ML20149G139
| ML20149G139 | |
| Person / Time | |
|---|---|
| Issue date: | 07/18/1997 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kostor M MALAYSIA |
| References | |
| SSD, NUDOCS 9707230029 | |
| Download: ML20149G139 (6) | |
Text
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1 July 18', 1997 i
' Atomic Energy Licensing Board-
-ATTN:
Monalija Kostor Ministry of Science Technology I
and the' Environment Tingkat 2 & 13, Plaza Pekeliling:
.)
No. 2. Jalan Tun Razak i
L
.50400 Kuala Lumpur, Malaysia
Dear Mr. Kostor:
1 I am responding to your May 29, 1997, letter requesting information about the' exempt licensing of check sources by the Nuclear Regulatory Commission (NRC).
l Section 30.18, Part 30 of Title 10 of the Code of' Federal Regulations provides an exemption to persons who receive, possess, use, transfer, own, or acquire byproduct material in individual quantities not ' exceeding limits set in 10 CFR l
30.71, Schedule B.
This exemption does not apply to persons who manufacture, transfer or distribute. Therefore, persons engaging in the commercial y
transfer or distribution of products containing byproduct material, such as 2
check sources, to persons exempt from licensing, must obtain an exempt l
distribution license from NRC.
The product information to be submitted for a
'l license to distribute exempt quantities is outlined in 10 CFR Part 32.
H specifically in Sections 32.18, 32.19, and 32.20.
j In response to Item 5. of your letter, I have provided a list of all current l
NRC licenses authorized to distribute exempt quantities pursuant to 10 CFR l
32.18.
For your information I have also enclosed reference copies of 10 CFR l
I Parts 30 and 32 and NUREG-1562, " Standard Review Plan for Applications for j
l Licenses to Distribute Byproduct Material to Persons' Exempt from the l
Requirements for an NRC License".
At this time, a working group is reviewing the risk associated with the current NRC licensing and inspection programs.
Part of this assessment will include a.re-assessmant of the current exemptions provided in 10 CFR Part 30.
1 If I can be of further assistance, please contact me at (301) 415-7273.
DISTRIBUTION:
Sincerely, IMNS r/f..
NRfCle-Room (original signed by) l fmz ssp 7 Steven L. Baggett, Section Leader t:
Commercial Section i
Medical. Academic, and Commercial f
Use Safety Branch L
Division of Industrial and Medical T
L Nuclear Safety g
l 030001 Office of Nuclear Materials Safety and Safeguards 4
Enclosures:
As stated MENT N P: MALAYSIA gg g g g QQfy i
NAME:
SLGr
~
SLBaggett DATE:
07/l
/7 07/10/97 c/4(Zl@
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PAGE 1
ACTIVE NRC LICENSES IN PROGRAM CODE 03253 - 03/11/97 (EXEMPT DIS,T,RIBUTION - 32.18 - SMALL QUANTITIES) i LICENSEE LOCATION LICENSE NO.
DOCKET.
EXPIRES STATUS
~~~~~~
ARLINGTON HEIGHTS-IL 12-12836-02E 3008047 20020731 0
AMEREHAM CORP.
BECKMAN INSTRUMENTS, INC.
FULLERTON CA 04-02624-03E 3009356 20020131 0
BECTON DICKINSON MICROBIOLOGY SYSTE COCKEYSVILLE MD 19-14977-01E 3008488 20040531 0
CHARM SCIENCES INC.
MALDEN MA 20-18145-01E 3014563 20030731-0 l COMMERCE,DEPARTMENTOF GAITHERSBURG MD 19-23454-01E 302220c 20020531 0
I DU PONT MERCK PMARMACEUTICAL CO.
NORTH BILLERICA MA 20-28598-02E 3033040 20030531 0
E R A SYSTEMS, INC.
CHATTANDOGA TN 41-15597-01E 3009417 20040630 0
E. I. DU PONT DE NEMOURS & CO.,
INC BOSTON MA 20-00320-14E 3009023 20050731 0
FISHER SCIENTIFIC PITTSBURGH PA 37-11287-05E 3022183 20020430 0
GEN-PROBE, INC.
SAN DIEGO CA 04-23500-01E 3022269 20041130 0
ICN BIDMEDICALS, INC.
COSTA MESA CA 04-23759-01E 3031264 20040630 0
INTER SCIENCE INSTITUTE INGLEWOOD CA 04-17814-01E 3013376 20010228 0
ISOTOPE PRODUCTS LABORATORIES BURBANK.
CA 04-16778-01E 3019192 20040531 0
' LIFE TECHNOLCSIES, INC GAITHERSBURG MD 19-17348-01E 3012611 20040531 0
LUDLUM MEASUREMENTS. INC.
SWEETWATER TX 42-21454-01E 3020785 20040930 0
NORTH AMERICAN SCIENTIFIC, INC.
NDRTH HOLLYWOOD CA 04-23840-01E 3033941 20001231 0
MILFORD OH 34-18214-03E 3033731 20010228 0
OVERHOFF TECHNOLOGY CORP.
l OXFORD INSTRUMENTS, INC.
DAK RIDGE TN 41-14168-01E 3008045 2002I03I O
+
' PACKARD INSTRUMENT CO.
DOWNERS GROVE IL 12-04933-06E 3013133 20001231 0
REFLEX _ INDUSTRIES, INC.
SAN DIEGO CA 04-23311-02E.
3031010 20041031 0
1 SA00FI DIAGNOSTICS PASTEUR, INC.
CHASKA MN 22-13838-05E 3032813 20020831 0
- SPECTRUM TECHNIQUES. INC.
GAK RIDGE TN 41-23845-01E 3034126 20010630 0
ADDISON IL 12-23580-0IE 3022536 20030430 0
TEST-ER, INC.
SANTA FE NM 30-23724-DIE 3030675 20040331 0
THE SOURCE..INC.
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ACTIVE NRC LICENSES IN PROGRAM CODE 03253 - 03/11/97 (EXEMPT DISTRIBUTION - 32.18 - SMALL QUANTITIES)
LOCATION LICENSE NO.
DOCKET EXPIRES STATUS j LICENSEE HUNTSVILLE
'AL 01-17172-01E 30:2304 20021130 0
TITERTEK-INSTRUMENTS. INC.
ALBUQUERQUE NM 30-23706-01E 3030357 20040131 0
TMA/EBERLINE ROUND ROCK TX 42-01485-06E 3032548 20020331 0
TN TECHNOLOGIES INC.
LINCOLNSHIRE IL 12-23843-03E 3034077 20050531 0
- ' Y/P MICROFIND, INC.
28 fTOTALFORPROGRAMCODE.03253; E
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- 1 l
UNITED STATES NUCLEAR REGULATORY COMMISSION t
RULES and REGULATIONS TITLE 10. CHAPTER 1, CODE OF FEDERAL REGULATIONS-ENERGY i
30,2 MT RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL g
OsasaAt Paoetstops Drrose:morr OrNERAI, Puovtstons 30 81 Modification and revocation of U.
30 3 Scope.
cenees.
30.3 Resoluuon of confilet, 30 42 Right to cause the withholding or i 30.1 Scope.
34 3 Activides requiring beenne.
recau of byproduct material.
This part prescribes rules apphcable 30 t 9efinluona.
to all persons in the United States 3$ $ "M b raa Peaa8"'5 governing domestic licensing of 30.7 Employee protection.
30.8 Informauon collecuon requirements:
byproduct material under the Atomic scusovts:
Energy Act of 1954 as amended (68 Stat.
own approval.
30 9 Completeness and accursey ofinform:uion 30 to Schedule A-exempt concentrations 919), and under Title 11 of the Energy 30.10 Dehberste misconduct 30 71 Schedule B Reorganization Act of 1974 (88 Stat.
30,72 Schedule C-Quantities of radioac.
ruurrious tae matenais requinne consideration of 1242), and exemptions from the domestic the need for an emergersey plan for re-h licensing requirements permitted by 30.11 8pectfle exemptions.
30.12 Penons ustns byproduct matertaj sponding to a release
- section 81 of the Act.This part also Arrrworz A-CalrEalA Rrtarinc to Usr or gives notice to all persons who under certa 1n Department of Energy and Reruistory Commission F3"*" cat Tests ano Paarnt Coutany C
cont,,N,uclear ovanannes ron P,ovininc Reason sta g knowingly provide to any licensee,
'i a
AssUnance or Pt'ncs Fon Dacouutslion contractor, or subcontractor.
no.3 3 c,,,,,,,
30.14 riempt concents,6uons.
components, equipment, matenals, or t"c 30.18 Ce iterns contaLning byproduct 30.18 Restna containins scandium.4s and APPr%Dn B to PaaT W1 licensee's activities subject to this part.
i designed for sand <onsolidation in oil that they niay be individually subject to weUs.
APPL NDR C TO PaaT hh Carria.lA ret ATING m NRC enforcement action for violation of 30.18 Exempt quantities.
t sg 0, Fi% Asciat it.sT5 AND SELF GL Aa4%.
30 to self luminous producta containins rtes toa vnouDt%G RE 450% AstE A5sta a%cE l 30.10.
~
tr10 urn, stypton SS, or promethium.141.
g, pt,,,05 W M COMwsWNNG 30.20 Osa arid aerosol detectors containing byproduct matertal.
9 30.2 Resolution of confliet.
p g,,,,,
The requirements of this part are in
,* addition to, and not in substitution cat nf peelfic ucenses.
- IOf* 'D ' equirements of this chap-30.33 Oerwrml requirementa for tasuance of a ter. In ans conflict between the re.
specific hoenses.
- quirements in this part and a specLfic 30.34 Terms and condluona of heenasa.
R requirement in another part of the
- 4) 35 Financial assurana and recordkeeping
) regulations in this chapter, the specif.
for decommmiomns Llc requirement governs, 30 % bpiration and terminauon of licemes and decommmioning of bles Authority: Secs. St.82,161,182,183.186.
and separate bmidings or outJoor areas 88 Stat. 935. 998. 953. 954,955,as amended.
30.31 AppHcation for renewal of Heenass.
sec. 234. 83. Stat. 444, as amended t42 U.S.C 30.34 Appucation for amendment of 11-2111.2112,2201,2232,2233,2236,2282h secs. 201 as amended,202,2o6, Sa Stat.
l censes.
30.38 Comin1asion action on appucauons t' 8 1242, as amended,1244,1246 (42 U S4 renew or amend.
- 5841.5842,5846).
30.41 Transfer of byproduct matertal.
E Section 30.7 sloo issued under Pub. l. 95-E 601. sec.10,92 Stat. 2951 as amended by Recoans. InstscTious.Tasts, asra R roars Pub. t.102-486 sec. 2902,106 Stat. 3123, 6
I (42 U.S C 5851). Section 30.34(b) also issued 30 $0 Reporung reqwrements under sec.184. 68 Stat. 954, as amended (42 30.5i Records U.S C 2234). Section 30 61 also issued under 30 5: Inspecuens sec.187. 68 Stat. 955 (42 U.S C 2237).
30 $3 Tests 30.5 $ Tntum reports i
4 4
30 1 September 29,1995
UNITED STATES NUCLEAR REGULATORY COMMISSION RULES and REGULATIONS TITLE 10, CHAPTER 1, CODE OF FEDERAL REGULATIONS-ENERGY PMT speciric oouestic 'iceNses to u4Nuracruae OR TRANSFER CERTAIN ITEMS CONTAINING 32 aveRooucrmarsRiat I
i Sec.
Subpart!
- -, Masamed Wees 32.1 Purpoor and scope.
32.3 Definth -
31st 3 contained in de-Authority: Secs. 81.161.182.181 Da Stat.
32.3 Maintenance of socords.
viens for use ur. der i 31J; requiremnants tw 935.948.953.354.as amended (42 U.S C. 2111.
32.8 Informasuon couscuan requirementa-for liep to saanufacture or instaany l 2201. 2232,2233): sec. 201, as Stat.1242. es OMB approval.
- transfer, e amended (42 U.S.C. 5641).
i 33J1a Saane: Conditions of taa ae==
E Sehpast ^
. Consenesuelene and lesens 32.53 Sanne: Material trsuster reports and records.
g 32.11 Introducuan of byproduct material 3183 Imataaus safety devlees for use in in enesept concentrauens into products aircraft. Requiressents for llaanse to or matartals, and transfer of 01rnerahlp manufacture, a====ahia, repair or intue or W Requirementa for heense, ty transfer.
j 32.13 Basse: Recores and snate tal transfer 3344 Same Tahaliat of destems.
)
[
reporta.
32.13 Same: Prohibiuce of introducuen.
3243 aasma-Quality assurance prohlbluon of transfer.
33.14 Certarn stems contaarung byproduct 33J4 Same: Material transfer reports.
matertal, reguarementa for lacerue to 32J7 Calibrauen or referoner sources con-apply or Wttally transfer RAW asnertcium-341: Requirements 32.16 Same: Quality assurance, pichibition for l'"*"a* to manufacture or taltially of transfer, and labehng.
- transfer, i
32.18 Certain items containing byproduct 33.58 Same:I.abeHas of devices.
snaterial: Records and reports of trans-33.80 Sanne:Imak testing of each source.
fer.
32.80 ERamervod) 33.17 Remins contawns scandium-46 and 32.81 Ice detectaan devlees containing designed for sandeonsolidsuon in ou i
weus: Requireements for incense to manu-stronuum-90: recuaremente ior beanse to I
facture, or inidany transfer for sale or raanufacwre or intuaur transfer.
32.02 Same: Guauty assurance; prohibidoc distribution.
of transfer.
32.18 Manufacture, distrfbuuon and trans-I fer of esempt quantities of byproduct 32.71 Manufacture and distributton of by-l material Requireenenta for heense-product material for certain in vitro clinical 32 19 Same: Conditaons of beenses-or laboratory test 6ng under general license.
32.30 Same: Records and raatertal transfer %3212 Manufacture, preparation, or transfer for ressorta.
commercial distribution of radioactive drugs contaimns byproduct mate *ial for medical 33.32 Self luminous products conta W ns use under Part 35.
tritium, krypton-46 or proemethium-147.
Requirements for heense to saanufac.
32.74 Manufacture and distribuuon of Eure, process, produce, or inlually trans.
aources or devtoss containing byproduct fer.
maternal for medical use.
32.33 Saane: Safety criterta.
32.101 Schedule E-prototype testa for lu-32.34 Seme: Table of organ domes-salnous amfety devlees for use in aircraft.
32.102 Schedule C-prototype testa for 32.28 Condiuens of heennes issued under t 32.22-Quality control, labeling, and re-caubrauon or reference sources contain-Ins amnericlum-341.
ports of transfer 32.103 Schedule D-prototype testa for ice 32.30 Des and aerosol detectors contaMas byproduct matettal: Requirements for 11 detacuan deytees containing strenuuan j
90.
i conse to manufacture, process. produce.
or intuauy tranafer.
Suhymet *
% Cameral Sampang j
32.27 Sanne: Safety crth
)
32.3 an=: Tahle of organ doses.
32.110,,Accepta,,ncemasapling procedures
,,,,ggg,ino,,,,,
33.30 Candluens of inamaa== lasued under 6 33.38: Quality sentrollabellas and re-g,,,,,
ports of transfer.
32.210 Registrauen of product taforma.
33.40 Schedule A-Prototype testa for USA-au*mna lock BluminaMet.
l Suhport E-Viotellons 32.301 Violations.
32.303 Criminal penalties.
)
I e
l g.9
)
l i
b Standard Review Plan for l
Applications for Licenses to l
Distribute Byproduct Material to l
Persons Exempt from the j
Requirements for an NRC License
[
l 10 CFR Parts 30.14,30.15,30.16,30.18,30.19, and 30.20 l
l Draft Report for Comment 4
U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards L Camper, T. Rich, S. Greene j
i Ok i
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