Wis. Admin. Code Department of Health Services DHS 157.09 - Exemptions

(1) EXEMPTIONS OF SOURCE MATERIAL.

(a) A person is exempt from subchs. III and X if the person receives, possesses, uses, owns or transfers any of the following types and forms of source material:

1. Any chemical mixture, compound, solution or alloy in which the source material by weight is less than 1/20 of one percent of the mixture, compound, solution or alloy.

2. Unrefined and unprocessed ore containing source material provided that, except as authorized in a specific license, the person does not refine or process the ore.

3. Rare earth metals and compounds, mixtures and products containing not more than 0.25% by weight thorium, uranium or any combination of these.

4. Any quantities of thorium contained in any of the following:

a. Incandescent gas mantles.

b. Vacuum tubes.

c. Welding rods.

d. Electric lamps for illuminating purposes provided that a lamp does not contain more than 50 milligrams of thorium.

e. Germicidal lamps, sunlamps and lamps for outdoor or industrial lighting provided that a lamp does not contain more than 2 grams of thorium.

f. Personnel neutron dosimeters, provided that a dosimeter does not contain more than 50 milligrams of thorium.

5. Source material contained in any of the following products:

a. Glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than 20% by weight source material.

b. Glassware containing not more than 2% by weight source material, or for glassware manufactured before August 27, 2013, 10% by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction.

c. Glass enamel or glass enamel frit containing not more than 10% by weight source material imported or ordered for importation into the United States or initially distributed by manufacturers in the United States, before July 25, 1983.

d. Piezoelectric ceramic containing not more than 2% by weight source material.

6. Photographic film, negatives and prints containing uranium or thorium.

7. Any finished product or part fabricated of tungsten-thorium or magnesium-thorium alloys, or containing tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4% by weight and that this exemption is not deemed to authorize the chemical, physical or metallurgical treatment or processing of any product or part.

8. Uranium contained in counterweights installed in aircraft, rockets, projectiles or missiles or stored or handled in connection with installation or removal of the counterweights, under all of the following conditions:

a. Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM". This requirement need not be met by counterweights manufactured prior to December 31, 1969 provided that the counterweights are impressed with the legend "CAUTION - RADIOACTIVE MATERIAL - URANIUM".

b. Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement, "UNAUTHORIZED ALTERATIONS PROHIBITED". This requirement need not be met by counterweights manufactured prior to December 31, 1969 provided that the counterweights are impressed with the legend "CAUTION - RADIOACTIVE MATERIAL - URANIUM".

c. This exemption may not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any of these counterweights other than repair or restoration of any plating or other covering.

9. Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that the shipping container is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM"; and the uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of 3.2 millimeter (one-eighth inch).

10. Thorium or uranium contained in or on finished optical lenses and mirrors, provided that a lens or mirror does not contain more than10% by weight of thorium or uranium or for lenses manufactured before August 27, 2013, 30% by weight of thorium and that this exemption is not deemed to authorize either of the following:

a. The shaping, grinding or polishing of the lens or manufacturing processes other than the assembly of the lens into optical systems and devices without any alteration of the lens.

b. The receipt, possession, use or transfer of thorium contained in contact lenses, spectacles, eyepieces in binoculars or other optical instruments.

11. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that the thorium is dispersed in the alloy in the form of finely divided thoria, and the thorium content in the nickel-thoria alloy does not exceed 4% by weight.

12. Only persons authorized by a license issued under 10 CFR 40.52, may initially transfer for sale or distribution such products containing source material to a person exempt under this subsection.

13. Persons authorized by an agreement state to manufacture, process, or produce materials or products containing source material, and persons who import finished products or parts for sale or distribution, shall be licensed for distribution only under 10 CFR 40.52, and are exempt from s. DHS 157.13 (2) (a) and (b) and subchs. III and X.

(b) The exemptions in par. (a) do not authorize the manufacture of any of the products described.

(2) EXEMPTIONS OF RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL.

(a) Exempt concentrations. Except as provided in this paragraph, a person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations no greater than those listed in ch. DHS 157 Appendix A. A person may not introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this paragraph or equivalent regulations of the NRC, any agreement state or licensing state, except under a specific license issued under 10 CFR 32.11 or s. DHS 157.13 (4) (a).

1. This paragraph does not authorize the import of radioactive material or products containing radioactive material.

2. A manufacturer, processor or producer of a product or material is exempt from the requirements of subch. II if they transfer radioactive material contained in a product or material in concentrations not in excess of those in ch. DHS 157 Appendix A and introduced into the product or material by a licensee holding a specific license issued by the department, the NRC or another agreement state expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(b) Exempt quantities. Except as provided in this paragraph, a person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in ch. DHS 157 Appendix B.

1. This paragraph does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution or the incorporation of radioactive material into products intended for commercial distribution.

2. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in ch. DHS 157 Appendix B to any person exempt from this chapter or equivalent regulations of the NRC, an agreement state or a licensing state, except under a specific license issued by the NRC under 10 CFR 32.18, or by the department under s. DHS 157.13 (4) (b) which license states that the radioactive material may be transferred by the licensee to persons exempt under this paragraph or the equivalent regulations of the NRC, an agreement state or a licensing state.

3. A person, who possesses byproduct material received or acquired before September 25, 1971, under the general license then provided in 10 CFR 31.4 or similar general license of a State, is exempt from the requirements of this subchapter to the extent that this person possesses, uses, transfers, or owns byproduct material.

Note: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555.

(c) Certain items containing radioactive material. Except for persons who apply radioactive material to the following products, or incorporate radioactive material into the following products, or initially transfer for sale or distribution the following products, a person is exempt from this subchapter if the person receives, possesses, uses, transfers, owns or acquires any of the following products:

1. Timepieces, hands or dials containing not more than the following specified quantities of radioactive material:

a. 925 MBq (25 millicuries) of tritium per timepiece.

b. 185 MBq (5 millicuries) of tritium per hand.

c. 555 MBq (15 millicuries) of tritium per dial.

Note: Bezels, when used, should be considered as part of the dial.

d. 3.7 MBq (100 microcuries) of promethium-147 per watch or 7.4 MBq (200 microcuries) of promethium-147 per any timepiece.

e. 0.74 MBq (20 microcuries) of promethium-147 per watch hand or 1.48 MBq (40 microcuries) of promethium-147 per other timepiece hand.

f. 2.22 MBq (60 microcuries) of promethium-147 per watch dial or 4.44 MBq (120 microcuries) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).

2. Timepieces, hands or dials containing promethium-147, when measured through 50 milligrams per square centimeter of absorber, not exceeding the following radiation dose rate:

a. For wrist watches, one microgray (0.1 millirad) per hour at 10 centimeters from any surface.

b. For pocket watches, one microgray (0.1 millirad) per hour at one centimeter from any surface.

c. For any other timepiece, 2 microgray (0.2 millirad) per hour at 10 centimeters from any surface.

3. Timepieces containing up to 37 kBq (1.0 microcurie) of radium-226 per timepiece acquired prior to November 30, 2007.

4. Ionization chamber smoke detectors containing not more than 37 kBq (1 microcurie) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

5. Precision balances containing not more than 37 MBq (1 millicurie) of tritium per balance or not more than 18.5 MBq (0.5 millicurie) of tritium per balance part.

6. Marine compasses containing not more than 27.8 GBq (750 millicuries) of tritium gas and other marine navigational instruments containing not more than 9.25 GBq (250 millicuries) of tritium gas.

7. Electron tubes, including spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents, provided that the radiation dose rate from each electron tube containing radioactive material does not exceed 10 microgray (1 millirad) per hour at one centimeter from any surface when measured through 7 milligrams per square centimeter of absorber and that each tube does not contain more than one of the following specified quantities of radioactive material:

a. 5.55 GBq (150 millicuries) of tritium per microwave receiver protector tube or 370 MBq (10 millicuries) of tritium per any other electron tube.

b. 37 kBq (1 microcurie) of cobalt-60.

c. 185 kBq (5 microcuries) of nickel-63.

d. 1.11 MBq (30 microcuries) of krypton-85.

e. 185 kBq (5 microcuries) of cesium-137.

f. 1.11 MBq (30 microcuries) of promethium-147.

8. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided all the following conditions are met:

a. Each source contains no more than one exempt quantity set forth in ch. DHS 157 Appendix B.

b. Each instrument contains no more than 10 exempt quantities. For the purposes of this subd. par., an instrument's source or sources may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in ch. DHS 157 Appendix B, provided that the sum of the fractions does not exceed unity.

c. For purposes of this subdivision, 1.85 kBq (0.05 microcurie) of americium-241 is considered to be an exempt quantity.

9. Static elimination devices which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device.

10. Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 microcuries) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.

11. Devices authorized before October 23, 2012 for use under the general license then provided in DHS 157.11 (2) (a), equivalent regulations of the NRC, or other agreement states, and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the NRC.

(d) Self-luminous products containing tritium, krypton-85,or promethium-147.

1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution of self-luminous products containing tritium, krypton-85 or promethium-147, and except as provided in subd. 3., any person is exempt from this subchapter to the extent that such person receives, possesses, uses, transfers, owns or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced or initially transferred under a specific license issued by the NRC according to 10 CFR 32.22, which authorizes the initial transfer of the product for use under this subdivision.

2. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85 or promethium-147, or to transfer such products for use according to subd. 1., shall apply for a license issued by the NRC according to 10 CFR 32.22, which states that the product may be transferred by the licensee to persons exempt from this subchapter according to subd. 1. or equivalent regulations of the NRC or an agreement state.

3. The exemption in subd. 1. does not apply to tritium, krypton-85 or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

(e) Gas and aerosol detectors containing radioactive material.

1. Except for persons who manufacture, process, produce or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, a person is exempt from this subchapter if the 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 the detectors containing radioactive material have been manufactured, processed, produced or initially transferred for sale or distribution under a specific license issued by the NRC under 10 CFR 32.26, a licensing state, other agreement state or the department under s. DHS 157.13 (4) (c), which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued by an agreement state under comparable provisions under 10 CFR 32.26 authorizing distribution to persons exempt from regulatory requirements.

2. Gas and aerosol detectors previously manufactured and distributed to general licensees under the specific license issued by an agreement state shall be considered exempt under this subdivision provided that the device is labeled under the specific license authorizing distribution of the generally licensed device and provided further that they meet the requirements of s. DHS 157.13 (4) (c).

3. Gas and aerosol detectors containing NARM previously manufactured and distributed under a specific license issued by a licensing state shall be considered exempt under this subdivision provided the devices are labeled under the specific license authorizing distribution, and provided further that they meet the requirements of s. DHS 157.13 (4) (c).

4. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products for use according to subd. 1., shall apply for a license issued by the NRC according to 10 CFR 32.26 and certificate of registration in accordance with 10 CFR 32.210, which states that the product may be transferred by the licensee to persons exempt from this subchapter according to subd. 1. or equivalent regulations of the NRC or an agreement state.

(f) Radioactive drug capsules containing no more than 37 kBq (1 microcurie) carbon-14 urea each for in vivo diagnostic use for humans.

1. Except as provided in subds. 2. and 3., a person is exempt from this subchapter provided that the person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 microcurie) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) 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 according to s. DHS 157.13.

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 according to 10 CFR 32.21.

4. Nothing in this section relieves persons from complying with applicable FDA and other federal and state requirements governing receipt, administration and use of drugs.

(g) Industrial use devices containing exempt quantities or distributed under a general license.

1. Except for persons who manufacture, process, produce or initially transfer for sale or distribution of industrial devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere containing radioactive material, a person is exempt from this subchapter if the person receives, possesses, uses, transfers, owns, or acquires radioactive material in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere have been manufactured, processed, produced, or initially transferred for sale or distribution under a specific license issued by the NRC under 10 CFR 32.30, a licensing state, other agreement state or the department under s. DHS 157.13 (4) (c), which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

2. Industrial devices previously manufactured and distributed to general licensees under the specific license issued by an agreement state shall be considered exempt under this subdivision provided that the device is labeled under the specific license authorizing distribution of the generally licensed device and provided further that they meet the requirements of s. DHS 157.13 (4) (c).

3. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution of industrial devices containing byproduct material for use according to subd. 1., shall apply for a license issued by the NRC according to 10 CFR 32.30 and certificate of registration in accordance with 10 CFR 32.210, which states that the product may be transferred by the licensee to persons exempt from this subchapter according to subd. 1. or equivalent regulations of the NRC or an agreement state.

(3) EXEMPTIONS OF CATEGORY 1 OR CATEGORY 2 QUANTITIES OF RADIOACTIVE WASTE. A licensee that possesses radioactive waste that contains category 1 or category 2 quantities of radioactive material, other than waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs), is exempt from the requirements of ss. DHS 157.9700 to 157.9722 and shall implement all the following requirements to secure the radioactive waste:

(a) Use continuous physical barriers that allow access to the radioactive waste only through established access control points.

(b) Use a locked door or gate with monitored alarm at the access control point.

(c) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred.

(d) Immediately notify the LLEA and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains category 1 or category 2 quantities of radioactive material.

Notes

Wis. Admin. Code Department of Health Services DHS 157.09

CR 01-108: cr. Register July 2002 No. 559, eff. - see Note at the start of the chapter; CR 06-021: r. and recr. (2) (a) 2., am. (2) (c) (intro.), 1. a. and 9. a., r. (2) (c) 12. and 15., cr. (2) (d) and (g), renum. (2) (c) 13. and 14. to be (2) (e) and (f) and am. (2) (e) 1. and (f) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: r. and recr. (2) Register April 2010 No. 652, eff. 5-1-10. Amended by, CR 16-078: am. (1) (a) (intro.), 5. a., b., r. (1) (a) 8. a., renum. (1) (a) 8. b. to d. to (1) (a) 8. a. to c., am. (1) (a) 10. (intro.), r. and recr. (1) (a) 11., 12., cr. (1) (a) 13., am. (2) (c) 7. (intro.), cr. (2) (c) 9. to 11., am. (2) (d) 1., 2., (e) 1., cr. (2) (e) 4., (g), (3) Register January 2018 No. 745, eff. 2-1-18; correction in (1) (a) (intro.), 13., (2) (a) (intro.), (c) 8. a., (g) (intro.), 2. made under s. 35.17, Stats., and correction in (3) made under s. 13.92(4) (b) 7, Stats., Register January 2018 No. 745, eff. 2/1/2018 Amended by, CR 22-015: am. (2) (c) 2. a. to c., 7. (intro.), (g) (title) Register June 2023 No. 810, eff. 7/1/2023

Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555.