Technical Assistance Request, Licensee's Request for an Exemption to 10 CFR 35.49 (a)

HPPOS-308 PDR-9306240390

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