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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 33:


==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
 
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 q gj0'11 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


==Description of Circumstances==
the institution
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.


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.
at any given time.In light of these events, licensees


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.
should review their programs to determine


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
whether they need to improve their radioactive


Atta Pnt 1IN 9'-s-1October 27, 1995 LIST OF EMERGENCY
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 The issues raised in these two cases should lead reexamining
 
their own methods to prevent and, if internal contamination
 
incidents.
 
licensees
 
to consider necessary, respond to The Information
 
in this notice inspections
 
in these two cases as necessary, once results are is preliminary, and the investigations
 
and are ongoing. NRC may issue further guidance, known and conclusions
 
drawn on these two cases.This information
 
notice requires no specific action or written response.
 
If you have any questions
 
about the information
 
in this notice, please contact the technical
 
contacts listed below or the appropriate
 
regional office."fA' 4~dl Donald A. Cool, Director Division of Industrial
 
and Medical Nuclear Safety Office of Nuclear Material and Safeguards
 
Safety Technical
 
contacts: Scott Moore, NMSS (301) 415-7875 B. J.(708)Holt, RIII 829-9836 Mohamed Shanbaky, RI (610) 337-5209 John Potter, RII (404) 331-5571 Thomas Kozak, RIII (708) 829-9866 Linda Howell, RIV (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 I. NRC Operations
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.
 
Center Telephone:  
301-816-5100
II. 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)576-3131 481-1000 (ask for REAC/TS):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 95-44 95-39 95-29 95-28 95-25 94-64, Supp. 1 95-07 Safety Defect in Gammamed 12i Bronchial
 
Catheter Clamping Adapters Ensuring Compatible
 
===Use of Drive Cables Incorporating===
Industrial
 
Nuclear Company Ball-type
 
===Male Connectors===
Brachytherapy
 
Incidents Invcyving
 
Treatment Planning Errors Oversight
 
of Design and and Fabrication
 
Activities
 
for Metal Components
 
Used in Spent Fuel Dry Storage Systems Emplacement
 
of Support Pads for Spent Fuel Dry Storage Installations
 
at Reactor Sites Valve Failure during Patient Treatment
 
with Gamma Stereotactic
 
Radiosurgery
 
Unit Reactivity
 
Insertion
 
Trans-ient and Accident Limits for High Burnup Fuel Radiopharmaceutical
 
===Vial Breakage during Preparation===
10/30/95 09/26/95 09/19/95 06/07/95 06/05/95 05/11/95 04/06/95 01/27/95 All High Dose Rate Afterloader (HDR) Licensees.
 
All Radiography
 
Licensees.
 
===All U.S. Nuclear Regulatory===
Commission
 
Medical Licensees.
 
All holders of OLs or CPs for nuclear power reactors.Independent
 
spent fuel storage installation
 
designers
 
and fabricators.
 
All holders of OLs or CPs for nuclear power reactors All U.S. Nuclear Regulatory
 
Commission
 
Medical Licensees.
 
All holders of OLs or CPs for Nuclear Power Reactors and all fuel fabrication
 
licensees.
 
===All U.S. Nuclear Regulatory===
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 95-49 95-48 95-47 95-46 Safety Defect in Gammamed 121 Bronchial
 
Catheter Clamping Adapters Seismic Adequacy of Thermo-Lag
 
Panels Results of Shift Staffing Study Unexpected
 
Opening of a Safety/Relief
 
Valve and Complications
 
Involving Suppression
 
===Pool Cooling Strainer Blockage Unplanned, Undetected===
Release of Radioactivity
 
from the Exhaust Ventilation
 
System of a Boiling Water Reactor Potentially
 
===Nonconforming===
Fasteners
 
Supplied by A&G Engineering
 
II, Inc.American Power Service Falsification
 
of American Society for Nondestructive
 
Testing (ASNT) Certificates
 
Ensuring Compatible
 
===Use of Drive Cables Incorporating===
Industrial
 
Nuclear Company Ball-Type
 
===Male Connectors===
Failure of the Bolt-Locking
 
Device on the Reactor Coolant Pump Turning Vane 10/30/95 10/27/95 10/10/95 10/04/95 10/06/95 10/05/95 10/04/95 09/26/95 09/28/95 All High Dose Rate Afterloader (HDR) Adapters.All holders of OLs or CPs for nuclear power reactors.All holders of OL,. or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All Radiography
 
Licensees.
 
All holders of OLs or CPs for nuclear power reactors designed by Westinghouse
 
Electric Corporation (W).95-12, Supp. 1 95-45 95-44 95-43 OL -Operating
 
License CP -Construction
 
Permit
 
0 1, .-:-V/I DOCUMENT NAME: G:INCIDENT.SWM


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
To receive a copy of this document, indicate in the box: *C. Copy without attachment/enct.


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
E = Copy with attachmentlencl


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Nz N Lo copy -0 i 1 KANE j Moore "JQones l 6 Pn rn / Caputo STreby X DATE /0 OFC TechEd l ASVAli*l>
INNX l. l KANE F _ __EK___ __Gus DATE Io/aV/4( 1 _l OFFICIAL RECORD COPY}}


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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 A
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.TVR on q5.osinI q gj0'11 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 The issues raised in these two cases should lead reexamining

their own methods to prevent and, if internal contamination

incidents.

licensees

to consider necessary, respond to The Information

in this notice inspections

in these two cases as necessary, once results are is preliminary, and the investigations

and are ongoing. NRC may issue further guidance, known and conclusions

drawn on these two cases.This information

notice requires no specific action or written response.

If you have any questions

about the information

in this notice, please contact the technical

contacts listed below or the appropriate

regional office."fA' 4~dl Donald A. Cool, Director Division of Industrial

and Medical Nuclear Safety Office of Nuclear Material and Safeguards

Safety Technical

contacts: Scott Moore, NMSS (301) 415-7875 B. J.(708)Holt, RIII 829-9836 Mohamed Shanbaky, RI (610) 337-5209 John Potter, RII (404) 331-5571 Thomas Kozak, RIII (708) 829-9866 Linda Howell, RIV (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

II. 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)576-3131 481-1000 (ask for REAC/TS):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 95-44 95-39 95-29 95-28 95-25 94-64, Supp. 1 95-07 Safety Defect in Gammamed 12i Bronchial

Catheter Clamping Adapters Ensuring Compatible

Use of Drive Cables Incorporating

Industrial

Nuclear Company Ball-type

Male Connectors

Brachytherapy

Incidents Invcyving

Treatment Planning Errors Oversight

of Design and and Fabrication

Activities

for Metal Components

Used in Spent Fuel Dry Storage Systems Emplacement

of Support Pads for Spent Fuel Dry Storage Installations

at Reactor Sites Valve Failure during Patient Treatment

with Gamma Stereotactic

Radiosurgery

Unit Reactivity

Insertion

Trans-ient and Accident Limits for High Burnup Fuel Radiopharmaceutical

Vial Breakage during Preparation

10/30/95 09/26/95 09/19/95 06/07/95 06/05/95 05/11/95 04/06/95 01/27/95 All High Dose Rate Afterloader (HDR) Licensees.

All Radiography

Licensees.

All U.S. Nuclear Regulatory

Commission

Medical Licensees.

All holders of OLs or CPs for nuclear power reactors.Independent

spent fuel storage installation

designers

and fabricators.

All holders of OLs or CPs for nuclear power reactors All U.S. Nuclear Regulatory

Commission

Medical Licensees.

All holders of OLs or CPs for Nuclear Power Reactors and all fuel fabrication

licensees.

All U.S. Nuclear Regulatory

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 95-49 95-48 95-47 95-46 Safety Defect in Gammamed 121 Bronchial

Catheter Clamping Adapters Seismic Adequacy of Thermo-Lag

Panels Results of Shift Staffing Study Unexpected

Opening of a Safety/Relief

Valve and Complications

Involving Suppression

Pool Cooling Strainer Blockage Unplanned, Undetected

Release of Radioactivity

from the Exhaust Ventilation

System of a Boiling Water Reactor Potentially

Nonconforming

Fasteners

Supplied by A&G Engineering

II, Inc.American Power Service Falsification

of American Society for Nondestructive

Testing (ASNT) Certificates

Ensuring Compatible

Use of Drive Cables Incorporating

Industrial

Nuclear Company Ball-Type

Male Connectors

Failure of the Bolt-Locking

Device on the Reactor Coolant Pump Turning Vane 10/30/95 10/27/95 10/10/95 10/04/95 10/06/95 10/05/95 10/04/95 09/26/95 09/28/95 All High Dose Rate Afterloader (HDR) Adapters.All holders of OLs or CPs for nuclear power reactors.All holders of OL,. or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All holders of OLs or CPs for nuclear power reactors.All Radiography

Licensees.

All holders of OLs or CPs for nuclear power reactors designed by Westinghouse

Electric Corporation (W).95-12, Supp. 1 95-45 95-44 95-43 OL -Operating

License CP -Construction

Permit

0 1, .-:-V/I DOCUMENT NAME: G:INCIDENT.SWM

To receive a copy of this document, indicate in the box: *C. Copy without attachment/enct.

E = Copy with attachmentlencl

Nz N Lo copy -0 i 1 KANE j Moore "JQones l 6 Pn rn / Caputo STreby X DATE /0 OFC TechEd l ASVAli*l>

INNX l. l KANE F _ __EK___ __Gus DATE Io/aV/4( 1 _l OFFICIAL RECORD COPY


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