N. C. Regulations for Protection Against Radiation

15A NCAC 11 .0305          EXEMPT ITEM CONTAINING OTHER THAN SOURCE MATERIAL

(a)  Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nuclear material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from the rules of this Chapter may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

(b)  Certain items containing radioactive material are exempt as provided in this Paragraph.

(1)           Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from the rules of this Chapter to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products:

(A)          timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(i)            25 millicuries of tritium per timepiece;

(ii)           five millicuries of tritium per hand;

(iii)          15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial);

(iv)          100 microcuries of promethium‑147 per watch or 200 microcuries of promethium‑147 per any other timepiece;

(v)           20 microcuries of promethium‑147 per watch hand or 40 microcuries of promethium‑147 per other timepiece hand;

(vi)          60 microcuries of promethium‑147 per watch dial or 120 microcuries of promethium‑147 per other timepiece dial (bezels when used shall be considered as part of the dial);

(vii)         the levels of radiation from hands and dials containing promethium‑147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(I)            for wrist watches, 0.1 millirad per hour at 10 centimeters from any surface;

(II)           for pocket watches, 0.1 millirad per hour at one centimeter from any surface;

(III)         for any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.

(B)           lock illuminators containing not more than 15 millicuries of tritium or not more than two millicuries of promethium‑147 installed in automobile locks (the levels of radiation from each lock illuminator containing promethium‑147 shall not exceed one millirad per hour at one centimeter from any surface when measured through 50 milligrams per square centimeter of absorber);

(C)           balances of precision containing not more than one millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part;

(D)          automobile shift quadrants containing not more than 25 millicuries of tritium;

(E)           marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas;

(F)           thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat;

(G)           electron tubes, provided that each tube does not contain more than one of the following specified quantities of radioactive material:

(i)            150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube;

(ii)           one microcurie of cobalt‑60;

(iii)          five microcuries of nickel‑63;

(iv)          30 microcuries of krypton‑85;

(v)           five microcuries of cesium‑137;

(vi)          30 microcuries of promethium‑147; and provided further, that the levels of radiation from each electron tube containing radioactive material does not exceed one millirad per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber (for purposes of this Subparagraph, "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents);

(H)          ionizing radiation measuring instruments containing for purposes of internal calibration or standardization, sources of radioactive material each not exceeding the applicable quantity set forth in Rule .0304(e) of this Section.

(I)            spark gap irradiation containing not more than one microcurie of cobalt‑60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least three gallons (11.4 liters) per hour.

(2)           For purposes of Part (b)(1)(H) of this Rule, where there is involved a combination of radionuclides, the limit for the combination shall be derived as follows:

(A)          Determine for each radionuclide in an ionizing radiation measuring instrument the ratio between the quantity present in the instrument and the exempt quantity established in Rule .0304(e) of this Section for the specific radionuclide when not in combination;

(B)           No ratio shall exceed one and the sum of such ratios shall not exceed 10.

(C)           For the purpose of Part (b)(1)(H) 0.05 microcurie of americium‑241 is considered an exempt quantity under Rule .0304 of this Section.

(c)  Self‑luminous products are exempt as provided in this Paragraph.

(1)           Except for persons who manufacture, process, or produce self‑luminous products containing tritium, krypton‑85, or promethium‑147, any person is exempt from the rules of this Chapter to the extent that any person receives, possesses, uses, transfers, owns, or acquires tritium, krypton‑85 or promethium‑147 in self‑luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements.

(2)           The exemption in Subparagraph (c)(1) of this Rule does not apply to tritium, krypton‑85, or promethium‑147 used in products for frivolous purposes or in toys or adornments.

(d)  Gas and aerosol detectors are exempt as provided in this Paragraph.

(1)           Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, any person is exempt from the rules of this Chapter to the extent that any person receives, possesses, uses, transfers, owns or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards provided that detectors containing radioactive material shall be manufactured, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or any agreement state, pursuant to Section 32.26 of 10 CFR 32, or equivalent, which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements.

(2)           Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state shall be considered exempt under Subparagraph (d)(1) of this Rule, provided that the devices are labeled in accordance with the specific license authorizing distribution of the general licensed device, and providing further that the devices meet the requirements of Rule .0327 of this Section.

(e)  Resins containing scandium‑46 are exempt as provided in this Paragraph.

(1)           Any person is exempt from these Rules to the extent that such person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium‑46 which are designed for sand consolidation in oil wells.  These resins shall be manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or shall be manufactured in accordance with the specifications contained in a specific license issued by the agency or any agreement state to the manufacturer of such resins pursuant to licensing requirements equivalent to those in Sections 32.16 and 32.17 of 10 CFR Part 32 of the regulations of the U.S. Nuclear Regulatory Commission.

(2)           This exemption does not authorize the manufacture of any resins containing scandium‑46.

(f)  Capsules containing Carbon-14 urea for "in-vivo" diagnostic use for humans are exempt as provided in this Paragraph:

(1)           Except as provided in Subparagraphs (2) and (3) of this Paragraph, any person is exempt from the requirements for a license set forth in this Section provided that such person receives, possesses, uses, transfers, owns or acquires capsules containing approximately one microcurie (37kBq) Carbon-14 urea each for "in-vivo" diagnostic use for humans.

(2)           Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license from the agency.

(3)           Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license from the U.S. Nuclear Regulatory Commission.

(4)           Nothing in this Rule relieves persons from complying with applicable FDA and other federal regulations, and North Carolina requirements governing the receipt, administration, and use of drugs.

History Note:        Authority G.S. 104E‑7; 104E‑10(b); 104E‑20.;

Eff. February 1, 1980;

Amended Eff. April 1, 1999; June 1, 1993; October 1, 1982; September 1, 1981.

NC Radiation Protection, 1645 Mail Service Center,
Raleigh, NC  27699-1645  919-571-4141  Fax  919-571-4148