Title: Section 16.2 - Definitions
(a) As used in these regulations, these terms have the definitions set forth below:
(1) "A(1)" means the maximum activity of special form radioactive material permitted in a Type A package. "A(2)" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed or may be derived in accordance with the procedure prescribed in Appendix 16-B, Table 1 of this Part.
(2) "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.
(3) "Accelerator-produced material" means any material made radioactive by a particle accelerator.
(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 18 years, or more, of age.
(6) "Agreement State" means any State with which the United State Nuclear Regulatory Commission or the United States Atomic Energy Commission has entered into an effective agreement under section 274b 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 dusts, fumes, particulates, mists, vapors, or gases.
(8) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:
(i) In excess of the derived air concentrations (DACs) specified in Appendix 16-C, Table 1, Column 3, infra, or
(ii) To such a 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 12 DAC-hours.
(9) "Aluminum equivalent" means the thickness of aluminum affording the same attenuation, under specified conditions, as the material in question.
(10) "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 Appendix 16-C, Table 1, Columns 1 and 2, infra.
(11) "As low as is reasonably achievable" (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economic of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.
(12) "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. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Department.
(13) "Becquerel" (Bq) means the SI unit of activity. One becquerel is equal to one disintegration or transformation per second (s -(1)).
(14) "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.
(15) "Byproduct material" shall include:
(i) 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;
(ii) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes; however, ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition; (iii) any discrete source of radium-226 that is produced, extracted, or converted after extraction for use for a commercial, medical, or research activity; (iv) any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction for use for a commercial, medical, or research activity. (v) any discrete source of naturally occurring radioactive material, other than source material, that is extracted or converted after extraction for use in a commercial medical or research activity that the Nuclear Regulatory Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security. (16) "Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such 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 licensee or registrant shall change the method used to determine calendar quarters for purposes of these regulations except at the beginning of a calendar year.
(17) "Calibration" means the determination of:
(i) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or
(ii) the strength of a source of radiation relative to a standard.
(18) "Certified radiation equipment safety officer" means an individual who holds an unexpired certificate as a radiation equipment safety officer issued by the department.
(i) The requirements for certification as a radiation equipment safety officer are as follows:
(a) at least 18 years of age at the time of application; and
(b) good moral character; and
(c) graduation from a regionally accredited college or university, or one recognized by New York State, with a bachelor's degree in physical or natural science, mathematics or engineering; or four years of satisfying full-time paid experience in radiation protection or control; or an equivalent combination of the education and experience specified in this clause; and
(d) successful completion, after meeting the requirements of clauses (a), (b), and (c) immediately above, of an examination prescribed by the department; and
(e) at least three years of satisfactory full-time paid experience in radiation protection or control including at least one year of experience dealing with radiation equipment, with the provision that up to two years of graduate training in physical or natural science, mathematics or engineering, may be substituted on a year for year basis for the required experience except for the one year of experience in radiation protection or control dealing with radiation equipment.
(ii) The department may accept in lieu of the requirements of clauses (c) and (d) of subparagraph (i) of this paragraph a certificate in radiation protection or control issued by the American Board of Health Physics, the American Board of Radiology or the American Board of Medical Physics.
(iii) A person meeting all requirements of subparagraph (i) of this paragraph except the experience or experience substitute requirement of clause (e) of said subparagraph may be certified as a radiation equipment safety officer with the restriction that he/she perform surveys only under the supervision of a certified radiation equipment safety officer who meets the requirements of said clause (e).
(iv) A certification as a radiation equipment safety officer shall be issued by the department for a period not to exceed two years. Eligibility for renewal of a certificate shall be based on a work record as a certified radiation equipment safety officer that is in conformance with the regulations of the department. The certificate may be revoked for cause by the department on due notice.
(19) "CFR" means Code of Federal Regulations.
(20) "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 10 days, for Class W, Weeks, from 10 to 100 days, and for Class Y, Years, of greater than 100 days. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms.
(21) "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.
(22) "Collimator" means a device or mechanism by which the X-ray or gamma-ray beam is restricted in size.
(23) "Commissioner" means the Commissioner of Health of the State of New York.
(24) "Committed dose equivalent" (H (t50)) 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 50-year period following the intake.
(25) "Committed effective dose equivalent" (H(e50)) is the sum of the products of the weighing 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 (H(e)(50) = W(t) H(t)(50)).
(26) "Cone" means a device used to indicate beam direction and to establish a minimum source-surface distance. It may or may not incorporate a collimator. (27) "Controlled area" means any area the access to which is controlled for the purpose of protecting individuals from exposure to radiation and radioactive material, but shall not mean any area used as residential quarters. "Controlled area" as used in this Part is synonymous to "restricted area".
(28) "Curie" means a unit of activity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 x 10(10) transformations per second (tps).
(29) "Declared pregnant woman" means a woman who has voluntarily informed her employer, in writing, of her pregnancy.
(30) "Deep dose equivalent" H(d), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm(2)).
(31) "Department" means the New York State Department of Health and shall include its duly authorized representatives.
(32) "Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present.
(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 2,000 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 2,000 hours in a year. DAC values are given in Appendix 16-C, Table 1, Column 3, infra.
(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 use 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).
(35) "Diagnostic type protective tube housing" means X-ray tube housing so constructed that the leakage radiation at a distance of one meter from the source does not exceed 100 milliroentgens in one hour when the tube is operated at its maximum continuous rated current for the maximum rated tube potential.
(36) "Diaphragm" means a device or mechanism by which the X-ray or gamma-ray beam is restricted in size.
(37) "Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.
(38) "Dose equivalent (H (t))" 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) "Effective dose equivalent (H (e))" means the sum of the products of the dose equivalent to each organ or tissue (H (t)) and the weighting factor (W (t)) applicable to each of the body organs or tissues that are irradiated (H(e) = W(t) H(t)).
(42) "Embryo/fetus" means the developing human organism from conception until the time of birth.
(43) "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 or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.
(44) "Explosive material" means any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.
(45) "Exposure" means either:
(i) being exposed to ionizing radiation or to radioactive material; or
(ii) the quotient of dQ by dm where "dQ" 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 "dm" are completely stopped in air. The special unit of exposure is the roentgen (R). 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) "Eye dose equivalent" means the external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeter (300 mg/cm(2)).
(50) "Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commissi on (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.
(51) "Gray" (Gy) means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule/kilogram. One gray is equal to 100 rad.
(52) "Half value layer" (HVL) means the thickness of a specified substance which, when introduced into the path of a given beam of radiation, reduces the exposure rate by one-half.
(53) "Health officer having jurisdiction" means the Commissioner or his/her designee, or the chief executive officer of the appropriate county or part-county health department or the New York City department of health, or the director of a State, regional, area or district office of public health.
(54) "High radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 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.
(55) "Human use" means the internal or external administration of radiation of radioactive material to human beings.
(56) "Image receptor" shall mean any device, such as fluoroscopic input phosphor or radiographic film which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further transformation.
(57) "Individual" shall mean any human being.
(58) "Individual monitoring" means the assessment of:
(i) Dose equivalent:
(a) by the use of individual monitoring devices or
(b) by the use of survey data; or
(ii) Committed effective dose equivalent:
(a) by bioassay or
(b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours.
(59) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, individual monitoring equipment and personnel monitoring equipment are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), pocket dosimeters, and personal air sampling devices.
(60) "Inherent filtration" means the filtration permanently in the useful beam; it includes the window of the X-ray tube and any permanent tube or source enclosure.
(61) "Inspection" means an official examination or observation including, but not limited to, reviews of records, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the department.
(62) "Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
(63) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.
(64) "Kilovolt" (kV) means a unit of electrical potential equal to 1000 volts. "Kilovolt peak" (kVp) means the crest value in kilovolts of the potential difference of a pulsating generator. When only one-half of the wave is used, the value refers to the useful half of the wave.
(65) "Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
(66) "Leakage radiation" means all radiation coming from within the source or tube housing except the useful beam.
(67) "License" means a radioactive material license issued by the Department in accordance with the regulations adopted by the Department. There are two types of licenses: general and specific. A "general license" means a license issued pursuant to the terms and conditions of Appendix 16-A, Table 6, infra. General licenses are effective without the filing of an application with or the issuance of a licensing document by the department. A "specific license" shall mean a license evidenced by a licensing document issued by the department to a licensee. A specific license also means a similar license issued by the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State. Unless otherwise specified, the type of license referred to in this Part will be a specific license. (68) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Department.
(69) "Licensee" means any person who is licensed by the Department in accordance with these regulations or one who possesses any radioactive material which is subject to the licensure requirements of this Part.
(70) "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.
(71) "Member of the public" means any individual, except an individual who is performing assigned duties for the licensee or registrant involving exposure to sources of radiation.
(72) "Minor" means an individual less than 18 years of age.
(73) "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.
(74) "NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.
(75) "Natural radioactivity" means radioactivity of naturally occurring nuclides.
(76) "Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
(77) "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, a "deterministic effect" is an equivalent term.
(78) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation, whether in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received: from background radiation, as a patient from medical practices, from voluntary participation in medical research programs, or as a member of the public.
(79) Operator means any person conducting the business or activities carried on within the radiation installation or having by law the administrative control of a radiation source whether as owner, lessee, contractor, or otherwise.
(80) Package means the packaging, together with its radioactive contents as presented for transport.
(81) 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 as energies usually in excess of 1 MeV.
(82) 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.
(83) Personnel monitoring equipment (See individual monitoring devices).
(84) Professional practice means the practice of medicine, dentistry, podiatry, osteopathy or chiropractic.
(85) Professional practitioner means any person licensed or otherwise authorized under the State Education Law to practice a professional practice.
(86) Protective apron means an apron made of radiation attenuating material(s), used to reduce exposure to radiation.
(87) Protective barrier means a barrier of radiation absorbing material(s) used to attenuate the useful beam and/or stray radiation to the degree required to assure compliance with sections 16.6 and 16.7 of this Part.
(88) Protective glove means a glove made of radiation absorbing material(s) used to reduce radiation exposure.
(89) Public dose means the dose received by a member of the public from exposure to sources of radiation. It does not include occupational dose, dose received from background radiation, dose received as a patient from medical practices, or dose from voluntary participa-tion in medical research programs.
(91) Qualified expert means an individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology or the American Board of Health Physics, or those having equivalent training and experience. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the above qualifications, training and experience in the clinical applica-tions of radiation physics to radiation therapy, for example, individuals certified in Therapeutic Radiological Physics or X-Ray and Radium Physics by the American Board of Radiology, or those having equivalent training and experience.
(92) Quality factor (Q) means the modifying factor, that is used to derive dose equivalent from absorbed dose.
(i) As used in these regulations, the quality factors for converting absorbed dose to dose equivalent are shown in Table I.
Quality Factors and Absorbed Dose Equivalents
|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||0.1||0.1|
a Absorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 Sv.
(ii) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in Table I, 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 11 to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.
Mean Quality Factors, Q, and Fluence per Unit Dose Equivalent for Monoenergetic Neutrons
(To receive a copy of Table II please contact William Johnson in the Office of Regulatory Reform at (518) 473-7488)
(93) Quarter (See Calendar quarter).
(94) Rod means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg/gram or 0.01 joulie/kilograrn (0.01 gray). One millirad equals 0.001 rad.
(95) 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 pur-poses of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.
(96) Radiation area means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess or 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
(97) Radiation equipment means any equipment or device which can emit radiation by virtue of the application thereto of high voltage.
(98) Radiation installation means place, facility or mobile unit where radiation equipment, in operable condition or intended to be used, is located or used, or where radioactive material is transferred, received, possessed or used including generally a hospital; medical, dental, chiro-practic, osteopathic, podiatric, or veterinarian institution, clinic or office; educational institu-tion; commercial, private or research laboratory performing diagnostic procedures or handling equipment or material for medical use; or any trucking, storage, messenger or delivery service establishment. Radiation installation shall include, whether or not it is specifically stated above, any place, facility or mobile unit where radiation is applied intentionally to a human. The limits of the radiation installation area shall be as designated by the operator.
(99) Radiation safety officer shall mean an individual who, under the authorization of the operator of a radiation installation, administers a radiation protection program in accordance with section 16.5 of this Part and who is qualified by training and experience in radiological health to evaluate the radiation hazards of such installation and administer such radiation protection program.
(i) For human use radiation equipment installations, the radiation safety officer (RSO) shall be:
(a) a professional practitioner as defined in paragraph (85) of this subdivision, practicing within his/her professional practice as defined in paragraph (84) of this subdivision; or
(b) a physicist certified by the American Board of Health Physics, the American Board of Radiology in a branch of physics related to the type of use of radiation sources in the installation, or, an individual with equivalent training and experience.
(ii) For non-human use radiation equipment installations, the radiation safety officer shall be:
(a) a veterinarian for veterinary installations; or
(b) a physicist certified by the American Board of Health Physics, the American Board of Radiology, or, an individual with equivalent training and experience; or
(c) a researcher determined by the institution as qualified by training and experience for installations using only X-ray diffraction and fluorescence analysis equipment.
(iii) For licensed radioactive materials installations, the radiation safety officer shall be:
(a) an authorized user named on the radioactive materials license issued by this department; or
(b) a physicist certified by the American Board of Health Physics or the American Board of Radiology in a branch of physics related to the type of use of radioactive material in the installation, or, an individual with equivalent training and experience.
(100) Radiation source means any radioactive material or any radiation equipment.
(101) Radioactive material means any solid, liquid, or gas which emits radiation spontaneously.
(102) Radioactivity means the transformation of unstable atomic nuclei by the emission of radiation.
(103) Radiobioassay (See Bioassay).
(104) Reference man means a hypothetical aggregation of human physical and physiologi-cal 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.
(105) Registrant means any person who is registered with the department or is legally obligated to register with the department pursuant to these regulations. (106) Registration means registration with the department in accordance with these regulations.
(107) 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 (one rem = 0.01 sievert).
(108) Research and development means:
(i) theoretical analysis, exploration, or experimentation; or
(ii) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experi-mental 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.
(109) Respiratory protective equipment means an apparatus, such as a respirator, used to reduce an individual * s intake of airborne radioactive material.
(110) Restricted area means any area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. A restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.
(111) Roentgen means the special unit of exposure. One roentgen (R) equals 2.58 x l0-- 4 coulombs/kilogram of air (See Exposure).
(112) Sanitary sewerage means a system of public sewers for carrying off waste and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant.
(113) Scattered radiation means radiation whose direction has been altered during passage through matter. (It may have been modified also by a decrease in energy.)
(114) Sealed source means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.
(115) Shallow dose equivalent (H5), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm 2) averaged over an area of one square centimeter.
(116) Shutter means: (i) in beam therapy equipment, an adjustable device, generally of lead, fixed to the X- or gamma-ray source housing to intercept or collimate the useful beam; or (ii) in diagnostic equipment, an adjustable device used to collimate the useful beam.
(117) SI means an abbreviation of the International System of Units.
(118) 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 (one Sv = 100 rem).
(119) Site boundary means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.
(120) Source material means:
(i) uranium or thorium, or any combination thereof, in any physical or chemical form; or
(ii) ores that contain by weight one-twentieth of one percent (0.05 percent) or more of uranium, thorium, or any combination of uranium and thorium, Source material does not include special nuclear material.
(121) Source of radiation means any radioactive material or any device or equipment emitting, or capable of producing, radiation.
(122) Source-skin distance (source-surface distance) means the distance measured along the central ray from the center of the front surface of the source (X-ray focal spot or sealed radioactive source) to the surface of the irradiated object.
(123) Special form radioactive material means radioactive material which satisfies the following conditions:
(i) it is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;
(ii) the piece or capsule has at least one dimension not less than five millimeters (0.197 inch); and
(iii) it satisfies the additional requirements specified in section 71 .4, special form radio-active material, of 10 CFR 71 (see section 16.200 of this Part).
(124) Special nuclear material means: (i) plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the U.S. Nuclear Regulatory Commission, pursuant to 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; or (ii) any material artificially enriched by any of the foregoing but does not include source material.
(125) Special nuclear material in quantities not sufficient to form a critical mass means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 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 such ratios for all of the kinds of special nuclear material in combination shall not exceed one. For example, the following quantities in combination would not exceed the limitation and are within the formula:
350 200 200
(126) State means the State of New York, unless the context of this Part clearly indicates that a different meaning is intended.
(127) 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 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.
(128) Stray radiation means the sum of leakage and scattered radiation.
(129) Supervision as used in radioactive materials licenses means the training of persons in the use of radioactive materials in other than medical procedures. Such training must include at least 30 hours of instruction in the principles and practices of radiation protection, radioactivity measurement standardization and monitoring techniques and instruments, mathematics and calculations basic to the use and measurement of radioactivity, and biological effects of radiation.
(130) Survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.
(131) Therapeutic type protective tube housing means:
(i) for X-ray therapy equipment not capable of operating at 500 kVp or above, an X-ray tube housing so constructed that the leakage radiation at a distance of one meter from the source does not exceed one roentgen in an hour when the tube is operated at its maximum rated continuous current for the maximum rated tube potential; or
(ii) for X-ray therapy equipment capable of operation at 500 kVp or above, an X ray tube housing so constructed that leakage radiation at a distance of one meter from the source does not exceed 0.1 percent of the useful beam dose rate at one meter from the source for any of its operating conditions.
(132) These regulations mean all parts of Part 16 of the State Sanitary Code.
(133) Total effective dose equivalent (TEDE) means the sume of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
(134) REPEALED and RESERVED.
(i) For diagnostic uses of radioactive materials, such training shall include at least 200 hours of instruction in the principles and practices of radiation protection, radioactivity measurement standardization and monitoring techniques and instruments, mathematics and calculations basic to the use and measurement of radioactivity, and biological effects of radiation, and at least 500 hours of clinical radionuclide training in an institutional nuclear medicine program which includes study, and discussion with preceptor, of case histories to establish the most appropriate diagnostic procedures, limitations, contraindications, etc.; supervised examination of patients to determine the suitability for radionuclide diagnosis and recommendation dosage to be prescribed (records of such clinical training, including the name of the preceptor shall be maintained on file at the institution for at least six years); collaboration in calibration of the dose and the actual administration of the dose to the patient, including calculations of the radiation dose, related measurements and plotting of data; and follow-up of patients when required. The 200 hours of basic training may be obtained concurrently with the 500 hours of clinical training if both types of training are taken concurrently as part of the same program.
(ii) For therapeutic uses of radiopharmaceuticals, such training shall include 200 hours of instruction in the topics described in subparagraph (i) of this paragraph, and 500 hours of supervised clinical experience at a medical institution in the use of radiopharmaceuticals for the treatment of disease which includes study and discussion with preceptor of case histories to establish appropriate therapeutic procedures, limitations, contraindications, etc.; supervised examination of patients to determine the suitability for radiopharmaceutical therapy and the appropriate dosage to be prescribed, (records of the patients treated, including the name of the preceptor shall be maintained on file at the institution for at least six years).
(iii) For therapeutic uses of radioactive sources by surface, intracavitary or interstitial application, such training shall include 200 hours of instruction in the topics described in subparagraph (i) of this paragraph, supervised clinical experience at a medical institution which included at least one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of a preceptor at a medical institution.
(135) U.S. 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 U.S. Atomic Energy Commission, its chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the administrator thereof pursuant to 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 transferred to the Secretary of Energy pursuant to 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.)
(136) Unrefined and unprocessed ore means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.
(137) Use as used in radioactive materials licenses means to employ or apply radioactive materials for the licensed purpose. It shall include instruction of, and responsibility for, technical and support staff members. lt does not include training others in the techniques of use of radioactive materials for the purpose of qualifying for licensure. In licenses authorizing human use of radioactive materials use will also include:
(i) ordering or directing the administration of radiation of radioactive materials to humans, including the method or route of administration;
(ii) actual use of, or direction of technologists or other paramedical personnel in the use of radioactive material;
(iii) interpretation of results of diagnostic procedures; and
(iv) regular view of the progress of patients receiving therapy and modification of the originally prescribed dose as warranted by the patient * s reaction to radiation therapy.
(138) Useful beam means the radiation which passes through the source or tube-housing port and the aperture of the collimating device when the exposure switch or timer is activated.
(139) Very high radiation area means an area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of five Gy (500 rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates.3
(140) Waste handling licensees mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive wastes.
(141) Week means seven consecutive days starting on Sunday.
(142) 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:
Organ Dose Weighting Factors
|Organ or tissue||WT|
|Red Bone Marrow||0.12|
3At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.
a 0.30 results from 0.06 for each of five “remainder” organs, excluding the skin and the lens of the eye, that receive the highest doses.
b For purposes 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.
(143) Whole body means, for purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee.
(144) Worker means an individual engaged in work under a license or registration issued by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.
(145) Working level (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy. The short-lived radon daughters, are — for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.
(146) Working level month (WLM) means an exposure to one working level for 170 hours — 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.
(147) Year means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.
VOLUME A (Title 10)