Information Notice 1995-51, Recent Incidents Involving Potential Loss of Control of Licensed Material: Difference between revisions

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| issue date = 10/27/1995
| issue date = 10/27/1995
| title = Recent Incidents Involving Potential Loss of Control of Licensed Material
| title = Recent Incidents Involving Potential Loss of Control of Licensed Material
| author name = Cool D A
| author name = Cool D
| author affiliation = NRC/NMSS/IMNS
| author affiliation = NRC/NMSS/IMNS
| addressee name =  
| addressee name =  
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| page count = 9
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{{#Wiki_filter:UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555-0001October 27, 1995NRC INFORMATION NOTICE 95-51: RECENT INCIDENTS INVOLVING POTENTIAL LOSS OFCONTROL OF LICENSED MATERIAL
{{#Wiki_filter:UNITED STATES
 
NUCLEAR REGULATORY COMMISSION
 
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
 
WASHINGTON, D.C. 20555-0001 October 27, 1995 NRC INFORMATION NOTICE 95-51:   RECENT INCIDENTS INVOLVING POTENTIAL LOSS OF
 
CONTROL OF LICENSED MATERIAL


==Addressees==
==Addressees==
Line 20: Line 28:


==Purpose==
==Purpose==
The U.S. Nuclear Regulatory Commission is issuing this information notice toalert addressees to two recent incidents involving potential loss of controlof licensed material, resulting in internal contamination of individuals. Itis expected that recipients will review the information for applicability totheir facilities and consider actions, as appropriate, to avoid similarproblems. However, suggestions contained in this information notice are notnew NRC requirements; therefore, no specific action nor written response isrequired.
The U.S. Nuclear Regulatory Commission is issuing this information notice to
 
alert addressees to two recent incidents involving potential loss of control
 
of licensed material, resulting in internal contamination of individuals. It
 
is expected that recipients will review the information for applicability to
 
their facilities and consider actions, as appropriate, to avoid similar
 
problems. However, suggestions contained in this information notice are not
 
new NRC requirements; therefore, no specific action nor written response is
 
required.


==Description of Circumstances==
==Description of Circumstances==
Recently, NRC was informed of and responded to two incidents involvingphosphorus-32 (P-32) internal contamination of individuals at biomedicalresearch facilities. P-32 is widely used in research institutions, as aremany other radionuclides. Although these incidents both involved P-32, theinherent security issues extend to all facilities using licensed material.Case 1: On June 30, 1995, a licensee informed NRC that an incident involvinginternal contamination of a female researcher had been reported tothe licensee's radiation safety office the previous evening. Theresearcher was in her fourth month of pregnancy at the time of theincident. Contamination was detected when the researcher's husband,who worked with her at the licensee's facility, performed a routinesurvey of their lab. The licensee identified the radionuclide asP-32. Accidental contamination appeared unlikely because the womanhad stopped working with radioactive material in their lab about amonth before, and because the radioisotope (P-32) identified inbioassay samples is not of the same type her lab used. Licenseesecurity officials and the Federal Bureau of Investigation areinvestigating the possibility that the woman ingested food orliquids deliberately contaminated with the radioisotope. Initialcalculations (now being refined by NRC, the licensee, and theresearcher's own technical experts) estimated that the researcheringested tens of megabecquerels (hundreds of microcuries) of P-32.TVR on q5.osinI q gj0'11 IN 95-51October 27, 1995 Subsequent licensee surveys identified a few droplets of P-32 on thefloor in front of a refrigerator in a lounge adjacent to labs thecouple use and an internally contaminated water cooler in the samebuilding. Urine bioassays of other workers identified approximately25 additional individuals who have low-level internal P-32contamination. In early July 1995, NRC sent an Augmented InspectionTeam to investigate the circumstances surrounding the contaminationincident. While the inspection and investigations are ongoing, NRChas obtained licensee agreement to improve the control ofradioactive materials used in its biological and medical researchprograms.Case 2: On October 16, 1995, a licensee informed NRC that an incidentinvolving internal contamination of a researcher had occurred at itsfacility almost 2 months earlier. Licensee officials told NRC staffthat they had not reported the incident earlier because theiranalyses suggest that the researcher's internal dose was below the10 CFR Part 20 reporting criteria.According to the licensee, the researcher discovered that he wascontaminated during a routine survey of his work area. Alsoaccording to the licensee, it subsequently detected P-32contamination on an item of clothing that the researcher had wornearlier that week, when he had last handled P-32 in the laboratory.The licensee performed urine bioassays, and informed the researcherthat he may have ingested what was described as a drop of P-32containing 21.4 megabecquerel (579 microcuries). The researcher hastold licensee campus police that he believes the contamination wasnot accidental. NRC and campus police are investigating hisallegation. Also, the researcher has requested that an independentconsultant prepare a second dose estimate.The licensee initially secured all radioactive materials in the labafter discovery of the contamination event. Since then, thelicensee has permitted work with radioactive material to resume,after requiring more stringent inventory and accountability in thelab and tightening security. On October 17, 1995, NRC dispatched anIncident Investigation Team to the licensee's site to begin animmediate investigation of the incident. NRC also sent a letter tothe licensee requiring that certain steps be taken, ensuring amongother things that control of radioisotopes is adequate to providereasonable assurance against another such incident. NRC'sinvestigation is ongoing.
Recently, NRC was informed of and responded to two incidents involving
 
phosphorus-32 (P-32) internal contamination of individuals at biomedical
 
research facilities. P-32 is widely used in research institutions, as are
 
many other radionuclides. Although these incidents both involved P-32, the
 
inherent security issues extend to all facilities using licensed material.
 
Case 1:   On June 30, 1995, a licensee informed NRC that an incident involving
 
internal contamination of a female researcher had been reported to
 
the licensee's radiation safety office the previous evening. The
 
researcher was in her fourth month of pregnancy at the time of the
 
incident. Contamination was detected when the researcher's husband, who worked with her at the licensee's facility, performed a routine
 
survey of their lab. The licensee identified the radionuclide as
 
P-32. Accidental contamination appeared unlikely because the woman
 
had stopped working with radioactive material in their lab about a
 
month before, and because the radioisotope (P-32) identified in
 
bioassay samples is not of the same type her lab used. Licensee
 
security officials and the Federal Bureau of Investigation are
 
investigating the possibility that the woman ingested food or
 
liquids deliberately contaminated with the radioisotope. Initial
 
calculations (now being refined by NRC, the licensee, and the
 
researcher's own technical experts) estimated that the researcher
 
ingested tens of megabecquerels (hundreds of microcuries) of P-32.
 
TVR       on                                 q5.osinI   qgj0
                                                                          '11
 
IN 95-51 October 27, 1995 Subsequent licensee surveys identified a few droplets of P-32 on the
 
floor in front of a refrigerator in a lounge adjacent to labs the
 
couple use and an internally contaminated water cooler in the same
 
building. Urine bioassays of other workers identified approximately
 
25 additional individuals who have low-level internal P-32 contamination. In early July 1995, NRC sent an Augmented Inspection
 
Team to investigate the circumstances surrounding the contamination
 
incident. While the inspection and investigations are ongoing, NRC
 
has obtained licensee agreement to improve the control of
 
radioactive materials used in its biological and medical research
 
programs.
 
Case 2: On October 16, 1995, a licensee informed NRC that an incident
 
involving internal contamination of a researcher had occurred at its
 
facility almost 2 months earlier. Licensee officials told NRC staff
 
that they had not reported the incident earlier because their
 
analyses suggest that the researcher's internal dose was below the
 
10 CFR Part 20 reporting criteria.
 
According to the licensee, the researcher discovered that he was
 
contaminated during a routine survey of his work area. Also
 
according to the licensee, it subsequently detected P-32 contamination on an item of clothing that the researcher had worn
 
earlier that week, when he had last handled P-32 in the laboratory.
 
The licensee performed urine bioassays, and informed the researcher
 
that he may have ingested what was described as a drop of P-32 containing 21.4 megabecquerel (579 microcuries). The researcher has
 
told licensee campus police that he believes the contamination was
 
not accidental. NRC and campus police are investigating his
 
allegation. Also, the researcher has requested that an independent
 
consultant prepare a second dose estimate.
 
The licensee initially secured all radioactive materials in the lab
 
after discovery of the contamination event. Since then, the
 
licensee has permitted work with radioactive material to resume, after requiring more stringent inventory and accountability in the
 
lab and tightening security. On October 17, 1995, NRC dispatched an
 
Incident Investigation Team to the licensee's site to begin an
 
immediate investigation of the incident. NRC also sent a letter to
 
the licensee requiring that certain steps be taken, ensuring among
 
other things that control of radioisotopes is adequate to provide
 
reasonable assurance against another such incident. NRC's
 
investigation is ongoing.
 
IN 95-51 October 27, 1995 Discussion
 
The two recent P-32 internal contamination incidents raise a number of safety
 
and regulatory issues. NRC is reviewing its regulations to determine if they
 
need to be revised in light of these events. Among these issues are
 
radioactive material security and accountability, survey procedures, preparation for bioassays, and reporting requirements. Each of these issues
 
is addressed separately below.
 
a. Security. In controlled or unrestricted areas, licensees are
 
required by 10 CFR 20.1801 and 20.1802 to secure stored material, and to control and maintain, under constant surveillance, licensed
 
material that is not in storage. Access to restricted areas is
 
required to be controlled to prevent unauthorized access to licensed
 
material. Licensees should review their programs to ensure that
 
they have a radiation safety program in place that will prevent
 
deliberate misuse of radioactive materials in all licensee areas.
 
b. Accountability. 10 CFR Part 20 requires the reporting of theft or
 
loss of materials above defined levels. In addition, the Draft
 
Regulatory Guide DG-0005, "Applications for Licenses of Broad
 
Scope," published for comment in October 1994, states that license
 
applicants:
              ... should develop and maintain a strong inventory and
 
accountability system. The institution should have the
 
capability to continually track incoming shipments of
 
licensed material and account for material usage, decay, transfer, and disposal. A licensee's inventory and control
 
system should have the capability to ensure that licensed
 
possession limits are not exceeded and that material is
 
accounted for throughout the institution at any given time.
 
In light of these events, licensees should review their programs to
 
determine whether they need to improve their radioactive material
 
accountability systems, commensurate with the scope of their
 
programs.
 
c. Detecting licensed material. NRC emphasizes that conducting surveys
 
with adequate, calibrated equipment is a crucial step in conducting
 
safe operations. Many commercially available survey instruments, such as Geiger-Mueller detectors, are capable of detecting P-32, even after ingestion, in the activity range used in research
 
facilities. In both of these cases, internal contamination was
 
originally detected when the researchers conducted routine surveys
 
of their laboratories and detected high background readings.
 
Licensees should review their programs to ensure that they are
 
conducting surveys with adequate, calibrated equipment.
 
IN 95-51 October 27, 1995 d. Bioassay preparation. All licensees are responsible for responding
 
to incidents. Some licensees already have bioassay programs in
 
place to comply with the requirement in 10 CFR 20.1502 to monitor
 
workers whose intake is likely to exceed 10 percent of the


IN 95-51October 27, 1995 DiscussionThe two recent P-32 internal contamination incidents raise a number of safetyand regulatory issues. NRC is reviewing its regulations to determine if theyneed to be revised in light of these events. Among these issues areradioactive material security and accountability, survey procedures,preparation for bioassays, and reporting requirements. Each of these issuesis addressed separately below.a. Security. In controlled or unrestricted areas, licensees arerequired by 10 CFR 20.1801 and 20.1802 to secure stored material,and to control and maintain, under constant surveillance, licensedmaterial that is not in storage. Access to restricted areas isrequired to be controlled to prevent unauthorized access to licensedmaterial. Licensees should review their programs to ensure thatthey have a radiation safety program in place that will preventdeliberate misuse of radioactive materials in all licensee areas.b. Accountability. 10 CFR Part 20 requires the reporting of theft orloss of materials above defined levels. In addition, the DraftRegulatory Guide DG-0005, "Applications for Licenses of BroadScope," published for comment in October 1994, states that licenseapplicants:... should develop and maintain a strong inventory andaccountability system. The institution should have thecapability to continually track incoming shipments oflicensed material and account for material usage, decay,transfer, and disposal. A licensee's inventory and controlsystem should have the capability to ensure that licensedpossession limits are not exceeded and that material isaccounted for throughout the institution at any given time.In light of these events, licensees should review their programs todetermine whether they need to improve their radioactive materialaccountability systems, commensurate with the scope of theirprograms.c. Detecting licensed material. NRC emphasizes that conducting surveyswith adequate, calibrated equipment is a crucial step in conductingsafe operations. Many commercially available survey instruments,such as Geiger-Mueller detectors, are capable of detecting P-32,even after ingestion, in the activity range used in researchfacilities. In both of these cases, internal contamination wasoriginally detected when the researchers conducted routine surveysof their laboratories and detected high background readings.Licensees should review their programs to ensure that they areconducting surveys with adequate, calibrated equipment.
occupational dose limits. Interpretation of bioassay data, when


IN 95-51October 27, 1995 d. Bioassay preparation. All licensees are responsible for respondingto incidents. Some licensees already have bioassay programs inplace to comply with the requirement in 10 CFR 20.1502 to monitorworkers whose intake is likely to exceed 10 percent of theoccupational dose limits. Interpretation of bioassay data, whenregulatory thresholds are approached, may be difficult. Importantinformation on the proper conduct of a bioassay program is providedin Regulatory Guide 8.9, Rev. 1, July 1993, "Acceptable Concepts,Models, Equations, and Assumptions for a Btoassay Program" andNUREG/CR-4884, 'Interpretation of Bioassay Measurements." Licenseesthat need immediate medical consultation to respond to an ongoinginternal contamination event can contact the Radiation EmergencyAssistance Center/Training Site (REAC/TS), which is funded by theU.S. Department of Energy to provide consultation in suchsituations. The NRC Operations Center can connect callers withREAC/TS.If internal contamination is detected, health physics consultantsare commercially available to assist with bioassay and otherresponse measures. However, licensees that plan to use consultantsmay want to identify and make arrangements for those resources now,rather than wait until an incident occurs. Licensees that need helpin identifying health physics services should contact professionalsocieties or organizations for references.e. Food and beverage storage. Generally, licensees have proceduresprohibiting eating, drinking, and smoking in radiologicallyrestricted areas. In light of these events, licensees should reviewtheir programs to determine how food, particularly lunches, snackfoods, and beverages in unsealed containers, are permitted or storedin their facilities.f. Contact NRC if deliberate misuse of licensed material is suspected.NRC considers deliberate misuse of licensed material to be ofsignificant regulatory interest, and expects to be contacted in suchsituations. Although the magnitude of the dose could be withinNRC's regulatory limits, the possibility that such a dose wasdelivered intentionally, and possibly with malice, raises concernsabout a licensee's, a contractor's, or any employee's deliberatemisconduct, as addressed in 10 CFR 30.10, 40.10, 70.10, and 72.12.In addition, pursuant to 10 CFR 30.9(b), 40.9(b), 70.9(b), and72.11(b), each licensee is required to I... notify the Commission ofinformation identified ... as having for the regulated activity asignificant implication for public health and safety ...."Notification shall be provided in such cases to the RegionalAdministrator within 2 working days.
regulatory thresholds are approached, may be difficult. Important


IN 95-51October 27, 995The issues raised in these two cases should leadreexamining their own methods to prevent and, ifinternal contamination incidents.licensees to considernecessary, respond toThe Information in this noticeinspections in these two casesas necessary, once results areis preliminary, and the investigations andare ongoing. NRC may issue further guidance,known and conclusions drawn on these two cases.This information notice requires no specific action or written response. Ifyou have any questions about the information in this notice, please contactthe technical contacts listed below or the appropriate regional office."fA' 4~dlDonald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Materialand SafeguardsSafetyTechnical contacts:Scott Moore, NMSS(301) 415-7875B. J.(708)Holt, RIII829-9836Mohamed Shanbaky, RI(610) 337-5209John Potter, RII(404) 331-5571Thomas Kozak, RIII(708) 829-9866Linda Howell, RIV(817) 860-8213Attachments:1. List of Emergency Contacts2. List of Recently Issued NMSS Information Notices3. List of Recently Issued NRC Information Notices~ 6 t i :'-TX a
information on the proper conduct of a bioassay program is provided


Atta Pnt 1IN 9'-s-1October 27, 1995 LIST OF EMERGENCY
in Regulatory Guide 8.9, Rev. 1, July 1993, "Acceptable Concepts, Models, Equations, and Assumptions for a Btoassay Program" and
 
NUREG/CR-4884, 'Interpretation of Bioassay Measurements." Licensees
 
that need immediate medical consultation to respond to an ongoing
 
internal contamination event can contact the Radiation Emergency
 
Assistance Center/Training Site (REAC/TS), which is funded by the
 
U.S. Department of Energy to provide consultation in such
 
situations. The NRC Operations Center can connect callers with
 
REAC/TS.
 
If internal contamination is detected, health physics consultants
 
are commercially available to assist with bioassay and other
 
response measures. However, licensees that plan to use consultants
 
may want to identify and make arrangements for those resources now, rather than wait until an incident occurs. Licensees that need help
 
in identifying health physics services should contact professional
 
societies or organizations for references.
 
e. Food and beverage storage. Generally, licensees have procedures
 
prohibiting eating, drinking, and smoking in radiologically
 
restricted areas. In light of these events, licensees should review
 
their programs to determine how food, particularly lunches, snack
 
foods, and beverages in unsealed containers, are permitted or stored
 
in their facilities.
 
f. Contact NRC if deliberate misuse of licensed material is suspected.
 
NRC considers deliberate misuse of licensed material to be of
 
significant regulatory interest, and expects to be contacted in such
 
situations. Although the magnitude of the dose could be within
 
NRC's regulatory limits, the possibility that such a dose was
 
delivered intentionally, and possibly with malice, raises concerns
 
about a licensee's, a contractor's, or any employee's deliberate
 
misconduct, as addressed in 10 CFR 30.10, 40.10, 70.10, and 72.12.
 
In addition, pursuant to 10 CFR 30.9(b), 40.9(b), 70.9(b), and
 
72.11(b), each licensee is required to I... notify the Commission of
 
information identified ... as having for the regulated activity a
 
significant implication for public health and safety .... "
  Notification shall be provided in such cases to the Regional
 
Administrator within 2 working days.
 
IN 95-51 October 27, 1995 consider
 
The issues raised in these two cases should lead licensees torespond  to
 
reexamining their own methods to prevent and, if necessary, internal contamination incidents.
 
and
 
The Information in this notice is preliminary, and the investigations guidance, further
 
inspections in these two cases are ongoing. NRC may issue on these two cases.
 
as necessary, once results are known and conclusions drawn
 
response. If
 
This information notice requires no specific action or writtenplease contact
 
you have any questions about the information in this notice,      office.
 
the technical contacts listed below or the appropriate regional
 
"fA'              4~dl
 
Donald A. Cool, Director
 
Division of Industrial and
 
Medical Nuclear Safety
 
Office of Nuclear Material Safety
 
and Safeguards
 
Technical contacts:  Scott Moore, NMSS          B. J. Holt, RIII
 
(301) 415-7875              (708) 829-9836 Mohamed Shanbaky, RI      Thomas Kozak, RIII
 
(610) 337-5209              (708) 829-9866 John Potter, RII            Linda Howell, RIV
 
(404) 331-5571              (817) 860-8213 Attachments:
1. List of Emergency Contacts
 
2. List of Recently Issued NMSS Information Notices
 
3. List of Recently Issued NRC Information Notices
 
~  6 t i :'-TX a
 
Atta     Pnt 1 IN 9'-s-1 October 27, 1995 LIST OF EMERGENCY


==CONTACT==
==CONTACT==
SI. NRC Operations CenterTelephone: 301-816-5100II. Radiation Emergency Assi!Daytime Telephone: 423-!24-hour Telephone: 423-4(to consult with a physli(will accept collect calls)stance Center/Training Site (REAC/TS)576-3131481-1000 (ask for REAC/TS):ian)  
S
Attachment 2IN 95-51October 27, 1995 LIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to95-5095-4495-3995-2995-2895-2594-64,Supp. 195-07Safety Defect in Gammamed12i Bronchial CatheterClamping AdaptersEnsuring Compatible Use ofDrive Cables IncorporatingIndustrial Nuclear CompanyBall-type Male ConnectorsBrachytherapy IncidentsInvcyving TreatmentPlanning ErrorsOversight of Design andand Fabrication Activitiesfor Metal Components Usedin Spent Fuel Dry StorageSystemsEmplacement of SupportPads for Spent Fuel DryStorage Installations atReactor SitesValve Failure duringPatient Treatment withGamma StereotacticRadiosurgery UnitReactivity Insertion Trans-ient and Accident Limitsfor High Burnup FuelRadiopharmaceutical VialBreakage during Preparation10/30/9509/26/9509/19/9506/07/9506/05/9505/11/9504/06/9501/27/95All High Dose RateAfterloader (HDR) Licensees.All Radiography Licensees.All U.S. Nuclear RegulatoryCommission MedicalLicensees.All holders of OLs or CPsfor nuclear power reactors.Independent spent fuelstorage installationdesigners and fabricators.All holders of OLs or CPsfor nuclear power reactorsAll U.S. Nuclear RegulatoryCommission MedicalLicensees.All holders of OLs or CPsfor Nuclear Power Reactorsand all fuel fabricationlicensees.All U.S. Nuclear RegulatoryCommission medical licenseesauthorized to use byproductmaterial for diagnosticprocedures.
 
===I. NRC Operations Center===
    Telephone: 301-816-5100    (will accept collect calls)
II. Radiation Emergency Assi!stance Center/Training Site (REAC/TS)
    Daytime Telephone: 423-!576-3131
    24-hour Telephone: 423-4481-1000 (ask for REAC/TS)
    (to consult with a physli :ian)
 
Attachment 2 IN 95-51 October 27, 1995 LIST OF RECENTLY ISSUED
 
NMSS INFORMATION NOTICES
 
===Information                                Date of===
Notice No.           Subject               Issuance   Issued to
 
95-50      Safety Defect in Gammamed      10/30/95  All High Dose Rate


Attachment 3IN 95-51October 27, 1995 LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to95-5095-4995-4895-4795-46Safety Defect in Gammamed121 Bronchial CatheterClamping AdaptersSeismic Adequacy ofThermo-Lag PanelsResults of Shift StaffingStudyUnexpected Opening of aSafety/Relief Valve andComplications InvolvingSuppression Pool CoolingStrainer BlockageUnplanned, UndetectedRelease of Radioactivityfrom the Exhaust VentilationSystem of a Boiling WaterReactorPotentially NonconformingFasteners Supplied byA&G Engineering II, Inc.American Power ServiceFalsification of AmericanSociety for NondestructiveTesting (ASNT) CertificatesEnsuring Compatible Use ofDrive Cables IncorporatingIndustrial Nuclear CompanyBall-Type Male ConnectorsFailure of the Bolt-LockingDevice on the ReactorCoolant Pump Turning Vane10/30/9510/27/9510/10/9510/04/9510/06/9510/05/9510/04/9509/26/9509/28/95All High Dose RateAfterloader (HDR) Adapters.All holders of OLs or CPsfor nuclear power reactors.All holders of OL,. or CPsfor nuclear power reactors.All holders of OLs or CPsfor nuclear power reactors.All holders of OLs or CPsfor nuclear power reactors.All holders of OLs or CPsfor nuclear power reactors.All holders of OLs or CPsfor nuclear power reactors.All Radiography Licensees.All holders of OLs or CPsfor nuclear power reactorsdesigned by WestinghouseElectric Corporation (W).95-12,Supp. 195-4595-4495-43OL -Operating LicenseCP -Construction Permit
12i Bronchial Catheter                    Afterloader (HDR) Licensees.


0 1, .-:-V/IDOCUMENT NAME: G:INCIDENT.SWMTo receive a copy of this document, indicate in the box: *C. Copy without attachment/enct. E = Copy with attachmentlenclNz N Lo copy -0 i 1KANE j Moore "JQones l 6 Pn rn / Caputo STreby XDATE /0OFC TechEd l ASVAli*l> INNX l. lKANE F _ __EK___ __GusDATE Io/aV/4( 1 _lOFFICIAL RECORD COPY
Clamping Adapters


}}
95-44      Ensuring Compatible Use of    09/26/95    All Radiography Licensees.
 
Drive Cables Incorporating
 
Industrial Nuclear Company
 
Ball-type Male Connectors
 
95-39      Brachytherapy Incidents        09/19/95    All U.S. Nuclear Regulatory
 
Invcyving Treatment                        Commission Medical
 
Planning Errors                            Licensees.
 
95-29      Oversight of Design and        06/07/95    All holders of OLs or CPs
 
and Fabrication Activities                for nuclear power reactors.
 
for Metal Components Used
 
in Spent Fuel Dry Storage                  Independent spent fuel
 
Systems                                    storage installation
 
designers and fabricators.
 
95-28      Emplacement of Support        06/05/95    All holders of OLs or CPs
 
Pads for Spent Fuel Dry                    for nuclear power reactors
 
Storage Installations at
 
Reactor Sites
 
95-25      Valve Failure during          05/11/95    All U.S. Nuclear Regulatory
 
Patient Treatment with                    Commission Medical
 
Gamma Stereotactic                        Licensees.
 
Radiosurgery Unit
 
94-64,      Reactivity Insertion Trans-    04/06/95  All holders of OLs or CPs
 
Supp. 1    ient and Accident Limits                  for Nuclear Power Reactors
 
for High Burnup Fuel                      and all fuel fabrication
 
licensees.
 
95-07      Radiopharmaceutical Vial        01/27/95  All U.S. Nuclear Regulatory
 
Breakage during Preparation                Commission medical licensees
 
authorized to use byproduct
 
material for diagnostic
 
procedures.
 
Attachment 3 IN 95-51 October 27, 1995 LIST OF RECENTLY ISSUED
 
NRC INFORMATION NOTICES
 
Information                                    Date of
 
Notice No.            Subject                Issuance  Issued to
 
95-50          Safety Defect in Gammamed      10/30/95  All High Dose Rate
 
121 Bronchial Catheter                    Afterloader (HDR) Adapters.
 
Clamping Adapters
 
95-49          Seismic Adequacy of            10/27/95  All holders of OLs or CPs
 
Thermo-Lag Panels                        for nuclear power reactors.
 
95-48          Results of Shift Staffing      10/10/95  All holders of OL,. or CPs
 
Study                                    for nuclear power reactors.
 
Unexpected Opening of a        10/04/95  All holders of OLs or CPs
 
95-47 Safety/Relief Valve and                  for nuclear power reactors.
 
Complications Involving
 
Suppression Pool Cooling
 
Strainer Blockage
 
95-46          Unplanned, Undetected          10/06/95  All holders of OLs or CPs
 
Release of Radioactivity                  for nuclear power reactors.
 
from the Exhaust Ventilation
 
System of a Boiling Water
 
Reactor
 
Potentially Nonconforming      10/05/95  All holders of OLs or CPs
 
95-12,                                                    for nuclear power reactors.
 
===Supp. 1        Fasteners Supplied by===
                A&G Engineering II, Inc.
 
95-45          American Power Service          10/04/95  All holders of OLs or CPs
 
Falsification of American                  for nuclear power reactors.
 
Society for Nondestructive
 
Testing (ASNT) Certificates
 
Ensuring Compatible Use of    09/26/95    All Radiography Licensees.
 
95-44 Drive Cables Incorporating
 
Industrial Nuclear Company
 
Ball-Type Male Connectors
 
Failure of the Bolt-Locking    09/28/95  All holders of OLs or CPs
 
95-43                                                      for nuclear power reactors
 
Device on the Reactor
 
Coolant Pump Turning Vane                  designed by Westinghouse
 
Electric Corporation (W).
 
OL  - Operating License
 
CP - Construction Permit
 
0 1, .  -:-
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Latest revision as of 04:36, 24 November 2019

Recent Incidents Involving Potential Loss of Control of Licensed Material
ML031060161
Person / Time
Site: Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant  Entergy icon.png
Issue date: 10/27/1995
From: Cool D
NRC/NMSS/IMNS
To:
References
IN-95-051, NUDOCS 9510260330
Download: ML031060161 (9)
v • d • e


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 October 27, 1995 NRC INFORMATION NOTICE 95-51: RECENT INCIDENTS INVOLVING POTENTIAL LOSS OF

CONTROL OF LICENSED MATERIAL

Addressees

All material and fuel cycle licensees.

Purpose

The U.S. Nuclear Regulatory Commission is issuing this information notice to

alert addressees to two recent incidents involving potential loss of control

of licensed material, resulting in internal contamination of individuals. It

is expected that recipients will review the information for applicability to

their facilities and consider actions, as appropriate, to avoid similar

problems. However, suggestions contained in this information notice are not

new NRC requirements; therefore, no specific action nor written response is

required.

Description of Circumstances

Recently, NRC was informed of and responded to two incidents involving

phosphorus-32 (P-32) internal contamination of individuals at biomedical

research facilities. P-32 is widely used in research institutions, as are

many other radionuclides. Although these incidents both involved P-32, the

inherent security issues extend to all facilities using licensed material.

Case 1: On June 30, 1995, a licensee informed NRC that an incident involving

internal contamination of a female researcher had been reported to

the licensee's radiation safety office the previous evening. The

researcher was in her fourth month of pregnancy at the time of the

incident. Contamination was detected when the researcher's husband, who worked with her at the licensee's facility, performed a routine

survey of their lab. The licensee identified the radionuclide as

P-32. Accidental contamination appeared unlikely because the woman

had stopped working with radioactive material in their lab about a

month before, and because the radioisotope (P-32) identified in

bioassay samples is not of the same type her lab used. Licensee

security officials and the Federal Bureau of Investigation are

investigating the possibility that the woman ingested food or

liquids deliberately contaminated with the radioisotope. Initial

calculations (now being refined by NRC, the licensee, and the

researcher's own technical experts) estimated that the researcher

ingested tens of megabecquerels (hundreds of microcuries) of P-32.

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'11

IN 95-51 October 27, 1995 Subsequent licensee surveys identified a few droplets of P-32 on the

floor in front of a refrigerator in a lounge adjacent to labs the

couple use and an internally contaminated water cooler in the same

building. Urine bioassays of other workers identified approximately

25 additional individuals who have low-level internal P-32 contamination. In early July 1995, NRC sent an Augmented Inspection

Team to investigate the circumstances surrounding the contamination

incident. While the inspection and investigations are ongoing, NRC

has obtained licensee agreement to improve the control of

radioactive materials used in its biological and medical research

programs.

Case 2: On October 16, 1995, a licensee informed NRC that an incident

involving internal contamination of a researcher had occurred at its

facility almost 2 months earlier. Licensee officials told NRC staff

that they had not reported the incident earlier because their

analyses suggest that the researcher's internal dose was below the

10 CFR Part 20 reporting criteria.

According to the licensee, the researcher discovered that he was

contaminated during a routine survey of his work area. Also

according to the licensee, it subsequently detected P-32 contamination on an item of clothing that the researcher had worn

earlier that week, when he had last handled P-32 in the laboratory.

The licensee performed urine bioassays, and informed the researcher

that he may have ingested what was described as a drop of P-32 containing 21.4 megabecquerel (579 microcuries). The researcher has

told licensee campus police that he believes the contamination was

not accidental. NRC and campus police are investigating his

allegation. Also, the researcher has requested that an independent

consultant prepare a second dose estimate.

The licensee initially secured all radioactive materials in the lab

after discovery of the contamination event. Since then, the

licensee has permitted work with radioactive material to resume, after requiring more stringent inventory and accountability in the

lab and tightening security. On October 17, 1995, NRC dispatched an

Incident Investigation Team to the licensee's site to begin an

immediate investigation of the incident. NRC also sent a letter to

the licensee requiring that certain steps be taken, ensuring among

other things that control of radioisotopes is adequate to provide

reasonable assurance against another such incident. NRC's

investigation is ongoing.

IN 95-51 October 27, 1995 Discussion

The two recent P-32 internal contamination incidents raise a number of safety

and regulatory issues. NRC is reviewing its regulations to determine if they

need to be revised in light of these events. Among these issues are

radioactive material security and accountability, survey procedures, preparation for bioassays, and reporting requirements. Each of these issues

is addressed separately below.

a. Security. In controlled or unrestricted areas, licensees are

required by 10 CFR 20.1801 and 20.1802 to secure stored material, and to control and maintain, under constant surveillance, licensed

material that is not in storage. Access to restricted areas is

required to be controlled to prevent unauthorized access to licensed

material. Licensees should review their programs to ensure that

they have a radiation safety program in place that will prevent

deliberate misuse of radioactive materials in all licensee areas.

b. Accountability. 10 CFR Part 20 requires the reporting of theft or

loss of materials above defined levels. In addition, the Draft

Regulatory Guide DG-0005, "Applications for Licenses of Broad

Scope," published for comment in October 1994, states that license

applicants:

... should develop and maintain a strong inventory and

accountability system. The institution should have the

capability to continually track incoming shipments of

licensed material and account for material usage, decay, transfer, and disposal. A licensee's inventory and control

system should have the capability to ensure that licensed

possession limits are not exceeded and that material is

accounted for throughout the institution at any given time.

In light of these events, licensees should review their programs to

determine whether they need to improve their radioactive material

accountability systems, commensurate with the scope of their

programs.

c. Detecting licensed material. NRC emphasizes that conducting surveys

with adequate, calibrated equipment is a crucial step in conducting

safe operations. Many commercially available survey instruments, such as Geiger-Mueller detectors, are capable of detecting P-32, even after ingestion, in the activity range used in research

facilities. In both of these cases, internal contamination was

originally detected when the researchers conducted routine surveys

of their laboratories and detected high background readings.

Licensees should review their programs to ensure that they are

conducting surveys with adequate, calibrated equipment.

IN 95-51 October 27, 1995 d. Bioassay preparation. All licensees are responsible for responding

to incidents. Some licensees already have bioassay programs in

place to comply with the requirement in 10 CFR 20.1502 to monitor

workers whose intake is likely to exceed 10 percent of the

occupational dose limits. Interpretation of bioassay data, when

regulatory thresholds are approached, may be difficult. Important

information on the proper conduct of a bioassay program is provided

in Regulatory Guide 8.9, Rev. 1, July 1993, "Acceptable Concepts, Models, Equations, and Assumptions for a Btoassay Program" and

NUREG/CR-4884, 'Interpretation of Bioassay Measurements." Licensees

that need immediate medical consultation to respond to an ongoing

internal contamination event can contact the Radiation Emergency

Assistance Center/Training Site (REAC/TS), which is funded by the

U.S. Department of Energy to provide consultation in such

situations. The NRC Operations Center can connect callers with

REAC/TS.

If internal contamination is detected, health physics consultants

are commercially available to assist with bioassay and other

response measures. However, licensees that plan to use consultants

may want to identify and make arrangements for those resources now, rather than wait until an incident occurs. Licensees that need help

in identifying health physics services should contact professional

societies or organizations for references.

e. Food and beverage storage. Generally, licensees have procedures

prohibiting eating, drinking, and smoking in radiologically

restricted areas. In light of these events, licensees should review

their programs to determine how food, particularly lunches, snack

foods, and beverages in unsealed containers, are permitted or stored

in their facilities.

f. Contact NRC if deliberate misuse of licensed material is suspected.

NRC considers deliberate misuse of licensed material to be of

significant regulatory interest, and expects to be contacted in such

situations. Although the magnitude of the dose could be within

NRC's regulatory limits, the possibility that such a dose was

delivered intentionally, and possibly with malice, raises concerns

about a licensee's, a contractor's, or any employee's deliberate

misconduct, as addressed in 10 CFR 30.10, 40.10, 70.10, and 72.12.

In addition, pursuant to 10 CFR 30.9(b), 40.9(b), 70.9(b), and

72.11(b), each licensee is required to I... notify the Commission of

information identified ... as having for the regulated activity a

significant implication for public health and safety .... "

Notification shall be provided in such cases to the Regional

Administrator within 2 working days.

IN 95-51 October 27, 1995 consider

The issues raised in these two cases should lead licensees torespond to

reexamining their own methods to prevent and, if necessary, internal contamination incidents.

and

The Information in this notice is preliminary, and the investigations guidance, further

inspections in these two cases are ongoing. NRC may issue on these two cases.

as necessary, once results are known and conclusions drawn

response. If

This information notice requires no specific action or writtenplease contact

you have any questions about the information in this notice, office.

the technical contacts listed below or the appropriate regional

"fA' 4~dl

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contacts: Scott Moore, NMSS B. J. Holt, RIII

(301) 415-7875 (708) 829-9836 Mohamed Shanbaky, RI Thomas Kozak, RIII

(610) 337-5209 (708) 829-9866 John Potter, RII Linda Howell, RIV

(404) 331-5571 (817) 860-8213 Attachments:

1. List of Emergency Contacts

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

~ 6 t i :'-TX a

Atta Pnt 1 IN 9'-s-1 October 27, 1995 LIST OF EMERGENCY

CONTACT

S

I. NRC Operations Center

Telephone: 301-816-5100 (will accept collect calls)

II. Radiation Emergency Assi!stance Center/Training Site (REAC/TS)

Daytime Telephone: 423-!576-3131

24-hour Telephone: 423-4481-1000 (ask for REAC/TS)

(to consult with a physli :ian)

Attachment 2 IN 95-51 October 27, 1995 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

95-50 Safety Defect in Gammamed 10/30/95 All High Dose Rate

12i Bronchial Catheter Afterloader (HDR) Licensees.

Clamping Adapters

95-44 Ensuring Compatible Use of 09/26/95 All Radiography Licensees.

Drive Cables Incorporating

Industrial Nuclear Company

Ball-type Male Connectors

95-39 Brachytherapy Incidents 09/19/95 All U.S. Nuclear Regulatory

Invcyving Treatment Commission Medical

Planning Errors Licensees.

95-29 Oversight of Design and 06/07/95 All holders of OLs or CPs

and Fabrication Activities for nuclear power reactors.

for Metal Components Used

in Spent Fuel Dry Storage Independent spent fuel

Systems storage installation

designers and fabricators.

95-28 Emplacement of Support 06/05/95 All holders of OLs or CPs

Pads for Spent Fuel Dry for nuclear power reactors

Storage Installations at

Reactor Sites

95-25 Valve Failure during 05/11/95 All U.S. Nuclear Regulatory

Patient Treatment with Commission Medical

Gamma Stereotactic Licensees.

Radiosurgery Unit

94-64, Reactivity Insertion Trans- 04/06/95 All holders of OLs or CPs

Supp. 1 ient and Accident Limits for Nuclear Power Reactors

for High Burnup Fuel and all fuel fabrication

licensees.

95-07 Radiopharmaceutical Vial 01/27/95 All U.S. Nuclear Regulatory

Breakage during Preparation Commission medical licensees

authorized to use byproduct

material for diagnostic

procedures.

Attachment 3 IN 95-51 October 27, 1995 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

95-50 Safety Defect in Gammamed 10/30/95 All High Dose Rate

121 Bronchial Catheter Afterloader (HDR) Adapters.

Clamping Adapters

95-49 Seismic Adequacy of 10/27/95 All holders of OLs or CPs

Thermo-Lag Panels for nuclear power reactors.

95-48 Results of Shift Staffing 10/10/95 All holders of OL,. or CPs

Study for nuclear power reactors.

Unexpected Opening of a 10/04/95 All holders of OLs or CPs

95-47 Safety/Relief Valve and for nuclear power reactors.

Complications Involving

Suppression Pool Cooling

Strainer Blockage

95-46 Unplanned, Undetected 10/06/95 All holders of OLs or CPs

Release of Radioactivity for nuclear power reactors.

from the Exhaust Ventilation

System of a Boiling Water

Reactor

Potentially Nonconforming 10/05/95 All holders of OLs or CPs

95-12, for nuclear power reactors.

Supp. 1 Fasteners Supplied by

A&G Engineering II, Inc.

95-45 American Power Service 10/04/95 All holders of OLs or CPs

Falsification of American for nuclear power reactors.

Society for Nondestructive

Testing (ASNT) Certificates

Ensuring Compatible Use of 09/26/95 All Radiography Licensees.

95-44 Drive Cables Incorporating

Industrial Nuclear Company

Ball-Type Male Connectors

Failure of the Bolt-Locking 09/28/95 All holders of OLs or CPs

95-43 for nuclear power reactors

Device on the Reactor

Coolant Pump Turning Vane designed by Westinghouse

Electric Corporation (W).

OL - Operating License

CP - Construction Permit

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