[28 Pa.B. 881]
[Continued from previous Web Page] (1) Based of alpha disintegration rate of TH-232, TH-230 and their daughter products.
(2) Based of alpha disintegration rate of U-233, U-234 and U-235.
Note---For purposes of § 217.58(a) (relating to financial assurance arrangements for reclaiming sites), where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of the ratios for all the isotopes in the combination equals ''R.''
APPENDIX F
CRITERIA RELATING TO USE OF FINANCIAL TESTS AND SELF GUARANTEES OF PROVIDING REASONABLE ASSURANCE OF FUNDS FOR DECOMMISSIONING I. Introduction.
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this Appendix,. The terms of the self-guarantee are in Section III of this Appendix. This Appendix establishes criteria for passing the financial test for the self guarantee and establishes the terms for a self-guarantee.
II. Financial Test.
A. To pass the financial test, a company must meet all of the following criteria:
1. Tangible net worth at least 10 times the total current decommissioning cost estimate (or the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.
2. Assets located in the United States amounting to at least 90% of total assets or least 10 times the total current decommissioning cost estimate (for the current amount required if certification is used) for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.
3. A current rating for its most recent bond issuance of AAA, AA or A as issued by Standard and Poors (S&P), or AAA, AA or A as issued by Moody's.
B. To pass the financial test, a company must meet all of the following additional requirements:
(1) The company must have at least one class of equity securities registered under the Securities Exchange Act of 1934.
(2) The company's independent certified public accountant must have compared the data used by the company in the financial test which is derived from the independently audited, yearend financial statements for the latest fiscal year, with the amounts in the financial statement, in connection with that procedure. The licensee shall inform the Department within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
(3) After the initial financial test, the company must repeat passage of the test within 90 days after the close of each succeeding fiscal year.
c. If the licensee no longer meets the requirements of Section II, A, of this Appendix, the licensee shall send immediate notice to the Department of its intent to establish alternate financial assurance as specified in the Department's regulations within 120 days of such notice.
III. Company Self-Guarantee.
The terms of a self-guarantee which an applicant or licensee furnishes shall provide that:
a. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by the Department, as evidenced by return receipt.
b. The licensee shall provide alternative financial assurance as specified in the Department's regulations within 90 days following receipt by the Department of a notice of cancellation of the guarantee.
c. The guarantee and financial test provisions shall remain in effect until the Department has terminated the license or until another financial as assurance method acceptable to the Department has been put in effect by the licensee.
D. The licensee will promptly forward to the Department and the licensee's independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission under the requirement of section 13 of the Securities and Exchange Act of 1934.
E. If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of ''A'' or above by either Standard and Poors or Moodys, the licensee will provided notice in writing of that fact to the Department with 20 days after publication of the change by the rating services. If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poors and Moody's the licensee no longer meets the requirements of Section II, A, of this Appendix.
F. The applicant or licensee must provide to the Department a written guarantee (a written commitment by a corporate officer) which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will set up and fund a trust in the amount of the current cost estimates for decommissioning.
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS § 219.3. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
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Constraint (dose constraint)--A value above which specified licensee actions are required.
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Subchapter B. RADIATION PROTECTION PROGRAMS § 219.21. Radiation protection programs.
(a) The licensee or registrant shall develop, document and implement a radiation protection program commensurate with the scope and extent of the licensee's or registrant's activities and sufficient to ensure compliance with this chapter.
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(f) To implement the ALARA requirements of subsection (b) and notwithstanding the requirements in § 219.51 (relating to dose limits for individual members of the public), a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees so that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedence as provided in § 219.223 (relating to reports of exposures, radiation levels and concentrations of radioactive material exceeding the limits) and promptly take appropriate corrective action to ensure against recurrence.
Subchapter D. RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC § 219.51. Dose limits for individual members of the public.
(a) The licensee or registrant shall conduct operations so that the following conditions are met:
(1) [Except as provided in paragraph (2), the] The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of the dose [contribution] contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with § 224.109 (relating to release of patients containing radiopharmaceuticals or permanent implants), from voluntary participation in medical research programs and from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with § 219.183 (relating to disposal by release into sanitary sewerage).
[(2) The total effective dose equivalent to individual members of the public in unrestricted areas from exposure to radiation from diagnostic radiation machines does not exceed 5 mSv (0.5 rem).]
[(3)] (2) The dose in any unrestricted area from external sources exclusive of the dose contributions from patients administered radioactive material and released in accordance with § 224.109, (relating to release of patients containing radiopharmaceuticals or permanent implants) does not exceed 0.02 mSv (0.002 rem) in any 1 hour, if an individual were continuously present in the area.
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Subchapter H. RESPIRATORY PROTECTION AND CONTROLS TO RESTRICT INTERNAL EXPOSURE IN RESTRICTED AREAS § 219.114. Further restrictions on the use of respiratory protection equipment.
The Department may impose restrictions in addition to those in §§ 219.112 and 219.113 (relating to use of other controls; and use of individual respiratory equipment) and Appendix A to:
(1) Ensure the respiratory protection program of the licensee is adequate to limit exposures of individuals to airborne radioactive material.
(2) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.
Subchapter M. REPORTS § 219.223. Reports of exposures, radiation levels and concentrations of radioactive material exceeding the limits.
(a) Reportable events. In addition to the notification required by § 219.222 (relating to notification of incidents), each licensee or registrant shall submit a written report within 30 days after learning of one or more of the following occurrences:
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(2) Doses in excess of one or more of the following:
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(vi) The ALARA constraints for air emissions established under § 219.21(f) (relating to radiation protection programs).
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(b) Contents of reports.
(1) Each report required by subsection (a) shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
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(iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.
CHAPTER 220. NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS § 220.2. Posting of notices to workers.
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(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.
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§ 220.3. Instructions to workers.
(a) An individual [working in or frequenting a portion of a restricted area] who is likely to receive in a year an occupational dose in excess of 100 mrem(1 mSv) shall be:
(1) Informed of the storage, transfer or use of radiation sources [in the portion of the restricted area].
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(b) The extent of the instruction shall be commensurate with potential radiological health protection problems in the [restricted area] work place.
§ 220.8. Inspections not warranted; informal review.
(a) If the Bureau of Radiation Protection determines that an inspection is not warranted for a complaint made under § 220.7 (relating to requests by workers for inspections) because there are no reasonable grounds to believe that a violation exists or has occurred, the Bureau of Radiation Protection will notify the complainant in writing of the determination. The complainant may obtain review of the determination by submitting a written statement of position to the Office of the Secretary, Department of Environmental [Resources] Protection. The Department will provide the licensee or registrant with a copy of the statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the Department which will provide the complainant with a copy of the statement by certified mail.
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CHAPTER 224. MEDICAL USE OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 224.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
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Authorized nuclear pharmacist--A pharmacist who meets one of the following requirements:
(i) Is board certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties.
(ii) Is identified as an authorized nuclear pharmacist on a Department, NRC or agreement state license that authorizes the use of radioactive material in the practice of nuclear pharmacy.
(iii) Is identified as an authorized nuclear pharmacist on a permit issued by the Department, NRC or agreement state specific license of broad scope that is authorized to permit the use of radioactive material in the practice of nuclear pharmacy.
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Diagnostic clinical procedures manual--A collection of written procedures that describes each method--and other instructions and precautions--by which the licensee performs clinical diagnostic procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical dosage and route of administration.
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Medical use--In the practice of medicine, the intentional administration (external or internal) of radioactive material, or the radiation therefrom, to human beings or human research subjects under the supervision of an authorized user.
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Misadministration--The administration of one of the following:
[(i) A radiopharmaceutical or radiation from a radiation source other than the one intended or prescribed.
(ii) A radiopharmaceutical or radiation therapy to a wrong patient.
(iii) A radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician or radiation therapy to an organ other than that prescribed by the physician.
(iv) A diagnostic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 50%.
(v) A therapy dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10%.
(vi) A therapy radiation dose from a radiation source such that errors in the source calibration, time of exposure and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10%.
(vii) Radioactive material not specifically authorized for human use, or medical irradiation by sources whose characteristics do not meet established criteria for that type of radiation source.]
(i) A radiopharmaceutical dosage greater than 30 µCi (1.11 MBq) of either sodium iodide I-125 or I-131 under one of the following conditions:
(A) Involving the wrong individual or wrong pharmaceutical.
(B) When both the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage and the difference between the administered and prescribed dosage exceeds 30 µCi (1.11 MBq).
(ii) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131 under one of the following conditions:
(A) Involving the wrong individual, wrong radiopharmaceutical or wrong route of administration.
(B) When the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage.
(iii) A gamma stereotactic radiosurgery radiation dose under one of the following conditions:
(A) Involving the wrong individual or wrong treatment site.
(B) When the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(iv) A teletherapy radiation dose under one of the following conditions:
(A) Involving the wrong individual, wrong mode of treatment or wrong treatment site.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.
(v) A brachytherapy radiation dose under one of the following conditions:
(A) Involving the wrong individual, wrong radioisotope, or wrong treatment site excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).
(B) Involving a sealed source that is leaking.
(C) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure.
(D) When the calculated administered dose differs from the prescribed dose by more than 20% of the prescribed dose.
(vi) A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 uCi (1.11 MBq) of either sodium iodide I-125 or I-131, when the conditions in clauses (A) and (B) apply:
(A) Involving the wrong individual, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage differs from the prescribed dosage.
(B) When the dose to the individual exceeds 5 rem (50 mSv) effective dose equivalent or 50 rems (0.5 Sv) dose equivalent to any individual organ.
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Prescribed dosage--The quantity of radiopharmaceutical activity as documented in one of the following methods:
(i) In a written directive.
(ii) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
Prescribed dose--One of the following:
(i) For gamma stereotactic radiosurgery, the total dose as documented in the written directive.
(ii) For teletherapy, the total dose and dose per fraction as documented in the written directive.
(iii) For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.
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Recordable event--The administration of:
(i) A radiopharmaceutical or radiation without a written directive when a written directive is required.
(ii) A radiopharmaceutical or radiation when a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation in the appropriate record.
(iii) A radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I-125 or I-131 when both:
(A) The administered dosage differs from the prescribed dosage by more than 10% of the prescribed dosage.
(B) The difference between the administered dosage and prescribed dosage exceeds 15 microcuries.
(iv) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than 10% of the prescribed dosage.
(v) A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15% or more of the weekly prescribed dose.
(vi) A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10% of the prescribed dose.
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Written directive--An order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in subparagraph (vi), containing the following information:
(i) For any administration of quantities greater than 30 µCi (1.11 MBq) of either sodium iodide I-125 or I-131 the dosage.
(ii) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage and route of administration.
(iii) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern and total dose.
(iv) For teletherapy: the total dose, dose per fraction, treatment site and overall treatment period.
(v) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site and total dose.
(vi) For all other brachytherapy the following apply:
(A) Prior to implantation: the radioisotope, number of sources and source strengths.
(B) After implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
§ 224.6. License amendments.
(a) A licensee shall apply for and receive a license amendment before it:
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(2) Permits anyone, except a visiting authorized user described in § 224.56 (relating to visiting authorized user), to work as an authorized user or authorized nuclear pharmacist under the license.
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(b) A licensee possessing a Type A specific license of broad scope for medical use is exempt from the following:
(1) Subsection (a)(2).
(2) Subsection (a)(5) regarding additions to or changes in the areas of use only at the addresses specified in the license.
§ 224.7. Notifications.
A licensee shall notify the Department by letter within 30 days when an authorized user, radiation safety officer or teletherapy physicist or authorized nuclear pharmacist permanently discontinues performance of duties under the license or has a name change, or when the licensee's mailing address changes. The licensee shall mail the report to the appropriate address identified in § 224.5(c) (relating to application for license, amendment or renewal).
§ 224.9. Specific exemptions.
The Department may, upon application of an interested person or upon its own initiative, grant exemptions from this article as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. The Department will review requests for exemptions from training and experience requirements with the assistance of its Radiation Protection Advisory Committee [on the Medical Uses of Radioactive Material].
§ 224.10. Provisions for research involving human subjects.
A licensee may conduct research involving human subjects using radioactive material if the research is conducted, funded, supported or regulated by a Federal agency which has implemented the Federal policy for the protection of human subjects. Otherwise, a licensee shall apply for and receive approval of a specific amendment to its license before conducting the research. Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an ''institutional review board'' in accordance with the meaning of these terms as defined in the Federal policy for the protection of human subjects.
§ 224.11. FDA, other Federal and State requirements.
This chapter does not relieve the licensee from complying with applicable FDA, other Federal and State requirements governing radioactive drugs or devices, and 49 Pa. Code Chapter 27 (relating to State Board of Pharmacy).
Subchapter B. GENERAL ADMINISTRATIVE REQUIREMENTS § 224.53. Radiation safety committee.
A medical institution licensee shall establish a radiation safety committee (committee) to oversee the use of radioactive material.
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(2) To oversee the use of licensed material, the committee shall:
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(ii) Review, on the basis of safety and with regard to the training and experience standards in Subchapter J (relating to training and experience requirements), and approve or disapprove an individual who is to be listed as an authorized user, the radiation safety officer, an authorized nuclear pharmacist or a teletherapy physicist before submitting a license application or request for amendment or renewal.
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§ 224.55. Supervision.
(a) A licensee that permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by § 224.4(b) (relating to license required) shall:
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(4) Permit only auxiliary personnel who have met the applicable requirements of 49 Pa. Code, Part I, Subpart A (relating to professional and occupational affairs) to use radioactive materials for diagnostic or therapeutic purposes.
(5) 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 employe qualifications.
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§ 224.60. Suppliers for sealed sources or devices for medical use.
A licensee may use the following for medical use only:
(1) [Radioactive material manufactured, labeled, packaged and distributed in accordance with a license issued under Chapter 217 (relating to licensing of radioactive material) or the equivalent regulations of an agreement state or the NRC.] Sealed sources or devices manufactured, labeled, packaged and distributed in accordance with a license issued under Chapter 217 (relating to licensing of radioactive material), the equivalent regulations of an agreement state or the NRC.
[(2) Reagent kits that have been manufactured, labeled, packaged and distributed in accordance with an approval by the Department under § 217.91 (relating to manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals), an agreement state or the NRC, under equivalent regulations for the preparation of radiopharmaceuticals for medical use.]
[(3)] (2) * * *
§ 224.61. Quality management program.
(a) An applicant or licensee under this chapter, as applicable, shall establish and maintain a written quality management program to provide high confidence that radioactive material or radiation from radioactive material will be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:
(1) Except as provided in subsections (h)--(j) that, prior to administration, a written directive is prepared for:
(i) Any teletherapy radiation dose.
(ii) Any gamma sterotactic radiosurgery dose.
(iii) Any brachytherapy radiation dose.
(iv) Any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131.
(v) Any therapeutic administration of radiopharmaceutical other than sodium iodide I-125 or I-131.
(2) That, prior to each administration the patient's identity is verified by more than one method as the individual named in the written directive.
(3) That final plans of treatment and related calculations for brachytherapy, teletherapy and gamma stereotactic radiosurgery are in accordance with the respective written directives.
(4) That each administration is in accordance with the written directive.
(5) That an unintended deviation from the written directive is identified and evaluated and appropriate action is taken.
(b) The licensee shall:
(1) Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of the following:
(i) A representative sample of patient administrations.
(ii) All recordable events.
(iii) All misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months.
(2) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of subsection (a).
(3) Retain records of each review, including the evaluations and findings of the review, in an auditable form for 3 years.
(c) The licensee shall evaluate and respond within 30 days after discovery of the recordable event, to each recordable event by:
(1) Assembling the relevant facts including the cause.
(2) Identifying what, if any, corrective action is required to prevent further recurrence.
(3) Retaining a record, in an auditable form for 3 years of the relevant facts and the corrective action taken if any was taken.
(d) The licensee shall retain:
(1) Each written directive.
(2) A record of each administered radiation dose or radiopharmaceutical dosage when a written directive is required in subsection (a)(1), in an auditable form, for 3 years after the date of administration.
(e) The licensee may make modifications to the quality management program to increase the program's efficiency so long as the program's effectiveness is not decreased. The licensee shall furnish the modification to the appropriate regional office within 30 days after the modification has been made.
(f) An applicant for a new license as applicable shall submit to the Department a quality management program as part of the application for a license and implement the program upon issuance of the license.
(g) An existing licensee shall submit to the Department a written certification that the quality management program has been implemented along with a copy of the program.
(h) If, because of the patient's condition, a delay in order to provide a written revision to an existing written direction would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, so long as the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
(i) A written revision to an existing written directive may be made for any diagnostic or therapeutic procedure so long as the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next teletherapy fractional dose.
(j) If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, so long as the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours of the oral directive.
Subchapter C. GENERAL TECHNICAL REQUIREMENTS
§ 224.101. Possession, use, calibration and check of dose calibrators.
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(b) A licensee shall:
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(3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the highest dosage that will be administered to a patient and [10] 30 microcuries ([370 kBq] 1.1 MBq).
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§ 224.103. Measurement of radiopharmaceutical dosages.
A licensee shall do the following:
(1) Measure the activity of each radiopharmaceutical [dosage that contains more than 10 microcuries (370 kBq)] of a photon-emitting radionuclide before medical use.
[(2) Measure the activity of each radiopharmaceutical dosage with a desired activity of 10 microcuries (370 kBq) or less of a photon-emitting radionuclide before medical use to verify that the dosage does not exceed 10 microcuries (370 kBq).] Measure by direct measurement or by combination of measurements and calculations, the activity of each dosage of an alpha- or beta-emitting radionuclide prior to medical use except for unit dosages obtained from a manufacturer or preparer licensed under § 217.90 (relating to manufacture and distribution of radiopharmaceuticals for medical use under group licenses) or equivalent agreement state requirements.
(3) Retain a record of the measurements required by this section for 3 years. To satisfy this requirement, the record shall contain the following:
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(iii) The prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than [10] 30 microcuries [(370 kBq)] (1.1 MBq).
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§ 224.104. Authorization for calibration and reference sources.
A person authorized by § 224.4 (relating to license required) for medical use of radioactive material may receive, possess and use the following radioactive material for check, calibration and reference use:
(1) Sealed sources manufactured and distributed by a person licensed under § 217.92 (relating to manufacture and distribution of sources or devices containing radioactive material for medical use), the NRC or equivalent agreement state regulations and that do not exceed 15 millicuries (555 mBq) each of byproduct material or 25 millicuries each of accelerator produced material.
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§ 224.105. Requirements for possession of sealed sources and brachytherapy sources.
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(f) A licensee is not required to perform a leakage test on the following sources:
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(4) Sources stored and not being used. The licensee shall, however, test these sources for leakage before the use or transfer unless it has been leakage-[treated] tested within 6 months before the date of use or transfer.
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§ 224.108. Surveys for contamination and ambient radiation exposure rate.
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(e) A licensee shall survey for removable contamination [each day of use the areas] once each week where radiopharmaceuticals are routinely prepared for use or administered and each week where radioactive materials are stored.
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§ 224.109. Release of patients containing radiopharmaceuticals or permanent implants.
(a) [A licensee may not authorize release from confinement for medical care a patient administered a radiopharmaceutical until one of the following conditions have been met:
(1) The measured dose rate from the patient is less than 5 millirem (50 µSv) per hour at a distance of 1 meter.
(2) The activity in the patient is less than 30 millicuries (1.11 GBq)]. The licensee may authorize the release from its control of an individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to another individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).
(b) [A licensee may not authorize release from confinement for medical care of a patient administered a permanent implant until the measured dose rate from the patient is less than 5 millirems (50 µSv) per hour at a distance of 1 meter.] The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals ALARA if the total effective dose equivalent to another individual is likely to exceed 1 mSv (0.1 rem). If the dose to a breastfeeding infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast feeding, the instructions shall also include both of the following:
(1) Guidance on the interruption or discontinuation of breast feeding.
(2) Information on the consequences of failure to follow guidance.
(c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated by any one of the following:
(1) Using the retained activity, rather than the activity administered.
(2) Using an occupancy factor less than 0.25 at 1 meter.
(3) Using the biological or effective half-life.
(4) Considering the shielding by tissue.
(d) The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breastfeeding woman if the radiation dose to the infant or child from continued breastfeeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).
§ 224.112. Decay-in-storage.
(a) A licensee may hold sealed sources of accelerator produced radioactive material with a physical half-life of up to 300 days and any radioactive material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of § 219.181 (relating to general requirements) if it:
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§ 224.113. Possession, use, calibration and check of instruments to measure dosages of alpha- or beta-emitting radionuclides.
(a) This section does not apply to unit dosages of alpha- or beta-emitting radionuclides that are obtained from a manufacturer or preparer licensed under § 217.90 (relating to manufacture and distribution of radiopharmaceuticals for medical use under group licenses) or equivalent.
(b) For other than unit dosages obtained to subsection (a), a licensee shall possess and use instrumentation to measure the radioactivity of alpha- or beta-emitting radionuclides. The licensee shall have procedures for use of the instrumentation. The licensee shall measure by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha- or beta-emitting radionuclides prior to administration to each patient or human research subject. In addition, the licensee shall do both of the following:
(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary.
(2) Check each instrument for constancy and proper operation at the beginning of each day of use.
Subchapter D. UPTAKE, DILUTION AND EXCRETION § 224.151. Use of radiopharmaceuticals for uptake dilution and excretion studies.
A licensee may use radioactive material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution or excretion [for which the FDA has accepted ''Notice of Claimed Investigational Exemption for a New Drug'' (IND) or approved a ''New Drug Application'' (NDA)] that is either:
(1) Obtained from a manufacturer or preparer licensed under § 217.90 (relating to manufacture and distribution of radiopharmaceuticals for medical use under group licenses) or equivalent NRC or agreement state requirements.
(2) Prepared by an authorized nuclear pharmacist, who meets the training criteria specified in § 224.466 (relating to training for an authorized nuclear pharmacist) or § 224.467 (relating to training for experienced nuclear pharmacists), a physician who is an authorized user and who meets the requirements specified in § 224.453 (relating to training for uptake, dilution and excretion studies) or an individual under the supervision of either specified in § 224.55 (relating to supervision).
§ 224.152. Possession of survey instrument.
A licensee authorized to use radioactive material for uptake, dilution and excretion studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem (1 µSv) per hour to [50] 100 millirem ([0.5] 1.0 mSv) per hour.
Subchapter E. IMAGING AND LOCALIZATION § 224.201. Use of radiopharmaceuticals[, generators and reagent kits] for imaging and localization studies.
[(a)] A licensee may use for imaging and localization studies any unsealed radioactive material [in a diagnostic radiopharmaceutical or a generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material provided for which the FDA has accepted a ''Notice of Claimed Investigational Exemption for a New Drug'' or approved a ''New Drug Application''] prepared for medical use that is either:
[(b) A licensee shall elute generators and prepare reagent kits in accordance with the manufacturer's instructions.]
(1) Obtained from a manufacturer or preparer licensed under § 217.91 (relating to manufacture and distribution of generator or reagent kits) or equivalent NRC or agreement requirements.
(2) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in § 224.454 (relating to training for imaging and localization studies) or an individual under the supervision of either specified in § 224.55 (relating to supervision).
§ 224.204. Possession of survey instruments.
A licensee authorized to use radioactive material for imaging and localization studies shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range of 0.1 millirem (1 µSv) per hour to [50] 100 millirem ([0.5] 1.0 mSv) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem (10 µSv) per hour to 1000 millirem (10 mSv) per hour.
Subchapter F. RADIOPHARMACEUTICALS FOR THERAPY § 224.251. Use of radiopharmaceuticals for therapy.
A licensee may use [a radioactive material in a radiopharmaceutical and for a therapeutic use for which the FDA has accepted a ''Notice of Claimed Investigational Exemption for a New Drug'' (IND), or approved a ''New Drug Application'' (NDA). The licensee shall comply with the package insert instructions regarding indications and method of administration.] for therapeutic administration any unsealed radioactive material prepared for medical use that is:
(1) Obtained from a manufacturer or preparer licensed under § 217.92 (relating to manufacture and distribution of sources or devices for medical use) or equivalent NRC or agreement state requirements.
(2) Prepared by an authorized nuclear pharmacist, who meets the training criteria specified in § 224.466 (relating to training for an authorized nuclear pharmacist) or § 224.467 (relating to training for experienced nuclear pharmacists), a physician who is an authorized user and who meets the requirements specified in § 224.454 (relating to training for imaging and localization studies) or an individual under the supervision of either specified in § 224.55 (relating to supervision).
§ 224.252. Safety instruction.
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(1) Patient or human research subject control.
§ 224.253. Safety precautions.
(a) For each patient receiving radiopharmaceutical therapy and hospitalized in compliance with § 224.109 (relating to release of patients containing radiopharmaceuticals or permanent implants), a licensee shall:
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[(6) Provide the patient with radiation safety guidance that will help to keep radiation dose to household members and the public ALARA before authorizing release of the patient.]
[(7)] (6) * * *
[(8)] (7) * * *
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Subchapter G. SOURCES FOR BRACHYTHERAPY § 224.305. Safety precautions.
(a) For each patient or human research subject receiving implant therapy, a licensee shall comply with the following conditions:
(1) The patient may not be quartered in the same room with a patient who is not receiving radiation therapy [unless the licensee can demonstrate compliance with § 219.51 (relating to dose limits for individual members of the public) at a distance of 1 meter from the implant].
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[(5) The patient shall be provided with radiation safety guidance that will help to keep radiation dose to household members and the public ALARA before releasing the patient if the patient was administered a permanent implant.]
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[(c) Nonoccupationally exposed individuals having incidental contact with patients having implanted or applied sealed sources--for example, visitors nurses and other patients--may not receive doses in excess of doses specified in 219.51 (relating to dose limits for individual members of the public) as a result of their contact with the patients.]
§ 224.306. Possession of survey instrument.
A licensee authorized to use radioactive material for implant therapy shall have in its possession a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem (1 µSv) per hour to [50] 100 millirem ([0.5] 1.0 mSv) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem (10 µSv) per hour to 1000 millirem (10 mSv) per hour.
Subchapter H. SEALED SOURCES FOR DIAGNOSIS § 224.352. Availability of survey instrument.
A licensee authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem (1 µSv) per hour to [50] 100 millirem ([0.5] 1.0 mSv) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem (10 µSv) per hour to 1000 millirem (10 mSv) per hour. The instrument shall have been calibrated in accordance with § 224.102 (relating to calibration and check of survey instruments).
Subchapter I. TELETHERAPY § 224.406. Possession of survey instrument.
A licensee authorized to use radioactive material in a teletherapy unit shall have in its possession a portable radiation detection survey instrument capable of detecting a dose rate over the range of 0.1 millirem (1 µSv) per hour to [50] 100 millirem ([0.5] 1.0 mSv) per hour or a portable radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem (10 µSv) per hour to 1000 millirem (10 mSv) per hour.
§ 224.408. Full calibration measurements.
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(b) To satisfy the requirement of subsection (a), full calibration measurements shall include determination of the following:
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(6) The accuracy of all distance measuring and localization devices in medical use.
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Subchapter J. TRAINING AND EXPERIENCE REQUIREMENTS § 224.451. Radiation safety officer.
Except as provided in § 224.452 (relating to training for experienced radiation safety officer), the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer as provided in § 224.54 (relating to statements of authority and responsibilities) to be an individual who meets one of the following requirements:
(1) Is certified by one of the following:
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(vi) The American Board of Medical Physics.
(vii) The Royal College of Physicians and Surgeons of Canada in Nuclear Medicine.
(viii) The American Osteopathic Board of Radiology.
(ix) The American Osteopathic Board of Nuclear Medicine.
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§ 224.453. Training for uptake, dilution and excretion studies.
Except as in § 224.463 or § 224.464 (relating to training for experienced authorized users; and physician training in a 3-month program), the licensee shall require the authorized user of a radiopharmaceutical in § 224.151 (relating to use of radiopharmaceuticals for uptake, dilution and excretion studies) to be a physician who meets one of the following requirements:
(1) Is certified in one of the following:
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(iii) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology.
(iv) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
(v) American Osteopathic Board of Nuclear Medicine in nuclear medicine.
§ 224.454. Training for imaging and localization studies.
Except as provided in §§ 224.463 and 224.464 (relating to training for experienced authorized users; and physician training in a 3-month program), the licensee shall require the authorized user of a radiopharmaceutical, generator or reagent kit in § 224.201(a) (relating to use of radiopharmaceuticals, generators and reagent kits for imaging and localization studies) to be a physician who meets one of the following requirements:
(1) Is certified in one of the following:
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(iii) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology.
(iv) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
(v) American Osteopathic Board of Nuclear Medicine in nuclear medicine.
(2) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators and reagent kits, work experience and has had supervised clinical experience as follows:
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(ii) Five hundred hours of supervised clinical experience under the supervision of an authorized user and that includes the following:
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(f) Eluting Technetium-99m from generator systems, measuring and testing the eluate for Molybdenum-99 and Alumina contamination and processing the eluate with reagent kits to prepare Technetium-99m labeled radiopharmaceuticals.
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§ 224.455. Training for therapeutic use of radiopharmaceuticals.
Except as provided in § 224.463 (relating to training for experienced authorized users), the licensee shall require the authorized user of radiopharmaceuticals in § 224.251 (relating to use of radiopharmaceuticals for therapy) to be a physician who meets one of the following requirements:
(1) Is certified by one of the following:
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(iii) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada.
(iv) The American Osteopathic Board of Radiology after 1984.
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