ML20153D329

NMSS Licensee Newsletter.Number 98-2.June-July 1998

ML20153D329
Person / Time
Issue date:	07/31/1998
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N98-2, NUREG-BR-117, NUREG-BR-117-N98-2, NUDOCS 9809250027
Download: ML20153D329 (8)

Text

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7 trit un na iNMS~Shinhib6WNekslettek Y ,m y, U.S. Nuclear Office of Nuclear NUREGlBR-0117 ,

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Regulatory Material Safety No. 98-2

% ,,,,/j Commission and Safeguards June - July '98 o ,

BIOASSAY REQUIREMENTS FOR personnel. Patients who did not need to be MEDICAL PERSONNEL WHO confined after administration of ADMINISTER RADIOIODINE TO radiopharmaceuticals were generally those PATIENTS Patients who received relatively small dosages of these materials, and preparation and administration of these dosages posed a relatively Medical personnel who admm. .ister substantial smaller risk to the medical personnel involved. l doses of radioiodine to patients may inhale or otherwise ingest some of the radioiodine, leading to significant thyroid burdens. To monitor this The situation regarding confinement of patients possible intake, the U.S. Nuclear Regulatory has changed with the recent revision of 10 CFR Commission (NRC) requires,in 10 CFR 35.75. The most significant change was that 10 35.315(a)(8), that "For each patient or human CFR 35.75 now bases the release of patients research subject receiving radiopharmaceutical administered radioactive materials on the doses therapy and hospitalized for compliance with that may be received by members of the public 35.75 of this chapter, a licensee shall... Measure from the released patients. These new dose-based the thyroid burden of each individual who helped release criteria may,in some cases, involve the .

prepare or administer a dosage of iodine-131 administration of relatively large dosages of within three days after administering the radioactive materials without requiring patient  !

dosage.. ." Section 35.75," Release ofindividualc confinement. Because the bioassay requirement i' containing radiopharmaceuticals or permanent foi medical personnel in $35.315(a)(8) is implants" specifies the requirements that must be applicable only in the case of administration to met to release patients from the hospital. The hospitalized patients, it is now possible, under the purpose of this article is to alert licensees and new patient release criteria, for medical personn  !

4 their radiation safety personnel to the fact that, to prepare and administer substantial doses of although some of their occupational workers may radiopharmaceuticals without coming under this

@35.315(a)(8) bioassay requirement. f) not be required to be included in a bioassay J program under 10 CFR Part 35, they may still be i required to be monitored for intakes under 10 Licensees should note, however, that although l CFR Part 20. medical personnel administering radiopharma-  !

ceuticals may not fall within the scope of the  !

Historically, bioassay for medical personnel has bioassay requirements specified in 10 CFR j been required only in cases of administration to 35.315(a), they are still subject to the require- i hospitalized patients because these are the ments of 10 CFR 20.1502, " Conditions requiring  ;

patients receiving substantial dosages of individual monitoring of external and internal radiopharmaceuticals. This in turn meant that the occupational dose." This section of the I

medical personnel who prepared and regulations requires licensees to monitor all administered the dosages to these patients occupationally expqsed personnel who may l handled substantial amounts of radioactive receive, in 1 year, an intake in excess of 10 percent material, and therefore were at greatest risk for of the applicable ALI(s) (Annual Limit on Intake) l intakes. This greater risk for intakes led to the in Table 1, Columns 1 and 2, of Appendix B to i requirement for bioassay for these medical 10 CFR Part 20.

9809250027 980731 .

PDR NUREG BR-0117 R PDR j I

Medical personnel who prepare or administer NMSS Lle:nsee Newsletter (June 1998 -July 1998) radiopharmaceuticals are occupationally exposed personnel, and therefore are subject to 10 CFR 20.1502 of the regulations. Licensees are required Page to review the potential exposures of their emPI Oyees for the upcoming year, and to monitor

1. BIOASSAY REQUIREMENTS FOR them for m. takes if there is a likelihood that this MEDICAL PERSONNEL WHO ntake, dunng the , year, may exceed 10 percent of ADMINISTER RADIOIODINE TO the limit. Monitonng, m the context of intakes, PATIENTS (Contact: Sami Sherbini, NMSS, means inclusion of these personnelin a bioassay 301-415-7902), e-mail: sxs2@nrc. gov) . . . . 1 program designed to monitor and quantify their intakes throughout the year. The bioassay

2. PROPER STORAGE OF HIGH-ENERGY Program may melude one or a combination of BETA- AND NEUTRON-PRODUCING whole body or thyroid counting, urine or fecal SOURCES (Contact: Dr. Donna-Beth Howe, ,

analysis, or any other form of bioassay, dependm, g NMSS,301-415-7848, ,

on the isotope or combination of isotopes handled e mail: dbh@nrc. gov) . . . . . . . . . . . . . . . . . 2 during the monitoring period. It should be noted that, although 10 CFR 35.315(a) specified only

3. PATIENTS RECEIVED LESS THAN thyroid burden monitonng for those handhng PRESCRIBED DOSAGE WHEN ONE OF i dine-131, Part 20 is more general, and applies to TWO I-131 CAPSULES WAS NOT intakes of any licensed matenal. It therefore has ADMINISTERED (Contact: Eric Compton, much broader applicability than 10 CFR NMSS,301--415-5799, 35.315(a). For medical heensees pnmanly using e mail: ebc@nrc. gov) . . . . . . . . . . . . . . . . . . 3 ,

radiciodme, thyroid monitonng may contmue to be the preferable form of bioassay.

4. CLOSING OF WALNUT CREEK (CA)

FIELD OFFICE (Contact: Mark Shaffer, Although 10 CFR 35.315(a) no longer requires RIV,817-860-8287, bioassay for some medical personnel who pre-e-mail: mrs@nrc. gov) . . . . . . . . . . . . . . . . . . 3 viously would have been monitored (under the old bioassay requirements in Part 35), the require-

5. SELECTED FEDERAL REGISTER ments in Part 20 to monitor for intakes apply to all NOTICES (April 1,1998 - May 31,1998) occupationally exposed personnel. Licensees are (General

Contact:

Paul Goldberg, NMSS, expected to assess potential exposures from all 301-415-7842, sources of radiation for their employees for the e-mail: pfg@nrc. gov) . . . . . . . . . . . . . . . . . 3 upcoming monitoring year and include them in a suitable monitoring program if their doses or

6. GENERIC COMMUNICATIONS ISSUED intakes may exceed 10 percent of the applicable (August 1,1997 - April 30,1998) (General limits. This assessment of potential exposures may

Contact:

Kevin Ramsey, NMSS, be based on past exposure histories, details of 301-415-7887, upcoming work schedules, or the professional e-mail: kmr@nrc. gov) . . . . . . . . . . . . . . . . 4 judgment of the radiation safety personnel.

7. SIGNIFICANT ENFORCEMENT ACTIONS (Contact: Sami Sherbini, NMSS, (Contact: Joseph DelMedico, OE, 301-415-7902, e-mail: sxs2@nrc. gov) 301-415-2739, e-mail: rjd@nrc. gov) . . . . . . . . . . . . . . . . . . . 6 PROPER STORAGE OF HIGH ENERGY

- BETA. AND NEUTRON-PRODUCING Comments, and suggestions you may have SOURCES for information that is not currently being included, that might be helpful to licensees, Licensees need to properly shield all radiation should be sent to: sources. Although gamma and x-ray sources require E. Kraus high-atomic-number materials like lead, tungsten, NMSS Licensee Newsletter Editor steel, or depleted uranium to provide adequate Office of Nuclear Material Safety shielding, high-energy beta and neutron sources and Safeguards require low atomic-weight materials such as plastics, Two White Flint North, Mail Stop 8-A-23 paraffin, water, or boronated water to provide U.S. Nuclear Regulatory Commission adequate shielding. Strontium eye applicators, Washington, D.C. 20555-0001 americium / beryllium sources in moisture density gauges, and plutoniurn/ beryllium sources in ne ron 2

l c L generators are examples of either high-energy-beta patient was administered only 260 MBq (7 mci)

! or neutron-producing sources. In many cases these of a prescribed 370-MBq (14 mci) dose of I-131, I

sources should be stored in their shipping containers because only one 260-MBq (7-mci) capsule of a l because the shipping containers have two-capsule dose was administered. The other l low-atomic-weight shielding materials. capsule (110 MBq) (3 mci) was found during an inventory survey of the hot lab on June 17,1998.

U.S. Nuclear Regulatory Commission inspectors recently observed higher than expected radiation There is a concern that nuclear medicine levels at the outside of two wooden boxes, each technologists are erroneously assuming that the I containing a strontium-90/ yttrium-90 eye Prescribed I-131 dose is contained in only one l applicator. One licensee had improperly stored capsule, when it may instead have been placed in l

the eye applicator in a tungsten / stainless steel multiple capsules. Based on review of 10

inner sleeve within another aluminum sleeve and misadministrations, the U.S. Nuclear Regulatory l a lead pig. The second licensee's wooden storage Commission suggests that licensees that l

box was lead-lined. The higher-than-expected administer I-131 capsules review their protocol radiation levels were caused by bremstrahlung and training, and take action appropriately.

produced when the high-energy betas interacted with the tungsten / steel sleeve and the lead, (Contact: En.c Compton, NMSS,301-415-5799, respectively. Similar problems were addressed e-mail : ebc@nrc. gov) in 1984,in Information Notice 84-43:" Storage and Handling of Ophthalmic Beta Radiatmn CLOSING OF WALNUT CREEK (CA)

Applicators." At that time, licensees were FIELD OFFICF' removing the loose pieces of aluminum that the manufacturer put in the boxes to shield the sour The U.S. Nuclear Regulatory Commission (NRC)

Region IV Walnut Creek Field Office, California and prevent excessive bremstrahlung.

(WCFO) will be closed after September 30,1998.

All activities performed by the WCFO will be In an unrelated case, the U.S. Department of transferred to the main Region IV office in Energy reported an employee receivmg an Arlington, Texas. When calling the office before unexpected radiological exposure to neutrons

, , its closure, please note that there is a new area from an improperly stored amencium-berylh,um code. The general number for the WCFO is source. The source had been stored m a 925-975-0200. Since the WCFO is currently lead-shielding container. The source had been transferring functions to the Arlington office, properly stored in its shippmg container for years i

effective immediately, all licensing and other before bem, g moved to the lead-shielding correspondence should be directed to the container. The shippmg container contamed Arlington office. The mailing address for the low-atomic-weight matenal and effectively Arlington office is:

absorbed the neutrons.

I USNRC, Region IV,611 Ryan Plaza Drive, Suite

(Contact

Dr. Donna-Beth Howe, NMSS, 400, Arlington, Texas 76011-8064.

l 301--415-7848, e-mail: dbh@nrc. gov)

Event notifications and other general PATIENTS RECEIVED LESS THAN communications with Agreement State officials PRESCRIBED DOSAGE WHEN ONE OF should be directed to the Region IV Arlington, TWO I-131 CAPSULES WAS NOT Texas, office. The general telephone number for ADMINISTERED the Arlington office is 817-860-8100. Emergency calls should be directed to the Headquarters

! A medical misadministration occurred at the Operations Center at 301-816-5100.

Edward Hospital in Naperville, Illinois, when a (Contact: Mark Shaffer, RIV,817-860-8287, patient was given less than the prescribed dose. A e-mail: mrs@nrc. gov) i patient was to have been given 5.6 GBq (150 mci) l of I-131 sodium iodide in two capsules on SELECTED FEDERAL REGISTER NOTICES May 21,1998. However, on June 6,1998,it was discovered that the patient was only administered (April 1,1998- May 31,1998) one capsule. The second capsule was found stillin the shipping container. NOTE: U.S. Nuclear Regulatory Commission (NRC) contacts may be reached by mail at the Another misadministration occurred at the Rhode U.S. Nuclear Regulatory Commission, Island Hospitalin Providence on June 3,1998. A Washington, DC 20555-0001.

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3 FINAL RULES GENERIC COMMUNICATIONS ISSUED (August 1,1997 - April 30,1998)

" Access Authorization Fee Schedule for Licensee Personnel," 63 FR 25156, May 7,1998.

Contact:

Note that these are only summaries of U.S.

Beth Bradshaw,301-415-6540,e mail Nuclear Regulatory Commission (NRC) generic mbb1@nrc. gov. communications. If one of these documents appears relevant to your needs and you have not received it, please call one of the technical PROPOSED RULES contacts listed below. The Internet address for the NRC library of generic communications is -

" Revision of Fee Schedules; 100% Fee Recovery, www.nrc. gov /nrc/fedworld/nrc-gc/index.html.

FY 1998," 63 FR 16046, April 1,1998.

Contact:

Please note that this address is case-sensitive and Glenda Jackson, Office of the Chief Financial must be entered exactly as shown.

Officer,301-415-6057, j " Revision of Fee Schedules; 100% Fee Recoverw Bulletins (BLs)

FY 1998 (Correction)," 63 FR 17130, April 8, BL 97-02," Puncture Testing of Shipping Packages 1998.

Contact:

Glenda Jackson, Office of the under 10 CFR Part 71," was issued on September Chief Financial Officer,301.-415-6057. 23,1997, to all holders of NRC Certificates of Compliance for shipping packages. The bulletin OTHER NOTICES informed addressees of physical tests that were not performed in accordance with Part 71 Issuance and Avnilabilit of Draft NUREG-1617, requirements and requested all certificate holders

" Standard Review Plan for Transportation to review the assessment of their certified package Packages for Spent Nuclear Fuel," 63 FR 16594, designs and determine if the tests were performed April 3,1998. in accordance with Part 71.

Contact:

David Tiktinsky, NMSS,301-415-8523, e-mail:

" State of Oregon Relinquishment of Scaled dht@nrc. gov.

Source and Device Evaluation and Approval Authority and Reassumption by the Commission," Information Notices (ins) 63 FR 17903, April 10,1998.

Contact:

James H.

Myers, 301-415-2328, e-mail, j hm@nrc. gov. IN 97-61,"U.S. Department of Health and Human Services (HHS) Letter to Medical Device Manufacturers on the Year 2000 Problem," was Availability of Draft NUREG-1556,Vol. 6,

" Consolidated Guidance About Irradiator issued on August 6,1997, to ali medicallicensees, Licensees," 63 FR 20224, April 23,1998.

Contact:

veterinarians, and manufacturers / distributors of Mrs. Sally L. Merchant,301--415-7874; e-mail, medical devices. It informs addressees of a letter sim2@nrc. gov. issued by the HHS Food and Drug Administration about the Year-2000 computer problem.

Contact:

Department of Energy," Technical Assistance and Patri, cia K. Holahan, NMSS,301-415-8125, e-mail:pkh@nrc. gov.

Funding for Safe Routine Transportation and Emergency IN,974," Potential Problems Associated with April 30,1998. Response

Contact:

Ms. Training," 63 FR Connne Macaluso 23753' Loss of Electrical Power in Certain Teletherapy U.S. Department of Energy,202-586-2837. Units,"was issued on August 13,1997, to all

" Revision of NRC Enforcement Policy," 63 FR

• " '"E ' "8##8' addressees of potential problems with the f""'

26630, May 13' 1998.

Contact:

James Lieberman, 30l- 415-2741; e-mail: jxl@nre 8ov-

' " ' " "' k""PY "* manufactured by Theratronics International, Limited.

Contact:

Nader Mamish, NMSS,301-415-6316, e-mail:

U.S. Environmental Protection Agercy," Criteria nlm@nrc. gov.

for the Certification and Recertification of the Waste Isolation Pilot Plant's Compliance with the IN 97-65," Failures of High-Dose-Rate (HDR)

Disposal Regulations," 63 FR 27354, May 18, Remote Afterloading Device Source Guide Tubes, 1998. Contacts: Betsy Forinash, Scott Monroe, or Catheters, and Applicators," was issued on August Sharon White, EPA,202 564-9310. 15,1997, to all HDR remote afterloader licensees.

It alerts addressees to reports of failures in (General

Contact:

Paul Goldberg, NMSS, equipment used with HDR devices supplied by 301-415-7842, e-mail: pfg@nrc. gov) three major U.S. vendors. Cotaact: Robert L.

4 a .

w Ayres, NMSS,301-415-5746, e-maih Broaddus, NMSS 301-415-5847, e-mail:

rxal@nrc. gov. dab @nrc. gov. l IN 97-72," Potential for Failure of the Omega IN 97-91,"Recent Failures of Control Cables Series Sprinkler Heads," was issued on September Used on Amersham Model 660 Posilock l 22,1997, to all power reactors and fuel cycle Radiography Systems, , was issued on December facilities. The notice alerts addressees to a 31,1997, to all industrial radiography licensees, potential problem with Omega Series sprinkler This notice alerts addressees to several recent heads manufactured by Central Sprinkler incidents where the control cable broke at the Company of Lansdale, PA. Contacts: E.A. male end, and emergency procedures were Connell, NRR,301-415-2838, e-mail: imp lemented to recover the disonnected source eac@nrc. gov; P.W. Lain, NMSS,301-415-6317, assembly.

Contact:

Larry W. Camper, NMSS, e-mail: pwl@nrc. gov. e-mail: lwc@nrc. gov.

IN 98-01," Theft of Portable Gauges," was issued '

IN 97-75," Enforcement Sanctions Issued as a on January 15,1998, to all portable gauge

' Result of Deliberate Violations of NRC licensees. This notice alerts addressees to several Requirements," was issued on September 24, recent incidents where portable gauges were 1997, to all NRC licensees. The notice informs stolen from vehicles and storage sheds.

Contact:

addressees of a company president who was Anthony S. Kirkwood, NMSS,301-415-6140, sentenced to 3 years probation and fined $3000 for e. mail: ask@nrc. gov.

falsifying equipment calibration records. Contacts:

Nader Mamish, NMSS,301-415-6316, e-mail: IN 98-04,"1997 Enforcement Sanctions for nlm@nrc. gov; John McGrath, RI,610-337-5069, Deliberate Violations of NRC Employee e-mail: jrm@nrc. gov. Protection Requirements,".was issued on February 9,1998, to all NRC licensees. It reminds IN 97-86," Additional Controls for Transport of licensees of the sanctions that could result from the Amersham Model No. 660 Series deliberately violating NRC requirements in the Radiographic Exposures Devices" was issued on area of employee protection.

Contact:

Michael December 12,1997, to all registered users of the Stein, OE, 301-415-1688, e-mail: mhs@nrc. gov.

packages and all industrial radiography licensees. l The notice alerts addressees to recent failures IN 98-06," Unauthorized Use of License to l during by mthetical accident tests and discusses Obtain Radioactive Materials, and Its additiona controls for transport that have been Implications Under the Expanded Title 18 of the added to Certificate of Compliance No. 9033. U.S. Code," was issued on February 19,1998, to Contacts: Ross Chappell, NMSS,301-415-8510, all NRC licensees. It alerts them to an incident e-mail: crcl@nrc. gov; David Tiktinsky, NMSS, involving unauthorized use of a broad scope 301-415-8523, e-mail: dht@nrc. gov. medicallicense to obtam, radioactive materials, and the subsequent criminalinvestigation.

nta " ' '

IN 97-87,"Second Retrofit to Industrial Nuclear '

Company IR-100 Radiography Camera to

"*"lNdO"I'8" Correct Inconsistency in 10 CFR Part 34 IN 98-08,"Information Likely to be Requested if Compatibility," was issued on December 12,1997, , an EmergencyIs Declared,"wasissued on to all industrial radiography licensees. The notice March 2,1998, to all nonreactor licensees informs addressees of a retrofit to the lock of the required to have an NRC-approved emergency IR-100 radiography camera. Contacts: David plan. It informs them of the information expected

Wesley, Califorma Dept. of Health Services, by NRC when an Alert or Site Area Emergency 916-445-1884; Michele Burgess, NMSS, is declared. Contacts: Yen-Ju Chen, NMSS, 301-415-5868, e-mail: mlb5@nre. gov. 301-415-5615, e-mail: yje@nrc. gov; Kevin Ramsey, NMSS,301-415-7887, e-maih

- IN 97-89," Distribution of Sources and Devices kmr@nrc. gov.

Without Authorization,"was issued on December 29,1997, to all sealed source and device IN 98-09," Collapse of an Iscocam II, manufacturers and distributors. The notice alerts Dual Headed Nuclear Medicine Gamma addressees to the recent breakdown, of a vendor's Camera,"was issued on March 5,1998, to all regulatory program, that resulted in unauthorized medicallicensees. It alerts them to an incident distribution of sources and devices to specific involving a gamma camera manufactured by Park licensees and general licensees.

Contact:

Douglas Medical Systems of Quebec, Canada.

Contact:

5

l 1

Steven Baggett, NMSS,301-415-7273, e-mail: The Stroh Brewzry Company, Lehigh, slb@nrc. gov. Pennsylvania, EA 97-486. A $4400 civil penalty was assessed for improper disposal of two IN 98-10," Probable Misadministrations generally licensed gauges, which were transferred Occurring During Intravascular Brachytherapy to a scrap recycler.

with the Novoste Beta-Cath System," was issued on March 9,1998, to all medical licensees. It Radiography alerts them to two reported incidents involving the failure of the sources to return to the device CTI, Alaska,Inc., Anchorage, Alaska, EA 97-539.

storage safe at the conclusion of the treatments. A $5500 civil penalty was assessed for violations

Contact:

Robert Ayres, NMSS,301-415-5746, tha* :nvolved: 1) approaching a radiography e-mad: rxal@nrc. gov. exposure device before the source was moved to its shielded position; and 2) failing to use an IN 98-12," Licensees' Responsibilities Regarding operable survey instrument to perform a radiation Reporting and Follow-up Requirements for survey of the device.

Nuclear-Powered Pacemakers," was issued on April 3,1998, to all nuclear pacemaker .

licensees. It reminds them of their responsibilities Other Materials Licensees regarding the reporting and follow-up requirements for nuclear-powered pacemakers. Koch Engineering Company, Inc., Newark,

Contact:

Torre Taylor, NMSS,301-415-7900, Delaware, EA 98-061. A $4400 civil penalty was e-mail: tmt@nrc. gov. assessed for failure to ensure, by examination or test, that each closure device of a package IN 98-16," Inadequate Operational Checks of containing cesium-137 sources was properly Alarm Ratemeters," was issued on April 30, installed, secured, and free of defects before 1998, to all industrial radiography licensees. It transportation. The package arrived empty and alerts them to an incident where two the sources were later recovered at a Federal radiographers approached an exposed source but Express facility.

neither alarm ratemeter alarmed because inadequate operational checks failed to detect Mallinckrodt Inc., Maryland Heights, Missouri, weak batteries. Contacts: Robert Oattone, RIII, EAs97-342 and 97-355. A $55,000 civil penalty 630-829-9823, e-mail: rgg@nrc. gov; J. Bruce was assessed for violations involving: (1) a Carrico, NMSS, 301-415-7826, e-mail: shallow-dose equivalent exposure to an jbc@nrc. gov. occupational worker in excess of 500 mSv (50 rems) caused by failure to survey; and (2) l (General

Contact:

Kevin Ramsey, NMSS, Molybdenum-99/Tecnetium-99m generators that 301- 415-7887, e-mail: kmr@nrc. gov) arrived at their destinations with contact radiation levels that exceeded 2mSv (200 millirem).

SIGNIFICANT ENFORCEMENT ACTIONS United States Enrichment Corporation, Paducah, Detailed information regarding these enforcement Kentucky, EA 97-431. A $55,000 civil penalty was ,

actions can be accessed via the U.S. Nuclear assessed for five examples of failure to maintam Regulatory Commission (NRC) homepage c ntrol of classified matter.

gov /. Access " Program Offices,"

then " Office of Enforcement," then " Enforcement United States Enrichment Corporation, Actions Issued." Cases are listed alphabetically. Portsmouth, Ohio, EA 98-012. A $55,000 civil To view the complete enforcement action, click penalty was assessed for 16 violations involving on the highlighted text following each major deficiencies in the nuclear criticality safety case description. and self-assessment programs at the facility.

Measuring Gauges Westinghouse Electric Corporation, Columbia, South Carolina, EA 97-442. A $13,750 civil Ground Engineering and Testing Service, Inc., Penalty was assessed for eight violations involving Louisville, Kentucky, EA 98-021. A $5500 civil criticality safety controls.

penalty was assessed for willful failure to file for reciprocity before conducting work in (Contact: Joseph DelMedico, OE,301-415-2739, NRCjurisdiction. e-mail: rjd@nrc. gov) 6

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