United States Nuclear Regulatory Commission - Protecting People and the Environment

U.S. Nuclear Regulatory Commission

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

Page Last Reviewed/Updated Thursday, March 29, 2012