IA-88-544, Final Response to FOIA Request for Documents.Forwards Documents Listed in App a & Documents Available in PDR
| ML20206E352 | |
| Person / Time | |
|---|---|
| Issue date: | 11/07/1988 |
| From: | Grimsley D NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM) |
| To: | Reilly W MISSOURI, UNIV. OF, COLUMBIA, MO |
| Shared Package | |
| ML20206E357 | List: |
| References | |
| FOIA-88-544 NUDOCS 8811180054 | |
| Download: ML20206E352 (2) | |
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.. U.S. CUCLEAR REGULATORY COMMISSION Nac H>a Movtst Nvustas.5#
FOIA 544 yss. ..es RESPONsfTYPt
[, ' n' ,k RESPONSE TO FREEDOM OF Di'ahu l I Paarm (e eese
/jj (jO j INFORMATION ACT (FOIA) REQUEST
NOV 7 088 00Cait hvh88f At$s est appacaeses REQVil4OR Mr. William F. Reilly PART l.- AGENCY RECORDS RELEASED OR NOT LOCATED iSee checasd bones)
No agency records subsect to the request have been located.
No additonal agency eecords subrect to the request have been located neovested records are available through anothet pu%c destribution prog <sm. See Comments $ntion.
Agency records sub.cl to the request that a'e dentJ ed on Appendialent are aiready avaiistde for publ.c inspecten and copyeg in the NRC Pubbe Docume<>t Room. 202 t L Street. N W . Washegion. DC 20555 Agency recoeds swtrect to the esquest that are deni.f.ed on Accend.miesi a<e being rnade avalable for pubhc essrecten and copyng en the XX NRC rubhc oocumeni noom. 202 L si,eei. N W . wassngton. oC. e a ,c4de, onde iss roi A numbe, sed ,eovesie, name The scep,opr.iery ,e.s.n se th. p,oposansi ihai voo ag.eed to ucepi in a iewphone con,e, sat.n ..th a -e., os ,ny sta ,e ,s no. being ,nade s.a.iave ec ponc especton and copyng at the NRC Pubhc Document Room 2021 L Street. N W . WanNngton. OC, e a fcader uncee tNs FOIA numbc., and reqvester name Agency records subrect to the reowest that are 4ent<f.d cc Aprend.niesi may be espected and :cp-es et the NRC Local Puta.c Doewment Room dent,f.d in the Comments Secten Enclosed is eformaton on hon you tray obtain access to and the che ges fo, cepreg records placed in te.e NRC Pvt-ac Document Room. 202 t t Street NW.
washmgton. oC XX A e+ao t" +'a ' ***>"i 'a t ** +++ a 'ac'~ 8 axo,da . b,oi io ihe ,eusi ha,e been ,0,e,,ed io anore, ,ede.a ageec,i.si vo, ,e .. and deui ,es-e to , u.
voo .in be b.ned by ihe NRC ro, ,ees iois:eng .R._45 xx in e,ee, o, NRC . ,es,.se io iss ,e, vest. no e.,ee, uton .S be.ng issen on a,eanette, dated No PART B. A-INFORMATION WITHHELD FROM PUBUC DISCLOSURE Ceda n n'ormaica e t*e veovested records 's beag a'tkne4 l'om puthe d4 soc sure ov'suant to the '= erect ons descree s n and 'or t** reasons stated e Part is SeClices S. C. a^d D Any 'eessed portions of the documetis fot *Nch only c4't 08 the record is beeg Othheld are terng made aw a.f atie f o, pubbe eespect<M and convog c the NaC Pubi.c Document Room. 2021 L Street. N W . Wa:Nngton. OC vs a folder unde' th s i ot A numee and reuster name COMMENTS The fees associated with the processing of your F0IA request are as follows:
Clerical Search " 15 minutes = $3.00 Professional Search / Review - 25 minutes = $10.25 Reproduction of Records - 81 pages = $16.20 Total = $29.45 8811100054 001107 PDR FOIA PDR REILLY88-544 A
afvRe, c.RtCtepvisio, a fittoou or moRvArios ANo PUBUCAviONS SERytCES sicj(6h W M O (I , ud
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Re: F0! A.88-544 APPENDIX A RECORDS MAINTAINED IN THE PDR UNDER THE ABOVE REQUEST NUMBER _ 1 NUMBER DATE DESCRIPTION ,
- 1. 3/3/88 Letter from Lanastra to Asmussen (7pages)
'2. 3/16/88 Letter from Asmussen to Lamastra (2pages) ,
- 3. 3/28/88 Letter from Lamastra to Asmussen (1page) l
- 4. 5/31/88 Letter from Asmussen to Lamastra (1page)
- 5. 6/F/88 Letter from Lamastra to Asmussen (1 page)
- 6. 5, s/.98 General Atomics - Application for
- taterial License (55oages)
- 7. 9/9/88 Letter from Asnussen to Lamastra (3pages) j
- 8. 9/14/68 Letter from Asmussen to Lamastra (9pages)
- 9. 10/12/88 Haterials License Number 04-14395-02E for General Atomics (2 pages) i i
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U March 3, 1988 GA Technologies Inc.
ATTN: Dr. Keith E. Asmussen, Manager Licensing and Nuclear Material Compliance P.O. Box 85608 San Diego, California 92138 Gentlemen:
This is in reference to your April 9,1986 and October 31, 1986 applications for a license to be issued pursuant to 10 CFR 32.11 to authorize distribution of irradiated crystalline material to persons exempt from licensing. This is also in partial response to the April 16, 1987 letter, signed by Mr. James R.
Edwards, General Counsel and Secretary of your organization.
We regret the delay in processing your application. However, as you probably know, your appilcation and two other similar requests were precedent-setting and required consultation with the Commission. During our review of the issues, we have appreciated the assistance provided by you and thc members of your organization. The information provided by telephone, letter and in the May 6,1987 meeting between members of the NRC staff and Dr. William Whittemore and Mr. Norval Carey of GA Technologies has been very helpful in clarifying some practical and technical issues associated with your application.
The Comission has recently directed the staff to process applications such as 1
yours. Licenses, if granted, will not be subject to the prohibition in 10 CFR 32.1)(c) against distribution c1 products intended for application to human beings. However, all other requirements of 10 CFR 32.11, 30.14, and 30.70 (copies en:losed) must be me'..
i Following the Comission's decision, the NRC staff prepared Enclosure 2 to assist domestic reactors with the preparation of their applications. We have
- reviewed your October 31, 1986 application, which was submitted in substitution for your April 9,1986 application. As a result of our review, we find that your application either does nct address the matters described in Enclosure 2 or addresses them incompletely. Some specific examples are outlined below.
o It is not clear whether all of the activities described in Item A.4 of Enclosure 2 to this letter will be conducted at the 10955 John Jay Hopkins :
Drive address in San Diego. ;
o As a research reactor in class 104 status, you have not provided information to demonstrate that less "than 50 percent of the annual cost !
of owning and operating the facility is devoted to the production of j materials, products, or energy for sale or commercial distribution, or to '
the sale af services, other than research and development or education or training." See 10 CFR 50.21-22. This must be demonstrated not only before we can issue you a Itcense pursuant to 10 CFR 32.11, but also on i an annual basis after such a license is issued.
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O Dr. Keith E. AsnJssen o Item 5.b of your application indicates that radioactive material will be in "[s]olid forms contained within crystalline raterial." Later in the application you refer to irradiated topaz. Although the language of Item 5.b. of your application is sufficiently general to include topaz, it is also broad enough to include other gems and other types of crystalline material.
Please be advised that, at this time, we are only considering authorized distribution of cut, polished, and finished irradiated topaz to persons exempt from licensing. If your application is to include other gems in addition to topaz, specific infonnation related to the other gems will be required as is the case for topaz.
o You propose to use a value of two nanocuries per gram as the maximum specific activity of gems released to persons exempt from licensing. In support of your choice of this value, you indicated that it is used by the International Atomic Energy Agency (IAEA), the U.S. Department of Transportation (DOT), and regulatory agencies in Europe and Asia. You are correct that, for purposes of safe transportation, materials with a specific activity lower than 'wo nanocuries per gram are not regulated by either IAEA or 00T. However, the limit for purposes of transportation does not imply that the distribution of gems containing up to two nanocuries per gram to members of the public is acceptable.
The two nanocuries per gram value exceeds the limits specified in 10 LR 30.70. For example, the exempt concentration limit in '.0 CFR 30.70 for tantalum-182, the principal radionuclide in your gemstones, is 0.4 nanocurie per gram. Note that this is the maximum concentration for tantalum-182, assuming that it is the only radionuclide present, and it is one-fifth of your proposed limit. A review of Table 1 in Enclosure 2 !
to your application indicates that, if only tantalum-182 is considered, '
13 of the 19 specimms have concentrations exceeding the limit in 10 CFR 30.70. ,
Information in Enclosure 2 to your application also indicates that ;
irradiated gemstones my contain other radionuclides, such as !
scandium-46, antimony-1,.' and 125, and cadmium-109, in addition to [
tantalum-182. In cases such as this, where a combination of radionuclides is present, Note 2 in 10 CFR 30.70 specifies that the !
concentration limit for the combination is to be derived by "the sum of :
ratios" method and the sum shall not exceed unity. Thus, it would be l necessary to identify and quantify the various radionuclides and to t ensure that the "sum of the ratios" does not exceed unity. As specified in 10 CFR 32.11(c), you will need to provide assurance not only that the concentration levels in 10 CFR Section 30.70 are not exceeded, but also ,
that lower concentrations are not feasible. (See item C in Enclosure 2 tothisletter.) i i
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Dr. Keith E. Asmussen !
o Although you indicate gems will be grouped by size for counting, it is not clear if they are also grouped according to geologic origin and/or i type (s) of irradiation received. It also is not clear what constitutes a "given lot" (as used on page 3 of Enclosure 3 of your application); what types of quality control (QC) will be exercised in the precutting stage; '
and whether this QC would offset our concern.
o Item B.2.g. of Enclosure 2 to this letter requests identification of all !
radionuclides with half-lives greater than 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> and classification of l each as "major" or "minor." It is not clear whether the listing of '
radionuclides in Enclosure 2 to your application is complete; even if it is, the radionuclides are not classified as requested.
In addition, it is not clear how we can be assured that the information ir Enclosure 2 to your application on radionuclides, their activities, and concentrations is representative of topaz to be irradiated in the :
future.
o Although your application mentions washing of irradiated stones to remove t "tactile" contamination, it does not describe procedures to be used to ;
ensure that each gem is free of removable contamination; see Item B.3.a. i of Enclosure 2 to this letter. [
o Your application preserts some apparently conflicting infonnation about the disposition of irradiated gems whose concentrations exceed your criteria. Item 11 of the application indicates that such stones "can" be .
disposed of with reactor waste, but does not necessarily imply that they ;
will be disposed of in that manner. On page 4 of Enclosure 3 to your application you mention twice that "rejected" stones will be held for :
further decay and evaluation.
o Your license and its suppor'.ing information should be a "stand alone" l j document (i.e., a document that does not referenc ' other licenses J
> for important information, such as training and experience of '
personnel). Thus, you should ccrrelata the names of your st**f members :
with their responsibilities under this license and submit du inentation !
i of their training and experience, particularly in handling and analyzing :
I low-levels of byproduct material, use of equipment, procedures and !
and statistical analyses appropriate for levels of activity not to exceed '
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! those specified in 10 CFR 30.70; and the control procedures, accountability and record-keeping responsibilities under this license. Experienced reactor l I operators, nuclear engineers, or nuclear physicists do not necessarily have i i the needed training and experience. !
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Dr. Keith E. Asmussen -
4-o Although your application provides some of the infomation requested in Item D of Enclosure 2 to this letter, it is incomplete and not sufficiently detailed for us to reach a decision about its adequacy. For example, we need more information about: the shielding surrounding your NaI(TI) and plastic scintillator detectors; the configuration of the detectors to provide 4 pi geometry, and the calibration of these systems. We note that in describing ysJr instrumentation you use the phrase "or equivalent." If you wish to have the flexibility to use "equivalent" equipment, theli your application must describe the minimum features of such equipment, j It is not clear to what instruments (i.e., G-M only; GM, NaI(Tl) and plastic scintillators) you are referring in item 9 of your application where calibration is described briefly.
Also yocr application does not provide all of the information requested in i Item D.3. of Enclosure 2 to this letter for your counting procedures. We
- need a clear description of the analyses done on irradiated geas and their sequence, being sure that the infomation requested Items D.1., 2., and 3.
l is provided for each type of analysis.
o Your "Safety Analysis" should be revised to include the information requested in Items E.2. and E.3. of Enclosure 2 to this letter.
Picase review Enclosure 2 to this letter and provide the infomation requested in Section II; it is not necessary to provide response; to items A.1., 2., 3.,
and 6. B.I.b., and F. Please submit your response in duplicate o refer to Control No. 019643, and mail to:
U.S. Nuclear negulatory Commission Medical, Academic, and Compercial Use j
Safety Branch (Mail Stop OWFN-6H3) 4 ATTN: Mr. Michael Lamastra Washington, DC 20555
! We note that you have requested that Enclosures 18, 2, 3B and 4 be withheld from public disclosure because they are "company confidential," were developed j at GA Technologies' expense, and, if released, "would cause substantial ham to GA Technologies Inc.'s competitive position." The infomation contained in j Enclosure 4, although interesting background information, is not needcd in 1 1 order to make a licensing decision and can be returned to you. The information contained in Enclosures 18, 2, and 3B is needed in order to make a f licensing decision. Based on past experience, we do not believe that the types of information contained in these enclosures (e.g., type of gems to be irradiated; radionuclide content, activity, and concentration; counting systems) constitute proprietary information that can be withheld from public disclosure.
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Dr. Keith E. Asmussen You may: (1) withdraw your request for withholdin from public disclosure, (2) modify your request (g the specified documentse.g., na or (3) ask that we proceed with a legal review of your original or modified request. Please inform us in writing of your decision.
We are prepared to expend the necessary resources to expedite review of yaur l application if we receive your reply to this letter within 45 calendar days of l the date of this letter. Please let us know if you need more time to prepire ,
your response. If we do not receive your response within 45 calendar days of the date of this letter or by the date agreed upon when you request an extension of time, we will assure that you do not wish to pursue your request for a license at this time. If you so choose, application (without paying any additional fee)you may reactivate yourby respon within one year of the date of this letter.
If you have any questions or wish to arrange a meeting, please call me at (301)492-3416.
Sincerely.
Orieinal Signed ey PATRICI A d. Yec; !
L Hichael A. Lamastra, Section Leader '
Comercial Use Section l
% dical, Academic, and Comercial
. Use Safety Branch l Division of Industrial and l Medical Nuclear Safety [
Enclosures:
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- 1. 10 CFR Parts 30 and 32 l
- 2. Information Needed from a j l
Ocire tic Reactor. . .
I cc w/o enclosures:
Mr. James R. Edwards General Counsel and t
. Secretary GA Technologies Inc. l l
P.O. Box 85608 l San Diego, CA 92136 ;
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., 1 Dr. Keith E. Asnissen i DISTRIBUTION:
IMN3 Central File VLMiller NMSS r/f GLSjoblom i IMAB r/f REcunningham j PCVacca LRubenstein, NRR MAlamastra AAdams, NRR :
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- 0FFICIAL RECCRD COPY
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i Dr. Keith Asmussen DISTRIBUTION:
IMNS Central File VLMiller NMSS r/f GLSjoblom IMAB r/f RECunningham PCVacca LRubenstein, NRR MAlamastra AAdams, NRR NRC Central File t
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