ML20205H207

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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Device Type self-shielded Irradiator,Models Husman 520,521 & 521a.Certificate:NR-8107-D-801-S
ML20205H207
Person / Time
Issue date: 04/05/1999
From: Samson Lee
NRC
To:
Shared Package
ML20205H174 List:
References
SSD, NUDOCS 9904080096
Download: ML20205H207 (13)


Text

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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE LOL: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 1 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator MODEL: Husman 520, 521, 521a MANUFACTURER: Isomedix, Inc.

~11 Apollo Drive Whippany, NJ 07981 DISTRIBUTOR: U.S. Department of Agriculture 4700 River Road, Unit 91 1 Riverdale, MD 20737-1228 l

SEALED SOURCE MODEL DESIGNATION J.L. Sheperd Model 6810 Amersham Model X.2157 ORNL, Drawing C-SK-2440 1 ORNL, Drawing C-SK-342 l ORNL, Drawing C-RD-2128  !

l ISOTOPE: MAXIMUM ACTIVITY:

Cs-137 42,000 Ci (1,554 TBq)

LEAK TEST FREOUENCY: 6 months l

PRINCIPAL USE: (J) Gamma Irradiator, Category I l

CUSTOM DEVICE: X YES NO CUSTOM USER: U.S. Department of Agriculture Anywhere in U.S.A.

9904080096 PDR RC 990405 SSD pgg

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQ2: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 2 OF 8.

(Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION:

The Models of Husman 520, 521, and 521a were irradiators designed j to provide an automated method to produce large quantities of sterile pupae to meet the requirements of the sterile fly rearing programs operated by the Animal and Plant Health Inspection Service, USDA. The Husman irradiators were installed in fixed locations. Their weight was 17,000 lb. (7,711 kg). Four units were used by USDA Agencies in the United States. Five units were on loan to the governments of Mexico and Guatemala for use in their programs.

The Husman irradiator consists of a rotating annular rotor between an integral central core and outer annular shell. Pupae containers are loaded by gravity-feed into one of the three equally spaced specimen chambers in the rotor, and are transported to irradiation position by revolving the rotor one- ,

i third revolution (12 0 ) . The dose absorbed is determined by the l dwell time of specimens at the position. After irradiation, the  ;

i specimens are rotated to another opening and unloaded by gravitational force. The irradiation cycle is controlled by an l

index drive system which cyclically and automatically loads the

! pupae containers into the rotor, irradiates, and unloads the l specimens within a specified period of time. The unit is self-l contained and fully shielded at all times regardless of rotor position.

The entire outer skin of the Husman irradiator was fabricated of 5/8" '(1.59 cm) thick carbon steel plate. All inner plates were l of stainless stael. Additionally, a minimum of 6" (15.24 cm) of I lead shielded each source canister in all directions. l The lead shielding was poured into the cylinders in a single operation to insure complete filling and to eliminate voids.

After source loading, radiation measurements were made to verify shielding integrity.

Upon installation of the source canisters into the Husman irradiator, a lead filled plug was installed into the access port. A 5/8" (1.59 cm) carbon steel plate was then sealed with either a full penetration groove weld, or was by bolting the l I

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) REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE I

HQ, : NR-8107-D-801-S DATE: April 5,1999 PAGE: 3 OF 8 (Supersedes NR-1060-D-801-S) )

DEVICE TYPE: Self-Shielded Irradiator l l

DESCRIPTION (Cont'd):

l plate to the outer skin, thus eliminating any possibility of l outside contact with the source. I The sealed source insert tube was fabricated of stainless steel.

The spacers were aluminum. The source tubes were sealed; no water or water vapor could enter to initiate a chemical reaction, and the electrochemical potential between the housing and the I source material should not support a reaction that would )

significantly degrade the sources. No other corrosive materials l were used near the irradiator that could have an impact on source integrity.

The radioactive sources to be used for the Husman irradiator were manufactured by Amersham as Model X-2157 and were purchased through J.L. Sheperd as their Model 6810 source.

The Husman 520 (Serial Number 001) was the original prototype of l this series. The Kusman 521 (Serial Numbers 002 through 005) I were produced with a minor change in external components used during transportation. The Husman 521a (Serial Numbers 006 through 009) were produced with a secondary heat shield added to the lower portion of the outer shell to increase its thermal  ;

resistance during a fire. l Isomedix, Inc. and J.L. Sheperd and Associates had developed a modification of the shield plug in the Model 6810 source to enable field reloading of the irradiators. At this time, only Serial Number 009 had this modification.

All other irradiators were designed in accordance with the information previously sent to NRC. The modification did not affect any operating system of the irradiator, did not change any of the dimensions, and did not decrease the stated shielding characteristic of the irradiators.

As these modifications were made-to other Husman irradiators, I they were redesignated with an (R) following the model number to l indicate that they had been modified for reloading in the field. i l

1

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-8107-D-801-S DATE: April 5,1999 PAGE: 4 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION (Cont'd):

The modification involved replacing the existing shield plug with the one shown in J.L. Sheperd's drawing No. A-0609-2-4124-1.

Prior to the insertion of the replacement sources, the shield plug was inserted in the end of the irradiator. A tungsten shielded source rod attached to the end of the ro6 containing the radioactive sources and the resulting assembly was inserted into the source chamber using a transfer cask. The tungsten plug was placed in position and steel plates were welded to the outer case of the irradiator to assure the integrity and shielding of the sources.

The original shield plug had been lead filled. The modified shield plug was also lead filled with the shielded source rod and secondary plug manufactured out of tungsten. This configuration increased the overall shielding capacity of the shield plug.

LABELING:

The Husman irradiator is labeled in accordance with 10 CFR 20.1901. The label displays the-radiation symbol, date, isotope, activity, model number, serial number, name and address of the manufacturer, and the words " CAUTION-RADIOACTIVE MATERIAL."

DIAGRAM:

l See Attachments 1, 2, and 3. )

1 CONDITIONS OF NORMAL USE: j i

l The Husman irradiators are operated in enclosed buildings and l designed for the following environment conditions: l i

l Temperature 10 C to 50*C (50 F to 122 F) l Pressure Atmospheric Vibration Ranges from zero to mild Corrosion Ranges from zero to low corrosive vapors Fire NEC Division 2 hazardous area possible

(

i Explosion NEC Division 2 hazardous area possible

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

^

EL.: NR- 8107 -D- 8 01 -S DATF: April 5, 1999 PAGE: 5 OF 8 (Gupersedes NR-1060-D-801-s)

DEVIC 2 TYPE: Self-Shielded Irradiator CONDITIONS OF NORMAL USE (Cont'd):

The expected useful life of these irradiators was 50 years.

PROTOTYPE TESTING:

A detailed thermal analysis had been performed where the Husman irradiator had been exposed to direct sunlight and L30*F (54.44"C) still air. The steady-state analysis conservatively had assumed a 24-hour day at maximum solar heat load. The maximum steady-state temperature had been found to be 223.6*F (106.44 C). These temperatures would have no detrimental effects on the Husman irradiator.

The materials of construction used in the Husman irradiator were able to resist brittle fracture failure at temperatures as low as

-40 F (-40 C).

The entire cask structure, with the exception of the outer shell, was fabricated of an austenitic stainless steel. Austenitic stainless steel did not experience a ductile to brittle transition in the temperature range of interest (i.e., as low as

-40 F [-40*C]).

Due to the lack of sealing devices on the Husman irradiator, a differential pressure of 0.5 atmosphere (50.66 kPa) would have no effect on the Husman irradiator.

The prototype Husman irradiator had been subjected to an extensive safety analysis in order to meet the Type B package requirements for transportation in accordance with 10 CFR 71. A safety analysis report had been submitted as part of the certification process and had been found acceptable under Certificate of Compliance No. 9182.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE I

HQt: NR-8107-D-801-S DATE: April 5,1999 PAGE: 6 OF 8 l (Supersedes NR-1060-D-801-S) ]

DEVICE TYPE: Self-Shielded Irradiator l

EXTERNAL RADIATION LEVELS:

The radiation levels around the outer shell averaged less than 2 mR/hr (20 Sv/hr) at the surface of the irradiator and less than 1 mR/hr (10 Sv/hr) at 1m (3.28'), when the source activity was at a maximum. The maximum radiation level found on the end of the unit, next to the source tube shield plate had been measured at 4 mR/hr (40 Sv/hr). These radiation levels had been measured at 45 increments at each end and in the middle of an irradiator, both surface and 3 readings had been obtained.

Radiation levels did not change during operation since the sources were fixed in position.

OUALITY ASSURANCE AND CONTROL:

At the time of construction, the Husman Irradiators had been manufactured under Quality Assurance Program Approval No. 0009.

As constructed, the Husman irradiators had met the construction and performance specifications for a Type B package. The manufacturer's Quality Control program and package certification for transportation expired on September 4, 1991.

All source capsule bodies and modifications had been completed under J.L. Sheperd and Associates Quality Assurance Program Approval No. 0122, Quality Control Manual QA-RM-001-A, which covered engineering design through final fabrication. Quality Control of source encapsulation was also controlled by the manufacturers' quality assurance programs.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

  • The device should be distributed to persons specifically listed in this registration by the NRC or an Agreement State.

e Handling, Storage, Use, Transfer, and Disposal: To be determined by the licensing authority.

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l 1

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NQ : NR-8107-D-801-S DATE: April 5, 1993 PAGE: 7 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd):

e These devices should be leak tested at intervals not to exceed-6 months using techniques capable of detecting 0.005 microcurie (185'Bq) of. removable contamination. )

e This registration sheet.and the information contained within

~

the references should not be changed without the written )

consent of the NRC.

1 e REVIEWER NOTE: In place of the expired QA program of the I

~

manufacturer, the USDA should implement.special procedures in operation and maintenance of the irradiators in order to ensure radiation safety.

e REVIEWER NOTE: All operators of the Husman irradiators are required to take a minimum 2 day course of instruction in the operation of the irradiator and in radiation safety procedures and precautions. Operators must take and pass an examination demonstrating their understanding and knowledge of the device prior to being certified in its operation.

This is a requirement of the USDA's irradiator license. ]

SAFETY ANALYSIS

SUMMARY

1 1

The Husman irradiators are no longer manufactured or distributed by the USDA and the USDA has no intention to have any more of these irradiators produced. Therefore, the registration  !

certificate is being converted to an inactive registration l certificate. )

The USDA maintained the records of the oldest unit (Serial Number 001), located in Mission, TX. The USDA had found no serious operational problems with unit since 1986 and indicated that no incidents involving the Cesium scurces or exposure to excess radiation to workers had been found. l l

Based on review of the operating experience with the Husman irradiators and J.L. Sheperd Model 6810 source capsule with modification to Serial Nnumber 009, and based on the information I

I i

REGISTRY OF. RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

, HGL.: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 8 OF'8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-ShirTded Irradiator SAFETY ANALYSIS

SUMMARY

(Cont'd):

and test data cited below, we concluded that the Husman irradiators are acceptable for-licensing purposes.

Furthermore, we concluded that the Husman irr. .'ator would be expected to maintain it's containment integri Jor normal conditions of use and' accidental conditions.which might occur during uses specified in this certificate.

1 Due to the location of the device, the only personnel likely to  !

be in the vicinity'of-the Husman irradiator were persons performing maintenance on the device.

I

REFERENCES:

The'following supporting documents for the Husman irradiators are hereby incorporated by reference and are made a part of this registry document:

e USDA's application dated July 16, 1996, letter received on ,

February 25, 1997, with enclosures thereto.

o USDA's correspondence dated May 7, 1996 and May 9, 1996, with enclosures thereto, o USDA's correspondence dated February 8, 1999.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission j l

Date: April 5, 1999 Reviewer: l

'Seung M Lee i (m P 2<th <g Date: Aoril 5. 1999 Ccacurrence: / N dohn P.' Jankovich j

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REGISTRY OF RADIOACTT.VE SEALED SOURCES AND DEVICES

. SAFETY EVALUATION OF DEVICE DATE: April 5, 1999

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h NR-8107-D-801-S. ATTACHMENT 1 (Supersedes NR-1060-D-801-S). -

STEEL. Otrrs:st CASE SoultCE CalAHitEli STAINLESS STEEL, .

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. >> l Cut-Away Illustration of the ",.cic Construction of the Husman 520 Irradiators

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE {

i NO,: NR-8107-D-801-S DATE: April 5, 1999 ATTACHMENT 2 (Supersedes NR-1060-D-801-F

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- SAFETY EVALUATION OF DEVICE NO.: NR-81'07-D-801-S. DATE: April 5 1999 ATTACHMENT 3 (Supersedes NR-1060-D-801-S)

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Major Components of the Husman 520 Series Irradiators

k Mr. John T. J:nson U.S. Departm:nt of Agriculture April 5, 1999 ,

4700 Riv:r Road, Unit 91 Riverdale, MD 20737

Dear Mr. Jenson:

Due to inconsistent numbering for your Husman irradiators registration certificate, we issue a new registration certificate number, NR-8107-D-801-S, which supercedes registration certificate number NR-1060-D-801-S.

Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions, i

If you have any questions, please contact me at (301) 415-5787 or Mr. John Jankovich at (301) 415-7904.

Sincerely,

/s/

Seung J. Lee, Mechanical Engineer l Materials Safety and Inspection Branch l Division of Industrial and i Medical Nuclear Safety '

Office of Nuclear Material Safety and Safeguards

Enclosure:

As ste'ad cc w/ encl: SKimberley, LFDCB Distribution:

MSB r/f IMNS r/f SSD-99-17 db NE01 SSD File # NO-8107-D-801-S DOCUMENT NAME: H:\SJL\N8107801. CMP Ta receive a copy of this document, Indicate in the box: "C" = Cr

  • without aitachment/ enclosure "E" = Copy with attachment / enclosure "N" =: No copy OFFICE MSB E MSB ,nl6 l l l NAME Slee ,, p JJan809ich/ 'W

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DATE 04/05/99 04/ 6 /99 bV OFFICIAL RECORD COPY Ti0cfd WCM if ' (l

r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 1 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator MODEL: Husman 520, 521, 521a MANUFACTURER: Isomedix, Inc.

11 Apollo Drive Whippany, NJ 07981 l

DISTRIBUTOR: U.S. Department of Agriculture 4700 River Road, Unit 91 i Riverdale, MD 20737-1228 l l

l SEALED SOURCE MODEL DESIGNATION J.L. Sheperd Model 6810 Amersham Model X.2157 ORNL, Drawing C-SK-2440  !

ORNL, Drawing C-SK-342 ORNL, Drawing C-RD-2128 1

ISOTOPE: MAXIMUM ACTIVITY:

Cs-137 42,000 Ci (1,554 TBq)

LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (J) Gamma Irradiator, Category I C'jTOM DEVICE: X YES NO CUSTOM USER: U.S. Department of Agriculture Anywhere in U.S.A.

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f REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE NO.: NR-8107-D-801-S DATE: April 5,1999 PAGE: 2 OF 8 1 i (Supersedes NR-1060-D-801-S) l DEVICE TYPE: Self-Shielded Irradiator  !

l DESCRIPTION:

The Models of Husman 520,'521, and 521a were irradiators designed to provide an automated method to produce large quantities of sterile pupae to meet'the requirements of the sterile fly rearing programs operated by the Animal and Plant. Health Inspection Service, USDA. The Husman irradiators were installed in fixed locations. Their weight was 17,000 lb. (7,711 kg). Four units were used by USDA Agencies in the United States. Five units were on loan to the governments of Mexico and Guatemala for use in their programs.

The Husman irradiator consists of a rotating annular rotor between an integral central core and outer annular shell. Pupae containers are loaded by gravity-feed into one of the three equally spaced specimen chambers in the rotor, and are transported to irradiation position by revolving the rotor one-third revolution (12 0 ) . The dose absorbed is determined by the dwell time of specimens at the position. After irradiation, the specimens are rotated to another opening and unloaded by gravitational force. The irradiation cycle is controlled by an index drive system which cyclically and automatically loads the pupae containers into the rotor, irradiates, and unloads the specimens within a specified period of time. The unit is self-contained and fully shielded at all times regardless of rotor position.

The entire outer skin of the Husman irradiator was fabricated of 5/8" (1.59 cm) thick carbon steel plate. All inner plates were of stainless steel. Additionally, a minimum of 6" (15.24 cm) of 3ead shielded each source canister in all directions.

The lead shielding was poured into the cylinders in a single operation to insure complete filling and to eliminate voids.

After source loading, radiation measurements were mude to verify shielding integrity.

Upon installation of the source canisters into the Husman irradiator, a lead filled plug was installed into the access port. A 5/8" (1.59 cm) carbon steel plate was then sealed with either.a full penetration groove weld, or was by bolting the

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE EL.: NR-8107-D-801-S _D_6TE:Apri1 5, 1999

_ PAGE: 3 OF'8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION (Cont'd):

plate to the outer skin, thus eliminating any possibility of outside contact with the source.

The sealed source insert tube was fabricated of stainless steel.

The spacers were aluminum. The source tubes were sealed; no water or water vapor could enter to initiate a chemical reaction, and the electrochemical potential between the housing and the source material should not support a reaction that would significantly degrade the ,ources. Na other corrosive materials were used near the irradiator that could have an impact on source integrity.

The radioactive sources to be used for the Husman irradiator were manufactured by Amersham as Model X-2157 and were purchased through J.L. Sheperd as their Model 6810 source.

The Husman 520 (Serial Number 001) was the original prototype of this series. The Husman 521 (Serial Numbers 002 through 005) ,

were produced with a minor change in external components used j during transportation. The Husman 521a (Serial Numbers 006 l through 009) were produced with a secondary heat shield added to the lower portion of the outer shell to increase its thermal resistance during a fire.

Isomedix, Inc. and J.L. Sheperd and Associates had developed a modification of the shield plug in the Model 6810 source to enable field reloading of the irradiators. At this time, only Serial Number 009 had this modification.

All other irradiators were designed in accordance with the

,. information previously sent to NRC. The modification did not affect any operating system of the irradiator, did not change any of the dimensions, and did not decrease the stated shielding characteristic of the irradiators.

As these modifications wcre made to other Husman ir. radiators, they were redesignated with an (R) following the model number to indicate that they had been modified for reloading, in the field.

)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUAT ON OF DEVICE NQt: NR-8107-D-801-S DATE: April 5,1999 PAGE: 4 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator  !

DESCRIPTION (Cont'd)- l l

The modification involved replacing the existing shield plug with the one shown in J.L. Sheperd's drawing No. A-0609-2-4124-1.

Prior to the insertion of the replacement sources, the shield plug was inserted in the end of the irradiator. A tungsten shielded source rod attached to the end of the rod containing the j radioactive sources and the resulting assembly was inserted into (

the source chamber using a transfer cask. The tungsten plug was I placed in position and steel plates were welded to the outer case of the irradiator to assure the integrity and shielding of the i sources.

I The original shield plug had been lead filled. The modified shield plug was also lead filled with the shielded source rod and secondary plug manufactured out of tungsten. This configuration increased the overall shielding capacity of the shield plug.

LABELING:

The Husman irradiator is labeled in accordance with 10 CFR 20.1901. The label displays the radiation symbol, date, isotope, 1 activity, model number, serial number, name and address of the l manufacturer, and the words " CAUTION-RADIOACTIVE MATERIAL." )

DIAGRAM:

See Attachments 1, 2, and 3.

CONDITIONS OF NORMAL USE:

.The Husman irradiators are operated in enclosed buildings and designed for the following environment conditions:

Temperature 10 C to 50 C (50 F to 122 F)

Pressure Atmospheric Vibration Ranges from zero to mild Corrosion Ranges from zero to low corrosive vapors )

Fire NEC Division 2 hazardous area possible Explosion NEC Division 2 hazardous area possible l

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE HQt: NR-8107-D-801-S DATE: April 5,1999 PAGE: 5 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator CONDITIONS OF NORMAL USE (Cont'd): 3

)

The expected useful life of these irradiators was 50 years.

PROTOTYPE TESTING:

A detailed thermal analysis had been performed where the Husman irradiator had been exposed to direct sunlight and 130 F (54.44 C) still air. The steady-state analysis conservatively had assumed a 24-hour day at maximum solar heat load. The maximum steady-state temperature had been found to be 223.6 F (106.44*C). These temperatures would have no detrimental effects on the Husman irradiator.

The materials of construction used in the Husman irradiator were J able to resist brittle fracture failure at temperatures as low as j -40 F (-40"C).

1 The entire cask structure, with the exception of the outer shell,  ;

l was fabricated of an austenitic stainless steel. Austenitic stainless steel did not experience a ductile to brittle transition in the temperature range of interest (i.e., as low as

-40 F (-40"C]).

Due to the lack of sealing devices on the Husman irradiator, a l differential pressure of 0.5 atmosphere (50.66 kPa} would have no effect on the Husman irradiator.

The prototype Husman irradiator had been subjected to an extensive safety analysis in order to meet the Type B package requirements for transportation in accordance with 10 CFR 71. A safety analysis report had been submitted as part of the certification process and had been found acceptable under Certificate of Compliance No. 9182.

l'

)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE LKL: NR-8107-D-801-S DATE: April 5,1999 PAGE: 6 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator EXTERNAL RADIATION LEVELS:

The radiation levels around the outer shell averaged less than 2 mR/hr (20 gSv/hr) at the surface of the i.rradiator and less than 1 mR/hr (10 Sv/hr) at 1m (3.28'), when the source activity was at a maximum.' The maximum radiation level found on the end of the unit, next to the source tube shield plate had been measured at 4 mR/hr (40 Sv/hr). These radiation levels had been measured at 45 increments at each end and in the middle of an irradiator, both surface and 3 readings had been obtained.

Radiation levels did not change during operation since the sources were fixed in position.

OUALITY ASSURANCE AND CONTROL:

At the time of construction, the Husman Irradiators had been manufactured under Quality Assurance Program Approval No. 0009.  !

As constructed, the Husman irradiators had met the construction and performance specifications for a Type B package. The manufacturer's Quality Control program and package certification for transportation expired on September 4, 1991.

All source capsule bodies and modifications had been completed  !

under J.L. Sheperd and Associates Quality Assurance Program l Approval No. 0122, Quality Control Manual QA-RM-001-A, which  !

coveref engineering design through final fabrication. Quality I Contrr! of source encapsulation was also controlled by the manufi turers' quality assurance programs.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

l e The device should be distributed to persons specifically i listed in ?his registration by the NRC or an Agreement I State.

l e Handling, Storage, Use, Transfer, and Disposal: To be j i determined by the licensing authority.  !

l i

l l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-8107-D-801-S DATE. April 5, 1999 PAGE: 7 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPF: Self-Shielded Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd) e These devices should be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.

e This registration sheet and the information contained within the references should not be changed without the written consent of the NRC. i i

e REVIEWER NOTE: place of the expired QA program of the manufacturer, the USDA should implement special procedures in operation and maintenance of the irradiators in order to ensure radiation safety.

e REVIEWER NOTE: All operators of the Husman irradiators are required to take a minimum 2 day course of instruction in the operation of the irradiator and in radiation safety procedures and precautions. Operators must take and pass an examination demonstrating their understanding and knowledge of the device prior to being certified in its operation.

This is a requirement of the USDA's irradiator license.

SAFETY ANALYSIS

SUMMARY

The Husman irradiators are no longer manufactured or distributed by the USDA and the USDA has no intention to have any more of these irradiators produced. Therefore, the registration certificate is being converted to an inactive registration certificate.

The USDA maintained the records of the oldest unit (Serial Number 001), located in Mission, TX. The USDA had found no serious operational problems with unit since 1986 and indicated that no incidents involving the Cesium sources or exposure to excess radiation to workers had been found.

Based on review of the operating experience with the Husman irradiators and J.L. Sheperd Model 6810 source capsule with modification to Serial Nnumber 009, and based on the information

s REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NQ : NR-8107-D-801-S DATE: April 5, 1999 PAGE: 8 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator SAFETY ANALYSIS

SUMMARY

(Cont'd)-

and test data cited below, we concluded that the Husman irradiators are acceptable for licensing purposes.

Furthermore, we concluded that the Husman irradiator would be expected to maintain it's containment integrity for normal q conditions of use and accidental conditions which might occur  ;

during uses specified in this certificate.

Due to the location of the device, the only personnel likely to be in the vicinity of the Husman irradiator were persons performing maintenance on the device.

l

REFERENCES:

The following supporting documents for the Husman irradiators are hereby incorporated by reference and are made a part of this registry document:

  • USDA's application dated July 16, 1996, letter received on February 25, 1997, with enclosures thereto.
  • USDA's correspondence dated May 7, 1996 and May 9, 1996, with enclosures thereto.
  • USDA's correspondence dated February 8, 1999.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission e

Date: April 5, 1999 Reviewer:

Seung Ad Lee Date: Aoril 5. 1999 Concurrence: / M6u P[ 2<c).<e dohn P.' Jankovich

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i h NR-8107-D-801-S DATE: April 5, 1999 ATTACHMENT 1 (Supersedes NR-1060-D-801-S) l I

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o REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-8107-D-801-S DATE: April 5, 1999 ATTACHMENT 2 (Supersedes NR-1060-D-801-S)

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Major Components of the Htisman 520 Series Irradiators

ia Mr. John T. J:nson i U.S. D:partment of Agricultura April 5, 1999 l

. 4700 Rivsr Road, Unit 91 Riverdale, MD 20737

Dear Mr. Jenson:

1 Due to inconsistent numbering for your Husman irradiators registration certificate, we issue a new registration certificate number, NR-8107-D-801-S, which supercedes registration certificate number NR-1060 D-801-S.

Please read over the registration certificate in its entirety and notify us immediately of any errors I or omissions. I If you have any questions, please contact me at (301) 415-5787 or Mr. John Jankovich at (301)

'415 7904.

Sincerely,

/s/

Seung J. Lee, Mechanical Engineer '

Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As stated cc w/enci: SKimberley, LFDCB Distribution: -

MSB r/f IMNS r/f SSD-99-17 NE01 SSD File # NO-8107-D-801-S DOCUMENT NAME: H:\SJL\N8107801. CMP Ts receive a cop r of thle document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment /encbsure "N" = No copy OFFICE MSB E MSB  !

n & l l NAME Slee ,, p

  1. ^

JJanko0ich / K DATE 04/05/99 04/ 6 /99 VV '

OFFICIAL RECORD COPY l

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l

l NQ2: NR-8107-D-801-S DATE: April 5,1999 PAGE: 1 OF 8 (Supersedes NR -1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator l

MODEL: Husman 520, 521, 521a MANUFACTURER: Isomedix, Inc. l 11 Apollo Drive Whippany, NJ 07981 DISTRIBUTOR: U.S. Department of Agriculture 4700 River Road, Unit 91 Riverdale, MD 20737-1228 SEALED SOURCE MODEL DESIGNATION J.L. Sheperd Model 6810 Amersham Model X.2157 ORNL, Drawing C-SK-2440 ORNL, Drawing C-SK-342 ORNL, Drawing C-RD-2128 ISOTOPE: MAXIMUM ACTIVITY:

Cs-137 42,000 Ci (1,554 TBq)

LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (J) Gamma Irradiator, Category I CUSTOM DEVICE: X YES NO CUSTOM USER: U.S. Department of Agriculture Anywhere in U.S.A.

4Ff tl C?M ?/ DN .

REGISTRY OF RADIOACrIVE SEALED SOURCES AMD DEVICES SAFETY EVALUATION OF DEVICE I i

I HQ_,_ : NR-8107-D-801-S DATE: April 5, 1999 PAGE: 2 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION:

The Models of Husman 520, 521, and 521a were irradiators designed to provide an automated method to produce large quantities of sterile pupae to meet the requirements of the sterile fly rearing programs operated by the Animal and Plant Health Inspection Service, USDA. The Husman irradiators were installed in fixed locations. Their weight was 17,000 lb. (7,711 kg). Four units were used by USDA Agencies in the United States. Five units were on loan to the governments of Mexico and Guatemala for use in their programs.

The Husman irradiator consists of a rotating annular rotor between an integral central core and outer annular shell. Pupae )

containers are loaded by gravity-feed into one of the three f equally spaced specimen chambers in the rotor, and are transported to irradiation position by revolving the rotor one-third revolution (120 ). The dose absorbed is determined by the dwell time of specimens at the position. After irradiation, the specimens are rotated to another opening and unloaded by gravitational force. The irradiation cycle is controlled by an index drive system which cyclically and automatically loads the t

pupae containers into the rotor, irradiates, and unloads the specimens within a specified period of time. The unit is self-contained and fully shielded at all times regardless of rotor position.

The entire outer skin of the Husman irradiator was fabricated of 5/8" (1.59 cm) thick carbon steel plate. All inner plates were of stainless steel. Additionally, a minimum of 6" (15.24 cm) of lead shielded each source canister in all directions.

- The lead shielding was poured into the cylinders in a single 1 operation to insure complete filling and to eliminate voids.

After source loading, radiation measurements were made to verify shielding integrity.

Upon installation of the source canisters into the Husman irradiator, a lead filled plug was installed into the access port. A 5/8" (1.59 cm) carbon steel plate was then sealed with either a full penetration groove weld, or was by bolting the a

b f

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 3 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION (Cont'd)-

plate to the outer skin, thus eliminating any possibility of outside contact with.the source.

The sealed source insert tube was fabricated of stainless steel.

The spacers were aluminum. The source tubes were sealed; no water or water vapor could enter to initiate a chemical reaction, and the electrochemical potential between the housing and the source material should not support a reaction that would significantly degrade the sources. Eo other corrosive materials were used near the irradiator that could have an impact on source integrity.

The radioactive sources to be used for the Husman irradiator were manufactured by Amersham as Model X-2157 and were purchased through J.L. Sheperd as their Model 6810 source.

The Husman 520 (Serial Number 001) was the original prototype of this series. The Husman 521 (Serial Numbers 002 through 005) were produced with as minor change in external components used during transportation. The Husman 521a (Serial Numbers 006 through 009) were produced with a secondary heat shield added to the lower portion of the outer shell to increase its thermal resistance during a fire. i Isomedix, Inc. and J.L. Sheperd and Associates had developed a modification of the shield plug in the Model 6810 source to enable field reloading of the irradiators. At this time, only Serial Number 009 had this modification.

All other irradiators were designed in accordance with the information previously sent to NRC. The modification did not affect any operating system of the irradiator, did not change any of the dimensions, and did not decrease the stated shielding characteristic of the irradiators.

As these modifications were made to other Husman irradiators, they were redesignated with an (R) following the model number to indicate that'they had been modified for reloading in the field.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVTCE NQ : NR-8107-D-801-S DATE: April 5, 1999 PAGE: 4 OF 8 (Supersedes NR-1060-D-801-S) ,

DEVICE TYPE: Self-Shielded Irradiator l 1

1 i

DESCRIPTION (Cont'd)- l The modification involved replacing the existing shield plug with the one shown in J.L. Sheperd's drawing No. A-0609-2-4124-1.

Prior to the insertion of the replacement sources, the shield plug was inserted in the end of the irradiator. A tungsten shielded source rod attached to the end of the rod containing the radioactive sources and the resulting assembly was inserted into the source chamber using a transfer cask. The tungsten plug was placed in ;osition and steel plates were welded to the outer case of the irradiator to assure the integrity and shielding of tha sources.

The original shield plug had been lead filled. The modified shield plug was also lead filled with the shielded source rod and secondary plug manufactured out of tungsten. This configuration increased the overall shielding capacity of the shield plug.

LABELING:

The Husman irradiator is labeled in accordance with 10 CFR 20.1901. The label displays the radiation symbol, date, isotope, activity, model number, serial number, name and address of the manufacturer, and the words " CAUTION-RADIOACTIVE MATERIAL."

DIAGRAM:

l

)

1 l

See Attachments 1, 2, and 3. j CONDITIONS OF NORMAL USE:

The Husman irradiators are operated in enclosed buildings and designed for the following environment conditions:

Temperature 10 C to 50 C (50 F to 122 F)

Pressure Atmospheric Vibration Ranges from zero to mild j Corrosion Ranges from zero to low corrosive vapors j Fire NEC Division 2 hazardous area possible i Explosion NEC Division 2 hazardous area possible j 1

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO : NR-8107-D-801-S DATE. April 5,1999 PAGE: 5 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator CONDITIONS OF NORMAL USE (Cont'd)-

The expected useful life of these irradiators was 50 years.

PROTOTYPE TESTING:

A detailed thermal analysis had been performed where the Husman irradiator had been exposed to direct sunlight and 130 F (54.44 C) still air. The steady-state analysis conservatively had assumed a 24-hour day at maximum solar heat load. The maximum steady-state temperature had been found to be 223.6*F (106.44 C). These temperatures would have no detrimental effects on the Husman irradiator.

The materials of construction used in the Husman irradiator were able to resist brittle fracture failure at temperatures as low as

-40 F (-40 C).

The entire cask structure, with the exception of the outer shell, was fabricated of an austenitic stainless steel. Austenitic stainless steel did not ;xperience a ductile to brittle transition in the temperature range of interest (i.e., as low as 1

-40 F (-40 C]).

Due to the lack of sealing devices on the Husman irradiator, a differential pressure of 0.5 atmosphere (50.66 kPa) would have no l effect on the Husman irradiator. '

The prototype Husman irradiator had been subjected to an extensive safety analysis in order to meet the Type B package requirements for transportation in accordance with 10 CFR 71. A safety analysis report had been submitted as part of the certification process and had been found acceptable under Certificate of Compliance No. 9182.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 6 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPS: Self-Shielded Irradiator EXTERNAL RADIATION LEVELS:

The radiation levels around the outer shell averaged less than 2 mR/hr (20 Sv/hr) at the surface of the irradiator and less than 1 mR/hr (10 Sv/hr) at 1m (3.28'), when the source activity was at a maximum. The maximum radiation level found on the end of the unit, next to the source tube shield plate had been measured at 4 mR/hr (40 Sv/hr). These radiation levels had been measured at 45 increments at each end and in the middle of an i irradiator, both surface and 3 readings had been obtained.

Radiation levels did not change during operation since the sources were fixed in position.

QUALITY ASSURANCE AND CONTROL:

l At the time of construction, the Husman Irradiators had been manufactured under Quality Assurance Program Approval No. 0009.

As constructed, the Husman irradiators had met the construction and performance specifications for a Type B package. The manufacturer's Quality Control program and package certification j for transportation expired on September 4, 1991. j All source capsule bodies and modifications had been completed under J.L. Sheperd and Associates Quality Assurance Program Approval No. 0122, Quality Control Manual QA-RM-001-A, which covered engineering design through final fabrication. Quality Control of source encapsulation was also controlled by the j manufacturers' quality assurance programs.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

e The device should be distributed to persons specifically listed in this registration by the NRC or an Agreement State.

e Handling, Storage, Use, Transfer, and Disposal: To be determined by tha licensing authority, i

4 i

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l

UfL: NR-8107-D-801-S DATE: April 5, 1999 PAGE: 7 OF 8 (Supersedes NR 060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd):

  • These devices should be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.

e This registration sheet and the information contained within '

the references should not be changed without the written consent of the NRC.

  • REVIEWER NOTE: In place of the 2xpired QA program of the l manufacturer, the USDA should implement special procedures in operation and maintenance of the irradiators in order to ensure radiation safety.
  • REVIEWER NOTE: All operators of ti:e Husman irradiators are required to take a minimum 2 day course of instruction in l the operation of the irradiator and in radiation safety l procedures and precautions. Operators must take and pass an )

examination demonstrating their understanding and knowledge of the device prior to being certified in its operation. >

This is a requirement of the USDA's irradiator license. ]

1 l

SAFETY ANALYSIS

SUMMARY

The Husman irradiators are no longer manufactured or distributed by the USDA and the USDA has no intention to have any more of these irradiators produced. Therefore, the registration certificate is being converted to an inactive registration certificate.

The USDA maintained the records of the oldest unit (Serial Number 001), located in Mission, TX. The USDA had found no serious operational problems with unit since 1986 and indicated that no incidents involving the Cesium sources or exposure to excess radiation to workers had been found.

Based on review of the operating experience with the Husman irradiators and J.L. Sheperd Model 6810 source capsule with .

modification to Serial Nnumber 009, and based on the information l

l l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF DE'?'CE NO

  • NR-8107-D-801-S DATE: April 5, 1999 PAGE: 8 OF 8 (Supersedes NR-1060-D-801-S)

DEVICE TYPE: Self-Shielded Irradiator SAFETY ANALYSIS

SUMMARY

(Cont'd) i i

and test data cited below, we concluded that the Husman I irradiators are acceptable for licensing purposes.

1 Furthermore, we concluded that the Husman .irradiator would be  !

expected to maintain it's containment integrity for normal conditions of use and accidental conditions which might occur i during uses specified in this certificate.

Due to the location of the device, the only personnel likely to be in the vicinity of the Husman irradiator were persons performing maintenance on the device.

REFERENCES:

The following supportino documents for the Husman irradiators are hereby incorporated by reference and are made a part of this registry document:

  • USDA's application dated July 16, 1996, letter received on February 25, 1997, with enclosures thereto.
  • USDA's correspondence dated May 7, 1996 and May 9, 1996, ith enclosures thereto.
  • JSDA's correspondence dated February 8, 1999.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission Date: April 5, 1999 Reviewer:

eung S Od Lee b

Date: Acril 5. 1999 Concurrence: /

4P /fLas dohn P.' Jankovich

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-8107-D-801-S DATE: April 5, 1999 ATTACfIMENT 1 (Supersedes NR-1060-D-801-5)

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE l

l NO.: NR-8107-D-801-S 7 ATE: April 5, 1999 ATTACHMENT 2 (Supersedes NR-1060-D-801-S)

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Major Cennponer.ts of the Husman 520 Series Irradiators

i NRC FORM 567 U.S. NUCLEAR REGULATORV COMMISSION 0

1-1999)

REQUEST FOR A SEALED SOURCE OR I

[p/

I DEVICE EVALUATION INSTRUCTIONS: Send this rerquest AND a copy of all related letters / applications and drangs to * ? Chief, Sealed Source Safety Section, OWFN Mail Stop O-6 H3 Change the License Tracking System rnilestone to 19 and assign to reviewer code 1-5.

NOTE: Retain a copy of this request with the application and background files.

m . T g ,. REGION /LOGAllON isomedix, Inc. Ill IV I 11 HQ LFARB TELEPHONE NUMBER DATE i

TYPE OF ACTION REQUESTED (Check as appropriate)  !

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NAMEO APPLICAN g~

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FOR SSSS USE ONLY REVIEWER MODEL NUMBERS NUM8ER ASSIGNED Scung Lee 11usman 520,521,521a 99-17 OATE RECEIVED DATE AS$1GNED DATE TO FEES 03/04/1999 03/05/1999 03/05/1999 TYPE OF ACTION (Indicate the number of each type) g COMMERCIAL DISTRIBUTION (FORMAL) USE BY A SINGLE APPLICANT (CUSTOM)

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NO OTHER (Specify) w--%e. - - . + . _ - + , . , . . ,, , , .

REVIEW HOURS Amendment to make registration certinicate noted above

__ _ NUMBER OF _ to inactive status. The new number will be DEFICIENCY LETTERS _ . NR-8107-D-801-S.

_ _ _ _ . . _ NUMBER OF DEFICIENCY CALLS VA

- ~ "FORFEE USE ONLY FEE CATEGORY'~ ^

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TYPE OF FEE- ~ ~ ~ ~ - ~ - ~ ~ - ~ ~ ~ ~ - - -

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-DATE F RETURN APPR sOVEDY .

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a NRC FORM 567

1-1999)

U.S. NUCLEAR REGULATO REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION {

INSTRUCTIONS: Send this rerquest AND a copy of all related letters / applications and drawings t^ *3 Chief. Sealed Source Safety Section, OWFN Mail Stop O-6 H3. Change the License Tracking System milestone to 19 and assign to reviewer code 15.

NOTE: Retain a copy of this request with the application and background files.

._r T w.. REGION,10 GALLON.

Isomedix, Inc.

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LFARB TYPE OF ACTION REQUESTED (Check as appropndte)

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REVIEWER. - . . - _ _ . . _ _ _ . _ - _ _ __MODEL NUMBERS . . _ . NUMBER ASSIGNED _ _ _ . _ _ _ _ _ _ _ _

Seung Lee Ilusman 520,521. 521a 99

- - _ _- 17__. - - - . _ _ _

03/04/1999 03/05/1999 03/05/1999 TYPE OF ACTION (Indicate the number of each type) g COMMERCIAL DISTRIBUTION (FORMAL) USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C) SOURCE (9A) SOURCE (9D) SOURCE (98)

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TOT i NOMBER OF - ' ~ ~ NOTES' " - ~ ~ ~ ~ ~

REVIEW HOURS Amendment to make registrc; ion certificate noted above NUMBER OF to inactive status. The new number will be DEFICIENCY LETTERS _ NR-8107-D-801-S.

DEFICIENCY CALLS

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4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO. NR-1060-D-801-S DATE: fi 7 it PAGE: 1 OF 8 DEVICE TYPE: Self-Shielded Irradiator MODEL: Husman 520, 521, 521a MANUFACTURER: Isomedix, Inc.

11 Apollo Drive Whippany, NJ 07981 DISTRIBUTOR: U.S. Department of Agriculture 4700 River Road, Unit 91 Riverdale, MD 20737-1228 SEALED SOURCE MODE.L DESIGNATION J.L. Sheperd Model 6810 Amersham Model X.2157 ORNL, Drawing C-SK-2440 ORE , Drawing C-SK-342 ORNL, Drawing C-RD-2128 ISOTOPE: MAXIMUM ACTIVITY:

Cs-137 42,000 Ci (1,554 TBq) i i

LEAK TEST FREOUENCY: 6 months  !

j l

PRINCIPAL USE: (J) Gamma Irradiator, Category I CUSTOM DEVICE: X YES NO CUSTOM USER: U.S. Department of Agriculture Anywhere in U.S.A.

??nWo WC0 94 W19 j

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-1060-D-801-S DATE: PAGE: 2 OF,_8 DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION:

The Models of Husman 520, 521, and 521a were irradiators designed to provide an automated method to produce large quantities of sterile pupae to meet the requirements of the sterile fly rearing programs operated by the Animal and Plant Health Inspection Service, USDA. The Husman irradiators were installed in fixed locations. Their weight was 17,000 lb. (7,711 kg). Four units were used by USDA Agencies in the United States. Five units were on loan to the governments of Mexico and Guatemala for use in their programs.

The Husman irradiator consists of a rotating annular rotor between an integral central core and outer annular shell. Pupae containers are loaded by gravity-feed into one of the three equally spaced specimen chambers ir. the rotor, and are transported to irradiation position by revolving the rotor one-third revolution (120 ). The dose absorbed is determined by the dwell time of specimens at the position. After irradiation, the specimens are rotated to another opening and unloaded by gravitational force. The irradiation cycle is controlled by an index drive system which cyclically and automatically loads the pupae containers into the rotor, irradiates, and unloads the specimens within a specified period of time. The unit is self-contained and fully shielded at all times regardless of rotor position. j The entire outer skin of the Husman irradiator was fabricated of 5/8" (1.59 cm) thick carbon steel plate. All inner plates were of stainless steel. Additionally, a minimum of 6" (15.24 cm) of lead shielded each source canister in all directions.

The lead shielding was poured into the cylinders in a single operation to insure complete filling and to eliminate voids.

After source loading, radiation measuremonts were made to verify i shielding integrity.

Upon installation of the source canisters into the Husman irradiator, a lead filled plug was instal'3d into the access port. A 5/8" (1.59 cm) carbon steel plate was then sealed with either a full penetration groove weld, or was by bolting the i

l l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-1060-D-801-S DATE: ' '

PAGE: 3 OF 8 DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION (Cont'd)-

plate to the outer skin, thus eliminating any possibility of outside contact with the source.

The sealed source insert tube was fabricated of stainless steel. j The spacers were aluminum. The source tubes were sealed; no water or water vapor could enter to initiate a chemical reaction,

..nd the electrochemical potential between the housing and the source material should not support a reaction that would significantly degrade the sources. No other corrosive materials were used near the irradiator that could have an impact on source integrity.

The radioactive sources to be used for the Husman irradiator were manufactured by Amersham as Model X-2157 and were purchased through J.L. Sheperd as their Model 6810 source.

The Husman 520 (Serial Number 001) was the original prototype of 1 this series. The Husman 521 (Serial Numbers 002 through 005) l were produced with a minor change in external components used f during transportation. The Husman 521a (Serial Numbers 006 )

through 009) were produced with a secondary heat shield added to i the lower portion of the outer shell to increase its thermal resistance during a fire.

Isomedix, Inc. and J.L. Sheperd and Associates had developed a modification of the shield plug in the Model 6810 source to enable field reloading of the irradiators. At this time, only Serial Number 009 had this modification.

All other irradiators were designed in accordance with the information previously sent to NRC. The modification did not affect any operating system of the irradiator, did not change any of the dimensions, and did not decrease the stated shielding characteristic of the irradiators.

As these modifications were made to other Husman irradiators, they were redesignated with an (R) following the model number to indicate that they had been modified for reloading in the field.

4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF C~~/ ICE

. ~f 6 i i Tj NO.: NR-1060-D-801-S DATE: PAGE: 4 OF 8 DEVICE TYPE: Self-Shielded Irradiator DESCRIPTION (Cont'd)-

The modification involved replacing the existing shield plug with the one shown in J.L. Sheperd's drawing No. A-0609-2-4124-1.

Prior to the insertion of the replacement sources, the shield plug was inserted in the end of the irradiator. A tungsten shielded source rod attached to the end of the rod containing the radioactive sources and the resulting assembly was inserted into the source chanber using a transfer cask. The tungsten plug was placed in position and steel plates were welded to the outer case I of the irradiator to assure the integrity and shielding of the sources.

The original shield plug had been lead filled. The modified shield plug was also lead filled with the shielded source rod and l secondary plug manufactured out of tungsten. This configuration increased the overall shielding capacity of the shield plug. I LABELING:

The Husman irradiator is labeled in accordance with 10 CFR 20.1901. The label displays the radiation symbol, date, isotope, activity, model number, serial number, name and address of the manufacturer, and the words " CAUTION-RADIOACTIVE MATERIAL."

DIAGRAM:

See Attachments 1, 2, and 3.

CONDITIONS OF NORMAL USE:

The Husman irradiators are operated in enclosed buildings and designed for the following environment conditions:

Temperature 10 C to 50 C (5J'F to 122 F)

Pressure Atmospheric Vibration Ranges from zero to mild Corrosion Ranges from zero to low corrosive vapors Fire NEC Division 2 hazardous area possible Explosion NEC Division 2 hazardous area possible

F REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE I

NO;: NR-1060-D-801-S DATE: a .; 7 : PAGF: 5 OF 8 DEVICE TYPE: Self-Shielded Irradiator CONDITIONS OF NORMAL USE (Cont'd)-

l The expected useful life of these irradiators was 50 years.

PROTOTYPE TESTING:

A detailed thermal analysis had been performed where the Husman irradiator had been exposed to direct sunlight and 130 F (54.44 C) still' air. The steady-state analysis conservatively had assumed a 24-hour day at maximum solar heat load. The maximum steady-state temperature had been found to be 223.6 F (106.44 C). These temperatures would have no detrimental effects on the Husman irradiator.

The materials of construction used in the Husman irradiator were able to resist brittle fracture failure at temperatures as low as

-40 F (-40 C).

l The' entire cask structure, with the exception of the outer shell, l was fabricated of an austenitic stainless smeel. Austenitic stainless steel did not experience a ductile to brittle l transition in the temperature range of interest (i.e., as low as l -40 F [-40 C]).

Due to the lack of sealing devices on the Husman irradiator, a differential pressure of 0.5 atmosphere (50.66 kPa) would have no effect on the Husman irradiator.

The prototype Husman irradiator had been subjected to an extensive safety analysis in order to meet the Type B package requirements for transportation in accordance with 10 CFR 71. A safety analysis report had been submitted as part of the certification process and had been found acceptable under Certificate of Compliance No. 9182.

EXTERNAL RADIATION LEVELS:

The radiation levels around the outer she:El averaged less than

!- 2 mR/hr (20 Sv/hr) et the surface of the innadiator and less l

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REGISTRY OF RADICACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

. l NO.: NR-1060-D-801-S DATE: # * PAGE: 6 OF 8 l 1

i DEVICE TYPE: Self-Shielded Irradiator l l

l EXTERNAL RADIATION LEVELS (Cont'd).

than 1 mR/hr (10 gSv/hr) at 1 m (3.28'), when the source activity was at a maximum. The maximum radiation level found on the end ]

of the unit, next to the source tube shield plate had been measured at 4 mR/hr (40 Sv/hr) These radiation levels had been measured at'45 increments at each end and in the middle of an ,

irradiator, both surface and 3 readings had been obtained.

nadiation levels did not change during operation since the sources were fixed in position.

OUALITY ASSURANCE AND CONTROL:

At the time of construction, the Husman Irradiators had been manufactured under Quality Assurance Program Approval No. 0009.

As constructed, the Husman irradiators had met the construction and performance specifications for a Type B package. The manufacturer's Quality Control program and package certification for transportation expired on September 4, 1991.

Alz Source ;apsule bodies and modifications had been ccmpleted under J.L. Sheperd and Associates Quality Assurance Program Approval No. 0122, Quality Control Manual QA-RM-001-A, which covered engineerlag design through final fabrication. Quality Control of source encapsulation was also controlled by the manufacturers' quality assurance programs.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

  • The device should be distributed to persons specifically listed in this registration by the NRC or an Agreement State.
  • Handling, Storage, Use, Transfer, and Disposal: To be  ;

determined by the licensing authority.

  • These devices should be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.- NR-1060-D-801-S DATE: If f i i . . PAGE: 7 OF 8 DEVICE TYPE: Self-Shielded Irradiator LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd) e This registration sheet and the information contained within the references should not be changed without the written consent of the NRC.

  • REVIEWER NOTE: In place of the expired QA program of the manufacturer, the USDA should implement special procedures  !

in operation and maintenance of the irradiators in order to

]

ensure radiation safety.

  • REVIEWER NOTE: All operators of the Husman irradiators are required to take a minimum 2 day course of instruction in the operation of the irradiator and in radiation safety procedures and precautions. Operators must take and pass an examination demonstrating their understanding and knowledge of the device prior to being certified in its operation.

This is a requirement of the USDA's irradiator license.

SAFETY ANALYSIS

SUMMARY

The Husman irradiators are no longer manufactured or distributed by the USDA and the USDA has no intention to have any more of these irradiators produced. Therefore, the registration certificate is being converted to an inactive registration certificate.

The USDA maintained the records of the oldest unit (Serial Number 001), located in Mission, TX. The USDA had found no serious operational problems with unit since 1986 and indicated that no incidents involving the Cesium sources or exposure to excess radiation to workers had been found.

Based on review of the operating experience with the Husman irradiators and J.L. Sheperd Model 6810 source capsule with modification to Serial Nnumber 009, and based on the information and test data cited below, we concluded that the Husman irradiators are acceptable for licensing purposes.

I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION CP CP ICE

'N I I '

NO.. NR-1060-D-801-S DATE: PAGE: 8 OF 8 DEVICE TYPE: Self-Shielded Irradiator SAFETY ANALYSIS

SUMMARY

(Cont'd)

Furthermore, we concluded that the Husman irradiator 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.

Due to the location of the device, the only personnel likely to be in the vicinity of the Husman irradiator were persons performing maintenance on the device.

REFERENCES:

The following supporting documents for the Husman irradiators are j hereby incorporated by reference and are made a part of this registry document:

e USDA's application dated July 16, 1996, letter received on February 25, 199' with enclosures thereto.

e USDA's correspondence dated May 7, 1996 and May 9, 1996, with enclosures thereto.

e USDA's correspondence dated February 8, 1999.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission fib 17'W Date: Reviewer: ./ /

SeungVJ. Lee r

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- ve ? W WY Date: Concurrence: <

l V John P. Jankovich I

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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i NO.- NR '.060-D-801-S DATE: EN ' ' '

ATTACHMENT 1 l

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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE i

NO. NR-1060-D-801-S DATE: ATTACHMENT 2

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NRC FORM 420 U.S. NUCLEAR R ,5ULATORY COMMISSION REQUIRED DELIVERY DATE (5 1998)

REQUEST FOR PREMlUM COST MAIL SERVICE 03/24/1999 REQUESTER ~ SEND COMPLETED FORM WITH MATERIAL TO. Mall SERVICES SECTION. ASC/ADM AFTER PROCESSING, A COPY WILL BE RETURNED TO YOU.

FROM.NAME ORGANIZATION (Offr.e/Dw/Brare) TELEPHONE NUMBER MAIL STOP Traci Kime NMSS/IMNS/MSU 301-415-8140 T:8FS TYPE OF MAIL SERVICE REQUESTED: Q EXPRESS (OVERNIGHT) [: PRIVATE COURIER DELIVERY , INTERNATIONAL EXPRESS BRIEF DESCRIPTION OF MATERIAL Scaled Source and Device Registration Certificate DESTWATON OF MATER 1AL JUSTIFICATION - State why premium mailis jushfied over the use of regular mail.

Comfort Inn Need signature on registration certificate so case can be ATTN: Mr. Seung Lee closed out. Employee not expected to be back in the office 433 outh Rutgers Avenue until April 5,1999.

Oak Ridge,TN 37830 j SiONA TURh - FLQUL5 ILR DAIL t

TraciKime 03/23/1999 FOR Mall SERVICES SECTION USE ONLY VENDOR CALL NUMBER DATE SHIPPED PROCESSED BY - SIGNATURE 1

NRC FORM 420 (5 1996) REQUESTER Inis furm was oessneo ussg inf orms l

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