ML20199F712
| ML20199F712 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1999 |
| From: | Bhachu U NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Howard R AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20199F717 | List: |
| References | |
| SSD, NUDOCS 9901220030 | |
| Download: ML20199F712 (5) | |
Text
.
i January 19, 1999 l
i Mr. Robert J Howard Engineering Support Manager Graseby Dynamics Limited '
3562 Queensbay Court i Oviedo, FL 32765 i
Dear Mr. Howard:
This is a response to your letter dated October 20,1998, requesting information related to the process of getting a sealed source device registered and obtaining a license for the commercial l distribution of the sealed source device CAM-2. From the information provided it appears the purpose of the device is to protect life and property from airborne hazards. If the device could i meet the safety requirements of 10 CFR 32.27, it may be distributed to perm ns exempt from licensing.
An applicant wishing to distribute or initially transfer products containing byproduct material, such as the CAM-2, to persons exempt from licensing, must also obtain an exempt distribution license. The contents required for an NRC license required for the exempt distribution of the imported CAM-2 type of devices are stated in 10 CFR 32.26 " Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer." A license issued, under 10 CFR 32.26, permits an applicant to distribute radioactive devices to persoqs exempt from licensing in accordance with 10 CFR 30.20.
In order to possess and use byproduct material, an applicant must satisfy the general requirements of 10 CFR 30.33, and must apply for and obtain a specific license authorizing the possession and use of a byproduct material.
Prior to licensing the CAM-2 for distribution, it will be necessary to perform a device review and safety evaluation pursusnt to the issuance of a device registration certificate. The product information to be submitted for a distribution license and a device registration is outlined in l 10 CFR 32.26,32.27, and 32.29(c), Regulatory Guide 6.9, and NUREG 1556 Vol. 3. It is not necessary to provide a sample of the device, however, applicants are required to submit detailed drawings of the device and an example of the point-of-sale package.
In the sealed source and device application, specific details are included regarding prototype g testing to demonstrate containment, shielding, and other safety features under normal, \
abnormal and severe conditions of handling, storage and use. Historical performance data of substantially similar products may be submitted in lieu of prototype testing. When using histo 4al data, include pertinent items such as the number of units distributed, typical service l lengin, incidents and problems encountered with the devices etc. If you are planning to include ;
ACALA's performance data please address the improper Ft. Stewart, Georgia storage incident. l l According to your letter, the CAM-2 will be produced in England then imported into the United j States. We note that Graseby has an established office in the State of Florida, and have a distributor located in the State of Florida for a registered device. Please note you are under the jurisdiction of the State of Florida which is an Agreement State, therefore, your applications are to be submitted through the State of Florida, and you may have to meet the Florida equivalent regulations cited herein.
9901220030 990119 PDR RC
- SSD PDR '
%oDOOD
~- -. _. -_ _ . -. . ..
January 19, 1999
{
s if you have any questions, please contact me at (301) 415-7894.
Sincerely, original signed by Ujgar Bhachu Ujagar S. Bhachu, Mechanical Engineer Material Safety Branch Division of Industr'al and Medical Nuclear Safety Office of Nuclear Materials and Safeguards.
Distribution:
SSSS r/f SSD-98 97 NEO1 NRC Central File IMNS r/f NMSS r/f DOCUMENT NAME: P:\GRASBY.W $D T= r i . em or thi. macum.ni, inoicat. in ih. box: c ., repy dithout attachment /enciesure'E' = Copy with attachment / enclosure *N' = No copy OFFICE MSB LC MSIM ,/ l l l NAME USBhachu UIV @ (aVeMz DATE 01//Z /99 Oh h/99 '
OFFICIAL RECORD l
j l
,a 8
January 19, 1999 Mr. Robert J Howard Engineering Support Manager Graseby Dynamics Limited 3562 Queensbay Court Oviedo, FL 32765
Dear Mr. Howard:
This is a response to your letter dated October 20,1998, requesting information related to the process of getting a sealed source device registered and obtaining a license for the commercial distribution of the sealed source device CAM-2. From the information provided it appears the purpose of the device is to protect life and property from airborne hazards. If the device could meet the safety requirements of 10 CFR 32.27, it may be distributed to persons exempt from licensing.
An applicant wishing to distribute or initially transfer products containing byproduct material, such as the CAM-2, to persons exempt from licensing, must also obtain an exempt distribution license. The contents required for an NRC license required for the exempt distribution of the imported CAM-2 type of devices are stated in 1~0 CFR 32.26 " Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer." A license issued, under 10 CFR 32.26, permits an applicant to distribute radioactive devices to persons exempt from licensing in accordance with 10 CFR 30.20.
In order to possess and use byproduct material, an applicant must satisfy the general requirements of 10 CFR 30.33, and must apply for and obtain a specific license authorizing the possession and use of a byproduct material.
Prior to licensing the CAM-2 for distribution, it will be necessary to pedorm a device review and safety evaluation pursuant to the issuance of a device registration certificate. The product information to be submitted for a distribution license and a device registration is outlined in 10 CFR 32.26,32 27, and 32.29(c), Regulatory Guide 6.9, and NUREG 1556 Vol. 3. It is not necessary to prowde a sample of the device, however, applicants are required to submit detailed drawinc/s of the device and an example of the point-of-sale package.
In the sealed source and device application, specific details are included regarding prototype testing to demonstrate containment, shielding, and other safety features under normal, abnormal and severe conditions of handling, storage and use. Historical performance data of Dostantially similar products may be submitted in lieu of prototype testing. When using historical data, include pertinent items such as the number of units distributed, typical service length, incidents and problems encountered with the devices etc. If you are planning to include ACALA's performance data please address the improper Ft. Stewart, Georgia storage incident.
According to your letter, the CAM-2 will be produced in England then imported into the United States. We note that Graseby has an established office in the State of Florida, and have a
! distributor located in the State of Florida for a registered device. Please note you are under the jurisdiction of the State of Florida which is an Agreement State, therefore, your applications are to be submitted through the State of Florida, and you may have to meet the Florida equivalent regulations cited herein.
l January 19, 1999 I
i if you have any questions, please contact me at (301) 415-7894.
Sincerely, original signed by Ujgar Bhachu l Ujagar S. Bhachu, Mechanical Engineer Material Safety Branch Division of industrial and Medical Nuclear Safety
- Office of Nuclear Materials and Safeguards.
Distribution:
SSSS r/f SSD-98-97 NEO1 NRC Central File IMNS r/f NMSS r/f DOCUMENT NAME: P:\GRASBY.W $D .
T* receiwo a coor of this document, Indicate in the box: C'= Copy thout attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy OFFICE MSB LC MSlhh ,/ l l l ,
NAME USBhachu UJV @(aVaMz l DATE 01//Z /99 OVh/99 OFFICIAL RECORD i
l I
PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION (Ike3) i REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNe request AND a copy of all reisted letters /apphcastions and drawings to: The Sealed Source Safety Seden, ATTN: Chsef, !
OWFN Mall Stop 6 H3. Change the Ucense Tracking Systern milestone to 19 and assign to reviewer code I-S.
I NOTE: Retain a copy of this request with the application a al background flies. ,
l REGION / LOCATION:
REQUESTF.Rhd9 [' x/ b/MmrsS TELDHONE NUMBER / DATIf li R li R iii R iv R v ' R HQ LFDCB !
l TYPE OF ACTION REQUESTED (Check as appropriate)
APPUCANTS NAME SOURCE REVIEW AMENDMENT OF ggy yg[g REGISTRATION SHEET ,
MAllCONTROL NUMBER ($) / d DEVICE REVIEW NUMBER (S) i AA
/"X- h, m A5"$
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umERfAPPUCATION DATE UCENSE NUMBER (S) CUSTOM REVIEW t c ""c**
Jn-M 98 //;5d?-/ ~
35G2 Gwta Cowtt l Ouudo, FL 3 Tfs5~ '
FOR 8888 USE ONLY REVIEWER MODEL NUMBERS NUMBER ASSIONED DATE RECEIVED Nff,NAch DATE ASSIONED DATE TO FEES
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N- Y~ f h- Y~ $ l TYPE OF ACTION (Indscate the number of each type) l
%l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPUCANT (CUSTOM)
SOURCE (90) DEVICE (9A) SOURCE (9D) DEVICE (9B) ;
~
NEW NEW NEW NEW t AMENDMENT AMENDMENT AMENDMENT AMENDMENT NO SAFETY EVALUATION REQUIRED j UCENSING ACTION RE QUIRED IF KNOWN -
NO FEES REQUIRED NO j OTHER (Spedfy) !
l TOTAL NUMBER OF NOTES - r REVIEW HOURS g ) . hO h [IIdI f NUMBER OF DEFICIENCY LETTERS NO .
/ 'J QW 6V '
NUMBER OF i DEFICIENCY CALLS FOR BILLING PURPOSES ONLY j NAME CHANGE j ADDRESS CHANGE j NEW REGISTRATION - d PRODUCT INACTIVE- 1 ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY .
TYf t OF FEE FEE CATEGORY o , x -
.A
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- nw i l /to Wy -
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y g 9gw_1gS;S ugTEo , j du APPROVED BY ah n DATtiRETURN DATE
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1 NRC FORM Se7 $43) I
,% NTO 8888 ~ ~.
PAGN NRC FORM $67 U. S. NUCLEAR REGULATORY COMMISSION 8H3)
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNs request AND a copy of all reisted lettere/Wahans and drawings to: The Sealed Source Safety Section, ATTN: Chef, OWFN Mall Stop 6 H3. Change the Ucense Tracidng System milestone to 19 and assign to rev6 ewer c-)de I-5.
NOTE: Retain a copy of this request with the apphcotton and background files. .
REGIOM/ LOCATION:
REoutsTEJhTdP/ 2 / bMomX S ~~l i Rn Rm Riv R v R HQ O LFDCB TEWMaNE NUMBER / DATif TYPE OF ACTION REQUESTED (Check as appropriate)
APPUCANT'S NAME SOURCE REVIEW AMENDMENT OF fft/ [ dmo & 7 '
MBER S
^ " "
MAIL CONTROL N0MBER05) / d DEVICE REVIEW M L, LETTER /APPUCATION DATE In-Jo-97 LICENSE NUMBER (S) CUSTOM REVIEW Mi Nd ce = a.
//% d?- / -
yaa y Quado, Pl. 8 ?&S' FOR SSSS USE ONLY REVIEWIO MODEL NUMBERS NUMBER ASSIGNED NM ,NAch '
?$~ ??
DATE RECEIVED DATE ASSIGNED DATE TO FEES
//-4-9W #-# 98
. TYPE OF ACTION (Indicate the number of each type)
Y l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPUCANT (CUSTOM)
SOURCE (9C) DEVICE (9A) SOURCE (90) DEVICE (98)
~ ~ ~ ~
NEW NEW NEW NEW ,
~_ AMENDMENT AMENDMENT ]AMENDMEldT ] AMENDMENT NO SAFETY EVALUATION REQUIRED j UCENSING ACTION REQUIRED IF KNOWN -
NO FEES REQUIRED NO j OTHER (Spec @)
q TOTAL NUMBER OF NOTES REVIEW HOURS jg j . hO h jOV[dI h NUMBER OF j
DEFICIENCY LETTERS O .
' "" / M W 44M NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE ] NEW REGISTRATION - J PRODUCT INACTIVE -
ADD TO BILUNG REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY f) f [ , 1 9A R 98 9C R 90
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COMMENTS y - R-gg y
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