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Subject 391-3-17 RADIOACTIVE MATERIALS

Rule 391-3-17-.01 General Provisions. Amended

(1) Scope. Except as otherwise specifically provided, this Chapter, 391-3-17, applies to all persons who manufacture, produce, receive, possess, use, transfer, own, or acquire any source of radiation; provided, however, that nothing in this Chapter shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.[1] Nothing in Rule 391-3-17-.03 of this Chapter shall be interpreted as limiting the intentional exposure of patients to radiation for the purpose of diagnosis or therapy.
(2) Definitions. As used in this Chapter, these terms have the definitions set forth below. Additional definitions used only in a certain Rule will be found in that Rule.
(a) "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, LSA and SCO material, permitted in a Type A package. These values are either listed in the "Table of A1 and A2 Values for Radionuclides" of 49 CFR 173.435 or may be derived in accordance with the procedure prescribed in 49 CFR 173.433 -173.435.
(b) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the Gray (Gy).
(c) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.
(d) "Act" means Chapter 13 of the Official Code of Georgia, Annotated, entitled "Radiation Control" as amended.
(e) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the Curie (Ci) and the Becquerel (Bq).
(f) "Adult" means an individual 18 or more years of age.
(g) "Agreement State" means any State with which the U.S. Nuclear Regulatory Commission or the U.S. Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).
(h) "Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
(i) "Airborne radioactivity area" means a room, enclosure or operating area in which airborne radioactive materials, composed wholly or partly of licensed materials, exist in concentrations;
1. In excess of the derived air concentrations (DACs) specified in Appendix B, to 10 CFR 20.1001 -20.2401, 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.
(j) "Annually" means once every 12 calendar months or no later than the last day of the same calendar month of the following year.
(k) "As low as is reasonably achievable" (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this Chapter as is practical, consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to the 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.
(l) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Department.
(m) "Becquerel" (Bq) means the SI unit of activity. One Becquerel is equal to one disintegration or transformation per second.
(n) "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 this Chapter, "radiobioassay" is an equivalent term.
(o) "By product 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 utilizing 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 "by product 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:
(I) Has been made radioactive by use of a particle accelerator; and
(II) 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 Nuclear Regulatory Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and
(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.
(p) "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.
(q) "CFR" means the Code of Federal Regulations.
(r) "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.
(s) "Committed dose" means the radiation dose that will accumulate over time as a result of retention in the body of radioactive material. Committed dose is a generic term for internal dose and must be calculated by summing the projected dose over the 50 years after intake for all irradiated organs or tissues multiplying the doses to individual organs and tissues by applicable tissue weighting factors.
(t) "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.
(u) "Committed effective dose equivalent" (HE,50) is the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = [SIGMA] wT,HT,50).
(v) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility.
(w) "Curie" means a unit of quantity of radioactivity. One Curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7 x 1010 transformations per second (tps).
(x) "Daily" means once every calendar day worked.
(y) "Deep dose equivalent" (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of one centimeter (1,000 mg/cm2).
(z) "Department" means the Department of Natural Resources of the State of Georgia.
(aa) "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.
(bb) "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. (Annual Limit on Intake defined in Rule .03(2) (d) ) DAC values are given in Table 1, Column 3 of Appendix B to 10 CFR 20.1001 - 20.2401.
(cc) "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.
(dd) "Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent.
(ee) "Dose equivalent" (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and Sievert (Sv).
(ff) "Dose limits" means the permissible upper bounds of radiation doses established in accordance with this Chapter. For purposes of this Chapter, "limits" is an equivalent term.
(gg) "Effective dose equivalent" (HE) means the sum of the products of the dose equivalent to each organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = [SIGMA] wTHT).
(hh) "Embryo/fetus" means the developing human organism from conception until the time of birth.
(ii) "Entrance or access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.
(jj) "Explosive material" means any chemical compound, mixture, or device that produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.
(kk) "Exposure" means being exposed to ionizing radiation or to radioactive material.
(ll) "Exposure rate" means the exposure per unit of time, such as Roentgen per minute or milliroentgen per hour.
(mm) "External dose" means that portion of the dose equivalent received from any source of radiation outside the body.
(nn) "Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.
(oo) "Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.
(pp) "Generally applicable environmental radiation standards" means standards issued by the U.S. Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures, levels, 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.
(qq) "Gray" (Gy) means the SI unit of absorbed dose. One Gray is equal to an absorbed dose of one Joule/kilogram (100 rad).
(rr) "Hazardous waste" means those wastes designated as hazardous by U.S. Environmental Protection Agency regulations in 40 CFR Part 261.
(ss) "Healing arts" means medicine, dentistry, chiropractic, podiatry, osteopathy or veterinary medicine.
(tt) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in one hour at 30 centimeters from any source of radiation or from any surface that the radiation penetrates. For purposes of this Chapter, rooms or areas in which diagnostic x-ray systems are used for healing arts purposes are not considered high radiation areas.
(uu) "Human use" means the internal or external administration of radiation or radioactive material to human beings.
(vv) "Individual" means any human being.
(ww) "Individual monitoring" means the assessment of:
1. Dose equivalent by the use of:
(i) Individual monitoring devices, or
(ii) Survey data; or
2. Committed effective dose equivalent:
(i) By bioassay, or
(ii) By determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours [See the definition of DAC-hours in Rule 391-3-17-.03(2)(q) ].
(xx) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this Chapter, individual monitoring devices and personnel monitoring equipment are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescent dosimeters (TLDs), optically stimulated luminescent devices, pocket ionization chambers, and personal air sampling devices.
(yy) "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 Department.
(zz) "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.
(aaa) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.
(bbb) "Lens dose equivalent" (LDE) means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
(ccc) "License" means a license issued by the Department in accordance with the Regulations promulgated by the Board.
(ddd) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Department.
(eee) "Licensee" means any person who is licensed by the Department in accordance with this Chapter and the Act.
(fff) "Licensing State" means any state with regulations equivalent to the Suggested State Regulations for Control of Radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.
(ggg) "Limits" [See Dose limits].
(hhh) "Lost or missing licensed material" means licensed material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
(iii) "Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four 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 Section 71.4 of 10 CFR Part 71.
(jjj) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.
(kkk) "Member of the public" means any individual except when that individual is receiving an occupational dose.
(lll) "Minor" means an individual less than 18 years of age.
(mmm) "Monthly" means once every calendar month, not to exceed an interval of 35 days.
(nnn) "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 this Chapter, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.
(ooo) "NARM" means any naturally-occurring or accelerator-produced radioactive material. It does not include by product, source, or special nuclear material.
(ppp) "Natural radioactivity" means radioactivity of naturally-occurring nuclides.
(qqq) "NORM" (Naturally-Occurring Radioactive Material) means any nuclide which is radioactive in its natural physical state (i.e., not man-made), but does not include by product, source, or special nuclear material.
(rrr) "Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
(sss) "Occupational dose" means the dose received by an individual in the course of employment while engaged in activities licensed by the Department in which the individual's assigned duties involve exposure to licensed and unlicensed sources of radiation whether in the possession of the licensee, or other person. Occupational dose does not include doses received from background radiation, as a patient from medical practices, from exposure from individuals administered radioactive material and released in accordance with Rule 391-3-17-.05(37), from voluntary participation in medical research programs, or as a member of the public.
(ttt) "Package" means the assembly of components necessary to ensure compliance with packing requirements of DOT regulations together with its radioactive contents as presented for transport.
1. "Fissile material package" means a fissile material packaging together with its fissile material contents.
2. "Type B package" means a Type B packaging together with its radioactive contents. On approval, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kPa (100 lb/in2) gauge or pressure relief device that will allow the release of radioactive material to the environment under the tests specified in 10 CFR 71 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 CFR 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 CFR 71.13.
(uuu) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one MeV. For purposes of this definition, "accelerator" is an equivalent term.
(vvv) "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 department of the foregoing, but shall not include federal government agencies.
(www) "Personnel monitoring equipment" [See Individual monitoring devices].
(xxx) "Pharmacist" means any individual who is licensed to practice Pharmacy in this State by the Georgia State Board of Pharmacy.
(yyy) "Physician" means any person who is licensed to engage in the practice of medicine under the Authority of O.C.G.A. 43-34-20 or the limited practice of medicine under O.C.G.A. 43-35-1.
(zzz) "Positron Emission Tomography (PET) radionuclide production facility" is defined as a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.
(aaaa) "Principal activities," as used in this Chapter, means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no license material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.
(bbbb) "Public dose" means the dose received by a member of the public from radiation and/or radioactive material released by a licensee or from any other source of radiation under the control of a licensee. It does not include occupational dose, doses received from background radiation, doses received as a patient from medical practices, from exposure from individuals administered radioactive material and released in accordance with Rule 391-3-17-.05(37), or doses from voluntary participation in medical research programs.
(cccc) "Pyrophoric liquid" means any liquid that ignites spontaneously in dry or moist air at or below 130 °F (54.4 °C). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.
(dddd) "Qualified expert" means an individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology or the American Board of Health Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the above qualifications, training and experience in the clinical applications of radiation physics to radiation therapy, for example, individuals certified in Therapeutic Radiological Physics or X-Ray and Radium Physics by the American Board of Radiology, or those having equivalent qualifications.
(eeee) "Quality factor" (Q) means the modifying factor, listed in Tables 1 and 2 of this Rule that is used to derive dose equivalent from absorbed dose.
(ffff) "Quarterly" means once every three calendar months or no later than the last day of the third month after the initial month.
(gggg) "Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 Joule/kilogram (0.01 Gray).
(hhhh) "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 this Chapter, ionizing radiation is an equivalent term. Radiation, as used in this Chapter, does not include non-ionizing radiation, such as radiowaves, microwaves, visible, infrared, or ultraviolet light.
(iiii) "Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 5 mrem (0.05 mSv) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
(jjjj) "Radiation machine" means any device capable of producing radiation except those devices with radioactive material as the only source of radiation.
(kkkk) "Radiation Safety Officer" (RSO) means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations.
(llll) "Radioactive material" means any solid, liquid, or gas that emits radiation spontaneously.
(mmmm) "Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.
(nnnn) "Regulations of the U.S. Department of Transportation" means the regulations in 49 CFR Parts 100-189.
(oooo) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sievert).
(pppp) "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.
(qqqq) "Restricted area" means any area to which access is limited by the licensee for purposes of protecting individuals against undue risks from exposure to sources of radiation and radioactive material. A restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.
(rrrr) "Roentgen" means the special unit of exposure. One Roentgen (R) equals 2.58 x 10-4 Coulombs/kilogram of air.
(ssss) "Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.
(tttt) "Sealed Source and Device Registry" means the national registry that contains all the registration certificates, generated by both the NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.
(uuuu) "Shallow dose equivalent" (Hs), which applies to the external exposure of the skin of the whole body or the skin of an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).
(vvvv) "SI" means an abbreviation of the International System of Units.
(wwww) "Sievert" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in Sievert is equal to the absorbed dose in Gray multiplied by the quality factor (1 Sv = 100 rem).
(xxxx) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.
(yyyy) "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 one percent (0.05 percent) or more of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.
(zzzz) "Source material milling" means any activity that results in the production of by product material as defined by.01(2)(o) 2.
(aaaaa) "Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.
(bbbbb) "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 five millimeters (0.197 inch); and
3. It satisfies the test requirements specified by the U.S. Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the U.S. 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.
(ccccc) "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 U.S. Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material but does not include source material; or
2. Any material artificially enriched by any of the foregoing but does not include source material.
(ddddd) "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:


                image: ga/admin/2017/391-3-17-.01-1.gif

(eeeee) "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.
(fffff) "Test" means the process of verifying compliance with an applicable regulation.
(ggggg) "This Chapter" means all of the Rules in Chapter 391-3-17.
(hhhhh) "Total effective dose equivalent" (TEDE) means the sum of the effectivedose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).
(iiiiii) "U.S. Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers, and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 ( Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and retransferred 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).
(jjjjj) "Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.
(kkkkk) "Unrestricted area" means an area to which access is neither limited nor controlled by the licensee.
(lllll) "Very High Radiation Area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving an absorbed dose in excess of 500 rads (5 Grays) in one hour at one meter from a radiation source or from any surface that the radiation penetrates.
(mmmmm) "Waste" means those low-level radioactive wastes containing source, special nuclear, or by product material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or by product material as defined in.01(2)(o) 2., 3., and 4.
(nnnnn) "Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.
(ooooo) "Weekly" means once every calendar week, not to exceed an interval of ten days.
(ppppp) "Whole body" means, for purposes of external exposure, head, trunk, including male gonads, arms above the elbow, or legs above the knee.
(qqqqq) "Worker" means an individual engaged in work under a license issued by the Department and controlled by a licensee. If the licensee is an individual rather than one of the other legal entities defined under "person," the radiation exposure limits for the worker also apply to the individual who is the licensee.
(rrrrr) "Working level" (WL) means any combination of short-lived radon daughters in one liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy. The short-lived radon daughters for radon-222 are: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.
(sssss) "Working level month" (WLM) means an exposure to one working level for 170 hours. Two thousand working hours per year divided by 12 months per year is approximately equal to 170 hours per month.
(ttttt) "Year" means the period of time beginning in January used to determine compliance with the provisions of this Chapter. The licensee may change the starting date of the year used to determine compliance by the licensee provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.
(3) Exemptions from the Regulatory Requirements.
(a) General Provision. The Department may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of this Chapter as it determines are authorized by law and will not result in undue hazard to public health and safety or property.
(b) U.S. Department of Energy Contractors and U.S. Nuclear Regulatory Commission Contractors. Any U.S. Department of Energy contractor or subcontractor and any U.S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State are exempt from this Chapter to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:
1. Prime contractors performing work for the U.S. Department of Energy at U.S. government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;
2. Prime contractors of the U.S. Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;
3. Prime contractors of the U.S. Department of Energy using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and
4. Any other prime contractor or subcontractor of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission when the Department and the Nuclear Regulatory Commission jointly determine:
(i) That the exemption of the prime contractor or subcontractor is authorized by law; and
(ii) That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to public health and safety.
(4) Records. Each licensee shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in this Chapter.
(5) Inspections.
(a) Each licensee shall afford the Department at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.
(b) Each licensee shall make available to the Department for inspection, upon reasonable notice, records maintained pursuant to this Chapter.
(c) The Department or its designated representative is authorized under the authority of O.C.G.A. 31-5-5(b) to classify as confidential and privileged such documents, reports, and other information and data obtained from persons, firms, corporations, municipalities, counties, and other public authorities and political subdivisions where such matters relate to:
1. Trade secrets and commercial or financial information furnished to the Department on a privileged or confidential basis. Matters subject to this exemption are those that are customarily held in confidence by the originator. They include, but are not limited to:
(i) Information received in confidence, such as trade secrets, inventions, and proprietary data;
(ii) Technical reports and data, designs, drawings, specifications, formulas, or other types of proprietary information which are furnished to the Department or which are generated or developed by the Department or for the Department under contract.
2. Personnel and medical files and similar files, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Examples of files exempt from disclosure include, but are not limited to names or identifying information regarding individuals who have received exposure to radiation.
(d) Discovery of material qualified pursuant to 391-3-17-.01 (5)(c) shall be subject to the statutory requirements found in O.C.G.A. 31-5-5.
(6) Tests. Each licensee shall perform upon instructions from the Department, or shall permit the Department to perform, such reasonable tests as the Department deems appropriate or necessary, including, but not limited to, tests of:
(a) Sources of radiation;
(b) Facilities wherein sources of radiation are used or stored;
(c) Radiation detection and monitoring instruments; and
(d) Other equipment and devices used in connection with utilization or storage of licensed sources of radiation.
(7) Additional Requirements. The Department, by Rule or Regulation, and the Director by Order, may impose upon any licensee such requirements in addition to those established in this Chapter as it deems appropriate or necessary to minimize danger to public health and safety or property.
(8) Violations.
(a) An injunction or other court order may be obtained prohibiting any violation of the provisions of the Act, this Chapter, or any Order issued thereunder in accordance with Rule 391-3-17-.11. Any person who willfully violates any provision of the Act, this Chapter, or any Order issued thereunder may be guilty of a misdemeanor as provided by law. Violators of this Chapter may also be subject to civil penalties in accordance with O.C.G.A. 31-13-15.
(b) Any licensee, certificate of registration holder, applicant for a license or certificate of registration, employee of a licensee, certificate of registration holder or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or certificate of registration holder or applicant for a license or certificate of registration, who knowingly provides to any licensee, applicant, certificate holder, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, certificate holder's or applicant's activities in this part, may not:
1. Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, certificate of registration holder, or applicant to be in violation of any Rule, Regulation, or Order; or any term, condition, or limitation of any license issued by the Department; or
2. Deliberately submit to the Department, a licensee, certificate of registration holder, an applicant, or a licensee's, certificate holder's or applicant's, contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the Department.
(c) A person who violates 8(b)1. or 8(b)2. may be subject to enforcement action in accordance with the provisions of Rule.11 of this Chapter.
(d) For the purposes of 8(b)1., deliberate misconduct by a person means an intentional act or omission that the person knows:
1. Would cause a licensee, certificate of registration holder or applicant to be in violation of any Rule, Regulation, or Order; or any term, condition, or limitation, of any license issued by the Department; or
2. Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, certificate of registration holder, applicant, contractor, or subcontractor.
(9) Impounding. The Department shall have the authority in the event of an emergency to impound or order the impounding of radioactive material in the possession of any person who is not equipped to observe or fails to observe the provisions of this Chapter or any Rules issued thereunder.
(a) Upon a showing that the emergency no longer exists and the owner of the radioactive material has demonstrated that he has achieved and is capable of maintaining compliance with the Act, the terms and conditions of his license, and all Rules, Regulations, and Orders of the Department, the Department may return the impounded radioactive material to its owner.
(b) In the event an owner cannot demonstrate his ability to achieve and maintain compliance with the Act, the terms and conditions of his license, and all Rules, Regulations, and Orders of the Department, the Department is authorized to seek a court order condemning such radioactive material and providing for its destruction or other disposition for the health and safety of the populace.
(10) Severability. Should any section, paragraph, sentence, clause or phrase of this Chapter be declared unconstitutional or invalid for any reason, the remainder of this Chapter shall not be affected thereby.
(11) Units of Exposure and Dose.
(a) As used in this Chapter, the unit of Exposure is the Coulomb per kilogram (C/kg). One Roentgen is equal to 2.58 x 10-4 Coulomb per kilogram of air.
(b) As used in this Chapter, the units of dose are:
1. Gray (Gy) is the SI unit of absorbed dose. One Gray is equal to an absorbed dose of 1 Joule/kilogram (100 rad).
2. Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 Joule/kilogram (0.01 Gy).
3. Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).
4. Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in Sievert is equal to the absorbed dose in Gray multiplied by the quality factor (1 Sv = 100 rem).
(c) As used in this Chapter, the quality factors for converting absorbed dose to dose equivalent are shown in Table I.

TABLE I

QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES

TYPE OF RADIATION

Quality Factor (Q)

Absorbed Dose Equal to a Unit Dose Equivalent (a)

X, gamma, or beta radiation and high-speed electrons

1

1

Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge

20

0.05

Neutrons of unknown energy

10

0.1

High-energy protons

10

0.1

(a) Absorbed dose in rad equal to 1 rem or the absorbed dose in Gray equal to 1 Sv.

(d) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in Sievert per hour or rem per hour, as provided in (11)(c) of this Rule, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of this Chapter, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in Gray or rad to dose equivalent in Sievert or rem.

TABLE II

MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE

EQUIVALENT FOR MONOENERGETIC NEUTRONS

 

Neutron Energy (MeV)

Quality Factor (a) (Q)

Fluence per Unit Dose Equivalent (b) (neutrons cm-2 rem-1)

Fluence per Unit Dose Equivalent (b) (neutronscm-2 Sv-1)

(thermal)

2.5 x 10-8

2

980 x 106

980 x 108

 

1 x 10-7

2

980 x 106

980 x 108

 

1 x 10-6

2

810 x 106

810 x 108

 

1 x 10-5

2

810 x 106

810 x 108

 

1 x 10-4

2

840 x 106

840 x 108

 

1 x 10-3

2

980 x 106

980 x 108

 

1 x 10-2

2.5

1010 x 106

1010 x 108

 

1 x 10-1

7.5

170 x 106

170 x 108

 

5 x 10-1

11

39 x 106

39 x 108

 

1

11

27 x 106

27 x 108

 

2.5

9

29 x 106

29 x 108

 

5

8

23 x 106

23 x 108

 

7

7

24 x 106

24 x 108

 

10

6.5

24 x 106

24 x 108

 

14

7.5

17 x 106

17 x 108

 

20

8

16 x 106

16 x 108

 

40

7

14 x 106

14 x 108

 

60

5.5

16 x 106

16 x 108

 

1 x 102

4

20 x 106

20 x 108

 

2 x 102

3.5

19 x 106

19 x 108

 

3 x 102

3.5

16 x 106

16 x 108

 

4 x 102

3.5

14 x 106

14 x 108

(a) Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent phantom.

(b) Monoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom.

(12) Units of Radioactivity. For purposes of this Chapter, activity is expressed in the SI unit of Becquerel (Bq) or in the special unit of Curie (Ci), or their multiples, or disintegrations or transformations per unit of time.
(a) One Becquerel (Bq) = 1 disintegration or transformation per second.
(b) One Curie (Ci) = 3.7 x 1010 disintegrations or transformations per second = 3.7 x 1010 Becquerel (Bq) = 2.22 x 1012 disintegrations or transformations per minute.
(13) Communications. All communications and reports concerning this Chapter, and applications filed thereunder should be addressed to the Georgia Department of Natural Resources/EPD, Radioactive Materials Program, at 4244 International Parkway, Suite 120, Atlanta, Georgia 30354.
a Georgia Emergency Radiological Assistance Numbers.

GEORGIA EMERGENCY RADIOLOGICAL ASSISTANCE TELEPHONE NUMBERS

To Report a Radiological Emergency or Request Emergency Radiological Assistance, Call the Following Number During Business Hours:

Georgia Environmental Protection Division

Radioactive Materials Program and Environmental Radiation Program

(404) 362-2675

or

(404) 363-7000

For 24-Hour Radiological Assistance, Call:

Georgia Emergency Management Agency

Emergency Operations Center

(404) 656-4863

Outside the Atlanta Toll-Free Calling Area (In Georgia Only), Call:

Georgia Emergency Management Agency

Emergency Operations Center

1-800-241-4113

Rule 391-3-17-.02 Licensing of Radioactive Material

(1) Purpose and Scope.
(a) This Rule, 391-3-17-.02, provides for the licensing of radioactive material. No person shall receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a specific or general license issued pursuant to this Rule or as otherwise provided in this Chapter. However, nothing in this Rule shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.
(b) In addition to the requirements of this Rule, all licensees are subject to the requirements of Rules .01, .03, .06, .07, .10, and .11 of this Chapter. Licensees engaged in industrial radiographic operations are subject to the requirements of Rule .04 of this Chapter. Licensees using radioactive material in the healing arts are also subject to the requirements of Rule .05 of this Chapter. Licensees engaged in the extrusion, mining, storage, beneficiating, processing, use, transfer, or disposal of NORM in such a manner as to alter the chemical properties or physical state of the NORM or its potential exposure pathways to humans are also subject to the requirements of Rule .08 of this Chapter. Licensees using irradiators whose dose rate exceeds 500 rads (5 Grays) per hour at one meter from the radioactive sealed sources are also subject to the requirements of Rule .09 of this Chapter.

Note: All numbered and lettered references within this Rule refer to parts of this Rule, unless stated otherwise.

(2) Exemptions/Source Material.
(a) Any person is exempt from this Rule to the extent that such person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of one percent (0.05 percent) of the mixture, compound, solution, or alloy.
(b) Any person is exempt from this Rule to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.
(c) Any person is exempt from this Rule to the extent that such person receives, possesses, uses, or transfers:
1. Any quantities of thorium contained in:
(i) Incandescent gas mantles,
(ii) Vacuum tubes,
(iii) Welding rods,
(iv) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium,
(v) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than two grams of thorium,
(vi) Rare earth metals and compounds, mixtures, and products containing not more than 0.25 percent by weight thorium, uranium, or any combination of these, or
(vii) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium;
2. Source material contained in the following products:
(i) Glazed ceramic tableware, provided that the glaze contains not more than 20 percent by weight source material,
(ii) Glassware containing not more than ten percent by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction,
(iii) Glass enamel or glass enamel frit containing not more than ten percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983, or
(iv) Piezoelectric ceramic containing not more than two percent by weight source material;
3. Photographic film, negatives, and prints containing uranium or thorium;
4. Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed four percent by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;
5. Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that:
(i) The counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission (NRC), authorizing distribution by the licensee pursuant to 10 CFR Part 40,
(ii) Each such counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM",
(iii) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED", and
(iv) This exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering;

Note: The requirements specified in (2)(c)5.(ii) and (iii) need not be met by counterweights manufactured prior to December 31, 1969, provided that such counterweights are impressed with the legend: "CAUTION - RADIOACTIVE MATERIAL - URANIUM".

6. Natural or depleted uranium metal used as shielding constituting part of any shipping container which is conspicuously and legibly impressed with the legend: "CAUTION - RADIOACTIVE SHIELDING - URANIUM" and the uranium metal is encased in mild steel or equally fire-resistant metal of minimum wall thickness of 1/8 inch (3.2 mm);
7. Thorium contained in finished optical lenses, provided that each lens does not contain more than 30 percent by weight of thorium, and that this exemption shall not be deemed to authorize either:
(i) The shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens, or
(ii) The receipt, possession, use, or transfer of thorium contained in contact lenses, in spectacles, or in eyepieces in binoculars or other optical instruments;
8. Uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of uranium; or
9. Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:
(i) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide), and
(ii) The thorium content in the nickel-thoria alloy does not exceed four percent by weight.
(d) The exemptions in paragraph (2)(c) do not authorize the manufacture of any of the products described.
(3) Exemptions/Radioactive Material Other Than Source Material.
(a) Exempt Concentrations.
1. Except as provided in (3)(a)3. and 4., any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires products containing radioactive material in concentrations not in excess of those listed in (21)(a), Schedule A.
2. This section shall not be deemed to authorize the import of radioactive material or products containing radioactive material.
3. A manufacturer, processor, or producer of a product or material is exempt from the requirements of this Rule to the extent that this person transfers products containing radioactive material in concentrations not in excess of those listed in (21)(a) Schedule A and introduced into the product or material by a licensee holding a specific license issued by the Department expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
4. No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under (3)(a). or equivalent Regulations of the U.S. Nuclear Regulatory Commission, any Agreement State, or a Licensing State, except in accordance with a specific license issued pursuant to 10 CFR 32.11.
(b) Exempt Quantities.
1. Except as provided in (3)(b)3. through 5., any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in (21)(b), Schedule B.
2. Any person, who possesses radioactive material received or acquired before September 25, 1971, under the general license then provided in 10 CFR 31.4, or similar general license of an Agreement State, is exempt from the requirements of this Chapter to the extent that this person possesses, uses, transfers, or owns byproduct material.
3. Paragraph (3)(b) does not authorize the production, packaging, repackaging, or transfer of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.
4. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in (21)(b), Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under (3)(b) or equivalent regulations of the U.S. Nuclear Regulatory Commission, any Agreement State, or a Licensing State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR, Part 32, or by the Department pursuant to (11)(b) which license states that the radioactive material may be transferred by the licensee to persons exempt under (3)(b) or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.
5. No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in (21)(b), Schedule B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by this Chapter.
(c) Exempt Items.
1. Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or who incorporate radioactive material into, the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from the requirements for a license set forth in this Chapter to the extent that he receives, possesses, uses, transfers, owns, or acquires the following products:

Note: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing radioactive material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C., 20555.

(i) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rates:
(I) 25 millicuries (925 MBq) of tritium per timepiece.
(II) 5 millicuries (185 MBq) of tritium per hand.
(III) 15 millicuries (555 MBq) of tritium per dial (bezels when used shall be considered as part of the dial).
(IV) 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece.
(V) 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand.
(VI) 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries (4.44 MBq) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial).
(VII) The levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:
I. For wrist watches, 0.1 millirad (1 µGy) per hour at ten centimeters from any surface.
II. For pocket watches, 0.1 millirad (1 µGy) per hour at one centimeter from any surface.
III. For any other timepiece, 0.2 millirad (2 µGy) per hour at ten centimeters from any surface.
(VIII) One microcurie (37 kBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.
(ii) Static elimination devices which contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device.
(iii) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium-210 per device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 (tritium) per device.
(iv) Such devices authorized before October 23, 2012, for use under the general license then provided in Section 31.3 of 10 CFR, Part 31 and equivalent regulations of Agreement States and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the Department.
(v) Precision balances containing not more than one millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.
(vi) [Reserved]
(vii) Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before December 17, 2007.
(viii) [Reserved]
(ix) Ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.
(x) Electron tubes, provided that the levels of radiation from each electron tube containing radioactive material will not exceed one millirad (10 µGy) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber. Provided also, that each tube does not contain more than one of the following specified quantities of radioactive material:
(I) 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or ten millicuries (370 MBq) of tritium per any other electron tube.
(II) 1 microcurie (37 kBq) of cobalt-60.
(III) 5 microcuries (185 kBq) of nickel-63.
(IV) 30 microcuries (1.11 MBq) of krypton-85.
(V) 5 microcuries (185 kBq) of cesium-137.
(VI) 30 microcuries (1.11 MBq) of promethium-147.

NOTE: For the purpose of.02(3)(c) 1.(x), "Electron tubes" includes spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.

(xi) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:
(I) Each source contains no more than one exempt quantity set forth in (21)(b), Schedule B;
(II) Each instrument contains no more than ten exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities specified in (21)(b), Schedule B, provided that the sum of such fractions shall not exceed unity; and
(III) For purposes of.02(3)(c) 1.(xi), 0.05 microcurie (1.85 kBq) of americium-241 is considered an exempt quantity under (21)(b), Schedule B.
(xii) [Reserved]
(xiii) Any person who desires to apply byproduct material to, or to incorporate byproduct material into, the products exempted in 3(c)1., or who desires to initially transfer for sale or distribution such products containing radioactive material, should apply for a specific license with the U.S. Nuclear Regulatory Commission pursuant to Section 32.14 of 10 CFR, Part 32, which license states that the product may be distributed by the licensee to persons exempt under (3)(c)1., or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.
2. Self-Luminous Products Containing Radioactive Material.
(i) Tritium, krypton-85, or promethium-147. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from the requirements for a license set forth in this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR, Part 32, which license authorizes the initial transfer of the product to persons who are exempt from regulatory requirements. This exemption does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.
(ii) Radium-226. Any person is exempt from this Chapter to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium-226 that were acquired prior to July 12, 1982.
(iii) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use under paragraph.02(3)(c) 2.(i) should apply for a license with the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 CFR Part 32 and apply to the U.S. Nuclear Regulatory Commission for a certificate of registration in accordance with Section 32.210 of 10 CFR Part 32.
3. Gas and Aerosol Detectors Containing Radioactive Material.
(i) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from the requirements for a license set forth in this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect health, safety, or property provided that detectors containing radioactive material shall have been manufactured, processed, produced, or initially transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR, Part 32. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a State under comparable provisions to Section 32.26 of 10 CFR, Part 32 authorizing distribution to persons exempt from regulatory requirements.
(ii) Gas and aerosol detectors containing naturally-occurring and accelerator-produced radioactive material (NARM) previously manufactured and distributed to general licensees in accordance with a specific license issued by an Agreement State shall be considered exempt under (3)(c)3.(i), provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of 10 CFR 32.26.
(iii) Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a Licensing State shall be considered exempt under (3)(c)3.(i), provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of 10 CFR 32.26.
(iv) Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use under.02(3)(c) 3.(i) should apply for a license with the U.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 CFR Part 32 and apply to the U.S. Nuclear Regulatory Commission for a certificate of registration in accordance with Section 32.210 of 10 CFR, Part 32.
4. Radioactive drug: Capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.
(i) Except as provided in .02(3)(c) 4.(ii) and.02(3)(c) 4.(iii), any person is exempt from the requirements for a license set forth in O.C.G.A. Section 31-13-5(a)(9) (Georgia Radiation Control Act) and from the regulations in this Chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing one µCi (37 kBq) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.
(ii) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Rule .02 and Rule .05 of this chapter.
(iii) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to Rule .02 of this chapter.
(iv) Nothing in.02(3)(c) 4. relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.
5. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in this Chapter to the extent that such person receives, possesses, uses, transfers, owns, or acquires byproduct material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under Section 32.30 of 10 CFR Part 32, which license authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.
6. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing byproduct material for use under.02(3)(c) 5. should apply for a license to the U.S. Nuclear Regulatory Commission pursuant to Section 32.30 of 10 CFR Part 32 and to the U.S. Nuclear Regulatory Commission for a certificate of registration in accordance with § 32.210 of 10 CFR, Part 32 .
(4) Types of Licenses. Licenses for radioactive materials are of two types: general and specific.
(a) General licenses provided in this Rule are effective without the filing of applications with the Department or the issuance of licensing documents to the particular persons, although the filing of a certificate with the Department may be required by the particular general license. The general licensee is subject to all other applicable portions of this Chapter and any limitations of the general license.
(b) Specific licenses require the submission of an application to the Department and the issuance of a licensing document by the Department to a named person. The licensee is subject to all applicable portions of this Chapter as well as any limitations specified in the licensing document.
(5) General Licenses - Source Material.
(a) A general license is hereby issued authorizing persons to hold bare title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material.
(b) A general license is hereby issued authorizing commercial and industrial firms, research, educational, and medical institutions, and State and local government agencies to use and transfer not more than 15 pounds (6.82 kg) of source material at any one time for research, development, educational, commercial, or operational purposes. A person authorized to use or transfer source material, pursuant to this general license, may not receive more than a total of 150 pounds (68.2 kg) of source material in any one calendar year.
(c) Persons who receive, possess, use, or transfer source material pursuant to the general license in (5)(b) are prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as authorized by the Department in a specific license, and are exempt from the provisions of Rule .03 and Rule .07 of this Chapter to the extent that such receipt, possession, use, or transfer is within the terms of such general license; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to this Rule.
(d) Depleted Uranium in Industrial Products and Devices.
1. A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of (5)(d)2., 3., 4., and 5., depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.
2. The general license in (5)(d)1. applies only to industrial products or devices which have been manufactured either in accordance with a specific license issued to the manufacturer of the products or devices in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission or an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission or an Agreement State.
3. Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by (5)(d)1. shall:
(i) File Department form "Registration Certificate - Use of Depleted Uranium Under General License" with the Department. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. The registrant shall furnish on the form the following information and such other information as may be required by that form:
(I) Name and address of the registrant;
(II) A statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in (5)(d)1. and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and
(III) Name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in (5)(d)3.(i)(II); and
(ii) Report in writing to the Department any changes in information furnished by him in Department form "Registration Certificate - Use of Depleted Uranium Under General License". The report shall be submitted within 30 days after the effective date of such change.
4. A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by (5)(d)1:
(i) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium;
(ii) Shall not abandon such depleted uranium;
(iii) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of (19). In the case where the transferee receives the depleted uranium pursuant to the general license established by (5)(d)1., the transferor shall furnish the transferee a copy of this Regulation and a copy of Department form "Registration Certificate - Use of Depleted Uranium Under General License". In the case where the transferee receives the depleted uranium pursuant to a general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to (5)(d)1., the transferor shall furnish the transferee a copy of this Regulation and a copy of Department form "Registration Certificate - Use of Depleted Uranium Under General License "accompanied by a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or Agreement State under requirements substantially the same as those in this Regulation;
(iv) Shall report in writing to the Department the name and address of the person receiving the depleted uranium pursuant to such transfer within 30 days of any transfer.
5. Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by (5)(d)1. is exempt from the requirements of Rule .03 and Rule .07 of this Chapter with respect to the depleted uranium covered by that general license.
(6) General Licenses - Radioactive Materials Other Than Source Material. Each general license issued under (6) has its own specific conditions and requirements.
(a) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Rule, this general license does not authorize the manufacture, production, transfer, receipt, possession, or use of radioactive material.
(b) [Reserved]
(c) Certain Detecting, Measuring, Gauging, or Controlling Devices and Certain Devices for Producing Light or an Ionizing Atmosphere.
1. A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and State or local government agencies to own, receive, acquire, possess, use, or transfer, in accordance with the provisions of (6)(c)2., 3., and 4., radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.
2. The general license in (6)(c)1. applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained:
(i) in a specific license issued by the Department pursuant to (11)(d); or
(ii) in accordance with the specifications contained In a specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, which authorizes distribution of devices to persons generally licensed by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

The devices must have been received from one of the specific licensees described in (i) or (ii) above or through a transfer made under (6)(c)3.(viii).

Note: Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in Section 179.21 of the Code of Federal Regulations, Title 21.

3. Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in (6)(c)1.:
(i) Shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels;
(ii) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on/off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however,
(I) Devices containing only krypton need not be tested for leakage of radioactive material, and
(II) Devices containing only tritium or not more than 100 microcuries (3.7 MBq) of other beta- and/or gamma-emitting material or ten microcuries (0.37 MBq) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;
(iii) Shall assure that the tests required by (6)(c)3.(ii) and other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are performed:
(I) In accordance with the instructions provided by the labels, or
(II) By a person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform such activities;
(iv) Shall maintain records showing compliance with the requirements of (6)(c)3.(ii) and (iii). The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding, or containment. Records of tests for leakage of radioactive material required by (6)(c)3.(ii) shall be maintained for three years after the next required leak test is performed. Records of tests of the on/off mechanism and indicator required by (6)(c)3.(ii) shall be maintained for three years after the next required test of the on/off mechanism and indicator is performed. Records which are required by (6)(c)3.(iii) shall be maintained for three years. In case of transfer or disposal, records required by this paragraph (iv) shall be maintained for three years after the transfer or disposal.
(v) Shall, upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on/off mechanism or indicator, or upon the detection of 0.005 microcurie (185 Bq) or more removable radioactive material, immediately suspend operation of the device. The device may not be operated until it has been repaired by the manufacturer or other person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to repair such devices. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device or as otherwise approved by the Department. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie (185 Bq) or more of removable radioactive material, or failure or damage to a source likely to result in contamination of the premises or environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the Department within 30 days. Under these circumstances, the criteria set out in Rule .03(7)(b) "Radiological requirements for unrestricted use" may be applicable, as determined by the Department on a case-by-case basis;
(vi) Shall not abandon the device containing radioactive material;
(vii)
(I) Shall transfer or dispose of the device containing radioactive material only by export as provided in (6)(c)3.(xiv), by transfer to another general licensee as specified in (6)(c)3.(viii) or equivalent regulations of the NRC or another Agreement State, by transfer to a specific licensee of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State whose specific license authorizes him to receive the device or authorizes him to collect waste, or as otherwise approved under (6)(c)(3)(vii)(III).
(II) Within 30 days after transfer of a device to a specific licensee or export, the licensee shall furnish to the Department a report containing identification of the device by manufacturer's (or initial transferor's) name, model number, serial number, the name and address and license number (license number not applicable if exported) of the person receiving the device and the date of transfer;
(III) If transfer is to any other licensee not identified in (vii)(I), the licensee shall obtain written approval from the Department before transferring the device to any other person; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if, the holder:
I. Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;
II. Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by Rule .02(6)(c) 3.(i) so that the device is labeled in compliance with Rule .03(12)(d); however the manufacturer, model number, and serial number must be retained;
III. Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and
IV. Reports the transfer under Rule .02(6)(c) 3.(vii)
(viii) Shall transfer the device to another general licensee only:
(I) Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this Regulation and any safety documents identified in the label on the device. Within 30 days of the transfer, report to the Department the manufacturer's (or initial transferor's) name, model number, serial number of the device transferred, the name and mailing address for place of use of the transferee, and the name, title and telephone number of a person identified by the transferee as the individual responsible for having knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or
(II) Where the device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee;
(ix) Shall comply with the provisions of Rule .03(15) of this Chapter for reporting radiation incidents, or the theft or loss of licensed material, but shall be exempt from the other requirements contained in Rules .03 and .07 of this Chapter;
(x) Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard;
(xi)
(I) Shall register, in accordance with paragraphs (6)(c)3.(xi)(II) and (III), devices containing at least 10 mCi (370 Mbq) of cesium-137, 0.1 mCi (3.7 MBq) of strontium-90, 1 mCi (37 MBq) of cobalt-60, 0.1 mCi (3.7 MBq) of radium 226, or 1 mCi (37 MBq) of americium-241 or any other transuranic [i.e., element with atomic number greater than uranium (92)], based on the activity indicated on the label. Each address for a location of use, as described under paragraph 3.(xi)(III)IV. of this section, represents a separate general licensee and requires a separate registration.
(II) If in possession of a device meeting the criteria of paragraph (6)(c)3.(xi)(I), shall register these devices annually with the Department. Registration must be done by verifying, correcting, and/or adding to the information provided in a request for registration received from the Department. The registration information must be submitted to the Department within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of (6)(c)3.(xi)(I) is subject to the bankruptcy notification requirement in (13)(e) of this rule.
(III) In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the Department;
I. Name and mailing address of the general licensee.
II. Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label).
III. Name, title, and telephone number of the responsible person designated as a representative of the general licensee under (6)(c)3.(x).
IV. Address or location at which the device(s) are used and/or stored.
V. Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.
VI. Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.
(IV) Persons generally licensed by the NRC, an Agreement State, or Licensing State are not eligible for reciprocity.
(xii) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the Department within 30 days of the effective date of the change;
(xiii) May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by (6)(c)3.(ii) need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
(xiv) Shall not export the device containing byproduct material except in accordance with the requirements of 10 CFR Part 110.
(xv) Shall respond to written requests from the Program to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Program a written justification for the request.
4. The general license in (6)(c)1. does not authorize the manufacture or import of devices containing radioactive material.
5. The general license provided in (6)(c)1. is subject to the provisions of (13), (18), and (19) of this rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rule .06 of this Chapter.
(d) Luminous Safety Devices for Aircraft.
1. A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided:
(i) Each device contains not more than ten Curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium-147; and
(ii) Each device has been manufactured, assembled, or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 CFR, Part 32, of the regulations of the U.S. Nuclear Regulatory Commission.
2. Persons who own, receive, acquire, possess, or use luminous safety devices pursuant to the general license in (6)(d) are exempt from the requirements of Rules .03 and .07 of this Chapter, except that they shall comply with the provisions of Rule .03(15) of this Chapter.
3. This general license does not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium-147.
4. This general license does not authorize the ownership, receipt, acquisition, possession, or use of promethium-147 contained in instrument dials.
5. This general license is subject to the provisions of paragraphs (13), (18), and (19) of this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rule .06 of this Chapter.
(e) Ice-Detection Devices.
1. A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice-detection devices, provided each device contains not more than 50 microcuries (1.85 MBq) of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR, Part 32, of the regulations of the U.S. Nuclear Regulatory Commission.
2. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice-detection devices pursuant to the general license in (6)(e)1.:
(i) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license or equivalent licensing document from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of Rule .03(13) of this Chapter;
(ii) Shall assure that all labels affixed to the device at the time of receipt and which bear a statement that prohibits removal of the labels are maintained thereon; and
(iii) Are exempt from the requirements of Rules .03 and .07 of this Chapter except that such persons shall comply with the provisions of Rule .03(13) and (15) of this Chapter.
3. This general license does not authorize the manufacture, assembly, disassembly, or repair of strontium-90 in ice-detection devices.
4. This general license is subject to the provisions of paragraphs (13), (18), and (19) of this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rule .06 of this Chapter.
(f) Calibration and Reference Sources.
1. A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of (6)(f)4. and 5., americium-241 in the form of calibration or reference sources:
(i) Any person who holds a specific license issued by the Department which authorizes him to receive, possess, use, and transfer radioactive material; and
(ii) Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use, and transfer special nuclear material.
2. A general license is hereby issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of (6)(f)4. and 5. to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use, and transfer radioactive material.
3. A general license is hereby issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of (6)(f)4. and 5. to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use, and transfer radioactive material.
4. The general licenses in (6)(f)1., 2., and 3. apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR, Part 32, or Section 70.39 of 10 CFR, Part 70, or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the Department, any Agreement State, or Licensing State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 CFR, Part 32, or Section 70.39 of 10 CFR, Part 70, of the regulations of the U.S. Nuclear Regulatory Commission.
5. The general licenses provided in (6)(f)1., 2., and 3. are subject to the provisions of paragraphs (13), (18), and (19) of this Rule, of paragraphs (4), (5), (6), (7), (8), (9) and (10) of Rule .01, and of Rules .03, .06, and .07 of this Chapter. In addition, persons who own, receive, acquire, possess, use, or transfer one or more calibration or reference sources pursuant to these general licenses:
(i) Shall not possess at any one time, at any one location of storage or use, more than five microcuries (185 kBq) of americium-241, five microcuries (185 kBq) of plutonium, or five microcuries (185 kBq) of radium-226 in such sources;
(ii) Shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label that includes one of the following statements, as appropriate, or a substantially similar statement that contains the information called for in one of the following statements, as appropriate:
(I) The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL -

THIS SOURCE CONTAINS (AMERICIUM-241)*

(PLUTONIUM) *. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

_______________________________________

(NAME OF MANUFACTURER OR IMPORTER)

*Note: Showing only the name of the appropriate material, i.e., either plutonium or americium.

(II) The receipt, possession, use, and transfer of this source, Model, Serial No., are subject to a general license and the regulations of a Licensing State. Do not remove this label.

CAUTION - RADIOACTIVE MATERIAL -

THIS SOURCE CONTAINS RADIUM-226.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

_______________________________________

(NAME OF MANUFACTURER OR IMPORTER)

(iii) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to receive the source;
(iv) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium-226 which might otherwise escape during storage; and
(v) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
6. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.
(g) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.

Note: The new drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specified diagnostic drugs in interstate commerce.

1. A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital to receive, acquire, possess, transfer, or use, for any of the following radioactive material, in accordance with the provisions of (6)(g) 2., 3., 4., 5., and 6., the following radioactive materials in prepackaged units for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
(i) Iodine-125, in units not exceeding ten microcuries (370 kBq) each.
(ii) Iodine-131, in units not exceeding ten microcuries (370 kBq) each.
(iii) Carbon-14, in units not exceeding ten microcuries (370 kBq) each.
(iv) Hydrogen-3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each.
(v) Iron-59, in units not exceeding 20 microcuries (740 kBq) each.
(vi) Cobalt-57, in units not exceeding ten microcuries (370 kBq) each.
(vii) Selenium-75, in units not exceeding ten microcuries (370 kBq) each.
(viii) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each.
2. No person shall receive, acquire, possess, use, or transfer radioactive material pursuant to the general license established by (6)(g)1. until he has filed Department form, "Certificate - In-Vitro Testing with Radioactive Material Under General License" with the Department and received from the Department a validated copy of this form with certification number assigned or until he has been authorized pursuant to (9)(e)3. to use radioactive material under the general license in (6)(g). The physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital shall furnish on the form the following information and such other information as may be required by that form:
(i) Name and address of the physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital;
(ii) The location of use; and
(iii) A statement that the physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general license in (6)(g)1. and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.
3. A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by (6)(g)1. shall comply with the following:
(i) The general licensee shall not possess at any one time, pursuant to the general license in (6)(g)1., at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200 microcuries (7.4 MBq).
(ii) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing the equivalent amount of radiation protection.
(iii) The general licensee shall use the radioactive material only as authorized by (6)(g)1.
(iv) The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Department, the U.S. Nuclear Regulatory Commission, any Agreement State, or Licensing State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
(v) The general licensee shall dispose of the Mock Iodine-125 reference or calibration sources described in (6)(g)1.(viii) as required by Rule .03(13) of this Chapter.
4. The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to (6)(g)1.:
(i) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to (11)(g) or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, any Agreement State, or Licensing State which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under (6)(g) or its equivalent, and
(ii) Unless one of the following statements, as appropriate, or a statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
(I) This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

__________________

(NAME OF MANUFACTURER)

(I) This radioactive material shall be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a Licensing State.

__________________

(NAME OF MANUFACTURER)

5. The physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital possessing or using radioactive material under the general license of (6)(g)1. shall report in writing to the Department any changes in the information furnished by him in the "Certificate - In Vitro Testing with Radioactive Material Under General License". The report shall be furnished within 30 days after the effective date of such change.
6. Any person using radioactive material pursuant to the general license of (6)(g)1. is exempt from the requirements of Rules .03 and .07 of this Chapter with respect to radioactive material covered by that general license, except that such persons using the Mock Iodine-125 described in (6)(g)1.(viii) shall comply with the provisions of (13) and (15) of Rule .03 of this Chapter.
(7) Filing Application for Specific Licenses.
(a) Applications for specific licenses shall be filed on forms supplied by the Georgia Department of Natural Resources, Radioactive Materials Program, 4244 International Parkway, Suite 120, Atlanta, Georgia, 30354, or current mailing address. The application shall set forth all applicable information called for by the form.
(b) The Department may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Department to determine whether the application should be granted or denied or whether a license should be modified or revoked.
(c) Each application shall be signed by the applicant or person duly authorized to act for and on his behalf.
(d) An application for a license may include a request for a license authorizing one or more activities.
(e) In his application, the applicant may incorporate, by reference, information contained in previous applications, statements, or reports filed with the Department, provided that such references are clear and specific by page, paragraph, and date.
(f) Applications and documents submitted to the Department may be made available for public inspection except those documents described in Rule .01(5)(c) which may be withheld from public inspection or discovery.
(g) The Department may verify information contained in applications and secure additional information deemed necessary to make a reasonable determination as to whether to issue a license and whether special conditions should be attached thereto by visiting the facility or location where radioactive materials would be possessed, or used, and by discussing details of proposed possession or use of the radioactive materials with the applicant or the applicant's designated representatives.
(h) Emergency Plan for Large Quantity Users.
1. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities specified in (21)(e), Schedule E, must contain either:
(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed one rem (.01 Sv) effective dose equivalent or five rems (.05 Sv) to the thyroid; or
(ii) An emergency plan for responding to a release of radioactive material.
2. One or more of the following factors may be used to support an evaluation submitted under (7)(h)1.(i):
(i) The radioactive material is physically separated so that only a portion could be involved in an accident;
(ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;
(iii) The release fraction in the respirable size range would be lower than the release fraction shown in (21)(e), Schedule E, due to the chemical or physical form of the material;
(iv) The solubility of the radioactive material would reduce the dose received;
(v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in (21)(e), Schedule E;
(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in (21)(e), Schedule E; or
(vii) Other factors appropriate for the specific facility.
3. An emergency plan for responding to a release of radioactive material submitted under (7)(h)1.(ii) must include the following information:
(i) Facility description - a brief description of the licensee's facility and the area near the site.
(ii) Types of accidents - an identification of each type of radioactive materials accident for which protective actions may be needed.
(iii) Classification of accidents - a classification system for classifying accidents as alerts or site area emergencies.
(iv) Detection of accidents - identification of the means of detecting each type of accident in a timely manner.
(v) Mitigation of consequences - a brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers on site, and a description of the program for maintaining the equipment.
(vi) Assessment of releases - a brief description of the methods and equipment to assess releases of radioactive materials.
(vii) Responsibilities - a brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Department; also responsibilities for developing, maintaining, and updating the plan.
(viii) Notification and coordination - a commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established to prevent spreading of contamination during recovery activities. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

Note: This Chapter does not supersede or release licensees from complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L-99-499 or other State or Federal reporting requirements.

(ix) Information to be communicated - a brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the Department.
(x) Training - a brief description of the frequency, performance objectives, and plans for the training that the licensee will provide workers on how to respond to an emergency, including any special instruction and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.
(xi) Safe shutdown - a brief description of the means of restoring the facility to a safe condition after an accident.
(xii) Exercises - provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site, and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and the overall effectiveness of the response. These exercises must be documented and deficiencies found by the critiques must be corrected.
(xiii) Hazardous chemicals - a certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L.99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.
4. The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the Department. The licensee shall provide any comments received within the 60 days to the Department with the emergency plan.
(i) Except as provided in paragraphs 2., 3. and 4. of this section, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must:
1. Identify the source or device by manufacturer and model number as registered with the Nuclear Regulatory Commission, an Agreement State, or for a source or a device containing radium-226 or accelerator produced radioactive material with a State under provisions comparable to Section 32.210 of 10 CFR Part 32;
2. For sources or devices manufactured before October 23, 2012, that are not registered with the Commission under Section 32.210 of 10 CFR, Part 32 or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in Section 32.210(c) of 10 CFR, Part 32, the application must include:
(i) All available information identified in Section 32.210(c) of 10 CFR, Part 32 concerning the source, and, if applicable, the device; and
(ii) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.
3. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with Section 32.210(g)(1) of 10 CFR, Part 32, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.
4. If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.
(j) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Rule .05 or equivalent Nuclear Regulatory Commission or Agreement State requirements shall include:
1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under Rule .02, Nuclear Regulatory Commission or of this chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.
2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in.02(11)(i) 2. of this Rule.
3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in.02(11)(i) 5. of this Rule.
4. Information identified in Rule .02(11)(i) 3. of this Rule on the PET drugs to be noncommercially transferred to members of its consortium.
(8) General Requirements for the Issuance of Specific Licenses. A license application will be approved if the Department determines the following:
(a) That the applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this Chapter in such a manner as to minimize danger to public health and safety or property;
(b) That the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;
(c) That the issuance of the license will not be inimical to the health and safety of the public; and
(d) That the applicant satisfies any applicable special requirements in (9), (10), and (11).
(e) Bonding Requirements.
1. Pursuant to Georgia Laws 1979, pp. 1059, 1060, a specific license will be issued to a Major Processor as defined in Rule .01(2) of this Chapter only if the applicant has posted a surety bond with, and made payable to, the Commissioner, Department of Natural Resources, to ensure the protection of the public health and safety in the event of abandonment, insolvency, or other inability of the licensee to meet the requirements of the Act and this Chapter.
(i) The bond provided shall be not less than $100,000.00, nor more than $5,000,000.00.
(ii) The exact amount of the bond shall be determined by the Director, Environmental Protection Division, and shall be based on the probable extent of contamination, the amount of possible property damage, the costs of removal and disposal of sources of radiation used by the licensee, and the costs of reclamation of the property in the event of abandonment, insolvency, or other inability of the licensee to perform such services to the satisfaction of the Department.
2. Persons licensed at the time the bonding requirements of this Chapter became effective, and upon notice by the Department, must, within a period of 90 days following such notice, provide the bond required by (8)(e)1. as a condition for continuation of the license.
(f) Environmental Report, Commencement of Construction. In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the Department determines will significantly affect the quality of the environment, commencement of construction of the plant or facility in which the activity will be conducted shall not begin until the Department has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph, the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.
(g) Financial assurance and record-keeping for decommissioning.
1. The following are required to furnish financial assurance and record-keeping for decommissioning:
(i) Each applicant for a specific license authorizing the possession and use of unsealed radioactive material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in Schedule F shall submit a decommissioning funding plan as described in subparagraphs (8)(g)5 and (8)(g)6. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity Rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Schedule F.
(ii) Each applicant for a specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities set forth in Schedule F shall submit a decommissioning funding plan as described in subparagraphs (8)(g)5 and (8)(g)6. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 1012 is greater than 1 (unity Rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Schedule F.
2. Each applicant for a specific license authorizing the possession and use of radioactive material of half-life greater than 120 days and in quantities specified in subparagraphs (8)(g)4. shall either:
(i) Submit a decommissioning funding plan as described in subparagraphs (8)(g)5 and (8)(g)6.; or
(ii) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by (8)(g)4. using one of the methods described in (8)(g)7. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but prior to the receipt of licensed material. As part of the certification, a copy of the financial instrument obtained to satisfy the requirements of (8)(g)7. is to be submitted to the Department. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements (8)(g)7. must be submitted to the Department before the receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the Department, as part of the certification a signed original of the financial instrument obtained to satisfy the requirements of (8)(g)7.
3.
(i) Each holder of a specific license issued on or after January 1, 1993, which is of a type described in (8)(g)1. or 2. shall provide financial assurance for decommissioning in accordance with the criteria set forth in this Rule.
(ii) Each holder of a specific license issued before January 1, 1993, which is of a type described in (8)(g)1. shall submit, on or before January 1, 1993, a decommissioning funding plan or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000 in accordance with the criteria set forth in this Rule. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan at this time, the licensee shall include a decommissioning funding plan in any application for license renewal.
(iii) Each holder of a specific license issued before January 1, 1993, and of a type described in (8)(g)2. shall submit, on or before January 1, 1993, a certification of financial assurance for decommissioning or a decommissioning funding plan in accordance with the criteria set forth in this.02(8)(g).
(iv) Waste collectors and waste processors shall provide financial assurance in an amount based on a decommissioning funding plan as described in subparagraphs.02(8)(g) 5 and (8)(g)6. The decommissioning funding plan must also include the cost of disposal of the maximum amount (curies) of radioactive material permitted by the license, and the cost of disposal of the maximum quantity, by volume, of radioactive material that could be present at the licensee's facility at any time, in addition to the cost to remediate the licensee's site to meet the license termination requirements in.02(18).
4. Table of required amounts of financial assurance for decommissioning by quantity of material.

Greater than 104 but less than or equal to 105 times the applicable quantities of Schedule F in unsealed form. (For a combination of isotopes, if R, as defined in (8)(g), divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1): $1,125,000

Greater than 103 but less than or equal to 104 times the applicable quantities of Schedule F in unsealed form. (For a combination of isotopes, if R, as defined in (8)(g), divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1): $225,000

Greater than 1010 times the applicable quantities of Schedule F in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in (8)(g), divided by 1010 is greater than 1): $113,000

5. Each decommissioning funding plan must be submitted for review and approval and must contain
(i) A detailed cost estimate for decommissioning, in an amount reflecting:
(I). The cost of an independent contractor to perform all decommissioning activities;
(II). The cost of meeting the.03(7)(b) criteria for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of.03(7)(c), the cost estimate may be based on meeting the.03(7)(c) criteria;
(III). The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and
(IV). An adequate contingency factor.
(ii) Identification of and justification for using the key assumptions contained in the DCE;
(iii) A description of the method of assuring funds for decommissioning from subparagraph 7 of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;
(iv) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and
(v) A signed original of the financial instrument obtained to satisfy the requirements of subparagraph 7 of this section (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).
6. At the time of license renewal and at intervals not to exceed 3 years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:
(i) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;
(ii) Waste inventory increasing above the amount previously estimated;
(iii) Waste disposal costs increasing above the amount previously estimated;
(iv) Facility modifications;
(v) Changes in authorized possession limits;
(vi) Actual remediation costs that exceed the previous cost estimate;
(vii) Onsite disposal; and
(viii) Use of a settling pond.
7. Financial assurance for decommissioning must be provided by one or more of the following methods:
(i) Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.
(ii) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in (21)(d) Schedule D. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in (21)(g) Schedule G. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning: costs may be used if the guarantee and test are as contained in (21)(d) Schedule D. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in (21)(h) Schedule H. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:
(I) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically, unless 90 days or more prior to the renewal date the issuer notifies the Department, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Department within 30 days after receipt of notification of cancellation.
(II) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Department. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
(III) The surety method or insurance must remain in effect until the Department has terminated the license.
(iii) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in (8)(g)2.
(iv) In the case of Federal, State, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on the Table in (8)(g)4., and indicating that funds for decommissioning will be obtained when necessary.
8. Each person licensed under this Chapter shall keep records of information important to the safe and effective decommissioning of the facility in an identified location until the site is released for unrestricted use by the Department. Before licensed activities are transferred or assigned in accordance with.02(13)(b), licensees shall transfer all records described in (7)(i) through (iv) to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records of relevant information to the decommissioning of a facility are kept for other purposes, references to these records and their locations may be used. Information the Department considers important to decommissioning consists of:
(i) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.
(ii) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.
(iii) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after any leak) or radioactive materials having only half-lives of less than 65 days, or depleted uranium used only for shielding or as penetrators in unused munitions, a list contained in a single document and updated every two years, of the following:
(I) All areas designated and formerly designated as restricted areas as defined under Rule 391-3-17-.01(2);
(II) All areas outside of restricted areas that require documentation under (8)(g)8.(i);
(III) All areas outside of restricted areas where current and previous wastes have been buried as documented under Rule .03(14)(i) of this Chapter; and
(IV) All areas outside of restricted areas that contain materials such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under Rule .03(13)(b) of this Chapter.
(iv) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.
9. Teletherapy licensees are exempted from decommissioning financial assurance requirements for possession of licensed material in sealed sources in quantities greater than 1010 times the applicable quantities of Schedule F of this rule, for the purpose of source changes only. This exemption is granted for no more than 30 days for any one source change.
(h) Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.
1. Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee shall:
(i) Limit actions involving radioactive material to those related to decommissioning; and
(ii) Continue to control entry to restricted areas until they are suitable for release in accordance with Department requirements.
2. Within 60 days of the occurrence of any of the following, each licensee shall provide notification to the Department in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with Department requirements, or submit within 12 months of notification a decommissioning plan, if required by (8)(h)5.(i), and begin decommissioning upon approval of that plan if:
(i) The license has expired pursuant to (14) or (18)(c); or
(ii) The licensee has decided to permanently cease principal activities, as defined in this part, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Department requirements; or
(iii) No principal activities under the license have been conducted for a period of 24 months; or
(iv) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Department requirements.
3. Coincident with the notification required by (8)(h)2., the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to (8)(g) in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance must be increased or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to (8)(h)5.(iv)(V).
(i) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so when this rule becomes effective.
(ii) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Department.
4. The Department may grant a request to extend the time periods in (8)(h)2. if the Department determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to (8)(h)2. The schedule for decommissioning set forth in (8)(h)2. may not commence until the Department has made a determination on the request.
5.
(i) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Department and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:
(I) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;
(II) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;
(III) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation or;
(IV) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.
(ii) The Department may approve an alternate schedule for submittal of a decommissioning plan required pursuant to (8)(h)2. if the Department determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.
(iii) Procedures such as those listed in (8)(h)5.(i) with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.
(iv) The proposed decommissioning plan for the site or separate building or outdoor area must include:
(I) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;
(II) A description of planned decommissioning activities;
(III) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;
(IV) A description of the planned final radiation survey; and
(V) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.
(VI) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan shall include a justification for the delay based on the criteria in (8)(h)7.
(v) The proposed decommissioning plan will be approved by the Department if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.
6.
(i) Except as provided in (8)(h)7., licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practical but no later than 24 months following the initiation of decommissioning.
(ii) Except as provided in (8)(h)7. when decommissioning involves the entire site, the licensee shall request license termination as soon as practical but no later than 24 months following the initiation of decommissioning.
7. The Department may approve a request for an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Department determines that the alternative is warranted by consideration for the following:
(i) Whether it is technically feasible to complete decommissioning within the allotted 24-month period;
(ii) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;
(iii) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;
(iv) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and
(v) Other site-specific factors which the Department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.
8. As the final step in decommissioning, the licensee shall follow the requirements of Rule .02(18)(d).
(9) Special Requirements for Issuance of Certain Specific Licenses for Radioactive Material.
(a) Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in (8), a specific license for the use of sealed sources in industrial radiography will be issued if the licensee meets all of the requirements of Rule .04 of this Chapter.
(b) Human Use of Radioactive Materials in Institutions. In addition to the requirements set forth in (8), a specific license for the human use of radioactive material in an institution will be issued only if the licensee also meets all of the requirements of Rule .05 of this Chapter.
(c) Specific Licenses to Individual Physicians for Human Use of Radioactive Material.
1. An application by an individual physician or group of physicians for a specific license for human use of radioactive material will be approved if:
(i) The applicant satisfies the general requirements specified in (8), and all of the requirements of Rule .05 of this Chapter;
(ii) The application is for use in the applicant's practice in an office outside a medical institution;
(iii) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable; and
(iv) The applicant has extensive experience in the proposed use, the handling and administration of radionuclides, and where applicable, the clinical management of radioactive patients.
2. The Department will not approve an application by an individual physician or group of physicians for a specific license to receive, possess, or use radioactive material on the premises of a medical institution unless:
(i) The use of radioactive material is limited to:
(I) The administration of radiopharmaceuticals for diagnostic or therapeutic purposes;
(II) The performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered;
(III) The performance of in vitro diagnostic studies; or
(IV) The calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation, and diagnostic instrumentation;
(ii) The physician brings the radioactive material with him and removes the radioactive material when he departs (The institution cannot receive, possess, or store radioactive material other than the amount of material remaining in the patient.); and
(iii) The medical institution does not hold a radioactive material license under (9)(b).
(d) Human Use of Sealed Sources Containing Radioactive Material. In addition to the requirements set forth in (8), a specific license for the human use of sealed sources containing radioactive material will be issued only if the applicant, or, if the application is made by an institution, the individual user is a physician and either:
1. Has specialized training in the therapeutic use of the sealed source considered (e.g., teletherapy unit, beta applicator), or has experience equivalent to such training; or
2. Has specialized training in the diagnostic use of the sealed source considered (e.g., bone mineral analyzer) or has experience equivalent to such training.
(e) Specific Licenses for Certain Medical Uses of Radioactive Material.
1. Subject to the provisions of (9)(e)2. and 3., an application for a specific license pursuant to (9)(b), (c), or (d), for any medical use or uses of radioactive material specified in Rule .05 of this Chapter, will be approved if:
(i) The applicant satisfies the requirements of (9)(b), (c), or (d);
(ii) The applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses specified in the application;
(iii) The applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, has adequate training and experience in the handling of radioactive material appropriate to his participation in the uses specified in the application;
(iv) The applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses specified in the application;
(v) The applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses specified in the application; and
(vi) For uses regulated by Rules .05(41) and (44) of this Chapter, any licensee using radioactive material for clinical procedures other than those specified in the product labeling (package insert) shall comply with the product labeling regarding:
(I) Chemical and physical form,
(II) Route of administration, and
(III) Dosage range.
2. Any licensee who is authorized to use radioactive material pursuant to (9)(e) and to Rule .05 of this Chapter is subject to the following conditions:
(i) For paragraphs (41), (44), and (48) of Rule .05 of this Chapter, no licensee shall receive, possess, or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, and labeled, packaged, and distributed in accordance with a specific license issued by the Department pursuant to (11)(i), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR, Part 32, or a specific license issued by an Agreement State or a Licensing State pursuant to equivalent regulations.
(ii) For Rule 391-3-17-.05(44), no licensee shall receive, possess, or use generators or reagent kits containing radioactive material or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except:
(I) Reagent kits not containing radioactive material that are approved by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State for use by persons licensed pursuant to (9)(d) and to Rule .05 of this Chapter or
(II) Generators or reagent kits containing radioactive material that are manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the Department pursuant to (11)(i), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.73 of 10 CFR, Part 32, or a specific license issued by an Agreement State or a Licensing State pursuant to equivalent regulations; and
(iii) For Brachytherapy, regulated by Rule .05 of this Chapter, no licensee shall receive, possess, or use radioactive material except as contained in a source or device that has been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the Department pursuant to (11)(j), a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR, Part 32, or a specific license issued to the manufacturer by an Agreement State or a Licensing State pursuant to equivalent regulations.
3. Any licensee who is licensed pursuant to (9) for one or more of the medical uses regulated by Rule .05 of this Chapter also is authorized to use radioactive material under the general license in (6)(g) for in vitro uses without filing the Certificate as required by (6)(g)2, provided that the licensee is subject to the other provisions of (6)(g).
(f) Use of Naturally-Occurring Radioactive Material (NORM). In addition to the requirements set forth in (8), a specific license for the use of NORM will be issued if the licensee meets all of the requirements of Rule .08 of this Chapter.
(g) Use of Sealed Sources in Irradiators. In addition to the requirements set forth in (8), a specific license for the use of sealed sources in large irradiators will be issued if the licensee meets all of the requirements of Rule .09 of this Chapter.
(10) Special Requirements for Specific Licenses of Broad Scope. These requirements are for the issuance of non-medical specific licenses of broad scope for radioactive material ("broad licenses") and contain certain regulations governing holders of such licenses. (The issuance of medical specific licenses of broad scope is addressed in (9).)

Nota Bene: See Note, in (3)(c)1.

(a) The different types of broad scope licenses are set forth below:
1. A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.
2. A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in (21)(c), Schedule C, for any authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in (21)(c), Schedule C, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in (21)(c), Schedule C, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.
3. A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in (21)(c), Schedule C, for any authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in (21)(c), Schedule C, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in (21)(c), Schedule C, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.
(b) An application for a Type A specific license of broad scope will be approved if:
1. The applicant satisfies the general requirements specified in (8);
2. The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and
3. The applicant has established administrative controls and provisions relating to organization and management, procedures, record-keeping, material control and accounting, and management review that are necessary to assure safe operations, including:
(i) The establishment of a Radiation Safety Committee composed of such persons as a Radiation Safety Officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;
(ii) The appointment of a Radiation Safety Officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and
(iii) The establishment of appropriate administrative procedures to assure:
(I) Control of procurement and use of radioactive material;
(II) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, the training and experience of the user, and the operating or handling procedures; and
(III) Review, approval, and recording by the Radiation Safety Committee of safety evaluations of proposed uses prepared in accordance with (10)(b)3.(iii)(II) prior to the use of the radioactive material.
(c) An application for a Type B specific license of broad scope will be approved if:
1. The applicant satisfies the general requirements specified in (8); and
2. The applicant has established administrative controls and provisions relating to organization and management, procedures, record-keeping, material control and accounting, and management review that are necessary to assure safe operations, including:
(i) The appointment of a Radiation Safety Officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and
(ii) The establishment of appropriate administrative procedures to assure:
(I) Control of procurement and use of radioactive material,
(II) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, the training and experience of the user, and the operating or handling procedures, and
(III) Review, approval, and recording by the Radiation Safety Officer of safety evaluations of proposed uses prepared in accordance with (10)(c)2.(ii)(II) prior to the use of the radioactive material.
(d) An application for a Type C specific license of broad scope will be approved if:
1. The applicant satisfies the general requirements specified in (8);
2. The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:
(i) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and
(ii) At least 40 hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and
3. The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record-keeping, material control and accounting, and management review necessary to assure safe operations.
(e) Specific non-medical licenses of broad scope are subject to the following conditions:
1. Unless specifically authorized, persons licensed pursuant to (10) shall not:
(i) Conduct tracer studies in the environment involving direct release of radioactive material;
(ii) Receive, acquire, own, possess, use, or transfer devices containing 100,000 Curies (3.7 PBq) or more of radioactive material in sealed sources used for irradiation of materials;
(iii) Conduct activities for which a specific license issued by the Department under (9) or (11) is required; or
(iv) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.
2. Each Type A specific license of broad scope issued under (10) shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Committee.
3. Each Type B specific license of broad scope issued under (10) shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Officer.
4. Each Type C specific license of broad scope issued under (10) shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of (10)(d).
(11) Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices which Contain Radioactive Material.
(a) [Reserved]
(b) Licensing the Distribution of Naturally-Occurring and Accelerator-Produced Radioactive Material (NARM) in Exempt Quantities.

Nota Bene: See Note, in (3)(c)1.

1. An application for a specific license to distribute NARM to persons exempted from this Chapter pursuant to (3)(b) will be approved if:
(i) The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;
(ii) The radioactive material is in the form of processed chemical elements, compounds, mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and
(iii) The applicant submits copies of prototype labels and brochures and the Department approves such labels and brochures.
2. The license issued under (11)(b)1. is subject to the following conditions:
(i) No more than ten exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantities provided the sum of the fractions shall not exceed unity.
(ii) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to (3)(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (5 µSv) per hour.
(iii) The immediate container of each quantity or separately- packaged fractional quantity of radioactive material shall bear a durable and legible label which:
(I) Identifies the radionuclide and the quantity of radioactivity, and
(II) Bears the words "Radioactive Material".
(iv) In addition to the labeling information required by (11)(b)2.(iii), the label affixed to the immediate container, or an accompanying brochure, shall:
(I) State that the contents are exempt from Licensing State requirements,
(II) Bear the words "Radioactive Material - Not for Human Use - Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited - Exempt Quantities Should Not Be Combined", and
(III) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.
3. Each person licensed under (11)(b) shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under (3)(b) or the equivalent regulations of a Licensing State, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Department. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to (11)(b) during the reporting period, the report shall so indicate.
(c) [Reserved]
(d) Licensing the Manufacture and Initial Transfer of Devices to Persons Generally Licensed Under (6)(c).
1. An application for a specific license to manufacture or initially transfer devices containing radioactive material to persons generally licensed under (6)(c) or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State will be approved if:
(i) The applicant satisfies the general requirements of (8);
(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:
(I) The device can be safely operated by persons not having training in radiological protection,
(II) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of one year a dose in excess of ten percent of the annual limits specified in Rule .03(5)(a) 1. of this Chapter, and
(III) Under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:
I. Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 rem (150 mSv);
II. Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one square centimeter 200 rem (2 Sv);
III. Other Organs 50 rem (500 mSv); and
(iii) Each device bears a durable, legible, and clearly visible label or labels approved by the Department, which contain in a clearly identified and separate statement:
(I) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);
(II) The requirement, or lack of requirement, for leak testing, or for testing any on/off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and
(III) The information called for in one of the following statements, as appropriate, in the same or substantially similar form:
I. The receipt, possession, use, and transfer of this device, Model ____, Serial No.____, are subject to a general license or the equivalent and to the regulations of the U.S. Nuclear Regulatory Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

______________________________

(NAME OF MANUFACTURER OR INITIAL TRANSFEROR)

II. The receipt, possession, use, and transfer of this device, Model ____, Serial No.____, are subject to a general license or the equivalent, and to the regulations of a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

______________________________

(NAME OF MANUFACTURER OR INITIAL TRANSFEROR)

Note: The model, serial number, and name of the manufacturer or distributor may be omitted from the appropriate label provided the information is elsewhere specified in labeling affixed to the device. Devices distributed pursuant to Regulations equivalent to (11)(d) prior to January 1, 1981, may bear labels authorized by the Regulations in effect on January 1, 1980. Devices distributed on or after January 1, 1981, including devices redistributed upon radioactive sources exchange, shall bear labels authorized in (11)(d).

(iv) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, "Caution-Radioactive Material," the radiation symbol described in Rule .03(12), and the name of the manufacturer or initial distributor.
(v) Each device meeting the criteria of (6)(c)3.(xii), bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution-Radioactive Material," and, if practical, the radiation symbol described in Rule .03(12).
(vi) The device has been registered in the Sealed Source and Device Registry.
2. In the event the applicant desires that the device be tested at intervals longer than six months, either for proper operation of the on/off mechanism and indicator, if any, or for leakage of radioactive material, or for both, the applicant shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on/off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Department will consider information that includes, but is not limited to:
(i) Primary containment (source capsule);
(ii) Protection of primary containment;
(iii) Method of sealing containment;
(iv) Containment construction materials;
(v) Form of contained radioactive material;
(vi) Maximum temperature withstood during prototype tests;
(vii) Maximum pressure withstood during prototype tests;
(viii) Maximum quantity of contained radioactive material;
(ix) Radiotoxicity of contained radioactive material; and
(x) Operating experience with identical devices or similarly designed and constructed devices.
3. In the event the applicant desires that the general licensee under (6)(c), or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on/off mechanism and indicator, or remove the device from installation, the applicant shall include in his application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the basis for such estimates. The submitted information shall demonstrate that the performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of ten percent of the annual limits specified in Rule .03(5)(a) 1. of this Chapter.
4. Each person licensed under (11)(d) shall provide the information specified in (11)(d)4.(i) to each generally licensed recipient to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person.
(i) The required information includes:
(I) A copy of the general license contained in (6)(c); if (6)(c)3.(ii) through (iv) or (6)(c)3.(xii) do not apply to the particular device, these rules may be omitted.
(II) A copy of Rule .01(4), (5), (6), (7), (8), (9) and (10), Rule .02(13), (18), and (19), Rule .03(15)(a) and (b) and Rule .06 ;
(III) A list of the services that can only be performed by a specific licensee;
(IV) Information on acceptable disposal options including estimated costs of disposal; and
(V) An indication that improper disposal can result in high civil penalties.
(ii) If a device containing radioactive material is to be transferred for use under a general license contained in the U.S. Nuclear Regulatory Commission's, Agreement State's, or Licensing State's regulation equivalent to (6)(c), the licensee shall provide the information specified in (11)(d)4.(ii) to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:
(I) A copy of this equivalent regulation or, alternatively, furnish a copy of the general license contained in (6)(c) to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission, the Agreement State, or the Licensing State. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. If a copy of the general license in (6)(c) is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State under requirements substantially the same as those in (6)(c); if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;
(II) A list of the services that can only be performed by a specific licensee;
(III) Information on acceptable disposal options including estimated costs of disposal;
(IV) An indication that improper disposal can result in high civil penalties; and
(V) The name or title, address, and telephone number of the contact at the appropriate NRC Regional Office or Agreement State from which additional information may be obtained.
(iii) An alternative approach to informing customers may be proposed by the licensee for approval by the Department.
5. Each device that is transferred after January 1, 2003, must meet the labeling requirements of (11)(d)1.(iii) through (v).
6. If a notification of bankruptcy has been made under (13)(e) or the license is to be terminated, each person licensed under (11)(d) shall provide, upon request, to the Department and as appropriate to any Agreement State or the NRC, records of final disposition required under (11)(d)4.(viii).
7. The licensee shall report to the Department all transfers of such devices to persons for use under the general license in (6)(c) and report all receipts of such devices from persons licensed under (6)(c).
(i) Such report shall identify each general licensee by the following:
(I) The name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use;
(II) The name, title, and telephone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;
(III) The date of the transfer;
(IV) The type, model number, and serial number of the device transferred; and
(V) The quantity and type of radioactive material contained in the device.
(ii) If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).
(iii) For devices received from a (6)(c) general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.
(iv) If the licensee makes changes to a device possessed by a (6)(c) general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.
(v) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
(vi) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.
(vii) If no transfers have been made to or from persons generally licensed under (6)(c) during the reporting period, the report shall so indicate.
8. The licensee shall furnish reports to other agencies as follows:
(i) Report to the U.S. Nuclear Regulatory Commission all transfers of such devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR, Part 31 and all receipts of devices from U.S. Nuclear Regulatory Commission Section 31.5 general licensees;
(ii) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to (11)(d) for use under a general license in that state's regulations equivalent to (6)(c) and all receipts of devices from general licensees in the state agency's jurisdiction;
(iii) The reports identified in 8.(i) and 8.(ii) shall identify each general licensee by the following:
(I) The name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.
(II) The name, title and telephone number the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;
(III) The date of the transfer;
(IV) The type, model, and serial number of the device transferred; and
(V) The quantity and type of radioactive material contained in the device.
(iv) If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).
(v) For devices received from a (6)(c) general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.
(vi) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.
(vii) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.
(viii) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.
(ix) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, report this information to the U.S. Nuclear Regulatory Commission; and
(x) If no transfers have been made to general licensees within a particular state during the reporting period, report this information to the responsible state agency upon request of that agency.
9. Each person licensed under (11)(d) to distribute devices to generally licensed persons shall maintain all information concerning transfers and receipts of devices that supports the reports required by (11)(d)4. These records shall be maintained for a period of three years following the date of the recorded event.
(e) Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific license to manufacture, assemble, repair, or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, and for distribution to persons generally licensed under (6)(d), will be approved subject to the following conditions:
1. The applicant satisfies the general requirements specified in (8), and
2. The applicant satisfies the requirements of Sections 32.53, 32.54, 32.55, and 32.56 of 10 CFR, Part 32, or their equivalent.
(f) Special Requirements for License to Manufacture or Initially Transfer Calibration Sources Containing Americium-241, Plutonium, or Radium-226 for Distribution to Persons Generally Licensed Under (6)(f). An application for a specific license to manufacture or initially transfercalibration and reference sources containing americium-241, plutonium, or radium-226 to persons generally licensed under (6)(f) will be approved subject to the following conditions:
1. The applicant satisfies the general requirement of (8), and
2. The applicant satisfies the requirements of Sections 32.57, 32.58, and 32.59 of 10 CFR, Part 32, and Section 70.39 of 10 CFR, Part 70, or their equivalent.
(g) Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of (6)(g) will be approved subject to the following conditions:
1. The applicant satisfies the general requirements specified in (8);
2. The radioactive material is to be prepared for distribution in prepackaged units of:
(i) Iodine-125 in units not exceeding ten microcuries (370 kBq) each,
(ii) Iodine-131 in units not exceeding ten microcuries (370 kBq) each,
(iii) Carbon-14 in units not exceeding ten microcuries (370 kBq) each,
(iv) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each,
(v) Iron-59 in units not exceeding 20 microcuries (740 kBq) each,
(vi) Cobalt-57 in units not exceeding ten microcuries (370 kBq) each,
(vii) Selenium-75 in units not exceeding ten microcuries (370 kBq) each,
(viii) Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each;
3. Each prepackaged unit bears a durable and clearly visible label:
(i) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed ten microcuries (370 kBq) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries (1.85 Mbq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each; and
(ii) Displaying the radiation caution symbol described in Rule 391-3-17-.03, of this Chapter, and the words, "CAUTION, RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals";
4. One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
(i) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations of and a general license of the U.S. Nuclear Regulatory Commission or of a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority.

________________________

(NAME OF MANUFACTURER)

(ii) This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations of and a general license of a Licensing State.

___________________________

(NAME OF MANUFACTURER);

and

5. The label affixed to the unit, or the leaflet or brochure, which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in Rule .03(13) of this Chapter.
(h) Licensing the Manufacture and Distribution of Ice-Detection Devices. An application for a specific license to manufacture and initially transfer ice-detection devices to persons generally licensed under (6)(e) will be approved subject to the following conditions:
1. The applicant satisfies the general requirements of (8), and
2. The criteria of Sections 32.61 and 32.62 of 10 CFR, Part 32, are met.
(i) Manufacture, Preparation, or Transfer, for Commercial Distribution of Pharmaceuticals Containing Radioactive Material for Medical Use. An application for a specific license to manufacture, prepare, or transfer for commercial distribution pharmaceuticals containing radioactive material for use by persons licensed pursuant to (9) for the uses listed in (41), (44), and (48) of Rule .05 of this Chapter will be approved subject to the following conditions:
1. The applicant satisfies the general requirements specified in (8);
2. The applicant submits evidence that the applicant is at least one of the following:
(i) Registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);
(ii) Registered or licensed with a State Agency as a drug manufacturer; or
(iii) Licensed as a pharmacy by the Georgia State Board of Pharmacy;
(iv) Operating as a nuclear pharmacy within a Federal medical institution; or
(v) A Positron Emission Tomography (PET) drug production facility registered with a State agency.
3. The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per vial, syringe, generator, or other container of the radiopharmaceutical, and shielding provided by the packaging to show it is appropriate for safe handling and storage of radiopharmaceuticals by licensees; and
4. The applicant satisfies the following requirements:
(i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radiopharmaceutical to be transferred for commercial distribution. The label must include the radiation symbol and words "Caution, Radioactive Material" or "Danger Radioactive Material"; the name of the radiopharmaceutical or its abbreviation, and quantity of radioactivity at a specified date and time. For radiopharmaceuticals with a half-life greater than 100 days, the time may be omitted.
(ii) A label is affixed to each syringe, vial, or other container used to hold a radiopharmaceutical to be transferred for commercial distribution. The label must include the words "Caution, Radioactive Material" or "Danger Radioactive Material" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label, leaflet, or brochure.
5. A licensee described by (11)(i)2.(iii) or (iv):
(i) May prepare radiopharmaceuticals for medical use, as defined in Rule .05(2)(s) provided that the radiopharmaceutical is prepared by either an authorized nuclear pharmacist, as specified in (ii) and (iv) or an individual under the supervision of an authorized nuclear pharmacist as specified in Rule .05(18)(b).
(ii) May allow a pharmacist to work as an authorized nuclear pharmacist if this individual:
(I) Qualifies as an authorized nuclear pharmacist as defined in.05(2)(e),
(II) Meets the requirements specified in Rule .05(24)(b) and .05(27) and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or has notified the Department in accordance with Rule .05(11), or
(III) Is designated as an authorized nuclear pharmacist in accordance with (iv).
(iii) The actions authorized in (i) and (ii) are permitted not withstanding more restrictive language in license conditions.
(iv) May designate a nuclear pharmacist in accordance with Rule .05(26) as an authorized nuclear pharmacist if the individual is identified as of December 31, 1996, as an "authorized user" on a license issued by the Department, the NRC, or an Agreement State, under this rule or equivalent requirements, or if the individual was a nuclear pharmacist preparing only radiopharmaceuticals containing accelerator produced radioactive material and the individual practiced at a Government Agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before 'August 8, 2009, or an earlier date as noticed by the NRC.
(v) Shall provide to the Department a copy of each individual's certification by the Board of Pharmaceutical Specialties, or the Department, NRC, Agreement State license, or permit issued by a licensee of broad scope, or documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, and a copy of the individual's license to practice pharmacy in the State of Georgia issued by the Secretary of State's office, no later than 30 days after the date that the licensee allows pursuant to (ii) and (iii), the individual to work as an authorized nuclear pharmacist.
6. A licensee shall possess and use instrumentation to measure the radioactivity of radiopharmaceuticals. The licensee shall measure, by direct measurements or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radiopharmaceuticals prior to transfer for commercial distribution. In addition, the licensee shall:
(i) Perform test before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and
(ii) Check each instrument for constancy and proper operation at the beginning of each day of use.
7. Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, or other State requirements governing radiopharmaceuticals.
(j) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Rule .05 of this chapter for use as a calibration, transmission, or reference source or for medical uses regulated by Rule .05(55), (65), or (67) of this Chapter will be approved subject to the following conditions:
1. The applicant satisfies the general requirements of (8);
2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:
(i) The radioactive material contained, its chemical and physical form, and amount,
(ii) Details of design and construction of the source or device,
(iii) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,
(iv) For devices containing radioactive material, the radiation profile of a prototype device,
(v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,
(vi) Procedures and standards for calibrating sources and devices,
(vii) Legend and methods for labeling sources and devices as to their radioactive content, and
(viii) Instructions for handling and storing the source or device from the radiation safety standpoint. (These instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device. Instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure that is referenced on the label.)
3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the source or device is licensed by the Department for distribution to persons licensed pursuant to (9) and to Rule .05(55), (65), or (67) of this Chapter or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State;
4. The source or device has been registered in the Sealed Source and Device Registry;
5. In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source;
6. In determining the acceptable interval for test of leakage of radioactive material, the Department will consider information that includes, but is not limited to, that which is listed in (11)(d)2.
(k) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications.
1. An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to (5)(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved subject to the following conditions:
(i) The applicant satisfies the general requirements specified in (8);
(ii) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of 1 year a radiation dose in excess of ten percent of the annual limits specified in Rule .03(5)(a) 1. of this Chapter; and
(iii) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.
2. In the case of an industrial product or device whose unique benefits are questionable, the Department will approve an application for a specific license under (11)(k) only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.
3. The Department may deny any application for a specific license under (11)(k) if the end use(s) of the industrial product or device cannot be reasonably foreseen.
4. Each person licensed pursuant to (11)(k)1. shall:
(i) Maintain the level of quality control required by the license in the manufacture of the industrial product or device and in the installation of the depleted uranium into the product or device;
(ii) Label or mark each unit to:
(I) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and
(II) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and to the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State;
(iii) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";
(iv) Furnish a copy of the general license contained in:
(I) (5)(d) and a copy of Department form "Registration Certificate - Use of Depleted Uranium Under General License" to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in (5)(d), or
(II) The U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to (5)(d) and a copy of the U.S. Nuclear Regulatory Commission's or Agreement State's certificate, or, alternatively, furnish a copy of the general license contained in (5)(d) and a copy of Department form "Registration Certificate - Use of Depleted Uranium Under General License" to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially the same as those in (5)(d);
(v) Report to the Department all transfers of industrial products or devices to persons for use under the general license in (5)(d). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under (5)(d) during the reporting period, the report shall so indicate;
(vi) Report to other agencies as follows:
(I) To the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Regulatory Commission general license in Section 40.25 of 10 CFR, Part 40;
(II) To the responsible state agency all transfers of devices manufactured and distributed pursuant to 10CFR32.210 for use under a general license in that state's regulations equivalent to (5)(d);
(III) Have such reports identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person;
(IV) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, report this information to the U.S. Nuclear Regulatory Commission; and
(V) If no transfers have been made to general licensees within a particular Agreement State during the reporting period, report this information to the responsible Agreement State agency upon the request of that agency; and
(vii) Keep records showing the name, address, and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in (5)(d) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of two years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of (11).
(l) [Reserved]
(12) Issuance of Specific Licenses.
(a) Upon a determination that an application meets the requirements of the Act and the Regulations of the Department, the Department may issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary to effectuate the purposes of the Act.
(b) The Department may incorporate in any license at the time of issuance, or thereafter, such additional requirements and conditions, as authorized by Rule, Regulation, or Order, with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this Chapter as necessary in order to:
1. Minimize danger to public health and safety or property;
2. Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as necessary to effectuate the purposes of the Act; and
3. Prevent loss or theft of material subject to this Rule.
(13) Specific Terms and Conditions of Licenses.
(a) Each license issued pursuant to this Rule shall be subject to all the provisions of the Act, and to all Rules, and Regulations of the Department and Orders of the Director.
(b) No license issued or granted under this Rule and no right to possess or utilize radioactive material granted by any license issued pursuant to this Rule shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the Department, after securing full information, finds that the transfer is in accordance with the provisions of the Act, and gives its consent in writing.
1. An application for transfer of license must include:
(i) The identity, technical and financial qualification of the proposed transferee; and
(ii) Financial assurance for decommissioning information required by.02(8)(g).
(c) Each person licensed by the Department pursuant to this Rule shall confine use and possession of the material licensed to the locations and purposes authorized in the license.
(d) Each licensee shall notify the Department in writing immediately and request termination of his license when the licensee decides to terminate all activities involving radioactive materials authorized under the license. This notification and request for termination must include the information specified in (18)(d).
(e) Each general licensee required to register by (6)(c)3.(xi) and each specific licensee shall notify the Department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 (Bankruptcy) of the United States Code by or against:
1. The licensee;
2. An entity (as that term is defined in 11 U.S.C. 101(15) ) controlling the licensee or listing the license or licensee as property of the estate; or
3. An affiliate (as that term is defined in 11 U.S.C. 101(2) of the licensee.
(f) The notification specified in (13)(e) shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.
(g) Security requirements for portable gauges. Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.
(h) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with Rule .05(45)(a)(b) and (c). The licensee shall record the results of each test and retain each record for 3 years after the record is made.
(i) Authorization under .02(7)(j) to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.
1. Each licensee authorized under.02(7)(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:
(i) Satisfy the labeling requirements in.02(11)(i) 4. of this Rule for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.
(ii) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in.02(11)(i) 6. of this Rule.
2. A licensee that is a pharmacy authorized under.02(7)(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:
(i) an authorized nuclear pharmacist that meets the requirements in.02(11)(i) 5. of this Rule, or
(ii) an individual under the supervision of an authorized nuclear pharmacist as specified in Rule .05(18).
3. A pharmacy, authorized under.02(7)(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of .02(11)(i) 5.(v) of this Rule.
(14) Expiration of Licenses. Except as provided in (15)(b), each specific license shall expire at the end of the day, in the month and year stated therein.
(15) Renewal of Licenses.
(a) No less than 30 days before the expiration date specified in a specific license, the licensee shall either:
1. Submit an application for license renewal filed in accordance with (7), or
2. Notify the Department in writing in accordance with (13)(d) and (15)(c) if the licensee decides not to renew the license.
(b) In any case in which a licensee, not less than 30 days prior to the expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by the Department.
(c) If a licensee does not submit an application for license renewal on or before the expiration date specified in the license, then the licensee shall, on or before that expiration date:
1. Terminate the use of radioactive material,
2. Remove radioactive contamination to the extent practicable,
3. Properly dispose of the radioactive material, and
4. Submit the information specified in (18)(d).
(16) Amendment of Licenses at Request of Licensee. Applications for amendment of a license shall be filed in accordance with (7) and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment.
(17) Department Action on Applications to Renew or Amend. In considering an application by a licensee to renew or amend the license, the Department will apply the criteria set forth in (8), (9), (10), or (11), as applicable.
(18) Modification, Revocation, and Termination of Licenses.
(a) The terms and conditions of all licenses shall be subject to amendment, revision, or modification, or the license may be suspended or revoked by reason of amendments to the Act, or by reason of Rules, Regulations, and Orders issued by the Director.
(b) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the Act or of this Rule, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the Department to refuse to grant a license on an original application, or for violation of, or failure to observe, any of the terms and conditions of the Act, of the license, or of any Rule, Regulation, or Order of the Department.
(c) Each specific license revoked by the Department expires at the end of the day on the date of the Department's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Department Order.
(d) The Department may terminate a specific license upon request submitted by the licensee to the Department in writing provided the following:
1. The licensee certifies the disposition of all licensed material, including accumulated wastes, by submitting a completed "Request to Terminate Radioactive Materials License" form or equivalent information; and
2. The licensee conducts a radiation survey of the premises where the licensed activities were carried out and submits a report of the results of the survey unless the licensee demonstrates that the premises are suitable for release in accordance with the requirements for decommissioning in Rule .03(7). As appropriate, the licensee shall:
(i) Report levels of gamma radiation in units of microroentgen (millisieverts) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of disintegrations per minute or microcuries (megabecquerels) per 100 square centimeters - removable and fixed - for surfaces, microcuries (megabecquerels) per milliliter for water, and picocuries (becquerels) per gram for solids such as soils or concrete; and
(ii) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.
3. If detectable levels of residual radioactive contamination are found, the license continues to be in effect, even beyond the expiration date if necessary, with respect to possession of residual radioactive material as contamination until the Department notifies the licensee in writing that the license is terminated. Each licensee who possesses residual radioactive material under this paragraph shall initiate decommissioning activities as required by (8)(h).
4. If no residual radioactive contamination is detected, the licensee shall submit a certification that no detectable radioactive contamination was found. If the information submitted is found to be adequate, the Department will notify the licensee in writing that the license is terminated.
(e) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Department determines that:
1. Radioactive material has been properly disposed;
2. Reasonable effort has been made to eliminate residual radioactive contamination, if present; and
3.
(i) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with Department requirements for decommissioning in Rule .03(7); or
(ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with Department requirements for decommissioning in Rule .03(7).
4. Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall forward the following records to the Department:
(i) Records of disposal of licensed material made under Rule .03(13)(b) (including burials authorized before January 28, 1982), .03(13)(c), .03(13)(d), .03(13)(e); and
(ii) Records required by Rule .03(14)(c) 2.(iv).
5. If licensed activities are transferred or assigned in accordance with Rule .02(13)(b), each licensee authorized to possess radioactive material, with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:
(i) Records of disposal of licensed material made under Rule .03(13)(b) (including burials authorized before January 28, 1982), .03(13)(c), .03(13)(d), .03(13)(e); and
(ii) Records required by Rule .03(14)(c) 2.(iv).
6. Prior to license termination, each licensee shall forward the records required by Rule .02(8)(g) 8. to the Department.
(19) Transfer of Material.
(a) Authorization for Transfer. No licensee shall transfer radioactive material except as authorized pursuant to (19)(b).
(b) Condition of Transfer. Any licensee may transfer radioactive material, subject to acceptance by the transferee, to:
1. The Department, after receiving prior approval from the Department;
2. The United States Department of Energy or any successor thereto;
3. Any person exempt from this Rule to the extent permitted under such exemption;
4. Any person licensed to receive such material under terms of a general license or its equivalent, or specific license or equivalent licensing document issued by the Department, the U.S. Nuclear Regulatory Commission, any Agreement State, or any Licensing State, to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Department, any Agreement State, or any Licensing State; or
5. Any person authorized by the Department in writing.
(c) Before transferring radioactive material to a specific licensee of the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, or to a general licensee who is required to register with the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.
(d) The following methods for the verification required by (19)(c) are acceptable:
1. The transferor may possess, and read, a current copy of the transferee's specific license or registration certificate.
2. The transferor may have in his possession a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date.
3. For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided that the oral certification is confirmed in writing within ten days.
4. The transferor may obtain other sources of information compiled by a reporting service from official records of the Department, the U.S. Nuclear Regulatory Commission, the licensing agency of an Agreement State, or a Licensing State regarding the identity of licensees and the scope and expiration date of licenses and registration.
5. When none of the methods of verification described in paragraphs (19)(d)1., 2., 3., and 4. is readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the Department, the U.S. Nuclear Regulatory Commission, the licensing agency of an Agreement State, or a Licensing State that the transferee is licensed to receive the radioactive material.
(e) Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of Rule .06 of this Chapter.
(20) Reciprocity.
(a) Persons licensed by other Agencies. Subject to the provisions of this Chapter, any person who holds a specific license from the U.S. Nuclear Regulatory Commission, a Licensing State, or any Agreement State, other than this State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State, except in areas of exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year provided that:
1. The licensing document does not limit the activity authorized by such document to specified installations or locations;
2. The out-of-state licensee notifies the Department in writing at least three days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the State, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the 3-day period would impose an undue hardship on the out-of-state licensee, he may, upon application to the Department, obtain permission to proceed sooner;
3. The out-of-state licensee complies with all applicable Rules of the Department, and with all the terms and conditions of his licensing document except any such terms and conditions that may be inconsistent with applicable Rules of the Department;
4. Provided further that the Department may require the out-of-state licensee to supply such other information as the Department may reasonably request; and
5. The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in (20)(a) except by transfer to a person who is:
(i) Specifically licensed by the Department, the U.S. Nuclear Regulatory Commission, or by another Licensing State to receive such material; or
(ii) Exempt from the requirements for a license for such material under (3)(a).
(b) Notwithstanding the provisions of (20)(a), any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission, a Licensing State, or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in (6)(c)1. within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate, or service such device in this State provided that:
1. Such person shall file a report with the Department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each such report shall identify each general licensee to whom such a device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;
2. The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission, a Licensing State, or an Agreement State;
3. Such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed the manufacturing of the device bear a statement that "Removal of This Label is Prohibited"; and
4. The holder of the specific license shall furnish to each general licensee to whom he transfers such a device or on whose premises he installs such a device a copy of the general license contained in (6)(c).
(c) The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety, to property, or to the environment.
(21) Schedules.
(a) Schedule A.

SCHEDULE A

EXEMPT CONCENTRATIONS

Exempt Concentrations

Element

(Atomic Number)

Schedule A

Isotope

Column I

Gas

Concentration

(µCi/mL)(1)

Column II

Liquid and Solid

Concentration

(µCi/mL)(2)

Antimony (51)

Sb 122

 

3 x 10-4

 

Sb 124

 

2 x 10-4

 

Sb 125

 

1 x 10-3

Argon (18)

Ar 37

1 x 10-3

 
 

Ar 41

4 x 10-7

 

Arsenic (33)

As 73

 

5 x 10-3

 

As 74

 

5 x 10-4

 

As 76

 

2 x 10-4

 

As 77

 

8 x 10-4

Barium (56)

Ba 131

 

2 x 10-3

 

Ba 140

 

3 x 10-4

Beryllium (4)

Be 7

 

2 x 10-2

Bismuth (83)

Bi 206

 

4 x 10-4

Bromine (35)

Br 82

4 x 10-7

3 x 10-3

Cadmium (48)

Cd 109

 

2 x 10-3

 

Cd 115m

 

3 x 10-4

 

Cd 115

 

3 x 10-4

Calcium (20)

Ca 45

 

9 x 10-5

 

Ca 47

 

5 x 10-4

Carbon (6)

C 14

1 x 10-6

8 x 10-3

Cerium (58)

Ce 141

 

9 x 10-4

 

Ce 143

 

4 x 10-4

 

Ce 144

 

1 x 10-4

Cesium (55)

Cs 131

 

2 x 10-2

 

Cs 134m

 

6 x 10-2

 

Cs 134

 

9 x 10-5

Chlorine (17)

Cl 38

9 x 10-7

4 x 10-3

Chromium (24)

Cr 51

 

2 x 10-2

Cobalt (27)

Co 57

 

5 x 10-3

 

Co 60

 

5 x 10-4

Copper (29)

Cu 64

 

3 x 10-3

Dysprosium (66)

Dy 165

 

4 x 10-3

 

Dy 166

 

4 x 10-4

Erbium (68)

Er 169

 

9 x 10-4

 

Er 171

 

1 x 10-3

Europium (63) (T0.5 = 9.2 h)

Eu 152

 

6 x 10-4

 

Eu 155

 

2 x 10-3

Fluorine (9)

F 18

2 x 10-6

8 x 10-3

Gadolinium (64)

Gd 153

 

2 x 10-3

 

Gd 159

 

8 x 10-4

Gallium (31)

Ga 72

 

4 x 10-4

Germanium (32)

Ge 71

 

2 x 10-2

Gold (79)

Au 196

 

2 x 10-3

 

Au 198

 

5 x 10-4

 

Au 199

 

2 x 10-3

Hafnium (72)

Hf 181

 

7 x 10-4

Hydrogen (1)

H 3

5 x 10-6

3 x 10-2

Indium (49)

In 113m

 

1 x 10-2

 

In 114m

 

2 x 10-4

Iodine (53)

I 126

3 x 10-9

2 x 10-5

 

I 131

3 x 10-9

2 x 10-5

 

I 132

8 x 10-8

6 x 10-4

 

I 133

1 x 10-8

7 x 10-5

 

I 134

2 x 10-7

1 x 10-3

Iridium (77)

Ir 190

 

2 x 10-3

 

Ir 192

 

4 x 10-4

 

Ir 194

 

3 x 10-4

Iron (26)

Fe 55

 

8 x 10-3

 

Fe 59

 

6 x 10-4

Krypton (36)

Kr 85m

1 x 10-6

 
 

Kr 85

3 x 10-6

 

Lanthanum (57)

La 140

 

2 x 10-4

Lead (82)

Pb 203

 

4 x 10-3

Lutetium (71)

Lu 177

 

1 x 10-3

Manganese (25)

Mn 52

 

3 x 10-4

 

Mn 54

 

1 x 10-3

 

Mn 56

 

1 x 10-3

Mercury (80)

Hg 197m

 

2 x 10-3

 

Hg 197

 

3 x 10-3

 

Hg 203

 

2 x 10-4

Molybdenum (42)

Mo 99

 

2 x 10-3

Neodymium (60)

Nd 147

 

6 x 10-4

 

Nd 149

 

3 x 10-3

Nickel (28)

Ni 65

 

1 x 10-3

Niobium (columbium) (41)

Nb 95

 

1 x 10-3

 

Nb 97

 

9 x 10-3

Osmium (76)

Os 185

 

7 x 10-4

 

Os 191m

 

3 x 10-2

 

Os 191

 

2 x 10-3

 

Os 193

 

6 x 10-4

Palladium (46)

Pd 103

 

3 x 10-3

 

Pd 109

 

9 x 10-4

Phosphorus (15)

P 32

 

2 x 10-4

Platinum (78)

Pt 191

 

1 x 10-3

 

Pt 193m

 

1 x 10-2

 

Pt 197m

 

1 x 10-2

 

Pt 197

 

1 x 10-3

Polonium (84)

Po 210

 

7 x 10-6

Potassium (19)

K 42

 

3 x 10-3

Praseodymium (59)

Pr 142

 

3 x 10-4

 

Pr 143

 

5 x 10-4

Promethium (61)

Pm 147

 

2 x 10-3

 

Pm 149

 

4 x 10-4

Radium (88)

Ra 226

 

1 x 10-7

 

Ra 228

 

3 x 10-7

Rhenium (75)

Re 183

 

6 x 10-3

 

Re 186

 

9 x 10-4

 

Re 188

 

6 x 10-4

Rhodium (45)

Rh 103m

 

1 x 10-1

Rubidium (37)

Rb 86

 

7 x 10-4

Ruthenium (44)

Ru 97

 

4 x 10-3

 

Ru 103

 

8 x 10-4

 

Ru 105

 

1 x 10-3

 

Ru 106

 

1 x 10-4

Samarium (62)

Sm 153

 

8 x 10-4

Scandium (21)

Sc 46

 

4 x 10-4

 

Sc 47

 

9 x 10-4

 

Sc 48

 

3 x 10-3

Selenium (34)

Se 75

 

3 x 10-3

Silicon (14)

Si 31

 

9 x 10-3

Silver (47)

Ag 105

 

1 x 10-3

 

Ag 110m

 

3 x 10-4

 

Ag 111

 

4 x 10-4

Sodium (11)

Na 24

 

2 x 10-3

Strontium (38)

Sr 85

 

1 x 10-3

 

Sr 89

 

1 x 10-4

 

Sr 91

 

7 x 10-4

 

Sr 92

 

7 x 10-4

Sulfur (16)

S 35

9 x 10-8

6 x 10-4

Tantalum (73)

Ta 182

 

4 x 10-4

Technetium (43)

Tc 96m

 

1 x 10-1

 

Tc 96

 

1 x 10-3

Tellurium (52)

Te 125m

 

2 x 10-3

 

Te 127m

 

6 x 10-4

 

Te 127

 

3 x 10-3

 

Te 129m

 

3 x 10-4

 

Te 131m

 

6 x 10-4

 

Te 132

 

3 x 10-4

Terbium (65)

Tb 160

 

4 x 10-4

Thallium (81)

Tl 200

 

4 x 10-3

 

Tl 201

 

3 x 10-3

 

Tl 202

 

1 x 10-3

 

Tl 204

 

1 x 10-3

Thulium (69)

Tm 170

 

5 x 10-4

Tin (50)

Sn 113

 

9 x 10-4

 

Sn 125

 

2 x 10-4

Tungsten (wolfram) (74)

W 181

 

4 x 10-3

 

W 187

 

7 x 10-4

Vanadium (23)

V 48

 

3 x 10-4

Xenon (54)

Xe 131m

4 x 10-6

 
 

Xe 133

3 x 10-6

 
 

Xe 135

1 x 10-6

 

Ytterbium (70)

Yb 175

 

1 x 10-3

Yttrium (39)

Y 90

 

2 x 10-4

 

Y 91m

 

3 x 10-2

 

Y 91

 

3 x 10-4

 

Y 92

 

6 x 10-4

 

Y 93

 

3 x 10-4

Zinc (30)

Zn 65

 

1 x 10-3

 

Zn 69m

 

7 x 10-4

 

Zn 69

 

2 x 10-2

Zirconium (40)

Zr 95

 

6 x 10-4

 

Zr 97

 

2 x 10-4

Beta- and/or gamma-emitting radioactive material not listed above with half-life less than three years

 

1 x 10-10

1 x 10-6

Note: Many radioisotopes disintegrate into isotopes that are also radioactive. In expressing the concentrations in Schedule A, the activity stated is that of the parent isotope and takes into account the daughters. For purposes of (3)(a) where there is involved a combination of isotopes, the limit for the combination should be derived as follows:

Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity).


                image: ga/admin/2017/391-3-17-.02_001.png

Footnotes: (1) Values are given only for those materials normally used as gases.

(2)µCi/gm for solids.

(b) Schedule B.

SCHEDULE B

EXEMPT QUANTITIES

Schedule B - Exempt Quantities

Radioactive Material

Exempt Quantity

(Microcuries)

Antimony-122 (Sb 122)

100

Antimony-124 (Sb 124)

10

Antimony-125 (Sb 125)

10

Arsenic-73 (As 73)

100

Arsenic-74 (As 74)

10

Arsenic-76 (As 76)

10

Arsenic-77 (As 77)

100

Barium-131 (Ba 131)

10

Barium-133 (Ba 133)

10

Barium-140 (Ba 140)

10

Bismuth-210 (Bi 210)

1

Bromine-82 (Br 82)

10

Cadmium-109 (Cd 109)

10

Cadmium-115m (Cd 115m)

10

Cadmium-115 (Cd 115)

100

Calcium-45 (Ca 45)

10

Calcium-47 (Ca 47)

10

Carbon-14 (C 14)

100

Cerium-141 (Ce 141)

100

Cerium-143 (Ce 143)

100

Cerium-144 (Ce 144)

1

Cesium-129 (Cs 129)

100

Cesium-131 (Cs 131)

1,000

Cesium-134m (Cs 134m)

100

Cesium-134 (Cs 134)

1

Cesium-135 (Cs 135)

10

Cesium-136 (Cs 136)

10

Cesium-137 (Cs 137)

10

Chlorine-36 (Cl 36)

10

Chlorine-38 (Cl 38)

10

Chromium-51 (Cr 51)

1,000

Cobalt-57 (Co 57)

100

Cobalt-58m (Co 58m)

10

Cobalt-58 (Co 58)

10

Cobalt-60 (Co 60)

1

Copper-64 (Cu 64)

100

Dysprosium-165 (Dy 165)

10

Dysprosium-166 (Dy 166)

100

Erbium-169 (Er 169)

100

Erbium-171 (Er 171)

100

Europium-152 (Eu 152) 9.2 h

100

Europium-152 (Eu 152) 13 yr

1

Europium-154 (Eu 154)

1

Europium-155 (Eu 155)

10

Fluorine-18 (F 18)

1,000

Gadolinium-153 (Gd 153)

10

Gadolinium-159 (Gd 159)

100

Gallium-67 (Ga 67)

100

Gallium-72 (Ga 72)

10

Germanium-68 (Ge 68)

10

Germanium-71 (Ge 71)

100

Gold-195 (Au 195)

10

Gold-198 (Au 198)

100

Gold-199 (Au 199)

100

Hafnium-181 (Hf 181)

10

Holmium-166 (Ho 166)

100

Hydrogen-3 (H 3)

1,000

Indium-111 (In 111)

100

Indium-113m (In 113m)

100

Indium-114m (In 114m)

10

Indium-115m (In 115m)

100

Indium-115 (In 115)

10

Iodine-123 (I 123)

100

Iodine-125 (I 125)

1

Iodine-126 (I 126)

1

Iodine-129 (I 129)

0.1

Iodine-131 (I 131)

1

Iodine-132 (I 132)

10

Iodine-133 (I 133)

1

Iodine-134 (I 134)

10

Iodine-135 (I 135)

10

Iridium-192 (Ir 192)

10

Iridium-194 (Ir 194)

100

Iron-52 (Fe 52)

10

Iron-55 (Fe 55)

100

Iron-59 (Fe 59)

10

Krypton-85 (Kr 85)

100

Krypton-87 (Kr 87)

100

Lanthanum-140 (La 140)

10

Lutetium-177 (Lu 177)

100

Manganese-52 (Mn 52)

10

Manganese-54 (Mn 54)

10

Manganese-56 (Mn 56)

10

Mercury-197m (Hg 197m)

100

Mercury-197 (Hg 197)

100

Mercury-203 (Hg 203)

10

Molybdenum-99 (Mo 99)

100

Neodymium-147 (Nd 147)

100

Neodymium-149 (Nd 149)

100

Nickel-59 (Ni 59)

100

Nickel-63 (Ni 63)

10

Nickel-65 (Ni 65)

100

Niobium-93m (Nb 93m)

10

Niobium-95 (Nb 95)

10

Niobium-97 (Nb 97)

10

Osmium-185 (Os 185)

10

Osmium-191m (Os 191m)

100

Osmium-191 (Os 191)

100

Osmium-193 (Os 193)

100

Palladium-103 (Pd 103)

100

Palladium-109 (Pd 109)

100

Phosphorus-32 (P 32)

10

Platinum-191 (Pt 191)

100

Platinum-193m (Pt 193m)

100

Platinum-193 (Pt 193)

100

Platinum-197m (Pt 197m)

100

Platinum-197 (Pt 197)

100

Polonium-210 (Po 210)

0.1

Potassium-42 (K 42)

10

Potassium-43 (K 43)

10

Praseodymium-142 (Pm 142)

100

Praseodymium-143 (Pr 143)

100

Promethium-147 (Pm 147)

10

Promethium-149 (Pm 149)

10

Rhenium-186 (Re 186)

100

Rhenium-188 (Re 188)

100

Rhodium-103m (Rh 103m)

100

Rhodium-105 (Rh 105)

100

Rubidium-81 (Rb 81)

10

Rubidium-86 (Rb 86)

10

Rubidium-87 (Rb 87)

10

Ruthenium-97 (Ru 97)

100

Ruthenium-103 (Ru 103)

10

Ruthenium-105 (Ru 105)

10

Ruthenium-106 (Ru 106)

1

Samarium-151 (Sm 151)

10

Samarium-153 (Sm 153)

100

Scandium-46 (Sc 46)

10

Scandium-47 (Sc 47)

100

Scandium-48 (Sc 48)

10

Selenium-75 (Se 75)

10

Silicon-31 (Si 31)

100

Silver-105 (Ag 105)

10

Silver-110m (Ag 110m)

1

Silver-111 (Ag 111)

100

Sodium-22 (Na 22)

10

Sodium-24 (Na 24)

10

Strontium-85 (Sr 85)

10

Strontium-89 (Sr 89)

1

Strontium-90 (Sr 90)

0.1

Strontium-91 (Sr 91)

10

Strontium-92 (Sr 92)

10

Sulphur-35 (S 35)

100

Tantalum-182 (Ta 182)

10

Technetium-96 (Tc 96)

10

Technetium-97m (Tc 97m)

100

Technetium-97 (Tc 97)

100

Technetium-99m (Tc 99m)

100

Technetium-99 (Tc 99)

10

Tellurium-125m (Te 125m)

10

Tellurium-127m (Te 127m)

10

Tellurium-127 (Te 127)

100

Tellurium-129m (Te 129m)

10

Tellurium-129 (Te 129)

100

Tellurium-131m (Te 131m)

10

Tellurium-132 (Te 132)

10

Terbium-160 (Tb 160)

10

Thallium-200 (Tl 200)

100

Thallium-201 (Tl 201)

100

Thallium-202 (Tl 202)

100

Thallium-204 (Tl 204)

10

Thulium-170 (Tm 170)

10

Thulium-171 (Tm 171)

10

Tin 113-(Sn 113)

10

Tin 125-(Sn 125)

10

Tungsten-181 (W 181)

10

Tungsten-185 (W 185)

10

Tungsten-187 (W 187)

100

Vanadium-48 (V 48)

10

Xenon-131m (Xe 131m)

1,000

Xenon-133 (Xe 133)

100

Xenon-135 (Xe 135)

100

Ytterbium-175 (Yb 175)

100

Yttrium-87 (Y 87)

10

Yttrium-88 (Y 88)

10

Yttrium-90 (Y 90)

10

Yttrium-91 (Y 91)

10

Yttrium-92 (Y 92)

100

Yttrium-93 (Y 93)

100

Zinc-65 (Zn 65)

10

Zinc-69m (Zn 69m)

100

Zinc-69 (Zn 69)

1,000

Zirconium-93 (Zr 93)

10

Zirconium-95 (Zr 95)

10

Zirconium-97 (Zr 97)

10

Any radioactive material not listed above other than alpha-emitting radioactive material

0.1

(c) Schedule C.

SCHEDULE C

LIMITS FOR BROAD LICENSES

Schedule C - Limits For Broad Licenses

Radioactive Materials

Column I

(Curies)

Column II

(Curies)

Antimony-122 (Sb 122)

1

0.01

Antimony-124 (Sb 124)

1

0.01

Antimony-125 (Sb 125)

1

0.01

Arsenic-73 (As 73)

10

0.1

Arsenic-74 (As 74)

1

0.01

Arsenic-76 (As 76)

1

0.01

Arsenic-77 (As 77)

10

0.1

Barium-131 (Ba 131)

10

0.1

Barium-140 (Ba 140)

1

0.01

Beryllium-7 (Be 7)

10

0.1

Bismuth-210 (Bi 210)

0.1

0.001

Bromine-82 (Br 82)

10

0.1

Cadmium-109 (Cd 109)

1

0.01

Cadmium-115m (Cd 115m)

1

0.01

Cadmium-115 (Cd 115)

10

0.1

Calcium-45 (Ca 45)

1

0.01

Calcium-47 (Ca 47)

10

0.1

Carbon-14 (C 14)

100

1.0

Cerium-141 (Ce 141)

10

0.1

Cerium-143 (Ce 143)

10

0.1

Cerium-144 (Ce 144)

0.1

0.001

Cesium-131 (Cs 131)

100

1.0

Cesium-134m (Cs 134m)

100

1.0

Cesium-134 (Cs 134)

0.1

0.001

Cesium-135 (Cs 135)

1

0.01

Cesium-136 (Cs 136)

10

0.1

Cesium-137 (Cs 137)

0.1

0.001

Chlorine-36 (Cl 36)

0.01

0.001

Chlorine-38 (Cl 38)

100

1.0

Chromium-51 (Cr 51)

100

1.0

Cobalt-57 (Co 57)

10

0.1

Cobalt-58m (Co 58m)

100

1.0

Cobalt-58 (Co 58)

1

0.01

Cobalt-60 (Co 60)

0.1

0.001

Copper-64 (Cu 64)

10

0.1

Dysprosium-165 (Dy 165)

100

1.0

Dysprosium-166 (Dy 166)

10

0.1

Erbium-169 (Er 169)

10

0.1

Erbium-171 (Er 171)

10

0.1

Europium-152 (Eu 152) 9.2 h

10

0.1

Europium-152 (Eu 152) 13 yr

0.1

0.001

Europium-154 (Eu 154)

0.1

0.001

Europium-155 (Eu 155)

1

0.01

Fluorine-18 (F 18)

100

1.0

Gadolinium-153 (Gd 153)

1

0.01

Gadolinium-159 (Gd 159)

10

0.1

Gallium-72 (Ga 72)

10

0.1

Germanium-71 (Ge 71)

100

1.0

Gold-198 (Au 198)

10

0.1

Gold-199 (Au 199)

10

0.1

Hafnium-181 (Hf 181)

1

0.01

Holmium-166 (Ho 166)

10

0.1

Hydrogen-3 (H 3)

100

1.0

Indium-113m (In 113m)

100

1.0

Indium-114m (In 114m)

1

0.01

Indium-115m (In 115m)

100

1.0

Indium-115 (In 115)

1

0.01

Iodine-125 (I 125)

0.1

0.001

Iodine-126 (I 126)

0.1

0.001

Iodine-129 (I 129)

0.1

0.001

Iodine-131 (I 131)

0.1

0.001

Iodine-132 (I 132)

10

0.1

Iodine-133 (I 133)

1

0.01

Iodine-134 (I 134)

10

0.1

Iodine-135 (I 135)

1

0.01

Iridium-192 (Ir 192)

1

0.01

Iridium-194 (Ir 194)

10

0.1

Iron-55 (Fe 55)

10

0.1

Iron-59 (Fe 59)

1

0.01

Krypton-85 (Kr 85)

100

1.0

Krypton-87 (Kr 87)

10

0.1

Lanthanum-140 (La 140)

1

0.01

Lutetium-177 (Lu 177)

10

0.1

Manganese-52 (Mn 52)

1

0.01

Manganese-54 (Mn 54)

1

0.01

Manganese-56 (Mn 56)

10

0.1

Mercury-197m (Hg 197m)

10

0.1

Mercury-197 (Hg 197)

10

0.1

Mercury-203 (Hg 203)

1

0.01

Molybdenum-99 (Mo 99)

10

0.1

Neodymium-147 (Nd 147)

10

0.1

Neodymium-149 (Nd 149)

10

0.1

Nickel-59 (Ni 59)

10

0.1

Nickel-63 (Ni 63)

1

0.01

Nickel-65 (Ni 65)

10

0.1

Niobium-93m (Nb 93m)

1

0.01

Niobium-95 (Nb 95)

1

0.01

Niobium-97 (Nb 97)

100

1.0

Osmium-185 (Os 185)

1

0.01

Osmium-191m (Os 191m)

100

1.0

Osmium-191 (Os 191)

10

0.1

Osmium-193 (Os 193)

10

0.1

Palladium-103 (Pd 103)

10

0.1

Palladium-109 (Pd 109)

10

0.1

Phosphorus-32 (P 32)

1

0.01

Platinum-191 (Pt 191)

10

0.1

Platinum-193m (Pt 193m)

100

1.0

Platinum-193 (Pt 193)

10

0.1

Platinum-197m (Pt 197m)

100

1.0

Platinum-197 (Pt 197)

10

0.1

Polonium-210 (Po 210)

0.01

0.0001

Potassium-42 (K 42)

1

0.01

Praseodymium-142 (Pm 142)

10

0.1

Praseodymium-143 (Pr 143)

10

0.1

Promethium-147 (Pm 147)

1

0.01

Promethium-149 (Pm 149)

10

0.1

Radium-226

0.01

0.0001

Rhenium-186 (Re 186)

10

0.1

Rhenium-188 (Re 188)

10

0.1

Rhodium-103m (Rh 103m)

1,000

0

Rhodium-105 (Rh 105)

10

0.1

Rubidium-86 (Rb 86)

1

0.01

Rubidium-87 (Rb 87)

1

0.01

Ruthenium-97 (Ru 97)

100

1.0

Ruthenium-103 (Ru 103)

1

0.01

Ruthenium-105 (Ru 105)

10

0.1

Ruthenium-106 (Ru 106)

0.1

0.001

Samarium-151 (Sm 151)

1

0.01

Samarium-153 (Sm 153)

10

0.1

Scandium-46 (Sc 46)

1

0.01

Scandium-47 (Sc 47)

10

0.1

Scandium-48 (Sc 48)

1

0.01

Selenium-75 (Se 75)

1

0.01

Silicon-31 (Si 31)

10

0.1

Silver-105 (Ag 105)

1

0.01

Silver-110m (Ag 110m)

0.1

0.001

Silver-111 (Ag 111)

10

0.1

Sodium-22 (Na 22)

0.1

0.001

Sodium-24 (Na 24)

1

0.01

Strontium-85m (Sr 85m)

1,000

10.0

Strontium-85 (Sr 85)

1

0.01

Strontium-89 (Sr 89)

1

0.01

Strontium-90 (Sr 90)

0.01

0.0001

Strontium-91 (Sr 91)

10

0.1

Strontium-92 (Sr 92)

10

0.1

Sulphur-35 (S 35)

10

0.1

Tantalum-182 (Ta 182)

1

0.01

Technetium-96 (Tc 96)

10

0.1

Technetium-97m (Tc 97m)

10

0.1

Technetium-97 (Tc 97)

10

0.1

Technetium-99m (Tc 99m)

100

1.0

Technetium-99 (Tc 99)

1

0.01

Tellurium-125m (Te 125m)

1

0.01

Tellurium-127m (Te 127m)

1

0.01

Tellurium-127 (Te 127)

10

0.1

Tellurium-129m (Te 129m)

1

0.01

Tellurium-129 (Te 129)

100

1.0

Tellurium-131m (Te 131m)

10

0.1

Tellurium-132 (Te 132)

1

0.01

Terbium-160 (Tb 160)

1

0.01

Thallium-200 (Tl 200)

10

0.1

Thallium-201 (Tl 201)

10

0.1

Thallium-202 (Tl 202)

10

0.1

Thallium-204 (Tl 204)

1

0.01

Thulium-170 (Tm 170)

1

0.01

Thulium-171 (Tm 171)

1

0.01

Tin 113-(Sn 113)

1

0.01

Tin 125-(Sn 125)

1

0.01

Tungsten-181 (W 181)

1

0.01

Tungsten-185 (W 185)

1

0.01

Tungsten-187 (W 187)

10

0.1

Vanadium-48 (V 48)

1

0.01

Xenon-131m (Xe 131m)

1,000

0

Xenon-133 (Xe 133)

100

1.0

Xenon-135 (Xe 135)

100

1.0

Ytterbium-175 (Yb 175)

10

0.1

Yttrium-90 (Y 90)

1

0.1

Yttrium-91 (Y 91)

1

0.1

Yttrium-92 (Y 92)

10

0.1

Yttrium-93 (Y 93)

1

0.01

Zinc-65 (Zn 65)

1

0.01

Zinc-69m (Zn 69m)

10

0.1

Zinc-69 (Zn 69)

100

1.0

Zirconium-93 (Zr 93)

1

0.01

Zirconium-95 (Zr 95)

1

0.01

Zirconium-97 (Zr 97)

1

0.01

     

Any radioactive material other than source material, or alpha-emitting radioactive material not listed above.

0.1

0.001

(d) Schedule D. Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning.
1. Introduction. An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This schedule establishes criteria for passing the financial test and for obtaining the parent company guarantee.
2. Financial Test. To pass the financial test, the parent company must meet the criteria of either (21)(d)2.(i) or (21)(d)2.(ii) as follows:
(i) The parent company must have:
(I) two of the following three ratios: a ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater than 1.5;
(II) Net working capital and tangible net worth each at least six times the current decommissioning cost estimates (or prescribed amount if a certification is used);
(III) Tangible net worth of at least $10 million; and
(IV) Assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates (or prescribed amount if a certification is used).
(ii) The parent company must have:
(I) A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's or Aaa, Aa, A, or Baa as issued by Moody's;
(II) Tangible net worth each at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used);
(III) Tangible net worth of at least $10 million; and
(IV) Assets located in the United States amounting to at least 90 percent of total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts thereof (or prescribed amount if a certification is used).
(iii) The parent company's independent certified public accountant must have compared the data used by the parent company in the financial test, which is derived from the independently-audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure the licensee shall inform the Department within 90 days of any matters coming to the auditor's attention that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
(iv) After the initial financial test, the parent company must repeat the passage of the test within 120 days after the close of each succeeding fiscal year. If the parent company no longer meets the requirements, as appropriate, of either (21)(d)2.(i) or (21)(d)2.(ii), the licensee must send notice to the Department of intent to establish alternate financial assurance as specified in the Department's Regulations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the year-end financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.
3. Parent Company Guarantee. The terms of a parent company guarantee which an applicant or licensee obtains must provide that:
(i) The parent company guarantee shall remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Department, as evidenced by the return receipts;
(ii) If the licensee fails to provide alternate financial assurance as specified in the Department's Regulations within 90 days after receipt by the licensee and the Department of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor shall provide such alternative financial assurance in the name of the licensee;
(iii) The parent company guarantee and financial test provisions must remain in effect until the Department has terminated the license; and
(iv) If a trust is established for decommissioning costs, the trustee and trust must be acceptable to the Department. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
(e) Schedule E.

SCHEDULE E

QUANTITIES OF RADIOACTIVE MATERIALS REQUIRING

CONSIDERATION OF THE NEED FOR AN EMERGENCY PLAN

FOR RESPONDING TO A RELEASE

Schedule E - Emergency Plan For Responding to a Release

Radioactive Material(1)

Release Fraction

Quantity

(Curies)

Actinium-228

0.001

4,000

Americium-241

0.001

2

Americium-242

0.001

2

Americium-243

0.001

2

Antimony-124

0.01

4,000

Antimony-126

0.01

6,000

Barium-133

0.01

10,000

Barium-140

0.01

30,000

Bismuth-207

0.01

5,000

Bismuth-210

0.01

600

Cadmium-109

0.01

1,000

Cadmium-113

0.01

80

Calcium-45

0.01

20,000

Californium-252

0.001

9 (20 mg)

Carbon-14 (Non Carbon dioxide)

0.01

50,000

Cerium-141

0.01

10,000

Cerium-144

0.01

300

Cesium-134

0.01

2,000

Cesium-137

0.01

3,000

Chlorine-36

0.5

100

Chromium-51

0.01

300,000

Cobalt-60

0.001

5,000

Copper-64

0.01

200,000

Curium-242

0.001

60

Curium-243

0.001

3

Curium-244

0.001

4

Curium-245

0.001

2

Europium-152

0.01

500

Europium-154

0.01

400

Europium-155

0.01

3,000

Germanium-68

0.01

2,000

Gadolinium-153

0.01

5,000

Gold-198

0.01

30,000

Hafnium-172

0.01

400

Hafnium-181

0.01

7,000

Holmium-166m

0.01

100

Hydrogen-3

0.5

20,000

Iodine-125

0.5

10

Iodine-131

0.5

10

Indium-114m

0.01

1,000

Iridium-192

0.001

40,000

Iron-55

0.01

40,000

Iron-59

0.01

7,000

Krypton-85

1.0

6,000,000

Lead-210

0.01

8

Manganese-56

0.01

60,000

Mercury-203

0.01

10,000

Molybdenum-99

0.01

30,000

Neptunium-237

0.001

2

Nickel-63

0.01

20,000

Niobium-94

0.01

300

Phosphorus-32

0.5

100

Phosphorus-33

0.5

1,000

Polonium-210

0.01

10

Potassium-42

0.01

9,000

Promethium-145

0.01

4,000

Promethium-147

0.01

4,000

Radium-226

0.001

100

Ruthenium-106

0.01

200

Samarium-151

0.01

4,000

Scandium-46

0.01

3,000

Selenium-75

0.01

10,000

Silver-110m

0.01

1,000

Sodium-22

0.01

9,000

Sodium-24

0.01

10,000

Strontium-89

0.01

3,000

Strontium-90

0.01

90

Sulfur-35

0.5

900

Technetium-99

0.01

10,000

Technetium-99m

0.01

400,000

Tellurium-127m

0.01

5,000

Tellurium-129m

0.01

5,000

Terbium-160

0.01

4,000

Thulium-170

0.01

4,000

Tin-13

0.01

10,000

Tin-123

0.01

3,000

Tin-126

0.01

1,000

Titanium-44

0.01

100

Vanadium-48

0.01

7,000

Xenon-133

1.0

900,000

Yttrium-91

0.01

2,000

Zinc-65

0.01

5,000

Zirconium-93

0.01

400

Zirconium-95

0.01

5,000

Any other beta-/gamma-emitter

0.01

10,000

Mixed fission products

0.01

1,000

Mixed Corrosion Products

0.01

10,000

Contaminated equipment, beta/gamma

0.001

10,000

Irradiated material, any form other than solid noncombustible

0.01

1,000

Irradiated material, solid noncombustible

0.001

10,000

Mixed radioactive waste, beta/gamma

0.01

1,000

Packaged mixed waste, beta/gamma2

0.001

10,000

Any other alpha-emitter

0.001

2

Contaminated equipment, alpha

0.0001

20

Packaged waste, alpha(2)

0.0001

20

Footnotes:(1) For combinations of radioactive materials listed above, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Schedule E exceeds one.

(2) Waste packaged in Type B containers does not require an emergency plan.

(f) Schedule F

SCHEDULE F

QUANTITIES FOR USE WITH DECOMMISSIONING

Schedule F - Quantities for Use With Decommissioning

Radioactive Material

Quantity

(Microcurie [1]/)

Americium-241

0.01

Antimony-122

100

Antimony-124

10

Antimony-125

10

Arsenic-73

100

Arsenic-74

10

Arsenic-76

10

Arsenic-77

100

Barium-131

10

Barium-133

10

Barium-140

10

Bismuth-210

1

Bromine-82

10

Cadmium-109

10

Cadmium-115m

10

Cadmium-115

100

Calcium-45

10

Calcium-47

10

Carbon-14

100

Cerium-141

100

Cerium-143

100

Cerium-144

1

Cesium-131

1,000

Cesium-134m

100

Cesium-134

1

Cesium-135

10

Cesium-136

10

Cesium-137

10

Chlorine-36

10

Chlorine-38

10

Chromium-51

1,000

Cobalt-58m

10

Cobalt-58

10

Cobalt-60

1

Copper-64

100

Dysprosium-165

10

Dysprosium-166

100

Erbium-169

100

Erbium-171

100

Europium-152 (9.2 h)

100

Europium-152 (13 yr)

1

Europium-154

1

Europium-155

10

Florine-18

1,000

Gadolinium-153

10

Gadolinium-159

100

Gallium-72

10

Germanium-71

0

Hafnium-181

10

Holmium-166

100

Hydrogen-3

1,000

Indium-113m

100

Indium-114m

10

Indium-115m

100

Indium-115

10

Iodine-125

1

Iodine-126

1

Iodine-129

0.1

Iodine-131

1

Iodine-132

10

Iodine-133

1

Iodine-134

10

Iodine-135

10

Iridium-192

10

Iridium-194

100

Iron-55

100

Iron-59

10

Krypton-85

100

Krypton-87

10

Lanthanum-140

10

Lutetium-177

100

Manganese-52

10

Manganese-54

10

Manganese-56

10

Mercury-197m

100

Mercury-197

100

Mercury-203

10

Molybdenum-99

100

Neodymium-147

100

Neodymium-149

100

Nickel-59

100

Nickel-63

10

Nickel-65

100

Niobium-93m

10

Niobium-95

10

Niobium-97

10

Osmium-185

10

Osmium-191m

100

Osmium-191

100

Osmium-193

100

Palladium-103

100

Palladium-109

100

Phosphorus-32

10

Platinum-191

100

Platinum-193m

100

Platinum-193

100

Platinum-197m

100

Platinum-197

100

Plutonium-239

0.01

Polonium-210

0.1

Potassium-42

10

Praseodymium-142

100

Praseodymium-143

100

Promethium-147

10

Promethium-149

10

Radium-226

0.01

Rhenium-186

100

Rhenium-188

100

Rhodium-103m

100

Rhodium-105

100

Rubidium-86

10

Rubidium-87

10

Ruthenium-97

100

Ruthenium-103

10

Ruthenium-105

10

Ruthenium-106

1

Samarium-151

10

Samarium-153

100

Scandium-46

10

Scandium-47

100

Scandium-48

10

Selenium-75

10

Silicon-31

100

Silver-105

10

Silver-110m

1

Silver-111

100

Sodium-22

1

Sodium-24

10

Strontium-85

10

Strontium-89

1

Strontium-90

0.1

Strontium-91

10

Strontium-92

10

Sulfur-35

100

Tantalum-182

10

Technetium-96

10

Technetium-97m

100

Technetium-97

100

Technetium-99m

100

Technetium-99

10

Tellurium-125m

10

Tellurium-127m

10

Tellurium-127

100

Tellurium-129m

10

Tellurium-129

100

Tellurium-131m

10

Tellurium-132

10

Terbium-160

10

Thallium-200

100

Thallium-201

100

Thallium-202

100

Thallium-204

10

Thorium (natural)[2]/

100

Thulium-170

10

Thulium-171

10

Tin-113

10

Tin-125

10

Tungsten-181

10

Tungsten-185

10

Tungsten-187

100

Uranium (natural)[3]/

100

Uranium-233

0.01

Uranium-234

0.01

Uranium-235

0.01

Vanadium-48

10

Xenon-131m

1,000

Xenon-133

100

Xenon-135

100

Ytterbium-175

100

Yttrium-90

10

Yttrium-91

10

Yttrium-92

100

Yttrium-93

100

Zinc-65

10

Zinc-69m

100

Zinc-69

1,000

Zirconium-93

10

Zirconium-95

10

Zirconium-97

10

   

Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition.

0.01

   

Any radionuclide other than alpha emitting radionuclides, not listed above or mixtures of beta emitters of unknown composition.

0.10

(g) Schedule G. Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning.
1. Introduction

An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of (21)(g)2. The terms of the self-guarantee are in (21)(g)3. This schedule establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.

2. Financial Test
(i) To pass the financial test, a company must meet all of the following criteria:
(I) Tangible net worth at least ten times the total current decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee.
(II) Assets located in the United States amounting to at least 90 percent of total decommissioning cost estimate for the total of all facilities or parts thereof (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee.
(III) A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys.
(ii) To pass the financial test, a company must meet all of the following additional requirements:
(I) The company must have at least one class of equity securities registered under the Security Exchange Act of 1934.
(II) The company's independent certified public accountant must have compared the data used by the company in the financial test, which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Department within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
(III) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.
(iii) If the licensee no longer meets the requirements of (21)(g)2.(i), the licensee must send immediate notice to the Department of its intent to establish alternate financial assurance as specified in the Department's regulations within 120 days of such notice.
3. Company Self-Guarantee

The terms of a self-guarantee which an applicant or licensee furnishes must provide that:

(i) The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Department, as evidence by the return receipt.
(ii) The licensee shall provide alternative financial assurance as specified in the Department's regulations within 90 days following receipt by the Department of a notice of cancellation of the guarantee.
(iii) The guarantee and financial test provisions must remain in effect until the Department has terminated the license or until another financial assurance method acceptable to the Department has been put in effect by the licensee.
(iv) The licensee will promptly forward to the Department and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of Section 13 of the Securities and Exchange Act of 1934.
(v) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poors or Moodys, the licensee will provide notice in writing of such fact to the Department within 20 days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moodys, the licensee no longer meets the requirements of (21)(g)2.(i).
(vi) The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.
(h) Schedule H. Criteria Relating to Use of Financial Tests and Self-Guarantee For Providing Reasonable Assurance of Funds For Decommissioning by Nonprofit Colleges, Universities, and Hospitals.
1. Introduction

An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of (h)2. The terms of the self-guarantee are in (h)3. This schedule establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee.

2. Financial Test
(i) For colleges and universities, to pass the financial test a college or university must meet either the criteria in (h)2.(i)(I) or the criteria in (h)2.(i)(II).
(I) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.
(II) For applicants or licensees that do not issue bonds, unrestricted endowment consisting of assets located in the United States of at least $50 million, or at least 30 times the total current decommissioning cost estimate (or the current amount required if certification is used), whichever is greater, for all decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee.
(ii) For hospitals, to pass the financial test a hospital must meet either the criteria in (h)2.(ii)(I) or the criteria in (h)2.(ii)(II):
(I) For applicants or licensees that issue bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P) or Aaa, Aa, or A as issued by Moodys.
(II) For applicants or licensees that do not issue bonds, all the following tests must be met:
I. (Total Revenues less total expenditures) divided by total revenues must be equal to or greater than 0.04.
II. Long term debt divided by net fixed assets must be less than or equal to 0.67.
III. (Current assets and depreciation fund) divided by current liabilities must be greater than or equal to 2.55.
IV. Operating revenues must be at least 100 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the hospital is responsible as a self-guaranteeing license.
(iii) In addition, to pass the financial test, a licensee must meet all the following requirements:
(I) The licensee's independent certified public accountant must have compared the data used by the licensee in the financial test, which is required to be derived from the independently audited year-end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in such financial statement. In connection with that procedure, the licensee shall inform the Department within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the licensee no longer passes the test.
(II) After the initial financial test, the licensee must repeat passage of the test within 90 days after the close of each succeeding fiscal year.
(III) If the licensee no longer meets the requirements of (h)1., the licensee must send notice to the Department of its intent to establish alternative financial assurance as specified in Department regulations. The notice must be sent by certified mail, return receipt requested, within 90 days after the end of the fiscal year for which the year-end financial data show that the licensee no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.
3. Self-Guarantee

The terms of a self-guarantee which an applicant or licensee furnishes must provide that:

(i) The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, and/or return receipt requested, to the Department. Cancellation may not occur unless an alternative financial assurance mechanism is in place.
(ii) The licensee shall provide alternative financial assurance as specified in the Department's regulations within 90 days following receipt by the Department of a notice of cancellation of the guarantee.
(iii) The guarantee and financial test provisions must remain in effect until the Department has terminated the license or until another financial assurance method acceptable to the Department has been put in effect by the licensee.
(iv) The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer or officer of the institution) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.
(v) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A" or above by either Standard and Poors or Moodys, the licensee shall provide notice in writing of such fact to the Department within 20 days after publication of the change by the rating service.

Rule 391-3-17-.03 Standards for Protection Against Radiation

(1) General Provisions
(a) Purpose.

This Rule, 391-3-17-.03, establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses issued by the Department. The requirements in this Rule are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee so that the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this Rule. However, nothing in this Rule shall be construed as limiting actions that may be necessary to protect health and safety.

(b) Scope.

This Rule applies to persons licensed by the Department on or after January 1, 1994, to receive, possess, use, transfer, or dispose of sources of radiation. The limits in this Rule 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.

(2) Definitions

The definitions set forth for certain terms under 391-3-17-.01 are applicable to those terms as used in this Rule, unless the term is otherwise defined herein. As used in this Rule:

(a) "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.
(b) "Assigned protection factor" (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.
(c) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.
(d) "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 five rem (0.05 Sv) or a committed dose equivalent of 50 rem (0.5 Sv) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Table I, Columns 1 and 2, of Appendix B to 10 CFR 20.
(e) "Chelating agent" means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.
(f) "Chemical description" means a description of the principal chemical characteristics of a low-level radioactive waste.
(g) "Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonnary region of the lung. Materials are classified as D, W, or Y, which apply to a range of clearance half-times: for Class D (Days), of less than ten days; for Class W (Weeks), from ten to 100 days; and for Class Y (Years), of greater than 100 days. For purposes of this Chapter, "lung class" and "inhalation class" are equivalent terms.
(h) "Computer-readable medium" means that the Department's computer can transfer the information from the medium into its memory.
(i) "Consignee" means the designated receiver of the shipment of low-level radioactive waste.
(j) "Constraint (dose constraint)" means a value above which specified licensee actions are required.
(k) "Critical Group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.
(l) "Declared pregnant woman" means any 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.
(m) "Decommission" means to remove a facility or site safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license.
(n) "Decontamination facility" means a facility operating under a Department, U.S. Nuclear Regulatory Commission, Agreement State or Licensing State license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this part, is not considered to be a consignee for LLW shipments.
(o) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.
(p) "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 of 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Table I, Column 3 of Appendix B to 10 CFR 20.
(q) "Derived air concentration-hour" (DAC-hour) means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of five rem (0.05 Sv).
(r) "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).
(s) "Disposal container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility (also see "high integrity container"). Note that for some shipments, the disposal container may be the transport package.
(t) "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.
(u) "Dosimetry processor" means a person that processes and evaluates individual monitoring equipment devices in order to determine the radiation dose delivered to the monitoring devices.
(v) "EPA identification number" means the number received by a transporter following application to the Administrator of EPA as required by 40 CFR part 263.
(w) "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.
(x) "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.
(y) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.
(z) "Generator" means a licensee operating under a Department, U.S. Nuclear Regulatory Commission or Agreement State license who (1) is a waste generator or (2) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (e.g., waste generated as a result of decontamination or recycle activities).
(aa) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.
(bb) "High integrity container (HIC)" means a container commonly designed to meet the structural stability requirements of Rule 391-3-17-.03(13)(g), and to meet Department of Transportation requirements for a Type A package.
(cc) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
(dd) "Land disposal facility" means the land, buildings and structures, and equipment that are intended to be used for the disposal of radioactive waste. For purposes of this Rule, a "geologic repository" as defined in 10 CFR Part 60 is not considered a "land disposal facility."
(ee) "Lens dose equivalent" (LDE) means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
(ff) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.
(gg) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Table 3 of 391-3-17-.03 (15). In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.
(hh) "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.
(ii) "Nonstochastic effect" means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of this Chapter, "deterministic effect" is an equivalent term.
(jj) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
(kk) "Physical description" means the items called for on NRC Form 541 or equivalent form to describe a low-level radioactive waste.
(ll) "Planned special exposure" means an infrequent exposure to radiation separate from and in addition to the annual occupational dose limits.
(mm) "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.
(nn) "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.
(oo) "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.
(pp) "Quantitative fit test" (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.
(qq) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.
(rr) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Rule .03 of this Chapter.
(ss) "Residual waste" means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.
(tt) "Respiratory protective device" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.
(uu) "Self-contained breathing apparatus" (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
(vv) "Sanitary sewerage" means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.
(ww) "Shipper" means the licensed entity (i.e., the waste generator, waste collector, or waste processor) who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.
(xx) "Shipping paper" means NRC Form 540 and, if required, NRC Form 540A or equivalent forms which include the information required by DOT in 49 CFR Part 172.
(yy) "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 one percent (0.05 percent) or more of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.
(zz) "Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of this Chapter, "probabilistic effect" is an equivalent term.
(aaa) "Supplied-air respirator" (SAR) or airline respirator means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.
(bbb) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.
(ccc) "Uniform Low-Level Radioactive Waste Manifest" or "Uniform Manifest" means the combination of NRC Forms 540, 541, and if necessary, 542, and their respective continuation sheets as needed, or equivalent forms.
(ddd) "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.
(eee) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radioactive materials external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 Gray) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates.[1]
(fff) "Waste collector" means an entity, operating under a Department, U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.
(ggg) "Waste description" means the physical, chemical and radiological description of a low-level radioactive waste as called for on NRC Form 541 or equivalent form.
(hhh) "Waste generator" means an entity, operating under a Department, U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State license, who (1) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and (2) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a "waste generator" if the transfer of low-level radioactive waste from its facility is defined as "residual waste."
(iii) "Waste processor" means an entity, operating under a Department, U.S. Nuclear Regulatory Commission, Agreement State, or Licensing State license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility.
(jjj) "Waste type" means a waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media).
(kkk) "Weighting factor" (wT) for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of wT are:

ORGAN DOSE WEIGHTING FACTORS

Organ or Tissue

wT

Gonads

0.25

Breast

0.15

Red bone marrow

0.12

Lung

0.12

Thyroid

0.03

Bone surfaces

0.03

Remainder

0.30a

Whole Body

1.00b

a 0.30 result s from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

b For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, wT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(3) Implementation
(a) Any existing license condition that is more restrictive than this Rule remains in force until there is an amendment or renewal of the license.
(b) If a license condition exempts a licensee from a provision of Rule 391-3-17-.03 in effect on or before January 1, 1994, it also exempts the licensee from the corresponding provision of this Rule.
(c) If a license condition cites provisions of Rule 391-3-17-.03 in effect prior to January 1, 1994, which do not correspond to any provisions of this Rule, the license condition remains in force until there is an amendment or renewal of the license that modifies or removes this condition.
(4) Radiation Protection Programs
(a) Each licensee shall develop, document, and implement a Radiation Protection Program sufficient to ensure compliance with the provisions of this Rule. See (14)(b) of this Rule for record-keeping requirements relating to these Programs.
(b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).
(c) The licensee shall, at least annually, review the Radiation Protection Program content and implementation.
(d) To implement the ALARA requirements of .03(4)(b), and notwithstanding the requirements in.03(5)(i) of this rule, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees 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 ten (10) mrem (0.1 mSv) 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.03(15)(c) and promptly take appropriate corrective action to ensure against recurrence.
(5) Occupational Dose Limits and Dose Limits for Individual Members of the Public
(a) Occupational Dose Limits for Adults.
1. The licensee shall control the occupational dose to individual adults, except for planned special exposures pursuant to (5)(f) of this Rule, in accordance with the following dose limits:
(i) An annual limit, which is the more limiting of:
(I) The total effective dose equivalent being equal to five (5) rem (0.05 Sv); or
(II) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rem (0.50 Sv).
(ii) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:
(I) A lens dose equivalent of 15 rem (0.15 Sv); and
(II) A shallow dose equivalent of 50 rem (0.50 Sv) to the skin of the whole body or to the skin of any extremity.
2. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime, listed in (5)(f)5.(i) and (ii) of this Rule.
3. When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the NRC. The assigned deep dose equivalent shall be for the portion of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous ten (10) square centimeters of skin receiving the highest exposure.
4. The deep dose equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure or the results of individual monitoring are unavailable.
5. Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in Table I of Appendix B to 10 CFR 20 and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See (14)(g) of this Rule for maintaining records of these exposures.
6. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity. See footnote 3 of Appendix B 10 CFR 20.
7. The licensee shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person during the current year. See (5)(e) of this Rule.
(b) Compliance with Requirements for Summation of External and Internal Doses.
1. General Requirements. If the licensee is required to monitor pursuant to both (8)(b)1. and 2. of this Rule, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only pursuant to (8)(b)1. of this Rule or only pursuant to (8)(b)2. of this Rule, then summation is not required to demonstrate compliance with the dose limits. The licensee must demonstrate compliance with the requirements for summation of external and internal doses pursuant to (5)(b)2., 3., and 4. of this Rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.
2. Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit and one of the following does not exceed unity:
(i) The sum of the fractions of the inhalation ALI for each radionuclide;
(ii) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; or
(iii) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, wT, and the committed dose equivalent, HT,50, per unit intake is greater than ten percent of the maximum weighted value of H50 (i.e., wTHT,50), per unit intake for any organ or tissue.
3. Intake by Oral Ingestion. If the occupationally-exposed individual receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits.
4. Intake through Wounds or Absorption through Skin. The licensee 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 (5)(b)4. of this Rule.
(c) Determination of External Dose from Airborne Radioactive Material.
1. Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Appendix B, footnotes 1 and 2, of 10 CFR 20.
2. Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.
(d) Determination of Internal Exposure.
1. For purposes of assessing the dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under (8)(b) of this Rule, take suitable and timely measurements of:
(i) Concentrations of radioactive materials in air in work areas during operations;
(ii) Quantities of radionuclides in the body;
(iii) Quantities of radionuclides excreted from the body; or
(iv) Combinations of these measurements.
2. Unless respiratory protective equipment is used, as provided in (10)(d) of this Rule, or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.
3. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:
(i) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record;
(ii) Upon prior approval of the Department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and
(iii) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See Appendix B of 10 CFR 20.
4. If the licensee chooses to assess intakes of Class Y material using the measurements given in (5)(d)1.(ii) or (iii) of this Rule, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by (15)(b) or (15)(c) of this Rule. This delay permits the licensee to make additional measurements basic to the assessments.
5. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:
(i) The sum of the ratios of the concentration to the appropriate DAC value (i.e. D, W, or Y) from Appendix B of 10 CFR 20, for each radionuclide in the mixture; or
(ii) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.
6. If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.
7. When a mixture of radionuclides in the air exists, a licensee may disregard certain radionuclides in the mixture if:
(i) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in (5)(a) of this Rule and in complying with the monitoring requirements in (8)(b)2. of this Rule;
(ii) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and
(iii) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.
8. When determining the committed effective dose equivalent, the following information may be considered:
(i) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours, results in a committed effective dose equivalent of five rem (0.05 Sv) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent;
(ii) When the ALI (and the associated DAC) is determined by the non-stochastic organ dose limit of 50 rem (0.50 Sv), the intake of radionuclides that would result in a committed effective dose equivalent of five rem (0.05 Sv), (i.e., the stochastic ALI) is listed in parentheses in Table I of Appendix B of 10 CFR 20. In this case, the licensee may, as a simplifying assumption, use the stochastic ALIs to determine the committed effective dose equivalent. However, if the licensee uses the stochastic ALIs, the licensee shall also demonstrate that the limit in (5)(a)1.(i)(II) of this Rule is not exceeded.
(e) Determination of Prior Occupational Dose.
1. For each individual who is likely to receive, in a year, an occupational dose requiring monitoring pursuant to (8)(b) of this Rule, the licensee shall:
(i) Determine the occupational radiation dose received during the current year; and
(ii) Attempt to obtain the records of lifetime cumulative occupational radiation dose.
2. Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:
(i) The internal and external doses from all previous planned special exposures; and
(ii) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.
3. In complying with the requirements of (5)(e)1. of this Rule, a licensee may:
(i) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;
(ii) Accept, as the record of lifetime cumulative radiation dose, an up-to-date Department Form "Occupational Radiation Exposure History" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer if the individual is not employed by the licensee; and
(iii) Obtain the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer if the individual is not employed by the licensee, by telephone, telegram, electronic media, facsimile, or letter. The licensee shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
4. The licensee shall record the exposure history, as required by (5)(e)1. of this Rule, on Department Form "Occupational Radiation Exposure History" or other clear and legible record, and all of the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee obtains, the licensee shall use the dose shown in the report in preparing the Department Form "Occupational Radiation Exposure History" or equivalent form. For any period in which the licensee does not obtain a report, the licensee shall place a notation on the "Occupational Radiation Exposure History" or equivalent form indicating the periods of time for which data are not available.
5. Licensees are not required to partition historical dose between external dose equivalents and internal committed dose equivalents of radionuclides assessed under the Regulations in effect before January 1, 1994. Further, occupational exposure histories obtained and recorded on Department Form "Occupational Radiation Exposure History" or equivalent before January 1, 1994, might not have included effective dose equivalent but may be used in the absence of specific information on the intake of radionuclides by the individual.
6. If the licensee is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee shall assume:
(i) In establishing administrative controls under (5)(a)7. of this Rule, for the current year, that the allowable dose limit for the individual is reduced by 1.25 rem (12.5 mSv) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and
(ii) That the individual is not available for planned special exposures.
7. The licensee shall retain the records on Department Form "Occupational Radiation Exposure History" or equivalent until the Department terminates each pertinent license requiring this record. The licensee shall retain records used in preparing Department Form "Occupational Radiation Exposure History" or equivalent for three years after the record is made.
(f) Planned Special Exposures. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in (5)(a) of this Rule provided that each of the following conditions is satisfied:
1. The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure estimated to result from the planned special exposure are unavailable or impractical (i.e., industrial radiography source retrieval for an area that cannot be evacuated).
2. The management official of the licensee (and employer if the employer is not the licensee) specifically authorizes the planned special exposure, in writing, before the exposure occurs.
3. Before a planned special exposure, the licensee ensures that each individual involved is:
(i) Informed of the purpose of the planned operation;
(ii) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and
(iii) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.
4. Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by (5)(e)2. of this Rule during the lifetime for each individual involved.
5. Subject to (5)(a)2. of this Rule, the licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:
(i) The numerical values of any of the dose limits in (5)(a)1. of this Rule in any year; and
(ii) Five times the annual dose limits in (5)(a)1. of this Rule during the individual's lifetime.
6. The licensee maintains records of the conduct of a planned special exposure in accordance with (14)(f) of this Rule and submits a written report in accordance with (15)(d) of this Rule.
7. The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days after the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling the future occupational dose of the individual pursuant to (5)(a)1. of this Rule but shall be included in evaluations required by (5)(f)1. and (5)(f)5. of this Rule.
(g) Occupational Dose Limits for Minors. The annual occupational dose limits for minors are ten percent of the annual occupational dose limits specified for adult workers in (5)(a) of this Rule.
(h) Dose to an Embryo/Fetus.
1. The licensee shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). For record-keeping requirements, see (14)(g) of this Rule.
2. The licensee shall make efforts to avoid substantial variation[2] above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in (5)(h)1. of this Rule.
3. The dose equivalent to an embryo/fetus shall be taken as the sum of:
(i) The deep-dose equivalent to the declared pregnant woman; and
(ii) The dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
4. If by the time the woman declares pregnancy to the licensee the dose equivalent to the embryo/fetus is found to have exceeded 0.50 rem (5.0 mSv), or is within 0.05 rem (0.5 mSv) of this dose equivalent, the licensee shall be deemed to be in compliance with (5)(h)1. of this Rule if the additional dose equivalent to the embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
(i) Radiation Dose Limits for Individual Members of the Public.
1. Each licensee shall conduct operations so that:
(i) Except as provided in (5)(i)1.(iii) the total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with Rule .05(37), from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with (13)(c) of this Rule; and
(ii) The dose in any unrestricted area from external sources, exclusive of the dose contributions from individuals administered radioactive material and released in accordance with Rule .05(37), does not exceed 0.002 rem (0.02 mSv) in any one hour.
(iii) The total effective dose equivalent to individual members of the public from infrequent exposure to radiation from radiation machines does not exceed 0.5 rem (5 mSv).
2. A licensee or license applicant may apply for prior Department authorization to operate up to an annual dose limit for an individual member of the public of 0.5 rem (5 mSv). The licensee or license applicant shall include the following information in this application:
(i) Demonstration of the need for and the expected duration of operations in excess of the limit in (5)(i)1. of this Rule;
(ii) The licensee's program to assess and control dose within the 0.5 rem (5 mSv) annual limit; and
(iii) The procedure to be followed to maintain the dose as low as is reasonably achievable (ALARA).
3. In addition to the requirements of this Rule, a licensee subject to the provisions of the U.S. Environmental Protection Agency's (EPA) generally applicable environmental radiation standards in 40 CFR Part 190 shall comply with those standards.
4. The Department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.
(j) Compliance with Dose Limits for Individual Members of the Public.
1. The licensee shall make or cause to be made, as appropriate, surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in (5)(i) of this Rule.
2. A licensee shall show compliance with the annual dose limit in (5)(i) of this Rule by:
(i) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit; or
(ii) Demonstrating that:
(I) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of Appendix B of 10 CFR 20.
(II) If an individual were continually present in an unrestricted area, the dose from external sources would not exceed 0.002 rem (0.02 mSv) in one hour and 0.05 rem (0.50 mSv) in one year.
3. Upon approval from the Department, the licensee may adjust the effluent concentration values in Appendix B, Table II of 10 CFR 20, for members of the public, to take into account the actual physical and chemical characteristics of the effluents (e.g., aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form).
(6) Testing for Leakage or Contamination of Sealed Sources
(a) The licensee in possession of any sealed source shall assure that:
1. Each sealed source, other than hydrogen-3, with a half-life greater than 30 days and in any form other than gas, shall be tested for leakage or contamination as follows:
(i) Prior to initial use;
(ii) Unless otherwise authorized by the Department, at intervals not to exceed six months, except that each source designed for the purpose of emitting alpha particles shall be tested at intervals not to exceed three months;
(iii) At any other time there is reason to suspect that a sealed source might have been damaged or might be leaking, it shall be tested for leakage before further use; and
(iv) In the absence of a certificate from a transferor indicating that a test for leakage has been made within six months prior to the transfer, the sealed source shall not be put into use until tested and the results received.
2. Tests for leakage for all sealed sources, except those manufactured to contain radium, shall be capable of detecting the presence of 0.005 µCi (185 Bq) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For sealed sources contained in a device, test samples are obtained when the source is in the "off" position.
3. Tests for leakage for sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of 0.001 µCi (37 Bq) of radon-222 in a 24-hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume, and time.
4. Test samples shall also be taken from the interior surfaces of the container in which sealed sources of radium are stored. This test shall be capable of detecting the presence of 0.005 µCi (185 Bq) of a radium daughter that has a half-life greater than four days.
5. Notwithstanding the periodic test for leakage required, any sealed source is exempt from such tests for leakage when the sealed source contains 100 µCi (3.7 MBq) or less of beta- or gamma-emitting material or ten µCi (370 kBq) or less of alpha-emitting material.
(b) Tests for leakage or contamination shall be performed by persons specifically authorized by the Department, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission to perform such services.
(c) The following shall be considered evidence that the sealed source is leaking:
1. The presence of 0.005 µCi (185 Bq) or more of removable contamination on any test sample. If the test of a sealed source, other than radium, reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination, the licensee shall immediately withdraw the sealed source from use, take action to prevent the spread of contamination, and cause the sealed source to be decontaminated and repaired or to be disposed of in accordance with this Rule.
2. Leakage of 0.001 µCi (37 Bq) of radon-222 per 24 hours for sealed sources manufactured to contain radium. If the test of a sealed source manufactured to contain radium reveals the presence of removable contamination resulting from the decay of 0.005 µCi (185 Bq) or more of radium-226, the licensee shall immediately withdraw the sealed source from use, take action to prevent the spread of contamination, and cause the sealed source to be decontaminated and repaired or to be disposed of in accordance with this Rule.
(d) Records of test results for sealed sources shall be made pursuant to (14)(d).
(e) Reports of test results for leaking or contaminated sealed sources shall be made pursuant to (15)(g) of this Rule.
(7) Radiological Requirements for License Termination
(a) General provisions and scope.
1. The requirements in this section apply to the decommissioning of facilities licensed under Rule .02(8)(g), (Licensing of Radioactive Materials. Amended);
2. The requirements in this section do not apply to sites which:
(i) Have been decommissioned prior to April 18, 2002 in accordance with requirements identified in.03(7) and Rule .02 of this Chapter; or
(ii) Have previously submitted and received Department approval on a decommissioning plan by April 18, 2002.
3. After a site has been decommissioned and the license terminated in accordance with the requirements in this section, the Department will require additional cleanup only if, based on new information, it determines that the requirements of this section were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety.
4. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first 1,000 years after decommissioning.
(b) Radiological requirements for unrestricted use. A site will be considered acceptable for unrestricted use if the residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem (0.25 mSv) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of any detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.
(c) Alternate requirements for license termination.
1. The Department may terminate a license using alternate requirements greater than the dose requirements of .03(7)(b) if the licensee:
(i) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the 100 mrem/year (1 mSv/year) limit of .03(5)(i), by submitting an analysis of possible sources of exposure;
(ii) Reduces doses to ALARA levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal;
(iii) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site; and
(iv) Has submitted a decommissioning plan to the Department indicating the licensee's intent to decommission in accordance with requirements of Rule .02(18)(d), and specifying that the licensee proposes to decommission by use of alternate requirements. The licensee shall document in the decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:
(I) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;
(II) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and
(III) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.
2. The use of alternate requirements to terminate a license requires the approval of the Department after consideration of the Department's recommendations that will address any comments provided by the U.S. Environmental Protection Agency (EPA) and any public comments submitted in accordance with (7)(d) of this rule.
(d) Public notification and public participation. Upon the receipt of a decommissioning plan from the licensee, or a proposal by the licensee for release of a site in accordance with (7)(c) of this Rule, or whenever the Department deems such notice to be in the public interest, the Department will:
1. Notify and solicit comments from:
(i) Local and State governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and
(ii) The EPA for cases where the licensee proposes to release a site in accordance with (7)(c).
2. Publish a notice in the local newspaper(s), letters to State or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and solicit comments from affected parties.
(e) Minimization of contamination.
1. Applicants for licenses, other than renewals, after April 18, 2002, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.
2. Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in.03(4) and radiological criteria for license termination in.03(7) of this Rule.
(8) Surveys and Monitoring
(a) General.
1. Each licensee shall make, or cause to be made, surveys of areas, including the subsurface, that:
(i) May be necessary for the licensee to demonstrate compliance with this Rule; and
(ii) Are reasonable under the circumstances to evaluate:
(I) The magnitude and extent of radiation levels;
(II) Concentrations or quantities of residual radioactivity; and
(III) The potential radiological hazards of the radiation levels and residual radioactivity detected.
2. Notwithstanding.03(14)(c) 1, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with.02(8)(g) 8, as applicable.
3. The licensee shall ensure that instruments and equipment used for quantitative radiation measurements (e.g., dose rate and effluent monitoring) are calibrated periodically, at least annually, for the radiation measured except when a more frequent interval is specified in other applicable parts of these Rules or a license condition.
4. All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees to comply with (5)(a) of this Rule, with other applicable provisions of this Chapter, or with conditions specified in a license shall be processed and evaluated by a qualified dosimetry processor. A dosimetry processor is qualified if it:
(i) Holds current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and
(ii) Is approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
5. The licensee shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.
(b) Conditions Requiring Individual Monitoring of External and Internal Occupational Dose. Each licensee shall monitor exposures to sources of radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this Rule. As a minimum:
1. Each licensee shall monitor occupational exposure to radiation and shall supply and require the use of individual monitoring devices by:
(i) Adults likely to receive, in one year from sources external to the body, a dose in excess of ten percent of the limits in (5)(a)1. of this Rule;
(ii) Minors likely to receive, in one year from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to extremities in excess of 0.5 rem (5mSv);
(iii) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);[3] and
(iv) Individuals entering a high or very high radiation area.
2. Each licensee shall monitor, to determine compliance with (5)(d) of this Rule, the occupational intake of radioactive material by, and assess the committed effective dose equivalent to:
(i) Adults likely to receive, in one year, an intake in excess of ten percent (10%) of the applicable ALI in Table I, Columns 1 and 2, of Appendix B of 10 CFR 20; and
(ii) Minors likely to receive, in one year, a committed effective dose equivalent in excess of 0.05 rem (0.50 mSv).
(iii) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).
(9) Control Of Exposure From External Sources In Restricted Areas
(a) Control of Access to High Radiation Areas.
1. The licensee shall ensure that each entrance or access point to a high radiation area has one or more of the following features:
(i) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 0.1 rem (1 mSv) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates;
(ii) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or
(iii) Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.
2. In place of the controls required by (9)(a)1. of this Rule, the licensee may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
3. The licensee may apply to the Department for approval of alternative methods for controlling access to high radiation areas.
4. The licensee shall establish the controls required by (9)(a)1. and (9)(a)3. of this Rule in a way that does not prevent individuals from leaving a high radiation area.
5. The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation provided that:
(i) The packages do not remain in the area longer than three days; and
(ii) The dose rate at one meter from the external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour.
6. The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who will take the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in this Rule and to ensure operation within the ALARA provisions of the licensee's Radiation Protection Program.
7. The licensee is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area if the licensee has met all the specific requirements for access and control specified in other applicable Rules, such as 391-3-17-.04 for industrial radiography.
(b) Control of Access to Very High Radiation Areas.
1. In addition to the requirements in (9)(a) of this Rule, the licensee shall institute additional measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 500 rads (5 Gy) or more in one hour at one meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation, or to non-self-shielded irradiators.
2. The licensee is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as defined in this Rule if the licensee has met all the specific requirements for access and control specified in other applicable Rules, such as 391-3-17-.04 for industrial radiography.
(10) Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas
(a) Use of Process or Other Engineering Controls. The licensee shall use, to the extent practicable, process or other engineering controls (e.g., containment, decontamination, or ventilation) to control the concentrations of radioactive material in air.
(b) Use of Other Controls. When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:
1. Control of access;
2. Limitation of exposure times;
3. Use of respiratory protection equipment; or
4. Other controls.
(c) If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee should also consider the impact of respirator use on workers' industrial health and safety.
(d) Use of Individual Respiratory Protection Equipment.
1. If the licensee uses respiratory protection equipment to limit intakes pursuant to (10)(b) of this Rule:
(i) Except as provided in (10)(d)1.(ii) of this Rule, the licensee shall use only respiratory protection equipment that is tested and certified by or had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration (NIOSH/MSHA).
(ii) The licensee may use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration or had certification extended by NIOSH/MSHA or for which there is no schedule for testing or certification, provided the licensee has submitted to the Department and the Department has approved an application for authorized use of that equipment, including a demonstration by testing, or a demonstration on the basis of reliable test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use.
(iii) The licensee shall implement and maintain a respiratory protection program that includes:
(I) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures;
(II) Surveys and bioassays, as appropriate, to evaluate actual intakes;
(III) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use;
(IV) Written procedures regarding: respirator selection; fit testing; breathing air quality; inventory control; storage, issuance, maintenance, repair, and quality assurance of respiratory protection equipment, including testing for operability immediately prior to each use; supervision and training of personnel; monitoring, including air sampling and bioassays; and record-keeping; and
(V) Determination by a physician prior to initial fitting of face sealing respirators; before the first use of non-face sealing respirators; and either every 12 months thereafter or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment.
(VI) Fit testing, with fit factor "ten times the APF for negative pressure devices", and a fit factor" 500 for any positive pressure, continuous flow, and pressure-demand devices", before the first field use of tight fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing must be performed with the facepiece operating in the negative pressure mode.
(iv) The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.
(v) The licensee shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee shall provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.
(vi) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.
(vii) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration ( 29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include:
(I) Oxygen content (v/v) of 19.5 -23.5 %;
(II) Hydrocarbon (condensed) content of five (5) milligrams per cubic meter of air or less;
(III) Carbon monoxide (CO) content of ten (10) ppm or less;
(IV) Carbon dioxide content of 1,000 ppm or less; and
(V) Lack of noticeable odor.
(viii) The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face to facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.
(ix) In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.
(e) Further Restrictions on the Use of Respiratory Protection Equipment. The Department may impose restrictions in addition to those in (10)(b) and (10)(c) of this Rule and Appendix A to 10 CFR 20, in order to:
1. Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and
2. Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.
(f) Application for use of higher assigned protection factors. The licensee shall obtain authorization from the Department before using assigned protection factors in excess of those specified in Appendix A to 10 CFR Part 20. The Department may authorize a licensee to use higher assigned protection factors on receipt of an application that:
1. Describes the situation for which a need exists for higher protection factors; and
2. Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
(11) Storage and Control of Licensed Material
(a) Security and Control of Licensed Radioactive Material. The licensee shall secure licensed materials from unauthorized removal or access.
(b) Control of material sources of radiation not in storage. The licensee shall maintain constant surveillance and use devices or administrative procedures to prevent unauthorized use of licensed radioactive material that is in an unrestricted area and that is not in storage or in a patient.
(12) Precautionary Procedures
(a) Caution Signs.
1. Standard Radiation Symbol. Unless otherwise authorized by the Department, the symbol prescribed by (12)(a) of this Rule uses the colors magenta (or purple or black) on yellow background. The symbol prescribed is the three-bladed design as follows:
(i) Cross-hatched area is to be magenta, purple, or black; and
(ii) The background is to be yellow.
2. Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of (12)(a)1. of this Rule, licensees 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 without a color requirement.


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3. In addition to the contents of signs and labels prescribed in this Rule, the licensee shall 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.
(b) Posting Requirements.
1. Posting of Radiation Areas. The licensee shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
2. Posting of High Radiation Areas. The licensee 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." The licensee may satisfy this requirement by posting the sign at the boundary of the high radiation area.
3. Posting of Very High Radiation Areas. The licensee 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."
4. Posting of Airborne Radioactivity Areas. The licensee 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."
5. Posting of Areas or Rooms in which Licensed Material is Used or Stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding ten times the quantity of such material specified in Appendix C of 10 CFR Part 20 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)".
(c) Exceptions to Posting Requirements.
1. A licensee is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than eight hours, if all of the following conditions are met:
(i) The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in this Rule; and
(ii) The area or room is subject to the licensee's control.
2. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to (12)(b) of this Rule provided that the patient could be released from licensee control pursuant to Rule 391-3-17-.05.
3. A room or area is not required to be posted with a caution sign pursuant to (12)(b) of this Rule because of the presence of a sealed source provided that the radiation level at 30 centimeters from the surface of the source container or housing does not exceed 0.005 rem (0.05 mSv) per hour.
(d) Labeling Containers and Radiation Machines.
1. The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label shall also provide information such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.
2. Each licensee shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.
(e) Exemptions to Labeling Requirements. A licensee is not required to label:
1. Containers holding licensed material in quantities less than the quantities listed in Appendix C of 10 CFR 20;
2. Containers holding licensed material in concentrations less than those specified in Table III of Appendix B of 10 CFR 20;
3. Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by this Rule;
4. Containers when they are in transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation[4];
5. Containers that are accessible only to individuals authorized to handle or use them or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or
6. Installed manufacturing or process equipment, such as chemical process equipment, piping, and tanks.
(f) Procedures for Receiving and Opening Packages.
1. Each licensee who is authorized to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in Rule 391-3-17-.06(3), shall make arrangements to receive:
(i) The package when the carrier offers it for delivery; or
(ii) The notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
2. Each licensee shall:
(i) Monitor the external surfaces of a labeled[5] package for radioactive contamination unless the package contains only radioactive material in the form of gas or in "special form" as defined in Rule 391-3-17-.01(2);
(ii) Monitor the external surfaces of a labeled 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 Rule 391-3-17-.06(3), and the radioactive material is in the form of a gas or in special form as defined in Rule 391-3-17-.01(2); and
(iii) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if the package has evidence of potential contamination, such as packages that are crushed, wet, or damaged.
3. The licensee shall perform the monitoring required by (12)(f)2. of this Rule as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility if it is received during the licensee's normal working hours, or not later than three hours from the beginning of the next working day if it is received after working hours.
4. The licensee shall immediately notify the final delivery carrier and the Department by telephone, telegram, mailgram, or facsimile, when:
(i) Removable radioactive surface contamination exceeds the limits of Rule 391-3-17-.06(16)(i); or
(ii) External radiation levels exceed the limits of Rule 391-3-17-.06(16)(j).
5. Each licensee shall:
(i) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and
(ii) Ensure that the procedures are followed and that special instructions for the type of package being opened are followed.
6. Licensees transferring special form sources in vehicles owned or operated by the licensee to and from a work site are exempt from the contamination monitoring requirements of (12)(f)2. of this Rule, but are not exempt from the monitoring requirement in (12)(f)2. of this Rule for measuring radiation levels to ensure that the source is still properly lodged in its shield.
(13) Waste Disposal
(a) General Requirements.
1. A licensee shall dispose of licensed material only:
(i) By transfer to an authorized recipient as provided in (13)(i) of this Rule and in Rule 391-3-17-.02(19), or to the U.S. Department of Energy;
(ii) By decay in storage;
(iii) By release in effluents within the limits in (5)(i) of this Rule; or
(iv) As authorized pursuant to (13)(b), (13)(c), (13)(d), (13)(e), or (13)(k) of this Rule.
2. A person shall be specifically licensed by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to receive waste containing licensed material from other persons for:
(i) Treatment prior to disposal;
(ii) Treatment or disposal by incineration;
(iii) Decay in storage;
(iv) Disposal at a land disposal facility licensed pursuant to 10 CFR Part 61, or equivalent regulations of an Agreement State; or
(v) Storage until transferred to a disposal facility authorized to receive the waste.
(b) Method for Obtaining Approval of Proposed Disposal Procedures. A licensee or applicant for a license may apply to the Department for approval of proposed procedures not otherwise authorized in this Chapter to dispose of licensed material generated in the licensee's operations. Each application shall include:
1. A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;
2. An analysis and evaluation of pertinent information on the nature of the environment;
3. The nature and location of other potentially affected facilities; and
4. Analyses and procedures to ensure that doses are maintained ALARA and within the dose limits in this Rule.
(c) Disposal by Release into Sanitary Sewerage.
1. A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:
(i) The material is readily soluble, or is readily dispersible biological material, in water;
(ii) The quantity of licensed radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table III of Appendix B of 10 CFR 20;
(iii) If more than one radionuclide is released, the following conditions must also be satisfied:
(I) The licensee shall determine the fraction of the limit in Table III of Appendix B of 10 CFR 20, represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in Table III of Appendix B of 10 CFR 20; and
(II) The sum of the fractions for each radionuclide required by (13)(c)1.(iii)(I) of this Rule does not exceed unity; and
(iv) The total quantity of licensed radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed five Ci (185 GBq) of hydrogen-3, one Ci (37 GBq) of carbon-14, and one Ci (37 GBq) of all other radioactive materials combined.
2. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in (13)(c)1. of this Rule.
(d) Treatment or Disposal by Incineration. A licensee may treat or dispose of licensed material by incineration only in the forms and concentrations specified in (13)(e) of this Rule or as specifically approved by the Department pursuant to (13)(b) of this Rule.
(e) Disposal of Specific Wastes.
1. A licensee may dispose of the following licensed material as if it were not radioactive:
(i) 0.05 µCi (1.85 kBq) or less of hydrogen-3, carbon-14, or iodine-125 per gram of medium used for liquid scintillation counting; and
(ii) 0.05 µCi (1.85 kBq) or less of hydrogen-3, carbon-14, or iodine-125 per gram of animal tissue, averaged over the weight of the entire animal.
2. A licensee shall not dispose of tissue under (13)(e)1.(ii) of this Rule in a manner that would permit its use either as food for humans or as animal feed.
3. The licensee shall maintain records in accordance with (14)(i) of this Rule.
(f) Classification of Radioactive Waste for Near-Surface Disposal.
1. Considerations. Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls, improved waste form, and deeper disposal have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.
2. Classes of waste.
(i) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of Class A waste must meet the minimum requirements set forth in (13)(g)1. of this Rule. If Class A waste also meets the stability requirements set forth in (13)(g)2. of this Rule, it is not necessary to segregate the waste for disposal.
(ii) Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of Class B waste must meet both the minimum and stability requirements set forth in (13)(g) of this Rule.
(iii) Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of Class C waste must meet both the minimum and stability requirements set forth in (13)(g) of this Rule.
3. Classification determined by long-lived radionuclides. If the waste contains only radionuclides listed in Table 1, classification shall be determined as follows:
(i) If the concentration does not exceed 0.1 times the value in Table 1, the waste is Class A.
(ii) If the concentration exceeds 0.1 times the value in Table 1, the waste is Class C.
(iii) If the concentration exceeds the value in Table 1, the waste is not generally acceptable for near-surface disposal.
(iv) For wastes containing mixtures of radionuclides listed in Table 1, the total concentration shall be determined by the sum of fractions rule described in (13)(f)7. of this Rule.

Table 1

Radionuclide

Concentration

(Curies/cubic meter)

C-14

8

C-14 in activated metal

80

Ni-59 in activated metal

220

Nb-94 in activated metal

0.2

Tc-99

3

I-129

0.08

Alpha-emitting transuranic radionuclides with half-life greater than five years

100 (a)

Pu-241

3,500 (a)

Cm-242

20,000 (a)

Ra-226

100 (a)

(a) Units are in nanocuries per gram.

4. Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in Table 1, classification shall be determined based on the concentrations shown in Table 2. If a nuclide is not listed in Table 2, it does not need to be considered in determining the waste class.
(i) If the concentration does not exceed the value in Column 1, the waste is Class A.
(ii) If the concentration exceeds the value in Column 1, but does not exceed the value in Column 2, the waste is Class B.
(iii) If the concentration exceeds the value in Column 2, but does not exceed the value in Column 3, the waste is Class C.
(iv) If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.
(v) For wastes containing mixtures of the radionuclides listed in Table 2, the total concentration shall be determined by the sum of fractions rule described in (13)(f)7. of this Rule.

Table 2

Radionuclide

Concentration (Curies/ cubic meter)

Column 1

Column 2

Column 3

Total of all radionuclides with less than five year half-life

700

(b)

(b)

H-3

40

(b)

(b)

Co-60

700

(b)

(b)

Ni-63

3.5

70

700

Ni-63 in activated metal

35

700

7000

Sr-90

0.04

150

7000

Cs-137

1

44

4600

(b) There are no limits established for these radionuclides in Class B or C wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall be Class B unless the concentrations of other radionuclides in Table 2 determine the waste to be Class C independent of these radionuclides.

5. Classification determined by both long- and short-lived radionuclides. If the waste contains a mixture of radionuclides, some of which are listed in Table 1 and some of which are listed in Table 2, classification shall be determined as follows:
(i) If the concentration of a radionuclide listed in Table 1 is less than 0.1 times the value listed in Table 1, the class shall be that determined by the concentration of radionuclides listed in Table 2.
(ii) If the concentration of a radionuclide listed in Table 1 exceeds 0.1 times the value listed in Table 1, the waste shall be Class C, provided the concentration of radionuclides listed in Table 2 does not exceed the value shown in Column 3 of Table 2.
6. Classification of wastes with radionuclides other than those listed in Tables 1 and 2. If the waste does not contain any radionuclides listed in either Table 1 or 2, it is Class A.
7. The sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 50 Ci/m3 and Cs-137 in a concentration of 22 Ci/m3. Since the concentrations both exceed the values in Column 1, Table 2, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33; for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B.
8. Determination of concentrations in wastes. The concentration of a radionuclide may be determined by indirect methods such as the use of scaling factors, which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste or weight of the waste if the units are expressed as nanocuries per gram.
(g) Radioactive Waste Characteristics.
1. The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide protection of health and safety of personnel at the disposal site:
(i) Wastes shall be packaged in conformance with the conditions of the license issued to the site operator to which the waste will be shipped. Where the conditions of the site license are more restrictive than the provisions of this Chapter, the site license conditions shall govern.
(ii) Wastes shall not be packaged for disposal in cardboard or fiberboard boxes.
(iii) Liquid waste shall be packaged in sufficient absorbent material to absorb twice the volume of the liquid.
(iv) Solid wastes containing liquid shall contain as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one percent of the volume.
(v) Wastes shall not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures or of explosive reaction with water.
(vi) Wastes shall not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous wastes packaged in accordance with (13)(g)1.(viii) of this Rule.
(vii) Pyrophoric materials contained in wastes shall be treated, prepared, and packaged to be nonflammable.
(viii) Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20 degrees Celsius. Total activity shall not exceed 100 Curies (3.7 TBq) per container.
(ix) Wastes containing hazardous, biological, pathogenic, or infectious material shall be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials.
2. The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.
(i) Waste shall have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form under the expected disposal conditions such as the weight of overburden and compaction equipment, the presence of moisture and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.
(ii) Notwithstanding the provisions in (13)(g)1.(iii) and (iv) of this Rule, liquid wastes, or wastes containing liquid, shall be converted into a form that contains as little freestanding and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one percent of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5 percent of the volume of the waste for waste processed to a stable form.
(iii) Void spaces within the waste and between the waste and its package shall be reduced to the extent practicable.
h Labeling. Each package of waste shall be clearly labeled to identify whether it is Class A, Class B, or Class C waste in accordance with (13)(f) of this Rule.
(i) Transfer for Disposal and Manifest.
1. A waste generator, collector, or processor who transports, or offers for transportation, low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste land disposal facility must prepare a Manifest reflecting information requested on applicable NRC Forms 540 or equivalent forms (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)) and if necessary, on an applicable NRC Form 542 or equivalent form (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation)). NRC Forms 540 and 540A or equivalent forms must be completed and must physically accompany the pertinent low-level radioactive waste shipment. Upon agreement between shipper and consignee, NRC Forms 541 and 541A and 542 and 542A or equivalent forms may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms. Licensees are not required by the Department to comply with the manifesting requirements of this Chapter when they ship:
(i) LLW for processing and expect its return (i.e., for storage under their license) prior to disposal at a licensed land disposal facility;
(ii) LLW that is being returned to the licensee who is the "waste generator" or "generator," as defined in this Rule; or
(iii) Radioactively contaminated material to a "waste processor" that becomes the processor's residual waste.

For guidance in completing these forms, refer to the instructions that accompany the forms. Copies of manifests required by this Rule may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest. NRC Forms 541 and 541A and 542 and 542A or equivalent forms and the accompanying instructions, in hard copy, may be obtained from Radioactive Materials Program, 4244 International Parkway, Suite 120, Atlanta, Georgia 30354, or current address.

This Rule includes information requirements of the Department of Transportation, as codified in 49 CFR Part 172. Information on hazardous, medical, or other waste, required to meet EPA regulations, as codified in 40 CFR Parts 259, 261 or elsewhere, is not addressed in this Rule, and must be provided on the required EPA forms. However, the required EPA forms must accompany the Uniform Low-Level Radioactive Waste Manifest required by this Rule.

2. General Information. The shipper of the low-level radioactive waste shall provide the following information on the uniform manifest:
(i) The name, facility address, and telephone number of the licensee shipping the waste;
(ii) An explicit declaration indicting whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and
(iii) The name, address, and telephone number, or the name and EPA identification number for the carrier transporting the waste.
3. Shipment Information. The shipper of the radioactive waste shall provide the following information regarding the waste shipment on the uniform manifest:
(i) The date of the waste shipment;
(ii) The total number of packages/disposal containers;
(iii) The total disposal volume and disposal weight in the shipment;
(iv) The total radionuclide activity in the shipment;
(v) The activity of each of the radionuclides H-3, C-14, Tc-99, and I-129 contained in the shipment; and
(vi) The total masses of U-233, U-235, and plutonium in the form of special nuclear material, and the total mass of uranium and thorium in the form of source material.
4. Disposal Container and Waste Information. The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:
(i) An alphabetic or numeric identification that uniquely identifies each disposal container in the shipment;
(ii) A physical description of the disposal container, including the manufacturer and model of any high integrity container;
(iii) The volume displaced by the disposal container;
(iv) The gross weight of the disposal container, including the waste;
(v) For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;
(vi) A physical and chemical description of the waste;
(vii) The total weight percentage of chelating agent for any waste containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;
(viii) The approximate volume of waste within a container;
(ix) The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name;
(x) The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in the form of special nuclear material, and the masses of uranium and thorium in the form of source material. For discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides associated with a disposal container shall be reported;
(xi) The total radioactivity within each container; and
(xii) For wastes consigned to a disposal facility, the classification of the waste pursuant to (13)(f). Waste not meeting the structural stability requirements of (13)(g)2. must be identified.
5. Uncontainerized Waste Information. The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container:
(i) The approximate volume and weight of the waste;
(ii) A physical and chemical description of the waste;
(iii) The total weight percentage of chelating agent if the chelating agent exceeds 0.1 percent by weight, plus the identity of the principal chelating agent;
(iv) For waste consigned to a disposal facility, the classification of the waste pursuant to (13)(f) of this Rule. Waste not meeting the structural stability requirements of (13)(g)2. of this Rule must be identified;
(v) The identities and activities of individual radionuclides contained in the waste, the masses of U-233, U-235, and plutonium in the form of special nuclear material, and the masses of uranium and thorium in the form of source material; and
(vi) For wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste.
6. Multi-Generator Disposal Container Information. This section applies to disposal containers enclosing mixtures of waste originating from different generators. (Note: The origin of the LLW resulting from a processor's activities may be attributable to one or more "generators" (including "waste generators") as defined in this Chapter). It also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators.
(i) For homogeneous mixtures of waste, such as incinerator ash, provide the waste description applicable to the mixture and the volume of the waste attributed to each generator.
(ii) For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, provide the following:
(I) The volume of waste within the disposal container;
(II) A physical and chemical description of the waste, including the solidification agent, if any;
(III) The total weight percentage of chelating agents for any disposal container containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;
(IV) The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements of (13)(g)2. of this Rule; and
(V) Radionuclide identities and activities contained in the waste, the masses of U-233, U-235, and plutonium in the form of special nuclear material, and the masses of uranium and thorium in the form of source material if contained in the waste.
7. An authorized representative of the waste generator, processor, or collector shall certify by signing and dating the shipment manifest that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the Department of Transportation and the Department. A collector in signing the certification is certifying that nothing has been done to the collected waste which would invalidate the waste generator's certification.
8. Control and Tracking. Any licensee who transfers radioactive waste to a land disposal facility or a licensed waste collector shall comply with all of the following requirements. Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of (13)(i)8.(iv) through (ix). A licensee shall:
(i) Prepare all wastes so that the waste is classified according to (13)(f) and meets waste characteristics requirements in (13)(g);
(ii) Label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater than Class C waste, in accordance with (13)(f);
(iii) Conduct a quality assurance program to assure compliance with (13)(f) and (13)(g) (the program must include management evaluation of audits);
(iv) Prepare the NRC Forms 540 and 540A or Equivalent Forms, "Uniform Low-Level Radioactive Waste Manifest" as required by this Section;
(v) Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either:
(I) Receipt of the manifest precedes the LLW shipment, or
(II) The manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee, or
(III) Both (I) and (II) is also acceptable.
(vi) Include NRC Form 540 (and NRC 540A, if required) or Equivalent Forms with the shipment regardless of the option in (13)(i)8.(v);
(vii) Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540 or Equivalent Form;
(viii) Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by Rule 391-3-17-.02; and
(ix) For any shipments or any part of a shipment for which acknowledgment of receipt has not been received within the times set forth in this section, conduct an investigation in accordance with (13)(i)12.
9. Any waste collector licensee who handles only prepackaged waste shall:
(i) Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540 or Equivalent Form.
(ii) Prepare a new manifest to reflect consolidated shipments that meet the requirements of this section. The waste collector shall ensure that, for each container of waste in the shipment, the manifest identifies the generator of that container of waste;
(iii) Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either:
(I) Receipt of the manifest precedes the LLW shipment, or
(II) The manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee, or
(III) Both (I) and (II) is also acceptable;
(iv) Include NRC Form 540 (and NRC From 540A, if required) or Equivalent Forms, with the shipment regardless of the option chosen in (13)(i)9.(iii);
(v) Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540 or Equivalent Form;
(vi) Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt;
(vii) For any shipments or any part of a shipment for which acknowledgment of receipt has not been received within the times set forth in this section, conduct an investigation in accordance with (13)(i)12.; and
(viii) Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.
10. Any licensed waste processor who treats or repackages waste shall:
(i) Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of NRC Form 540 or Equivalent Form;
(ii) Prepare a new manifest that meets the requirements of this section. Preparation of the new manifest reflects that the processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest shall identify the waste generators, the preprocessed waste volume, and other information as required in (13)(i)6.;
(iii) Prepare all wastes so that the waste is classified according to (13)(f) and meets the waste characteristics requirements in (13)(g);
(iv) Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with (13)(f) and (13)(h);
(v) Conduct a quality assurance program to assure compliance with (13)(f) and (13)(g) (the program shall include management evaluation of audits);
(vi) Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either:
(I) Receipt of the manifest precedes the LLW shipment, or
(II) The manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee, or
(III) Both (I) and (II) is also acceptable;
(vii) Include NRC Form 540 (and NRC Form 540A if required) or Equivalent Forms, with the shipment regardless of the option chosen in (13)(i)10.(vi);
(viii) Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540 or Equivalent Form;
(ix) Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by Rule 391-3-17-.02;
(x) For any shipment or any part of a shipment for which acknowledgment of receipt has not been received within the times set forth in this section, conduct an investigation in accordance with (13)(i)12.; and
(xi) Notify the shipper and the Department when any shipment, or any part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.
11. The land disposal facility operator shall:
(i) Acknowledge receipt of the waste within one week of receipt by returning, as a minimum, a signed copy of NRC Form 540 or Equivalent Form to the shipper. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the Uniform Low-Level Radioactive Waste Manifest and materials received, copies or electronic transfer of the affected forms must be returned indicating that discrepancy.
(ii) Maintain copies of all completed manifests and electronically store the information until the Department terminates the license; and
(iii) Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.
12. Any shipments or part of a shipment for which acknowledgment is not received within the times set forth in this section must:
(i) Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and
(ii) Be traced and reported. The investigation shall include tracing the shipment and filing a report with the Department. Each licensee who conducts a trace investigation shall file a written report with the Department within two weeks of completion of the investigation.
13. The requirements of this section are to:
(i) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in this section, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level waste land disposal facility (as defined in 10 CFR 61 );
(ii) Establish a manifest tracking system; and
(iii) Supplement existing requirements concerning transfers and recordkeeping for those wastes.
14. Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility must document the information required on NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with (13)(i)1. through 12. of this Rule.
15. Each shipment manifest must include a certification by the waste generator as specified in (13)(i)7. of this Rule.
16. Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in (13)(i)8. of this Rule.
17. Any licensee shipping byproduct material as defined in paragraphs (3) and (4) of the definition of Byproduct material set forth in Rule .01(2)(o), intended for ultimate disposal at a land disposal facility licensed under 10 CFR 61 must document the information required on the NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with (13)(i)1. through 12. of this Rule.
(j) Compliance with Environmental and Health Protection Regulations. Nothing in this Rule relieves the licensee from complying with other applicable Federal, State, and local regulations governing other toxic or hazardous properties of materials that may be disposed of pursuant to this Rule.
(k) Disposal of Certain Byproduct Material
1. Licensed material as defined in Rule .01(2)(o) 3. and 4. of the definition of Byproduct material may be disposed of in accordance with.03(13) of this chapter, even though it is not defined as low-level radioactive waste. Therefore, any licensed byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed under.03(13) of this chapter, must meet the requirements of Rule .03(13)(i).
2. A licensee may dispose of byproduct material, as defined in Rule .01(2)(o) 3. and 4. of the definition of Byproduct, at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005.
(14) Records
(a) General Provisions.
1. Each licensee shall use the units of Curie, rad, rem, and dpm, including multiples and subdivisions and shall clearly indicate the units of all quantities on records required by this Rule.
2. In the records required by this rule, the licensee may record quantities in SI units in parentheses following each of the units specified in (14)(a)1. However, all quantities must be recorded as stated in (14)(a)1.
3. The licensee shall make a clear distinction among the quantities entered on the records required by this Rule, such as total effective dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, total organ dose equivalent, or committed effective dose equivalent.
(b) Records of Radiation Protection Programs.