PROPOSED RULES
Supplemental Notice to WSR 05-19-053.
Exempt from preproposal statement of inquiry under RCW 34.05.310(4).
Title of Rule and Other Identifying Information: Medical use of radioactive material, chapter 246-240 WAC (sections are being added, amended and repealed). Sections of other chapters in the radiation protection regulations are being changed to bring them into conformity with the US Nuclear Regulatory Commission (USNRC) rules for medical use of radioactive material. In addition to those sections in chapter 246-240 WAC, the following sections of existing regulations are amended or repealed: WAC 246-220-010, 246-221-001, 246-221-060, 246-221-130; 246-232-001, 246-232-014, 246-235-020, 246-235-080, 246-235-090, 246-235-100, 246-235-102, 246-235-110, 246-235-120 Schedule A (repealed), 246-239-001, 246-239-010, 246-239-020, 246-239-022, 246-239-025, 246-239-030, 246-239-035, 246-239-040, 246-239-050, 246-239-055, 246-239-060, 246-239-070, 246-239-080, 246-239-090, and 246-239-100 (all repealed).
Hearing Location(s): Washington State Department of Health, Town Center 2, Room 145, 111 Israel Road S.E., Tumwater, WA 98501, on January 10, 2006, at 10:00 a.m.
Date of Intended Adoption: January 12, 2006.
Submit Written Comments to: Arden C. Scroggs, P.O. Box 47827, Olympia, WA 98504, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2255, by January 10, 2005 [2006].
Assistance for Persons with Disabilities: Contact Arden C. Scroggs by January 3, 2006, TTY (800) 838-6388.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: A hearing was held on October 28, 2005. Changes have been made to the original text based on comments received at the hearing and from the Nuclear Regulatory Commission. The changes incorporate portions of the federal rule that were inadvertently omitted from the proposal as well as several other changes made for clarity and consistency with other rules.
In response to comments received at the public hearing, in writing, and from the USNRC, the following changes have been made:
A. WAC 246-220-010, the definition of "physician" was changed to clearly include doctors of osteopathy as well as medical doctors;
B. WAC 246-240-001 Purpose and scope, now includes the sentence formerly contained in 10 C.F.R. 35.10(e), and inadvertently omitted in the original proposal, i.e. "When a requirement in this chapter differs from the requirement in an existing license condition, the requirement in this chapter shall govern";
C. The inadvertently omitted word "verifies" was added to the definition of preceptor in WAC 246-240-010 as required by 10 C.F.R. 35.2;
D. Inadvertently omitted references to certain written requirements for an authorized medical physicist to perform certification functions have been added to WAC 246-240-072 as required by 10 C.F.R. 35.51;
E. The number of required training hours referenced in WAC 246-240-075 as seven hundred hours has been changed to reflect the two hundred hours currently required by 10 C.F.R. 35.55;
F. Inadvertently omitted references to certain written requirements for an authorized nuclear pharmacist to perform certification functions have been added to WAC 246-240-075 as required by 10 C.F.R. 35.55;
G. The minimum requirement of eight hours classroom and laboratory training, inadvertently omitted from WAC 246-240-154, has been added as required by 10 C.F.R. 35.190;
H. The minimum requirement of eighty hours of classroom and laboratory training, inadvertently omitted from WAC 246-240-163, has been added as required by 10 C.F.R. 35.290;
I. WAC 246-240-210 as proposed requires a minimum three year residency training period while the USNRC rule does not specify a minimum training period. The minimum training period of three years has been deleted as required by 10 C.F.R. 35.390;
J. WAC 246-240-210 does not include the minimum two hundred hours of classroom and laboratory training requirement. The two hundred hour training requirement has been added as required by 10 C.F.R. 35.390; and
K. Training for the parenteral administration of unsealed radioactive material requiring a written directive was inadvertently omitted. This new section, WAC 246-240-219, has been added as required by 10 C.F.R. 35.396.
Reasons Supporting Proposal: Uniformity of regulations is intended to promote ease of use, and thus greater conformity, with regulations governing licensees who use radioactive material for medical purposes.
Statutory Authority for Adoption: RCW 70.98.050.
Statute Being Implemented: RCW 70.98.050.
Rule is necessary because of federal law, 67 F.R. 20250, 10 C.F.R. 35, 70 F.R. 16336.
Name of Proponent: Department of Health, governmental.
Name of Agency Personnel Responsible for Drafting: C. DeMaris, 111 Israel Road S.W., Tumwater, WA, (360) 236-3223; Implementation and Enforcement: A. Scroggs, 111 Israel Road S.W., Tumwater, WA, (360) 236-3221.
No small business economic impact statement has been prepared under chapter 19.85 RCW. This rule change is exempt from the small business impact statement requirement under RCW 19.85.025(3) because it adopts federal regulations without material change. This rule also has a "regulatory flexibility certification" prepared by USNRC stating that the "rule will not have a significant economic impact upon a substantial number of small entities."
A cost-benefit analysis is not required under RCW 34.05.328. Under RCW 34.05.328 (5)(b)(iii) and (iv), RCW 34.05.328 (1)-(4) do not apply to this rule adoption because this rule adopts federal regulations without material change and clarifies the language of a rule or otherwise makes housekeeping changes. This rule is for conformance with the USNRC regulations and is mandatory under our agreement state status with the federal government.
December 5, 2005
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-7750.7
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.
RADIATION PROTECTION -- MEDICAL ((THERAPY)) USE OF RADIOACTIVE
MATERIAL
[Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-240-001, filed 12/27/90, effective 1/31/91; Order 1084, § 402-32-010, filed 1/14/76; Order 1, § 402-32-010, filed 1/8/69; Rules (part), filed 10/26/66.]
[]
(2) If the research is conducted, funded, supported, or regulated by another federal agency that has implemented the Federal Policy for the Protection of Human Subjects (federal policy), the licensee shall, before conducting research:
(a) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy; and
(b) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.
(3) If the research will not be conducted, funded, supported, or regulated by another federal agency that has implemented the federal policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:
(a) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy; and
(b) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.
(4) Nothing in this section relieves licensees from complying with the other requirements in this chapter.
[]
(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.
(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.
(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.
(7) "Therapy misadministration" means the administration of:
(a) A gamma stereotactic radiosurgery radiation dose:
(i) Involving the wrong 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 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 exceeds the weekly prescribed dose by thirty percent 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 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.
(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).)) Address of use means the building or buildings that are identified on the license and where radioactive material may be received, prepared, used, or stored.
Area of use means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing radioactive material.
Authorized medical physicist means an individual who:
(1) Meets the requirements in WAC 246-240-072 and 246-240-081; or
(2) Is identified as an authorized medical physicist or teletherapy physicist on a specific medical use license issued by the department, the U.S. Nuclear Regulatory Commission or agreement state prior to October 5, 2005.
(3) A permit issued by a commission or agreement state broad scope medical use licensee prior to October 5, 2005; or
(4) A permit issued by a commission master material license broad scope medical use permittee prior to October 5, 2005.
Authorized nuclear pharmacist means a pharmacist who:
(1) Meets the requirements in WAC 246-240-075 and 246-240-081; or
(2) Is identified as an authorized nuclear pharmacist on a specific license issued by the department, the U.S. NRC or agreement state prior to October 5, 2005, that authorizes medical use or the practice of nuclear pharmacy; or
(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or
(4) A permit issued by a commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;
(5) A permit issued by a commission or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or
(6) A permit issued by a commission master material license board scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or
(7) Is designated as an authorized nuclear pharmacist in accordance with WAC 246-235-100(2).
Authorized user means a physician, dentist, or podiatrist who:
(1) Meets the requirements in WAC 246-240-081 and 246-240-154, 246-240-163, 246-240-210, 246-240-213, 246-240-216, 246-240-278, 246-240-301, or 246-240-399;
(2) Is identified as an authorized user on a department, U.S. NRC, or agreement state license prior to October 5, 2005, that authorizes the medical use of radioactive material.
(3) A permit issued by a commission master material licensee that is authorized to permit the medical use of by-product material;
(4) A permit issued by a commission or agreement state specific licensee of broad scope that is authorized to permit the medical use of by-product material; or
(5) A permit issued by a commission master material license broad scope permittee that is authorized to permit the medical use of by-product material.
Brachytherapy means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.
Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.
Client's address means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with WAC 246-240-125.
Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.
Dentist means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.
High dose-rate remote afterloader, as used in this chapter, means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.
Low dose-rate remote afterloader, as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.
Management means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or that person's delegate or delegates.
Manual brachytherapy, as used in this chapter, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.
Medical event means an event that meets the criteria in WAC 246-240-651.
Medical institution means an organization in which more than one medical discipline is practiced.
Medical use means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.
Medium dose-rate remote afterloader, as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than or equal to 12 grays (1200 rads) per hour at the point or surface where the dose is prescribed.
Mobile medical service means the transportation of radioactive material to and its medical use at the client's address.
Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.
Patient intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.
Podiatrist means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.
Preceptor means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer.
Prescribed dosage means the specified activity or range of activity of unsealed radioactive material as documented:
(1) In a written directive; or
(2) In accordance with the directions of the authorized user for procedures performed under WAC 246-240-151 and 246-240-157.
Prescribed dose means:
(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;
(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;
(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or
(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.
Pulsed dose-rate remote afterloader, as used in this chapter, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate" range, but:
(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and
(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.
Radiation safety officer means an individual who:
(1) Meets the requirements in WAC 246-240-069 and 246-240-081;
(2) Is identified as a radiation safety officer on a specific medical use license issued by the department prior to October 5, 2005, the U.S. NRC or an agreement state; or
(3) A medical use permit issued by a commission master material licensee.
Sealed source and device registry means the national registry that contains all the registration certificates, generated by both the U.S. NRC and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.
Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.
Structured educational program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.
Teletherapy, as used in this chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.
Temporary job site means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.
Therapeutic dosage means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.
Therapeutic dose means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.
Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.
Type of use means use of radioactive material under WAC 246-240-151, 246-240-157, 246-240-201, 246-240-251, 246-240-301, 246-240-351, or 246-240-501.
Unit dosage means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.
Written directive means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in WAC 246-240-060.
[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-240-010, filed 6/8/98, effective 7/9/98. 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.]
[]
(2) A specific license is not needed for an individual who:
(a) Receives, possesses, uses, or transfers radioactive material in accordance with these rules under the supervision of an authorized user under in WAC 246-240-057, unless prohibited by license condition; or
(b) Prepares unsealed radioactive material for medical use in accordance with these rules under the supervision of an authorized nuclear pharmacist or authorized user under WAC 246-240-057, unless prohibited by license condition.
[]
(2) An application for a license for medical use of radioactive material as described in WAC 246-240-151, 246-240-157, 246-240-201, 246-240-251, 246-240-301, 246-240-351, and 246-240-501 must be made by:
(a) Filing the original "Application for Radioactive Material License Medical," with the department that includes the facility diagram, equipment, and training and experience qualifications of the radiation safety officer, authorized user(s), authorized medical physicist(s), and authorized nuclear pharmacist(s); and
(b) Submitting applicable procedures required by WAC 246-240-360, 246-240-378, 246-240-381, and 246-240-384.
(3) A request for a license amendment or renewal must be made by:
(a) Submitting an original of either to the department:
(i) "Application for Radioactive Material License Medical"; or
(ii) A letter requesting the amendment or renewal; and
(b) Submitting applicable procedures required by WAC 246-240-360, 246-240-378, 246-240-381, and 246-240-384.
(4) In addition to the requirements in subsections (2) and (3) of this section, an application for a license or amendment for medical use of radioactive material as described in WAC 246-240-501 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in this chapter.
(a) The applicant shall also provide specific information on:
(i) Radiation safety precautions and instructions;
(ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and
(iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.
(b) The applicant or licensee shall also provide any other information requested by the department in its review of the application.
(5) An applicant that satisfies the requirements specified in WAC 246-235-090 may apply for a Type A specific license of broad scope.
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(1) Receives, prepares, or uses radioactive material for a type of use that is permitted under this chapter, but that is not authorized on the licensee's current license issued under this chapter;
(2) Permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except:
(a) For an authorized user, an individual who meets the requirements in WAC 246-240-154, 246-240-163, 246-240-210, 246-240-213, 246-240-216, 246-240-278, or 246-240-399;
(b) For an authorized nuclear pharmacist, an individual who meets the requirements in WAC 246-240-075 and 246-240-081;
(c) For an authorized medical physicist, an individual who meets the requirements in WAC 246-240-072 and 246-240-081;
(d) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist:
(i) On an agreement state or U.S. NRC license or other equivalent license recognized by the department that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy; or
(ii) On a permit issued by a commission or agreement state specific license of broad scope that is authorized to permit the use of by-product material in medical use or in the practice of nuclear pharmacy;
(iii) On a permit issued by a commission master material licensee that is authorized to permit the use of by-product material in medical use or in the practice of nuclear pharmacy; or
(iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists.
(3) Changes radiation safety officers, except as provided in WAC 246-240-051;
(4) Receives radioactive material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;
(5) Adds to or changes the areas of use identified in the application or on the license, except for areas of use where radioactive material is used only in accordance with either WAC 246-240-151 or 246-240-157;
(6) Changes the address(es) of use identified in the application or on the license; and
(7) Revises procedures required by WAC 246-240-360, 246-240-378, 246-240-381, and 246-240-384, as applicable, where the revision reduces radiation safety.
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(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.)) A licensee shall notify the department no later than thirty days after:
(a) An authorized user, an authorized nuclear pharmacist, a radiation safety officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;
(b) The licensee's mailing address changes;
(c) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in WAC 246-232-050(2); or
(d) The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used under either WAC 246-240-151 or 246-240-157.
(2) The licensee shall send the documents required in this section to the department at P.O. Box 47827, Olympia WA 98504-7827.
[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-240-025, filed 6/8/98, effective 7/9/98.]
(1) WAC 246-240-019 regarding the need to file an amendment to the license for medical use of radioactive material, as described in WAC 246-240-501;
(2) WAC 246-240-022;
(3) WAC 246-240-022 regarding additions to or changes in the areas of use at the addresses identified in the application or on the license;
(4) WAC 246-240-025;
(5) WAC 246-240-025 for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist;
(6) WAC 246-240-025 regarding additions to or changes in the areas of use identified in the application or on the license where radioactive material is used in accordance with either WAC 246-240-151 or 246-240-157;
(7) WAC 246-240-122.
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(a) The applicant has filed "Application for Radioactive Material License Medical" in accordance with the instructions in WAC 246-240-019;
(b) The applicant has paid applicable fee under chapter 246-254 WAC;
(c) The department finds the applicant equipped and committed to observe the safety standards established by the department in these regulations for the protection of the public health and safety; and
(d) The applicant meets the requirements of chapter 246-232 WAC.
(2) The department shall issue a license for mobile medical service if the applicant:
(a) Meets the requirements in subsection (1) of this section; and
(b) Assures that individuals or human research subjects to whom unsealed radioactive material, or radiation from implants containing radioactive material, will be administered may be released following treatment in accordance with WAC 246-240-122.
(3) The department may, upon application of any interested person or upon its own initiative, grant exemptions from this chapter that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
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(a) Requests for a license application, renewal, or amendment before submittal to the department;
(b) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and
(c) Radiation protection program changes that do not require a license amendment and are permitted under WAC 246-240-054;
(2) A licensee's management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements.
(3) For up to sixty days each year, a licensee may permit an authorized user or an individual qualified to be a radiation safety officer, under WAC 246-240-069 and 246-240-081, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, under subsection (7) of this section, if the licensee takes the actions required in subsections (2), (5), (7), and (8) of this section and notifies the department in accordance with WAC 246-240-025.
(4) A licensee may simultaneously appoint more than one temporary radiation safety officer under subsection (3) of this section, if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different types of uses of radioactive material permitted by the license.
(5) A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.
(6) Licensees that are authorized for two or more different types of use of radioactive material under WAC 246-240-201, 246-240-251, and/or 246-240-351, shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee must include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a radiation safety officer. The committee may include other members the licensee considers appropriate.
(7) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:
(a) Identify radiation safety problems;
(b) Initiate, recommend, or provide corrective actions;
(c) Stop unsafe operations; and
(d) Verify implementation of corrective actions.
(8) A licensee shall retain a record of actions taken under subsections (1), (2), and (5) of this section in accordance with WAC 246-240-551.
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(a) The revision does not require a license amendment under WAC 246-240-022;
(b) The revision is in compliance with this chapter and the license;
(c) The revision has been reviewed and approved by the radiation safety officer and licensee management; and
(d) The affected individuals are instructed on the revised program before the changes are implemented.
(2) A licensee shall retain a record of each change in accordance with WAC 246-240-554.
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(a) Instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, this chapter, and license conditions with respect to the use of radioactive material; and
(b) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations of these regulations, and license conditions with respect to the medical use of radioactive material.
(2) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by WAC 246-240-016, shall:
(a) In addition to the requirements in WAC 246-222-030, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and
(b) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, this chapter, and license conditions.
(c) A licensee that permits supervised activities under subsections (1) and (2) of this section is responsible for the acts and omissions of the supervised individual.
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If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within forty-eight hours of the oral directive.
(2) The written directive must contain the patient or human research subject's name and the following information:
(a) For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide I-131: The dosage;
(b) For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide I-131: The radioactive drug, dosage, and route of administration;
(c) For gamma stereotactic radiosurgery: The total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;
(d) For teletherapy: The total dose, dose per fraction, number of fractions, and treatment site;
(e) For high dose-rate remote afterloading brachytherapy: The radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or
(f) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:
(i) Before implantation: Treatment site, the radionuclide, and dose; and
(ii) After implantation but before completion of the procedure: The radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose). (3) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within forty-eight hours of the oral revision.
(4) The licensee shall retain a copy of the written directive in accordance with WAC 246-240-557.
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(a) The patient's or human research subject's identity is verified before each administration; and
(b) Each administration is in accordance with the written directive.
(2) At a minimum, the procedures required by subsection (1) of this section must address the following items that are applicable to the licensee's use of radioactive material:
(a) Verifying the identity of the patient or human research subject;
(b) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;
(c) Checking both manual and computer-generated dose calculations; and
(d) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by WAC 246-240-351.
(3) A licensee shall retain a copy of the procedures required under subsection (1) of this section in accordance with WAC 246-240-560.
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(1) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under WAC 246-235-102.
(2) Sealed sources or devices noncommercially transferred from a U.S. NRC or agreement state licensee; or
(3) Teletherapy sources manufactured and distributed in accordance with a license issued under chapter 246-232 WAC.
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(1) Is certified by a specialty board whose certification process has been recognized by the department, the U.S. NRC, or an agreement state. (Specialty boards whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state will be posted on the NRC's web page, at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:
(a) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of twenty college credits in physical science;
(b) Have five or more years of professional experience in health physics (graduate training may be substituted for no more than two years of the required experience) including at least three years in applied health physics;
(c) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or
(i) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;
(ii) Have two years of full-time practical training and/or supervised experience in medical physics:
(A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the commission or an agreement state; or
(B) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users under these rules before October 24, 2005; and
(iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or
(d) Obtain written certification signed by a preceptor radiation safety officer that the individual has achieved a level of radiation safety knowledge sufficient to function independently as a radiation safety officer for a medical use licensee; or
(2)(a) Has completed a structured educational program consisting of both:
(i) Two hundred hours of didactic training in the following areas:
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of radioactivity;
(D) Radiation biology; and
(E) Radiation dosimetry; and
(ii) One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a dep