[30 Pa.B. 4503]
[Continued from previous Web Page]
TABLE 1
EXEMPT CONCENTRATIONS Note: Some of the Values in Table A-1 are presented in the computer ''E'' notation. In this notation a value of 6E-02 represents a value of 6 × 10-2 or 0.06, 6E+2 represents 6 × 102 or 600 and 6E+0 represents 6 × 100 or 6.
Column II Column I Liquid and solid Element Gas concentration concentration (atomic number)
Isotope µCi/ml µCi/ml Actinium (89) Ac-228 9E-04 Cadmium (48) Cd-109 2E-03 Cesium (55) Cs-129 3E-03 Europium (63) Eu-154 2E-04 Gallium (31) Ga-67 2E-03 Germanium (32) Ge-68 9E-03 Gold (79) Au-195 1E-02 Indium (49) In-111 1E-03 Iodine (53) I-123 3E-04 I-124 4E-06 I-125 2E-06 Lead (82) Pb-212 2E-04 Phosphorus (15) P-33 3E-04 Potassium (19) K-43 2E-04 Protactinium (91) Pa-230 2E-03 Radium(88) Ra-223 7E-06 Ra-224 2E-05 Ra-228 3E-07 Radon (86) Rn-220 1E-07 Rn-222 3E-08 Sodium (11) Na-22 4E-04 Technetium (43) Tc-97m 4E-03 Xenon (54) Xe-127 4E-06 Yttrium (39) Y-88 8E-04
§ 217.137. Exempt quantities.
In addition to the parts of 10 CFR 30 incorporated by reference, the following requirements apply:
(1) A person may receive, possess, use, transfer, own or acquire radioactive material in individual quantities each of which is less than those listed in Table 2 if the person does not produce, package or repackage radioactive material for purposes of commercial distribution or incorporate radioactive material into products intended for commercial distribution.
(2) Except under a specific license issued by the Department or the NRC under 10 CFR 32.18 (relating to manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license), a person may not, for purposes of commercial distribution, transfer radioactive material for distribution to persons exempt under paragraph (1) or equivalent regulations of the NRC, an agreement state or licensing state.
TABLE 2
EXEMPT QUANTITIES
Radioactive Material Microcuries Actinium-228 (Ac 228) 1 Beryllium-7 (Be 7) 10 Bismuth-207 (Bi 207) 10 Cesium-129 (Cs 129) 100 Cobalt-57 (Co 57) 100 Gallium-67 (Ga 67) 100 Germanium-68 10 Gold-195 (Au 195) 10 Gold-196 (Au 196) 1 Indium-111 (In 111) 100 Iodine-123 (I 123) 100 Iodine-124 (I 124) 1 Iridium-190 (Ir 190) 100 Lead-203 (Pb 203) 100 Lead-210 (Pb 210) 0.1 Lead-212 (Pb 212) 10 Phosphorus-33 (P 33) 10 Potassium-43 (K 43) 10 Protactinium-230 (Pa 230) 10 Protactinium-231 (Pa 231) 0.1 Radium-223 (Ra 223) 1 Radium-224 (Ra 224) 1 Radium-226 (Ra 226) 0.1 Radium-228 (Ra 228) 0.1 Radon-220 (Rn 220) 1 Radon-222 (Rn 222) 1 Rhenium-183 (Re 183) 100 Rhenium-187 (Re 187) 100 Rubidium-81 (Rb 81) 10 Scandium-46 (Sc 46) 10 Sodium-22 (Na 22) 10 Technetium-96m (Tc 96m) 100 Xenon-127 (Xe 127) 1,000 Yttrium-87 (Y 87) 10 Yttrium-88 (Y 88) 10
Subchapter C. GENERAL LICENSES FOR RADIOACTIVE MATERIAL Sec.
217.141. Incorporation by reference. 217.142. Effect of incorporation of 10 CFR Part 31. 217.143. Certain measuring, gauging or controlling devices. 217.144. Incidental radioactive material produced by a particle accelerator. § 217.141. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 31 (relating to general domestic licenses for byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 31.4 (relating to information collection requirements: OMB approval), 10 CFR 31.13 (relating to violations) and 10 CFR 31.14 (relating to criminal penalties) are not incorporated by reference.
§ 217.142. Effect of incorporation of 10 CFR Part 31.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 31 (relating to general domestic licenses for byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 31 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) The definition of ''licensed material'' includes NARM.
§ 217.143. Certain measuring, gauging or controlling devices.
In addition to the parts of 10 CFR 30.5 (relating to interpretations) incorporated by reference, general licensees shall also comply with the following:
(1) Conduct a physical inventory every 6 months to account for all sources or devices, or both, received and possessed under this section and do the following:
(i) Maintain the physical inventory records for 3 years from the date of each inventory.
(ii) Furnish a report to the Department annually showing to the extent practicable, the make, model, serial number, isotope, source activity and location of each device. The report shall list an individual to contact regarding questions about this report.
(2) For portable devices, shall also comply with the following:
(i) A person who initiates acquisition, transfer or disposal of a portable device shall notify the Department within 15 days of the action. Sending a portable device for calibration, maintenance or source replacement does not constitute transfer.
(ii) Portable devices may only be used by or under the direct supervision of individuals who have been instructed in the operating and emergency procedures necessary to ensure safe use.
(iii) For each individual that the licensee permits to use a portable device, the licensee shall maintain a record showing the type of device use permitted and the basis, such as training certificates, for that authorization. An individual's record shall be kept for at least 3 years after the individual terminates association with the licensee.
(iv) Portable devices shall be secured from access by unauthorized personnel whenever the device is not under the direct surveillance of an individual authorized to use the device.
(v) The licensee shall maintain a current sign out log at the permanent storage location of the portable device. Log entries shall be available for inspection by the Department for 3 years from the date of entry. The following information shall be recorded for each portable device:
(A) The model and serial number of the device.
(B) The name of the assigned user.
(C) Locations and dates of use.
(vi) Emergency instructions shall accompany each portable device taken off the premises of the licensee.
§ 217.144. Incidental radioactive material produced by a particle accelerator.
A general license is issued to possess radioactive material produced incidentally to the operation of a particle accelerator. The general license is also subject to the applicable provisions of Chapters 215, 217, 219 and 220. A licensee may transfer this radioactive material only under Subchapter I and Chapter 230 (relating to transfer of radioactive material; and packaging and transportation of radioactive material). A licensee may dispose of this radioactive material only with Department approval.
Subchapter D. SPECIFIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL Sec.
217.151. Incorporation by reference. 217.152. Effect of incorporation of 10 CFR Part 32. 217.153. Licensing the incorporation of NARM into gas and aerosol detectors. 217.154. Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226. 217.155. Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. § 217.151. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 32.8 (relating to information collection requirements: OMB approval) is not incorporated by reference.
§ 217.152. Effect of incorporation of 10 CFR Part 32.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 32 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) The definition of ''licensed material'' includes NARM.
(5) A reference to byproduct material includes NARM.
§ 217.153. Licensing the incorporation of NARM into gas and aerosol detectors.
An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under Subchapter B (relating to general provisions for radioactive material) will be approved if the application satisfies requirements equivalent to those in 10 CFR 32.26--32.29. The maximum quantity of radium-226 may not exceed 0.1 microcuries (3.7 kBq).
§ 217.154. Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226.
In addition to the incorporation by reference of requirements in 10 CFR 32.57 (relating to calibration sources containing americium-241) applicants using plutonium and radium-226 in the manufacture of calibration or reference sources shall comply with 10 CFR 32.57.
§ 217.155. Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license.
(a) In addition to the incorporation by reference of requirements in 10 CFR 32.71 (relating to manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license) applicants using cobalt-57 shall prepare for distribution the cobalt-57 in prepackaged units that do not exceed 10 microcuries (370 kBq) of cobalt-57.
(b) A prepackaged unit shall bear a durable, clearly visible label identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (370 kBq) cobalt-57.
Subchapter E. [Reserved]
Subchapter F. SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR RADIOACTIVE MATERIAL Sec.
217.161. Incorporation by reference. 217.162. Effect of incorporation of 10 CFR Part 33. 217.163. Types of specific licenses of broad scope. § 217.161. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 33 (relating to specific domestic licenses of broad scope for byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 33.8 (relating to information collection requirements: OMB approval), 10 CFR 33.21 (relating to violations) and 10 CFR 33.22 (relating to criminal penalties) are not incorporated by reference.
§ 217.162. Effect of incorporation of 10 CFR Part 33.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 33, the following words and phrases shall be substituted for the language in 10 CFR Part 33 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) The definition of ''licensed material'' includes NARM.
(5) A reference to byproduct material includes NARM.
§ 217.163. Types of specific licenses of broad scope.
In addition to the incorporation by reference of 10 CFR 33.11 (relating to types of specific licenses of broad scope), the following requirements for licensees using NARM also apply:
(1) A Type A specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in the license, but not exceeding quantities specified in the license, for purposes authorized by the act. The quantities specified exceed those specified in Column I, Table 3 and 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 a chemical or physical form of radioactive material specified in Table 3, for an 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 Column I, Table 3. 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 Column I, Table 3, for that radionuclide; the sum of the ratios for radionuclides possessed under the license may 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 a chemical or physical form of radioactive material specified in Table 3, for an 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 Column II, Table 3. 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 Column II, Table 3, for that radionuclide; the sum of the ratios for radionuclides possessed under the license may not exceed unity.
TABLE 3
LIMITS FOR BROAD LICENSES
Radioactive Material Col. I curies Col. II curies Beryllium-7 10 0.1 Cobalt-57 10 0.1 Radium-226 0.01 0.0001 Scandium-46 1 0.01 Sodium-22 0.1 0.001
Subchapter G. LICENSING OF SOURCE MATERIAL Sec.
217.171. Incorporation by reference. 217.172. Effect of incorporation of 10 CFR Part 40. § 217.171. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 40 (relating to domestic licensing of source material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 40.5 (relating to communications), 10 CFR 40.6 (relating to interpretations), 10 CFR 40.8 (relating to information collection requirements: OMB approval), 10 CFR Part 40.81 (relating to violations) and 10 CFR Part 40.82 (relating to criminal penalties) are not incorporated by reference.
§ 217.172. Effect of incorporation of 10 CFR Part 40.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 40 (relating to domestic licensing of source material), the following words and phrases shall be substituted for the language in 10 CFR Part 40 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) The definition of ''licensed material'' includes NARM.
Subchapter H. LICENSING OF SPECIAL NUCLEAR MATERIAL Sec.
217.181. Incorporation by reference. 217.182. Effect of incorporation of 10 CFR Part 70. § 217.181. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 70 (relating to domestic licensing of special nuclear material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 70.5 (relating to communications), 10 CFR 70.6 (relating to interpretations), 10 CFR 70.8 (relating to information collection requirements: OMB approval), 10 CFR 70.71 (relating to violations) and 10 CFR 70.72 (relating to criminal penalties) are not incorporated by reference.
§ 217.182. Effect of incorporation of 10 CFR Part 70.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 70 (relating to domestic licensing of special nuclear material), the following words and phrases shall be substituted for the language in 10 CFR Part 70 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) The definition of ''licensed material'' includes NARM.
Subchapter I. TRANSFER OF RADIOACTIVE MATERIAL Sec.
217.191. Transfer of material. § 217.191. Transfer of material.
(a) Subject to subsections (b)--(d), a licensee may transfer radioactive material only to one or more of the following:
(1) The Department, but only after receiving prior approval from the Department.
(2) The United States Department of Energy.
(3) A person exempt from this article to the extent permitted under the exemption.
(4) A person authorized to receive the material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Department, the NRC, an agreement state or a licensing state, or to a person otherwise authorized to receive the material by the Federal government or an agency thereof, the Department, an agreement state or a licensing state.
(5) A person otherwise authorized by the Department in writing.
(b) Prior to the receipt of radioactive material that is being transferred to a specific licensee of the Department, of the NRC, of an agreement state, of a licensing state, or to a general licensee who is required to furnish information to the NRC, to an agreement state, to a licensing state, or to the Department under Subchapters C or G (relating to general licenses for radioactive material; and licensing of source material), the licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form and quantity of radioactive material to be transferred.
(c) The following methods for the verification required by subsection (b) are acceptable:
(1) The transferor may possess a current copy of the transferee's specific license or certificate.
(2) The transferor may possess 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 certificate number, issuing agency and expiration date.
(3) For emergency shipments, the transferor may accept oral certification from the transferee that he is authorized by license or certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or certificate number, issuing agency and expiration date. The oral certification shall be confirmed in writing within 10 days.
(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the Department, the NRC, the licensing agency of an agreement state or a licensing state as to the identity of licensees and the scope and expiration dates of licenses.
(d) If none of the methods of verification described in subsection (c) are readily available or if a transferor desires to verify that information received by one of the methods is correct or up-to-date, the transferor may obtain and record confirmation from the Department, the NRC, 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 Chapter 230 (relating to packaging and transportation of radioactive material).
Subchapter J. RECIPROCITY Sec.
217.201. Incorporation by reference. 217.202. Effect of incorporation of 10 CFR Part 150. 217.203. Reciprocity of licenses of naturally occurring and accelerator-produced radioactive material. § 217.201. Incorporation by reference.
Except as provided in this subchapter, the requirements of 10 CFR 150.2 (relating to scope), 10 CFR 150.11 (relating to critical mass) and 10 CFR 150.20 (relating to recognition of Agreement State licenses) are incorporated by reference.
§ 217.202. Effect of incorporation of 10 CFR Part 150.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 150 (relating to exemptions and continued regulatory authorization agreement states and in offshore waters under section 274), the following words and phrases shall be substituted for the language in 10 CFR Part 150:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) The definition of ''licensed material'' includes NARM.
§ 217.203. Reciprocity of licenses of naturally occurring and accelerator-produced radioactive material.
(a) Subject to this article, a person who holds a specific license from a licensing state where the licensee maintains an office, issued by the agency having jurisdiction to direct the licensed activity and to maintain radiation safety records, is granted a general license to conduct the activities authorized in the licensing document within this Commonwealth for a period not in excess of 180 days in a calendar year if:
(1) The licensing document does not limit the activity authorized by the document to specified installation or locations.
(2) The out-of-State licensee notifies the Department in writing at least 3 days prior to engaging in the activity. The notification shall indicate the location, period and type of proposed possession and use within this Commonwealth, 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, the licensee may, upon application to the Department, obtain permission to proceed sooner. The Department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in this subsection.
(3) The out-of-State licensee complies with this title and with the terms and conditions of the licensee's document, except terms and conditions which may be inconsistent with this title.
(4) The out-of-State licensee supplies other information as the Department may request.
(5) The out-of-State licensee does not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person who is one of the following:
(i) Specifically licensed by the Department or by another licensing state to receive the material.
(ii) Exempt from the requirements for a license for the material under Subchapter B (relating to general provisions for radioactive material).
(b) Notwithstanding the provisions of subsection (a), a person who holds a specific license issued by a licensing state authorizing the holder to manufacture, transfer, install or service a device described in Subchapter C (relating to general licenses for radioactive material) within areas subject to the jurisdiction of the licensing body is granted a general license to install, transfer, demonstrate or service the device in this Commonwealth subject to the following conditions:
(1) The person files a report with the Department within 30 days after the end of a calendar quarter in which a device is transferred to or installed in this Commonwealth. The report shall identify the general licensee to whom the 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 the specific license issued to the person by a licensing state.
(3) The person assures that labels required to be affixed to the device, under regulations of the authority which licensed manufacture of the device, bear a statement that ''Removal of this label is prohibited.''
(4) The holder of the specific license or his intermediary shall provide a copy of the conditions of general license contained in Subchapter C (relating to general license for radioactive material) to the general licensee upon transfer of the radioactive material or installation of a device containing the radioactive material.
(c) The Department may withdraw, limit or qualify its acceptance of a specific license or equivalent licensing document issued by another agency, or product distributed under the licensing document, upon determining that the action is necessary to prevent undue hazard to public health and safety or property.
(d) When a person is granted a general license under subsection (a) and subsequently exceeds the prescribed 180-day period, the person shall file a license application with the Department under Subchapter B (relating to general provisions for radioactive material) within 30 days after the end of the 180-day period.
(Editors Note: As part of this proposed rulemaking, the Department is proposing to delete the existing text of §§ 219.3, 219.4, 219.21, 219.31--219.38, 219.51, 219.52, 219.61, 219.71--219.73, 219.91--219.93, 219.111--219.113, 219.131, 219.132, 219.151--219.159, 219.160--219.162, 219.181--219.186, 219.201--219.211, 219.221--219.228, 219.241, Appendix A, Appendix B and Appendix C which appear at 25 Code pages 219-1--219-138, serial pages (252831), (252832), (204035)--(204038), (249251), (249252), (204041), (204042), (249253), (249254), (204045)--(204048), (249255), (249256), (204051)--(204054), (249257), (249258), (204057)--(204062), (249259), (249260), (204065)--(204070), (249261)--(249267), (204077)--(204080), (249269)--(249270) and (204083)--(204170).) The following text is new and has been printed in regular type to enhance readability.)
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS § 219.5. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 20 (relating to standards for protection against radiation) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 20.1006 (relating to interpretations), 10 CFR 20.1009 (relating to information collection requirements: OMB approval), 10 CFR 20.2401 (relating to violations) and 10 CFR 20.2402 (relating to criminal penalties) are not incorporated by reference.
§ 219.6. Effect of incorporation of 10 CFR Part 20.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 20 (relating to standards for protection against radiation), the following words and phrases shall be substituted for the language in 10 CFR Part 20 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) A reference to ''licensee'' includes registrant.
(4) A reference to ''license'' includes registration.
(5) A reference to ''licensed'' includes registered.
(6) A reference to ''Department'' in this chapter means the United States Department of Energy.
§ 219.51. Dose limits for individual members of the public.
In addition to incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation), registrants who met the previous limit (5 mSv or 0.5 REM in 1 year) for locations having existing radiation-producing machines or equipment or other registered radiation sources will not be required to retrofit installations existing before November 18, 1995. The Department does not require the retrofitting of shielding for the replacement of equipment in the facility as long as the equipment is being replaced with similar equipment.
§ 219.61. Testing for leakage or contamination of sealed sources.
(a) In addition to incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation), a licensee possessing a sealed source shall assure that:
(1) Except as specified in subsection (b), each sealed source is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within 6 months before transfer to the licensee.
(2) Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 6 months or at alternative intervals approved by the Department, and agreement state, a licensing state or the NRC, except that the maximum interval between leak tests may not exceed 3 years.
(3) Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed 3 months or at alternative intervals approved by the Department, an agreement state, a licensing state or the NRC, except that the maximum interval between leak tests may not exceed 3 years.
(4) For each sealed source that is required to be tested for leakage or contamination, the sealed source is tested for leakage or contamination before further use at any time there is reason to suspect that the sealed source might have been damaged or might be leaking.
(5) Except for brachytherapy sources manufactured to contain radium, tests for leakage for sealed sources shall be capable of detecting the presence of 185 Bq (0.005 mCi) 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 a sealed source contained in a device, test samples are obtained when the source is in the ''off'' position.
(6) The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of 37 Bq (0.001 mCi) of radon-222 in a 24-hour period when the collection efficiency for radon-222 and its progeny has been determined with respect to collection method, volume and time.
(7) Tests for contamination from radium progeny shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 mCi) of any radium progeny which has a half-life greater than 4 days.
(b) A licensee need not perform tests for leakage or contamination on the following sealed sources:
(1) Sealed sources containing only radioactive material with a half-life of less than 30 days.
(2) Sealed sources containing only radioactive material as a gas.
(3) Sealed sources containing 3.7 MBq (100 mCi) or less of beta or photon-emitting material or 370 kBq (10 mCi) or less of alpha-emitting material.
(4) Sealed sources containing only hydrogen-3.
(5) Seeds of iridium-192 encased in nylon ribbon.
(6) Sealed sources, except teletherapy and brachytherapy sources, which are stored, are not being used, and are identified as in storage. The licensee shall, however, test each of these sealed sources for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within 6 months before the date of use or transfer. The maximum interval between tests for leakage or contamination may not exceed 3 years.
(c) Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the Department, an agreement state, a licensing state or the NRC to perform these services.
(d) Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the Department.
(e) The following shall be considered evidence that a sealed source is leaking:
(1) The presence of 185 Bq (0.005 mCi) or more of removable contamination on any test sample.
(2) Leakage of 37 Bq (0.001 mCi) of radon-222 per 24 hours for brachytherapy sources manufactured to contain radium.
(3) The presence of removable contamination resulting from the decay of 185 Bq (0.005 mCi) or more of radium.
(f) The licensee shall immediately withdraw a leaking sealed source from use and take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this article.
(g) Reports of test results for leaking or contaminated sealed sources shall be made under § 219.227 (relating to reports of leaking or contaminated sealed sources).
§ 219.131. Security of stored sources of radiation.
In addition to incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation), the licensee or registrant shall secure from unauthorized removal or access radiation sources that are in storage.
§ 219.132. Control of sources of radiation not in storage.
In addition to incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation), the licensee or registrant shall maintain control of radiation producing machines that are not in storage.
§ 219.159. Posting of radiation-producing machines.
The registrant or licensee shall ensure that each radiation producing machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized. For example:
''CAUTION--RADIATION
THIS EQUIPMENT PRODUCES RADIATION
WHEN ENERGIZED.''§ 219.160. Exceptions to posting requirements.
In addition to incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation), a room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.
§ 219.221. Reports of stolen, lost or missing licensed or registered sources of radiation.
In addition to incorporation by reference of the requirements in 10 CFR Part 20 (relating to standards for protection against radiation) covering the reporting requirements associated with reports of theft or loss of licensed material, the following reporting requirements apply to radiation producing machines:
(1) Telephone reports. Each licensee or registrant shall report to the Department by telephone immediately, after its occurrence becomes known, a stolen, lost or missing radiation producing machine.
(2) Written reports. Each licensee or registrant required to make a report under paragraph (1) shall, within 30 days after making the telephone report, make a written report to the Department setting forth the following information:
(i) A description of the licensed or registered source of radiation involved, including, for radiation producing machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted.
(ii) A description of the circumstances under which the loss or theft occurred.
(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved.
(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred and the possible total effective dose equivalent to persons in unrestricted areas.
(v) Actions that have been taken, or will be taken, to recover the source of radiation.
(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.
(3) Additional information. Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of the information.
(4) Detachable reports. The licensee or registrant shall prepare a report filed with the Department under this section so that the names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.
§ 219.222. Notification of incidents.
In addition to incorporation by reference of the requirements in 10 CFR Part 20 (relating to standards for protection against radiation), regarding notification of incidents, those notification requirements also apply to radiation producing machines and NARM.
§ 219.228. Reports of misadministrations from X-ray.
(a) For a misadministration from X-ray, the licensee or registrant shall do the following:
(1) Notify the Department by telephone no later than 24 hours after discovery of the misadministration.
(2) Submit a written report to the Department within 15 days after discovery of the misadministration. The written report shall include the licensee's or registrant's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee or registrant notified the patient, or the patient's responsible relative or guardian (for notification purposes under this section, this person will be included in subsequent references to ''the patient''), and if not, why not; and if the patient was notified, what information was provided to the patient. The report may not include the patient's name or other information that could lead to identification of the patient.
(3) Notify the referring physician and also notify the patient of the misadministration not later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee or registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the licensee or registrant shall notify the patient as soon as possible thereafter. The licensee or registrant may not delay appropriate medical care for the patient, including necessary remedial care as a result of the misadministration, because of delay in notification.
(4) If the patient was notified, the licensee or registrant shall also furnish, within 15 days after discovery of the misadministration, a written report to the patient by sending one of the following:
(i) A copy of the report that was submitted to the Department.
(ii) A brief description of both the event and the consequences, as they may affect the patient, if a statement is included that the report submitted to the Department can be obtained from the licensee or registrant.
(b) The licensee or registrant shall retain a record of each misadministration for 5 years. The record shall contain the names of the individuals involved (including the prescribing physician, allied health personnel, the patient and the patient's referring physician), the patient's Social Security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, this section does not affect rights or duties of licensees or registrants and physicians in relation to each other, patients or the patient's responsible relatives or guardians.
CHAPTER 220. NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS § 220.2. Posting of notices to workers.
(a) A licensee or registrant shall post current copies of the following documents:
(1) This chapter and Chapter 219 (relating to standards for protection against radiation).
(2) The license, certificate of registration, conditions or documents incorporated into the license by reference and amendments thereto.
(3) The operating procedures applicable to activities under the license or registration.
(4) A notice of violation involving radiological working conditions, proposed imposition of civil penalty or order issued under Chapter 215 (relating to general provisions) and response from the licensee or registrant.
(b) If posting of a document specified in subsection (a)(1), (2) or (3) is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.
(c) Department Form ER-BRP-3, ''Notice to Employees,'' shall be posted by a licensee or registrant as required by this article.
(d) Department documents posted under subsection (a)(4) shall be posted within [5] 2 working days after receipt of the documents from the Department; the licensee's or registrant's response shall be posted within 5 working days after dispatch from the licensee or registrant. The documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.
(e) Documents, notices or forms posted under this section shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from the particular work location to which the document applies. The documents, notices or forms shall be conspicuous and shall be replaced if defaced or altered.
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to delete the existing version of §§ 220.3--220.8 which appear at 25 Pa. Code pages 220-2--220-7, serial pages (249272), (203893)--(203897). The following text is new and has been printed in regular type to enhance readability.)
§ 220.9. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 19 (relating to notices, instructions and reports to workers; inspections and investigations) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 19.4 (relating to interpretations), 10 CFR 19.5 (relating to communications), 10 CFR 19.8 (relating to information collection requirements: OMB approval), 10 CFR 19.30 (relating to violations) and 10 CFR 19.40 (relating to criminal penalties) are not incorporated by reference.
§ 220.10. Effect of incorporation of 10 CFR Part 19.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 19 (relating to notices, instructions and reports to workers; inspections and investigations), the following words and phrases shall be substituted for the language in 10 CFR Part 19 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
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