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16 DE Admin. Code 4465
Copies of the proposed regulations are available for review in the May 1, 2015 edition of the Delaware Register of Regulations, accessible online at: http://regulations.delaware.gov/default.shtml or by calling the Office of Radiation Control at (302) 744-4546.
Sec. D.2 Scope. Except as specifically provided in other Parts of the regulations, Part D applies to persons licensed or registered by the Agency to receive, possess, use, transfer, or dispose of sources of radiation. The dose limits in Part D do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, or to voluntary participation in medical research programs.
Sec. D.3 Definitions. As used in Part D:
“Equivalent dose (H)” means the product of absorbed dose (D) and the radiation weighting factor (wR), formerly called the quality factor (Q): H = wR H D. The unit of equivalent dose is the Sievert (Sv). See Appendix C, Part F, for a table of radiation weighting factors (WR).
"Tissue Weighting factor wT”” means a weighting factor used in calculating effective dose intended to assign the proportion of risk of stochastic effects resulting from irradiation of a particular tissue compared to uniform whole body irradiation.
Tissue Weighting Factors (wT) Assigned by the International Commission on Radiological Protection*
wT
b. Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective equivalent dose (H) limit is not exceeded if the sum of the deep equivalent dose (H) divided by the total effective equivalent dose (H) limit, and one of the following, does not exceed unity:
c. Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee or registrant shall account for this intake and include it in demonstrating compliance with the limits.
d. Intake through Wounds or Absorption through Skin. The licensee or registrant shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated or accounted for pursuant to D.201.
b. The licensee or registrant shall make efforts to avoid substantial variation22 above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in D.208a.
Sec. D.701 Use of Process or Other Engineering Controls. The licensee or registrant shall use, to the extent practicable, process or other engineering controls, such as, containment or ventilation, to control the concentrations of radioactive material in air. (56 FR 23400, May 21, 1991 as amended at 60 Fr 20185, April 25, 1995)
Sec. D.702 Use of Other Controls. When it is not practicable to apply process or other engineering controls to restrict the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee or registrant shall, consistent with maintaining the total effective equivalent dose (H) ALARA, increase monitoring and limit intakes by one or more of the following means:
a. Standard Radiation Symbol. Unless otherwise authorized by the Agency, the symbol prescribed by D.901 shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:
b. Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of D.901a., licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.
c. Additional Information on Signs and Labels. In addition to the contents of signs and labels prescribed in Part D, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.
a. Posting of Radiation Areas. The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
b. Posting of High Radiation Areas. The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."
c. Posting of Very High Radiation Areas. The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."
d. Posting of Airborne Radioactivity Areas. The licensee or registrant shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."
e. Posting of Areas or Rooms in which Licensed or Registered Material is Used or Stored. The licensee or registrant shall post each area or room in which there is used or stored an amount of licensed or registered material exceeding 10 times the quantity of such material specified in Appendix C with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
Sec. D.905 Exemptions to Labeling Requirements. A licensee or registrant is not required to label:
i. Monitor the external surfaces of a labeled55 package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in A.2 of the regulations; and
ii. Monitor the external surfaces of a labeled66 package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in the regulations; and
Sec. D.1002 Method for Obtaining Approval of Proposed Disposal Procedures. A licensee or registrant or applicant for a license or registration may apply to the Agency for approval of proposed procedures, not otherwise authorized in the regulations, to dispose of licensed or registered material generated in the licensee's or registrant's operations. Each application shall include:
Sec. D.1004 Treatment or Disposal by Incineration. A licensee or registrant may treat or dispose of licensed or registered material by incineration only in the form and concentration specified in D.1005 or as specifically approved by the Agency pursuant to D.1002.
Sec. D.1007 Compliance with Environmental and Health Protection Regulations. Nothing in D.1001, D.1002, D.1003, D.1004, D.1005, or D.1006 relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials that may be disposed of to D.1001, D.1002, D.1003, D.1004, D.1005, or D.1006.
Sec. D.1104 Records of Tests for Leakage or Contamination of Sealed Sources. Records of tests for leakage or contamination of sealed sources required by D.401 shall be kept in units of becquerel or microcurie and maintained for inspection by the Agency for 5 years after the records are made.
a. Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to D.502, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of equivalent dose (H) and records made using units in effect before the effective date of Part D need not be changed. The licensee or registrant shall make available to all employees who have been exposed to radiation their appropriate Form Y or equivalent records. These records shall include, when applicable:
b. Recordkeeping Frequency. The licensee or registrant shall make entries of the records specified in D.1107a. at intervals not to exceed 1 year.
c. Recordkeeping Format. The licensee or registrant shall maintain the records specified in D.1107a. on Agency Form Z, in accordance with the instructions for Agency Form Z, or in clear and legible records containing all the information required by Agency Form Z.
Sec. D.1111 Form of Records. Each record required by Part D shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.
a. Telephone Reports. Each licensee or registrant shall report to the Agency by telephone as follows:
b. Written Reports. Each licensee or registrant required to make a report pursuant to D.1201a. shall, within 30 days after making the telephone report, make a written report to the Agency setting forth the following information:
a. Immediate Notification. Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:
b. Twenty-Four Hour Notification. Each licensee or registrant shall, within 24 hours of discovery of the event, report to the Agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:
a. Reportable Events. In addition to the notification required by D.1202, each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:
b. Contents of Reports
Sec. D.1204 Reports of Planned Special Exposures. The licensee or registrant shall submit a written report to the Agency within 30 days following any planned special exposure conducted in accordance with D.206, informing the Agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by Sec. D.1106.
Ci GBq
a/ The Agency may require as a license condition, or by rule, regulation, or order pursuant to A.7 of the regulations, reports from licensees or registrants who are licensed or registered to use radionuclides not on this list, in quantities sufficient to cause comparable radiation levels.
Sec. D.1208 Reports of Leaking or Contaminated Sealed Sources. The licensee or registrant shall file a report within 5 days with the Agency if the test for leakage or contamination [required pursuant to D.401] indicates a sealed source is leaking or contaminated. The report shall include the equipment involved, the test results and the corrective action taken.
Sec. D.1301 Vacating Premises. Each specific licensee or registrant shall, no less than 30 days before vacating or relinquishing possession or control of premises notify the Agency in writing of intent to vacate. When deemed necessary by the Agency, the licensee shall decontaminate the premises in such a manner as the Agency may specify.
"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.
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:
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:
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 = Σ 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:
"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.
"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology
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.
"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 are defined in T.2 of these regulations.
"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:
"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 State-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” means an individual qualified in accordance with Regulation 4465, Part X, Therapeutic Radiation Machines, Section 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 A.13, 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/JRCCVT approved program in radiation technology and has passed a national certification examination in his/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.9.1 of this part.)
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:
"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:
"Special nuclear material" means:
"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:
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.82/
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.
5.4 To implement the ALARA requirements of subsection 5.2, and notwithstanding the requirements in Section 13.0, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to 10 CFR Part 50.34a of the USNRC regulations, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert (10 mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in Section 47.0 and promptly take appropriate corrective action to ensure against recurrence.
12.2 The licensee or registrant shall make efforts to avoid substantial variation*/ above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in subsection 12.1.
Compliance with Environmental and Health Protection Regulations. Nothing in these regulations relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials that may be disposed of by the licensee or registrant.
47.2 Contents of Reports.
47.2.2 Each report filed pursuant to subsection 47.1 shall include for each occupationally overexposeda/ individual: the name, unique identification number such as employee or Social Security number, and date of birth. With respect to the limit for the embryo/fetus in Section 12.0, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.
Sec. J.1 - Purpose and Scope. This Part establishes requirements for notices, instructions and reports by licensees or registrants to individuals engaged in activities under a license or registration and options available to such individuals in connection with Agency inspections of licensees or registrants to ascertain compliance with the provisions of the Act and regulations, orders, and licenses issued thereunder regarding radiological working conditions. The regulations in this Part apply to all persons who receive, possess, use, own, or transfer sources of radiation registered with or licensed by the Agency pursuant to Parts B and C of the regulations.
1.0 Purpose and Scope.
2.1 Each licensee or registrant shall post current copies of the following documents:
2.1.1 The regulations in this Part and in Part D of these regulations;
2.1.2 The license or certificate of registration,
2.1.3 The operating safety procedures applicable to activities under the license or registration; and
2.2 If posting of a document specified in subsections 2.1.1, or 2.1.3 is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.
2.3 Agency Form X "Notice to Workers" shall be posted conspicuously by each licensee or registrant as required by these regulations, see Appendix A.
2.4 Agency documents posted pursuant to subsection 2.1.4 shall be posted conspicuously within 5 working days after receipt of the documents from the Agency; the licensee's or registrant's response, if any, shall be posted within five working days after dispatch from the licensee or registrant. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.
2.5 Documents, notices, or forms posted pursuant to Section 2.0 shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.
3.1 All individuals who in the course of employment, education, or training are likely to receive in a year an occupational dose in excess of 1 millisievert (100 mrem):
3.1.1 Shall be kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;
3.1.2 Shall be instructed in the health protection problems associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;
3.1.3 Shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material;
3.1.4 Shall be instructed of their responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of the Act, these regulations, or license condition, or any unnecessary exposure to radiation or radioactive material;
3.1.5 Shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and
3.1.6 Shall be advised as to the radiation exposure reports which workers shall be furnished pursuant to Section 4.0.
3.2 In determining those individuals subject to the requirements of subsection 3.1, licensees or registrant must take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and/or radioactive material which can reasonably be expected to occur during the life of a licensed facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.
4.1.1 Be in writing;
4.1.2 Include appropriate identifying data such as: the name of the licensee or registrant, the name of the individual, and the individual's unique identification number, such as employee number or Social Security Number;
4.1.3 Include the individual's exposure information; and
4.2 The licensee shall provide an annual report to each individual required to be monitored under these regulations of the dose received in that monitoring year if their occupational dose is in excess of 1 millisievert (100 mrem).
4.3 Each licensee or registrant shall furnish a written report of the worker's exposure to sources of radiation at the request of a worker currently or formerly engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to Part D, Section 17.0 of these regulations such report shall be furnished within 30 days from the date of the request, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated during this period.
4.4 When a licensee or registrant is required pursuant to Sections 46.0, 47.0, 48.0, or 49.0 of these regulations to report to the Agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the Agency.
5.2 During an inspection, Agency inspectors may consult privately with workers as specified in Section 6.0. The licensee or registrant may accompany Agency inspectors during other phases of an inspection.
5.3 If, at the time of inspection, an individual has been authorized by the workers to represent them during Agency inspections, the licensee or registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.
5.4 Each worker's representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in Section 3.0.
5.5 Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors.
5.6 With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany Agency inspectors during the inspection of physical working conditions.
5.7 Notwithstanding the other provisions of Section 5.0, Agency inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an Agency of the US Government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.
6.0 Consultation with Workers During Inspections.
6.1 Agency inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of these regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.
6.2 During the course of an inspection, any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of the Act, these regulations, or license condition, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements of subsection 7.1.
6.3 The provisions of subsection 6.2 shall not be interpreted as authorization to disregard instructions pursuant to Section 3.0
7.1 Any worker or representative of workers believing that a violation of the Act, these regulations, or license conditions exists or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged may request an inspection by giving notice of the alleged violation to the Office of Radiation Control. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the Office of Radiation Control no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the Agency, except for good cause shown.
7.2 If, upon receipt of such notice, the Office of Radiation Control determines that the complaint meets the requirements set forth in subsection 7.1, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections pursuant to Section 7.0 need not be limited to matters referred to in the complaint.
7.3 No licensee, registrant, or contractor or subcontractor of a licensee or registrant shall discharge or in any manner retaliate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of such worker or others of any option afforded by this Part.
8.1 If the Office of Radiation Control determines, with respect to a complaint under Section 7.0, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the Office of Radiation Control shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the Division of Public Health. Such Agency will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the Division of Public Health. The Division of Public Health will provide the complainant with a copy of such statement by certified mail.
8.2 Upon the request of the complainant, the Division of Public Health may hold a conference in which the complainant and the licensee or registrant may orally present their views. A conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written and oral views presented, the Division of Public Health shall affirm, modify, or reverse the determination of the “Office of Radiation Control” and furnish the complainant and the licensee or registrant a written notification of the decision and the reason therefore.
APPENDIX A
All licensed or registered activities are subject to inspection by representatives of the Office of Radiation Control. In addition, any worker or representative of workers who believes that there is a violation of the Delaware Radiation Control Act, the regulations issued thereunder, or the terms of the facility license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by sending a notice of the alleged violation to the Office of Radiation Control. The written request must set forth the specific grounds for the notice, and must be signed by the worker as the representative of the workers. During inspections, Agency inspectors may confer privately with workers, and any worker may
INSTRUCTIONS AND ADDITIONAL INFORMATION PERTINENT TO THE COMPLETION OF AGENCY FORM Y
1. Type or print the full name of the monitored individual in the order of last name
2. Enter the individual's unique identification number, including punctuation. This number should preferably be the employee number (EN). If the EN is unavailable; enter the 9-digit social security number (SSN). If the individual has no social security number, enter the number from another official identification such as a passport or work permit.
3. Enter the code for the type of identification used as shown below:
Code ID Type
4. Check the box that denotes the sex of the individual being monitored.
5. Enter the date of birth of the individual being monitored in the format MM/DD/YYYY.
6. Enter the monitoring period for which this report is filed. The format should be MM/DD/YYYY - MM/DD/YYYY.
7. Enter the name of the licensee or facility not licensed by NRC that provided monitoring.
8. Enter the NRC license number or numbers.
9. Place an "X" in Record, Estimate, or No Record. Choose "Record" if the dose data listed represent a final determination of the dose received to the best of the licensee's knowledge. Choose "Estimate" only if the listed dose data are preliminary and will be superseded by a final determination resulting in a subsequent report. An example of such an instance would be dose data based on self-reading dosimeter results and the licensee intends to assign the record dose on the basis of TLD results that are not yet available.
10. Place an "X" in either Routine or “PSE” (Planned Special Exposure). Choose "Routine" if the data represent the results of monitoring for routine exposures. Choose "PSE" if the listed dose data represents the results of monitoring of planned special exposures received during the monitoring period. If more than one PSE was received in a single year, the licensee should sum them and report the total of all planned special exposures.
OF AGENCY FORM Y (Con’t.) All doses should be stated in rems
11. Enter the deep dose equivalent (DDE) to the whole body.
12. Enter the eye dose equivalent (LDE) recorded for the lens of the eye.
13. Enter the shallow dose equivalent recorded for the skin of the whole body (SDE, WB).
14. Enter the shallow dose equivalent recorded for the skin of the extremity receiving the maximum dose
15. Enter the committed effective dose equivalent (CEDE).
16. Enter the committed dose equivalent (CDE) recorded for the maximally exposed organ.
17. Enter the committed dose equivalent (TEDE). The TEDE is the sum of items 11 and 15.
18. Enter the total organ dose equivalent (TODE) for the maximally exposed organ. The TODE is the sum of items 11 and 16.
19. Signature of the monitored individual.The signature of the monitored individual on this form indicates that the information contained on the form is complete and correct to the best of his or her knowledge.
20. [OPTIONAL] Enter the date this form was signed by the monitored individual.
21. Enter the name of the licensee or facility not licensed by the Agency providing monitoring for exposure to radiation (such as a VA facility) or the employer if the individual is not employed by the licensee and the employer chooses to maintain exposure records for its employees.
22. [OPTIONAL] Signature of the person designated to represent the licensee or employer entered in item
21. The licensee or employer who chooses to countersign the form should have on file documentation of all the information on the Agency Form 4 being signed.
23. [OPTIONAL] Enter the date this form was signed by the designated representative.
INSTRUCTIONS AND ADDITIONAL INFORMATION PERTINENT TO THE COMPLETION OF AGENCY FORM Z
1. Type or print the full name of the monitored individual in the order of last name
2. Enter the individual's unique identification number, including punctuation. This number should preferably be the employee number (EN). If the EN is unavailable the 9-digit social security number (SSN). If the individual has no social security number, enter the number from another official identification such as a passport or work permit.
3. Enter the code for the type of identification used as shown below:
Code ID Type
4. Check the box that denotes the sex of the individual being monitored.
5. Enter the date of birth of the individual being monitored in the format MM/DD/YYYY.
6. Enter the monitoring period for which this report is filed. The format should be MM/DD/YYYY - MM/DD/YYYY.
7. Enter the name of the registered facility not licensed by NRC that provided monitoring.
8. Enter the registration number or numbers.
9. Place an "X" in Record, Estimate, or No Record. Choose "Record" if the dose data listed represent a final determination of the dose received to the best of the licensee's knowledge. Choose "Estimate" only if the listed dose data are preliminary and will be superseded by a final determination resulting in a subsequent report. An example of such an instance would be dose data based on self-reading dosimeter results and the licensee intends to assign the record dose on the basis of TLD results that are not yet available.
10. Place an "X" in either Routine or “PSE” (Planned Special Exposure). Choose "Routine" if the data represent the results of monitoring for routine exposures. Choose "PSE" if the listed dose data represents the results of monitoring of planned special exposures received during the monitoring period. If more than one PSE was received in a single year, the licensee should sum them and report the total of all planned special exposures.

1
At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate rather than units of equivalent dose (H), sievert and rem.

2
2 The National Council on Radiation Protection and Measurements recommended in NCRP Report No. 91 “Recommendations on Limits for Exposure to Ionizing Radiation” (June 1, 1987) that no more than 0.5 mSv (0.05 rem) to the embryo/fetus be received in any one month.

3
3 Retrofit shall not be required for locations within facilities where only radiation machines existed prior to [the effective date of the regulations] and met the previous requirements of 5 mSv (0.5 rem) in a year.

4
4 Labeling of packages containing radioactive materials is required by the Department of Transportation if the amount and type of radioactive material exceeds the limits for an accepted quantity or article as defined and limited by Department of Transportation regulations 49 CFR 173.403(m) and (w) and 173.421-424.

5
5 Labeled means labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in Department of Transportation regulations 49 CFR 172.436-440.

6
6 See Footnote # 33

7
7 A previous D.394 permitted burial of small quantities of licensed materials in soil before [date of rule that removed authorization], without specific Agency authorization.

8
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.

Last Updated: December 31 1969 19:00:00.
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