Technical Assistance Request, Licensee's Request for an Exemption to 10 CFR 35.49 (a)
HPPOS-308 PDR-9306240390
Title: Technical Assistance Request, Licensee's Request
for an Exemption to 10 CFR 35.49 (a)
See the memorandum from J. E. Glenn to J. A. Grobe dated
December 21, 1990. This memo responds to a technical
assistance request from Region III, dated March 28, 1989,
concerning 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 1c of the directive, which grants an exemption to
10 CFR 35.14 (b) [now 10 CFR 35.49 (a)], concerns the
transfer of byproduct material. HPPOS-131 and HPPOS-189
contain related topics.
In an effort to respond to this request, NRC Headquarters
queried the Regions regarding their current practices
and/or guidelines concerning the issue. Based on the
responses, Headquarters did not identify specific problems
with current licensing practices on this matter. In
addition, the occurrence for such applications was minimal.
The following responses were compiled from questionnaires
sent to the Regions:
Question 1: Is there a maximum number of facilities to
which we should allow a license to distribute material?
Several of the Regions suggested that three facilities be
the maximum number 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 transferred. Three
facilities appear to be acceptable to approve for
inter-hospital 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.
Question 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 commercial
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.
Question 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 fee
categories would not change.
Question 4: What is considered acceptable justification
from the licensee before we authorize or deny the transfer
of material?
Headquarters is reluctant to state specific requirements
for acceptance of denial of routine exemptions to 10 CFR
35.49 (a) since the Regional offices would no longer have
the flexibility to make 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
and 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 Medial and
Academic Section. All non-routine authorizations and
exemptions should be coordinated with the Medical and
Academic Section prior to final licensing action.
Regulatory references: 10 CFR 35.49
Subject codes: 3.5, 11.1, 11.3, 12.19
Applicability: Byproduct Material