United States Nuclear Regulatory Commission - Protecting People and the Environment

No License is Required for a Person to Receive Exempt Quantity Byproduct Material

HPPOS-131 PDR-9111210347

See the letter from T. F. Dorian to P. F. Gustafson (Illinois Department of Nuclear Safety) dated July 30, 1982.

It is an OELD opinion that a person does not need a license to possess an exempt quantity of byproduct material even if it was received from a person not licensed under 10 CFR 32.18 to distribute. There are no restrictions on subsequent transfer, except as provided in 10 CFR 30.18 (c) and (d). HPPOS-189 and HPPOS-203 contain related topics.

Prior to answering two specific questions, 10 CFR Sections 30.14 and 30.18 were explained. Section 30.14, "Exempt Concentrations," is divided into four paragraphs. Paragraph (a) exempts persons from NRC regulations if they receive, possess, use, transfer, own, or acquire products or materials that have less than the concentrations of byproduct material listed in 10 CFR 30.70, "Schedule A - Exempt Concentrations." Paragraph (b) states that 10 CFR 30.14 does not authorize the import of byproduct material or products containing byproduct material. Paragraph (c) exempts from NRC regulations a manufacturer, processor, or producer in an Agreement State of a product or material containing byproduct material if that material is less than the concentrations listed in 10 CFR 30.70 and if it is introduced into the product or material by a specific licensee of the NRC or an Agreement State that expressly authorizes the introduction.

This exemption does not apply to the transfer of byproduct material in foods, beverages, etc., used by people. Paragraph (d) specifies that a person who wants to introduce byproduct material into a product or material that is to be transferred to a person exempted under Paragraph (a) or under equivalent Agreement State regulations can do so only under a license issued by the NRC under 10 CFR 32.11 or under the general license provided in 10 CFR 150.20.

10 CFR Section 30.18, "Exempt Quantities," is also divided into four paragraphs. Paragraph (a) exempts persons from the Commission's regulations if they receive, possess, use, transfer, own, or acquire byproduct material in individual quantities, each of which does not exceed that listed in 10 CFR 30.71, "Schedule B." Paragraph (b) exempts from licensing persons who received byproduct material before September 15, 1971, under a general license provided in 10 CFR 31.4. Paragraph (c) states that 10 CFR 30.18 does not authorize for "commercial distribution" the production, packaging, repackaging, or transfer of byproduct material or the incorporation of byproduct material into products intended for commercial distribution. Paragraph (d) specifies that a person can transfer byproduct material for commercial distribution in the quantities listed in 10 CFR 30.71 only in accordance with a license issued under 10 CFR 32.18.

The first question concerned whether a facility must have a license to possess a quantity of radioactive material less than the exempt quantity as stated in 10 CFR 30.71. NRC stated that a facility does not need a specific license to possess an exempt quantity of byproduct material provided it does not plan on possession for the purposes outlined in 10 CFR 30.18 (c) and (d). The facility does not need documentation that the byproduct material was received from a person licensed under 10 CFR 30.18. In addition, exempt material may be transferred from a facility that possessed the material as an exempt quantity and the facility is not responsible for providing labeling; a requirement placed on the manufacturer as specified in 10 CFR 32.19.

The second question concerned whether a licensee (Facility A), who had bought an exempt quantity of radioactivity material from the manufacturer, can give the radioactive material to Facility B. (As examples, Facility B is not licensed for the possession of any radioactive material, or Facility B does possess a radioactive material license, but it is not licensed for this radioactive material.) In reply, NRC stated that Facility A may give an exempt quantity of material to Facility B provided that it does not transfer the material as part of a commercial distribution under the provisions of 10 CFR 30.18 (c) and (d) or does not have reason to believe Facility B will transfer the material for purposes of commercial distribution to persons exempt under 10 CFR 30.18 or equivalent Agreement State regulations. Therefore, Facility A may transfer the material provided it is an exempt quantity and that paragraphs (c) and (d) of 10 CFR 30.18 do not apply.

Regulatory references: 10 CFR 30.14, 10 CFR 30.18, 10 CFR 30.71

Subject codes: 3.5, 3.8

Applicability: All

Page Last Reviewed/Updated Friday, June 12, 2015