ML20044B430
| ML20044B430 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1990 |
| From: | Glenn J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Grobe J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20042D132 | List: |
| References | |
| HPPOS-308, NUDOCS 9101030175 | |
| Download: ML20044B430 (3) | |
Text
s o
y.
f* "*%
0%
UNITED STATES i
i NUCLEAR REGULATORY COMMISSION
'[
WASHINGTON. D.C. 20EEE o
\\.%,....f m 2 1 1990 MEMORANDUM FOR:
John A. Grobe, Chief Nuclear Materials Safety Branch, RIII FROM:
John E. Glenn, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS 1
SUBJECT:
TECHNICAL ASSISTANCE REQUEST: LICENSEE'S REQUEST-FOR AN EXEMPTION TO 10 CFR 35.49(a)
This memorandum responds to the technical assistance request dated March 28, 1989, from Region III, requesting guidance in the application of Policy and Guidance Directive FC 84-12, Revision 2, which authorizes the Regions to grant special authorizations and exemptions.
Exemption ic, on Enclosure 1, of this directive, which grants an exemption to 10 CFR 35.14(b), now 10 CFR 35.49(a), concerns the transfer of byproduct material.
In an effort to adequately respond to this request, Headquarters queried the Regions (questionnaire enclosed), as to their current practices and/or guidelines concerning this issue. Based on a review of those responses, Headquarters has not identified specific problems with current licensing practices on this matter.
Furthermore, the frequency of occurrence for such applications is minimal.
The following questions were posed:
1.
Is there a maximum number of facilities that we should allow a license to distribute material to?
Several of the Regions suggested that three facilities was the maximum number that should be allowed. Headquarters is not aware of any existing problems with current methods used by each region to determine the maximum number of facilities to which byproduct material may be transfered. Three facilities appears to be acceptable to approve for interhospital transfer.
In order to provide a more uniform practice in this matter, approvals for more facilities should be coordinated with the Medical and Academic Section.
2.
At what point should we require the transferor to obtain a Part 32 license?
A Part 32 license is required when there is a comercial relationship between the~ supplier and the receiver, such that the supplier is operating a business for monetary profit, i.e., conducting a nuclear pharmacy. At some point, collective purchasing and processing of byproduct material takes on a commercial aspect. Therefore, the justification for inter-hospital transfers should be examined carefully.
310103o 15i se
~
r p
DFC t i 1990 Mr. John A. Grobe.
3.
Should additional fees be charged for those licensees who request authorization to transfer materials if a Part 32 license is not required?
Since the exemptions should cover only transfers and not commercial distributing, the authorized uses and, therefore, fee catagories would not change.
4 What is considered ac::eptable justification from the licensee before we authorize, or deny, the transfer of material?
Headquarters is reluctant to state specific requirements for acceptance or denial of routine exemptions to 10 CFR 35.49(a) since the Regional offices would no longer have the flexibility to me.ke those licensing decisions on a case-by-case basis.
However, the Regional office should thoroughly investigate the affiliation or relationship between the supplying facility and those receiving the radiopharmaceuticals to ensure that there exists a valid, non commercial reason for granting an exemption.
In those instances when the Regional office is not comfortable with the nature of the interaction between facilities requesting an exemption to 10 CFR 35.49(a), the number of facilities to which a licensee has applied to distribute, or the necessity of a part 32 license, technical assistance can be obtained from the Medical and Academic Section. All non-routine authorizations and exemptions should be coordinated with the Medical and Academic Section prior to final licensing action.
John E. Glenn, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated DISTRIBUTION NMSS r/f NRC File Center TAR, r/f' JEGlenn WAdams, RIII GSjoblom IMNS Central File PCYacca RJPate, RV WECline, RII JGrobe, RIII REcunningham RJPate, RV RBellainy, RI MShanbacky, RI JWhite, RI JKinneman, RI MLamastra RFonner, OGC CHosey, RII ABBeach, RIY GMMcCann, RIII PRathbun CCain, RIV BRiedlinger, RV SLBaggett EMcAlpine, RII LWCamper WFisher, RIY YLMiller, GPA/SP JRicci, AEOD/TTC OFC
- IMAB I
- imp
- IMA kAkh S h h tkk WCamper :Jh heky enn s
DATE :12/Jf/90 i :12/JQ90 :12/y790
.12/p/90 0FFICIAL RECORD COPY TRANSFER
k QUESTIONNA' IRE 1.
Does your Regior limit the number of facilities a licensee can transfer material to before a distribution license is required?
(a) What is the limit?
(b) Why was this limit chosen?
(c) Have you granted licensees permissier. to exceed this limit when transferring to other licensees?
(d) Why was the limit exceeded?
2.
Does your Regicn limit the quantity of materialf the licensee can
' transfer to another licensee before a distribution license is required?
(a) What is this quantityi (b) Why was this limit chosen?
(c) Have you granted licensees pemission to exceed this quantity when transferring to other licensees?
3.
Do you have reviewer guidelines for evaluating the licensee's request?
If so, please provide a copy.
4.
Do you have guidelines for denying requests? If so, provide a copy.
I 5.
Other comments on Region III's request:
'