United States Nuclear Regulatory Commission - Protecting People and the Environment

Policy and Guidance Directive FC 92-04, "Issuance of New Licenses for Material Use Programs"

HPPOS-261 PDR-306070203

See the memorandum from R. E. Cunningham to R. W. Cooper (and others) dated September 14, 1992.

The purpose of this Directive is to summarize current NMSS policy for issuance of new licenses for material use programs (Enclosure 1) and to provide guidance to the reviewer (Enclosure 2). The enclosed guidance is based on concerns raised by NRC staff pertaining to specific items in applications for material use, e.g., industrial or medical. The Directive identifies two specific areas that may require additional information from the applicant, i.e., the status of the facility and the present use of the proposed location of the facility.

The general rule governing domestic licensing of byproduct material are contained in 10 CFR Part 30. Section 30.33, "General requirements for issuance of specific licenses", provides, among other things, that the proposed equipment and facilities are adequate to protect health and minimize danger to life and property. NRC staff anticipates, and as a matter of practice encourages, license applicants to delay completion of facilities and acquisition of equipment until after the application review is completed. This allows for cost-effective safety improvements in the applicant's facilities and equipment when indicated as a result of NRC's technical review. It also ensures the adequacy of the facilities and equipment prior to significant financial investment by the applicant. However, the applicant may not possess and use licensed material until the approved facilities are completed and equipment procured.

The technical review of the application should include an evaluation of the completeness and accuracy of the information submitted and should identify any necessary safety improvements in the facilities and equipment. If the following information is not evident in the license application, or is ambiguous, or appears to be misleading, the review should contact the applicant by telephone to request the additional information:

A.   Status of the facility.

  1. If completed, document the discussion.
  2. If not in existence or completed, inquire as to the plans for completing the facility. If construction is not to be completed within 12 months after receiving the license determine: (a) when the applicant intends to possess and used licensed material in the proposed facility at the locations of use described in the license application; or (b) if the applicant indicates only future use at a facility or location other than that described in the license application (which would require a license application revision), why the license is requested at this time.

B.   Present use of the proposed location. If the location of use is a private residence, the applicant must submit the following additional information:

  1. Confirmation that the use of licensed material does not conflict with local codes and zoning laws; and
  2. Diagrams of the facility to include the building and adjacent areas, including above and below restricted areas. The facility should be of adequate design to permit security of licensed material and prevent unauthorized access from the residence. Commitments that restricted areas do not include residential quarters are required.

The applicant should discuss how radiation levels in unrestricted areas will be controlled and monitored to comply with 10 CFR 20.105 or 20.1301.

The two enclosures to this Directive should be consulted for additional guidance concerning the issuance of new licenses for material use programs.

Regulatory references: 10 CFR 30

Subject codes: 5.0, 11.2, 11.3

Applicability: Byproduct material

Page Last Reviewed/Updated Tuesday, June 30, 2015