelty A.
License 43 datedCondition June 4, No. 30 as contained in Amendment No.
1992, states, in part, that the licensee shall conduct its program in accordance with the statements, representations and procedures contained in an application dated March 31, 1991, and a letter dated July 11, 1991.
The letter dated July 11, 1991, states in Item o.b,
" Phosphorus-32 Safety Instructions," that a weekly survey for removable contamination is required if the laboratory possess greater than 10 ALI (10 times 900 microcuries) phosphorus-32 and uses more than 10 microcuries of phosphorus-32 at any one time.
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Contrary to the above, weekly surveys for removable contamination were not performed in Guggenheim Building Room 319 during the weeks of January 18 through 22, 1993; January 25 through 29, 1993; and February 22
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Notice of violation June 9, 1993 through 26, 1993, and the laboratory possessed greater than 10 ALI phosphorus-32 and used more that 10 micro-curies of phosphorus-32 at any one time during those weeks.
This is a Severity Level IV violation (Supplement 7I).
B.
License 43 datedCondition June 4, 1992, No. 30 as contained in Anandment No.
states, in part, that the license 6 shall conduct its program in accordance with the statements, representations and procedures contained in an application dated March 31, 1991, and a letter dated July 11, 1991.
The letter dated July 11, 1991, states in Item 6.c,
" Phosphorus-32 Safety Instruutions," that finger dosimeters are required to be used by personnel working vith millicurie quantitles of phosphorus-32 unless previous measurements have shown exposure to be minimal.
Contrary to the above, an individual who routinely used millicurie quantitles of phosphorus-32 from approximately September 1992 through March 23, 1993, failed to use a finger dosimeter when working with millicurie quantities of phosphorus-32 and the licensee did not have previrus measurements that showed his exposure to be minimal.
This is a Severity Level IV violation (supplement VI).
C.
License 43 dated June 4, Condition No. 30 as contained in Amendment No.
1992, states, in part, that the licensee shall conduct its program in accordance with the statements, representations and procedures contained in an application dated March 31, 1991, and a letter dated July 11, 1991.
The application dated March 31, 1991, states in Attachment 10.16, Item III. A, that radiation workers who use a total of 10 millicuries of any beta emitting radioisotopes are required to have quarterly urinalysis.
Contrary to the above, a re11ation worker who used at least 10 millicuries of phosphorus-32 during the fourth calendar quarter of 1992, did not have a quarterly urinalysis for that quarter.
This is a Severity Level IV violation (Supplement VI).
D. License Condition No. 30 as contained in Amendment h .
43 dated June 4, 1992, states, in part, that the
) i i .
!' Notice of Violation June 9, 1993 ;
' licensee shall conduct its program in accordance with the statements, representations and procedures !
contained in an application dated March 31, 1991, and a letter dated July 11, 1991.
The application dated March 31, 1991, states, in part, in Attachment 10.4, page 1, that laboratory rules be
- followed at nil times when working with radioactive materials including wearing laboratory coats.
contrary to the above, on March 21, 1993, an individual
- who worked with radioactive phosphorus-32 did not wear j a laboratory coat when working with the material.
s This is a severity Level IV violation (supplement VI).
E. License Condition No. 30 as contair.ed in Amendment No.
43 dated June 4, 1992, states, in part, that the 4
licenses shall conduct its program in accordance with the stLeements, representations and procedures contained in an application dated March 31, 1991, and a l 1etter dated .Tuly 11, 1991.
The application dated March 31, 1991, states, in part, in Item 8, " Training for Individuals Working in or Frequenting Restricted Areas," that individuals using byproduct material will receive radiation safety orientation training upon employment.
4 Contrary to the above, as of April 3, 1993, an individual who used byproduct material routinely since approximately September 1992 did not receive radiation safety orientation training upon his employment in September 1992.
This is a Severity Level IV violation (supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Mayo Foundation (Licensee) is hereby required-to submit a written statement of explanation to the Director, office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days-c' the date of this Notice of Violation and Proposed Imposition 4 Civil Penalty (Notice).
This reply should be clearly marked us a " Reply to a Notice of Vi olat ion" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation it. admitted, and if denied, the reasons why, (3) the' corrective steps-that have been taken and the re,ults achieved, (4) the corrective steps that will be taken to avoid further_ violations, and (5)_the date when full compliance is achieved.- If an adequate reply is not received within the time specified in this Notice, an order or a demand for information may be-issued as to why the license should not be modified, suspended, or revoked or why such other actions as may be proper
O o- 4 I
, Notice of Violation June 9, 1993 should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required under 10 CFR 2.201, the Licenses may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, office of Enforcement, U. S.
Nuclear Regulatory Commission. Shoub' the Licenses fail to answer within the time penalty will be issued.
specified, an order imposing the civil Should the Licensee elect to file an answer in accordance with 10 CFR 2.20r $rotesting the civil penalty, in whole or in part, such a, r should be clearly marked as an " Answer to a Notice of Va sation" and may (1) deny the violation listed in this Notice in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, imposed.
or (4) show other reasons why the penalty should not be In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section V.B of 10 CFR Part 2, Appendix C, should be addressen. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure fe; imposing a civil penalty.
Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The responses noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Director, Office of
, e g Notice of Violation June 9, 1993 Enforcement, U.S. Nuclear Regulatory Commission, ATTN Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III, 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
FOR THE NUCLEAR REGULATORY COMMISSION 1
Joh B. Martin i Regional Administrator Dated at Glen Ellyn, Illinois this g day of June 1993 e
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i 5 UNITED STATES S NUCLEAR REGULATORY COMMISSION g *...* waswiwotow, o.c. sones eooi AUG g 41993 Docket No. 030-02195 License No. 22-00519-03 EA 93-079 Mayo Foundation ATTN Sharon E. Dunemann )
Chief Administrative officer Rochester, Minnesota l
l 55905
Dear Ms,
Dunemann
SUBJECT:
ORDER IMPOSING CIVIL MONETARY PENALTY - $6,000 This refers to your letters dated June 30 and July 1, 1993, in response to the Notice of Violation a.id Proposed Imposition of Civil 1993.
Penalty (Notice) sent to you by our letter dated June 9, Our letter and Notice describe seven violations identified during an NRC in:tpaction conducted on April 2 through 7, 1993.
To emphasize the importance the NRC places on the performance of necessary surveys and the unacceptability of willful violations, n civil penalty of $6,000 was proposed.
In your responses, you object to the characterization of violation penalty.
I.A as willful, and request mitigation of the civil After consideration of your responses, we have concluded, for the reasons given in the Appendix attached to the enclosed order Imposing civil Monetary Penalty, that Violation I.A was willful, and an adequate basis has not been provided for mitigation of the civil penalty. Accordinoly we hereby serve the enclosed order on Mayo Foundation impos;,ng,a civil monetary penalty in the enount of $6,000. We will review the effectiveness of your corrective actions during a subsequent inspection.
In accordance P.'.th 10 CFR 2.790 of the NRC's " Rules of Practice,"
a copy of thim .M O,ar and the enclosure will be placed in the NRC's Nblic Do nwant Room, sincerely, ames Lieberman, Director ,
ffice of Enfore-ment Enclosures As stated cc w/ enclosures Richard Vetter, Ph.D, Radiation safety officer, Mayo Foundation A30[INO'l0& lP'
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UNITED STATES
' NUCLEAR REGULATORY COMMISSION In the M&tter of )
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MAYO FOUNDATION ) Docket No. 0:1-02195 Rochester, Minnesota ) License No. 2. 00519-03
) EA 93-079 ORDER IMPOSING CIVIL h0NETARY PENALTY I
Mayo Foundation (Licensee) is the holder of Byproduct Material License No. 22-00519-03 issued by the Nuclear Regulatory Commission (NRC or Commission) on June 4, 1992. The license authorizes the Licensee to possess and use byproduct materials for medical diagnosis, therapy, and research on humans; and research and development, including animal studies and student instruction, in accordance with the conditions specified therein.
II An inspection of the Licensee's activities was conducted on April 2 through 7, 1993. The results of this inspection indicated that the Licensee had not conducted its activities in full compliance with NRC requirements. A written Notice of violation and Proposed Imposition of Civil Penalty (Notice) was served upon the Licensee by letter dated June 9, 1993. The Notice states the nature of the violations, the provisions of the NRC's requirements that the Licensee had violated, and the amount of the civil penalty proposed for the--violations. The Licensee responded to the Notice by letters dated June 30 and July 1, Q%h!?!C!??-8PP' .
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1993. In its responses, the Licensee objsets te the characterisation of Violation I.A as wil.tul and requests mitigation of the civil penalty.
i III After consideration of the Licensee's responses and the statenmit.s of fact, explanation, and argument for mitigation contained therein, the NRC staff has determined, as set forth in the Appendix to this order, that the violation occurred as stated and that the penalty proposed for the violation designated in the Notice should be imposed.
- IV In view of the foregoing and pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, IT IS HEREBY ORDERED THAT:
The Licensee pay a civil penalty in the amount of $6,000 within 30 days of the date of this order, by check, draft, money order, or electrcnic transfer, payable to the Treasurer of the United Ststes and mailed to the Director, Office of Enforcement, U.S. Nuclear Regulatory commission, ATrN: Document control Desk, Washington, D.C. 20555.
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l The Licensee may request a hearing within 30 days of the date of this order. A request for a hearing should be clearly marked as a " Request for an Enforcement Hearing" and shall be addressed to l
the Director, office of Enforcement, U.S. Nuclear Regulatory Commission, ATTN Document Control Desk, Washington, D.C. 20555.
l copies also shall be sent to the Assistant General counsel for Hearings and Enforcement at the same address and to the Regional Administrator, NRC Region III, 799 Roosevelt Road, Glen Ellyn, Illinois 60137.
If a honring is requested, the commission will issue an order designating the time and place of the hearing. If the Licensee fails to request a hearing within 30 days of the date of this order, the provisions of this order shall be effective without further proceedings. If payment has not been made by that time, the matter may be referred to the Attorney General for collection.
In the event t.he Licenses requests a hearing as provided above, the issues to be considered at such hearing shall be
l Whether on the basis of Violations I.A and I.B admitted by the Licensee, this order should be sustained.
FOR THE NUCLEAR REGULATORY COMMISSION M
mes Lieberman, Director ffica of Enforcement Dated Rockville, Maryland this day of August 1993
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e APPENDIX EVALUATIONS AND CONCLUSIONS On June 9, 1993, a Notice of Violation and Proposed Imposition of Civil Penalty (Notice) was issued for violations identified during an NRC inspection on April 2 through 7, 1993. Mayo l Foundation (Licensee) responded to the Notice on June 30 and July 1, 1993. In its responses, the Licenses admits all of the violations, objects to the characterization of Violation I.A as willful, and requests mitigation of the civil penalty. The NRC's evaluation and conclusions regarding the licensee's requests are as follows:
i Rastatament of Violation I A. License Condition No. 30 as contained in Amendment No. 43 dated June 4, 1992, states, in part, that the licensee shall conduct its program in accordance with the statements, representations and procedures contained in an application dated March 31, 1991, and a letter dated July 11, 1991.
The letter dated July 11, 1991, states, in part, in Item 6.b, " Phosphorus-32 Safety Instructions," that a daily meter i survey is required if the laboratory possesses greater tham l 10 times the Annual Limit of Intake (ALI) (ten times 900 '
microcuries) or uses more than 10 microcuries of phosphorus-32 on that day.
Contrary to the above, on March 21 and 22, 1993, a daily meter survey was not performed and the laboratory (Guggenheim Building Room 319) possessed 10 mil 11 curies of phosphorus-32, a quantity greater than 10 ALI and used more than 10 microcuries on those days.
B. License Condition No. 30 as contained in Amendment No. 43 dated June 4, 1992, states, in part, that the licensee shall conduct its program in accordance with the statements,-
representations and procedures contained in an application dated March 31, 1991, and a letter dated July 11, 1991.
The application dated March 31, 1991, states, in part, in Attachment 10.12, " Procedure for Area Surveys," that if major contamination (equal to or greater than 220 dpa/100cm8) is found of a beta emitter in an unrestricted area, decontamination by laboratory personnel and resurvey by Radiation Safety Officer personnel within two working days are required.
10 CFR 20.201(b) requires that each licensee make such surveys as may be necessary to comply with the requirements of Part 20 and which are reasonable under the circumstances to evaluate the extent of radiation hazards that may be present. As defined in 10 CFR 20.201(a), " survey" means an evaluation of the radiation hazards incident to the
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production, use, release, disposal, or presence of radioactive specific setmaterials or other sources of radiation under a of conditions.
con *rary to the above:
- 1. From March 23, 1993, through April 3, 1993, the licensee did not perform adequate surveys to determine the t
presence of phosphorus-32 contamination in unrestricted areas including individuals' clothing, vehicles, homes, and a church, to assure that contamination limits in these unrestricted areas were not exceeded.
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On March 25, 1993, major contamination (approximately 3,300 dpa) of phosphorus-32 (a beta emitter) was found by a laboratory person in his home (an uhrestricted area) and a resurvey was not performed by Radiation safety office personnel until April 2, 1993, a period exceeding two days.
gn===rv of Licanmaa's sammensa to Violation I '
The Licensee admits Violation I.
Bu===rv af Licanama's manuant for Mitiention The Licensee objects to the characterisation that Violation I.A was willful in nature. The Licensee asserts that the term willful carries deliberate, was planned, the strong and connotation that the action (omission) intentional. The Licensee asserts that while the omission of a daily survey by this trainee was careless and negligent, it cannot be character'ged as an omission that resulted from careful and thorough consideration, i.e., a deliberate decision, nor was the omission meant to deceive anyone.
- The Licensee argues that the failure of the research trkinee to conduct daily surveys should be characterized as an omission that resulted from a lad of thought and a lack of awareness of conser2enoes, and that this omission does not differ in principle fron-many other violations that have resulted in enforcement actions where the violations were not considered wilitul in nature even though the licensee knew about the specific regulatory requirements associated with the violation.
In the Licensee's view, characterisation of one type of violation as willful without informing licensees that such violations will be considered willful constitutes inconsistent, arbitrary, and capricious enforcement of regulatory requirements, which is unfair and-injurious to the licensee.
The Licensee further asserts that characterization of a violation as willful on the basis that a trainee knew about a requirement
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but failed to follow f.t, is a change in priority of importance that should be communicated to the replated cor.74nity prior to its implementation.
The Licensee believes that r<illfulness" is understood by the regulated community to be a deliberate action taken on the part of a licensee to avoid the implementation of a 4
regulatory requirement or the failure to incorporate such a i
requirement into the licensee's safety program. The Licensee also asserts that characterisation of the failure of an j
individual employee of a licensee to perform a specific safety I requirement that has been incorperated into the licensee's safety
- program as willful is precedent setting and has not been i
' communicated to licensees. Finally, the Licensee argues that the discussion of willful violations in 10 CFR Part 2 distinguishes between a person who is a licensee official, such as the Radiation safety Officer anC a non-supervisory empl9yee.
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According to the Licensee,, the individual in question was a trainee who stood to gain no economic or other significant 1
advantage as a result of this violation.
4 NRC Evaluation of Licenmaa's Ramuant for Mitiaation i
- The NRC's policy on willfulness has been formally communicated to this Licensee and the licensed community in general by the i
General statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy) 10 CFR Part 2, Appendix C.
1 section IV.C of the policy states:
! (T)the severity level of a violation may be increased if i the circumstances surrounding the matter involve i
careless disregard of requirements, deception, or other indications of willfulness. The term 'stilfulness' as
! usied in this policy embraces a spectrum of violations j
ranging from deliberate intent to violate or falsify to and including careless disregard for requirements." In determining the specific severity level of a violation
! involving willfulness, consideration will be given to i
' auch factors as the position and responsibilities of the person involved in the violation (e.g., licensee i official or non-supervisory employee), the significance i of any underlyig violation, the intent of the violator (i.e., careless disregard or deliberateness), and the economic or other advantage, if any, gained as a result
, of the violation. The relative weight given to each of
' these factors in arriving at the appropriate severity level will be dependent on the circumstances of the
} violation.
l' Violations I.A and I.B vere catgottsed in the aggregate as a severity Level II problem and a $6,000 civil penalty was assessed for Violation I.A. Violations I.A and I.B would normally have been categorised at severity Level III; however, the severity 1evel was increased to severity Level II because of the willful nature of Violation I.A.
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for Violation I.A. Violations I.A and I.B would normally have been categorised at severity Level III; however, the severity i
' Iwvel was increased to severity Level I because of the willful 1 nature of Violation I.A.
Violation I.A was willful, as that term is used in the Enforcement policy, because the researcher had been trained on the survey requirement and was aware of the requirement, yet i chose not to follow it. Further, the researcher was performing l post doctorate research and had previously used phosphorous-32 at another institution which indicates significant education and i
knowledge as to why such requirements exist and should be followed. on March 21, 1993, the researcher unknowingly contaminated his hands when he opened a new vial containing 10 i mil 11 curies of phosphorus-32, and he spread phosphorus-32 within the laboratory and on his clothing.- The contamination went i undetected due to the researcher's failure to survey himself and l the laboratory prior to leaving the work area. The researcher indicated that the survey meter located in the laboratory had low i
j batteries and that he was in a hurry to leave. The researcher j
worked survey.
in the laboratory again that night, and again failed to On March 22, 1993, the researcher continued to work with 1
phosphorus-32, and again, he did net survey himself and the l
j laboratory. In all three cases, he did not take the time to have l the meter batteries changed or to use a functioning meter from an j adjacent laboratory. The authorized user had trained the researcher on the survey requirement, and the researcher j andicated that he was aware of the requirement.
1 i While the NRC staff agrees that the researcher's actions were not
! done for daception or monetary gain, those actions went well beyond mere forgetfulness or accidental omission; they demonstrated an unwillingness to comply with a known requirement.
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' Moreover, if the researcher's actions had been based on deception j
or monetary gain, then direct enforcement action against the researcher under 10 CFR 30.10 would have been considered. The severity level of the problem was appropriately categorised at Severity Level II based on the willful nature of Violation I.A.
i In determining the severity level, the NRC staff wei j significanos of the underlying violation (including,ghed the in this case, the consequences), the advantage to the researcher (saving j
time), and the fact that the researcher was a non-supervisory
) employne. Moreover, if the surveys had been performed by the researcher, the offsite release would not have occurred.
i i Based on the above, the Licensee's argument that Violation I.A.-
was not willful does not provide an adequate basis for mitigation
! of the. civil penalty. Additionally, the Licensee has provided no other-basis for mitigation of the civil penalty.
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