ML20209D963

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Responds to Requesting All Documentation Re GL 99-01, Recent NMSS Decision Concerning Bundling of Exempt Quantities
ML20209D963
Person / Time
Issue date: 06/14/1999
From: Sturz F
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Hyer R
AFFILIATION NOT ASSIGNED
References
GL-99-01, GL-99-1, NUDOCS 9907140097
Download: ML20209D963 (2)


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magg I*a UMTED STATES y

NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20086-0001 June 14, 1999 TN Technologies '

ATTN: Ralph S. Hyer,.

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Radiation Safety Officer and Manager of Regulatory Affairs 2555 North Interstate Highway 35 -

Post Office Box 800 PUGUC COCUMENT ROOM Round Rock, Texas 78680-0000

'99 JUN 17 It0:35

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 manufecturer 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 raladng 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.

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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

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Concoming Bundling of Exempt Quantities"(Enclosure 1). GL 99-01 explains current Nuclear

/7 Regulation Commission (NRC) policy and recommendations conceming the possession and use of bundled exempt quantity sources pursuant to the exemptions in 10 CFR Part 30.

i 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 h,

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 other by the State of Kentucky.

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4 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 generallicensee 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 generallicensee. 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.

Sincerely, (orig. signed by) e 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 Roorn IMNs r/f PDR-YEs TCombs DOCUMENT NAME: H:\\EXEM PT\\32.18;lNFoLTRs\\R HYER2_M AY99.WPD C = COVER E = cover & ENCLOSURE N = NO COPY oFC MSlB.NMSs C

MStB:NMSs C

MSIB:NMSS C

NAME ASKirkwood:ask vield MLBurgess FCsturz DATE 06/1o /99 06/

/99 06/1 4 /99 OFFICIAL RECORD COPY l

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I UNITED STATES NUCLEAR REGULATCRY COMMISSION OFFICE OF NUCLEAR M.ATERIAL 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 i

Addressees: All materiais licensees.

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Purpose:

The U.S. Nuclear Regulatory Commission (NRC) is issuing this generic letter to notify

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addressees about a recent Office of Nuclear Material Safety and Safeguards decision conceming 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 j

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 Ibensing requirements to the extent that such a person possesses, uses, transfers, owns, or acquires byproduct material in 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 infortnation 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, procest,, 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.

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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 gauging devices. On June 3,1994, NRC determined that, under ovtain limited circum 'ences, bundling of exempt sources did not present a health and safety hazard.

Howes 3r. ecently NRC has received requests for permission to distribute an increased number of buru j sources in similar devices. As a result, NRC became concemed that the individual numbers of exempt sources bundled in such devices would reach some point where a general or specific license would normally be required. In the case where the bundled exempt sources remamed exempt, NRC would have no mechanism to ensure 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 inconsistent with the regulations, pursuant to 10 CFR 30.18, 32.18, 32.19, and 32.20.

instructing persons exempt from licensing to combine exempt quantities, and providing devices for them to do so, is in direct conflict with NRC's requirements for labeling of exempt sources.

Section 32.19 specifically instructs persons not to combine exempt quantities, since the exemption 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 j

remain separate and Wstinct from other quantities of exempt byproduct materials. The labeling requirements in 10 C' i 32.19, which address shipments to exempt persons, instruct 10 CFR 32.18 licent es to label the "immediate container" with information identifying the radioisotope and the quantity of radioactivity, and in addition to that information, the container "

.. shall also taear 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 j

use a wide variety of byproduct materials, and to possess and use specific byproduct materials without restnction as to the total quantity that may be possessed ac

  • used at any one time, the regulabons do not authorize, but rather discourage, grouping exemps quantities of byproduct material.

At this time, devices already in use. having multiple exempt quantities of byproduct material, may continue to be usei %RC does not plan to take any action regarding these devices or users unless a radiologicali.:afety hazard is identified. However, persons possessing such devices should maintam control and account for these devices and the exempt sources contained within them. To this end, it is good pi:tice to clearly label the devices with I

radioactive materials waming labels bearing the standard radiation waming symbol and j

standard magenta (or purple) and yellow colors. Additionally, it is preferable to not dispose of j

devices containing mulbple 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 desposal opbons.

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GL 99-01 May 3,1999 Page 3 of 3 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 pub!ic health and safety and with consideration of property protection. It is anticipated that the evaluation and rulemaking process, if undertaken, will take 2 to 3 years.

I If you have any questions about this matter, please call the technical contact listed below or the appropriate regional office.

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Donald A. Cool, Director Division of industrial and

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Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Contact:

Anthony S. Kirkwood, NMSS j

(301) 415-6140 E-mail: ask@nrc. gov I

Attachmont: List of Recently issued NRC Generic Letter's.

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Attachrrent GL 99-01 May 3,1999 Page 1 of 1 LIST OF RECENTLY ISSUED GENERIC _LETTERG GENERIC DATE OF LETTER SUBJECT ISSUANCE ISSUED TO 98-01, Supp.1 Year 2000 Perdiness of Computer 1/11/99 All holders of operating li Systems at Mclear Power Plants licenses for nuclear power Piants, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.

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 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 certified 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 hexafluorida production plants, uranium enrichment plants, and uranium fuel fabrication plants, except those that have permanently mased operations

. OP = Operating License e

CP. = Construction Permit

.'NPR = Nuclear Power Reactors

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

.g SAFETY EVALUATION OF DEVICE

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DEVICE TYPE:

Gamma Gauge MODEL:

,NW-201 Series, NW-301 Series, NW-401 Series MANUFACTURER / DISTRIBUTOR:

Berthold Systems, Inc.

Hopewell Business Park 101 Corporation Drive Aliquippa, PA 15001 1

l SEALED SOURCE MODEL DESIGNATION:

Berthold Systems, Inc.: 39002 1

ISOTOPE:

MAXIMUM ACTIVITY:

Cesium-137 900 microcuries (33.3 M3q) no single source to exceed 10 microcuries (370 kBq) i LEAK TEST FREOUENCY:

Not Require.

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Gamma Gauge CUSTOM DEVICE:

YES X

NO

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES q

SAFETY EVALUATION OF DEVICE l

NO.- NR-186-D-117-G DATE:

AUG 2 8 gg PAGE 2 OF 9 i'

DEVICE TYPE:

Gamma Gauge DESCRIPTION:

The Model NW-201 Series, NW-301 Series, and NN-401 Series source housings are designed to be installed in fixed locations to measure material density or fill Aevel 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 j

multiple sources are installed into macnined " pockets" and are held in place by epoxy.

Descriptions of each source housing are listed below.

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NW-201 Series The Model NW-201 Series source housings have >ariable dimensions 1

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 housir.g 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 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

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while providing additional shielding at the back of the source 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 ySv/hr), installation of the Model NW-201 Series source housings are subject to the following:

Pioes:

  • 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 microcuries (11.1 MBq).
  • no smaller than 14" (35.6 cm) diameter, schedule 40 pipe when containing more than 500 microcuries (18.5 MBq).

Vessels:

  • no smaller than 14" (3 5. 6 cm) diameter, schedule 43 pipe under any conditions.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

,J' AUG 2 3 IEB NO.- NR-186-D-117-G DATE:

PAGE 3 OF 9 DEVICE TYPE; Gamma Gauge pESCRIPTION (Cont.)-

NW-301 Series The Model NW-301 Series source housir.js have variable dimensions ranging from 12-60" (3 0. 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 ecurce housing is " folded" in half so that the beam ports of the 1

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 ySv/hr)

Model NW-301 i

Series source housings may only contain up to 300 microcuries 1

(11.1 MPq) of cesium-137.

NW-401 Series l

The Model NW-401 Series source housings have variable dimensions with a minimum diameter cf 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.

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 rf 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 housing does not have a shutter mechanism.

Te ensure that the dose rates at the accessible surfaces of the 4

applications do not exceed 2 mrem /hr (20 gSv/hr), Model NW-401 Series searce 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).

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.

NR-186-D-117-G DATE-28E PAGE 4 OF 9 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 cin) in diameter by 0.008-0.009" (0.20-0.23 mm) thick and may contain up to 10 microcuries (370 kBq) of cesium-137.

The source is not manufactured by Berthold Systems but must be manufactured to Berthold's specifications.

1 Since no single source used in the source housings exceeds 10 microcuries (3 73 kBq), leak testing of the source housings is not required.

LAPELING:

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

Agreement State. Operation prohibited if there is indication of failure of or damage to persons specifically licensed b/ the U.S. Nuclear Regulatory Commission or an housing or source containment. !nstallation and relocation can only be performed 4F-using the specific instructions suppled in the operating manual of the device.

Dismanthng, maintenance, repair and testing involving the radioactive material, its housing or containment shall be perform by Berthold Systems, Inc. and other specific licensees. The device is not required to be tested for radioactive leakage. Loss, theft, or transfer of this device and failure of or damage to the shielding and source containment must be reported to Berthold Systems, Inc. and the U.S. Nuclear Regulatory Commission or an Agreement State. The receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the U.S. NRC or of a State wrth which the NRC has entered into an agreement of the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of 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

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b 28 090 NO,: NR-186-D-117-G DATE:

PAGE 5 OF 9 j

DEVICE TYPE:

Gamma Gauge LABELING (Cont.):

The source housing labeling is exempt from the conventional color requirements of 10 CFR 20.1901.

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DIAGRAM:

See attachments.1-3.

1 CONDITIONS OF NORMAL USE:

The source housings will be used in industrial applications to measure material density or fill level in various applications 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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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

3, SAFETY EVALUATION OF DEVICE 3

l NO,: NR-186-D-117-G DATE:

rfyg g g, PAGE 6 OF 9 DEVICE TYPE:

Gamma Gauge i

PROTOTYPE TESTING:

Prototypes of the source housings were constructed and subjected to the tests listed below.

No malfunction occurred nor was there 1

any loss of shielding or containment integrity as a result of the testing.

Temperature Cycle testing frcm -25 C to 100*C (-13 to

)

212 *F).

1 Held at 538*C (1000*F) for 5 minutes.

2 Humidity 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 /> Impact 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 j

surface of each source housing will not exceed 0.5 mrem /hr I

(5 Sv/hr), except at the surface of the beam port, which will 1

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 uSv/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 USE1

  • 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 g,

SAFETY EVALUATION OF DEVICE

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NO.

NR-186-D-117-G DATE: XUG 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 ir. tall the devices provided the installation is in acco mince 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:

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b The device can be safely operated by persons not having e

training in radiological protection.

Under ordinary conditions of handling, storage, and use of

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the device, the byproduct material contained in the device l

will not be released or inadvertently removed from the l

source housing, and it is unlikely that any person,will l

receive in any period of one year a dose in excess of 1]

percent of the limits specified in Section 20.1201(a),

l 10 CFR'Part 20.

l Under accident conditions associated with handling, sto rage,

e and use of the source housing, 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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e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ 1 NR-186-D-117-G' DATE:

' 7g PAGE 8 OF 9

_ DEVICE TYPE:

Gamma Gauge l

_ SAFETY ANALYSIS

SUMMARY

(Cont.)-

PART OF BODY DOSE I

Whole.bcdy; head and trunk; active blood-forming organs; j

. gonads; or lens of eye 15 rem (0.15 Sv) i Hands and forearms; feet and ankles; localized areas.of skin j

averaged over areas no' larger than 1 cm2 (0.15 in )

200 rem (2.0 Sv) 2 Other.orcans 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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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

~.w r 06 2 81938 4

NO.: NR-186-D-117-G

_D_ A, T E :

DAGE 9 OF 9

. DEVICE TYPE:

Gamma. Gauge

REFERENCES:

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The following supporting. documents 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.
  • Berthold Systems' fasimile dated August 25, 1998, with enclosures thereto.

ISSUING AGENCY:

.U.S. Nuclear Regulatory Commission N 2 8 $$

A Date:

Reviewer:

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/Tohn -W Lubinski Date:

Concurrence:

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' Steven L7 Baggett

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

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