[31 Pa.B. 5239]
[Continued from previous Web Page] § 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 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, 33.21 and 33.23 (relating to information collection requirements: OMB approval; violations; and 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) A reference to byproduct material includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 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 40.6, 40.8, 40.12(b), 40.23, 40.27, 40.28, 40.31(k) and (i), 40.32(d), (e) and (g), 40.38, 40.41(d), (e)(1) and (3) and (g), 40.51(b)(6), 40.64, 40.66, 40.67, 40.81 and 40.82 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) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
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 70.1(c), (d) and (e), 70.5, 70.6, 70.8, 70.13, 70.13a, 70.20a, 70.20b, 70.21(a)(1), (c), (f), (g) and (h), 70.22(b), (c), (f), (g), (h), (i), (j), (k), (l), (m) and (n), 70.23(a)(6), (7), (8), (9), (10), (11) and (12) and (b), 70.23a, 70.24, 70.25(a), 70.31(c), (d) and (e), 70.32(a)(1), (4), (5), (6) and (7) and (b)(1), (3) and (4) and (c), (d), (e), (f), (g), (h), (i), (j) and (k), 70.37, 70.40, 70.42(b)(6), 70.44, 70.51(c), (d) and (e), 70.52, 70.53, 70.54, 70.55(c)(1), (2) and (3), 70.56(c) and (d), 70.57, 70.58, 70.59, 70.62, 70.71 and 70.72 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) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
Subchapter I. TRANSFER OF RADIOACTIVE MATERIAL Sec.
217.191. Transfer of material. § 217.191. Transfer of material.
The requirements of 10 CFR 30.41 (relating to transfer of byproduct material) also apply to NARM.
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 150.1, 150.2, 150.3, 10 CFR 150.11 and 10 CFR 150.20(a)(1) (2) and (b) (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) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 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.
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS § 219.3. Definitions.
The following term, when used this subchapter, has the following meaning, unless the context clearly indicates otherwise:
Medical reportable event for radiation--producing machine therapy--The administration to a human being, except for an administration resulting from a direct intervention of a patient that could not have been reasonably prevented by the licensee or registrant, that results in one of the following:
(i) An administration of a therapeutic radiation dose to the wrong individual.
(ii) An administration of a dose for therapy when the result is an increase in the total expected doses inside or outside of the intended treatment volume for organs, tissue or skin that exceeds 20% of the total prescribed dose for the intended target volume.
(iii) A total dose delivered to the treatment site identified in a written directive for therapy that differs from the total prescribed dose by more than 20%, or for a fractionated dose, when the weekly administered dose differs from the weekly prescribed dose by more than 30%.
§ 219.4. (Reserved).
§ 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, 20.1006, 20.1009, 20.2206(a)(1), (3), (4) and (5), 20.2401 and 20.2402 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 10 CFR means the United States Department of Energy.
(7) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 219.7. Effect of incorporation of 10 CFR 20.1403 ''Criteria for license termination under restricted conditions.''
The Department will not terminate a license under the conditions of restricted release as provided for in 10 CFR 20.1403 (relating to criteria for license termination under restricted conditions) until a license termination plan (LTP), approved by the Department, has been in effect for a period of time sufficient to demonstrate to the Department that continued implementation of the plan will be effective in maintaining compliance with the required conditions of the plan. The Department may choose to implement the license termination process in one or more of the following steps:
(1) The license is amended to authorize activities necessary to begin decommissioning under the LTP.
(2) After decommissioning activities are complete and the provisions of 10 CFR 20.1403 are in effect under the LTP, the license may be amended to end authorization of licensed activities. The license shall remain in effect for up to 5 years being limited to ownership/possession of the decommissioned material.
(3) At the end of the period prescribed in paragraph (2), the Department will make a determination of the effectiveness of the LTP as enacted. If the LTP has demonstrated the ability to maintain compliance with 10 CFR 20.1403, the license will be terminated subject to the revisitation provision of 10 CFR 20.1401(c) (relating to general provision and scope) regarding new evidence of a significant threat to health and safety. Otherwise, the licensee will be directed by the Department to take corrective actions as necessary to conform to 10 CFR 20.1403 and the process shall revert back to paragraph (2).
§ 219.21. (Rserved).
§§ 219.31--219.38. (Reserved).
Subchapter D. RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC § 219.51. Dose limits for individual members of the public.
In addition to incorporation by reference of 10 CFR Part 20 Subpart D (relating to dose limits for individual members of the public), 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.
§ 219.52. (Reserved).
Subchapter E. TESTING FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES § 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 under §§ 217.81--217.93 (relating to specific license to manufacture, assemble, repair or distribute commodities, products or devices which contain radioactive material), an 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 under §§ 217.81--217.93, 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 µCi) 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 µCi) 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 µCi) 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 µCi) or less of beta or photon-emitting material or 370 kBq (10 µCi) 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 µCi) or more of removable contamination on any test sample.
(2) Leakage of 37 Bq (0.001 µCi) 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 µCi) 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).
§§ 219.71--219.73. (Reserved).
§§ 219.91--219.93. (Reserved).
§§ 219.111--219.113. (Reserved).
Subchapter I. STORAGE AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION § 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.
Subchapter J. PRECAUTIONARY PROCEDURES §§ 219.151--219.158. (Reserved).
§ 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.
§ 219.161. (Reserved).
§ 219.162. (Reserved).
§§ 219.181--219.186. (Reserved).
§§ 219.201--219.211. (Reserved).
Subchapter M. REPORTS § 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 and reportable events.
In addition to incorporation by reference of the requirements in 10 CFR 20.2202 and 20.2203 (relating to notification of incidents; and reports of exposures, radiation levels and concentrations of radioactive material exceeding the constraints or limits), those notification requirements, as well as written 30-day reports under 10 CFR 20.2203(a), also apply to radiation-producing machines and NARM.
§§ 219.223--219.226. (Reserved).
§ 219.228. Reports of medical reportable events for radiation-producing machine therapy.
(a) For a medical reportable event for radiation-producing machine therapy, the licensee or registrant shall do the following:
(1) Notify the Department by telephone within 24 hours after discovery of the event.
(2) Submit a written report to the Department within 15 days after discovery of the event. 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 event within 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 event, 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 medical reportable event for radiation-producing machine therapy 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 event, 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.
§ 219.229 Other medical reports.
Within 30 days of the discovery of either actual or suspected acute or long-term functional damage to tissue of a patient exposed to therapeutic or diagnostic radiation from a radiation-producing machine, the registrant or licensee shall document the finding and provide a report to the Department and provide a clinical summary to the prescribing physician and the patient. The report shall be retained for at least 5 years. Exempt from this reporting requirement are any events already reported under § 219.228 (relating to notification of incidents and reportable events) and any functional damage to patient tissue that was an expected outcome when the causative procedures were prescribed.
§ 219.241. (Reserved).
Appendix A (Reserved)
Appendix B (Reserved)
Appendix C (Reserved)
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 2 working days after receipt of the documents from the Department; the licensee's or registrant's response shall be posted within 2 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.
§§ 220.3--220.8. (Reserved).
§ 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, 19.5, 19.8, 19.30 and 19.40 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.
(3) A reference to ''license,'' ''licenses,'' ''licensed'' and ''licensed radioactive material'' also include ''registration,'' ''registrant'' ''registered,'' and ''registered source of radiation,'' respectively.
(4) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
CHAPTER 224. MEDICAL USE OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL §§ 224.2--224.9. (Reserved).
§ 224.10. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 35 (relating to medical use of byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 35.8, 35.990 and 35.991 (relating to information collection requirements: OMB approval; violations; and criminal penalties) are not incorporated by reference.
§ 224.11. Effect of incorporation of 10 CFR Part 35.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 35 (relating to medical use of byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 35 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 ''byproduct material'' includes NARM.
(4) The definition of ''sealed source'' includes NARM.
(5) A reference to the Advisory Committee on the Medical Uses of Isotopes is synonymous with the Department's Radiation Protection Advisory Committee.
(6) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
Subchapter B. OTHER REQUIREMENTS § 224.21. Supervision.
In addition to the incorporation by reference of 10 CFR Part 35 (relating to medical use of byproduct material), the licensee shall also:
(1) Permit only auxiliary personnel who have met the applicable radiologic requirements of 49 Pa. Code, Part I, Subpart A (relating to professional and occupational affairs) to use radioactive materials for diagnostic or therapeutic purposes.
(2) Permit only auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government to use radioactive materials for diagnostic or therapeutic purposes in accordance with written job descriptions and employee qualifications.
§ 224.22. Authorization for calibration and reference sources.
Notwithstanding the incorporation by reference of 10 CFR Part 35, a licensee authorized for medical use radioactive materials may receive, possess and use sealed sources of radioactive material up to 1,110 MBq (30 mCi) apiece for check, calibration and reference use.
§ 224.23. Decay-in-storage.
Notwithstanding the incorporation by reference of 10 CFR Part 35 (relating to medical use of byproduct material), a licensee may hold sealed sources of radioactive material with a physical half-life-of up to 300 days for decay-in-storage before disposal in ordinary trash.
§§ 224.51--224.60. (Reserved).
§§ 224.101--224.112. (Reserved).
§ 224.151. (Reserved).
§ 224.152. (Reserved).
§§ 224.201--224.204. (Reserved).
§§ 224.251--224.254. (Reserved).
§§ 224.301--224.306. (Reserved).
§ 224.351. (Reserved).
§ 224.352. (Reserved).
§§ 224.401--224.414. (Reserved).
§§ 224.451--224.465. (Reserved).
§ 224.501. (Reserved).
CHAPTER 225. RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES AND RADIOGRAPHIC OPERATIONS
Subchapter A. GENERAL PROVISIONS Sec.
225.1. Purpose and scope. 225.2. (Reserved). 225.2a. Incorporation by reference. 225.3a. Effect of incorporation of 10 CFR Part 34. 225.4a. Radiation safety program. 225.5a. Reciprocity. 225.6a. Prohibitions. 225.11--225.18. (Reserved). 225.21--225.23. (Reserved). 225.31--225.33. (Reserved). 225.41--225.44. (Reserved). 225.51--225.53. (Reserved). § 225.1. Purpose and scope.
(a) This chapter establishes radiation safety requirements for persons utilizing radiation sources for industrial radiography. Licensees and registrants who use radiation sources for industrial radiography shall comply with this chapter. The requirements of this chapter are in addition to and not in substitution for other applicable requirements in this article, in particular, the requirements and provisions of Chapters 215, 217--220, 228 and 230.
(b) Persons using only radiation-producing machines for industrial radiographic operations need not comply with § 225.2a (relating to incorporation by reference) unless otherwise specified in Subchapter B (relating to radiation producing machines).
(c) This chapter does not apply to the use of radiation sources for medical diagnosis or therapy.
§ 225.2. (Reserved).
§ 225.2a. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 34 (relating to licenses for industrial radiography and radiation safety requirements for industrial radiographic operations) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 34.5, 34.8, 34.121 and 34.123 are not incorporated by reference.
§ 225.3a. Effect of incorporation of 10 CFR Part 34.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 34, the following words and phrases shall be substituted for the language in 10 CFR Part 34 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) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 225.4a. Radiation safety program.
A person who intends to use radiation-producing machines for industrial radiography shall have a program for training personnel, written operating procedures and emergency procedures, an internal review system and an organizational structure for radiographic operations which includes specified delegations of authority and responsibility for operation of the program. This program shall be approved by the Department before commencing industrial radiographic operations.
§ 225.5a. Reciprocity.
Out-of-State users of radiation producing machines shall meet the requirements of § 216.7 (relating to out-of-State radiation-producing machines).
§ 225.6a. Prohibitions.
Use of radiation sources covered under this chapter for diagnosis or therapy on humans or animals is not permitted.
§§ 225.11--225.18. (Reserved).
§§ 225.21--224.23. (Reserved).
§§ 225.31--225.33. (Reserved).
§§ 225.41--224.44. (Reserved).
§§ 225.51--225.53. (Reserved).
Subchapter B. RADIATION-PRODUCING MACHINES GENERAL ADMINISTRATIVE REQUIREMENTS
Sec.
225.71. Definitions. 225.72. Duties of personnel. 225.73. Training of personnel. 225.74. Training and testing. 225.75. Audits and safety reviews of radiographers and radiographer's assistants. 225.76. Reporting requirements. GENERAL TECHNICAL REQUIREMENTS
225.81. Permanent radiographic installations. 225.82. Operating requirements. 225.83. Records required at temporary job sites. 225.84. Operating and emergency procedures. 225.85. Surveys and survey records. 225.86. Utilization logs. 225.87. Security. 225.88. Posting. RADIATION SURVEY INSTRUMENT AND PERSONNEL MONITORING REQUIREMENTS
225.91. Radiation survey meter requirements. 225.92. Radiation survey meter calibration requirements. 225.93. Personnel monitoring control. RADIATION-PRODUCING MACHINE REQUIREMENTS
225.101. Cabinet X-ray systems and baggage/package X-ray systems. 225.102. Shielded room X-ray radiography. 225.103. Temporary job site radiography. 225.104. X-ray detection systems for explosives, weapons and illegal items.
GENERAL ADMINISTRATIVE REQUIREMENTS § 225.71. Definitions.
The following words and terms, when used this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Cabinet radiography--Industrial radiography conducted in an enclosure or cabinet (not a room) so shielded that doses to individual members of the public at every location on the exterior meet the limitations specified in 10 CFR 20.1301 (relating to dose limits for individual members of the public).
Cabinet X-ray system--An X-ray system with the X-ray tube installed in an interlocked enclosure or cabinet, designed to exclude personnel from its interior during operation.
(i) Included are all X-ray systems designed primarily for the inspection of baggage or packages.
(ii) An X-ray tube used within a shielded part of a building or X-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet X-ray system.
Certified cabinet X-ray system--An X-ray system which has been certified under 21 CFR 1010.2 (relating to certification) as being manufactured and assembled under 21 CFR 1020.40 (relating to cabinet x-ray systems).
DRD--Direct reading dosimeter--
(i) As used in this subchapter, means an ''individual monitoring device'' (see 10 CFR 20.1003 (relating to definitions)) that does not require additional processing to measure an individual's dose.
(ii) The term also includes the direct reading personnel (individual) monitoring devices known as pocket dosimeter, pocket ionization chamber and electronic personal dosimeter (EPD).
Industrial radiography--An examination of the structure of materials by nondestructive methods, including fluoroscopy, which utilizes radiation producing machines to make radiographic images.
NVLAP--National Voluntary Laboratory Accreditation Program.
Permanent radiographic installation--A shielded installation or structure designed or intended for radiography in which radiography is regularly performed.
Personal supervision--The provision of guidance and instruction to a radiographer's assistant given by a radiographer who is:
(i) Physically present at the site.
(ii) In visual contact with the radiographer's assistant while the assistant is using radiation sources.
(iii) In proximity so that immediate assistance can be given if required.
Personnel dosimeter--As used in this subchapter, means any of the ''individual monitoring devices'' (see 10 CFR 20.1003) that shall be processed and evaluated to generate a permanent record of an individual's dose, for example, a film badge, thermoluminescent dosimeter (TLD) or optically stimulated luminescent dosimeter (OSLD).
RSO--radiation safety officer--An individual who ensures that, in the daily operation of the registrant's or licensee's radiation safety program, activities are being performed in accordance with approved procedures and are in compliance with Department requirements.
Radiographer--An individual who performs radiographic operations or an individual in attendance at a site where radiation producing machines are being used who personally supervises industrial radiographic operations.
Radiographer's assistant--An individual who, under the personal supervision of a radiographer, uses radiation producing machines or radiation survey instrumentation.
Radiographer trainee--An individual who is in the process of becoming a radiographer's assistant or a radiographer.
Radiographic operations--The activities associated with a radiation producing machine during use of the machine, to include surveys to confirm adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.
Shielded room radiography--Industrial radiography that is conducted in an enclosed room, the interior of which is not occupied during radiographic operations.
Temporary job site--A location where industrial radiography is performed for 180 days or less during any consecutive 12 months other than the location listed in a registration.
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