ML20042D131
| ML20042D131 | |
| Person / Time | |
|---|---|
| Issue date: | 03/23/1989 |
| From: | Mallett B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Joseph Austin NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20042D132 | List: |
| References | |
| HPPOS-308, NUDOCS 8906130277 | |
| Download: ML20042D131 (3) | |
Text
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- sJhKlo UNITED ' STATES f
NUCLEAR REGULATORY COMMisslON
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GLEN ELLYN, GLUNots 40m MAR 2 S..ESS MEMORANDUM FOR: John Austin, Acting Chief. Medical,' Academic and Commercial Use Safety Branch, NMSS FROM:
Bruce S. Mallett, Chief, Nuclear Materials Safety Branch, Region III
SUBJECT:
TECHNICAL ASSISTANCE REQUEST:
LICENSEE'S REQUEST FOR AN EXEMPTION TO 10 CFR 35.49(a)
Prior to the revision of Part 35 in April 1987, a number of medical licensee's in Region III had requested and were granted an exemption to Section 35.14(b)
(now 35.49(a) of the revised Part 35) for the following cases:
7 a.
Transfer of radiopharmaceuticals between two medical institutions that have provided adequate justification to support the request; and b.
Transfer of Section 35.400 material from a licensee authorized for storage of therapy sources to an authorized medical institution. Upon completion of the therapeutic procedure, the sources are then transferred back to the licensee authorized to store the material.
We have attached the information that we typically request of licensee's who wish to be granted authorization to transfer material as described in either of the two above situations.
l It is Region III's opinion that such requests should be granted on a case-by-case basis.
However, for consistency throughout the NRC, we feel NMSS should consider providing guidance in light of the following:
a.
Is there a maximum number of facilities that we should allow a licensee to, distribute material to? At what point should we require the t
transferor to obtain a Part 32 license? In the past, Region III felt-that the maximum number of facilities should be three, though we do have one licensee who is authorized to distribute Section 35.400 material.to five licensees authorized to use brachytherapy sources ~.
b.
Should additional fees be charged for those licensees who request authorization to transfer materials if a Part 32 license is not required?
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I John Austin 2
c.
What grounds, if any, are there for denying such requests?
d.
What is considered acceptable justification from the licensee before we authorize the transfer of material?
The Region III contact for this request is Kevin Null (388-5711).
j' M g-MBruceS.Malett, Chief v Nuclear Materials Safety Branch Attachments: As stated i
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TRANSFER OF RADIDACTIVE MATERIALS BETWEEN NRC. LICENSED MEDICAL INSTITUTIONS-SITUATIONS THAT DO NOT REQUIRE THE TRANSFER 0R TO OBTAIN A DISTRIBUTION LICENSE The review and approval of requests of this nature require an exemption from the regulations contained in Section 35.14(b) of 10 CFR Part 35. These requests shall, therefore, be reviewed on a case-by-case basis. Please submit the following information in support of your application:
1.
Justification for this request, i.e., the reason that the facilities involved cannot receive materials solely in accordance with 10 CFR 35.14.
2.
Concurrence from the administrator of each participating institution.-
3.
Identification of each type and quantity of radiopharmaceuticals that will be transported (e.g., unit doses of Tc-sulfur colloid, etc.).
4.
For transfers involving Group VI sources, procedures for maintaining source accountability at all participating institutions.
5.
A general, but complete description of how a typical transfer will work (i.e. which institution will transfer material, how a typical transfer will be initiated, the title of tne person re. pone Aple for initiating and implementing the transfer, a general description of the events that will follow once the materials are on the site of the receiving inatitution, etc.)
6.
Identification of the individuals who will transport the material, and the training they will receive. This training should, as a minimum, include all the items outlined in 10 CFR 19.12 and decontamination procedures in case of spills.
7.
Safety measures to be used in transporting the radioactive materials in the applicants' vehicles (e.g. security against unauthorized removal, away from passenger compartment, absorbent paper, lead shields, etc.).
8.
Emergency procedures to be followed in case of accidents involving spills or loss of radioactive materials.
.l 9.
Confirmation that vehicles used for transporting materials will be surveyed for contamination after each transfer.
10.
C efir.::1:n 05:- ::.ai;- 1-! ; ;i_; c;;cing procuderes will be at i
least equivslent to those outlined in Appendin F of Regulatory Guide 10.8, October 1980.
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