PERMANENT RULES
Effective Date of Rule: Thirty-one days after filing.
Purpose: To update the regulations for medical use of radioactive material. These changes are required for compatibility with the United States Nuclear Regulatory Commission (NRC) regulations, 10 C.F.R. 35 and RCW 70.98.050.
Citation of Existing Rules Affected by this Order: Repealing WAC 246-235-120, 246-239-001, 246-239-010, 246-239-020, 246-239-022, 246-239-025, 246-239-030, 246-239-035, 246-239-040, 246-239-050, 246-239-055, 246-239-060, 246-239-070, 246-239-080, 246-239-090, 246-239-100, 246-240-015, 246-240-020, 246-240-030, 246-240-040, and 246-240-050; and amending WAC 246-220-010, 246-221-001, 246-221-060, 246-221-130, 246-232-001, 246-232-014, 246-235-020, 246-235-080, 246-235-090, 246-235-100, 246-235-102, 246-235-110, 246-240-001, 246-240-010, and 246-240-025.
Statutory Authority for Adoption: RCW 70.98.050.
Adopted under notice filed as WSR 05-19-053 on September 15, 2005 and 05-24-115 on December 7, 2005.
Changes Other than Editing from Proposed to Adopted Version: The NRC noted an error in the cross references in WAC 246-240-219 (4)(b) and (5). For consistency with 71 FR 1926, the reference in both cases was changed from WAC 246-240-210 (2)(b)(vii)(D) and/or (E) to WAC 246-240-210 (2)(b)(vii)(C) and/or (D).
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 116, Amended 16, Repealed 21; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 116, Amended 16, Repealed 21.
Date Adopted: February 6, 2006.
Mary C. Selecky
Secretary
OTS-8021.3
AMENDATORY SECTION(Amending WSR 04-23-093, filed 11/17/04,
effective 12/18/04)
WAC 246-220-010
Definitions.
As used in these
regulations, these terms have the definitions set forth below.
Additional definitions used only in a certain part will be
found in that part.
(1) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.
(2) "Accelerator produced material" means any material made radioactive by exposing it in a particle accelerator.
(3) "Act" means Nuclear energy and radiation, chapter 70.98 RCW.
(4) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).
(5) "Adult" means an individual eighteen or more years of age.
(6) "Agreement state" means any state with which the United States Nuclear Regulatory Commission has entered into an effective agreement under section 274 b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).
(7) "Airborne radioactive material" means any radioactive material dispersed in the air in the form of particulates, dusts, fumes, mists, vapors, or gases.
(8) "Airborne radioactivity area" means a room,
enclosure, or operating area in which airborne radioactive
material exists in concentrations (a) in excess of the derived
air concentration (DAC) specified in WAC 246-221-290, Appendix
A, or (b) to ((such a)) the degree that an individual present
in the area without respiratory protective equipment could
exceed, during the hours an individual is present in a week,
an intake of 0.6 percent of the annual limit on intake (ALI)
or twelve DAC-hours.
(9) "Air purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
(10) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.
(11) "Annual limit on intake" (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in WAC 246-221-290.
(12) "Assigned protection factor" (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.
(13) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.
(14) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include sources of radiation from radioactive materials regulated by the department.
(15) "Becquerel" (Bq) means the SI unit of activity. One becquerel is equal to 1 disintegration or transformation per second (s-1).
(16) "Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.
(17) "Byproduct material" means: (a) Any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material, and (b) the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition.
(18) "Calendar quarter" means ((not less than)) at least
twelve ((consecutive weeks nor)) but no more than fourteen
consecutive weeks. The first calendar quarter of each year
((shall)) begins in January and subsequent calendar quarters
shall be ((so)) arranged ((such)) so that no day is included
in more than one calendar quarter and no day in any one year
is omitted from inclusion within a calendar quarter. ((No)) A
licensee or registrant ((shall)) may not change the method of
determining calendar quarters for purposes of these
regulations ((except at the beginning of a calendar year)).
(19) "Calibration" means the determination of (a) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (b) the strength of a source of radiation relative to a standard.
(20) "CFR" means Code of Federal Regulations.
(21) "Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: For Class D, Days, of less than ten days, for Class W, Weeks, from ten to one hundred days, and for Class Y, Years, of greater than one hundred days. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms. For "class of waste" see WAC 246-249-040.
(22) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
(23) "Committed dose equivalent" (HT,50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the fifty-year period following the intake.
(24) "Committed effective dose equivalent" (HE,50) is the
sum of the products of the weighting factors applicable to
each of the body organs or tissues that are irradiated and the
committed dose equivalent to each of these organs or tissues
(HE,50 = ((&Sgr;)) Sgr; wT,HT,50).
(25) "Constraint" or dose constraint means a value above which specified licensee actions are required.
(26) "Controlled area." See "Restricted area."
(27) "Curie" means a unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 x 1010 transformations per second (tps).
(28) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy, and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.
(29) "Deep dose equivalent" (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).
(30) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.
(31) "Department" means the Washington state department
of health, ((division)) office of radiation protection, which
has been designated as the state radiation control agency
under chapter 70.98 RCW.
(32) "Depleted uranium" means the source material uranium in which the isotope Uranium-235 is less than 0.711 percent by weight of the total uranium present. Depleted uranium does not include special nuclear material.
(33) "Derived air concentration" (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. For purposes of these regulations, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in WAC 246-221-290.
(34) "Derived air concentration-hour" (DAC-hour) means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).
(35) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).
(36) "Dose" is a generic term that means absorbed dose,
dose equivalent, effective dose equivalent, committed dose
equivalent, committed effective dose equivalent, total organ
dose equivalent, or total effective dose equivalent. For
purposes of these ((regulations)) rules, "radiation dose" is
an equivalent term.
(37) "Dose commitment" means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed fifty years.
(38) "Dose equivalent" (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.
(39) "Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.
(40) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.
(41) "dpm" means disintegrations per minute. See also "curie."
(42) "Effective dose equivalent" (HE) means the sum of the
products of the dose equivalent to each organ or tissue (HT)
and the weighting factor (wT) applicable to each of the body
organs or tissues that are irradiated (HE = ((&Sgr;)) Sgr; wTHT).
(43) "Embryo/fetus" means the developing human organism from conception until the time of birth.
(44) "Entrance or access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, without respect to their intended use.
(45) "Exposure" means (a) being exposed to ionizing radiation or to radioactive material, or (b) the quotient of &Dgr;Q by &Dgr;m where "&Dgr;Q" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "&Dgr;m" are completely stopped in air. The special unit of exposure is the roentgen (R) and the SI equivalent is the coulomb per kilogram. One roentgen is equal to 2.58 x 10-4 coulomb per kilogram of air.
(46) "Exposure rate" means the exposure per unit of time, such as roentgen per minute and milliroentgen per hour.
(47) "External dose" means that portion of the dose equivalent received from any source of radiation outside the body.
(48) "Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.
(49) "Filtering facepiece" (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.
(50) "Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.
(51) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.
(52) "Former United States Atomic Energy Commission (AEC) or United States Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.
(53) "Generally applicable environmental radiation standards" means standards issued by the United States Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
(54) "Gray" (Gy) means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule/kilogram (100 rad).
(55) "Healing arts" means the disciplines of medicine, dentistry, osteopathy, chiropractic, podiatry, and veterinary medicine.
(56) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.
(57) "High radiation area" means any area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in one hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates. For purposes of these regulations, rooms or areas in which diagnostic X-ray systems are used for healing arts purposes are not considered high radiation areas.
(58) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
(59) "Human use" means the intentional internal or external administration of radiation or radioactive material to human beings.
(60) "Immediate" or "immediately" means as soon as possible but no later than four hours after the initiating condition.
(61) "IND" means investigatory new drug for which an exemption has been claimed under the United States Food, Drug and Cosmetic Act (Title 21 CFR).
(62) "Individual" means any human being.
(63) "Individual monitoring" means the assessment of:
(a) Dose equivalent (i) by the use of individual monitoring devices or (ii) by the use of survey data; or
(b) Committed effective dose equivalent (i) by bioassay or (ii) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours.
(64) "Individual monitoring devices" (individual
monitoring equipment) means devices designed to be worn by a
single individual for the assessment of dose equivalent
((such)) e.g., as film badges, thermoluminescent dosimeters
(TLDs), pocket ionization chambers, and personal ("lapel") air
sampling devices.
(65) "Inspection" means an official examination or
observation by the department including but not limited to,
tests, surveys, and monitoring to determine compliance with
rules, ((regulations,)) orders, requirements and conditions of
the department.
(66) "Interlock" means a device arranged or connected
((such)) so that the occurrence of an event or condition is
required before a second event or condition can occur or
continue to occur.
(67) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.
(68) "Irretrievable source" means any sealed source containing licensed material which is pulled off or not connected to the wireline downhole and for which all reasonable effort at recovery, as determined by the department, has been expended.
(69) "Lens dose equivalent" (LDE) applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters (300 mg/cm2).
(70) "License" means a license issued by the department
((in accordance with the regulations adopted by the
department)).
(71) "Licensed material" means radioactive material received, possessed, used, transferred, or disposed under a general or specific license issued by the department.
(72) "Licensee" means any person who is licensed by the
department ((in accordance with)) under these ((regulations))
rules and the act.
(73) "Licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.
(74) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.
(75) "Lost or missing licensed material" means licensed material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
(76) "Member of the public" means an individual except when the individual is receiving an occupational dose.
(77) "Minor" means an individual less than eighteen years of age.
(78) "Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, radiation monitoring and radiation protection monitoring are equivalent terms.
(79) "NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include by-product, source, or special nuclear material. For the purpose of meeting the definition of a Licensing State by the Conference of Radiation Control Program Directors, Inc. (CRCPD), NARM refers only to discrete sources of NARM. Diffuse sources of NARM are excluded from consideration by the CRCPD for Licensing State designation purposes.
(80) "Natural radioactivity" means radioactivity of naturally occurring nuclides.
(81) "NDA" means a new drug application which has been submitted to the United States Food and Drug Administration.
(82) "Negative pressure respirator" (tight-fitting) means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.
(83) "Nonstochastic effect" means a health effect, the
severity of which varies with the dose and for which a
threshold is believed to exist. Radiation-induced cataract
formation is an example of a nonstochastic effect. For
purposes of these ((regulations)) rules, a "deterministic
effect" is an equivalent term.
(84) "Nuclear Regulatory Commission" (NRC) means the United States Nuclear Regulatory Commission or its duly authorized representatives.
(85) "Occupational dose" means the dose received by an
individual in the course of employment in which the
individual's assigned duties involve exposure to radiation or
to radioactive material from licensed and unlicensed sources
of radiation, whether in the possession of the licensee,
registrant, or other person. Occupational dose does not
include dose received: From background radiation, from any
medical administration the individual has received, from
exposure to individuals administered radioactive material and
released ((pursuant to)) under chapter((s 246-239 and))
246-240 WAC, from voluntary participation in medical research
programs, or as a member of the public.
(86) "Ore refineries" means all processors of a radioactive material ore.
(87) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV.
(88) "Permittee" means a person who has applied for, and received, a valid site use permit for use of the low-level waste disposal facility at Hanford, Washington.
(89) "Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent or agency of the foregoing, but shall not include federal government agencies.
(90) "Personal supervision" means supervision ((such
that)) where the supervisor is physically present at the
facility and in ((such)) sufficient proximity that contact can
be maintained and immediate assistance given as required.
(91) "Personnel monitoring equipment." See individual monitoring devices.
(92) "Pharmacist" means an individual licensed by this state to compound and dispense drugs, and poisons.
(93) "Physician" means ((an individual)) a medical doctor
or doctor of osteopathy licensed by this state to prescribe
and dispense drugs in the practice of medicine.
(94) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.
(95) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
(96) "Powered air-purifying respirator" (PAPR) means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
(97) "Practitioner" means an individual licensed by the state in the practice of a healing art (i.e., physician, dentist, podiatrist, chiropractor, etc.).
(98) "Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
(99) "Public dose" means the dose received by a member of
the public from exposure to sources of radiation under the
licensee's or registrant's control or to radiation or
radioactive material released by the licensee. Public dose
does not include occupational dose or doses received from
background radiation, from any medical administration the
individual has received, from exposure to individuals
administered radioactive material and released ((pursuant to))
under chapter((s 246-239 and)) 246-240 WAC, or from voluntary
participation in medical research programs.
(100) "Qualified expert" means an individual who has demonstrated to the satisfaction of the department he/she has the knowledge, training, and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs. The department reserves the right to recognize the qualifications of an individual in specific areas of radiation protection.
(101) "Qualitative fit test" (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.
(102) "Quality factor" (Q) means the modifying factor, listed in Tables I and II, that is used to derive dose equivalent from absorbed dose.
| TABLE I | ||
| QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES | ||
TYPE OF RADIATION |
Quality Factor (Q) |
Absorbed Dose
Equal to A Unit Dose Equivalenta |
| X, gamma, or beta
radiation and high-speed electrons |
1 | 1 |
| Alpha particles, multiple- charged particles, fission fragments and heavy particles of unknown charge |
20 | 0.05 |
| Neutrons of unknown energy | 10 | 0.1 |
| High-energy protons | 10 | 0.1 |
EQUIVALENT FOR MONOENERGETIC NEUTRONS Energy (MeV) (Q) Dose
Equivalentb (neutrons cm-2 rem-1) Dose
Equivalentb (neutrons cm-2 Sv-1) (103) "Quantitative fit test" (QNFT) means an assessment
of the adequacy of respirator fit by numerically measuring the
amount of leakage into the respirator. (104) "Quarter" means a period of time equal to
one-fourth of the year observed by the licensee, approximately
thirteen consecutive weeks, providing that the beginning of
the first quarter in a year coincides with the starting date
of the year and that no day is omitted or duplicated in
consecutive quarters. (105) "Rad" means the special unit of absorbed dose. One
rad equals one-hundredth of a joule per kilogram of material;
for example, if tissue is the material of interest, then 1 rad
equals 100 ergs per gram of tissue. One rad is equal to an
absorbed dose of 100 erg/gram or 0.01 joule/kilogram (0.01
gray). (106) "Radiation" means alpha particles, beta particles,
gamma rays, X rays, neutrons, high-speed electrons, high-speed
protons, and other particles capable of producing ions. For
purposes of these regulations, ionizing radiation is an
equivalent term. Radiation, as used in these regulations,
does not include magnetic fields or nonionizing radiation,
(( (107) "Radiation area" means any area, accessible to
individuals, in which radiation levels could result in an
individual receiving a dose equivalent in excess of 0.05 mSv
(0.005 rem) in one hour at thirty centimeters from the source
of radiation or from any surface that the radiation
penetrates. (108) "Radiation machine" means any device capable of
producing ionizing radiation except those devices with
radioactive materials as the only source of radiation. (109) "Radiation safety officer" means an individual who
has the knowledge and responsibility to apply appropriate
radiation protection regulations and has been assigned
(( (110) "Radiation source." See "Source of radiation." (111) "Radioactive material" means any material (solid,
liquid, or gas) which emits radiation spontaneously. (112) "Radioactive waste" means any radioactive material
which is no longer of use and intended for disposal or
treatment for the purposes of disposal. (113) "Radioactivity" means the transformation of
unstable atomic nuclei by the emission of radiation. (114) "Reference man" means a hypothetical aggregation of
human physical and physiological characteristics determined by
international consensus. These characteristics may be used by
researchers and public health workers to standardize results
of experiments and to relate biological insult to a common
base. (115) "Registrable item" means any radiation machine
except those exempted by RCW 70.98.180 or exempted by the
department (( (116) "Registrant" means any person who is registered by
the department or is legally obligated to register with the
department in accordance with these (( (117) "Registration" means registration with the
department in accordance with the regulations adopted by the
department. (118) "Regulations of the United States Department of
Transportation" means the regulations in 49 CFR Parts 170-189,
14 CFR Part 103, and 46 CFR Part 146. (119) "Rem" means the special unit of any of the
quantities expressed as dose equivalent. The dose equivalent
in rem is equal to the absorbed dose in rad multiplied by the
quality factor (1 rem = 0.01 Sv). (120) "Research and development" means: (a) Theoretical
analysis, exploration, or experimentation; or (b) the
extension of investigative findings and theories of a
scientific or technical nature into practical application for
experimental and demonstration purposes, including the
experimental production and testing of models, devices,
equipment, materials, and processes. Research and development
does not include the internal or external administration of
radiation or radioactive material to human beings. (121) "Respiratory protective equipment" means an
apparatus, such as a respirator, used to reduce an
individual's intake of airborne radioactive materials. (122) "Restricted area" means any area to which access is
limited by the licensee or registrant for purposes of
protecting individuals against undue risks from exposure to
radiation and radioactive material. "Restricted area"
(( (123) "Roentgen" (R) means the special unit of exposure. One roentgen equals 2.58 x 10-4 coulombs/kilogram of air. (124) "Sanitary sewerage" means a system of public sewers
for carrying off waste water and refuse, but excluding sewage
treatment facilities, septic tanks, and leach fields owned or
operated by the licensee or registrant. (125) "Sealed source" means any radioactive material that
is encased in a capsule designed to prevent leakage or the
escape of the radioactive material. (126) "Self-contained breathing apparatus" (SCBA) means
an atmosphere-supplying respirator for which the breathing air
source is designed to be carried by the user. (127) "Shallow dose equivalent" (Hs), which applies to the
external exposure of the skin of the whole body or the skin of
an extremity, means the dose equivalent at a tissue depth of
0.007 centimeter (7 mg/cm2). (128) "SI" means an abbreviation of the International
System of Units. (129) "Sievert" means the SI unit of any of the
quantities expressed as dose equivalent. The dose equivalent
in sievert is equal to the absorbed dose in gray multiplied by
the quality factor (1 Sv = 100 rem). (130) "Site area emergency" means events may occur, are
in progress, or have occurred that could lead to a significant
release of radioactive material and that could require a
response by offsite response organizations to protect persons
offsite. (131) "Site boundary" means that line beyond which the
land or property is not owned, leased, or otherwise controlled
by the licensee or registrant. (132) "Source container" means a device in which
radioactive material is transported or stored. (133) "Source material" means: (a) Uranium or thorium,
or any combination thereof, in any physical or chemical form,
or (b) ores which contain by weight one-twentieth of one
percent (0.05 percent) or more of (i) uranium, (ii) thorium,
or (iii) any combination thereof. Source material does not
include special nuclear material. (134) "Source material milling" means the extraction or
concentration of uranium or thorium from any ore processing
primarily for its source material content. (135) "Source of radiation" means any radioactive
material, or any device or equipment emitting or capable of
producing ionizing radiation. (136) "Special nuclear material" means: (a) Plutonium, uranium-233, uranium enriched in the
isotope 233 or in the isotope 235, and any other material that
the United States Nuclear Regulatory Commission, (( (b) Any material artificially enriched in any of the
foregoing, but does not include source material. (137) "Special nuclear material in quantities not
sufficient to form a critical mass" means uranium enriched in
the isotope U-235 in quantities not exceeding three hundred
fifty grams of contained U-235; Uranium-233 in quantities not
exceeding two hundred grams; Plutonium in quantities not
exceeding two hundred grams; or any combination of them in
accordance with the following formula: For each kind of
special nuclear material, determine the ratio between the
quantity of that special nuclear material and the quantity
specified above for the same kind of special nuclear material.
The sum of (( 350 200 200 (139) "Supplied-air respirator" (SAR) or "airline
respirator" means an atmosphere-supplying respirator for which
the source of breathing air is not designed to be carried by
the user. (140) "Survey" means an evaluation of the radiological
conditions and potential hazards incident to the production,
use, release, disposal, or presence of sources of radiation. When appropriate, (( (141) "Test" means (a) the process of verifying
compliance with an applicable regulation, or (b) a method for
determining the characteristics or condition of sources of
radiation or components thereof. (142) "These (( (143) "Tight-fitting facepiece" means a respiratory inlet
covering that forms a complete seal with the face. (144) "Total effective dose equivalent" (TEDE) means the
sum of the deep dose equivalent for external exposures and the
committed effective dose equivalent for internal exposures. (145) "Total organ dose equivalent" (TODE) means the sum
of the deep dose equivalent and the committed dose equivalent
to the organ or tissue receiving the highest dose. (146) "United States Department of Energy" means the
Department of Energy established by Public Law 95-91, August
4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent
that the department exercises functions formerly vested in the
United States Atomic Energy Commission, its chairman, members,
officers and components and transferred to the United States
Energy Research and Development Administration and to the
administrator thereof (( (147) "Unrefined and unprocessed ore" means ore in its
natural form prior to any processing, such as grinding,
roasting, beneficiating, or refining. (148) "Unrestricted area" (uncontrolled area) means any
area which is not a restricted area. Areas where the external
dose exceeds 2 mrem in any one hour or where the public dose,
taking into account occupancy factors, will exceed 100 mrem
total effective dose equivalent in any one year must be
restricted. (149) "User seal check" (fit check) means an action
conducted by the respirator user to determine if the
respirator is properly seated to the face. Examples include
negative pressure check, positive pressure check, irritant
smoke check, or isoamyl acetate check. (150) "Very high radiation area" means an area,
accessible to individuals, in which radiation levels from
radiation sources external to the body could result in an
individual receiving an absorbed dose in excess of 5 Gy (500
rad) in one hour at one meter from a source of radiation or
one meter from any surface that the radiation penetrates. (151) "Waste handling licensees" mean persons licensed to
receive and store radioactive wastes prior to disposal and/or
persons licensed to dispose of radioactive waste. (152) "Week" means seven consecutive days starting on
Sunday. (153) "Weighting factor" wT for an organ or tissue (T)
means the proportion of the risk of stochastic effects
resulting from irradiation of that organ or tissue to the
total risk of stochastic effects when the whole body is
irradiated uniformly. For calculating the effective dose
equivalent, the values of wT are: Tissue wT (154) "Whole body" means, for purposes of external
exposure, head, trunk including male gonads, arms above the
elbow, or legs above the knee. (155) "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. (156) "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. (157) "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. (158) "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. 04-23-093, §
246-220-010, filed 11/17/04, effective 12/18/04; 01-05-110, §
246-220-010, filed 2/21/01, effective 3/24/01; 00-08-013, §
246-220-010, filed 3/24/00, effective 4/24/00; 99-15-105, §
246-220-010, filed 7/21/99, effective 8/21/99; 98-13-037, §
246-220-010, filed 6/8/98, effective 7/9/98; 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.] OTS-7622.2 (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 (( (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. 98-13-037, §
246-221-001, filed 6/8/98, effective 7/9/98; 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.] (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 (( (b) The dose in any unrestricted area from external
sources, exclusive of the dose contributions from patients
administered radioactive material and released (( (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, (( (a) The facility's approved operating conditions for each
radiation source remain the same. Any increase in the
following operating conditions shall require reevaluation by
the department 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 (( (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. 98-13-037, §
246-221-060, filed 6/8/98, effective 7/9/98; 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.] (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 (( (3) Caution signs are not required to be posted in areas
or rooms containing radioactive material for periods of less
than eight hours (( (a) The material is constantly attended during (( (b) (( (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 (( (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. 98-13-037, §
246-221-130, filed 6/8/98, effective 7/9/98; 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.] OTS-8022.2 (2) In addition to the requirements of this chapter,
((
[Statutory Authority: RCW 70.98.050. 99-15-105, §
246-232-001, filed 7/21/99, effective 8/21/99. Statutory
Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order
184), § 246-232-001, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121),
recodified as § 246-232-001, filed 12/27/90, effective
1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050
(Order 2026), § 402-19-010, filed 9/16/83; 79-12-073 (Order
1459), § 402-19-010, filed 11/30/79, effective 1/1/80. Formerly chapter 402-20 WAC.] (2) A person who desires to use the capsules for research
involving human subjects shall apply for and receive a
specific license under chapters 246-240 and 246-235 WAC
(( (3) A person who desires to manufacture, prepare,
process, produce, package, repackage, or transfer for
commercial distribution these capsules shall apply for and
receive a specific license from the United States Nuclear
Regulatory Commission under Section 32.21 of 10 C.F.R. Part
32. (4) Nothing in this section relieves persons from
complying with applicable United States Food and Drug
Administration, other federal, and state requirements
governing receipt, administration, and use of drugs.
[Statutory Authority: RCW 70.98.050. 01-02-068, §
246-232-014, filed 12/29/00, effective 1/29/01.] OTS-7623.4 (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 (( (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 (( (4) The applicant satisfies any applicable special
requirements in WAC 246-235-075 through 246-235-110, and
chapters (( (5) ((
[Statutory Authority: RCW 70.98.050. 98-13-037, §
246-235-020, filed 6/8/98, effective 7/9/98. 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.] (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 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) If the application is for use 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, the department will issue a specific
license 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, 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 unless manufactured, labeled, packaged
and distributed in accordance with a specific license issued
by the department pursuant to WAC 246-235-100, a specific
license issued by the United States Nuclear Regulatory
Commission under Section 32.73 of 10 CFR Part 32, or a
specific license issued by an agreement state or a licensing
state under 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 under WAC 246-235-102, a specific license issued by the United States
Nuclear Regulatory Commission under Section 32.74 of 10 CFR
Part 32, or a specific license issued to the manufacturer by
an agreement state or a licensing state under 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 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. (c) Any licensee who is licensed under (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 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 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 50
millicuries; (iv) Any radioactive material excluding Radium-226, in
amounts not to exceed fifteen millicuries per sealed source,
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 246-235-102, 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))) (1) Leak tests. (( (( (B) The sealed source is stored and is not being used:
Provided, a physical inventory of the source and wipe surveys
of the storage area or storage container are conducted)) or
the sealed source is stored and is not being used: Provided,
a physical inventory of the source and wipe surveys of the
storage area or storage container are conducted as required by
these rules or license condition. (( (( (( (( (( (( (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.))
[Statutory Authority: RCW 70.98.050. 00-08-013, §
246-235-080, filed 3/24/00, effective 4/24/00; 98-13-037, §
246-235-080, filed 6/8/98, effective 7/9/98. 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.] (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 (( (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
(( (2) The department will approve an application for a Type
A specific license of broad scope (( (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 (( (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 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 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) The department will approve an application for a Type
B specific license of broad scope (( (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) The department will approve an application for a Type
C specific license of broad scope (( (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 under 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 chapter 246-240 WAC
(( (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) For each Type A specific license of broad scope
(( (c) For each Type B specific license of broad scope
(( (d) For each Type C specific license of broad scope
((
[Statutory Authority: RCW 70.98.050. 00-08-013, §
246-235-090, filed 3/24/00, effective 4/24/00; 98-13-037, §
246-235-090, filed 6/8/98, effective 7/9/98. 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.] (a) The applicant satisfies the general requirements
specified in WAC 246-235-020 (( (b) The applicant submits evidence that: (i) 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, maximum activity per
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 medical use
licensees; and (d) The applicant satisfies the labeling requirements
specified by the state board of pharmacy in WAC 246-903-020. For a drug manufacturer, the labels required by this
subsection are in addition to the labeling required by the
Food and Drug Administration (FDA) and may be separate from
or, with the approval of FDA, may be combined with the
labeling required by FDA. (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,
(( (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. 98-13-037, §
246-235-100, filed 6/8/98, effective 7/9/98. 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.] (1) The applicant satisfies the general requirements in
a
Absorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 Sv.
If it is more convenient to measure the neutron fluence rate
rather than to determine the neutron dose equivalent rate in
sievert per hour or rem per hour as required for Table I, then
0.01 Sv (1 rem) of neutron radiation of unknown energies may,
for purposes of these regulations, be assumed to result from a
total fluence of 25 million neutrons per square centimeter
incident upon the body. If sufficient information exists to
estimate the approximate energy distribution of the neutrons,
the licensee or registrant may use the fluence rate per unit
dose equivalent or the appropriate Q value from Table II to
convert a measured tissue dose in gray or rad to dose
equivalent in sievert or rem.TABLE II
MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE
Neutron
Quality
Factora
Fluence per
Unit
Fluence per
Unit
(thermal) 2.5 x
10-8
2
980 x 106
980 x 108
1 x 10-7
2
980 x 106
980 x 108
1 x 10-6
2
810 x 106
810 x 108
1 x 10-5
2
810 x 106
810 x 108
1 x 10-4
2
840 x 106
840 x 108
1 x 10-3
2
980 x 106
980 x 108
1 x 10-2
2.5
1010 x 106
1010 x 108
1 x 10-1
7.5
170 x 106
170 x 108
5 x 10-1
11
39 x 106
39 x 108
1
11
27 x 106
27 x 108
2.5
9
29 x 106
29 x 108
5
8
23 x 106
23 x 108
7
7
24 x 106
24 x 108
10
6.5
24 x 106
24 x 108
14
7.5
17 x 106
17 x 108
20
8
16 x 106
16 x 108
40
7
14 x 106
14 x 108
60
5.5
16 x 106
16 x 108
1 x 102
4
20 x 106
20 x 108
2 x 102
3.5
19 x 106
19 x 108
3 x 102
3.5
16 x 106
16 x 108
4 x 102
3.5
14 x 106
14 x 108
a
Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder
tissue-equivalent phantom.
b
Monoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom.
such as)) like radiowaves or microwaves, visible, infrared,
or ultraviolet light.such)) that responsibility by the licensee or registrant.pursuant to)) under the authority of RCW 70.98.080.regulations)) rules and
the act.shall)) does not include any areas used for residential
quarters, although a separate room or rooms in a residential
building may be set apart as a restricted area.pursuant
to)) under the provisions of section 51 of the Atomic Energy
Act of 1954, as amended, determines to be special nuclear
material, but does not include source material; orsuch)) the ratios for all of the kinds of
special nuclear material in combination shall not exceed "1"
(i.e., unity). For example, the following quantities in
combination would not exceed the limitation and are within the
formula:175 (grams contained U-235)
+
50 (grams U-233)
+
50 (grams Pu)
< 1
(138) "Stochastic effect" means a health effect that
occurs randomly and for which the probability of the effect
occurring, rather than its severity, is assumed to be a linear
function of dose without threshold. Hereditary effects and
cancer incidence are examples of stochastic effects. For
purposes of these regulations, probabilistic effect is an
equivalent term.such)) the evaluation includes, but is not
limited to, tests, physical examinations, calculations and
measurements of levels of radiation or concentration of
radioactive material present.regulations)) rules" mean all parts of the
rules for radiation protection of the state of Washington.pursuant to)) under sections 104 (b),
(c) and (d) of the Energy Reorganization Act of 1974 (Public
Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C.
5814 effective January 19, 1975) and retransferred to the
Secretary of Energy ((pursuant to)) under section 301(a) of
the Department of Energy Organization Act (Public Law 95-91,
August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151,
effective October 1, 1977).
ORGAN DOSE WEIGHTING FACTORS
Organ or
Gonads
0.25
Breast
0.15
Red bone marrow
0.12
Lung
0.12
Thyroid
0.03
Bone surfaces
0.03
Remainder
0.30a
Whole Body
1.00b
a
0.30 results form 0.06 for each of 5 "remainder” organs, excluding the skin and the lens of the eye, that receive
the highest doses.
b
For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting
factor, wT =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.
AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98,
effective 7/9/98)
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.pursuant to)) under chapter((s 246-239 and))
246-240 WAC, or to voluntary participation in medical research
programs.
AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98,
effective 7/9/98)
WAC 246-221-060
Dose limits for individual members of
the public.
(1) Each licensee or registrant shall conduct
operations so that:pursuant to)) under chapter((s 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; andpursuant to))
under chapter((s 246-239 and)) 246-240 WAC, does not exceed
0.02 mSv (0.002 rem) in any one hour.provided)) if:shall)) requires
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.
AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98,
effective 7/9/98)
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.provided that)) if the patient could be released
from licensee control ((pursuant to)) under chapter((s 246-239
and)) 246-240 WAC.provided that)) if:such))
those periods by an individual who ((shall)) takes ((the))
precautions necessary to prevent the exposure of any
individual to radiation or radioactive material in excess of
the limits established in ((this part)) these rules; andSuch)) The area or room is subject to the
licensee's or registrant's control.such)) the posting is
conspicuously placed at the entrance(s) to the rooms.
AMENDATORY SECTION(Amending WSR 99-15-105, filed 7/21/99,
effective 8/21/99)
WAC 246-232-001
Purpose and scope.
(1) This chapter
prescribes rules governing licensing of radioactive material. ((No)) A person ((shall)) may not receive, possess, use,
transfer, own or acquire radioactive material except as
authorized in a specific or general license issued ((pursuant
to)) under chapters 246-233 or 246-235 WAC or as otherwise
provided in this chapter.or)) and chapters 246-233 or 246-235 WAC, all licensees
((are subject to the requirements of)) must comply with
chapters 246-220, 246-221, 246-222, 246-231, 246-247, and
246-254 WAC. Licensees engaged in the practice of nuclear
medicine are subject to ((the requirements of)) chapter
((246-239)) 246-240 WAC, licensees engaged in industrial
radiographic operations are subject to ((the requirements of))
chapter 246-243 WAC, licensees using sealed sources in the
healing arts are subject to ((the requirements of)) chapter 246-240 WAC, licensees using radioactive material in well
logging and subsurface tracer studies are subject to ((the
requirements of)) chapter 246-244 WAC, licensees engaged in
land disposal of radioactive waste are subject to ((the
requirements of)) chapter 246-250 WAC, and licensees owning or
operating uranium or thorium mills and associated mill
tailings are subject to ((the requirements of)) chapter 246-252 WAC.
AMENDATORY SECTION(Amending WSR 01-02-068, filed 12/29/00,
effective 1/29/01)
WAC 246-232-014
Exemption of C-14 urea diagnostic
capsules for human use.
(1) Except as provided in subsections
(2) and (3) of this section, a person is exempt from the
requirements for a license set forth in chapters 246-233 and
246-235 WAC if the person receives, possesses, uses,
transfers, owns, or acquires capsules containing 37
kilobequerels (1 microcurie) carbon-14 urea (allowing for
nominal variation that may occur during the manufacturing
process) each, for "in vivo" diagnostic use for humans.246-235-080)).
AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98,
effective 7/9/98)
WAC 246-235-020
General requirements for the issuance of
specific licenses.
A license application will be approved if
the department determines that:such)) a
manner ((as)) to minimize danger to public health and safety
or property;be inimical
to)) harm the health and safety of the public; and246-239)) 246-240 through 246-252 WAC.In the case of)) When 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))
applicant shall not begin construction until the department
has weighed the environmental, economic, technical, and other
benefits against the environmental costs and has concluded
that the issuance of the license is appropriate. Commencement
of construction prior to ((such conclusion)) approval by the
department shall be grounds for denial of a license to receive
and possess radioactive material in ((such)) the 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.
AMENDATORY SECTION(Amending WSR 00-08-013, filed 3/24/00,
effective 4/24/00)
WAC 246-235-080
Special requirements for ((issuance of
specific licenses for medical use of radioactive material))
possession and use of medical calibration and reference
sources.
(((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:(i))) (a) Any licensee or registrant who possesses
sealed sources as calibration or reference sources ((under (c)
of this subsection)) shall ((cause)) test for leakage 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)) least every 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. However, leak tests are not 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((;(ii))) (b) The leak test shall be capable of detecting
the presence of 0.005 microcurie (185 becquerels) 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))) (c) 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. The licensee must file 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))) (2) Any licensee or registrant who possesses and
uses calibration and reference sources ((under (c)(iv) of this
subsection)) shall:(i))) (a) 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 the instructions in a legible and conveniently
available form; and(ii))) (b) 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
individual applicant or, if the application is made by an
institution, the individual user:
AMENDATORY SECTION(Amending WSR 00-08-013, filed 3/24/00,
effective 4/24/00)
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)) these 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)) listed below: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.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.will be approved)) if:such persons as)) a radiation safety officer, a
representative of management, and persons trained and
experienced in the safe use of radioactive material;will be approved)) if:will be approved)) if:246-235-080 through)), WAC 246-235-086 or ((WAC))
246-235-091 through 246-235-105 is required; orissued 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.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.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.
AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98,
effective 7/9/98)
WAC 246-235-100
Manufacture, preparation, or commercial
transfer of radiopharmaceuticals for medical use.
(1) An
application for a specific license to manufacture and,
prepare, or transfer for commercial distribution
radiopharmaceuticals containing radioactive material for use
by persons licensed ((pursuant to)) under chapter 246-240 WAC
((246-235-080 (1), (2), or (3))) for medical use in humans
will be approved if:of this part));no later than)) within thirty days ((after)) of the date the
licensee allows the individual to work as an authorized
nuclear pharmacist ((pursuant to)) under (b) of this
subsection.
AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98,
effective 7/9/98)
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)) under chapter 246-240 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: