^b For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, w_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(143) "Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

(144) "Worker" means an individual engaged in activities under a license or registration issued by the department and controlled by a licensee or registrant but does not include the licensee or registrant. Where the licensee or registrant is an individual rather than one of the other legal entities defined under "person," the radiation exposure limits for the worker also apply to the individual who is the licensee or registrant. If students of age eighteen years or older are subjected routinely to work involving radiation, then the students are considered to be workers. Individuals of less than eighteen years of age shall meet the requirements of WAC 246-221-050.

(145) "Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 10⁵ MeV of potential alpha particle energy. The short-lived radon daughters are -- for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.

(146) "Working level month" (WLM) means an exposure to one working level for one hundred seventy hours -- two thousand working hours per year divided by twelve months per year is approximately equal to one hundred seventy hours per month.

(147) "Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

[Statutory Authority: RCW 70.98.050. 95-01-108, § 246-220-010, filed 12/21/94, effective 1/21/95; 94-01-073, § 246-220-010, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-220-010, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-220-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-12-050, filed 12/11/86; 83-19-050 (Order 2026), § 402-12-050, filed 9/16/83. Statutory Authority: Chapter 70.121 RCW. 81-16-031 (Order 1683), § 402-12-050, filed 7/28/81. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-12-050, filed 12/8/80; Order 1095, § 402-12-050, filed 2/6/76; Order 708, § 402-12-050, filed 8/24/72; Order 1, § 402-12-050, filed 7/2/71; Order 1, § 402-12-050, filed 1/8/69; Rules (part), filed 10/26/66.]

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)

WAC 246-221-001  Purpose and scope. (1) This chapter establishes standards for protection against radiation hazards. Except as otherwise specifically provided, this chapter applies to all licensees or registrants. The requirements of this chapter are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter.

(2) The limits in this chapter do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released pursuant to chapters 246-239 and 246-240 WAC, or to voluntary participation in medical research programs.

(3) Nothing in this chapter shall be interpreted as limiting actions that may be necessary to protect health and safety in an emergency.

(4) The definitions contained in WAC 246-220-010 also apply to this chapter. WAC 246-220-007, Statement of philosophy, is directly applicable to this chapter.

[Statutory Authority: RCW 70.98.050. 94-01-073, § 246-221-001, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-001, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-001, filed 12/27/90, effective 1/31/91; Order 1095, § 402-24-010, filed 2/6/76; Order 1, § 402-24-010, filed 1/8/69; Rules (part), filed 10/26/66.]

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)

WAC 246-221-060  Dose limits for individual members of the public. (1) Each licensee or registrant shall conduct operations so that:

(a) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released pursuant to chapters 246-239 and 246-240 WAC, from voluntary participation in medical research programs, and from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with WAC 246-221-190; and

(b) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released pursuant to chapters 246-239 and 246-240 WAC, does not exceed 0.02 mSv (0.002 rem) in any one hour.

(2) If the licensee or registrant permits members of the public to have access to restricted areas, they shall be escorted and the limits for members of the public continue to apply to those individuals.

(3) Notwithstanding subsection (1) of this section, a licensee or registrant may continue to operate a facility constructed and put into operation prior to January 1, 1994, where the annual dose limit for an individual member of the public is more than 1 mSv (0.1 rem) and less than 5 mSv (0.5 rem) total effective dose equivalent, provided:

(a) The facility's approved operating conditions for each radiation source remain the same. Any increase in the following operating conditions shall require reevaluation and/or modification of the facility shielding applicable to the source of radiation to meet the 1 mSv (0.1 rem) total effective dose equivalent limit for individual members of the public: size of the radiation source, workload, or occupancy factors associated with the source of radiation; and

(b) Any change in the permanent shielding of the facility due to remodeling, repair or replacement shall require the facility to meet the 1 mSv (0.1 rem) total effective dose equivalent limit for individual members of the public for areas affected by that portion of the shielding.

(4) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public.

[Statutory Authority: RCW 70.98.050. 94-01-073, § 246-221-060, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-060, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-060, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-24-040, filed 12/11/86. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-24-040, filed 12/8/80; Order 1095, § 402-24-040, filed 2/6/76; Order 1, § 402-24-040, filed 1/8/69; Rules (part), filed 10/26/66.]

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)

WAC 246-221-130  Exceptions from posting and labeling requirements. (1) A room or area is not required to be posted with a caution sign because of the presence of a sealed source, provided the radiation level 30 centimeters from the surface of the source container or housing does not exceed 0.05 mSv (five millirem) per hour.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs because of the presence of patients containing radioactive material provided that ((confinement is not required)) the patient could be released from licensee control pursuant to chapters 246-239 and 246-240 WAC.

(3) Caution signs are not required to be posted in areas or rooms containing radioactive material for periods of less than eight hours provided that:

(a) The material is constantly attended during such periods by an individual who shall take the precautions necessary to prevent the exposure of any individual to radiation or radioactive material in excess of the limits established in this part; and

(b) Such area or room is subject to the licensee's or registrant's control.

(4) A room or other area is not required to be posted with a caution sign because of the presence of radioactive material prepared for transport and packaged and labeled in accordance with regulations of the United States Department of Transportation.

(5) A room or area is not required to be posted with a caution sign because of the presence of a diagnostic x-ray system used solely for healing arts purposes.

(6) The interior of a teletherapy room is not required to be posted with caution signs provided such posting is conspicuously placed at the entrance(s) to the rooms.

(7) A licensee is not required to label:

(a) Containers holding licensed material in quantities less than the quantities listed in WAC 246-221-300; or

(b) Containers holding licensed material in concentrations less than those specified in WAC 246-221-290, Table III; or

(c) Containers attended by an individual who takes the precautions necessary to prevent the exposure of any individual to radiation or radioactive material in excess of the limits established by this chapter; or

(d) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States Department of Transportation; or

(e) Containers such as those located in water-filled canals, storage vaults, or hot cells, that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, provided the contents are identified to these individuals by a readily available written record. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(f) Installed manufacturing or process equipment, such as chemical process equipment, piping, and tanks.

(8) Each licensee, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, shall remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

[Statutory Authority: RCW 70.98.050. 94-01-073, § 246-221-130, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-130, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-130, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050 (Order 2026), § 402-24-095, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-24-095, filed 12/8/80; Order 1095, § 402-24-095, filed 2/6/76.]

AMENDATORY SECTION (Amending WSR 95-01-108, filed 12/21/94, effective 1/21/95)

WAC 246-221-250  Notification of incidents. (1) Immediate notification. Notwithstanding other requirements for notification, each licensee and/or registrant shall immediately (as soon as possible but no later than four hours after discovery of an incident) notify the State Department of Health, Division of Radiation Protection, P.O. Box 47827, Olympia, Washington 98504-7827, by telephone (206/682-5327) and confirming letter, telegram, mailgram, or facsimile of any incident involving any radiation source which may have caused or threatens to cause:

(a) An individual to receive:

(i) A total effective dose equivalent of 0.25 Sv (25 rem) or more; or

(ii) An eye dose equivalent of 0.75 Sv (75 rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 Sv (250 rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures; or

(c) The loss of ability to take immediate protective actions necessary to avoid exposure to sources of radiation or releases of radioactive material that could exceed regulatory limits. Events which could cause such a loss of ability include fires, explosions, toxic gas releases, etc.

(2) Twenty-four hour notification. Each licensee and/or registrant shall within twenty-four hours of discovery of the event, notify the State Department of Health, Division of Radiation Protection, P.O. Box 47827, Olympia, Washington 98504-7827, by telephone (206/682-5327) and confirming letter, telegram, mailgram, or facsimile of any incident involving any radiation source possessed which may have caused or threatens to cause:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 Sv (5 rem); or

(ii) An eye dose equivalent exceeding 0.15 Sv (15 rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 Sv (50 rem); or

(b) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures; or

(c) An unplanned contamination incident that:

(i) Requires access to the contaminated area, by workers or the general public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in WAC 246-221-290; and

(iii) Has access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination; or

(d) Equipment failure or inability to function as designed when:

(i) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive material exceeding regulatory limits or to mitigate the consequences of an accident;

(ii) The equipment is required to be available and operable at the time it becomes disabled or fails to function; and

(iii) No redundant equipment is available and operable to perform the required safety functions; or

(e) An unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body; or

(f) An unplanned fire or explosion damaging any radioactive material or any device, container or equipment containing radioactive material when:

(i) The quantity of radioactive material involved is greater than five times the lowest annual limit on intake specified in WAC 246-221-290; and

(ii) The damage affects the integrity of the radioactive material or its container.

(3) For each occurrence requiring notification pursuant to this section, a prompt investigation of the situation shall be initiated by the licensee/registrant. A written report of the findings of the investigation shall be sent to the department within thirty days.

(4) The licensee or registrant shall prepare each report filed with the department pursuant to this section so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

Any report filed with the department pursuant to this section shall contain the information described in WAC 246-221-260 (2) and (3).

(5) The provisions of this section do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported pursuant to WAC 246-221-265.

(6) Telephone notifications that do not involve immediate or twenty-four hour notification shall not be made to the emergency number (Seattle 206/682-5327). Routine calls should be made to the Olympia office (((360/753-3468))) (360 236-3300).

(7) Telephone notification required under this section shall include, to the extent that the information is available at the time of notification:

(a) The caller's name and call-back telephone number;

(b) A description of the incident including date and time;

(c) The exact location of the incident;

(d) The radionuclides, quantities, and chemical and physical forms of the radioactive materials involved; and

(e) Any personnel radiation exposure data available.

[Statutory Authority: RCW 70.98.050. 95-01-108, § 246-221-250, filed 12/21/94, effective 1/21/95; 94-01-073, § 246-221-250, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-250, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-250, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-24-190, filed 12/11/86; 83-19-050 (Order 2026), § 402-24-190, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-24-190, filed 12/8/80; Order 1095, § 402-24-190, filed 2/6/76; Order 708, § 402-24-190, filed 8/24/72; Order 1, § 402-24-190, filed 7/2/71; Order 1, § 402-24-190, filed 1/8/69; Rules (part), filed 10/26/66.]

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)

WAC 246-222-080  Inspections not warranted--Informal review. (1) If the department of health, division of radiation protection determines, with respect to a complaint under WAC 246-222-070 that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the division of radiation protection shall notify the complainant in writing of such determination.

(a) If the complaint resulted from activities concerning naturally occurring or accelerator produced radioactive materials and/or radiation producing machines: The complainant may obtain review of such determination by submitting a written statement of position to the Assistant Director, Division of Industrial Safety and Health, P.O. Box 4600, Olympia, Washington 98504-4600. Such request for informal review will be processed according to the provisions of WAC 296-350-460 and the provisions of the interagency agreement between the department of labor and industries and the department of health, division of radiation protection, if any.

(b) If the complaint resulted from activities concerning byproduct material, source material, and/or special nuclear material: The complainant may obtain review of such determination by submitting a written statement of position with the Department of Health, Division of Radiation Protection, P.O. Box 47827, Olympia, Washington 98504-7827 (((360/753-3468))) (360 236-3300), who will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the department of health, division of radiation protection, who will provide the complainant with a copy of such statement by certified mail. Upon the request of the complainant, the department of health may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written or oral views presented, the department of health shall affirm, modify, or reverse the determination of the division of radiation protection and furnish the complainant and the licensee or registrant a written notification of the decision and the reason therefor.

(2) If the division of radiation protection determines that an inspection is not warranted because the requirements of WAC 246-222-070(1) have not been met, it shall notify the complainant in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of WAC 246-222-070(1).

[Statutory Authority: RCW 70.98.050. 94-01-073, § 246-222-080, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-222-080, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-222-080, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-48-080, filed 12/11/86; Order 1084, § 402-48-080, filed 1/14/76.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-232-010  Exemptions. (1) Source material.

(a) Any person is exempt from this chapter and chapters 246-233 and 246-235 WAC to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution or alloy in which the source material is by weight less than 1/20 of one percent (0.05 percent) of the mixture, compound, solution, or alloy.

(b) Any person is exempt from this chapter and chapters 246-233 and 246-235 WAC to the extent that such person receives, possesses, uses or transfers unrefined and unprocessed ore containing source material: Provided, That, except as authorized in a specific license, such person shall not refine or process such ore.

(c) Any person is exempt from this chapter and chapters 246-233 and 246-235 WAC to the extent that such person receives, possesses, uses or transfers:

(i) Any quantities of thorium contained in:

(A) Incandescent gas mantles;

(B) Vacuum tubes;

(C) Welding rods;

(D) Electric lamps for illuminating purposes provided that each lamp does not contain more than fifty milligrams of thorium;

(E) Germicidal lamps, sunlamps and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium;

(F) Rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these; or

(G) Personnel neutron dosimeters, provided each dosimeter does not contain more than 50 milligrams of thorium;

(ii) Source material contained in the following products:

(A) Glazed ceramic tableware: Provided, That the glaze contains not more than twenty percent by weight source material; and

(B) Piezoelectric ceramic containing not more than two percent by weight source material;

(iii) Photographic film, negatives and prints containing uranium or thorium;

(iv) Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys: Provided, That the thorium content of the alloy does not exceed four percent by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such product or part;

(v) Depleted uranium contained in counterweights installed in aircraft, rockets, projectiles and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that:

(A) The counterweights are manufactured in accordance with a specific license issued by the United States Nuclear Regulatory Commission authorizing distribution by the licensee pursuant to 10 CFR Part 40;

(B) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "depleted uranium"*;

(C) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "unauthorized alterations prohibited"*; and

(D) The exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such counterweight other than repair or restoration of any plating or other covering;

*Note: The requirements specified in (c)(v)(B) and (C) of this subsection need not be met by counterweights manufactured prior to December 31, 1969: Provided, That such counterweights are impressed with the legend, "caution - radioactive material - uranium," as previously required by the regulations.

(vi) Depleted uranium used as shielding constituting part of any shipping container which is conspicuously and legibly impressed with the legend "caution - radioactive shielding - uranium" and the uranium metal is encased in mild steel or in an equally fire resistant metal of a minimum wall thickness of 3.2 millimeters.

(vii) Thorium contained in finished optical lenses: Provided, That each lens does not contain more than thirty percent by weight of thorium, and that the exemption contained in this subparagraph shall not be deemed to authorize either:

(A) The shaping, grinding or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without alteration of the lens; or

(B) The receipt, possession, use or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments;

(viii) Uranium contained in detector heads for use in fire detection units: Provided, That each detector head contains not more than 0.005 microcuries of uranium; or

(ix) Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

(A) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

(B) The thorium content in the nickel-thoria alloy does not exceed four percent by weight.

(d) The exemptions in (c) of this subsection do not authorize the manufacture of any of the products described.

(2) Radioactive material other than source material.

(a) Exempt concentrations.

(i) Except as provided in (a)(ii) of this subsection any person is exempt from this chapter and chapters 246-233 and 246-235 WAC to the extent that such person receives, possesses, uses, transfers, owns or acquires products or materials containing radioactive material in concentrations not in excess of those listed in WAC 246-232-130, Schedule C.

(ii) No person may introduce radioactive material into a product or material, knowing or having reason to believe, that it will be transferred to persons exempt under (a)(i) of this subsection or equivalent regulations of the United States Nuclear Regulatory Commission, any agreement state or licensing state, except in accordance with a specific license issued pursuant to WAC ((246-235-100(1))) 246-235-105 or the general license provided in WAC 246-232-040.

(b) Exempt quantities.

(i) Except as provided in (b)(ii) and (iii) of this subsection any person is exempt from these regulations to the extent that such 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 WAC 246-232-120, Schedule B.

(ii) This paragraph, WAC 246-232-010 (2)(b), 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.

(iii) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in WAC 246-232-120, Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under (b) of this subsection or equivalent regulations of the United States Nuclear Regulatory Commission or any agreement state or licensing state, except in accordance with a specific license issued by the United States Nuclear Regulatory Commission, pursuant to Section 32.18 of 10 CFR Part 32 or by the department pursuant to WAC ((246-235-100(2))) 246-235-105 which license states that the radioactive material may be transferred by the licensee to persons exempt under (b) of this subsection or the equivalent regulations of the United States Nuclear Regulatory Commission or any agreement state or licensing state.

(c) Exempt items.

(i) Certain items containing radioactive material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from these regulations to the extent that person receives, possesses, uses, transfers, owns or acquires the following products:*

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

(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:

25 millicuries of tritium per timepiece;

5 millicuries of tritium per hand;

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

100 microcuries of promethium - 147 per watch or 200 microcuries of promethium - 147 per any other timepiece;

20 microcuries of promethium - 147 per watch hand or 40 microcuries of promethium - 147 per other timepiece hand;

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);

The levels of radiation from hands and dials containing promethium - 147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

For wrist watches, 0.1 millirad per hour at 1 centimeter from any surface;

For pocket watches, 0.1 millirad per hour at 1 centimeter from any surface;

For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.

One microcurie of radium-226 per timepiece in timepieces manufactured prior to the effective date of these regulations.

(B) Lock illuminators containing not more than 15 millicuries of tritium or not more than 2 millicuries of promethium - 147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium - 147 will not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.

(C) Precision balances containing not more than 1 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:

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

(bb) 1 microcurie of cobalt-60;

(cc) 5 microcuries of nickel-63;

(dd) 30 microcuries of krypton-85;

(ee) 5 microcuries of cesium-137;

(ff) 30 microcuries of promethium-147;

(gg) 1 microcurie of radium-226:

And provided further, That the levels of radiation from each electron tube containing radioactive material does not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber.*

*Note: For purposes of this subdivision, "electron tubes" include 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.

(H) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, a source of radioactive material not exceeding 0.05 microcuries of americium-241 or the applicable quantity set forth in WAC 246-232-120, Schedule B.

(I) Spark gap irradiators containing not more than 1 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.

(ii) Self-luminous products containing radioactive material(s).

(A) Tritium, krypton-85 or promethium-147. Except for persons who manufacture, process or produce self-luminous products containing tritium, krypton-85 or promethium-147, any person is exempt from these regulations 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, imported or transferred in accordance with a specific license issued by the United States 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. The exemption in (c)(ii) of this subsection does not apply to tritium, krypton-85 or promethium-147 used in products for frivolous purposes or in toys or adornments.

(B) Radium-226. Any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers or owns articles containing less than 0.1 microcurie of radium-226 which were manufactured prior to October 1983.

(iii) Gas and aerosol detectors containing radioactive material.

(A) Except for persons who manufacture, process or produce gas and aerosol detectors containing radioactive material, any person is exempt from these regulations to the extent that such 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 have been manufactured, imported, or transferred in accordance with a specific license issued by the United States Nuclear Regulatory Commission* or an agreement state, pursuant to Section 32.26 of 10 CFR Part 32, or licensing state pursuant to WAC ((246-235-100(3))) 246-235-105, which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements.

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

(B) 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 (c)(iii)(A) of this subsection: Provided, That the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device: And provided further, That they meet the requirements of WAC ((246-235-100(3))) 246-235-105.

(C) Gas and aerosol detectors containing naturally occurring and accelerator-produced radioactive material (NARM) previously manufactured and distributed in accordance with a specific license issued by a licensing state shall be considered exempt under (c)(iii)(A) of this subsection: Provided, That the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of WAC ((246-235-100(3))) 246-235-105.

(iv) Resins containing scandium-46 and designed for sand consolidation in oil wells. Any person is exempt from these regulations 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. Such resins shall have been manufactured or imported in accordance with a specific license issued by the United States Nuclear Regulatory Commission or shall have been manufactured in accordance with the specifications contained in a specific license issued by the department 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 United States Nuclear Regulatory Commission. This exemption does not authorize the manufacture of any resins containing scandium-46.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-232-010, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-232-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-19-190, filed 12/11/86; 83-19-050 (Order 2026), § 402-19-190, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-19-190, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-19-190, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-190.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-232-040  Reciprocal recognition of licenses. (1) Subject to these regulations, any person who holds a specific license from the United States Nuclear Regulatory Commission or any agreement state or licensing state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of one hundred eighty days in that twelve month period which commences the date approval is granted, and the appropriate fee received, by the department provided that:

(a) The licensing document does not limit the activity authorized by such document to specified installations or locations;

(b) The out-of-state licensee notifies the department in writing and pays or has paid the appropriate fee (refer to chapter 246-254 WAC), at least three days prior to each entry to the state to engage in such activity. The written notification must be sent to the Radioactive Materials Section, Department of Health, Mailstop ((LE-13)) 47827, Olympia, Washington 98504-7827 and the fee should be sent to Washington State Department of Health, Revenue Accounting, P.O. Box 1099, Olympia, Washington 98504. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by copies of the pertinent licensing documents. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon telephone application to the department (((360-753-4481))) (360 236-3220), obtain permission to proceed sooner. The department may waive the requirement for filing additional written notifications during the remainder of the twelve months following the receipt of the initial notification from a person engaging in activities under the general license provided in this subsection;

(c) The out-of-state licensee complies with all applicable regulations of the department and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the department;

(d) The out-of-state licensee supplies such other information as the department may request; and

(e) The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person:

(i) Specifically licensed by the department or by the United States Nuclear Regulatory Commission, an agreement state or a licensing state to receive such material; or

(ii) Exempt from the requirements for a license for such material under WAC 246-232-010 (2)(a).

(2) Notwithstanding the provisions of subsection (1) of this section, any person who holds a specific license issued by the United States Nuclear Regulatory Commission, an agreement state or a licensing state authorizing the holder to manufacture, transfer, install, or service a device described in WAC 246-233-020(4) within the areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service a device in this state provided that:

(a) Such person shall file a report with the department within thirty days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

(b) The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the United States Nuclear Regulatory Commission, an agreement state or a licensing state;

(c) Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and

(d) The holder of the specific license shall furnish to each general licensee to whom such device is transferred or on whose premises such device is installed a copy of the general license contained in WAC 246-233-020(4).

(3) The department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-232-040, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-232-040, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-19-250, filed 12/11/86; 83-19-050 (Order 2026), § 402-19-250, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-19-250, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-19-250, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-210.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-233-010  General licenses--Source material. (1) A general license is hereby issued authorizing use, possession, and transfer of not more than fifteen pounds of source material at any one time by persons in the following categories:

(a) Pharmacists using the source material solely for the preparation of medicinal compounds;

(b) Physicians using the source material for medicinal purposes;

(c) Persons receiving possession of source material from pharmacists and physicians in the form of medicinals or drugs;

(d) Commercial and industrial firms, and research, educational, and medical institutions, and state and local government agencies for research, development, educational, operational, or commercial purposes: And provided, That no such person shall, pursuant to this general license, receive more than a total of one hundred fifty pounds of source material in any one calendar year.

(2) Persons who receive, possess, use, or transfer source material pursuant to the general license issued in subsection (1) of this section are exempt from the provisions of chapters 246-221 and 246-222 WAC to the extent that such receipt, possession, use, or transfer is within the terms of such general license: Provided, however, That this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to chapter 246-235 WAC.

(3) A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material.

(4) Depleted uranium in industrial products and devices.

(a) A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of paragraphs (4)(b), (c), (d), and (e) of this section, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.

(b) The general license in paragraph (4)(a) of this section applies only to industrial products or devices which have been manufactured either in accordance with a specific license issued to the manufacturer of the products or devices pursuant to WAC ((246-235-100(13))) 246-235-091 or in accordance with a specific license issued to the manufacturer by the United States Nuclear Regulatory Commission or an agreement state which authorizes manufacture of the products or devices for distribution to persons generally licensed by the United States Nuclear Regulatory Commission or an agreement state.

(c)(i) Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by paragraph (4)(a) of this section shall file department form RHF-20 "Registration certificate - Use of depleted uranium under general license," with the department. The form shall be submitted within thirty days after the first receipt or acquisition of such depleted uranium. The registrant shall furnish on department form RHF-20 the following information and such other information as may be required by that form:

(A) Name and address of the registrant;

(B) A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in paragraph (4)(a) of this section and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

(C) Name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in item (4)(c)(i)(B) of this section.

(ii) The registrant possessing or using depleted uranium under the general license established by paragraph (4)(a) of this section shall report in writing to the department any changes in information previously furnished on the "Registration certificate - Use of depleted uranium under general license." The report shall be submitted within thirty days after the effective date of such change.

(d) A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by paragraph (4)(a) of this section:

(i) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.

(ii) Shall not abandon such depleted uranium.

(iii) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provision of chapter 246-232 WAC. In the case where the transferee receives the depleted uranium pursuant to the general license established by paragraph (4)(a) of this section the transferor shall furnish the transferee a copy of this regulation and a copy of department form RHF-20.

In the case where the transferee receives the depleted uranium pursuant to a general license contained in the United States Nuclear Regulatory Commission's or agreement state's regulation equivalent to paragraph (4)(a) of this section the transferor shall furnish the transferee a copy of this regulation and a copy of department form RHF-20 accompanied by a note explaining that use of the product or device is regulated by the United States Nuclear Regulatory Commission or agreement state under requirements substantially the same as those in this regulation.

(iv) Shall maintain and make available to the department upon request the name and address of the person receiving the depleted uranium pursuant to such transfer.

(v) Shall not export such depleted uranium except in accordance with a license issued by the United States Nuclear Regulatory Commission pursuant to 10 CFR Part 110.

(e) Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by paragraph (4)(a) of this section is exempt from the requirements of chapters 246-221 and 246-222 WAC of these regulations with respect to the depleted uranium covered by that general license.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-233-010, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-233-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-21-030, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-21-030, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-030.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-233-020  General licenses*--Radioactive material other than source material.

*Note: Different general licenses are issued in this section, each of which has its own specific conditions and requirements.

(1) Certain devices and equipment. A general license is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the United States Nuclear Regulatory Commission for use pursuant to Section 31.3 of 10 CFR Part 31. This general license is subject to the provisions of WAC 246-220-020, 246-220-030, 246-220-040, 246-220-050, 246-220-060, 246-220-070, chapters 246-232, 246-221** and 246-222 WAC.

(a) Static elimination device. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of Polonium-210 per device.

(b) Ion generating tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of Polonium-210 per device or a total of not more than 50 millicuries of Hydrogen-3 (tritium) per device.

** Attention is directed particularly to the provisions of chapter 246-221 WAC of these regulations which relate to the labeling of containers.

(2) Reserved.

(3) Reserved.

(4) Certain measuring, gauging or controlling devices.

(a) A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and state or local government agencies to own, acquire, receive, possess, use or transfer, in accordance with the provisions of (b), (c), and (d) of this subsection, radioactive material excluding special nuclear material contained in 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 light or an ionized atmosphere.

(b) The general license in (a) of this subsection applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific license issued by the department pursuant to WAC ((246-235-100(4))) 246-235-093 or in accordance with the Nuclear Regulatory Commission, an agreement state or a licensing state, which authorizes distribution of devices to persons generally licensed by the United States Nuclear Regulatory Commission, an agreement state or licensing state**.

*Note: Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in Section 179.21 of 21 CFR Part 179.

(c) Any person who owns, acquires, receives, possesses, uses or transfers radioactive material in a device pursuant to the general license in (a) of this subsection:

(i) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;

(ii) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label, however:

(A) Devices containing only krypton need not be tested for leakage of radioactive material; and

(B) Devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting material or 10 microcuries of alpha emitting material need not be tested for any purpose. Devices held in storage in the original shipping container prior to initial installation need not be tested until immediately prior to use;

(iii) Shall assure that the tests required by (c)(ii) of this subsection and other testing, installing, servicing, and removing from installation involving the radioactive materials, its shielding or containment, are performed:

(A) In accordance with the instructions provided by the labels; or

(B) By a person holding a specific license from the department or from the United States Nuclear Regulatory Commission or from any agreement state or from a licensing state to perform such activities;

(iv) Shall maintain records showing compliance with the requirements of (c)(ii) and (iii) of this subsection. The records shall show the results of tests. The records also shall show the dates of performance and the names of persons performing, testing, installing, servicing, and removing from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by (c)(ii) of this subsection shall be maintained for one year after the next required leak test is performed or the sealed source is transferred or disposed. Records of tests of the on/off mechanism and indicator required by (c)(ii) of this subsection shall be maintained for one year after the next required test of the on/off mechanism and indicator is performed or the sealed source is transferred or disposed. Records of other testing, installation, servicing, and removal from installation required by (c)(iii) of this subsection shall be maintained for a period of two years from the date of the recorded event or until the device is transferred or disposed;

(v) Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on/off mechanism or indicator, or upon the detection of 0.005 microcuries or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding a specific license from the department, the United States Nuclear Regulatory Commission, or from an agreement state or a licensing state to repair such devices, or disposed by transfer to a person authorized by a specific license to receive the radioactive material contained in the device and, within thirty days, furnish to the department a written report containing a brief description of the event and the remedial action taken;

(vi) Shall not abandon the device containing radioactive material;

(vii) Except as provided in (c)(viii) of this subsection, shall transfer or dispose the device containing radioactive material only by transfer to a person holding a specific license of the department, the United States Nuclear Regulatory Commission, or an agreement state, or a licensing state whose specific license authorizes the person to receive the device and within thirty days after transfer of a device to a specific licensee shall furnish to the department a report containing identification of the device by manufacturer's name, model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific licensee in order to obtain a replacement device;

(viii) Shall transfer the device to another general licensee only:

(A) Where the device remains in use at a particular location. In such case, the transferor shall give the transferee a copy of this subsection and any safety documents identified in the label of the device and within thirty days of the transfer, report to the department the manufacturer's name, model number of device transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between the department and the transferee; or

(B) Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee:

(ix) Shall comply with the provisions of WAC 246-221-240 and 246-221-250 for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of chapters 246-221 and 246-222 WAC.

(d) The general license in (a) of this subsection does not authorize the manufacture, import or export of devices containing radioactive material.

(e) The general license provided in this subsection is subject to the provisions of WAC 246-220-020, 246-220-030, 246-220-040, 246-220-060, 246-220-070, 246-220-100, 246-232-050, 246-232-070, 246-232-080, and 246-232-090.

(5) Luminous safety devices for aircraft.

(a) A general license is hereby issued to own, receive, acquire, possess and use tritium or Promethium-147 contained in luminous safety devices for use in aircraft, provided:

(i) Each device contains not more than 10 curies of tritium or 300 millicuries of Promethium-147; and

(ii) Each device has been manufactured, assembled or imported in accordance with a specific license issued by the United States Nuclear Regulatory Commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the department or any agreement state to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 CFR Part 32 of the regulations of the United States Nuclear Regulatory Commission.

(b) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this subsection are exempt from the requirements of chapters 246-221 and 246-222 WAC except that they shall comply with the provisions of WAC 246-221-240 and 246-221-250.

(c) This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or Promethium-147.

(d) This general license does not authorize the ownership, receipt, acquisition, possession or use of Promethium-147 contained in instrument dials.

(e) This general license is subject to the provisions of WAC 246-220-020, 246-220-030, 246-220-040, 246-220-050, 246-220-060, 246-220-070, 246-220-100, 246-232-050, 246-232-070, 246-232-080, and 246-232-090.

(6) Ownership of radioactive material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this chapter, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.

(7) Calibration and reference sources.

(a) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with the provisions of (d) and (e) of this subsection, Americium-241 in the form of calibration or reference sources:

(i) Any person who holds a specific license issued by the department which authorizes that person to receive, possess, use and transfer radioactive material; or

(ii) Any person who holds a specific license issued by the United States Nuclear Regulatory Commission which authorizes that person to receive, possess, use and transfer special nuclear material.

(b) A general license is hereby issued to own, receive, possess, use and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of (d) and (e) of this subsection to any person who holds a specific license issued by the department which authorizes that person to receive, possess, use and transfer radioactive material.

(c) A general license is hereby issued to own, receive, possess, use and transfer Radium-226 in the form of calibration or reference sources in accordance with the provisions of (d) and (e) of this subsection to any person who holds a specific license issued by the department which authorizes that person to receive, possess, use and transfer radioactive material.

(d) The general licenses in (a), (b) and (c) of this subsection apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the United States Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the department or any agreement state or licensing state pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section 70.39 of 10 CFR Part 70 of the regulations of the United States Nuclear Regulatory Commission.

(e) The general licenses provided in (a), (b) and (c) of this subsection are subject to the provisions of WAC 246-220-020, 246-220-030, 246-220-040, 246-220-060, 246-220-070, 246-220-100, 246-232-050, 246-232-070, 246-232-080, 246-232-090, chapters 246-221 and 246-222 WAC.

In addition, persons who own, receive, acquire, possess, use or transfer one or more calibration or reference sources pursuant to these general licenses:

(i) Shall not possess at any one time, at any one location of storage or use, more than 5 microcuries of Americium-241 and 5 microcuries of plutonium and 5 microcuries of Radium-226 in such sources;

(ii) Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements or a substantially similar statement which contains the information called for in the following statement:

(A) The receipt, possession, use and transfer of this source, Model . . . . . ., Serial No. . . . . . ., are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

caution - radioactive material - this source contains (americium-241). (plutonium)*. do not touch radioactive portion of this source

caution - radioactive material - this source contains radium-226. do not touch radioactive portion of this source.

(iii) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the department, the United States Nuclear Regulatory Commission, or an agreement state or licensing state to receive the source;

(iv) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain Americium-241, Plutonium, or Radium-226/Radon-222 which might otherwise escape during storage; and

(v) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(f) These general licenses do not authorize the manufacture of calibration or reference sources containing Americium-241, Plutonium, or Radium-226.

(8) General license for use of radioactive material for certain in vitro clinical or laboratory testing.*

(a) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of or use, for any of the following stated tests, in accordance with the provisions of (b), (c), (d), (e), and (f) of this subsection the following radioactive materials in prepackaged units:

(i) Iodine-125, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(ii) Iodine-131, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(iii) Carbon-14, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(iv) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(v) Iron-59, in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(vi) Cobalt-57, in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(vii) Selenium-75, in units not to exceed 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(viii) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of Iodine-129 and 0.005 microcurie of Americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

*Note: The new drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.

(b) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by (a) of this subsection until that person has received a validated copy of department Form RHF-15 "Certificate-in vitro testing with radioactive material under general license." Annual validation requires resubmittal of revised department Form RHF-15 and submittal of the annual fee to the department. The physician, veterinarian, clinical laboratory or hospital shall furnish on department Form RHF-15 the following information and such other information as may be required by that form:

(i) Name and address of the physician, veterinarian, clinical laboratory or hospital;

(ii) The location of use; and

(iii) A statement that the physician, veterinarian, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general license in (a) of this subsection and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.

(c) A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by (a) of this subsection shall comply with the following:

(i) The general licensee shall not possess at any one time, pursuant to the general license in (a) of this subsection at any one location of storage or use, a total amount of Iodine-125, Iodine-131, Selenium-75, Iron-59, and/or Cobalt-57 in excess of 200 microcuries.

(ii) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(iii) The general licensee shall use the radioactive material only for the uses authorized by (a) of this subsection.

(iv) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the department, the United States Nuclear Regulatory Commission, any agreement state or licensing state, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(v) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in (a)(viii) of this subsection as required by WAC 246-221-170.

(d) The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to (a) of this subsection:

(i) Except as prepackaged units which are labeled in accordance with the provision of an applicable specific license issued pursuant to WAC ((246-235-100(8))) 246-235-097 or in accordance with the provisions of a specific license issued by the United States Nuclear Regulatory Commission, or any agreement state or licensing state which authorizes the manufacture and distribution of Iodine-125, Iodine-131, Carbon-14, Hydrogen-3 (tritium), Iron-59, Selenium-75, Cobalt-57, or Mock Iodine-125 to persons generally licensed under this subsection or its equivalent; and

(ii) Unless one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a licensing state.

(e) The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license of (a) of this subsection shall report in writing to the department, any changes in the information previously furnished in the "Certificate - in vitro testing with radioactive material under general license," department Form RHF-15. The report shall be furnished within thirty days after the effective date of such change.

(f) This general license is subject to the provisions of WAC 246-220-020, 246-220-030, 246-220-040, 246-220-060, 246-220-070, 246-220-090 and 246-220-100. In addition, any person using radioactive material pursuant to the general license of (a) of this subsection is exempt from the requirements of chapters 246-221 and 246-222 WAC with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in (a)(viii) of this subsection shall comply with the provisions of WAC 246-221-170, 246-221-240, and 246-221-250 and of these regulations.

(9) Ice detection devices.

(a) A general license is hereby issued to own, receive, acquire, possess, use and transfer Strontium-90 contained in ice detection devices, provided each device contains not more than 50 microcuries of Strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the United States Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the department or any agreement state to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR Part 32 of the regulations of the United States Nuclear Regulatory Commission.

(b) Persons who own, receive, acquire, possess, use or transfer Strontium-90 contained in ice detection devices pursuant to the general license in (a) of this subsection:

(i) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license from the United States Nuclear Regulatory Commission or an agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of these regulations;

(ii) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and

(iii) Are exempt from the requirements of chapters 246-221 and 246-222 WAC except that such persons shall comply with the provisions of WAC 246-221-170, 246-221-240, and 246-221-250.

(c) This general license does not authorize the manufacture, assembly, disassembly or repair of Strontium-90 sources in ice detection devices.

(d) This general license is subject to the provisions of WAC 246-220-020, 246-220-030, 246-220-040, 246-220-060, 246-220-070, 246-220-100, 246-232-050, 246-232-070, 246-232-080, and 246-232-090.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-233-020, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-233-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-21-050, filed 12/11/86; 83-19-050 (Order 2026), § 402-21-050, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-21-050, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-21-050, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-040.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-235-020  General requirements for the issuance of specific licenses. A license application will be approved if the department determines that:

(1) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with these regulations in such a manner as to minimize danger to public health and safety or property;

(2) The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;

(3) The issuance of the license will not be inimical to the health and safety of the public; and

(4) The applicant satisfies any applicable special requirements in WAC ((246-235-080, 246-235-090, 246-235-095, 246-235-100, and 246-247-050)) 246-235-075 through 246-235-110, and chapters 246-239 through 246-252 WAC.

(5) In the case of an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, source material milling, or for the conduct of any other activity which the agency determines will significantly affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after independently weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-020, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-22-040, filed 12/11/86. Statutory Authority: Chapter 70.121 RCW. 81-16-031 (Order 1683), § 402-22-040, filed 7/28/81. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-040, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-060.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-235-080  Special requirements for issuance of certain specific licenses for radioactive material. (1) Human use of radioactive material in institutions. In addition to the requirements set forth in WAC 246-235-020 a specific license for human use of radioactive material in institutions will be issued if:

(a) The applicant has appointed a radiation safety committee to coordinate the use of radioactive material throughout that institution and to maintain surveillance over the institution's radiation safety program. Membership of the committee should include a specialist (where applicable a physician) from each department where radioactive material is used, a representative of the institution's management, a representative of the nursing staff, and a person trained in radiation safety. The radiation safety committee shall meet at ((intervals not to exceed six months)) least quarterly. Minutes shall be taken and maintained for two years for inspection by the department;

(b) The applicant possesses adequate facilities for the clinical care of patients. The applicant is advised that construction of new radioisotope facilities and modification of existing facilities must also comply with the requirements of WAC 246-318-660 of the construction review section of the department;

(c) The physician(s) designated on the application as the individual user(s) has (or have) substantial experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients; and

(d) If the application is for a license to use unspecified quantities or multiple types of radioactive material, the applicant's staff has substantial experience in the use of a variety of radioactive materials for a variety of human uses.

(2) Licensing of individual physicians for human use of radioactive material. In addition to the requirements set forth in WAC 246-235-020 a specific license for the human use of radioactive material will be issued to an individual physician if:

(a) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable;

(b) The applicant has extensive experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients;

(c) The application is for use in the applicant's practice in an office outside a medical institution; and

(d) The department will approve an application by an individual physician or group of physicians for a specific license to receive, possess or use radioactive material on the premises of a medical institution only if:

(i) The use of radioactive material is limited to the:

(A) Administration of radiopharmaceuticals for diagnostic or therapeutic purposes;

(B) Performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered;

(C) Performance of in vitro diagnostic studies; or

(D) Calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation and diagnostic instrumentation;

(ii) The physician brings the radioactive material with him or her and removes the radioactive material when he or she departs. (The institution cannot receive, possess or store radioactive material other than the amount of material remaining in the patient); and

(iii) The medical institution does not hold a radioactive material license issued pursuant to the provisions of subsection (1) of this section.

(3) Specific licenses for certain groups of medical uses of radioactive material.

(a) Subject to the provisions of (b), (c) and (d) of this subsection an application for a specific license pursuant to subsection (1), (2) or (4) of this section, or for any medical use or uses of radioactive material specified in one or more of Groups I to VI, inclusive, of WAC 246-235-120, Schedule A, will be approved for all of the uses within the group or groups which include the use or uses specified in the application if:

(i) The applicant satisfies the requirements of subsection (1), (2) or (4) of this section;

(ii) The applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses included in the group or groups;

(iii) The applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, have adequate training and experience in the handling of radioactive material appropriate to their participation in the uses included in the group or groups;

(iv) The applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses included in the group or groups, specifically:

(A) For Groups I through V, applicant must possess and use a calibrated and operable low-range survey instrument with a thin window (less than 7 mg/cm²) capable of detecting radiation levels of 0.05 milliroentgen per hour up to at least 20 milliroentgens per hour;

(B) For Groups III, V, and VI, applicant must possess a calibrated and operable high-range survey instrument capable of detecting radiation levels up to at least one Roentgen per hour;

(v) The applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups.

(b) Any licensee or registrant who is authorized to use radioactive material pursuant to one or more groups in (a) of this subsection and WAC 246-235-120, Schedule A, is subject to the following conditions:

(i) For Groups I, II, IV, and V, no licensee or registrant shall receive, possess or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged and distributed in accordance with a specific license issued by the department pursuant to WAC 246-235-100(((10))), a specific license issued by the United States Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR Part 32, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(ii) For Group III, no licensee or registrant shall receive, possess or use generators or reagent kits containing radioactive material ((or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except:

(A) Reagent kits not containing radioactive material that are approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state for use by persons licensed pursuant to this subsection and WAC 246-235-120, Schedule A, or equivalent regulations; or

(B) Generators or reagent kits containing radioactive material that are)) unless manufactured, labeled, packaged and distributed in accordance with a specific license issued by the department pursuant to WAC 246-235-100(((11))), a specific license issued by the United States Nuclear Regulatory Commission pursuant to Section 32.73 of 10 CFR Part 32, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(iii) For Group VI, no licensee or registrant shall receive, possess or use radioactive material except as contained in a source or device that has been manufactured, labeled, packaged and distributed in accordance with a specific license issued by the department pursuant to WAC ((246-235-100(12))) 246-235-102, a specific license issued by the United States Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(iv) For Group III, any licensee or registrant who uses generators or reagent kits shall elute the generator or process radioactive material with the reagent kit in accordance with instructions which are approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state and are furnished by the manufacturer on the label attached to or in the leaflet or brochure which accompanies the generator or reagent kit.

(((v) For Groups I, II and III any licensee using byproduct material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding:

(A) Chemical and physical form;

(B) Route of administration; and

(C) Dosage range.))

(c) Any licensee who is licensed pursuant to (a) of this subsection for one or more of the medical use groups in WAC 246-235-120, Schedule A, also is authorized, subject to the provisions of (c) and (d) of this subsection to receive, possess and use for calibration and reference standards:

(i) Any radioactive material authorized for use ((in IND/NDA products)) under Group I, Group II, or Group III of WAC 246--235-120, Schedule A, with a half-life not longer than one hundred days, in amounts not to exceed 15 millicuries total;

(ii) Any radioactive material authorized for use ((in IND/NDA products)) under Group I, Group II, or Group III of WAC 246-235-120, Schedule A, with half-life greater than one hundred days in amounts not to exceed 200 microcuries total;

(iii) Technetium-99m in amounts not to exceed ((30)) 50 millicuries;

(iv) Any radioactive material excluding Radium-226, in amounts not to exceed ((three)) fifteen millicuries per sealed source (((except Cobalt-57, which may be possessed in amounts not to exceed 5.5 millicuries))), contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to WAC ((246-235-100(11))) 246-235-102, a specific license issued by the United States Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(d) Leak tests.

(i) Any licensee or registrant who possesses sealed sources as calibration or reference sources pursuant to (c) of this subsection shall cause each sealed source containing radioactive material, other than Hydrogen-3, with a half-life greater than thirty days in any form other than gas to be tested for leakage and/or contamination at intervals not to exceed six months. In the absence of a certificate from a transferor indicating that a test has been made within six months prior to the transfer, the sealed sources shall not be used until tested: Provided, however, That no leak tests are required when:

(A) The source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material;

(B) The sealed source is stored and is not being used: Provided, That a physical inventory of the source and wipe surveys of the storage area or storage container are conducted.

(ii) The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which contamination might be expected to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department.

(iii) If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee or registrant shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with chapters 246-235 and 246-221 WAC. A report shall be filed within five days of the test with the department describing the equipment involved, the test results, and the corrective action taken.

(e) Any licensee or registrant who possesses and uses calibration and reference sources pursuant to (c)(iv) of this subsection shall:

(i) Follow the radiation safety and handling instructions approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form; and

(ii) Conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include at a minimum the quantities and kinds of radioactive material, location of sources, name of person performing the inventory, and the date of the inventory.

(4) Human use of sealed sources. In addition to the requirements set forth in WAC 246-235-020, a specific license for human use of sealed sources will be issued only if the applicant or, if the application is made by an institution, the individual user:

(a) Has specialized training in the diagnostic or therapeutic use of the sealed source considered, or has experience equivalent to such training; and

(b) Is a physician.

(5) Use of sealed sources in industrial radiography. In addition to the requirements set forth in WAC 246-235-020, a specific license for use of sealed sources in industrial radiography will be issued if:

(a) The applicant will have an adequate program for training radiographers and radiographer's assistants and submits to the department a schedule or description of such program which specifies the:

(i) Initial training;

(ii) Periodic training;

(iii) On-the-job training;

(iv) Means to be used by the licensee to determine the radiographer's knowledge and understanding of and ability to comply with department regulations and licensing requirements, and the operating and emergency procedures of the applicant; and

(v) Means to be used by the licensee to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant;

(b) The applicant submits to the department and complies with satisfactory written operating and emergency procedures (described in WAC 246-243-140);

(c) The applicant will have a quarterly internal inspection system, to assure that license provisions, regulations, and the applicant's operating and emergency procedures are followed by radiographers and radiographer's assistants. Records of this management control program shall be maintained for two years;

(d) The applicant submits to the department a description of the applicant's overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;

(e) The applicant who desires to conduct leak tests has established adequate procedures to be followed in leak testing sealed sources for possible leakage and contamination and submits to the department a description of such procedures including:

(i) Instrumentation to be used;

(ii) Method of performing tests, e.g., points on equipment to be smeared and method of taking smear; and

(iii) Pertinent experience of the person who will perform the tests;

(f) The licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.

(6) Environmentally significant licensing actions. In addition to the requirements set forth in WAC 246-235-020, a specific license for any activity within the licensing authority of the department which the department determines will significantly affect the radiological quality of the human environment, including those specified in WAC 197-11-845(1) and 246-03-030 (1)(a)(ii) (i.e., licenses to operate low level waste burial facilities or licenses to operate or expand beyond the design capacity, mineral processing facilities or their tailings areas, whose products, or byproducts, have concentrations of naturally occurring radioactive material in excess of exempt concentrations as specified in WAC 246-232-130, Schedule C), will be issued if the following conditions are met:

(a) Environmental impact statement.

(i) The application for a license or license amendment (other than administrative amendments) is accompanied or preceded by a final environmental impact statement or final declaration of nonsignificance completed in accordance with the State Environmental Policy Act (SEPA) procedures and guidelines specified in chapters 197-11 and 246-03 WAC. For any uranium or thorium mill in operation on or before the effective date of this regulation for which an environmental impact statement has not been prepared previously, an application for license renewal must be accompanied or preceded by a final environmental impact statement or final declaration of nonsignificance completed in accordance with SEPA guidelines.

Note: No construction shall be commenced until the license has been issued or unless an emergency exemption from SEPA requirements is granted in accordance with WAC 197-11-880. For the purposes of this subsection, the term "commencement of construction" means any clearing of land, excavation or other substantial action related to a proposed activity for specific licensing that would adversely affect the natural environment of a site; this term does not include changes desirable for the temporary use of the land for public recreational use, limited borings to determine site characteristics as necessary for environmental assessment, or other preconstruction monitoring to establish background information related to suitability of a site or to the protection of environmental values. In the case where an exemption is granted, the applicant shall assume all financial risk for construction activity; waive any claim of entitlement to the issuance of a license based solely upon the grant of the exemption or the commencement of construction pursuant thereto; and furnish, if the circumstances warrant and the department so requires, a financial surety arrangement to insure the protection of the public health, safety and the environment in the event of abandonment, default, or inability of the license applicant to meet the requirements of the act or these regulations.

(ii) In addition to the information required in chapter 197-11 WAC, the following additional areas shall be addressed in the final environmental impact statement:

(A) Alternative sites to those chosen by the applicant shall include all alternative sites, whether or not those sites are under the control or ownership of the applicant.

(B) Long term impacts shall include, but not be limited to, decommissioning, decontamination, reclamation impacts and material management associated with the proposed activities.

(C) Environmental reviews, dose assessments, ecology, construction effects on biota, impact on the environment from the use of chemicals, and socioeconomic effects shall be addressed.

(D) Alternative disposal sites and techniques for disposal shall be evaluated to determine if a site or technique is clearly superior.

(b) For uranium or thorium milling operations, a bond made payable to the department of health or other acceptable government agency, and in an amount specified by the department, shall be posted to ensure the protection of the public health and safety in the event of abandonment, default or other inability of the licensee to meet the requirements for reclamation and disposal of tailings and for decommissioning the site. The bond, or a copy thereof when the bond is made payable to another government agency, shall be received by the department prior to issuance of the license, or prior to license renewal for mills in operation on or before the effective date of this regulation. Other acceptable surety arrangements in addition to surety bonding include cash deposits, certificates of deposit, deposits of government securities, letters or lines of credit or combinations of the foregoing. The amount and mechanism of the surety arrangement may be reviewed by the department preceding each license renewal and adjustments may be required of the licensee prior to such renewal.

(c) The owner of the proposed uranium or thorium mill and tailings site(s) agrees to transfer or revert to the appropriate state or federal agency upon termination of the license, all lands, buildings and grounds, and any interest therein, necessary to fulfill the purposes of this subsection, except where the lands are held in trust for, or are owned by any Indian tribe. For any uranium or thorium mill in operation on or before the effective date of this regulation, such an agreement will be required prior to license renewal.

(d) For all uranium and thorium milling operations, the owner or operator shall arrange to pay to the department or its designee a fee in accordance with WAC 246-254-150 for a special security fund for the further maintenance, surveillance or care which may be required after a licensee has ceased to operate.

A minimum fund of two hundred fifty thousand dollars shall be provided by the licensee payable to the state. If a shortfall exists between the amount of money in the special security fund and the two hundred fifty thousand dollars minimum amount, a surety bond, or other acceptable surety instrument as defined above shall be arranged.

(e) The application for a license includes a description of an appropriate program for effluent monitoring, environmental monitoring and data reporting. Such description shall encompass locations, frequency, and types of sampling, analytical plans and procedures, minimum detection levels, sampling equipment and quality assurance programs.

(f) All licensees or registrants required to meet the additional requirements set forth in this subsection shall establish environmental monitoring programs adequate to determine the impact of their activity on the natural environment around the site of their environmentally significant activity. The established environmental and effluent monitoring program shall address all environmentally significant radionuclide releases and external radiation sources caused or threatened to be caused by the licensee's activities.

(i) Effluent and environmental monitoring results shall include the following minimum information as pertinent:

(A) Information as to flow rates, total volume of effluent, peak concentration, concentration of each radionuclide in the effluent averaged over a period of one year at the point where the effluent leaves a stack, tube, pipe, or similar conduit;

(B) A description of the properties of the effluents, including:

(I) Chemical composition;

(II) Physical characteristics, including suspended solids content in liquid effluents, and nature of gas aerosol for air effluents;

(III) The hydrogen ion concentrations (pH) of liquid effluents; and

(IV) The size range of particulates in effluent released into air;

(C) A description of the anticipated human occupancy in the unrestricted area where the highest concentration of radioactive material from the effluent is expected, and, in the case of a river stream a description of water uses downstream from the point of release of the effluent.

(D) Information as to the highest concentration of each radionuclide in an unrestricted area, including anticipated concentrations averaged over a period of one year:

(I) In air at any point of human occupancy; or

(II) In water at points of use downstream from the point of release of the effluent;

(E) The background concentration of radionuclides in the receiving river or stream prior to the release of liquid effluent;

(F) A description of the waste treatment facilities and procedures used to reduce the concentration of radionuclides in effluents prior to their release;

(G) A written description of sampling techniques and sample analysis methods;

(H) A written description of how all calculated results were obtained from sample analysis data. This explanation shall include example calculations and estimates of the precision and sensitivity of monitoring results;

(I) A written description of the licensee's quality control program including specification of control samples and standard samples used.

(ii) The licensee shall submit in writing to the department within sixty days after January 1 and July 1 of each year, reports specifying the quantities of each of the principle radionuclides released to unrestricted areas in liquid and in gaseous effluent during the previous six months of operations. This data shall be reported in a manner that will permit the department to confirm the potential annual radiation doses to the public. All data from the radiological and nonradiological environmental monitoring program will also be submitted for the same time period and frequency as specified above. The data shall be reported in a manner which will allow the department to confirm the potential annual radiation doses to the public.

(g) For land disposal of radioactive material, the provisions of chapter 246-250 WAC must also be met.

(h) For operation of mineral processing facilities, the provisions of chapter 246-252 WAC must also be met.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-080, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-080, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-22-070, filed 12/11/86; 83-19-050 (Order 2026), § 402-22-070, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-22-070, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-070, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-070.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-235-090  Special requirements for specific licenses of broad scope. This section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material ("broad licenses") and certain regulations governing holders of such licenses.*

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

(1) The different types of broad licenses are set forth below:

(a) A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

(b) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in WAC 246-235-140 Schedule B, for any authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in WAC 246-235-140 Schedule B, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in WAC 246-235-140 Schedule B, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(c) A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in WAC 246-235-140 Schedule B, for any authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in WAC 246-235-140 Schedule B, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in WAC 246-235-140 Schedule B, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(2) An application for a Type A specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020.

(b) The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

(c) The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(i) The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

(ii) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

(iii) The establishment of appropriate administrative procedures to assure:

(A) Control of procurement and use of radioactive material;

(B) Completion of safety evaluation of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(C) Review, approval, and recording by the radiation safety committee of safety evaluation of proposed uses prepared in accordance with item (2)(c)(iii)(B) of this section prior to use of the radioactive material.

(3) An application for a Type B specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020; and

(b) The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(i) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

(ii) The establishment of appropriate administrative procedures to assure:

(A) Control of procurement and use of radioactive material;

(B) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(C) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with item (3)(b)(ii)(B) of this section prior to use of the radioactive material.

(4) An application for a Type C specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020.

(b) The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of individuals, who have received:

(i) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

(ii) At least forty hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

(c) The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, recordkeeping, material control and accounting, and management review necessary to assure safe operations.

(5) Specific licenses of broad scope are subject to the following conditions:

(a) Unless specifically authorized by the department, persons licensed pursuant to this section shall not:

(i) Conduct tracer studies in the environment involving direct release of radioactive material;

(ii) Receive, acquire, own, possess, use or transfer devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;

(iii) Conduct activities for which a specific license issued by the department under WAC 246-235-080 or ((246-235-100)) 246-235-091 through 246-235-105 is required; or

(iv) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug or other product designed for ingestion or inhalation by, or application to, a human being.

(b) Each Type A specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

(c) Each Type B specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

(d) Each Type C specific license of broad scope issued under this part shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of subsection (4) of this section.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-090, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-090, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-090, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-073.]

NEW SECTION

WAC 246-235-091  Manufacture and distribution of industrial products containing depleted uranium under general license. (1) An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to WAC 246-233-010(4) or equivalent regulations of the United States Nuclear Regulatory Commission or an agreement state will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020;

(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in one year a radiation dose in excess of ten percent of the limits specified in WAC 246-221-010(1); and

(c) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

(2) In the case of an industrial product or device whose unique benefits are questionable, the department will approve an application for a specific license under this section only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

(3) The department may deny any application for a specific license under this section if the end use(s) of the industrial product or device cannot be reasonably foreseen.

(4) Each person licensed pursuant to subsection (1) of this section shall:

(a) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

(b) Label or mark each unit to:

(i) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(ii) State that the receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the United States Nuclear Regulatory Commission or of an agreement state;

(c) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted uranium";

(d) Furnish to each person to whom depleted uranium in a product or device is transferred for use pursuant to the general license contained in WAC 246-233-010(4) or its equivalent:

(i) A copy of the general license contained in WAC 246-233-010(4) and a copy of department Form RHF-20; or

(ii) A copy of the general license contained in the United States Nuclear Regulatory Commission's or agreement state's regulation equivalent to WAC 246-233-010(4) and a copy of the United States Nuclear Regulatory Commission's or agreement state's certificate, or alternatively, furnish a copy of the general license contained in WAC 246-233-010(4) and a copy of department Form RHF-20 with a note explaining that use of the product or device is regulated by the United States Nuclear Regulatory Commission or an agreement state under requirements substantially the same as those in WAC 246-233-010(4).

(e) Report to the department all transfers of industrial products or devices to persons for use under the general license in WAC 246-233-010(4). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under chapter 246-233 WAC during the reporting period, the report shall so indicate;

(f) Provide certain other reports as follows:

(i) Report to the United States Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the United States Nuclear Regulatory Commission general license in Section 40.25 of 10 CFR Part 40;

(ii) Report to the responsible department all transfers of devices manufactured and distributed pursuant to this section for use under a general license in that state's regulations equivalent to WAC 246-233-010(4);

(iii) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person;

(iv) If no transfers have been made to United States Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the United States Nuclear Regulatory Commission;

(v) If no transfers have been made to general licensees within a particular agreement state during the reporting period, this information shall be reported to the responsible department; and

(g) Keep records showing the name, address and point of contact for each general licensee to whom the person transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in WAC 246-233-010(4) or equivalent regulations of the United States Nuclear Regulatory Commission or of an agreement state. The records shall be maintained for a period of two years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.

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NEW SECTION

WAC 246-235-093  Manufacture, assembly or distribution of devices under general license. (1) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under WAC 246-233-020(4) or equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state will be approved if:

(a) The applicant satisfies the general requirements of WAC 246-235-020;

(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(i) The device can be safely operated by persons not having training in radiological protection;

(ii) Under ordinary conditions of handling, storage and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in one year a dose in excess of ten percent of the limits specified in the table in WAC 246-221-010(1); and

(iii) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

(c) Each device bears a durable, legible, clearly visible label or labels approved by the department, which contain in a clearly identified and separate statement:

(i) Instructions and precautions necessary to assure safe installation, operation and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(ii) The requirement, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(iii) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

(A) The receipt, possession, use and transfer of this device, Model . . . . . . ., Serial No . . . . . . .Note*, are subject to a general license or the equivalent, and the regulations of the United States Nuclear Regulatory Commission or a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

(B) The receipt, possession, use and transfer of this device, Model . . . . . ., Serial No. . . . . . . Note*, are subject to a general license or the equivalent, and the regulations of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

(2) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the department will consider information which includes, but is not limited to:

(a) Primary containment (source capsule);

(b) Protection of primary containment;

(c) Method of sealing containment;

(d) Containment construction materials;

(e) Form of contained radioactive material;

(f) Maximum temperature withstood during prototype tests;

(g) Maximum pressure withstood during prototype tests;

(h) Maximum quantity of contained radioactive material;

(i) Radiotoxicity of contained radioactive material; and

(j) Operating experience with identical devices or similarly designed and constructed devices.

(3) In the event the applicant desires that the general licensee under WAC 246-233-020(4), or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive in one year a radiation dose in excess of ten percent of the limits specified in the table in WAC 246-221-010(1).

(4) Each person licensed under subsection (1) of this section to distribute devices to generally licensed persons shall:

(a) Furnish a copy of the general license contained in WAC 246-233-020(4) to each person to whom the person directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in WAC 246-233-020(4);

(b) Furnish a copy of the general license contained in the United States Nuclear Regulatory Commission's, agreement state's, or licensing state's regulation equivalent to WAC 246-233-020(4), or alternatively, furnish a copy of the general license contained in WAC 246-233-020(4) to each person to whom, directly or through an intermediate person, is transferred radioactive material in a device for use pursuant to the general license of the United States Nuclear Regulatory Commission, the agreement state or the licensing state. If a copy of the general license in WAC 246-233-020(4) is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the United States Nuclear Regulatory Commission, agreement state or licensing state under requirements substantially the same as those in WAC 246-233-020(4);

(c) Report to the department all transfers of such devices to persons for use under the general license in WAC 246-233-020(4). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under WAC 246-233-020(4) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within thirty days thereafter.

(d) Reports to other departments.

(i) Report to the United States Nuclear Regulatory Commission all transfers of such devices to persons for use under the United States Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part 31.

(ii) Report to the responsible department all transfers of devices manufactured and distributed pursuant to this section for use under a general license in that state's regulations equivalent to WAC 246-233-020(4).

(iii) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within thirty days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.

(iv) If no transfers have been made to United States Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the United States Nuclear Regulatory Commission.

(v) If no transfers have been made to general licensees within a particular state during the reporting period, this information shall be reported to the responsible department upon request of the department.

(e) Keep records showing the name, address and the point of contact for each general licensee to whom the person directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in WAC 246-233-020(4), or equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of subsection (4) of this section.

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NEW SECTION

WAC 246-235-095  Manufacture, assembly, or distribution of luminous safety devices, certain calibration sources or ice detectors under general license. (1) Special requirements for the manufacture, assembly or repair of luminous safety devices for use in aircraft. An application for a specific license to manufacture, assemble or repair luminous safety devices containing tritium or promethium-147 for use in aircraft for distribution to persons generally licensed under WAC 246-233-020(5) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020; and

(b) The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.56, 32.101 of 10 CFR Part 32 or their equivalent.

(2) Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under WAC 246-233-020(7). An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under WAC 246-233-020(7) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirement of WAC 246-235-020; and

(b) The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.

(3) Licensing the manufacture and distribution of ice detection devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under WAC 246-233-020(9) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirements of WAC 246-235-020; and

(b) The criteria of Sections 32.61, 32.62, 32.103 of 10 CFR Part 32 are met.

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NEW SECTION

WAC 246-235-097  Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. An application for a specific license to manufacture or distribute radioactive material for use under the general license of WAC 246-233-020(8) will be approved if:

(1) The applicant satisfies the general requirements specified in WAC 246-235-020;

(2) The radioactive material is to be prepared for distribution in prepackaged units of:

(a) Iodine-125 in units not exceeding 10 microcuries each;

(b) Iodine-131 in units not exceeding 10 microcuries each;

(c) Carbon-14 in units not exceeding 10 microcuries each;

(d) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each;

(e) Iron-59 in units not exceeding 20 microcuries each;

(f) Cobalt-57 in units not exceeding 10 microcuries each;

(g) Selenium-75 in units not exceeding 10 microcuries each;

(h) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.

(3) Each prepackaged unit bears a durable, clearly visible label:

(a) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries of hydrogen-3 (tritium); 20 microcuries of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; and

(b) Displaying the radiation caution symbol described in WAC 246-221-120 (1)(a) and the words, "caution, radioactive material," and "Not for internal or external use in humans or animals."

(4) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(a) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

(b) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a licensing state.

(5) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in WAC 246-221-170 of these regulations.

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AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-235-100  ((Special requirements for a specific license to manufacture, assemble, repair, or distribute commodities, products, or devices which contain radioactive material.)) Manufacture, preparation, or commercial transfer of radiopharmaceuticals for medical use. (1) ((Licensing the introduction of radioactive material into products in exempt concentrations. In addition to the requirements set forth in WAC246-235-020, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under WAC 246-232-010 (2)(a) will be issued if:

(a) The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

(b) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in WAC 246-232-130, Schedule C, that reconstruction of the radioactive material in concentrations exceeding those in WAC 246-232-130, Schedule C, is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to a human being.

(c) Each person licensed under subsection (1) of this section shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product and material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to subsection (1) of this section during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within thirty days thereafter.

(2) Licensing the distribution of radioactive material in exempt quantities.*

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

(a) An application for a specific license to distribute naturally occurring and accelerator-produced radioactive material (NARM) to persons exempted from these regulations pursuant to WAC 246-232-010 (2)(b) will be approved if:

(i) The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or application to, a human being;

(ii) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(iii) The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

(b) The license issued under paragraph (2)(a) of this section is subject to the following conditions:

(i) No more than ten exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

(ii) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to WAC 246-232-010 (2)(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

(A) Identifies the radionuclide and the quantity of radioactivity; and

(B) Bears the words "radioactive material."

(iv) In addition to the labeling information required by item (2)(b)(iii) of this section, the label affixed to the immediate container, or an accompanying brochure, shall:

(A) State that the contents are exempt from licensing state requirements;

(B) Bear the words "Radioactive material--Not for human use--Introduction into foods, beverages, cosmetics, drugs, or medicinals, or into products manufactured for commercial distribution is prohibited--Exempt quantities should not be combined"; and

(C) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

(c) Each person licensed under paragraph (2)(a) of this section shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under WAC 246-232-010 (2)(b) or the equivalent regulations of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the department. Each report shall cover the year ending June 30, and shall be filed within thirty days thereafter. If no transfers of radioactive material have been made pursuant to subsection (2) of this section during the reporting period, the report shall so indicate.

(3) Licensing the incorporation of naturally occurring and accelerator-produced radioactive material into gas and aerosol detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under WAC 246-232-010 (2)(c)(iii) will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32.

(4) Licensing the manufacture and distribution of devices to person generally licensed under WAC 246-233-020(4).

(a) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under WAC 246-233-020(4) or equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state will be approved if:

(i) The applicant satisfies the general requirements of WAC 246-235-020;

(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(A) The device can be safely operated by persons not having training in radiological protection;

(B) Under ordinary conditions of handling, storage and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of ten percent of the limits specified in the table in WAC 246-221-010(1); and

(C) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

(iii) Each device bears a durable, legible, clearly visible label or labels approved by the department, which contain in a clearly identified and separate statement:

(A) Instructions and precautions necessary to assure safe installation, operation and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(B) The requirement, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and

(C) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

(aa) The receipt, possession, use and transfer of this device, Model . . . . . . ., Serial No . . . . . . . Note*, are subject to a general license or the equivalent, and the regulations of the United States Nuclear Regulatory Commission or a state with which the United States Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

(bb) The receipt, possession, use and transfer of this device, Model . . . . . ., Serial No. . . . . . . Note*, are subject to a general license or the equivalent, and the regulations of a licensing state. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

(b) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the department will consider information which includes, but is not limited to:

(i) Primary containment (source capsule);

(ii) Protection of primary containment;

(iii) Method of sealing containment;

(iv) Containment construction materials;

(v) Form of contained radioactive material;

(vi) Maximum temperature withstood during prototype tests;

(vii) Maximum pressure withstood during prototype tests;

(viii) Maximum quantity of contained radioactive material;

(ix) Radiotoxicity of contained radioactive material; and

(x) Operating experience with identical devices or similarly designed and constructed devices.

(c) In the event the applicant desires that the general licensee under WAC 246-233-020(4), or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of ten percent of the limits specified in the table in WAC 246-221-010(1).

(d) Each person licensed under paragraph (4)(a) of this section to distribute devices to generally licensed persons shall:

(i) Furnish a copy of the general license contained in WAC 246-233-020(4) to each person to whom the person directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in WAC 246-233-020(4);

(ii) Furnish a copy of the general license contained in the United States Nuclear Regulatory Commission's, agreement state's, or licensing state's regulation equivalent to WAC 246-233-020(4), or alternatively, furnish a copy of the general license contained in WAC 246-233-020(4) to each person to whom, directly or through an intermediate person, is transferred radioactive material in a device for use pursuant to the general license of the United States Nuclear Regulatory Commission, the agreement state or the licensing state. If a copy of the general license in WAC 246-233-020(4) is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the United States Nuclear Regulatory Commission, agreement state or licensing state under requirements substantially the same as those in WAC 246-233-020(4);

(iii) Report to the department all transfers of such devices to persons for use under the general license in WAC 246-233-020(4). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under WAC 246-233-020(4) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within thirty days thereafter.

(iv) Reports to other departments.

(A) Report to the United States Nuclear Regulatory Commission all transfers of such devices to persons for use under the United States Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part 31.

(B) Report to the responsible department all transfers of devices manufactured and distributed pursuant to subsection (4) of this section for use under a general license in that state's regulations equivalent to WAC 246-233-020(4).

(C) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within thirty days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.

(D) If no transfers have been made to United States Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the United States Nuclear Regulatory Commission.

(E) If no transfers have been made to general licensees within a particular state during the reporting period, this information shall be reported to the responsible department upon request of the department.

(v) Keep records showing the name, address and the point of contact for each general licensee to whom the person directly or through an intermediate person transfers radioactive material in devices for use pursuant to the general license provided in WAC 246-233-020(4), or equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state. The records shall show the date of each transfer, the radionuclide and the quantity of radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of paragraph (4)(d) of this section.

(5) Special requirements for the manufacture, assembly or repair of luminous safety devices for use in aircraft. An application for a specific license to manufacture, assemble or repair luminous safety devices containing tritium or promethium-147 for use in aircraft for distribution to persons generally licensed under WAC 246-233-020(5) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020; and

(b) The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, 32.56, 32.101 of 10 CFR Part 32 or their equivalent.

(6) Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226 for distribution to persons generally licensed under WAC 246-233-020(7). An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under WAC 246-233-020(7) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirement of WAC 246-235-020; and

(b) The applicant satisfies the requirements of Sections 32.57, 32.58, 32.59, 32.102 of 10 CFR Part 32 and Section 70.39 of 10 CFR Part 70 or their equivalent.

(7) Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. An application for a specific license to manufacture or distribute radioactive material for use under the general license of WAC 246-233-020(8) will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020;

(b) The radioactive material is to be prepared for distribution in prepackaged units of:

(i) Iodine-125 in units not exceeding 10 microcuries each;

(ii) Iodine-131 in units not exceeding 10 microcuries each;

(iii) Carbon-14 in units not exceeding 10 microcuries each;

(iv) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each;

(v) Iron-59 in units not exceeding 20 microcuries each;

(vi) Cobalt-57 in units not exceeding 10 microcuries each;

(vii) Selenium-75 in units not exceeding 10 microcuries each;

(viii) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.

(c) Each prepackaged unit bears a durable, clearly visible label:

(i) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries of hydrogen-3 (tritium); 20 microcuries of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; and

(ii) Displaying the radiation caution symbol described in WAC 246-221-120 (1)(a) and the words, "caution, radioactive material," and "Not for internal or external use in humans or animals."

(d) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(i) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

(ii) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a licensing state.

(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in WAC 246-221-170 of these regulations.

(8) Licensing the manufacture and distribution of ice detection devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under WAC 246-233-020(9) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirements of WAC 246-235-020; and

(b) The criteria of Sections 32.61, 32.62, 32.103 of 10 CFR Part 32 are met.

(9) Manufacture and distribution of radiopharmaceuticals containing radioactive material for medical use under group licenses.))An application for a specific license to manufacture and ((distribute)), prepare, or transfer for commercial distribution radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to WAC 246-235-080 (1), (2), or (3) for ((the uses listed in Group I, Group II, Group IV, or Group V of WAC 246-235-120, Schedule A,)) medical use in humans will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020 of this part;

(b) The applicant submits evidence that:

(i) ((The radiopharmaceutical containing radioactive material will be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the United States Food and Drug Administration (FDA), a biologic product license issued by FDA or a "notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA; or

(ii) The manufacture, compounding and distribution of the radiopharmaceutical containing radioactive material is not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;)) The applicant is registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer; or

(ii) The applicant is licensed as a nuclear pharmacy by the state board of pharmacy;

(c) The applicant submits information on the radionuclide, chemical and physical form, ((packaging including)) maximum activity per ((package)) vial, syringe, generator, or other container of the radiopharmaceutical, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by ((group)) medical use licensees; and

(d) ((The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity and date of assay, and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the department for distribution to persons licensed pursuant to WAC 246-235-080(3) and 246-235-120 Schedule A, Group I, Group II, Group IV, and Group V, as appropriate, or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state.)) The applicant satisfies the labeling requirements specified by the state board of pharmacy in WAC 246-903-020. For a drug manufacturer, the labels((, leaflets or brochures)) required by this subsection (((9) of this section)) are in addition to the labeling required by the Food and Drug Administration (FDA) and ((they)) may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

(((10) Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing radioactive material. An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to WAC 246-235-080(3) for the uses listed in Group III of WAC 246-235-120, Schedule A will be approved if:

(a) The applicant satisfies the general requirements specified in WAC 246-235-020;

(b) The applicant submits evidence that:

(i) The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), a biologic product license issued by FDA, or a "Notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA; or

(ii) The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;

(c) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;

(d) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and

(e) The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit; contains:

(i) Adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit; and

(ii) A statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the department pursuant to WAC 246-235-080(3) and Group III of WAC 246-235-120, Schedule A, or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state. The labels, leaflets or brochures required by subsection (10) of this section are in addition to the labeling required by FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

Note: Although the department does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have reagent kits approved by the department for use by persons licensed pursuant to WAC 246-235-080(3) and Group III of WAC 246-235-120 Schedule A may submit the pertinent information specified in subsection (10) of this section.

(11) Manufacture and distribution of sources or devices containing radioactive material for medical use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to WAC 246-235-080(3) for use as a calibration or reference source or for the uses listed in Group VI of WAC 246-235-120 Schedule A of this part will be approved if:

(a) The applicant satisfies the general requirements in WAC 246-235-020 of this part;

(b) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(i) The radioactive material contained, its chemical and physical form and amount;

(ii) Details of design and construction of the source or device;

(iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(iv) For devices containing radioactive material, the radiation profile of a prototype device;

(v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(vi) Procedures and standards for calibrating sources and devices;

(vii) Legend and methods for labeling sources and devices as to their radioactive content; and

(viii) Instructions for handling and storing the source or device from the radiation safety standpoint, these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: Provided, That instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.

(c) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the named source or device is licensed by the department for distribution to persons licensed pursuant to WAC 246-235-080(3) and Group VI of WAC 246-235-120 Schedule A or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state: Provided, That such labeling for sources which do not require long term storage (e.g., gold-198 seeds) may be on a leaflet or brochure which accompanies the source.

(d) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(e) In determining the acceptable interval for test of leakage of radioactive material, the department will consider information that includes, but is not limited to:

(i) Primary containment (source capsule);

(ii) Protection of primary containment;

(iii) Method of sealing containment;

(iv) Containment construction materials;

(v) Form of contained radioactive material;

(vi) Maximum temperature withstood during prototype tests;

(vii) Maximum pressure withstood during prototype tests;

(viii) Maximum quantity of contained radioactive material;

(ix) Radiotoxicity of contained radioactive material; and

(x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

(12) Requirements for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications.

(a) An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to WAC 246-233-010(4) or equivalent regulations of the United States Nuclear Regulatory Commission or an agreement state will be approved if:

(i) The applicant satisfies the general requirements specified in WAC 246-235-020;

(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one calendar quarter a radiation dose in excess of ten percent of the limits specified in WAC 246-221-010(1); and

(iii) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

(b) In the case of an industrial product or device whose unique benefits are questionable, the department will approve an application for a specific license under subsection (12) of this section only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

(c) The department may deny any application for a specific license under subsection (12) of this section if the end use(s) of the industrial product or device cannot be reasonably foreseen.

(d) Each person licensed pursuant to paragraph (12)(a) of this section shall:

(i) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

(ii) Label or mark each unit to:

(A) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(B) State that the receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the United States Nuclear Regulatory Commission or of an agreement state;

(iii) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted uranium";

(iv) Furnish to each person to whom depleted uranium in a product or device is transferred for use pursuant to the general license contained in WAC 246-233-010(4) or its equivalent:

(A) A copy of the general license contained in WAC 246-233-010(4) and a copy of department Form RHF-20; or

(B) A copy of the general license contained in the United States Nuclear Regulatory Commission's or agreement state's regulation equivalent to WAC 246-233-010(4) and a copy of the United States Nuclear Regulatory Commission's or agreement state's certificate, or alternatively, furnish a copy of the general license contained in WAC 246-233-010(4) and a copy of department Form RHF-20 with a note explaining that use of the product or device is regulated by the United States Nuclear Regulatory Commission or an agreement state under requirements substantially the same as those in WAC 246-233-010(4).

(v) Report to the department all transfers of industrial products or devices to persons for use under the general license in WAC 246-233-010(4). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under chapter 246-233 WAC during the reporting period, the report shall so indicate;

(vi) Provide certain other reports as follows:

(A) Report to the United States Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the United States Nuclear Regulatory Commission general license in Section 40.25 of 10 CFR Part 40;

(B) Report to the responsible department all transfers of devices manufactured and distributed pursuant to subsection (12) of this section for use under a general license in that state's regulations equivalent to WAC 246-233-010(4);

(C) Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person;

(D) If no transfers have been made to United States Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the United States Nuclear Regulatory Commission;

(E) If no transfers have been made to general licensees within a particular agreement state during the reporting period, this information shall be reported to the responsible department; and

(vii) Keep records showing the name, address and point of contact for each general licensee to whom the person transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in WAC 246-233-010(4) or equivalent regulations of the United States Nuclear Regulatory Commission or of an agreement state. The records shall be maintained for a period of two years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this section.)) (2) A nuclear pharmacy licensee:

(a) May prepare radiopharmaceuticals for medical use provided the radiopharmaceutical is prepared by or under the supervision of an authorized nuclear pharmacist.

(b) May allow a pharmacist to work as an authorized nuclear pharmacist if this individual meets the state board of pharmacy requirements in WAC 246-903-030, Nuclear pharmacists.

(c) Shall provide to the department a copy of each individual's letter of notification from the state board of pharmacy recognizing the individual as a nuclear pharmacist, no later than thirty days after the date the licensee allows the individual to work as an authorized nuclear pharmacist pursuant to (b) of this subsection.

(3) A manufacturer or nuclear pharmacy licensee shall possess and use instrumentation to measure the radioactivity of radiopharmaceuticals. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radiopharmaceuticals, prior to transfer for commercial distribution. In addition, the licensee shall:

(a) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(b) Check each instrument for constancy and proper operation at the beginning of each day of use.

(4) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radiopharmaceuticals.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-100, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-100, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-22-110, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-110, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-076.]

NEW SECTION

WAC 246-235-102  Manufacture and distribution of sources or devices containing radioactive material for medical use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to WAC 246-235-080(3) for use as a calibration or reference source or for the uses listed in Group VI of WAC 246-235-120 Schedule A of this part will be approved if:

(1) The applicant satisfies the general requirements in WAC 246-235-020 of this part;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form and amount;

(b) Details of design and construction of the source or device;

(c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(d) For devices containing radioactive material, the radiation profile of a prototype device;

(e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(f) Procedures and standards for calibrating sources and devices;

(g) Legend and methods for labeling sources and devices as to their radioactive content; and

(h) Instructions for handling and storing the source or device from the radiation safety standpoint, these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: Provided, That instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the named source or device is licensed by the department for distribution to persons licensed pursuant to WAC 246-235-080(3) and Group VI of WAC 246-235-120 Schedule A or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state: Provided, That such labeling for sources which do not require long term storage (e.g., gold-198 seeds) may be on a leaflet or brochure which accompanies the source.

(4) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(5) In determining the acceptable interval for test of leakage of radioactive material, the department will consider information that includes, but is not limited to:

(a) Primary containment (source capsule);

(b) Protection of primary containment;

(c) Method of sealing containment;

(d) Containment construction materials;

(e) Form of contained radioactive material;

(f) Maximum temperature withstood during prototype tests;

(g) Maximum pressure withstood during prototype tests;

(h) Maximum quantity of contained radioactive material;

(i) Radiotoxicity of contained radioactive material; and

(j) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

[]

NEW SECTION

WAC 246-235-105  Manufacture, assembly or distribution of radioactive material exempt from regulation. (1) Licensing the introduction of radioactive material into products in exempt concentrations. In addition to the requirements set forth in WAC 246-235-020, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under WAC 246-232-010 (2)(a) will be issued if:

(a) The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

(b) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in WAC 246-232-130, Schedule C, that reconstruction of the radioactive material in concentrations exceeding those in WAC 246-232-130, Schedule C, is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to a human being.

(c) Each person licensed under subsection (1) of this section shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product and material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to subsection (1) of this section during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within thirty days thereafter.

(2) Licensing the distribution of certain radioactive material in exempt quantities.*

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

(a) An application for a specific license to distribute naturally occurring and accelerator-produced radioactive material (NARM) to persons exempted from these regulations pursuant to WAC 246-232-010 (2)(b) will be approved if:

(i) The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or application to, a human being;

(ii) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(iii) The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

(b) The license issued under paragraph (2)(a) of this section is subject to the following conditions:

(i) No more than ten exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

(ii) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to WAC 246-232-010 (2)(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

(A) Identifies the radionuclide and the quantity of radioactivity; and

(B) Bears the words "radioactive material."

(iv) In addition to the labeling information required by item (2)(b)(iii) of this section, the label affixed to the immediate container, or an accompanying brochure, shall:

(A) State that the contents are exempt from licensing state requirements;

(B) Bear the words "Radioactive material--Not for human use--Introduction into foods, beverages, cosmetics, drugs, or medicinals, or into products manufactured for commercial distribution is prohibited--Exempt quantities should not be combined"; and

(C) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

(c) Each person licensed under paragraph (2)(a) of this section shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under WAC 246-232-010 (2)(b) or the equivalent regulations of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the department. Each report shall cover the year ending June 30, and shall be filed within thirty days thereafter. If no transfers of radioactive material have been made pursuant to subsection (2) of this section during the reporting period, the report shall so indicate.

(3) Licensing the incorporation of naturally occurring and accelerator-produced radioactive material into gas and aerosol detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under WAC 246-232-010 (2)(c)(iii) will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32.

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AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-235-120  Schedule A groups of medical uses of radioactive material (ref. WAC 246-235-080(3) and 246-235-100(9)). (1) Group I. Use of prepared radiopharmaceuticals for certain diagnostic studies involving measurements of uptake, dilution and excretion. This group does not include imaging or localization studies.

(a) Any radioactive material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution or excretion ((for which a "Notice of claimed investigational exemption for a new drug" (IND) has been accepted by the Food and Drug Administration (FDA) or for which a "New drug application" (NDA) is in effect)) obtained from a manufacturer or preparer licensed pursuant to WAC 246-235-100, 10 CFR 32.72 or equivalent regulation of an agreement state or licensing state; or prepared by an authorized nuclear pharmacist, a physician who is an authorized user for this group of medical uses, or an individual under the supervision of either as permitted by statute.

(b) The provisions of (a) of this subsection notwithstanding, no radioactive material in gaseous form or for use as an aerosol is permitted by this subsection except as specifically authorized in a license.

(2) Group II. Use of prepared radiopharmaceuticals for diagnostic imaging and localization studies.

(a) Any radioactive material in a radiopharmaceutical and for a diagnostic use involving imaging or localizing ((for which a "Notice of claimed investigational exemption for a new drug" (IND) has been accepted by the Food and Drug Administration (FDA) or for which a "New drug application" (NDA) is in effect)) obtained from a manufacturer or preparer licensed pursuant to WAC 246-235-100, 10 CFR 32.72 or equivalent regulation of an agreement state or licensing state; or prepared by an authorized nuclear pharmacist, a physician who is an authorized user for this group of medical uses, or an individual under the supervision of either as permitted by statute;

(b) The provisions of (a) of this subsection notwithstanding, no radioactive material in gaseous form or for use as an aerosol is permitted by this subsection except as specifically authorized by a license or subsection (3)(b) of this section.

(3) Group III. Use of generators and reagent kits for the preparation and use of radiopharmaceuticals containing radioactive material for diagnostic imaging and localization studies.

(a) Any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material ((for which generator or reagent kit a "Notice of claimed investigational exemption of a new drug" (IND) has been accepted by the Food and Drug Administration (FDA) or for which a "New drug application" (NDA) is in effect)) obtained from a manufacturer or preparer licensed pursuant to WAC 246-235-100, 10 CFR 32.72 or equivalent regulation of an agreement state or licensing state; or prepared by an authorized nuclear pharmacist, a physician who is an authorized user for this group of medical uses, or an individual under the supervision of either as permitted by statute.

(b) The provisions of (a) of this subsection notwithstanding, no generator or reagent kit is authorized for preparation of any gaseous form or aerosol of a radioactive material, except Technetium-99m as sodium pentetate as an aerosol for pulmonary function studies when used only with an approved and shielded delivery system, and disposed in accordance with applicable requirements, or as specifically authorized in a license.

(4) Group IV. Use of prepared radiopharmaceuticals for certain therapeutic uses that do not normally require hospitalization for purposes of radiation safety.

(a) Iodine-131 as iodide for treatment of hyperthyroidism and cardiac dysfunction;

(b) Phosphorus-32 as soluble phosphate for treatment of polycythemia vera, leukemia and bone metastases;

(c) Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of malignant effusions;

(d) Any radioactive material in a radiopharmaceutical and for a therapeutic use not normally requiring hospitalization for purposes of radiation safety ((for which a "Notice of claimed investigational exemption for a new drug" (IND) has been accepted by the Food and Drug Administration (FDA) or for which a "New drug application" (NDA) is in effect)) obtained from a manufacturer or preparer licensed pursuant to WAC 246-235-100, 10 CFR 32.72 or equivalent regulation of an agreement state or licensing state; or prepared by an authorized nuclear pharmacist, a physician who is an authorized user for this group of medical uses, or an individual under the supervision of either as permitted by statute.

(5) Group V. Use of prepared radiopharmaceuticals for certain therapeutic uses that normally require hospitalization for purposes of radiation safety.

(a) Gold-198 as colloid for intracavitary treatment of malignant effusions;

(b) Iodine-131 as iodide for treatment of thyroid carcinoma;

(c) Any radioactive material in a radiopharmaceutical and for a therapeutic use normally requiring hospitalization for radiation safety reasons ((for which a "Notice of claimed investigational exemption for a new drug" (IND) has been accepted by the Food and Drug Administration (FDA) or for which a "New drug application" (NDA) is in effect)) obtained from a manufacturer or preparer licensed pursuant to WAC 246-235-100, 10 CFR 32.72 or equivalent regulation of an agreement state or licensing state; or prepared by an authorized nuclear pharmacist, a physician who is an authorized user for this group of medical uses, or an individual under the supervision of either as permitted by statute.

(6) Group VI. Use of sources and devices containing radioactive material for certain medical uses.

(a) Americium-241 as a sealed source in a device for bone mineral analysis;

(b) Cesium-137 encased in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

(c) Cobalt-60 encased in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer;

(d) Gold-198 as seeds for interstitial treatment of cancer;

(e) Iodine-125 as a sealed source in a device for bone mineral analysis;

(f) Gadolinium-153 as a sealed source in a device for bone mineral analysis;

(g) Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer;

(h) Strontium-90 sealed in an applicator for treatment of superficial eye conditions; and

(i) Iodine-125 as seeds for interstitial treatment of cancer.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-120, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-120, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-22-200, filed 12/11/86. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-22-200, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-200, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-260.]

AMENDATORY SECTION (Amending Order 245, filed 2/21/92, effective 3/23/92)

WAC 246-239-010  Definitions. (1) "Authorized nuclear pharmacist" means a pharmacist who is identified as an authorized nuclear pharmacist on a department license that authorizes the use of radioactive material in the practice of nuclear pharmacy.

(2) "Authorized user" means a physician who is identified as an authorized user on a department, U.S. Nuclear Regulatory Commission or agreement state license that authorizes the medical use of radioactive material.

(3) "Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

(((2))) (4) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(5) "Nuclear medicine" means the intentional internal or external administration of unsealed radioactive material to human beings.

(((3))) (6) "Nuclear medicine technologist" means any individual who performs nuclear medical procedures under the supervision of a physician licensed pursuant to chapter 246-235 WAC.

(((4))) (7) "Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:

(a) In a written directive; or

(b) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

(((5))) (8) "Radiopharmaceutical misadministration" means the administration of:

(a) A radiopharmaceutical dosage greater than 30 microcuries of sodium iodide I-125 or I-131:

(i) Involving the wrong ((patient)) individual or wrong radiopharmaceutical; or

(ii) When both the administered dosage differs from the prescribed dosage by more than twenty percent of the prescribed dosage, and the difference between the administered dosage and prescribed dosage exceeds 30 microcuries;

(b) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:

(i) Involving the wrong ((patient)) individual, wrong radiopharmaceutical, or wrong route of administration; or

(ii) When the administered dosage differs from the prescribed dosage by more than twenty percent of the prescribed dosage;

(c) A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries of sodium iodide I-125 or I-131, both:

(i) Involving the wrong ((patient)) individual, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage; and

(ii) When the dose to the ((patient)) individual exceeds 5 rems effective dose equivalent or 50 rems dose equivalent to any individual organ.

(((6))) (9) "Recordable event" means the administration of:

(a) A radiopharmaceutical without a written directive where a written directive is required;

(b) A radiopharmaceutical where a written directive is required without daily recording of each administered radiopharmaceutical dosage in the appropriate record;

(c) A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I-125 or I-131 when both:

(i) The administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage; and

(ii) The difference between the administered dosage and prescribed dosage exceeds 15 microcuries;

(d) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage.

(10) "Training" means instruction or experience acquired under the direct supervision of a physician, a certified/registered nuclear medicine technologist, and/or a qualified expert who has the necessary knowledge and training to advise personnel on radiation protection.

(((7))) (11) "Written directive" means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical, containing the following information:

(a) For any administration of quantities greater than 30 microcuries of sodium iodide I-125 or I-131: The dosage;

(b) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: The radiopharmaceutical, dosage, and route of administration.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 92-06-008 (Order 245), § 246-239-010, filed 2/21/92, effective 3/23/92; 91-15-112 (Order 184), § 246-239-010, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-239-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050 (Order 2026), § 402-34-030, filed 9/16/83.]

AMENDATORY SECTION (Amending WSR 94-06-017, filed 2/22/94, effective 3/25/94)

WAC 246-239-022  Policy and procedures for radiopharmaceutical administration. (1) Each licensee shall establish and maintain a written program to provide assurance that radioactive material or radiation from radioactive material will be administered as directed by the authorized user ordering the administration. The program must include written policies and procedures to meet the following specific objectives:

(a) That, prior to administration, a written directive is prepared for:

(i) Any administration of quantities greater than 30 microcuries of sodium iodide I-131; or

(ii) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I-131. A written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided the revision is dated and signed by the authorized user prior to the administration of the radiopharmaceutical or radiobiologic dosage. If a delay would jeopardize the patient's health, and the authorized user is not personally assaying and administering the dose, an oral directive or revision to an existing written directive will be acceptable, provided the oral revision is documented immediately in the patient's chart or record, and the revised written directive is signed by the authorized user within forty-eight hours of the oral revision;

Note: A written directive is not required when an authorized user personally assays and administers a dosage provided the pertinent facts are documented as otherwise required.

(b) That, prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive;

(c) That each administration is in accordance with the written directive; and

(d) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

(2) The licensee shall:

(a) Develop procedures for and conduct a review of the radiopharmaceutical administration program including, since the last review, an evaluation of:

(i) A representative sample of patient and human research subject administrations;

(ii) All recordable events; and

(iii) All misadministrations to verify compliance with all aspects of the radiopharmaceutical administration program; these reviews shall be conducted at intervals no greater than twelve months;

(b) Evaluate each of these reviews to determine the effectiveness of the radiopharmaceutical administration program and, if required, make modifications to meet the objectives of subsection (1) of this section; and

(c) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.

(3) The licensee shall evaluate and respond, within thirty days after discovery of the recordable event, to each recordable event by:

(a) Assembling the relevant facts including the cause;

(b) Identifying what, if any, corrective action is required to prevent recurrence; and

(c) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.

(((3))) (4) The licensee shall retain:

(a) Each written directive (provided, however, that such written directive is not required if the dose is both personally assayed and administered by the authorized user); and

(b) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in subsection (1)(a) of this section, in an auditable form, for three years after the date of administration.

(((4))) (5) The licensee may make modifications to the program to increase the program's efficiency provided the program's effectiveness is not decreased.

[Statutory Authority: RCW 70.98.050. 94-06-017, § 246-239-022, filed 2/22/94, effective 3/25/94.]

AMENDATORY SECTION (Amending Order 245, filed 2/21/92, effective 3/23/92)

WAC 246-239-025  Notifications, records, and reports of radiopharmaceutical misadministrations. (1) The licensee shall notify the department by telephone at (206) 682-5327 no later than the next calendar day after the discovery of a radiopharmaceutical misadministration.

(2) The licensee also shall notify the referring physician and the ((patient or the patient's)) individual receiving the radiopharmaceutical misadministration (or the individual's responsible relative or guardian (((hereinafter referred to as "the patient"))) of the radiopharmaceutical misadministration not later than twenty-four hours after its discovery, unless the referring physician personally informs the licensee either that the physician will inform the ((patient)) individual or that, based on medical judgment, telling the ((patient)) individual would be harmful. The licensee is not required to notify the ((patient)) individual without first consulting the referring physician. If the referring physician or ((patient)) individual receiving the radiopharmaceutical misadministration cannot be reached within twenty-four hours, the licensee shall notify the ((patient)) individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the ((patient)) individual, including any necessary remedial care as a result of the radiopharmaceutical misadministration, because of any delay in notification.

(3) The licensee shall submit a written report to the department within fifteen days after discovery of the radiopharmaceutical misadministration. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the ((patient)) individual who received the radiopharmaceutical misadministration; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the ((patient)) individual, and if not, why not, and if ((the patient was notified)) there was notification, what information was provided ((to the patient)). The report shall not include the ((patient's)) individual's name or other ((identifying)) information that could lead to identification of the individual. To meet the requirements of this section, the notification of the individual receiving the radiopharmaceutical misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.

(4) If the ((patient)) individual was notified, the licensee shall also furnish, within fifteen days after discovery of the radiopharmaceutical misadministration, a written report to the ((patient)) individual by sending either:

(a) A copy of the report that was submitted to the department; or

(b) A brief description of both the radiopharmaceutical misadministration and the consequences, as they may affect the ((patient)) individual, and a statement informing the ((patient)) individual that the report submitted to the department can be obtained from the licensee.

(5) Each licensee shall retain a record of each radiopharmaceutical misadministration for five years. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the ((patient)) individual who received the radiopharmaceutical misadministration, and the ((patient's)) individual's referring physician, if applicable), the ((patient's)) individual's Social Security number or identification number if one has been assigned, a brief description of the radiopharmaceutical misadministration, why it occurred, the effect on the ((patient)) individual, ((what)) improvements ((are)) needed to prevent recurrence, and the actions taken to prevent recurrence.

(6) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, ((patients, or the patient's)) to individuals receiving radiopharmaceutical misadministrations, or to that individual's responsible relatives or guardians.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 92-06-008 (Order 245), § 246-239-025, filed 2/21/92, effective 3/23/92.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-239-040  Radiopharmaceuticals. (1) Radioactive material to be administered to humans shall be ((the subject of an FDA-approved "new drug application" (NDA) or an FDA-accepted "notice of claimed investigational exemption for a new drug" (IND), unless otherwise stated in the license)) obtained from a manufacturer or preparer licensed pursuant to WAC 246-235-100, 10 CFR 32.72 or equivalent regulation of an agreement state or licensing state; or prepared by an authorized nuclear pharmacist, a physician who is an authorized user for the radioactive material to be administered, or an individual under the supervision of either as permitted by statute.

(2) ((Any licensee using radioactive material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding:

(a) Chemical and physical form;

(b) Route of administration; and

(c) Dosage range.

(3) No licensee shall receive, possess, or use radioactive material as a radiopharmaceutical except when it has been:

(a) Manufactured in the form to be administered to the patient, and labeled, packaged, and distributed, in accordance with a specific license; or

(b) Prepared from reagent kits and/or radionuclide generators approved in accordance with WAC 246-235-080 (3)(b) and 246-235-100(10).

(4))) The provisions of this part notwithstanding:

(a) No radioactive material in gaseous form or for use as an aerosol is permitted except Technetium-99m pentetate used as an aerosol for lung function studies, or as specifically authorized by license condition. Radioactive aerosols must be administered with a closed, shielded system that either is vented to the outside atmosphere through an air exhaust or provides for collection and disposal of the aerosol; and

(b) No generator or reagent kit is authorized for preparation of any gaseous form or aerosol of the radioactive material, except as specifically authorized by license condition.

(((5))) (3) Radioactive material to be administered to humans shall be assayed for activity to determine the dose within ten percent accuracy of the prescribed dose prior to being administered to patients.

(a) In the absence of a certificate from a supplier which specifies the activity of each dose, the license shall establish written procedures for the personnel to perform assays to an accuracy of ten percent of the prescribed dose prior to being administered to patients.

(b) The licensee shall maintain for inspection by the department, records of the results of each assay performed to determine the activity of each dose administered to a patient. Records shall be maintained for two years following performance of each assay.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-239-040, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-239-040, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050 (Order 2026), § 402-34-100, filed 9/16/83.]

NEW SECTION

WAC 246-239-055  Release of individuals containing radiopharmaceuticals. (1) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).

(2) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include:

(a) Guidance on the interruption or discontinuation of breast-feeding; and

(b) Information on the consequences of failure to follow the guidance.

(3) The licensee shall maintain a record of the basis for authorizing the release of an individual, for three years after the date of release, if the total effective dose equivalent is calculated by:

(a) Using the retained activity rather than the activity administered;

(b) Using an occupancy factor less than 0.25 at 1 meter;

(c) Using the biological or effective half-life; or

(d) Considering the shielding by tissue.

(4) The licensee shall maintain a record, for three years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem).

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AMENDATORY SECTION (Amending Order 245, filed 2/21/92, effective 3/23/92)

WAC 246-240-010  Definitions. As used in this chapter, the following definitions apply:

(1) "Authorized user" means a physician who is identified as an authorized user on a department, U.S. Nuclear Regulatory Commission or agreement state license that authorizes the medical use of radioactive material.

(2) "Brachytherapy" means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

(((2))) (3) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(4) "Prescribed dose" means:

(a) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(b) For teletherapy, the total dose and dose per fraction as documented in the written directive; or

(c) For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.

(((3))) (5) "Recordable therapy event" means the administration of:

(a) Radiation without a written directive where a written directive is required;

(b) Radiation where a written directive is required without daily recording of each radiation dose in the appropriate record;

(c) A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by fifteen percent or more of the weekly prescribed dose; or

(d) A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than ten percent of the prescribed dose.

(6) "Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

(((4))) (7) "Therapy misadministration" means the administration of:

(a) A gamma stereotactic radiosurgery radiation dose:

(i) Involving the wrong ((patient)) individual or wrong treatment site; or

(ii) When the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

(b) A teletherapy radiation dose:

(i) Involving the wrong ((patient)) individual, wrong mode of treatment, or wrong treatment site;

(ii) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

(iii) When the calculated weekly administered dose ((is)) exceeds the weekly prescribed dose by thirty percent ((greater than)) or more of the weekly prescribed dose; or

(iv) When the calculated total administered dose differs from the total prescribed dose by more than twenty percent of the total prescribed dose;

(c) A brachytherapy radiation dose:

(i) Involving the wrong ((patient)) individual, wrong radioisotope, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site);

(ii) Involving a sealed source that is leaking;

(iii) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or

(iv) When the calculated administered dose to the treatment site differs from the prescribed dose by more than twenty percent of the prescribed dose.

(((5))) (8) "Written directive" means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of radiation, except as specified in (d) of this subsection, containing the following information:

(a) For gamma stereotactic radiosurgery: Target coordinates, collimator size, plug pattern, and total dose;

(b) For teletherapy: The total dose, dose per fraction, treatment site, and overall treatment period;

(c) For high-dose-rate remote after loading brachytherapy: The radioisotope, treatment site, and total dose; or

(d) For all other brachytherapy, (i) prior to implantation: The radioisotope, number of sources, and source strengths; and (ii) after implantation but prior to completion of the procedure: The radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

[Statutory Authority: RCW 70.98.050 and 70.98.080. 92-06-008 (Order 245), § 246-240-010, filed 2/21/92, effective 3/23/92.]

AMENDATORY SECTION (Amending WSR 95-01-108, filed 12/21/94, effective 1/21/95)

WAC 246-240-015  Policy and procedures for therapy administration. (1) Each licensee shall establish and maintain a written program to provide assurance that radioactive material or radiation from radioactive material will be administered as directed by the authorized user. The program must include written polices and procedures to meet the following specific objectives:

(a) That, prior to administration, a written directive is prepared for:

(i) Any teletherapy radiation dose;

(ii) Any gamma stereotactic radiosurgery radiation dose; or

(iii) Any brachytherapy radiation dose. A written revision to an existing written directive may be made for any therapeutic procedure provided the revision is dated and signed by the authorized user prior to the administration of radioactive material or radiation from radioactive material for that therapeutic use. If a delay would jeopardize the patient's health, and the authorized user is not personally present to administer the dose, an oral directive or oral revision to an existing written directive by the authorized user will be acceptable provided the oral directive or oral revision is documented immediately in the patient's chart or record, and the revised written directive is signed by the authorized user within forty-eight hours of the oral revision. Note: A written directive is not required when an authorized user personally assays and administers a dosage, provided the pertinent facts are documented as otherwise required;

(b) That, prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive;

(c) That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;

(d) That each administration is in accordance with the written directive; and

(e) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

(2) The licensee shall:

(a) Develop procedures for and conduct a review of the therapy administration program including, since the last review, an evaluation of:

(i) A representative sample of patient and human research subject administrations;

(ii) All recordable events; and

(iii) All therapy misadministrations to verify compliance with all aspects of the therapy administration program; these reviews shall be conducted at intervals no greater than twelve months;

(b) Evaluate each of these reviews to determine the effectiveness of the therapy administration program and, if required, make modifications to meet the objectives of subsection (1) of this section; and

(c) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.

(3) The licensee shall evaluate and respond, within thirty days after the discovery of the recordable therapy event, to each recordable therapy event by:

(a) Assembling the relevant facts including the cause;

(b) Identifying what, if any, corrective action is required to prevent recurrence; and

(c) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.

(((3))) (4) The licensee shall retain:

(a) Each written directive (provided, however, that such written directive is not required if the dose is both personally assayed and administered by the authorized user); and

(b) A record of each administered radiation dose where a written directive is required in subsection (1)(a) of this section, in an auditable form for three years after the date of the administration.

(((4))) (5) The licensee may make modifications to the program to increase the program's efficiency provided the program's effectiveness is not decreased.

[Statutory Authority: RCW 70.98.050. 95-01-108, § 246-240-015, filed 12/21/94, effective 1/21/95.]

AMENDATORY SECTION (Amending WSR 94-06-017, filed 2/22/94, effective 3/25/94)

WAC 246-240-020  Interstitial, intracavitary and superficial applications. (1) Accountability, storage, and handling.

(a) Except as otherwise specifically authorized by the department, each licensee shall provide accountability of sealed sources and shall keep a record of the issue and return of all sealed sources to their place of storage.

(b) Each licensee shall conduct a quarterly physical inventory to account for all sources and devices received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include the activities, radionuclide(s), and serial numbers of radioactive sources, location of sources and devices, the date of the inventory, and the initials or name of the person performing the inventory.

(c) Each licensee shall follow the radiation safety and handling instructions approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, device or permanent container thereof, or in the leaflet or brochure which accompanies the source or device, and maintain such instruction in a legible and conveniently available form.

(d) Each licensee shall assure that sealed therapy sources are not opened/breached, or physically modified while in the licensee's possession unless specifically authorized by license condition.

(2) Testing sealed sources for leakage and contamination.

(a) All sealed sources containing more than 100 microcuries (3.7 megabecquerels) of radioactive material with a half-life greater than thirty days, except Iridium-192 seeds encased in nylon ribbon, shall be tested for contamination and/or leakage at intervals not to exceed six months or at such other intervals as are approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state and described by the manufacturer on the label attached to the source, device, or permanent container thereof, or in the leaflet or brochure which accompanies the source or device. Each source or device shall be so tested prior to its first use unless the supplier furnishes a certificate that the source or device has been so tested within six months prior to the transfer.

(b) Leak tests shall be capable of detecting the presence of 0.005 microcurie (185 becquerels) of radioactive material on the test sample or in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 becquerels) per twenty-four hours. The test sample shall be taken from the source or from the surfaces of the device in which the source is permanently or semipermanently mounted or stored on which one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries or becquerels and maintained for inspection by the department.

(c) Any leak test conducted pursuant to (a) of this subsection which reveals the presence of 0.005 microcurie (185 becquerels) or more of removable contamination or in the case of radium, the escape of radon at the rate of 0.001 microcurie (37 becquerels) per twenty-four hours, shall be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the source from use and cause it to be decontaminated and repaired or to be disposed of in accordance with department regulations. A report shall be filed within five days of the test with the department, describing the equipment involved, the test results, and the corrective action taken.

(3) Radiation surveys.

(a) The maximum exposure rate radiation level at a distance of one meter from the patient in whom brachytherapy sources have been inserted shall be determined by measurement or calculation. This radiation level shall be entered on the patient's chart and other signs as required under subsection (4) of this section.

(b) The exposure rate radiation levels in the patient's room and the surrounding area shall be determined, recorded, and maintained for inspection by the department.

(c) The licensee shall assure that patients treated with Cobalt-60, Cesium-137, Iridium-192, Radium-226, or any other nonpermanent implants, including High Dose Rate (HDR), Medium Dose Rate (MDR), or Low Dose Rate (LDR) therapy systems used on an in-patient or out-patient basis, remain hospitalized until a source count and a radiation survey of the patient and the patient's room confirm that all implants have been removed and are accounted for immediately after removing the last source.

(((d) Patients administered any therapeutic radiopharmaceutical shall remain hospitalized until the residual activity is 30 millicuries (1110 megabecquerels) or less, or the measured dose rate from the unshielded patient is less than 5.0 millirem (50 microsieverts) per hour at a distance of one meter.))

(4) Signs and records.

(a) In addition to the requirements of WAC 246-221-120, the bed, cubicle, or room of the hospital brachytherapy patient shall be marked with a sign indicating the presence of brachytherapy sources. This sign shall incorporate the radiation symbol and specify the radionuclide, the activity, date, and the individual(s) to contact for radiation safety instructions.

(b) The following information shall be included for the duration of the patient's treatment in the patient's official hospital medical record/chart:

(i) The radionuclide administered, number of sources, activity in millicuries or becquerels and time and date of administration;

(ii) The exposure rate at one meter, the time the determination was made, and by whom;

(iii) The radiation symbol; and

(iv) The precautionary instructions necessary to assure that the exposure of individuals does not exceed that permitted under WAC 246-221-010.

(c) Information required by subsection (4)(b)(i) and (ii) of this section shall be retained for review by the department.

(d) A record of the survey conducted to confirm that all sources have been removed from a patient or human research subject prior to release shall be retained for three years. Each record shall include the date of the survey, the name of the patient or human research subject, the dose rate from the patient or human research subject expressed as millirem per hour and measured at one meter from the patient or human research subject, the survey instrument used, and the initials of the individual who made the survey.

[Statutory Authority: RCW 70.98.050. 94-06-017, § 246-240-020, filed 2/22/94, effective 3/25/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-240-020, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-240-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-32-020, filed 12/11/86; 83-19-050 (Order 2026), § 402-32-020, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-32-020, filed 12/8/80; Order 1084, § 402-32-020, filed 1/14/76; Order 1, § 402-32-020, filed 1/8/69; Rules (part), filed 10/26/66.]

NEW SECTION

WAC 246-240-025  Release of individuals containing permanent implants. (1) The licensee may authorize the release from its control of any individual who has permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).

(2) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem).

(3) The licensee shall maintain a record of the basis for authorizing the release of an individual, for three years after the date of release, if the total effective dose equivalent is calculated by:

(a) Using an occupancy factor less then 0.25 at 1 meter; or

(b) Considering the shielding by tissue.

[]

AMENDATORY SECTION (Amending Order 245, filed 2/21/92, effective 3/23/92)

WAC 246-240-050  Notifications, records, and reports of therapy misadministrations. (1) The licensee shall notify by telephone the division of radiation protection at (206) 682-5327 no later than the next calendar day after the discovery of a therapy misadministration.

(2) The licensee also shall notify the referring physician and the ((patient or the patient's)) individual receiving the therapy misadministration (or the individual's responsible relative or guardian (((hereinafter referred to as "the patient"))) of the therapy misadministration not later than twenty-four hours after its discovery, unless the referring physician personally informs the licensee either that the physician will inform the ((patient)) individual or that, based on medical judgment, telling the ((patient)) individual would be harmful. The licensee is not required to notify the ((patient)) individual without first consulting the referring physician. If the referring physician or ((patient)) the patient receiving the therapy misadministration cannot be reached within twenty-four hours, the licensee shall notify the ((patient)) individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the ((patient)) individual, including any necessary remedial care as a result of the therapy misadministration, because of any delay in notification.

(3) The licensee shall submit a written report to the department within fifteen days after discovery of the therapy misadministration. The written report must include the licensee's name; the prescribing physician's name; a brief description of the therapy misadministration; why it occurred; the effect on the ((patient)) individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the ((patient)) individual, and if not, why not, and if ((the patient was notified)) there was notification, what information was provided ((to the patient)). The report shall not include the ((patient's)) individual's name or other ((identifying)) information that could lead to identification of the individual. To meet the requirements of this section, the notification of the individual receiving the therapy misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.

(4) If the ((patient)) individual was notified, the licensee shall also furnish, within fifteen days after discovery of the therapy misadministration, a written report to the ((patient)) individual by sending either:

(a) A copy of the report that was submitted to the department; or

(b) A brief description of both the therapy misadministration and the consequences, as they may affect the ((patient)) individual, and a statement informing the ((patient)) individual that the report submitted to the department can be obtained from the licensee.

(5) Each licensee shall retain a record of each therapy misadministration for five years. The record must contain the names of all individuals involved (including the prescribing physician, allied health personnel, the ((patient)) individual who received the therapy misadministration, and ((the patient's)) that individual's referring physician), the ((patient's)) individual's Social Security number or identification number if one has been assigned, a brief description of the therapy misadministration, why it occurred, the effect on the ((patient)) individual, ((what)) improvements ((are)) needed to prevent recurrence, and the actions taken to prevent recurrence.

(6) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, ((patients, or the patient's)) to individual's receiving therapy misadministrations, or to that individual's responsible relatives or guardians.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 92-06-008 (Order 245), § 246-240-050, filed 2/21/92, effective 3/23/92.]

AMENDATORY SECTION (Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-244-240  Notification of incidents, abandonment, and lost sources. (1) Notification of incidents and sources lost in other than downhole logging operations shall be made in accordance with appropriate provisions of chapter 246-221 WAC.

(2) The licensee shall immediately notify the state of Washington division of radiation protection by telephone (((360/753-3468))) (206 682-5327) and subsequently within five days by confirmatory letter if:

(a) Licensed material has been lost in or near a fresh water aquifer; or

(b) A sealed source has been ruptured. This notice must designate the well or other location and describe the magnitude and extent of licensed materials, assess the consequences of the loss or rupture, and explain efforts planned or being taken to mitigate these consequences.

(3) Whenever a sealed source or device containing radioactive material is lodged downhole, the licensee shall:

(a) Monitor the surface for the presence of radioactive contamination with an appropriate radiation survey instrument (not the logging tool itself) during logging tool recovery operations; and

(b) Notify the department immediately by telephone if radioactive contamination is detected at the surface or if the source appears to be damaged.

(4) When it becomes apparent that efforts to recover the radioactive source will not be successful, the licensee shall:

(a) Advise the well operator or owner, as appropriate, of the regulations of the state of Washington regarding abandonment, and an appropriate method of abandonment. The licensee shall ensure that such abandonment procedures are implemented within thirty days after the sealed source has been classified as irretrievable. Such abandonment procedures shall include:

(i) Immobilization and sealing in place of the radioactive source with a cement plug;

(ii) The setting of a whipstock or deflection device; and

(iii) The mounting of a permanent identification plaque at the surface of the well, containing the appropriate information required by subsection (5) of this section;

(b) Immediately notify the department by telephone (((360/753-3468))) (206 682-5327), giving the circumstances of the loss, and request and receive approval of the proposed abandonment procedures; and

(c) File a written report with the department within thirty days of the abandonment, setting forth the following information:

(i) Date and time of occurrence and a brief description of attempts to recover the source;

(ii) A description of the radioactive source(s) involved, including radionuclide, quantity, make, model and serial number, and chemical and physical form;

(iii) Surface location and identification of well;

(iv) Results of efforts to immobilize and seal the source in place;

(v) Depth of the radioactive source in meters or feet;

(vi) Depth to the top of cement plug in meters or feet;

(vii) Depth of the well in meters or feet; and

(viii) Information contained on the permanent identification plaque.

(5) Whenever a sealed source containing radioactive material is not recovered and is abandoned downhole, the licensee shall provide a permanent plaque at least eighteen centimeters square for posting the well or well bore (see Appendix A). This plaque shall:

(a) Be constructed of long lasting material, such as stainless steel or monel; and

(b) Contain the following information permanently and conspicuously engraved on its face:

(i) The word "caution (or danger)";

(ii) The radiation symbol(s) with or without the conventional color requirement;

(iii) The date of abandonment (month/day/year);

(iv) The name of the well operator or well owner;

(v) The well name and well identification number(s) or other designation;

(vi) The sealed source(s) by radionuclide and quantity of activity (if more than one source is involved, information for each source shall be included);

(vii) The source depth and the depth to the top of the plug in meters or feet; and

(viii) An appropriate warning, depending on the specific circumstances of each abandonment.¹

(6) The department may, at its own discretion, impose such other requirements as it may deem necessary.

¹ An example of a suggested plaque is shown in Appendix A of this section. Appropriate warnings may include:

(a) "Do not drill below plug back depth";

(b) "Do not enlarge casing"; and/or

(c) "Do not reenter the hole before contacting the state of Washington division of radiation protection."

appendix a

Example of Plaque for Identifying Wells Containing Sealed Sources Containing Radioactive Material Abandoned Downhole