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Indiana Administrative Code (Last Updated: December 20, 2016) |
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Title 410. INDIANA STATE DEPARTMENT OF HEALTH |
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Article 410IAC5. RADIOLOGICAL HEALTH |
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Rule 410IAC5-3. Licensing of Radioactive Material |
Section 410IAC5-3-7. General licenses for materials other than source materials
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General Licenses*─Radioactive Material Other Than Source Material. (a) Certain Devices and Equipment. A general license is hereby issued to transfer, receive, acquire, own, possess and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested, and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission for use pursuant to Section 31.3 of 10 CFR Part 31. This general license is subject to the provisions of 410 IAC 5-1-4 through 410 IAC 5-1-9, 410 IAC 5-3-4(a)(2), 410 IAC 5-3-15, 410 IAC 5-3-22, 410 IAC 5-3-23, 410 IAC 5-3-25, 410 IAC 5-4,4/ and 410 IAC 5-10.
*Different general licenses are issued in this section, each of which has its own specific conditions and requirements.
4/ Attention is directed particularly to the provisions of 410 IAC 5-4 which relates to the labeling of containers.
(1) Static Elimination Device. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of polonium-210 per device or a total of not more than 50 millicuries of hydrogen-3 (tritium) per device.
(2) Ion Generating Tube. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of polonium-210 per device or a total of not more than 50 millicuries of hydrogen-3 (tritium) per device.
(b) Reserved
(c) Reserved
(d) Certain Measuring, Gauging or Controlling Devices.
(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 410 IAC 5-3-7(d)(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 410 IAC 5-3-7(d)(1) applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific license issued by the board pursuant to 410 IAC 5-3-13(d) or 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.5/
5/ 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 21 CFR 179.21.
(3) Any person who owns, receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license in 410 IAC 5-3-7(d)(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 on the label; however,
(A) Devices containing only krypton need not be tested for leakage of radioactive material, and
(B) Devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting material or 10 microcuries 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 other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment, are performed:
(A) In accordance with the instructions provided by the labels; or
(B) By a person holding an applicable specific license from the board, 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 410 IAC 5-3-7(d)(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 410 IAC 5-3-7(d)(3)(ii) shall be maintained for 1 year after the next required leak test is performed or until the sealed source is transferred or disposed of. Records of tests of the on/off mechanism and indicator required by 410 IAC 5-3-7(d)(3)(ii) shall be maintained for 1 year after the next required test of the on/off mechanism and indicator is performed or until the sealed source is transferred or disposed of. Records which are required by 410 IAC 5-3-7(d)(3)(iii) shall be maintained for a period of 2 years from the date of the recorded event or until the device is transferred or disposed of;
(v) 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 or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the board, the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state to repair such devices, or disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device and, within 30 days, furnish to the board a report containing a brief description of the event and the remedial action taken;
(vi) Shall not abandon the device containing radioactive material;
(vii) Except as provided in 410 IAC 5-3-7(d)(3)(viii), shall transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the board, the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state whose specific license authorizes him to receive the device and within 30 days after transfer of a device to a specific licensee shall furnish to the board a report containing identification of the device by manufacturer's name and model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific licensee in order to obtain a replacement device;
(viii) Shall transfer the device to another general licensee only:
(A) Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of 410 IAC 5 and any safety documents identified in the label on the device and within 30 days of the transfer, report to the board the manufacturer's name and model number of device transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between the board and the transferee; or
(B) Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee; and
(ix) Shall comply with the provisions of 410 IAC 5-4-22 and 410 IAC 5-4-23 for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of 410 IAC 5-4 and 410 IAC 5-10.
(4) The general license in 410 IAC 5-3-7(d)(1) does not authorize the manufacture of devices containing radioactive material.
(5) The general license provided in 410 IAC 5-3-7(d)(1) is subject to the provisions of 410 IAC 5-1-4 through 410 IAC 5-1-9, 410 IAC 5-3-15, 410 IAC 5-3-22, 410 IAC 5-3-23, and 410 IAC 5-3-25.
(e) 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 10 curies of tritium or 300 millicuries 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 board 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.
(2) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in 410 IAC 5-3-7(e)(1) are exempt from the requirements of 410 IAC 5-4 and 410 IAC 5-10 except that they shall comply with the provisions of 410 IAC 5-4-22 and 410 IAC 5-4-23.
(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 410 IAC 5-1-4 through 410 IAC 5-1-9, 410 IAC 5-3-15, 410 IAC 5-3-22, 410 IAC 5-3-23, and 410 IAC 5-3-25.
(f) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of 410 IAC 5-3, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.
(g) 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 410 IAC 5-3-7(g)(4) and (5), americium-241 in the form of calibration or reference sources:
(i) Any person who holds a specific license issued by the board 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 410 IAC 5-3-7(g)(4) and (5) to any person who holds a specific license issued by the board 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 410 IAC 5-3-7(g)(4) and (5) to any person who holds a specific license issued by the board which authorizes him to receive, possess, use and transfer radioactive material.
(4) The general licenses in 410 IAC 5-3-7(g)(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 board, 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.
(5) The general licenses provided in 410 IAC 5-3-7(g)(1), (2) and (3) are subject to the provisions of 410 IAC 5-1-4 through 410 IAC 5-1-9, 410 IAC 5-3-15, 410 IAC 5-3-22, 410 IAC 5-3-23, and 410 IAC 5-3-25 and 410 IAC 5-4, and 410 IAC 5-10. 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 5 microcuries of americium-241, 5 microcuries of plutonium or 5 microcuries 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 which includes the following statements as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:
(A) 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 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)6/ DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_____________________________
Name of manufacturer or importer
6/ Showing only the name of the appropriate material.
(B) 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 board, the U.S. Nuclear Regulatory Commission, an agreement state, or 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.
(h) Medical Diagnostic Uses7/8/
7/ 410 IAC 5-3-13 requires manufacturers of radiopharmaceuticals which are under the general license in this paragraph to affix a certain identifying label to the container or in the leaflet or brochure which accompanies the radiopharmaceutical.
8/ The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.
(1) A general license is hereby issued to any physician to receive, possess, transfer or use radioactive material set forth below for the stated diagnostic uses, provided, however, that the use is in accordance with the provision of 410 IAC 5-3-7(h)(2), (3), and (4), the radioactive material is in the form of capsules, disposable syringes or other prepackaged individual doses; and the radioactive material has been manufactured in accordance with a specific license issued by the board pursuant to 410 IAC 5-3-13(g), or by the U.S. Nuclear Regulatory Commission, any agreement state or a licensing state pursuant to equivalent rules authorizing distribution to persons generally licensed pursuant to 410 IAC 5-3-7(h) or its equivalent.
(i) Chromium-51 as sodium radiochromate for determination of red blood cell volumes and studies of red blood cell survival time;
(ii) Cobalt-57 for the measurement of intestinal absorption of cyanocobalamin;
(iii) Cobalt-58 for the measurement of intestinal absorption of cyanocobalamin;
(iv) Cobalt-60 for the measurement of intestinal absorption of cyanocobalamin;
(v) Iodine-125 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume;
(vi) Iodine-131 as sodium iodide for measurement of thyroid uptake; and
(vii) Iodine-131 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume;
(2) No physician shall receive, possess, use or transfer radioactive material pursuant to the general license established by 410 IAC 5-3-7(h)(1) until he has filed board form "U," 410 IAC 5-3-30, "Certificate─Medical Use of Radioactive Material Under General License" with the board and received from the board a validated copy of the board form "U," 410 IAC 5-3-30, with certification number assigned. The generally licensed physician shall furnish on board form "U," 410 IAC 5-3-30, the following information and such other information as may be required by that form:
(i) name and address of the generally licensed physician;
(ii) a statement that the generally licensed physician is a duly licensed physician (authorized to dispense drugs) in the practice of medicine in Indiana; and
(iii) a statement that the generally licensed physician has appropriate radiation measuring instruments to carry out the diagnostic procedures for which he proposes to use radioactive material under the general license of 410 IAC 5-3-7(h) and that he is competent in the use of such instruments.
(3) A physician who receives, possesses, or uses a pharmaceutical containing radioactive material pursuant to the general license established by 410 IAC 5-3-7(h)(1) shall comply with the following:
(i) he shall not possess at any one time, pursuant to the general license in 410 IAC 5-3-7(h)(1) more than:
(A) 200 microcuries of iodine-131,
(B) 200 microcuries of iodine-125,
(C) 5 microcuries of cobalt-57,
(D) 5 microcuries of cobalt-58,
(E) 5 microcuries of cobalt-60, and
(F) 200 microcuries of chromium-51;
(ii) he shall store the pharmaceutical until administered in the original shipping container, or a container providing equivalent radiation protection;
(iii) he shall use the pharmaceutical only for the uses authorized by 410 IAC 5-3-7(h)(1);
(iv) he shall not administer the pharmaceutical to a woman with confirmed pregnancy or to a person under 18 years of age; and
(v) he shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the board, the U.S. Nuclear Regulatory Commission, any agreement state or licensing state, or in any manner other than in the unopened, labeled shipping container as received from the supplier, except by administering it to a patient.
(4) The generally licensed physician possessing or using radioactive material under the general license of 410 IAC 5-3-7(h)(1) shall report in duplicate to the board, any changes in the information furnished by him in the "Certificate─Medical Use of Radioactive Material Under General License," board form "U." The report shall be submitted within 30 days after the effective date of such change.
(5) Any person using radioactive material pursuant to the general license of 410 IAC 5-3-7(h)(1) is exempt from the requirements of 410 IAC 5-4 and 410 IAC 5-10 with respect to the radioactive material covered by the general license.
(i) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.8/
8/ The New Drug provisions of the Federal Food, Drug, and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.
(1) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of 410 IAC 5-3-7(i)(2), (3), (4), (5), and (6), the following radioactive materials in prepackaged units for use 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) Carbon-14, in units not exceeding 10 microcuries each;
(ii) Cobalt-57, in units not exceeding 10 microcuries each;
(iii) Hydrogen-3 (tritium), in units not exceeding 50 microcuries each;
(iv) Iodine-125, in units not exceeding 10 microcuries each;
(v) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie iodine-129 and 0.005 microcurie of americium-241 each;
(vi) Iodine-131, in units not exceeding 10 microcuries each;
(vii) Iron-59, in units not exceeding 20 microcuries each;
(viii) Selenium-75, in units not exceeding 10 microcuries each;
(2) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by 410 IAC 5-3-7(i)(1) until he has filed board form "V," 410 IAC 5-3-31, "Certificate─In Vitro Testing with Radioactive Material Under General License," with the board and received from the board a validated copy of board form "V" with certification number assigned, or until he has been authorized pursuant to 410 IAC 5-3-11(c)(3) to use radioactive material under the general license in 410 IAC 5-3-7(i). The physician, veterinarian, clinical laboratory or hospital shall furnish on board form "V" the following information and such other information as may be required by that form:
(i) name and address of the physician, veterinarian, clinical laboratory or hospital;
(ii) the location of use; and
(iii) a statement that the physician, veterinarian, 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 410 IAC 5-3-7(i)(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 410 IAC 5-3-7(i)(1) shall comply with the following:
(i) the general licensee shall not possess at any one time, pursuant to the general license in 410 IAC 5-3-7(i)(1) at any one location of storage or use, a total amount of iodine-125, iodine-131, iron-59, selenium-75, and/or cobalt-57 in excess of 200 microcuries;
(ii) the general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection;
(iii) the general licensee shall use the radioactive material only for the uses authorized by 410 IAC 5-3-7(i)(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 board, 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 410 IAC 5-3-7(i)(1)(viii) as required by 410 IAC 5-4-16.
(4) The general licensee shall not receive, acquire, possess or use radioactive material pursuant to 410 IAC 5-3-7(i)(1):
(i) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to 410 IAC 5-3-13(h), 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 410 IAC 5-3-7(i) or its equivalent; and
(ii) Unless 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:
(A) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, 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.
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Name of manufacturer
(B) This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, 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, clinical laboratory or hospital possessing or using radioactive material under the general license of 410 IAC 5-3-7(i)(1) shall report in writing to the board, any changes in the information furnished by him in the "Certificate─In Vitro Testing with Radioactive Material Under General License," board form "V," 410 IAC 5-3-31. 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 410 IAC 5-3-7(i)(1) is exempt from the requirements of 410 IAC 5-4 and 410 IAC 5-10 with respect to radioactive material covered by that general license, except, that such persons using the Mock Iodine-125 described in 410 IAC 5-3-7(i)(1)(viii) shall comply with the provisions of 410 IAC 5-4-16, 410 IAC 5-4-22, and 410 IAC 5-4-23.
(j) 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 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 board or an agreement state to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 CFR Part 32.
(2) Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in 410 IAC 5-3-7(j)(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 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 410 IAC 5-4-16;
(ii) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and
(iii) Are exempt from the requirements of 410 IAC 5-4 and 410 IAC 5-10 except that such persons shall comply with the provisions of 410 IAC 5-4-16, 410 IAC 5-4-22, and 410 IAC 5-4-23.
(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 410 IAC 5-1-4 through 410 IAC 5-1-9, 410 IAC 5-3-15, 410 IAC 5-3-22, 410 IAC 5-3-23, and 410 IAC 5-3-25.
(Indiana State Department of Health; Rule HRH-2,PT C,Sec C.22; filed May 26, 1978, 3:30 pm: 1 IR 141; filed Feb 29, 1984, 10:10 am: 7 IR 847; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA)