ML20196J917
| ML20196J917 | |
| Person / Time | |
|---|---|
| Issue date: | 06/14/1999 |
| From: | Sturz F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Hyer R TN TECHNOLOGIES, INC. (FORMERLY TEXAS NUCLEAR CORP.) |
| References | |
| GL-99-01, GL-99-1, NUDOCS 9907080075 | |
| Download: ML20196J917 (2) | |
Text
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- y. t UNITED STATES NUCLEAR REGULATORY COMMISSION f WASHINGTON, D.C. 20565 4 001 June 14, 1999 TN Technologies ATTN: Ralph S. Hyer, Radiation Sdety Officer and Manager of Regulatory Affairs 2555 North PAerstate Highway 35 Post Offica Box 800 FUBLIC COCUMENT ROOM Round Hock, Texas 78680-0300
'99 JIN 17 I"0 N
Dear Mr. Hyer:
Your letter dated May 10,1999, requested all documentation relating to a risk assessment on bundled exempt sources; it asked "how can a manufacturer distribute unknown quantities of plastic sources with no regulatory standards for accountability or record keeping requirements,"
and it also asked if the NRC Registry "is consistent with the goals and objectives outlined in SECY-97-273 . . . ?"
Your request for all documentation relating to a risk assessment on bundled exempt sources has been referred to our Rulemaking and Guidance Branch, who manage risk assessment projects, through the Freedom of Information Act (FOIA) process.
We believe your question on how a manufacturer can distribute unknown quantities of plastic sources with no regulatory standards for accountability or record keeping requirements is answered by our enclosed Generic Letter 99-01 (GL 99-01), 'Recent NMSS Decision Concerning Bundling of Exempt Quantities"(Enclosure 1). GL 99-01 explains current Nuclear Regulation Commission (NRC) policy and recommendations concerning the possession and use of bundled exempt quantity sources pursuant to the exemptions in 10 CFR Part 30.
Authorized licensees may distribute these devices to a specific or general licensee only. At the present time, NRC authorizes the distribution of these devices only in accordance with the controls, such as accountability and record keeping, associated with a general distribution or specific license.
Our July 27,1998 letter, also indicated that device distributors must have their designs evaluated and registered with the NRC or an Agreement State. In addition, to distribute a generally licensed gauging device pursuant to 10 CFR 31.5, the requirements in 10 CFR 32.51 must be met. An applicant must submit sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device. Currently two manufacturers have been authorized to distribute gauging devices containing bundled exempt sources to general licensees. One manufacturer has been authorized by NRC and the l other by the State of Kentucky. g 9907080075 990614 '
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e UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 May 3,1999 NRC GENERIC LETTER 99-01: RECENT NUCLEAR MATERIAL SAFETY AND SAFEGUARDS DECISION ON BUNDLING EXEMPT QUANTITIES Addressees: All materials licensees.
Purpose:
The U.S. Nuclear Regulatory Commission (NRC) is issuing this generic letter to notify addressees about a recent Office of Nuclear Material Safety and Safeguards decision concerning bundling exempt quantities. NRC does not authorize: (a) the bundling of exempt quantities of byproduct material; (b) any program advising persons to combine exempt quantity sources; and (c) the possession and use of bundled exempt sources, in unregistered devices, by persons exempt from licensing. It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate. However, no specific action nor written response is required.
Discussion:
The NRC regulations that exempt any person from the requirements for a license for byproduct material are found in 10 CFR 30.18. A person is exempt from licensing requirements to the extent that such a person possesses, uses, transfers, owns, or acquires byproduct materialin individual quantities, each of which does not exceed the applicable quantity in 10 CFR 30.71, Schedule B (i.e., an " exempt quantity"). A person wishing to commercially distribute or initially transfer products containing byproduct material, such as exempt quantity check sources, to persons exempt from licensing, must obtain an exempt distribution license from NRC.
To obtain an exempt distribution license from _NRC, product information must be submitted as outlined in 10 CFR Part 32 and, specifically, for exempt quantities, as outlined in 10 CFR 32.18, 32.19, and 32.20. In addition, pursuant to 10 CFR 32.18(c), NRC will not approve a license to manufacture, process, produce, package, repackage, or transfer quantities of byproduct
! material to persons exempt, pursuant to 10 CFR 30.18, if the exempt quantities are incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution.
-9904290i55 -
1 Enclosure 1 l
Y l-J GL 99-01 May 3,1999 Page 2 of 3 Several years ago staff became aware of the bundling of a limited number of exempt quantity sources in gaugmg devices. On June 3,1994, NRC determined that, under certain limited circumstances, bundling of exempt sources did not present a health and safety hazard.
However, recently NRC has received requests for permission to distribute an increased number of bundled sources in similar devices.. As a result, NRC became concerned that the individual numbers of exempt sources bundled in such devices would reach some point where a general or specdic hcense would normally be required. In the case whe.:: the bundled exempt sources remamed exempt, NRC would have no mechanism to ensme their safe possession, use, and disposal Based upon a thorough reexamination, including discussions with Agreement States to ascertain their perspectives, NRC now has determined that combining any exempt sources is mconsstent with the regulations, pursuant to 10 CFR 30.18, 32.18, 32.19, and 32.20.
Instructog persons exempt from licensing to combine exempt quantities, c.d providina devices for them to do so, is in direct conflict with NRC's requirements for labeling of exempt sources.
Sechon 32.19 specifically instructs persons not to combine exempt quantities, since the exemphon provided in 10 CFR 30.18 is applicable only as long as no individual nor discreet quantity of the byproduct materials exceeds the quantity limits specified in 10 CFR 30.71, Schedule B, and as long as the quantities set out in that schedule are originally received and remain wparate and distinct from other quantities of exempt byproduct materials. The labeling requirements in 10 CFR 32.19, which address shipments to exempt persons, instruct 10 CFR 32.18 licensees to label the "immediate container" with information identifying the radmisotope and the quantity of radioactivity, and in addition to that information, the container ".
. . shall also bear the words . . . ' Exempt Quantities Should Not Be Combined." Therefore, although the exemption in 10 CFR 30.18 provides for persons without a license to possess and use a wide variety of byproduct materials, and to possess and use specific byproduct materials ;
without restriction as to the total quantity that may be possessed and used at any one time, the regulabons do not authorize, but rather discourage, grouping exempt quantities of byproduct material. j
. At this time, devices already in use, having multiple exempt quantities of byproduct material, may contmue to be used. NRC does not plan to take any action regarding these devices or users unless a radiologecal safety hazard is identified. However, persons possessing such J devices should maintain control and account for these dev6ces and the exempt sources contamed within them To this end, it is good practice to clearly label the devices with radmactive matenals waming labels bearing the standard radiation warning symbol and !
standard magenta (or purple) and yellow colors. Additionally, it is preferable to not dispose of devices containing multiple exempt sources through ordinary commercial waste disposal or metal recycling channels because of the presence of bundled radioactive material. If devices containing sources are no longer needed, the supplier should be consulted for advice regarding proper deposal options.
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GL 99-01 May 3,1999 Page 3 of 3 l NRC plans to further evaluate the risks associated with these devices. After this evaluation, NRC will consider appropriate steps, including rulemaking, to clarify the regulatory status of these devices and assure the protection of the public health and safety and with consideration of property protection. It is anticipated that the evaluation and rulemaking process, if undertaken, I will take 2 to 3 years.
If you have any questions about this matter, please call the technical contact listed below or the appropriate regional office.
1 1-c-
Donald A. Cool, Director Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l
Contact:
Anthony S. Kirkwood, NMSS l
(301)415-6140 l E-mail: ask@nrc. gov i
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Attachment:
List of Recently issued NRC Generic Letter's. l l
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! Attachment GL 99-01 May 3,1999 Page 1 of 1 LIST OF RECENTLY ISSUED GENERIC LETTERS l
GENERIC DATE OF LETTER SUBJECT ISSUANCE ISSUED TO 98-01, Supp.1 Year 2000 Readiness of Computer 1/11/99 All holders of operating li Systems at Nuclear Power Plants licenses for nuclear power Plants, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel. j 98-05 Boiling Water Reactor Licensees 11/10/98 All holders of operating Use of the BWRVIP-05 Report licenses (or construction ,
To Request Relief From Augmented permits) for BWRs, except !
Examination Requirements on Reactor those who have permanently l Pressure Vessel Circumferential Shell ceased operations and have Welds certified that fuel has been permanently removed from the reactor vessel.
98-04 Potential for Degradation of the 07/14/98 All holders of operating Emergency Core Cooling System licenses for nuclear power And the Containment Spray System reactors, except those who After a Loss-of-Coolant Accident have permanently ceased Because of Construction and operations and have certfied Protective Coating Deficiencies that fuel has been and Foreign Materialin Containment permanently removed from the reactor vessel.
98-03 NMSS Licensees' and Certificate 06/22/98 Alllicensees or certificate Holders' Year 2000 Readiness holders for uranium Programs hexafluoride production plants, uranium enrichment plants, and uranium fuel fabrication plants, except l those that have permanently l ceased operations OP = Operating License CP = Construction Permit NPR = Nuclear Power Reactors
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
! SAFETY EVALUATION OF DEVICE
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l NO. NR-186-D-117-G DATE: AUG pp gg PAGE 1 OF 9 l
l DEVICE TYPE: Gamma Gauge MODEL: NW-201 Series, NW-301 Series, NW-401 Series i
l MANUFACTURER / DISTRIBUTOR: Berthold Systems,.Inc. l Hopewell Business Park l 101 Corporation Drive Aliquippa, PA 15001 l
l SEALED SOURCE MODEL DESIGNATION: Berthold Systems, Inc.: 39002 ISOTOPE: MAXIMUM ACTIVITY:
Cesium-137 900 microcuries (33. 3 - MBq) no single source to exceed 10 microcuries (370 kBq)
LEAK TEST FREOUENCY: Not Required 1 PRINCIPAL USE: (D) Gamma Gauge CUSTOM DEVICE: YES X NO l
Enclosure 2 l A 'l)vi&5CvVO lb ff. l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
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NO.- NR-185-D-117-G DATE:
AUG 2 8 338 PAGE 2 OF 9 DEVICE TYPE: Gamma Gauge DESCRIPTION:
The Model NW-201 Series, NW-301 Series, and NW-401 Series source housings are designed to be installed in fixed locations to measure material density or fill level in various applications including pipelines, tanks, and other containers or flow processes. Each source housing contains multiple sources, each source containing no more than 10 microcuries (370 kBq). The multiple sources are installed into machined " pockets" and are held in place by epoxy. Descriptions of each source housing are listed below.
NW-201 Series The Model NW-201 Series source housings have variable dimensions ranging from 5-8." (12. 7 - 2 0. 3 cm) in diameter and 2-6" (5.1-15.2 cm) in height. The construction of the source housing is either lead or tungsten shielding sandwiched between stainless steel plates.
In its shipping condition, the source housing has the source sandwiched between two halves of the shielding. However, upon i installation, one half of the shielding (the removable shipping cap) is removed and installed on the back of the other half of the shielding. This condition will expose the radiation beam while providing additional shielding at the back of the source l 1
housing. The source housing does not have a shutter mechanism.
To ensure'that the dose rates at the accessible surfaces of the applications do not exceed 2 mrem /hr (20 pSv/hr), installation of the Model NW-201 Series source housings are subject to the following:
Pipes l
- no smaller than 4" (10.2 cm) diameter, schedule 40 pipe '
under any conditions.
no smaller than 10" (25.4 cm) diameter, schedule 40 pipe when containing more than 300 microc:uries (11.1 MBq)
- no smaller than 14" (35.6 cm) diameter, schedule 40 pipe when containing more than 500 microcuries (18. 5 MBq) l l
l Vessels:
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- no smaller than 14" (35.6 cm) diameter, schedule 40 pipe under any conditions.
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p L-e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
' .1,.1 AUG 28 IBB NO.- NR-186-D-117-G_ DATE: PAGE 3 OF 9 DEVICE TYPE: Gamma Gauge DESCRIPTION (Cont.)-
NW-301 Series l The Model NW-301 Series source housir.js have variable dimensions ranging from 12-60" (30.5-152.4 cm) in length, 1-4" (2.5-10.2 cm) in height, and 2-6" (5~.1-15.2 cm) in width. The construction of the source housing is either solid tungsten or lead encased in steel. Upon installation, the housing acts similar to a strip source mounted on the side of a vessel. The source housing does
! not have a shutter mechanism. In its shipping condition, the source housing is " folded" in half so that the beam ports of the two halves are facing each other.
To ensure that the~ dose rates at the accessible surfaces of the
' applications do not exceed 2 mrem /hr (20 Sv/hr), Model NW-301 Series' source housings may only contain up to 300 microcuries (11.1 MBq) of cesium-137.
NW-401 Series The Model NW-401 Series source housings have variable dimensions i with a minimum diameter of 2.5 (6.4 cm) and minimum height of 2.5" (6.4 cm). The source housing is constructed of tungsten with a machined area that would allow for mounting to a pipe.
l The radius of the machined area is the same as the pipe to which it will be attached. The sources are mounted in the center of i
the cylindrical construction.
In its shipping condition, a source is installed in the machined area to provide' shielding. However, upon installation, the source cap is removed. The source 'ising does not have a shutter mechanism.
To ensure that the dose rates at the accessible surfaces of the applications do not exceed 2 mrem /hr (20 pSv/hr), Model NW-401 Series source housings may only contain up to 300 microcuries
'(11.1 MBq) of cesium-137 and may be attached to pipes with a minimum diameter of 2" (5.1 cm).
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE NO.- NR-186-D-117-G DATE: 28E PAGE 4 OF 9 !
i DEVICE TYPE: Gamma Gauge DESCRIPTION (Cont.)-
39002 Source The Berthold 39002 source is registered as part of this source housing and is not registered separately. The 39002 source is !
0.375" (1.0 cm) in diameter by 0.008-0.009" (0.20-0.23 mm) thick l and may contain up to 10 microcuries (370 kBq) of cesium-137.
The source is not manufactured by Berthold Systems but must be l
manufactured to Berthold's specifications. l Since no single source used in the source housings exceeds 10 microcuries (370 kBq), leak testing of the source housings is not required.
LABELING:
The source housings are labeled in accordance with 10 CFR 20.1901 and 10 CFR 32.51.
The source housing serial number is engraved into each source housing. A stainless label, either attached to the source housings by rivets or a stainless steel tether, will be engraved with the source housing model number, isotope, activity, date of assay, the radiation symbol, and the name and telephone number of the distributor. In addition, it will contain the following wording:
Abandonment or disposal prohibited unless transferred to Berthold Systems, or B persons specifically hcensed by the U.S. Nuclear Regulatory Commission or an Agreement State. Operation prohibited if there is indication of failure of or damage to housing or source containment. Installation and relocation can only be performed using the specific instructions suppled in the operating manual of the device.
Dismantling, rraintenance, repair and testing involving the radioactive material, its housing o', containment shall be perform by Berthold Systems, Inc and other specific 4-licensee <,. The device is not required to be tested for radioactive leakage. Loss, theft, or tran'.,fer of this device and failure of or damage to the shielding and source contranment must be reported to Berthold Systems. Inc. and the U S Nuclear l Regulatory Commission or an Agreement State The receipt, possession, use, and transfer of the device are subject to a general heense or the equivalent and the l regulations of the U.S. NRC or of a State with which the NRC has entered into an l agreement of the exercise of regulatory authority, This label shall be maintained on the device in a legible condition. Removal cf this label is prohibited. This device is registered with the U.S. Nuclear Regulatory Commission.
CAUTION - RADIOACTIVE MATERIAL
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REGISTRY OF RADIOACTIVE ~ SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-186-D-117-G DATE: 2 0 UN PAGE 5 OF 9 DEVICE TYPE: Gamma Gauge LABELING (Cont.):
The source housing labeling is exempt from the conventional color requirements of 10 CFR 20.1901.
- DIAGRAM:
See attachments 1-3. I CONDITIONS OF NORMAL USE: l The source housings will be used in industrial applications to measure material density or fill level in various applications j I
including _ pipelines, tanks, and other containers or flow {
processes. = Possession and use of the source housings is restricted to environments that do not exceed the following conditions:
Temperature: -25 to 100*C (-13 to 212 *F)
Unlikely to be subjected to thermal shock Humidity: 0 to 100%
Impact: Cannot be mounted at heights exceeding 30 feet (7.6 m).
External-Pressure: 3.6 psi to 1 atmosphere vibration: Low - simple harmonic motion having a maximum amplitude of 0 03" (0.76 mm) and maximum frequency _of 50 Hz.
-Corrosion: Slight - i.e., low concentrations of corrosive fumes / chemicals.
Fire and Explosion: Environments where fire and explosion are unlikely.
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-186-D-117-G DATE: rggg PAGE 6 OF 9
.gg DEVICE TYPE: Gamma Gauge PROTOTYPE TESTING:
Prototypes of the source housings were constructed and subjected to the tests listed below. No malfunction occurred nor was there any loss of shielding or cc.'+ainment integrity as a result of the testing.
Temperature Cycle testing from -25"C to 100 C (-13 to 212*F).
Humidity Held at 538*C (1000 F) for 5 minutes.
Impact 100% at 50 C (122 F) for 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> Drop from 30 feet (7.6 m).
The' sealed source was tested as part of the source housings.
No information was submitted concerning prototype testing of the sources when not installed in.the source housings.
EXTERNAL RADIATION LEVELS:
Berthold has committed to verify that the dose rates at the surface of each source housing will not exceed 0.5 mrem /hr (5 uSv/hr), except at the surface of the beam port, which will not exceed 100 mrem /hr (1 mSv/hr). In addition, Berthold has demonstrated that the dose rates on all accessible surfaces of the installation will not exceed 2 mrem /hr (20 Sv/hr).
OUALITY ASSURANCE AND CONTROL:
Berthold maintains a quality assurance and control program which has been deemed acceptable for licensing purposes by NRC. A copy of the program is on file with the NRC.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The device shall be distributed to persons generally licensed by the NRC or an Agreement State.
- Devices users are not subject to leak testing requirements.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.*-NR-186-D-117-G DATE: 10G 28158 PAGE 7 OF 9 DEVICE TYPE: Gamma Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont.)-
- Handling, storage, use, transfer, and disposal: as required by 10 CFR 31.5 or Agreement State equivalent.
+ The device labeling is exempt from the conventional color requirements of 10 CFR 20.'1901.
- General licensees may install the devices provided the installation is in accordance with the instructions provided by Berthold Systems, Inc. However, general licensees may not perform any other type of servicing of the devices.
- -This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Berthold has submitted sufficient information to provide reasonable assurance that-3
- The device can be safely operated by persons not having i training in-radiological protection.
- Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device i will not be released or inadvertently removed from the !
source housing, and it is unlikely that any person will l receive-in any period of one year a dose in excess of 10 percent of the limits specified in Section 2 0 .12 01 ( a ) ,
- Under accident conditions associated with handling, storage, and use of the source housiag, it is unlikely that any person would receive an external radiation dose or dose ;
commitment in excess of the dose to the appropriate organ as ;
specified in the following chart:
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-REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE 4llf.
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NO. NR-186-D-117-G DATE: PAGE 8 OF 9
-400 2 8 293 DEVICE TYPE: Gamma Gauge SAFETY ANALYSIS
SUMMARY
(Cont.)-
PART OF BODY DOSE
-Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv)
Hands'and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 cm2 (0.15 in 2) 200 rem (2.0 Sv)
Other organs 50 rem (0.50 Sv)
Based on review of the Models NW-201 Series, NW-301 Series, and NW-401' Series source housings, and the information and test data cited below, we conclude that'the source housing is acceptable for licensing purposes.
Furthermore, we conclude that the source housing would be expected to maintain it's containment integrity for~ normal conditions of'use-and accidental conditions which might occur during uses specified in this certificate.
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' ' GISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
, , SAFETY ~ EVALUATION OF DEVICE
~
-a NO.: NR-186-D-117-G DATE: A nUG 2 8 EG8 PAGE 9 OF 9 DEVICE TYPE: Gamma Gauge
REFERENCES:
The following supporting decuments for the Model NW-201 Series, NW-301 Series,-NW-401 Series source housings are hereby incorporated by reference and are made a part of this registry document.
- Berthold Systems' letters dated August 25, 1998, August 21, 1998, July 29, 1998, and July 2, 1998, with~ enclosures thereto.
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- Berthold Systems' fasimile dated August 25, 1998, with enclosures thereto.
ISSUING AGENCY 1 U.S. Nuclear Regulatory Commission ,-
306 p g $gy Date: Reviewer
/@ohn W- Lubinski Date: Concurrence: / #
' Steven L7 Baggett
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R. Hyer . You also asked if the NRC Registry Certificate No. NR-186-D-117-G "is consistent with the goals and objectives outlined in SECY-97-273." We believe the NRC registry review for the distribution of devices containing bundled exempt sources to generallicensees is consistent with the risk-based, accountability and loss prevention registry program proposed for general
. licensees in SECY-97-273. .NRC Registration Certificate No. NR-186-D-117-G (Enclosure 2) allows the installation and relocation of the devices by the general licensee using the specific
. instructions supplied in the operating manual of the device. These instructions were reviewed and found acceptable for use by a person not specifically trained in radiation safety, i.e., the general licensee. In addition, requirements for accountability and loss prevention are described in 10 CFR 31.5, for all persons possessing and using generally licensed gauging devices.
Should you have any questions concerning this letter, please contact Anthony Kirkwood, of my staff at (301) 415-6140.
i Sincerely, (orig. signed by)
Frederick C. Sturz, Chief Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards cc: JLubenau, NRC, OCM/GJD
Enclosures:
- 1. GL 99-01
~ 2. NR-186-D-117-G DISTRIBUTION: NRC File Room IMNs r!! POR-YEs TCombs DOCUMENT NAME: H:\EX E M PT\32.18VNFoLTRs\R HYER2_M AY99.W PD C = COVER E = COVER & ENCLOSURE N = NO COPY oFC MslB,NMss C MslB.NMSs C MslB.NMss C NAME AsKirkwood:ask ag]d MLBurgess FCsturz l DATE 06/10 /99 06/ /99 06/N /99 OFFICIAL RECORD COPY I
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