16 Del. Admin. Code § 4465-D-3.0

Current through Register Vol. 28, No. 7, January 1, 2025
Section 4465-D-3.0 - Definitions.

As used in Part D:

"A1" means the maximum activity of special form radioactive material permitted in a Type A package.

"A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package.

These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

"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.

"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. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material" means any material made radioactive by a particle accelerator.

"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).

"Address of use" means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

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

"Agency" means the Division of Public Health, Delaware Department of Health and Social Services.

"Agreement State" means any State with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

"Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of these regulations; or
(2) 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.

"Airline respirator" (see "Supplied-air respirator (SAR)").

"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.

"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 to 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 Appendix B of this regulation.

"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 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 or registered sources of radiation in the public interest.

"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 trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"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 (SAR's) and self-contained breathing apparatus (SCBA) units.

"Authorized user" means a practitioner of the healing arts who is identified as an authorized user on an Agency, Agreement State, Licensing State or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

"Background radiation" means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) 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 or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.

"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

"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.

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

"Byproduct material" means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;
(2) 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 solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;
(3)
(i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or
(ii) Any material that-
(A) Has been made radioactive by use of a particle accelerator; and
(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and
(4) Any discrete source of naturally occurring radioactive material, other than source material, that-
(i) The 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; and
(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

"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. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

"Calibration" means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

"CFR" means Code of Federal Regulations.

"Chiropractic" means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.

"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.

"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.

"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 50-year period following the intake.

"Committed effective dose equivalent" (HE.50) is the sum of the products of the weighting factors (wT) 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 = Σ wT HT,50).

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

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

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

"Curie" means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

"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.

"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).

"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

"Dentist" shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.

"Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the 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 re-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 as amended.)

"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. Depleted uranium does not include special nuclear material.

"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 Appendix B of this regulation.

"Discrete Source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"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).

"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.

"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, "radiation dose" is an equivalent term.

"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.

"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.

"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = [SIGMA] wTHT).

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

"Exposure" generally means being exposed to ionizing radiation or to radioactive material;

"Exposure Units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section 9.1 of Part A for Units of Exposure and Dose.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"External Source" means all ionizing radiation sources that could present exposure or external dose to an individual.

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

"Facility" means the location, building vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.

"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.

"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.

"Fit Test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency 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.

"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

"Healing arts" includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

"Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

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

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

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

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or
(2) 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. [See the definition of DAC-hours in 4465 Part D of these regulations.]
(3) Dose equivalent by the use of survey data.

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

"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.

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

"JRCNMT" means Joint Review Committee on Nuclear Medicine Technology

"JRCERT" means Joint Review Committee on Education in Radiologic Technology

"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

"License" means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.

"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state. For the purpose of this regulation, Advanced Practice Registered Nurses (APRNs) and Physicians Assistants (PAs) may order diagnostic or supportive x-ray procedures for patients in accordance with Title 24, Delaware Code. APRNs and PAs who supervise, perform, view, or interpret x-ray procedures do so within their scope of practice, as governed by Title 24, Delaware Code.

"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

"Licensee" means the holder of a license.

"Limits" [See "Dose limits"].

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

"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities, as defined by the federal Nuclear Regulatory Commission.

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

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

"Misadministration" means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.

"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.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"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.

"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.

"Notice of Violation" means a written statement of one or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

Corrective steps to be taken to prevent recurrence; and

The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

"Occupational dose" means the dose received by an individual in the course of employment, education or training, in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

"Office of Engineering" means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.

"Office of Radiation Control" means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

"Owner/Leasee" means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.

"Package" means the packaging together with its radioactive contents as presented for transport.

"Particle accelerator" [See "Accelerator"].

"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].

"Personnel monitoring equipment" [See "Individual monitoring devices"].

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

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

"Podiatrist" means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

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

"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.

"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.

"Principal Supervisor" means the licensed practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.

"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. 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 in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

"Qualified expert" means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.

"Qualified medical physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and
2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or
3. Is credentialed in accordance with Regulation 4465, Part X, Therapeutic Radiation machines, subsection 3.4, as amended.

"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.

"Quality factor" (Q) means the modifying factor, listed in Tables I and II of Part A, Section 13.0, that is used to derive dose equivalent from absorbed dose.

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

"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"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 non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"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 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" [See "Dose"].

"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

"Radiation Safety Officer" or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

"Radiation Technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

"Radiation Technologist" means any individual who has successfully completed a JRCERT or JRCNMT approved program in radiation technology and has passed a national certification examination in his or her field of specialization.

"Radiation Technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" [See "Bioassay"].

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and the Act.

"Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.

"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.

"Rem" means the traditional 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)

"Research and development" means

(1) theoretical analysis, exploration, or experimentation; or
(2) 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 in the healing arts.

"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 materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of these regulations.

"Restricted area" means an 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. 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.

"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A, subsection 9.1).

"State Radiation Control Act" or "the Act" means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.

"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

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

"Shallow dose equivalent" (Hs), 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/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.

"Sievert" means the Standard Internationale (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)

"Source material" means:

(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or
(2) Ores that contain by weight one-twentieth of 1 percent (0.05 percent) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;
(2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and
(3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the 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
(2) Any material artificially enriched by any of the foregoing but does not include source material.

"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 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

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"Standard Internationale (SI)" means the international metric systems of measurement.

"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"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.

"Test" means the process of verifying compliance with an applicable regulation.

"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.

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

"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.

"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in subsection 39.1.6 of these regulations.

"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"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.

"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 500 rads (5 grays) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates. 12/

"Veterinarian" shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.

"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

"Week" means 7 consecutive days starting on Sunday.

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

"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, including but not limited to employees, but does not include the licensee or registrant.

"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" (WLM) means an exposure to 1 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.

"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. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

1 2/ At 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.

16 Del. Admin. Code § 4465-D-3.0

22 DE Reg. 401 (11/1/2018)
23 DE Reg. 306 (10/1/2019)
28 DE Reg. 312 (10/1/2024) (Final)