ML20116M890
| ML20116M890 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/1990 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-BR-0117, NUREG-BR-0117-N90-3, NUREG-BR-117, NUREG-BR-117-N90-3, NUDOCS 9608210147 | |
| Download: ML20116M890 (12) | |
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U.S. Nuclear Office of Nuclear NUREG/BR-0117 i,
j Regulatory Material Safety No.90-3
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Commission and Safeguards September 1990 i
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NRC ANNOUNCES HELOW REGULATORY amounts of radioactive material; (3) very low-level radioac-i CONCERN POLICY tive waste; and (4) recycled equipment and materials with slight amounts of radiation. For many years, NRC has made The U.S. Nuclear Regulatory Commission (NRC) recently exemption decisions on a case.by-case basis. One example f
issued a new policy to guide its future decisions on small is NRC's exemption for smoke detectors.
quantities of radioactive materials. The policy establishes the basis for future agency regulations and licensing deci.
Now, for the first time, the Commission has a policy to pro-i sions that would exempt sery low-level radioactive material vide consistency, when considering exemption requests.
from regulatory controls, where NRC determines that such controls are not necessary to protect the public health and BRC DOSE CRITERIA safety. NRC mailed the Below Regulatory Concern (BRC) l policy statement to licensees and other NMSS Licensee The policy statement provides radiation dose criteria that the i
Newsletter recipients on June 27, and published the state.
Commission will use when making exemption decisions.
i ment in the Federal Register on July 3,1990 (55 FR 27522 The levels are set low so that the public and the environment 37).
will be protected when NRC approves exemptions under the j
BRC policy. Two types of criteria are given in the Commis-In announcing the policy, NRC's Chairman, Kenneth M.
sion's statement: individual radiation dose levtis and collec-Carr, noted that one of his highest priorities is to establish tive dose levels.
]
safe levels of cleanup for contaminated nuclear sites across j
the country. Chairman Carr said the BRC policy, ".. pro.
For individuals, the Commission has decided that the radia-i vides the framework for detenning these safe levels. The tion exposure from a single activity or product may be con-country needs a safe Below Regulatory Concern policy to.
sidexd for exemption if it will result in an average dose of day."
less than 10 millirem per year. People are exposed to similar levels when they choose to live in a brick rather than a wood The policy covers a wide scope of NRC licensees, poten.
frame house (a difference that can exceed 10 millirem per j
tially affecting medical, industrial, academic, commercial, year).
]
and fuel cycle licensees, as well as reactor facilities. How.
ever, the policy statement is not a regulation it does not in As an added assurance of safety, the Commission has de-itself change current regulations or licenses. The statement cided to apply an interim individual dose criterion of I milli-i provides the Commission's policy on how NRC will decide tem per year for materials or products involving widespread j
on future requests for rulemaking or licensing actions that distribution of radioactive materials in items such as con-involve very low levels of radioactivity, and the policy de.
sumer products or recycled material and equipment. His I i
fines those BRC levels.
millirem per year interim criterion will protect individuals j
from receiving a radiation dose from several different activi-j NRC will use the policy in responding to requests for rule.
ties or products.
makings or licensing actions to exempt from some or all regulatory controls certain practices involving very low.
De Commission also has established a criterion that will level radioactive material. The policy covers such activities apply to collective dose-the sum of all the individual doses or products as: (1) cleanup of decommissioned and decon.
for the population exposed as a result of an exempted prac-6 taminated facilities; (2) consumer products containing small tice. De BRC collective dose level is set in the statement at a
9608210147 900930 PDR NUREG BR-0117 R PDR
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2 1000 person-rem per year, from an exempted practice. The BENEFITS OF BRC Commission policy statement indicates that,if the collective dose resulting from an exempted practice is less than 1000 The BRC statement establishes the first consistent policy for person-rem per year, the resources of the Commission and granting exemption requests concerning small amounts of its licensees would be better spent to address more signifi-radioactive material and for setting cleanup levels at con-cant health and safety issues.
taminated nuclear sites. Chainnan Carr noted that, "..this will help ensure every operating facility will complete clean-COMPARABLE RADIATION RISKS up in a timely manner and will have adequate levels of fund-ing to complete that cleanup." By limiting regulation of All activities involve some risk. The Commission recognizes very low levels of radioactive materials, NRC can focus its the risk involved in using radiation or radioactive materials.
resources on solving the agency's more important health and The levels of risk associated with exemptions under the safety issues.
BRC policy are small, especially in comparison to risk from our everyday activities. The chart below provides a compari-son of the BRC levels to radiation doses from other activi-
"The country needs a safe Below ties, such as living in Denver, CO, vs. Washington, DC, or Regulatory Concem policy today."
flying on a round-trip cross-country flight. These types of common societal choices-deciding where to live or how to
- Chairman Carr travel-can result in low radiation doses from cosmic rays and natural radio nuclides in soils and building materials.
The BRC dose criteria are set in the same range as the doses OCCUPATIONAL RADIATION DOSES,1987 from these other societal activities, and they are only 3 per-cent, when compared to the 300-millirem dose people re-The Nuclear Regulatory Commission (NRC) will soon pub-ceive each year from naturally occurring radiation sources.
lish NUREG-0713, Vol. 9, " Occupational Radiation Expo-sure at Commercial Nuclear Power Reactors and Other Fa-COMPARISON OF BELOW REGULATORY cilities,1987." The report summarizes the exposure infor-CONCERN DOSES TO DOSES FROM mation, submitted pursuant to 10 CFR Part 20, for employ.
SELECTED OTHER RADIATION SOURCES ces of NRC licensees who: (1) conduct industrial radiogra-phy; (2) fabricate fuel for reactors; (3) manufacture and dis-o = com westeem oc rppgyppppppppppffppfgy70 tribute byproduct material; (4) dispose of low-level waste; (5) operate commercial power reactors; and (6) operate inde-g
- * * " * * " F/B pendent spent-fuel storage installations. The average annual measurable whole-body doses calculated from the 455 an-gs nounnip cm.ecounn ne nual statistical reports that are received from licensees in these groups in 1987 were: (1) 0.41 rem; (2) 0.13 rem; (3)
SnC Preceae AAsceng 10 une oenveera m a
- 0.31 rem; (4) 0.14 rem; (5) 0.38 rem; and (6) 0.64 rem, re-anc e=ceog l1 spectively. In each case, these values are about the same or o
io no ao 40 so ao 70 ao less than the values found for 1986.
Rutsuon Does (mrom)
CONTINUED NRC OVERSIGHT The report contains numerous graphical displays of the dose data and tables that provide data for past years. There is also Any licensee who produces materials containing very low a section that provides information on these six groups of levels of radioactivity that are exempted from NRC controls workers who have terminated employment, and a section would continue to be subject to the full range of NRC regu.
that summarizes the 13 exposures that exceeded applicable latory oversight, inspection, and enforcement actions, to en.
limits during 1987. The report will be sent to those licensees sure compliance with any constraints, requirements, and that submit annual reports. It will be made available in pub-conditions established by the Commission. For example, the lic document rooms, or may be purchased from the Govern-j Commission may require labeling, so consumers can make ment Printing Office.
informed decisions about purchasing a product containing exempted material. NRC will also continue to vigorously P.O. Box 37082 regulate manufacturers and generators of BRC materials, to Washington, D.C. 20013-7082 ensure that the public and environment are properly pro-(202) 275-2060 tected.
SELECTED SIGNIFICANT EVENTS REPORTED TO PUBLIC MEETINGS TIIE U.S. NUCLEAR REGULATORY COMMISSION in August and September 1990, NRC held five public meet-Event 1: Source Disk >dge-A cesium-137 brachyther-ment-Unintended apy source became dis-j ings across the nation, to discuss the BRC policy, hear state-Dose lodged from its applicator ments from the public, and answer questions about the pol.
icy. The meetings were held near NRC regional offices in while a patient was undergo-Philadelphia, Atlanta, Chicago, Dallas, and San Francisco.
Date Reported: January 17, ing treatment. A remote af-
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1990 ter loading device was being i
NRC licensees, as well as Agreement State licensees, gov-ernment officials, and the public, were encouraged to attend.
used for irradiation of a pa-
3 SEI'TEMBER 1990 NMSS LICENSEE NEWSLET-CONTENTS (Continued)
TER CONTENTS Page Page
- 1. NRC ANNOUNCES BELOW REGULA-
- 14. ADVISORY COMMITTEE ON THE TORY CONCERN POLICY (Contact:
MEDICAL USE OFISOTOPES (ACMUI)
Scott Moore (301) 492-0514) =
1 (Contact: Sally Merchant (301) 492-0134) -
- 8
- 2. OCCUPATIONAL RADIATION DOSES,1987 (Contact: Barbara Brooks
- 15. MEDICAL VISITING FELLOWS PRO-(301) 492-3738)...
.2 GRAM (Contacts: Sally Merchant (301) 492-0134) Janet Schueter
- 3. SELECTED SIGNIFICANT EVENTS (301)492-0633) -
- 8 REPORTED TO THE U.S. NUCLEAR REGULATORY COMMISSION (NRC)
- 16. SIGNIFICANT ENFORCEMENT AC-(Contact: Kathleen Black (301)492-4995). 2 TIONS AGAINSTMATERIALS LICENSEES (Contact: Jenny Johansen
- 4. LICENSEE VIOLATIONS INVOLVING (301)492-3282)
.9 ENFORCEMENT ALTION (Contact:
Paul Goldberg (301) 492-0631).
.4
- 17. HUMAN FACTORS EVALUATIONS (Contact: Dennis Serig
- 5. VETERANS ADMINISTRATION /NRC (301)492-3362).
11 MEDICAL USE WORKSHOPS (Contact:
Deborah Seymour (401) 841-2605) -
- 5 Licensee
- Monogahela Val-tient, when the tube used to
- 6. PATHFINDER DECOMMISSIONING ley Hospital transfer the sources from the (Contact: Dan Martin (301) 492-0577)
.5 ng a, PA sMeM storage unit to the patient became discon-
- 7. SITED STATES NOTIFY MICHIGAN nected, resulting in one of OF PROPOSED DENIAL OF ACCESS the cesium 437 sources TO EXISTING LOW-LEVEL RADIO-being unintentionally lo-ACTIVE WASTE (LLW) FACILITIES 6 pa(i t'
eg The i
(Contacts: Jim Kennedy (301) 492-3401; Nick Orlando (301) 492-0566)..
-5 tended dose to a localized area of the patient's leg was
- 8. PART 72 AMENDMENT REGARDING SPENT FUEL STORAGE (Contact:
23, 37 e
James Schneider (301) 492-0692) 6 failure appeared to be the use of faulty materialin the
- 9. INFORMATION NOTICES PUB-LISHED APRIL 1,1990-JULY 31,1990 d de pli-(Contact: Paul Goldberg (301) 492-0631)... 7 cator, or inadequate equip-ment design.
- 10. RULEMAKINGS (FINAL AND PRO-Event 2: Brachytherapy Mis-Two therapy misadministra-POSED)(Contact: Paul Goldberg administration tions, on February 7 and (301)492-0631).
7 March 15,1990, resulted Date Reported: February 7, from erroneous information
- 11. REGULATORY GUIDES ISSUED 1990 being entered into the com-(FINAL AND DRAFF FORMS) puter controlling the treat-(Contact: Paul Goldberg (301) 492-0631)..7 Licensee: University of ment location.
- 12. SURVEY EVALUATING GENERAL Madison, WI The treatments used a re-LICENSE EFFECTIVENESS (Contact:
m te after-loading brachy-S. Baggett (301) 492-0542)
.-. 8 therapy device. Incorrect data were entered into the
- 13. MEDICAL USE OF IODINE-131 INCI.
treatment planning com-DENT (Contact: Sally Merchant Puter, and the results from (301)492-0134).
., g the planning computer were entered into the computer controlling the remote after-loading brachytherapy de-vice.
4 LICENSEE VIOLATIONS INVOLVING ENFORCE.
Agreement States account for an additional 5000 medical MENT ACTION nse licensees. Approximately seven million diagnostic pro-cedures and 150.000 therapy procedures are performed na-The U.S. Nuclear Regulatory Commission's (NRC's) en-tionwide cach ycar.
forcement program is designed to promote the public health I
and safety by:
The following types of hospital violations have been most frequent, according to NRC's most recent experience:
ensuring compliance with Commission requirements;
- 1. Lack of quality control of dose calibrators (accuracy.
- obtaining prompt correction of violations and adverse linearity, constancy).
conditions that may affect safety;
- 2. Failure to conduct required annual radiation safety
- ercouraging the prompt identification and reporting of training.
potential safety problems;
- 3. Failure to perform ambient radiation and contamina.
- deterTing future violations; and tion surveys.
- encouraging improvement in performance of licensees.
- 4. Incomplete waste disposal records.
The enforcement program is based on the NRC Enforcement
- 5. Failure of the Radiation Safety Committee to meet at Policy, which is published as Appendix C to 10 CFR Part 2 quarterly intervals.
of the Commission's regulations. The policy provides that licensees who commit signincant violations may be assessed In addition, NRC has found a number of instances of falsifi-civil penalties, or be subject to orders.
cation of records to indicate that meetings were held or other activities conducted, which did not actually occur as re-MEDICAL LICENSEES corded. These have resulted and can result in severe sanc-tions, including referral to the Department of Justice for pos-The number of civil penalties assessed from 1986 to 1989 is sible criminal prosecution, shown for four classes of licensees in the accompanying chart. The clearest trend is an increase in civil penalties for In addition to ensuring that these specific violations are hospitals.
avoided, licensee senior management should take the fol-MATERIALS UCENSEES lowing measures to avoid such violations:
CASES WITH CIVIL PENALTIES
.-.mc 80
- 1. Ensure that users of radioactive material and the radia-tion staff are familiar with the requirements of 10 C
CFR Part 35 and with the hospital's NRC license.
3
- 2. Ensure that adequate resources are provided for the ra-diation safety program; that training is conducted; and 10 y
,,gg that periodic testing, such as daily dose calibrator test-n Hi ing, is done and the results recorded.
- 3. Ensure that regt lar audits and reviews, especially the annual radiation safety audit required by 10 CFR Part O Gauge Ucensees I E Hospitals 35, are performed, reviewed, and that problems are O Radiographers M Well Loggers addressed.
There may be several reasons for this increase. The Com-
- 4. Ensure that radiation safety meetings are held and that mission has focused attention on the medical area as a result minutes accurately reflect discussions.
of concerns about misadministrations and violations that fre-quently indicated a breakdown of oversight by hospital man-
- 5. Ensure that qualified individuals are available to per-agement. Consequently, more NRC staff resources are being form radiation safety tasks. If such individuals with devoted to inspection and enforcement for medical licen-spec al skills are not available on the licensee's staff, sees, and the frequency of hospital inspections has m-the licensee might consider hiring a qualified radiation creased. The new Comm,ssion regulation,10 CFR Part 35, safety consultant.
i which more clearly lays out responsibihties of medical h-censees, became effective April 1,1987. The new 10 CFR RADIOGRAPHY LICENSEES Part 35 consolidates and clarifies requirements and includes some new requirements. Licenses have not completely im-Although the number of civil penalties for radiography li-plemented these new requirements.
censees has not increased as has the number for hospitals, NRC has found a number of recurring problems while in-NRC regulates medical use of byproduct material m. ap-specting radiographers. NRC is now devoting more time to proximately 2200 hospitals and 400 private-practice chmcs.
5 inspecting field inspection activities of radiographers, be-The unrestricted-use criteria that must be met are: (1) the cause most exposure incidents occur during field radiogra-guidelines in Regulatory Guide 1.86 for surface contamina-phy, as opposed to fixed facilities. Among the most serious tion; and (2) a maximum of 5 micro-R per hour above back.
problems is the failure of radiographers to always perform ground at a distance of I meter, for gamma radiation.
surveys, as required by 10 CFR 34.43. Given the high radia-l tion levels that can result if a radiography source is not re-After completion of decontamination activities, NRC will tracted completely, it is essential that surveys required by conduct confirmatory surveys to ensure that the cleanup ac-l procedures always be performed. Licensees are responsible, tivities are effective.
under 10 CFR 34.11, for inspecting radiographers' compli-ance with NRC requirements, including observing perform-In connection with this licensing action, the Nuclear Regula-ance, at intervals not to exceed 3 months. NRC will issue tory Commission staff issued both an Environmental As-sanctions, which may include civil penalties and orders, to sessment and a Safety Evaluation Report. These documents licensees, for significant errors of their radiographers, may be of interest to licensees who are engaged in or con-sidering decommissioning activities at their facilities. For Also, in a number of recent cases, radiographers did not re-funher information, please contact: John Austin, Branch port potential exposures when off-scale dosimeters resulted Chief, Division of Low-Level Waste Management and De-from inadequate surveys.10 CFR 20.403 requires reporting, commissioning, at (301) 492-3435.
within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, of potential exposure of greater than 5 rem.
Absent conclusive evidence that an exposure did not occur, SITED STATES NOTIFY MICHIGAN OF PROPOSED reporting is expected.
DENIAL OF ACCESS TO EXISTING LOW LEVEL VETERANS ADMINISTRATION /NRC MEDICAL USE WORKSHOPS The States of South Carolina, Washington, and Nevada have informed the State of Michigan that, beginning in November On September 24-29, 1990, the U.S. Nuclear Regulatory 1990, LLW generators in Michigan could be denied access Commission (NRC) Regions 11 and IV, Headquarters, and to the three existing LLW disposal facilities.
the Veterans Administration (VA) conducted two Radiation Safety Workshops for VA Medical Centers Radiation Safety On July 12,1990, Governor James J. Blanchard of Michigan Officers (RSOs) from around the country. Each workshop was infonned by Dr. John B. Patel, Chairman of the Board lasted 21/2 days. De purpose of the workshops was to give of Health and Environmental Control for the State of South the RSOs a working knowledge of the requirements for a Carolina, that, commencing 60 days after the post-Labor quality radiation safety program and ways to implement the Day reconvening of the Michigan Legislature, access to the program at their facilities. The RSOs were from VA Medi-Barnwell, South Carolina, disposal facility could be denied cal Centers holding specific NRC licenses for medical use of to all LLW generators in the State of Michigan. This letter byproduct material. He NRC staff discussed the licensing followed similar letters sent to the Govemor by Christine process, inspection procedures, enforcement policy, and Gregoire, Director of the Washington Department of Eccl-upcoming nilemaking affecting medical users. The VA had ogy, and Jerry Griepentrog, Director of the Nevada Depart-about 60 RSOs attend these workshops.
ment of Human Resources, on June 28,1990. These letters were in response to Michigan's elimination of the three can-PATHFINDER DECOMMISSIONING didate areas from consideration for siting as a regional LLW disposal facility.
On June 28, 1990, a license amendment was issued to Northern States Power Company (NSP) authorizing decom-The letters outline nine actions, in addition to the elimina-missioning activities at the Pathf'mder Generating Plant, near tion of the candidate sites, taken by Michigan, that ".. make Sioux Falls, SD. NSP will continue to operate the Pathfinder a prima facie case that Michigan will not honor its commit-facility as a fossil-fueled peaking unit, as it has since 1969, ment to host a facility for the Midwest Compact."
while the radiologically controlled areas of the Fuel Han-dling Building (FHB) and the Reactor Building (RB) are The Low-Level Radioactive Waste Policy Amendments Act restored to conditions allowing unrestricted use.
of 1985 (LLRWPAA) requires States and compacts to de-velop siting plans, including a schedule, by January 1,1988, he lower levels of the FHB and the entire RB have been for the establishment of a facility for LLW disposal. The maintained in protected isolation since Pathfinder was con-LLRWPAA also requires that by January 1,1990, non-sited vened to fossil fuel. After cleanup, the FHB will be used for compacts or non-member States file a complete application other purposes. The RB will be demolished, and all the to operate a LLW facility, or the Governor shall provide above-grade portions of the RB will be removed and dis-written certification to the Nuclear Regulatory Commission posed of. After removal of all contaminated equipment, (NRC) (or the appropriate agency in an Agreement State) hardware, and concrete, and confirmation that unrestricted-that the State shall provide for the storage, disposal, or man-use criteria have been met, the remaining underground por-agement of the waste. If a written certification is provided tions of the RB concrete cylinder will be buried in place.
by the Governor of a non-member State, the LLRWPAA Void spaces will be backfilled with clean material, and a requires, by January 1,1992, that the State submit a com-graded infiltration-resistant soil cover will be installed above plete application for a license to operate a LLW disposal the buried concrete, facility.
a__
+
6 Officials from Washington, Nevada, and South Carolina Roland Lickus, Director, State and Govemment Affairs, indicated that the denial of access to Michigan LLW genera-Region III, at (708) 790-5666 tors could be alleviated if:
or
- 1) A revised siting criteria bill is signed into law that ad-Paul Lohaus, Branch Chief, Division of Low-Ixvel Waste dresses items outlined in letters by Washington, Ne-Management and Decommissioning, at (301) 492-0553 vada, and South Carolina.
or
- 2) Candidate sites are designated for characterization, John Ilickey, Branch Chief, Division of Industrial and and Michigan provides evidence of good faith action Medical Nuclear Safety, at (301) 492-3425.
that speak to items outlined in letters by Washington, Nevada, and South Carolina.
PART 72 AMENDMENT REGARDING SPENT FUEL STORAGE James Cleary, Commissioner of the Michigan Low-Level Radioactive Waste Authority attributed the sited States, The U.S. Nuclear Regulatory Commission (NRC) amended threatened action against Michigan to the State's ".. leader-its regulations to authonze nuclear power plant licensees to ship and candor in regard to the unnecessary proliferation of store spent fuel, on reactor sites, in storage casks approved waste sites, as currently required under Federal law." Cleary by NRC under a general license, without requiring a specific license for that site. The rule also described criteria and pro-added "We are proceeding with a sound and comprehensive plan and, we believe, there is no defensible reason for any of cedures for obtammg NRC approval of a cask.
the currently sited facilities to deny access to Michigan."
ne reactor licensee must ensure, through written evalu-(Excerpt from LLW Forum Notes, July,1990) ations, that there are no unreviewed safety questions or Denial of access to disposal sites could disrupt licensed op-changes needed to use the casks at its reactor site. He licen-see also has to comply with the conditions of the cask's Cer-erations that generate waste by preventing licensees from tificate of Compliance and has to develop operating proce-shipping waste from their facilities. His, in tum, could dures for use of the casks. On-site spent fuel storage could cause regulatory and safety problems, such as the exceeding continue after the reactor shuts down permanently, but the of authorized possession limits, due to the accumulation of licensee would have to indicate how the spent fuel would be waste, inadequate waste management capability, or inade-quate waste storage facilities. De NRC staff has issued removed from storage and shipped offsite, before decorn-
""SS, ""E-guidance to waste generators on how to manage waste if access to disposal sites is denied. In particular, Information Notice 89-13 outlines actions that licensees should consider To obtam NRC approval of a storage cask, an applicant has t submit a safety analysis report desen,bmg the proposed if access to disposal sites is denied, such as amending li-cask and how it should be used to store spent fuel safely.
censes to increase possession limits and using volume reduc-tion techniques and alternative management and disposal Re applicant would have to make provisions for NRC to techniques.
inspect the facihties where the casks are fabncated and tested. In addition, the applicant must perform, and allow NRC guidance on the storage of radioactive waste is out-NRC to perform, tests that NRC decides are necessary.
lined in the following:
Design, fabrication, testing, maintenance, and use of a stor-
- 1) Information Notice No. 90-09: " Extended Interim age cask have to comply with technical criteria in the Com-Storage of Low-Level Radioactive Waste by Fuel mission's regulations and must be conducted under a quality Cycle and Materials Licensees" assurance program that meets NRC's requirements. A Cer-tificate of Compliance is valid for 20 years; after that, the
- 2) Information Notice No. 89-13: "Altemative Waste cask would have to be reapproved by NRC.
Management Procedures in Case of Denial of Access to Low-Level Waste Disposal Sites" The rule also notes that, to the extent practicable, in design-ing a cask, consideration should be given to the compatibil.
- 3) Generic Letter 85-14:" Commercial Storage at Power ity of the cask with transportation and other activities related Reactors of low-Level Radioactive Waste Not Gen-to the removal of the spent fuel from the reactor site, for ul-erated by the Utility" timate disposition by the Department of Energy.
- 4) Generic Letter 81-38: " Storage of Low-Level Radio.
The four storage cask models that have been approved by active Wastes at Power Reactors "
NRC am the CASTOR V/21, by General Nuclear Systems, Inc., Columbia, SC; the MC-10, by Westinghouse Electric Copies of these documents may be obtained by contacting Corporation, Pittsburgh, PA; and the NAC Sff and the Roland Lickus, at the NRC Region 111 Office, at (708) 790-NAC-C28 Sff, by Nuclear Assurance Corporation, 5666.
Norcross, GA.
NRC is prepared to address questions that LLW generators Other details of the amendment, which is principally to Part may have on the licensing consequences of site-access de-72 of the regulations, are contained in a Federal Register nial. Questions should be addressed to:
notice published on May 5,1989.
7
)
INFORMATION NOTICES PUBLISHED NRC licensees. The DOT regulations (49 CFR Pans 170 April 1,1990-July 31,1990 to 178) have been incorporated into NRC regulations (10 CFR Part 71).
A. Transportation of Model SPEC 2-T Radiographic Expo-sure Device-IN 90-24, dated April 10,1990.
E. Requirements for Processing Financial Assurance Sub-mittals for Decommissioning-IN 90-38, dated May 29, This information notice informs licensees of a recent 1990.
change in the U.S. Nuclear Regulatory Commission (NRC) Cenificate of Compliance (COC) No. 9056, This notice reminds licensees of requirements for finan-which imposes more restrictive requirements for proper cial assurance submittals for decommissioning.
transportation of the model SPEC 2-T device. As a result of reevaluation of possible dose rates for the device F. Dose-Rate Instruments Underresponding to the True Ra-when loaded with the 100 curies ofiridium-192 formerly diation Fields-IN 90-44, dated June 29,1990.
permitted under the COC, Conditions 8 and 9 of the COC were amended to limit the activity in the device to This notice informs licensees of the potential for under-45 curies and to reduce the maximum activity of irid-response at the two lower ranges for all magnet ann ium-192 per package trom 240 curies to 225 curies.
switching dose-rate instruments. Malfunctions may oc-cur for the Bicron Model RSO-5, the Bieron Model B. Clarification of the Recent Revisions to the Regulatory RSO-50, the Eberlire Model RO-2, and the Eberline Requirements for Packaging of Uranium Hexafluoride Model RO-2A.
(UF6) for Transponation-IN 90-27, dated April 30, i
1990.
RULEMAKINGS PUBLISHED This notice reviews and clarifies two rulemaking actions March 9,1990-July 31,1990 by the U.S. Department of Transportation. The new 49 FINAL RULES CFR 173.420 in Docket HM-166V formalizes, as regu-latory requirements, the use of cylinders, for UF6 trans-
. " Credit Check-Expanded Personnel Security Investiga-ponation, that have already been in use for many years, tive Coverage" and adds several other requirements. The rulemaking in Docket HM.190 upgrades the regulatory requirements
- 1. Published 3/29/90; correction published 04/17/90 for the fabrication, maintenance, and use of the DOT Specification 21PF-1 protective overpacks.
2.
Contact:
Jim Dunleavy (301) 492-7343 C. Update on Waste Form and High Integrity Container
. " Revision of Fee Schedules: Radioisotope Licenses and Topical Report Review Status, Identification of Prob-Topical Reports" lems with Cement Solidification, and Reporting of Waste Mishaps-IN 90-31, dated May 4,1990.
- 1. Published 05/23/90; corrections published 06/12/90, 06/22/90 This notice informs licensees of recent developments conceming the stability of waste forms that contain 2.
Contact:
C. James Holloway (301) 492-4301 Classes B or C low-level waste. Attachment I lists the status of NRC reviews of topical reports on waste forms
. " Storage of Spent Nuclear Fuel in NRC-Approved Stor-and high integrity containers. Licensees are encouraged age Casks at Nuclear Power Sites" to obtain a copy of NUREG/ CP-0103, which repons the results of the Workshop on Cement Stabilization of I. Published O7/18/90 Low-Level Radioactive Waste, which NRC hosted on May 31 - June 2,1989, to determine if any of the topics 2.
Contact:
John Telford (301) 492-3796 discussed will potentially improve their application of waste solidification processes. Licensees should be PROPOSED RULES aware of the possibility of deleterious chemical reaction during waste solidification using cement. Attachment 2
" Willful Misconduct by Unh.eensed Persons" lists waste constituents that could cause problems with campaigns. NRC is increasingly concerned about mis-
- 1. Published 04/03/90; correction published 04/11/90 haps that have occurred during the solidification oflow-level waste and is evaluating mechanisms for obtaining 2.
Contact:
Geoffrey Cant (301) 492-3283 reports on such mishaps.
D. Transportation of Type A Quantities of Non-Fissile Ra-i dioactive Materials-IN 90-35, dated May 24,1990.
- 1. Published 05/14/90 1
7his notice summarizes and clarifies the basic require-2
Contact:
Joe Mate (301) 492-3795 ments of DOT Hazardous Materials Regulations that ar most frequently cited regarding deficiencies or viola-REGULATORY GUIDES ISSUED tions, during inspections of transportation activities of October 6,1989-July 31,1989
I 3
Guides in Final Form exposure to the thyroid of 30,000 rads. The mother received an estimated exposure of 8.9 rads to her breasts.
- 3.66," Standard Format and Content of Financial Assur-ance Mechanisms Required for Decommissioning under Another similar incident at a smaller facility involved a 10 CFR Parts 30,40,70, and 72" young woman, scheduled for a thyroid evaluation, who ar-rived carrying a young baby. The technologist assumed the
- 1. Published:06/90 baby was hers, and that she was not pregnant. Without ask.
- 2. For information. contact: Keith Steyer (301) 492-3824.
ing if the patient was pregnant, the technologist adminis-j tered 15 microcuries of iodine-131. Almost immediately af-Guides in Draft Form ter receiving tbc dose, the patient told the technologist that she was 4 to 5 weeks pregnant. The total body dose to the
- 3.58, Revision 1," Criticality Safety for Handling, Storing, fetus was estimated to be 2.7 to 4.6 millirems. Since the fetal and Transporting LWR Fuel at Fuels and Materials Facili-thyroid is incapable of concentrating iodine-131 until 10 to ties" 12 weeks, there was estimated to be no additional radiation exposure to the thyroid. There was no requirement at this
- 1. Published: 05/90 facility to ask if a patient were pregnant or nursing a child.
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- 2. For information, contact: Keith Steyer (301) 492-3824.
l-NRC is preparing an information notice concerning the l
- " Basic Quality Assurance Program for Medical Use" aforementioned incidents and several others in an attempt to I
draw attention to the serious consequences of errors in the
- 1. INblished:01/90 administration ofiodine-131.
- 2. For information, contact: Anthony Tse (301) 492-I 2797.
ADVISORY COMMITTEE ON THE MEDICAL USE OF ISOTOPES (ACMUI)
SURVEY EVALUATING GENERAL LICENSE EF-FECTIVENESS The U.S. Nuclear Regulatory Commission (NRC) convened a meeting of the ACMUI on July 10,1990, at the Holiday The U.S. Nuclear Regulatory Commission's (NRC's) rules Inn, Crown Plaza Hotel. De meeting was open to the pub-l governing the licensing of byproduct material provide for lic.
the use of a general license for the receipt, possession, use, and transfer of certain devices. NRC is carrying out a survey The committee was provided with status updates on: The of general licensees, under 10 CFR Part 31.5, to evaluate the Visiting Fellows Program, Rulemaking for Basic Quality effectiveness of the general license. Three-thousand firms Assurance in Medical Use, and Rulemaking for the Practice i
have been chosen to panicipate in the survey during the next of Medicine and Pharmacy.
6 months. The survey, conducted under a contract with ICF Incorporated, is intended to confinn the placements, use, The following items were discussed: Training and Experi-condition, and/or disposition of devices transferred to gen-ence Criteria for Medical Users of Byproduct Material, the eral licensees between 1980 and 1989. A report will be is-desired frequency of meetings of the ACMUI, and how best sued upon completion of the survey, to expand the membership of the committee.
It is important that general licensees who receive a survey The next meeting of the ACMUI will be in January 1991, questionnaire fill it out fully and accurately and return it in with fall and spring meetings to follow thereafter.
the postage-paid envelope provided. General licensees who have questions about the survey questionnaire should con-MEDICAL VISITING FELLOWS PROGRAM tact ICF Incorporated at (800) 331-9212. The survey has The U.S. Nuclear Regulatory Commission (NRC) is seeking been approved by the Office of Management and Budget.
to expand its understanding of the regulated community bh creating a program for Medical Visiting Fellows. The objec-MEDICAL USE OF IODINE 131 INCIDENT tives of this program are to improve NRC,s knowledge of The U.S. Nuclear Regulatory Commission (NRC) recently the medical community; to keep abreast of new technology received notification of a medical incident at a large broad-and developments in the diagnostic and therapeutic uses of scope licensed facility. The incident involved the adminis-isotopes; to develop an awareness of the socio-economic tration of iodine-131 to a nursing mother and the resulting factors governing health care; to develop and sustain a base radiation exposure to her child.
of experienced individuals familiar with the regulatory envi-ronment; to improve NRC's regulatory process; and to de-The incident occurred when a patient, scheduled for a yearly velop medical use regulations that minimally intrude into total body scan, was administered 4.8 millicuries of iodine-medical practice.
131, and later found to be nursing a child. This facility's procedures require assessment for pregnancy and determina-Individuals participating in the Medical Visiting Fellows tion of whether a patient is nursing a child. In this case, the Program (MVFP) would join NRC full-time, for approxi-patient was sent for a pregnancy test, but was not questioned mately 1 year, at Headquarters, in Rockville, MD, ne pur-tbout nursing. The 2-week old infant received an estimated pose is to undertake activities consistent with the interests whole-body radiation exposure of 17 rads, and an estimated and needs of NRC, and with the individual's training and
9 experience, that will result in a clearly defined assignment based on a violation involving the release of radon-useful to NRC's medical regulatory program.
222 concentrations to an unrestricted area in excess of 220 percent of the maximum permissible con-It is anticipated that the Fellows would attend meetings of centrations permitted by 10 CFR 20.106, when av-NRC's Advisory Committee on Medical Use of Isotopes eraged over 1 year. The civil penalty was increased (ACMUI) meetings of Federal, State, and local agencies; by 25 percent because of prior notice. The licensee meetings of professional organizations; and meetings of responded in letters dated November 3,1989, and other groups, to participate in discussions on issues related January 12,1990. After consideration of the licen-i to medical affairs and radiation medicine. Former Fellows see's responses, the staff concluded that the licen-may be asked to participate, from time to time, in sponsored see provided justification for the civil penalty to be meetings and seminars, after their appointments end, to pro-r-duced by $2,500. An Order imposing Civil Pen-vide advice and consultation about the regulated program alty for $3,750 was issued March 27,1990.
and the MVFP.
2.
Basin Testing Laboratory, Inc., Williston, North In the Federal Register Notice of June 7,1990, NRC invited Dakota, Supplement VI, EA 88-265 nominations of physicians having expert qualifications in the medical specialty fields of Nuclear Medicine or Radia.
A Notice of Violation and Proposed Irrposition of tion Oncology. Others having expert qualifications in related Civil Penalty in the amount of $5,000 was issued fields such as Diagnostic Radiological Physics, Therapeutic January 19, 1989, to emphasize the need for in-Radiological Physics, or Radiopharmacy were also invited creased and improved management attention to ac-to apply. Candidates were nominated by professional tivities authorized by the lic:nse, so as to ensure groups, medical societies, or were self-nominated. The that these activities are condeted safely and in ac-cordance with the license. The action was based on nomination period closed on August 31,1990.
violations involving: (1) permitting radiography ac-An NRC evaluation panel will complete a review of each tivities to be independently conducted by an indi-applicant primarily on the basis of the nomination packet Vidual who was not qualified to conduct these ac-submitted. Each individual's professional experience and tivities except under direct supervision; (2) failing interest in terms of the objectives of the Commission will be to notify NRC of licensed activities in Wyoming reviewed. 'Ihe review and selection process will also include and Montana; (3) violations of the requirements an interview with NRC personnel. One or more individuals associated with the transportation of radioactive will be selected, depending on the availability of qualified materials; and (4) providing NRC inaccurate infor-applicants and the needs of the Commission at the time of mation m response to violations identified during selection. The commencement and duration for each Fel-an NRC inspection. The licensee responded on low's appointment will be determined on a case-by-case February 22, 1989, requesting mitigation. After basis.
considering the licensee's response, an Order Im-posing Civil Penalty and an Order to Show Cause NRC intends to periodically publish Federal Register No.
Why License Should not be Suspended were issued tices announcing a call for nominations of Fellows for the December 6,1989. The licensee requested a hear-MVFP. If you would like additional information about this ing on December 29, 1989. A settlement was program, please contact Janet Schlueter, Medical and Aca-reached on April 9,1990, with the licensee agree-demic Section at (301) 492-0633.
ing to pay the penalty by installment.
3.
Bass Memorial Baptist Hospital, Enid, Oklahoma SIGNIFICANT ENFORCEMENT ACTIONS AGAINST MATERIALS LICENSEES Supplements IV and VI. EA 90-057 One way to avoid regulatory problems is to be aware of en-A Notice of Violation and Proposed imposition of forcement problems others have faced. Thus, we have in.
Civil Penalty in the amount of $3,125 was issued cluded here a discussion of some representative enforcement May 2,1990, to emphasize the importance of com-actions against materials licensees. These enforcement ac-pliance with radiction safety requirements and the tions include civil penalties, orders of various types, and need for the licensee to establish effective manage-notices of violations, ment and audit programs. The action was based on violations relating to the licensee's failures to:
A. CIVIL PENALTIES AND ORDERS comply with NRC's requirements related to ensur-ing the proper operation of the licensee's dose cali-1.
Atlas Corporation, Grand Junction, Colorado Sup-brator; perform surveys and calibrate survey instru-plement IV, EA 89-110 ments; inventory, label, and maintain surveillance over licensed materials; and keep required and ade-A Notice of Violation and Proposed Imposition of quate records required by the radiation safety pro-Civil Penalty in the amount of $6,250 was issued gram. The civil penalty was escalated by 25 per-October 5,1989, to emphasize the licensee's re-cent because NRC identified the violations.
sponsibility to conduct its activities in compliance with radioactivity release limits and its responsibil-4.
Bridgestone/Firestone, Inc., Oklahoma City, Okla-ity to heed regulatory requirements. The action was homa, Supplements IV and VI, EA 90-004
10 A Notice of Violation and Proposed Imposition of ties authorized by the license. The action was based Civil Penalty in the amount of $1,000 was issued on the deliberate administration of excessive pa-March 13,1990, to emphasize the importance NRC tient doses of licensed radioactive material by the places on the effective management of radiation licensee's nuclear medicine technologist for a 4-safety programs and compliance with license re-year period, the deliberate falsification of records quirements. The action was based on incidents in-to reflect the prescribed doses rather than the actual volving: (1) loss of a measuring gauge containing assayed and subsequently administered doses, and 25 millicuries of cesium-137; and (2) entries into a the failure to report the misadministrations caused vessel equipped with a radioactive gauge, when the by this practice, when it became known to the li-shutter on the gauge was not closed or locked.
censee's Director of Radiology.
- 9. San Juan Cement Company, San Juan, Puerto Rico Supplements IV and VI, EA 90-016 An Order Modifying License was issued February 13,1990, based on the identification of an unmoni-A Notice of Violation and Proposed Imposition of tored release of radioactively contaminated water Civil Penalty in the amount of $750 was issued from the facility's reactor building to an onsite re-March 28,1990, to emphasize the importance of tention pond, as a result of a failure of the concrete radiation safety requirements and adequate prepa-wall of the gamma pit and a subsequent failure of ration and coordination of those requirements with the holdup tank. He licensee responded to the Or-regard to NRC-licensed materials. The action was der on March 5,1990, and it was determined that based on failures to: supervise activities involving the response was not adequate. After further com-licensed material; secure licensed material from un-munication with the licensee, the licensee notified authorized removal; maintain radiation levels in NRC that it was decommissioning the plant.
unrestricted areas below regulatory limits; conduct surveys to evaluate the extent of radiation hazards 6.
Divine Providence Hospital, Williamsport, Penn-present; and post NRC regulations, sylvania, Supplements IV and VI, EA 90-038
- 10. United States Testing Company, Modesto, Califor-A Notice of Violation and Proposed Imposition of nia, Supplements IV and VI, EA 89-148 Civil Penalty in the amount of $2,500 was issued April 11,1990, to emphasize the need for the medi-A Notice of Violation and Proposed Imposition of cal centar management, the Radiation Safety Com-Civil Penalty in the amount of $5,000 was issued mittee, and the Radiation Safety Officer to aggres.
September 26,1989, to emphasize the unaccepta-sively monitor and evaluate licensed activities, to bility of violations that individually or collectively ensure that these activities are conducted safely and cause a substantial potential for exposure in excess in accordance with the terms of the license. The of 10 CFR Part 20 limits and the need for adequate action was based on numerous violations that were planning and execution of operations, to avoid such considered to represent a breakdown in the control violations. De action was based on a number of of the licensee's radiation safety program.
violations, including the failure to properly estab-lish and provide surveillance of radiation bounda-7.
Milford Memorial Hospital, Milford, Delaware, ries during radiograhic operations at a hospital. The EA 87-44 licensee responded on November 22,1989, contest-ing the violations and civil penalty. A settlement An Order Modifying License, Effective immedi-was signed May 21,1990, ately, was issued June 15,1987, to remove an indi-vidual from the positioit of Radiation Safety Offi-
- 11. Veterans Administration Medical
- Center, cer (RSO). The Order also suspended his authority Brooklyn, New York, Supplement VI, EA 89-190 to independently use or supervise the use of li-censed material, required independent monthly au-A Notice of Violation and Proposed Imposition of dits of the radiation safety program, and required Civil Penalties in the amount of $8,750 was issued the new RSO to review the program, take correc-November 28,1989, to emphasize the need for the tive action for identified deficiencies, and submit a licensee to aggressively monitor and evaluate li-letter to NRC certifying that the program is being censed activities throughout the facility. De action operated safely and in accordance with the tenns was based on violations involving: (1) failure to and conditions of the license. On May 31,1989, a follow emergency procedures to remove the patient letter was issued indicating that the conditions of from the room when a teletherapy treatment timer the order had all been met.
continued to operate beyond its present time and the source did not return to its shielded position; 8.
Russell County Medical Center, lebanon, Virginia and (2) 14 violations which m the aggregate dem-Supplements VI and VII, EA 90-006 onstrate a lack of management oversight. He li-censee responded to the Notice in a letter dated A Notice of Violation and Proposed Imposition of January 3,1990. After consideration of the licen-Civil Penalty in the amount of $3,750 was issued see's response, the staff concluded the violations March 16,1990, to emphasize the need for contin-occurred as stated. An Order Imposing Civil Penal-ued and effective management control over activi-ties was issued April 20,1990.
1 l
e
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.o 11 B. SEVERITY LEVEL III VIOLATION, NO CIVIL PEN-tact or visit will depend on the contractor's specific goal for ALTY that contact or visit. Contractors will offer participants the greatest degree of confidentiality possible. Information pro-1.
Kettering Medical Center, Kettering, Ohio, Supple-vided by panicipants will only be used to identify potential ment VI, EA 90-075 root causes for human error in brachytherapy, teletherapy, and industrial radiography.
A Notice of Violation was issued June 5,1990, based on the following: (1) ambient dose rates in If you have any questions about the human factors evalu-the storage area for branchy-therapy sources were ations, the Nuclear Material Safety and Safeguards (NMSS) not measured on a quarterly basis; (2) records to contact for all three projects is Dennis Serig. He may be show the receipt or transfer of byproduct material reached at (301) 492-3362.
were not generated before January 1,1988; (3) the calibration and reference sealed sources in the pos-session of the licensee were not listed on invento-ries; (4) the sealed source leak test results were re-corded in counts per minute, rather than in micro-curie amounts; (5) a patient with a permanent im-Comments and suggestions you may have for infor-plant of radioactive material was not surveyed be-mation that is not currently being included, that might fore discharge from the hospital; (6) the radiation be helpful to licensees, should be sent to:
safety program was not reviewed on an annual ba-sis by the radiation safety committee; (7) bioassays K. Kraus of employees handling liquid iodine-131 were not NMSS Licensee Newsletter Editor always conducted within the specified time period; Office of Nuclear Material Safety and Safeguards (8) rooms of therapy patients were not always sur-One White Flint North, Mail Stop 6-A-4 veyed; and (9) employees did not receive required U.S. Nuclear Regulatory Commission refresher training on an annual basis. A civil pen-Washington, D.C. 20555 alty was not proposed because the individual viola-tions were identified by the licensee's employees before the inspection, and the licensee took exten-sive corrective actions to correct the breakdown in the management of the radiation safety program.
HUMAN FACTORS EVALUATIONS Misadministrations of nuclear material used for medical pur-poses and occupational exposures of workers involved in industrial radiography are often blamed, at least in part, on human error. Reduction of human error in medical and in-dustrial use of nuclear material requires detailed knowledge of the tasks people perform, of the requirements those tasks place on the people who perform them, and of the factors thit can enhance or degrade performance of those tasks. To obtain this knowledge, the U.S. Nuclear Regulatory Com-mission (NRC) has selected contractors to perform " human factors evaluations" of brachytherapy using remote after-loaders (Pacific Science and Engineering Group, Inc.), tele-therapy (CAE-Link Corporation), and industrial radiography (B:ttelle Human Affairs Research Centers).
Conduct of the human factors evaluations will require the contractors to contact and visit a number of NRC and State licensees over the next 18 months. Those contacts and visits will not be inspections. NRC encourages participation if you are contacted, but you are under no obligation to participate.
Contractors will use a variety of means during contacts and visits to learn how and under what conditions tasks associ-sted with brachytherapy, teletherapy, and industrial radiog-r phy are performed. Examples are direct observation of ac-tual or simulated operations, comparison of equipment and procedures against accepted human factors guidelines, inter-views, and questionnaires. Means used on a particular con-
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UNITED STATES nn., et,,,,,3 NUCLEAR REGULATORY COMMISSION Post ^os*ressraio WASHINGTON, D.C. 20555 PERMIT No. 0-47 OFFICIAL P%INESS PFNALTY FOR PRIVATE USE, $300 t -
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D U.S. Covernment Printing Office i 1990 232 326/40003