Information Notice No. 95-51: Recent Incidents Involving Potential Loss of Control of Licensed Material

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
                         WASHINGTON, D.C.  20555-0001

                               October 27, 1995

                               CONTROL OF LICENSED MATERIAL


All material and fuel cycle licensees.


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

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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          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

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.

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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

             ... 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

      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
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      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 Bioassay 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

          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 "... 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.  
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The issues raised in these two cases should lead licensees to consider
reexamining their own methods to prevent and, if necessary, respond to
internal contamination incidents.

The information in this notice is preliminary, and the investigations and
inspections in these two cases are ongoing.  NRC may issue further guidance,
as necessary, once results are 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.

                              /S/'D BY DACOOL

                              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

1.  List of Emergency Contacts
2.  List of Recently Issued NMSS Information Notices
3.  List of Recently Issued NRC Information Notices

                                             Attachment 1
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                                             Page 1 of 1

                                   LIST OF EMERGENCY CONTACTS

I.    NRC Operations Center
      Telephone:  301-816-5100  (will accept collect calls)

II.   Radiation Emergency Assistance Center/Training Site (REAC/TS)
      Daytime Telephone:  423-576-3131
      24-hour Telephone:  423-481-1000 (ask for REAC/TS)
      (to consult with a physician)


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