ML20211J655

Responds to 961107 Application for Radiation SE & Registration of Model 31000 Series Source Housing.Listed Info Requested in Order to Continue Evaluation

ML20211J655
Person / Time
Issue date:	10/06/1997
From:	Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Galen Smith APGEE CORP.
References
SSD, NUDOCS 9710080225
Download: ML20211J655 (12)

Text

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's NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20%!@001 (

.....,6 October 6,1997 i

G. M. Srnith, Jr.

Apgee Corporation Hopewell Business Park 103 Corporation Drive '

Aliquippa, PA 15001

Dear Mr. Smith:

This letter is in responw to Apgee Corporation's (Apgee's) application dated November 7, 1996, for radiation safety evaluation and registration of the Model 31000 series source housings, Apgee's February 25,1997, letter that provided additionalinformation, and BSI Instruments' (BSl's) letter dated October 1,1997. Apgee is requesting approval for the source housings to be used in industrial applications tc measure filllevel or density while containing up to 111 gigbecquerels (3 curies) of ceslum 137 or 1.85 gigbecquerels (50 millicuries) of cobalt-60.

We are in the process of evaluating Apgee's request for radiation nfety evaluation and registration of the soun:e housings. The evaluation is based solely on the letters referenced above without consideration of previous device registration certificates issued to Apgee. The application is being handled in this manner since Apgee will be the manufacturer of the l source housings. In order to continue our evaluation, the following information is necessary:

1. Apgee's application contains information that is marked confidential or proprietary, in order for NRC to withhold the information from public disclosure, Apgee must submit an application, including an affidavit, as specified in 10 CFR 2.790. Please provide either an application requesting to keep the information withheld from public disclosure or indicate that NRC should disregard the reference that the information is confidential or proprietary.

2. Apgee's application notes Apgee as the manufacturer of the source housings.

However, during a recent NRC inspection of Apgee's operations, it was indicated that the manufacturing of source housings is performed by another company under contract to Apgee. Please indicate whether this is the case for the Model 31000 series source housings, if so, please provide complete details of the functions of Apgee and its contractor (s). /f

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Seale,d Sources:

3. The sealed sources manufactured by Labe Berthold (Berthold), located in Germany, are registered with NRC for use only in specific devices manufactured by Berthold.

The sealed source designs must be evaluated for use in the Model 31000 series source housings and registered by Apgee or by another U.S. company. Pleese indicate whether Apgee will apply for registration of the sealed sources as part of it's application for a cafety evaluation of the Model 31000 series source housings of 9710000223 971006 g RC

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G. M. Smith 2 October 6,1997 indicate the company that will be applying for the registration. The ideal situation would be for the U.S. company respontible for distribution of Berthold products to be the holder of the registration certificate for the sealed sources. The sealed sources must be registered with NRC or an Agreement State before NRC can approve the use of the sealed sources in the Model 31000 series source housings.

Please note that if Apgee elects to register the source design for use in the Model 31000 series source housings, the application for registration of the sealed sources must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses, and leak testing.

Furthermore, Apgee will be held responsibie for the manufacture and distribution of .

the Berthold sources used in the Model 31000 series source housings. '

4. Please provide information that clearly indicates how each source design will be installed in the source housing. From the information provided, the design and applicability of source adapters is unclear. Apgee may consider providing a diagram of the mounting onfiguration for each source design. In addition, for sources and/or adapters that are round (i.e., not hexagonal), please indicate the type of tool that will be used to install the sources.

5. It oppears that some source designs may be incorporated into welded source holders / adapters. For these designs, please indicate how the holders / adapters will be labeled sinco holders / adapters will fully encapsulate the sources.

6. Please demonstrate that the installation of the sources will not be negatively effected by vibration (i.e., the source will not loosen from the threaded mounting). Please provide information concerning mechanisms (e.g., lock washers) that are used to ensure the source does not loosen from the mounting.

7. Please demonstrate that the tools used to install the sealed sources will not negatively impact the integrity of the source designs. For example, some sealed sources have thin walls, e.g., the Model P 2602100 has a 1 mm (0.04") thick wall, and twisting these sources with an installation tool may have a negative impact on the source.

8. Please provide information concerning the design of the tool (s) used to install the sources, in some cases there appears to be only a small amount of space between the edges of the source adapter, e.g.,11.5 mm (0.45") diameter point to point, and the side of the source cavity,13.8 mm (0.55") diameter. Therefore, it is difficult to envision a tool that would fit around the source holder and still fit in the source cavity.

Leak Testing:

Apgee's application requests a 3 year leak test frequency for the source housings and justification for the request is provided starting on page 15 of the application. However, please address the following concems with the justification:

1 G. M. Smith 3 Oc'ober 6,1997

9. Apgee's justification indicates that the sealed sources are double encapsulated. I However, from the information provided, it appears that not all sources (e.g., the Model P 2602100) are double encapsulated. Please clanfy this discrepancy.

10. Apgee's justification states that there has never been a sealed point source distributed by Apgee or BSI in North America which has lost containment and caused a positive leak test. This statement was provided based on Apgee and BSI experience during distribution, installation, and servicing of gauges. Please provide specific information conceming the experience of Apgee and BSIin handling similar source housings, includi'1g the number of sources distrib','ted, years of usage of the sources, and number of leak tests performed on the sources, in addition, please address how Apgee's and BSI's experience applies to the Model 31000 series source housings since the Model 31000 series source housings are of different design and are manufactured by a different manufacturer than source housings previously distributed by Apgee or Berthold.

Drawings of Source Hausings:

11. Please provide assembly drawings of each source housing. The drawings need to include clear reference to each component drawing and include details of how the components are assembled, Drawings 31000,31001,31002, and 31003 that were included in attachments 52,53, and 54 of the November 7,1996, application, include the appropriate level of detail for the assembly drawings. However, Apgee's February 25,1997, letter requested that these attachments be replaced with the enclosures to the February 2.5,1997, letter.

The new attachments 52,53, and 54 do not include the drawings referenced above, however, drawings 31001 and 31002 are included as attachments 24 and 25 of the November 7,1996, application and were replaced (by the same drawings) in the February 25,1997, letter, if Apgee plans to resubmit drawings 31000 ond 31003, the drawings should include the following additionalinformatien, in addition, Apgee should provide the following additional details for drawings 31001 and 31002.

• Complete details of all welds (size of the welds including length and throat).

• A clear indication of parts to the bills of materials.

• The expansion gap for lead in the rotor shutters.

• The handle on the drawings is incorrectly shown. Specifically, the handle indicates the shutter is closed when it is open.

12. The revision levels of the drawings listed on bills of materials for the source housings do not match those included on the drawings. Please clarify or provide the appropriate bills of materials for the drawings.

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G. M. Smith 4 October 6,1997

13. Please provide specifications Ee., materials of construction and dim 9nsions) for the roll pin (item 1 of the bills of materials) and the machine screws (item 24 of the bills of materials) used in the assembly of the source housings.

Construction:

14. The source housings incorporate two Viton@ gaskets, located at the top and bottom of the source housings, to seal the housings from foreign material. Please provide information that demonstrates that the gasketing will withstand the likely environmental conditions for the useful working life of the source housing.

15. Apgee's application included calculations for the void space necessary within the Models 31004 and 31006 source housings to account for expansion of the lead j

shielding. Please provide this information for the shielding in the Model 31008 source housing and for the shutter in all three source housings.

Labeling:

16. Please, govide details of the construction of the label for generally licensed devices.

Please include materials of construction, method of attachment to the source housing, and justification for why the labeling will withstand the likely environmental conditions of use. Please note tha* it appears that plastic labels would not be capable of withstanding the environments encountered during normal use of these source housings.

17. The proposed labeling included in Apgee's application for generally-licensed devices includes the following (reference attachment 28): 'The receipt, possession, use, and transfer of the device Models 31004,31006, and 31008 are subject to a general license...." However, Apgee's application did not request approval for distribution of the Model 31008 to general licensees. Please clarify this discrepancy.

18. The proposed labeling included in Apgee's application for generally-licensed source housings includes the following (reference attachment 28):

• installation, dismantling, relocation, maintenance, repair and testing involving the radioactive material, its shielding or containment shall be performed by persons licensed by the NRC or an Agreement States.' However, persons performing these activities need to be

'specifically" licensed to perform these activities. Please commit to modify the label to include the word 'specifically," '

19, Page 10 of Apgee's application indicates that for conveyor applications, fences or barriers used to stop individuals from inserting any part of the body in the beam path, willinclude the label provided in attachment 33. Please provide details of the construction of the label, including materials of construction, method of attachment to the fencing or barrier, and justification for why the labeling will withstand the likely environmental conditions of use Please note that it appears t1at plastic labels would not be capable of withstanding the environments encountered during normal use of these source housings for the useful working life of the source housing.

G. kl. Smitn 5 October 6,1997

20. Page 18 of Apgee's application indicates that the label provided in attachment 17 will be posted at entrances to tanks or vessels where entry is possible. The label indicates that the area is a radiation area and advises that the individual check to ensure the shutter is closed prior to entry into the tank or vessel. For source housings that are distributed to general licensees, this label should also include an i additional form of protection / notification (e g., a reference to a lock out/ tag out procedure or list a person to contact prior to entry). This is due to the fact that generallicensees are not provided radiation safety training and may not be familiar i with the source housing, and that the source houshg may be Installed such that the i

shutter indicator may not be easily seen.

i Conditions of Use:

1

21. Page 9 of Apgee's application indicates that the source housing will be subject to

• certain environmental conditions, such as high/ low temperatures, corrosive atmospheres, high humidity, and vibration." Please provide quantitative values for both the likely and extreme environmental conditions to which the source housings w0

. be subjected.

22. Page 9 of Apgee's application indicates that "The 31000 series device ... requires little maintenance." Please indicate the types and frequency of maintenance required to ensure the source housing maintains in operationalintegrity,

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23. Apgee's application indicates that the useful life of the source housings is 15 years.

This appears to be based solely on the usefullife of the sources as specified by the source manufacturers. Please provide justification for why the mechanical usefullife of source housing is expected to be 15 years.

Quality Assurance:

24. Apgee's application included a copy of Apgee's quality assurance manual (revision 2) that was submitted with Apgee's application. Please commit, as part of the registration application, that Apgee will adhere to the commitments included in Apgee's quality assurance manual.

25. If a centractor will be manufacturing the source housings (reference item 2 of this letter), please provide details of the quality control program that will be followed during manufacture of the source housings, how Apgee will ensure the contractor adheres to the program, and how Apgee will ensure the source housings meet the requirements included in the application since tne quality ast.urance manual does not indicate that all suppliers will be audited.

26. Apgee's quality assurance manual indicates that a document control system will be implemented. This system willinclude assignment of drawing dates and revision

-levels and inclusion of this information on bills of materials. - However, review of the drawings and bills of materials submitted in the original application and Apgee's February 25,1997, letter indicates that a number of drawings were revised (based on

G. M. Smith 6 October 6,1997 the date on the drawings), but the revision levels were not changed or were changed from 1 back to 0. Also, the manual indicates that approved suppliers will be listed on the drawings. Not all of the drawings submitted include approved suppliers. Please explain how these discrepancies occurred if Apgee is implementing the quality assurance manual provided in attachment 48.

27. The inspection and testing section of Appee's manualindicates that Apgee willinspect on a samplo basis, except for ' critical" components which will be 100% inspected.

Please indicate the method for choosing samples and the criteria used for determining  !

' critical" components. Please provide a listing of ' critical" components for the source j housings. Also, indicate how Apgee will verify that components of assemblies manufactured by subcontractors will be verified as part of incoming inspection.

Radiation Levels: l

28. Attachment 16 of Apgee's application includes radiation profiles for the Models 31004 and 31006 before being subject to extreme temperatures, after being subjected to cooling, and after being subjected to heating. Please explain why there are differences in the radiation levels after being subjected to heating and cooling, in addition, please explain why there is a difference between the radiation levels observed prior to being subjected to the temperatures and the radiation levels obwerved during the surveys provided with the September 6,1996, report from Professional Service Industries, Inc. In addition, page 1 of attachment 1 of the September 6,1996, report was not included in the application. Please provide a copy of this page.

29. For Model 31008 source housing, please provide the calculations performed in the development of the radiation profiles included in Attachments 42 and 43 of Apgee's application, in addition, please indicate whether the calculations are based on the design of the housing provided on drawing 31001 dated August 13,1996, (i.e., shutter height of 13.49 cm (5 5/16")) or the revised information included on drawing 31001 dated October 7,1996 (i.e., shutter height of 9.37 cm (3-11/10")).

30. For Model 31008 source housing, please provide the expected radiation levels in the beam path (similar to the information provided on page 13 of Apgee's application for the Models 31004 and 31006) and at 5 cm (1.9"), 30 cm (11.8"), and 100 cm (39.4")

around a typicalinstallation of the source housing (similar to the information provided in Attachment 16 of Apgee's application for the Models 31004 and 31000).  !

Prototype Testing:

31. Apgee's original application included drawings dated October and November,1996, and Apgee's February 25,1997, letter included some revisions dated February 1997.

However, the prototype testing of the source housings, Models 31004 and 31006, was 4

-performed during March and April 1996. Please indicate whether either set of drawings submitted represent the design of the source housings as tested during March and April 1996. If the design of the tested source housings are different than

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i G. M. Smith 7 October 6,1997 l the design indicated in the February 25,1997, letter, please provide justification why the design changes would have no detrimental effects on the source housings and ,

why it is expected that the new designs (i.e., the design included in the February 25, 1997, letter) would pass the same testing requirements.

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32. Prototype testing performed in accordance with 49 CFR is designed to demonstrate that products will withstand conditions incident to transportation. However, meeting these criteria does not necessarily demonstrate that the source housings would ,

withstand likely conditions of use and extreme conditions during operation of the source housings. Please demonstrate how the prototype testing parameters to which the source housings were subjected verify that tSc source housings would be expected to maintain their integrity during likely conditions of use and extreme conditions that will be experienced. Specifically, compare and analyze the conditions of the prototype testing to the likely conditions of use and extreme conditions that will be experienced during use and handling of the source housings. In performing this comparison, please address the following concerns:

• The applicability of a drop test from 0.30 meter (4 feet) of the source housings since it appears the source housings will be mounted at locations higher than 0.30 meter (4 feet).

• What was the compressive load applied during the compressive load testing -

and how do they compare to the conditions of use?

• The applicability of subjecting the shutter mechanism to 100 cycles of use and how this compares to the number of cycles it will experience over its useful working life.

• The applicability of the shutter cycling test since it was performed under laboratory conditions and not the likely conditions of use of the source housings.

• It appears the source housings are likely to experience vibration in excess of that experienced during the prototype testing. However, even when subjected to a smaller level of vibration for a limited amount of time, the machine screws for the rotor cover plate loosened. Therefore, please p: ovide justification for why the machine screws are not expected to loosen during likely conditions of use.

33. Please explain why there war a loss of 0.45 kilogram (1 pound) of lead (i.e., where it is leaked and why) and why the shutter mechanism was not operational after subjecting the Model 31004 to the 538'C (1000'F) for 5 minutes. Please explain the exact failure of the tested source housing and why the source housing should be approved for use by general licensees since there was a failure during the fire test.

. 34. A prototype of the Model 31008 source housing was not subjected to the same testing as prototypes of the Models 31004 and 31006. Therefore, please provide information I

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_. . _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _._ .~. _ _ _ _ _ _ _ _ _ _ _ _ . _ .

1 G. M. Smith 8 Ociober 6,1997 conceming testing of a prototype of the Model 31008 or an engineering analysis that demonstrates that the Model 31008 design would pass the same testing requirements, installation:

35. Apgee's application includes examples of typical conditions under which the source housings will be Installed. These examples incl 9de the locations (e.g., on pipes, tanks, and conveyor belts), exanmles of the radiation levels at locations (e g., when attached to a 4" pipe), and possible use of fencing or barriers (e.g., on conveyor belts). The applict 11!so includes radiations levels based on a particular installation of the ,te housings. However, Apgee's application does not provide clear enteria on the extreme conditions of the installation (e.g., maximum air gaps between the source housings and detectors, maximum radiation levels in accessible areas, when fencing or barriers will be used). Please provide information that clearly indicates the worst case conditions, from a radiation safety standpoint, for installations of the source housings.

In lieu of providing specific information conceming all possible configurations for conditions for installation, Apgee may commit that, as part of installation, certain safety conditions will be verified. These conditions may include the following types of criteria:

• The radiation levels at (distance) from any accessible surface of the installation will not exceed (radiation level) .. Accessible surface of the installation will be defined as fany surface that could come into contact with a 12" diameter schere) .

• If barriers will serve as accessible surfaces of the installation, the barriors will be of metal construction, will be attached with mechanical fasteners (welded or bolted construction - not hinged), and will hear the specified labeling.

• The maximum air gap between the source housing and the structure to which it is mounted (i.e., the air gap between source houtmg mounting and the pipe, tank, or conveyor system) will not exceed - (distance) .

For cases where the radiation levels in the beam exceed (radiation level) at (distance) from the beam port of the source housing, access to the radiation

' beam will be restricted by - _(controls) .

The above criteria is only provided as an excmple and is not a requirement for registration of the source housings.

Since Apgee intends the source housings to be distributed to both general and specific licensees, Apgee may elect to provide two sets of criteria (i.e., one for general license installations and one for specific license installations).

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G. M. Smith 9 October 6,1997 If Apgee subn6ts criteria similar to the criteria listed above, as a condition for a license to distribute or install the product, persons would be required to commit to follow the

!ristallation criteria soecified by Apgee. Therefore, BSI or other licensed distributors or kstallers would nehd to commit to follow the installation criteria specified by Apgee.

M. Page 14 of Apgee's application indicates that a t' ar will be installed to stop persons from insertir.g body parts in the beam path. Howt .or, from the diagram of the barri3r irscluded in attachment 14, it appears the barrier would only stop body parts being inserted into the center of the beam. Please explain how the barrier would restrict access to higher radiation levels that are in the center of the beam since the diameter -

of the beam wlIl become larger at distancas from the source housing.

In addition, Apgee's application notes that the barrier may be constructed of plastic. '

Plastic would not be expected to withstand the conditions of use of these source c housings. Therefore, please commit that the barriers would be of metal construction.

Information to End Usern:

37 Attachment 46 of Apgee's application indicates for general licensees that " Receipt, installation, removal, and shipping can only be performed under the direct supervision i

of a BSI trained Engineer or spsdfically licensed individual." However, these services

! can only be performed by s.pec:Lally licensed individuals and not under the l supcivision of such individuals Please clarify this discrepancy. Apgee's response t

should specifically note the activities that may be performed by general licensees that do not have training ir adiation safety.

38. Attachment 46 of Apgee's application provides half value layers for C3-137 and Co-

60. There appears to be a discrepancy with the values provided for concrete for these two isotcpes. Apgea's application indicates the values are 110 mm (4.3") for Ca-60 and 90 mm (3.5") br Cs-137. However, " Introduction to Health Physics,"

Herman Camber,1980, Fifth printing, indicates the half-value layers to be 62 mm (2.4") for Co-60 and 48 mm (1.9") for Cs-137. Please clarify this discrepancy.

General Licensing Requirements:

39.

Please address the following concems identified with the information provided, starting on page 18 of the applicption, to provide verification that the source housings do not exceed the limitations prouded in 10 CFR 32.51(a)(2)(ii) and (iii):

The public dose to individuals is based on 1 microsievert/hr (0.1 millirem /hr)

L exposure at the detector for the gauging systems. However, radiation profiles included in the application indicate that the levels can be higher that 1 microsievert/hr (0.1 miliirem/hr).

Apgee indicates that the maximum exposure rate at the detectoit ousing will not exceed 10 microsieverts/br (1 millirem /hr). However, radiation profiles

IG; M. Smith 10 ~ October 6,1997 -

includad' in the application indicate that the levels can be higher that -

10 microsieverts/hr (1 millirem /hr).

• Apgee's calculations provide expected doses as a result of tuming the source

[ _ housing on and off. However, Apgee did not provide the expected number of times per. year that an individual is likely to tum the source housing on and off -

. during normel use.

[

• Page 18 of Apgee's application indicates that the inside of tanks or vessels

! ' where entry is possible may be defined as radiation areas. Please provide -

U _ information tiist justifies why source housings used on tanks or vessels should _

- be considered for use by general licensees.

40i The information provided, starting on page 18 of the application, to provide verification -

, that the source housings do not exceed the limitations provided in t

10 CFR 32.51(a)(2)(ii) and (iii) is based on the information fror, one oroposed

. installation of the source housings. To approve the source housings for use by

[ general licensees in _other installations, Apgee must provide similar analyses for these

[ installations, in lieu of providing information for each tyos of application, Apgee may

consider basing the analyses on criteria similar tc that addressed in item 35 of this letter, p 41. Page 8 of Apgee's application _ indicates products used by general licensees will

. ".... have a wire and lead security seal connected across the mounting bolts used with p the clamping devices." Please clearly indicate how the wire and lead security seal will

[  ! be attached (i.e., to which components of the source housing) and how the seal will i- discourage general licensees from obtaining access to the sealed source.

t

42. Page g of Apgee's application indicates that users will be trained ard well informed of '

' the principals of ALARA. 'It appears that Apgee believes that source housings must c only be_used by trained individuals. However.10 CFR 32.51(a)(2(l) indicates that

,' products designed for use under a general license be designed such that the product -

can be safely operated by persons not having training in radiation protection. Please p  ; demonstrate why _use of the source housings by general licensees should bo

approved.

b . Licensing:

43. ~ Apgee's application indicates that the source housings will only be distributed by Berthold Systems, Inc. (assumed to be the another nsma for BSI Instruments) and other approved licensees. Please note tt'at since the distributor of the source

. housings'will be responsible for certain registration activities, distributors _will need to

' be specifically approved for installation of the source housings and will need to 1

commit to.certain requirements (e.g., distribution of information to end users and installation conditions) included in Apgee's application and in the limitations and conditions'of use specified in the registration certificate for the Model 31000 series l

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G. M. Smith - 11 October 6,1997 source housings. This will be handled as part of the licensing actions with our Regicn 1 office.

-In Apgoe's 'tebruary '.6,1997, letter, Apgee requested that NRC retum all attachments, i

- except attachmentt 16 and 48, of the original application. Please find enclosed all copies of /

- the attechments inat were provided to NRC, 4

~

in addition to the technical issues specified above, I'd like to respond to BSl's October 1, 1997, letter. Specifically, I provide my understanding and response to these issues.

1. . lssuance by the NRC of a registration certificate for our new 31000 series device.

It is my understanding from the September 30,1997, meeting that NRC will make -

L -

every effort to complete its evaluation of Apgee's application as quickly as possible

and, if 9ppropriate, will issue a registration certificate based _on the application.

, However, NRC cannot guarantee if or when a registration certificate will be issued.

NRC will work with Apgee to address any concems or deficiencies in the neplication as quickly as possible.

_ 3. Amendmcat by your Region I to our distribution licenses, so that we may distribute and service this product.

NRC's Region I office has not received an application from Apgee to amend its license for manufacture and distribution of the Model 31000 series source housir.gs.

Therefore, Apgee must submit an application, with appropriate fees,' to NRC's l Region I office to manufacture and distribute the Model 31000 series. Once received,  !

NRC will evaluate the applicatica.

NRC's Rugion I effice has received an application from BSI to amend its license for - -

- distribution of the Model 31000 series source housings. However, NRC's Region 1 -

cannot complete this amendment until the regietration certificate for the source -

housings is issued. NRC's Region I office will coatact you if additional informatiori or clarification is necessary. Once 2e registration certificate is issued, NRC's Regior, i office will make every effort to complete its review of the application as quickly as possible and, if appropriate, will issue the amendment to the license.

- 3.' . On October 16th, I request a meeting to recieve the registration document or answer any additional questions.

This letter includes the additional information necessary for NRC to continue its evaluation of the Model 31000 series source housings. My staff and I are willing to meet with .Apgee on October 16,1997, so Apgee can prot *a or discuss the-information requested in this letter. Please cal. me to discuss the details (time,

location, subject) of the meeting or whether a different date is more appropriate for the meeting.

i G. M. Smith 12 October 6,1997 To assist you in developing a response to this letter, I nave enclosed a copy of NUREG-1550, ' Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations." If-you have any questions, please contact me at

- (301) 415-7273 or Mr. John Lubinski of my staff at (301) 415 7868.

Sincerely, .

Steven L. Baggett, Section Chief Sealed Source Safety Section Medical, Academic, and Commercial l Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Attachments to Apgee's November 7,1996, Application

2. NUREG-1550, ' Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations." ,

cc (w/ copy of NUREG-1550):

Thomas Madden, Office of Congressional Affairs, NRC U.S. Senator Rick Santorum U.S. R6presentative Ron Klink L

Distribution:

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lDATE 10/06/97 10/06/97 10/06/97 OFFICIAL RECORD COPY h _.