South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-63 - Radioactive Materials (Title A)
Part III - STANDARDS FOR PROTECTION AGAINST RADIATION
Section 61-63.III.RHA 3.2 - Definitions

Universal Citation: SC Code Regs 61-63.III.RHA 3.2

Current through Register Vol. 48, No. 9, September 27, 2024

As used in this part:

3.2.1 "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the gray (Gy).

3.2.2 "Activity" is the rate of disintegration (transformation) or decay of radioactive material. The units of activity are the curie (Ci) and the becquerel (Bq).

3.2.3 "Adult" means an individual 18 or more years of age.

3.2.4 "Airborne radioactivity" area means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations--

i) In excess of the derived air concentrations (DACs) specified in Appendix B, RHA 3.53, 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.

3.2.5 "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.

3.2.6 "ALARA" (acronym for "as low as is reasonably achievable") means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics 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 materials in the public interest.

3.2.7 "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 5 rems (0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Table 1, Columns 1 and 2, of Appendix B, RHA 3.53).

3.2.8 "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.

3.2.9 "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.

3.2.10 "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 global fallout as it exists in the environment from the testing of nuclear explosive devices. "Background radiation" does not include radiation from source, byproduct, or special nuclear materials regulated by the Department.

3.2.11 "Bioassay" (radiobioassay) 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.

3.2.12 "Chelating agent" means amine polycarboxylic acids, hydrocarboxylic, gluconic acid, and polycarboxylic acids.

3.2.13 "Chemical description" means a description of the principal chemical characteristics of a low-level radioactive waste.

3.2.14 "Class" (or lung class or inhalation 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.

3.2.15 "Collective dose" is 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.

3.2.16 "Committed dose equivalent" (H) 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.

3.2.17 "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 these organs or tissues (HE,50 = 508)D WT HT,50).

3.2.18 "Computer-readable medium" means a medium selected from the available technologies, as authorized by the Department, that can be used to transfer the information to the Department's computer.

3.2.19 "Consignee" means the designated receiver of the shipment of low-level radioactive waste.

3.2.20 "Constraint (dose constraint)" means a value above which specified licensee actions are required.

3.2.21 "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason.

3.2.22 "Critical Group" means the group of individuals reasonably expected to receive the greatest exposure to residual radiation for any applicable set of circumstances.

3.2.23 "Declared pregnant woman" means a woman who has voluntarily informed the licensee, 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.

3.2.24 "Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to level that permits 1) release of the property for unrestricted use and termination of the license; or 2) release of the property under restricted conditions and termination of the license.

3.2.25 "Decontamination facility" means a facility operating under a license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this part, is not considered to be a consignee for LLW shipments.

3.2.26 "Deep-dose equivalent" (Hd), which applies to external whole-body exposure, is the dose equivalent at a tissue depth of 1 cm (1000 mg/cm2).

3.2.27 "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.

3.2.28 "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 (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Table 1, Column 3, of Appendix B, RHA 3.53.

3.2.29 "Derived air concentration-hour" (DAC-hour) is 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 may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 5 rems (0.05 Sv).

3.2.30 "Disposal container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see "high integrity container"). Note that for some shipments, the disposal container may be the transport package.

3.2.31 "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).

3.2.32 "Distinguishable from Background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

3.2.33 "Dose or radiation 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, as defined in other paragraphs of this section.

3.2.34 "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 rem and sievert (Sv).

3.2.35 "Effective dose equivalent" (HE) is the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factors (WT) applicable to each of the body organs or tissues that are irradiated (HE = 508)D WT HT).

3.2.36 "Embryo/fetus" means the developing human organism from conception until the time of birth.

3.2.37 "Entrance or access point" means any location through which an individual could gain access to radiation areas or to radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

3.2.38 "EPA identification number" means the number received by a transporter following application to the administrator of EPA as required by 40 CFR Part 263.

3.2.39 "Exposure" means being exposed to ionizing radiation or to radioactive material.

3.2.40 "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

3.2.41 "Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

3.2.42 "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.

3.2.43 "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.

3.2.44 "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

3.2.45 "Generally applicable environmental radiation standards" means standards issued by the 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.

3.2.46 "Generator" means a licensee operating under a Commission or Agreement State license who (1) is a radioactive waste generator as defined in this part, or (2) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (e.g. waste generated as a result of decontamination or recycle activities).

3.2.47 "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

3.2.48 "High Integrity Container (HIC)" means a container commonly designed to meet the structural stability requirements of Appendix E, RHA 3.56.2.2, and to meet Department of Transportation requirements for a Type A package.

3.2.49 "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 a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates.

3.2.50 "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

3.2.51 "Individual monitoring" means:

(1) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(2) The assessment of committed effective dose equivalent by bioassay (see Bioassay) or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e., DAC-hours; or

(3) The assessment of dose equivalent by the use of survey data.

3.2.52 "Individual monitoring devices (individual monitoring equipment)" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, and personal (lapel) air sampling devices.

3.2.53 "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

3.2.54 "Land disposal facility" means the land buildings and structures, and equipment which are intended to be used for the disposal of radioactive wastes.

3.2.55 "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 centimeter (300 mg/cm2).

3.2.56 "Licensed material" means source material, special nuclear material, or byproduct material received, possessed, used, transferred or disposed of under a general or specific license issued by the Department.

3.2.57 "Limits (dose limits)" means the permissible upper bounds of radiation doses.

3.2.58 "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

3.2.59 "Lost or missing licensed material" means licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

3.2.60 "Member of the public" means any individual except when that individual is receiving an occupational dose.

3.2.61 "Minor" means an individual less than 18 years of age.

3.2.62 "Monitoring" (radiation monitoring, radiation protection monitoring) means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

3.2.63 "Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or 2 levels of any radioactive material listed in Appendix G to Part 3 of these Regulations. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.

3.2.64 "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.

3.2.65 "Nonstochastic effect" means health effects, 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 (also called a deterministic effect).

3.2.66 "NRC Forms 540, 540A, 541, 541A, 542, and 542A" are official NRC forms referenced in this regulation. Licensees need not use originals of these NRC Forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information. Upon agreement between the shipper and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.

3.2.67 "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 or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released under RHA 4.32, or from voluntary participation in medical research programs, or as a member of the public.

3.2.68 "Package" means the assembly of components necessary to ensure compliance with the packaging requirements of DOT regulations, together with its radioactive contents, as presented for transport.

3.2.69 "Physical description" means the items called for on NRC Form 541 to describe a low-level radioactive waste.

3.2.70 "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

3.2.71 "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

3.2.72 "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.

3.2.73 "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.

3.2.74 "Public dose" means the dose received by a member of the public from exposure to radiation or to radioactive material released by a licensee, or to any other source of radiation under the control of the licensee. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual had received, from exposure to individuals administered radioactive material and released under RHA 4.32, or from voluntary participation in medical research programs.

3.2.75 "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.

3.2.76 "Quality Factor" (Q) means the modifying factor (listed in tables 1 and 2 of RHA 3.3) that is used to derive dose equivalent from absorbed dose.

3.2.77 "Quantitative fit test" (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

3.2.78 "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at 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.

3.2.79 "Residual Radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with this Regulation.

3.2.80 "Residual waste" means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.

3.2.81 "Respiratory protective device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

3.2.82 "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.

3.2.83 "Self-contained breathing apparatus" (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

3.2.84 "Shallow-dose equivalent" (Hs), which applies to the external exposure of the skin of the_whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

3.2.85 "Shipper" means the licensed entity (i.e. the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.

3.2.86 "Shipping paper" means NRC Form 540 and if required, NRC Form 540A which includes the information required by DOT in 49 CFR Part 172.

3.2.87 "Source material" means (1) uranium or thorium, or any combination thereof, in any physical or chemical form, or (2) ores which contain by weight one-twentieth of one percent (0.05 percent) or more of (a) uranium, (b) thorium, or (c) any combination thereof. Source material does not include special nuclear material (SNM).

3.2.88 "Special nuclear material" means (1) plutonium, uranium-233, uranium-enriched in the isotope-233 or the isotope-235, or (2) any material artificially enriched by any of the foregoing. This definition does not include source material.

3.2.89 "Stochastic effects" means health effects that occur 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.

3.2.90 "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.

3.2.91 "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

3.2.92 "Total Effective Dose Equivalent" (TEDE) means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

3.2.93 "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radioactive material, where A1 and A2 are given in Appendix A 10 CFR Part 71 or may be determined by procedures described in Appendix A 10 CFR Part 71.

3.2.94 "Uniform Low-Level Radioactive Waste Manifest or uniform manifest" means the combination of NRC Forms 540, 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent.

3.2.95 "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.

3.2.96 "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 500 rads (5 grays) in 1 hour at 1 meter from a radiation source or from any surface that the radiation penetrates.

[Note: At very high doses received at high dose rates, units of absorbed dose (e.g., rads and grays) are appropriate, rather than units of dose equivalent (e.g., rems and sieverts).]

3.2.97 "Waste collector" means an entity, operating under a license issued by the Department, the U.S. Nuclear Regulatory Commission, or another Agreement State, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.

3.2.98 "Waste description" means the physical, chemical and radiological description of a low-level radioactive waste as called for on NRC Form 541.

3.2.99 "Waste generator" means an entity, operating under a license issued by the Department, the U.S. Nuclear Regulatory Commission, or another Agreement State, who possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a "waste generator" if the transfer of low-level radioactive waste from its facility is defined as "residual waste."

3.2.100 "Waste processor" means an entity, operating under a license issued by the Department, the U.S. Nuclear Regulatory Commission, or another Agreement State, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility.

3.2.101 "Waste type" means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste solidified in a specifically defined media).

3.2.102 "Weighting factor, WT," for an organ or tissue (T) is 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

Gonads ...................................................................

0.25

Breast ...................................................................

0.15

Red bone marrow ..........................................................

0.12

Lung .....................................................................

0.12

Thyroid ..................................................................

0.03

Bone surfaces ............................................................

0.03

Remainder ..........................................................

[FN1] 0.30

Whole Body .........................................................

[FN2] 1.00

[FN1] 0.30 results from 0.06 for each of 5 "remainder" organs (excluding the skin and the lens of the eye) that receive the highest doses.

[FN2] 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.

3.2.103 "Working level" (WL) is any combination of short-lived radon daughters (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) in 1 liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy.

3.2.104 "Working level month" (WLM) means an exposure to 1 working level for 170 hours (2,000 working hours per year/12 months per year = approximately 170 hours per month).

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

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