[33 Pa.B. 4393]
[Continued from previous Web Page]
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE V. RADIOLOGICAL HEALTH
CHAPTER 215. GENERAL PROVISIONS § 215.1. Purpose and scope.
* * * * * (e) Title 10 Chapter I (Nuclear Regulatory Commission) Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 70, 71 and §§ 150.1, 150.2, 150.3, 150.11, [150.20(a)(1), 150.20(a)(2) and 150.20(b)] 150.20 of the CFR is incorporated by reference with the exceptions set forth in paragraphs (1)--(13). Notwithstanding the requirements incorporated by reference, nothing in this article relieves or limits a person from complying with the laws of the Commonwealth, including the act and the Low-Level Radioactive Waste Disposal Act (35 P. S. §§ 7130.101--7130.905).
* * * * * (4) Sections [31.3,] 31.4 and 31.14 are not incorporated.
* * * * * (8) Sections 35.8, [35.990] 35.4001 and [35.991] 35.4002 are not incorporated.
* * * * * (11) Sections 40.6, 40.8, 40.12(b), 40.23, 40.27, 40.28, 40.31(k) and (i), 40.32(d), (e) and (g), 40.33, 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.
* * * * * (13) Sections 71.2, 71.6, 71.13(c) and (d), 71.24, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, [71.47,] 71.51, 71.52, 71.53, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, [71.83,] 71.99 and 71.100 are not incorporated.
* * * * * § 215.2. Definitions.
The definitions in 10 CFR Chapter 1, Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 70, 71 and 150 are incorporated by reference in this article unless indicated otherwise. In addition, the following words and terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:
* * * * * License--Permission issued by the Department in accordance with this article to possess and use [radioactive material] radiation sources. Types of licenses are as follows:
* * * * * (ii) Specific license--Written permission to possess and use radioactive material issued by the Department after the Department reviews and approves an application for the possession and use of the [radioactive material] radiation sources.
* * * * * Major X-ray system component--A tube housing assembly, X-ray control, X-ray high voltage generator, X-ray table, cradle, film changer, fixed cassette holder, beam limiting device, fluoroscopic or digital radiographic imaging assembly, spot film device, image intensifier or cephalometric device.
* * * * * Qualified expert--
(i) [An] For radiation protection, an individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs; for example: individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics or those having equivalent qualifications.
(ii) [With reference to the calibration of radiation therapy equipment An] For radiation therapy calibrations, an individual having, in addition to the qualifications in subparagraph (i), training and experience in the clinical applications of radiation physics to radiation therapy[; for example: individuals certified in therapeutic radiological physics or X-ray and radium physics by the American Board of Radiology, or radiation oncology physics by the American Board of Radiology, or radiation oncology physics by the American Board of Medical Physics or those having equivalent qualifications].
(iii) For diagnostic X-ray performance evaluations, an individual having, in addition to the qualifications of subparagraph (i), training and experience in the physics of diagnostic radiology.
* * * * * [Radiological physicist--An individual who complies with one of the following:
(i) Is certified by the American Board of Radiology in therapeutic radiological physics, radiological physics or x- and gamma-ray physics.
(ii) Has a bachelor's degree in one of the physical sciences or engineering and 3 years full-time experience working in therapeutic radiological physics under the direction of a physicist certified by the American Board of Radiology. The work duties shall include duties involving the calibration and spot checks of a medical accelerator or a teletherapy unit.
(iii) Has a master's or a doctor's degree in physics, biophysics, radiological physics, health physics or engineering; has had 1 year's full-time training in therapeutic radiological physics; and has had 1 year's full-time work experience in a radiotherapy facility where that person's duties involve calibration and spot checks of a medical accelerator or a teletherapy unit.]
* * * * *
RIGHTS AND RESPONSIBILITIES OF THE DEPARTMENT § 215.12. Inspections and investigations.
(a) Maintenance of records. Licensees and registrants shall maintain records under this article and have these records available for inspection by the Department at permanent sites or facilities of use identified in a license or registration issued under this article.
* * * * * (c) Inspections and investigations by the Department. [(1)] The Department, its employees and agents may conduct inspections and investigations of the facilities and regulated activities of registrants of radiation-producing machines and licensees of radioactive material necessary to demonstrate compliance with the act or this article. [at the following frequencies:
(i) For major medical facilities, including hospitals, at least once every 3 years for X-ray operations.
(ii) For all other facilities, at least once every 4 years for X-ray operations.
(iii) For licensees, at the frequencies recommended by the NRC. ]
(d) Additional inspections and investigations. The Department, its employees and agents may conduct additional follow-up inspections and investigations if violations of the act or regulations promulgated thereunder were noted at the time of the original inspection, or if a person presents information, or circumstances arise which give the Department reason to believe that the health and safety of a person is threatened or that the act or this article are being violated.
§ 215.14. Availability of records for public inspection.
The following Department records are not available for public inspection, unless the Department determines that disclosure is in the public interest and is necessary for the Department to carry out its duties under the act:
* * * * * (2) A report of investigation [or inspection], not pertaining to safety and health in industrial plants, which would disclose the institution, progress or results of an investigation undertaken by the Department.
* * * * *
PROHIBITIONS AND RESTRICTIONS § 215.24. Human use.
(a) No human use of radiation sources may be permitted except under this article, and the following:
* * * * * (b) Only auxiliary personnel who have met the applicable radiologic requirements of 49 Pa. Code, Part I, Subpart A (relating to professional and occupational affairs) may use radiation sources in the healing arts when employed by a licensed practitioner of the healing arts at the location at which the licensed practitioner practices.
(c) Auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government may only use radiation sources in the healing arts in accordance with written job descriptions and employee qualifications.
(d) Subsections (b) and (c) notwithstanding human use of radiation sources is permitted by individuals enrolled in clinical training programs approved by the Department.
§ 215.28. [Deliberate exposure] Improper use of a monitoring device.
The deliberate exposure of, failure to use, or improper use of, an individual monitoring device or area monitoring device [to falsely indicate the dose delivered to] by an individual is prohibited.
EXEMPTIONS § 215.32. Exemption qualifications.
The following sources, uses and types of users are exempt from Chapters 216--221, 223--228, 230 [and] 232 and 240:
* * * * *
CHAPTER 216. REGISTRATION OF RADIATION-PRODUCING MACHINES AND RADIATION-PRODUCING MACHINE SERVICE PROVIDERS § 216.1. Purpose and scope.
(a) This chapter establishes requirements for the registration of radiation-producing machines and radiation-producing machine service providers. A person who possesses a radiation-producing machine or provides services described in this chapter shall comply with this chapter.
(b) A person possessing an accelerator as defined in § 228.2 (relating to definitions) is exempt from the requirements of § 216.2 (relating to registration of radiation-producing machines). Accelerators are licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators) and license fees are specified in § 218.11(d) (relating to registration, renewal of registration and license fees.).
§ 216.2. Registration of radiation-producing machines.
* * * * * § 216.2a. Registration of radiation-producing machine service providers.
After ____ (Editor's Note: The blank refers to the effective date of adoption of this rulemaking.), a person who engages in the business of assembling or installing radiation-producing machines or who offers to assemble or install radiation-producing machines or who is in the business of furnishing or offering to furnish radiation-producing machine servicing or services or who is in the business of selling, leasing or lending radiation-producing machines in this Commonwealth shall apply for registration of the activities with the Department prior to furnishing or offering to furnish those services.
(1) Registration is for 12 months and is renewable.
(2) An application for registration or renewal will not be accepted unless accompanied by the appropriate fee specified in § 218.11(h) (relating to registration, renewal of registration and license fees). Fees are not refundable after issuance of a registration.
(3) An application for registration shall be submitted on forms provided by the Department. The Department will issue a certificate of registration for radiation-producing machine services to the applicant when the application is complete, contains all the information required by the Department and when the appropriate fee specified in § 218.11(h) has been paid.
(4) A person who, on ____ (Editor's Note: The blank refers to the effective date of adoption of this rulemaking.), is currently in the business of providing radiation-producing machine services shall apply for registration by ____ (Editor's Note: The blank refers to a date 60 days after the date of adoption of this rulemaking.)
§ 216.2b. Reporting and recordkeeping requirements for registered radiation-producing machine service providers.
(a) A radiation-producing machine service provider who installs, services, sells, leases or otherwise transfers a radiation producing-machine or major X-ray system component in this Commonwealth shall submit information to the Department and maintain records as described in this section.
(1) The following information shall be submitted in writing to the Department within 15 days of the action:
(i) The date of installation, service or transfer.
(ii) The name, address, telephone number and registration number, if registered, of the client facility.
(iii) The type of radiation-producing machine, the manufacturer's name, model number and control panel serial number of each radiation-producing machine, or major X-ray system components involved in the transaction.
(iv) A contact name of the individual for the service action.
(2) A copy of the assembler's report on United States Food and Drug Administration (FDA) form 2579, prepared in compliance with requirements of the Federal diagnostic X-ray standard (21 CFR 1020.30(d)(1) (relating to diagnostic x-ray systems and their major components)), when completed in full and submitted to the Department within 15 days following the service, satisfies the requirements of pargraph (1) and subsection (d) for services provided under the assembler's report.
(b) Services performed under preventative maintenance that do not involve replacement or refurbishing of major X-ray system components are exempt from the reporting requirements specified in this section except subsection (d).
(c) A radiation-producing machine service provider shall maintain a log or other record of radiation-producing machines installed or serviced in this Commonwealth. The record shall be maintained for 5 years for inspection by the Department and shall list the following information:
(1) The date the machine was installed or service provided.
(2) The name of the customer, address, telephone number and customer's State registration number.
(3) The type of radiation-producing machine, the manufacturer's name, model number and control panel serial number of each radiation-producing machine or major X-ray system component involved.
(4) The name of the individual performing the service.
(d) A radiation-producing machine service provider who services a radiation-producing machine in a radiation installation in this Commonwealth that is not registered shall report the service to the Department. The report shall be submitted in writing within 15 days after the services and contain the following information:
(1) The date service was provided.
(2) The name, address and telephone number of the client.
(3) The type of radiation-producing machine, the manufacturer's name, model number and control panel serial number of each radiation-producing machine or major X-ray system component.
(4) The name of the individual performing the service.
§ 216.3. Exemptions.
The following radiation-producing machines or equipment are exempt from registration:
* * * * * (2) Radiation-producing machines while in transit [or storage incidental thereto] in the possession of a transport carrier.
* * * * * (4) Accelerators are exempt from registration. Accelerators shall be licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators). Accelerator service providers are not exempt from registration of services under § 216.2a (relating to registration of radiation-producing machine services).
§ 216.4a. Expiration and termination of certificates of registration.
* * * * * (c) If a registrant does not submit a renewal for a certificate of registration under § 216.4 (relating to renewal of certificate of registration), the registrant shall, on or before the expiration date specified in the certificate of registration, do the following:
(1) Terminate use of all radiation-producing machines subject to registration under § 216.2 (relating to registration of radiation producing-machines) or cease all radiation--producing machine services subject to registration under § 216.2a (relating to registration of radiation-producing machine service providers).
(2) Transfer or dispose of all radiation-producing machines subject to registration under § 216.2 in accordance with § 216.6 (relating to [assembly,] transfer and disposal obligations).
* * * * * § 216.6. [Assembly,] Transfer and disposal obligations.
(a) A person, distributor, retailer or other agent who [sells, leases, transfers, lends, assembles or installs], by selling, leasing, lending or gifting, transfers possession of radiation-producing machines or major X-ray system components in this Commonwealth that are not otherwise reported under 216.2b (relating to reporting and recordkeeping requirements for registered radiation-producing machine service providers), shall notify the Department within [90] 30 days of the following information:
* * * * * (2) The manufacturer, model and serial number of a machine or component transferred[, assembled or installed].
(3) The date of transfer [or installation] of a radiation-producing machine or [equipment] major X-ray system component.
* * * * * [(c) A distributor, retailer or other agent who sells, leases, transfers, lends, assembles or installs radiation-producing machines or equipment in this Commonwealth shall register the activities with the Department on a form supplied by the Department.]
§ 216.7. Out-of-State radiation-producing machines.
(a) If a radiation-producing machine is brought into this Commonwealth for temporary use, the person proposing to do so or an authorized agent shall give written notice to the Department at least 2 working days before the machine enters this Commonwealth. The notice shall include the type of machine, the nature, duration and scope of use and the exact location where the machine is to be used. In addition, the person shall:
* * * * * (3) Not operate within this Commonwealth on a temporary basis in excess of [180] 60 calendar days per year.
* * * * * (c) When a radiation-producing machine is brought into this Commonwealth for temporary use exceeding [180] 60 days per year, a person possessing the machine shall register with the Department under § 216.2 (relating to registration of radiation-producing machines) within [30] 15 days after the [180th] 60th day.
CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL
Subchapter B. GENERAL PROVISIONS FOR RADIOACTIVE MATERIAL § 217.136. Exempt concentrations.
In the addition to the parts of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material) incorporated by reference, the following requirements apply:
* * * * *
TABLE 1
EXEMPT CONCENTRATIONS Note: Some of the Values in Table A-1 are presented in the computer ''E'' notation. In this notation a value of 6E-02 represents a value of 6 × 10-2 or 0.06, 6E+2 represents 6 × 102 or 600 and 6E+0 represents 6 × 100 or 6.
Element
(atomic number)
Isotope Column I
Gas concentration
µCi/ml
Column II
Liquid and solid
concentration
µCi/ml
Actinium (89) Ac-228 9E-04 [Cadmium (48) Cd-109 2E-03] Cesium (55) Cs-129 3E-03 Europium (63) Eu-154 2E-04 Gallium (31) Ga-67 2E-03 Germanium (32) Ge-68 9E-03 Gold (79) Au-195 1E-02 Indium (49) In-111 1E-03 Iodine (53) I-123 3E-04 I-124 4E-06 I-125 2E-06 Lead (82) Pb-212 2E-04 Phosphorus (15) P-33 3E-04 Potassium (19) K-43 2E-04 Protactinium (91) Pa-230 2E-03 Radium(88) Ra-223 7E-06 Ra-224 2E-05 Ra-228 3E-07 Radon (86) Rn-220 1E-07 Rn-222 3E-08 Sodium (11) Na-22 4E-04 Technetium (43) Tc-97m 4E-03 Xenon (54) Xe-127 4E-06 Yttrium (39) Y-88 8E-04
Subchapter C. GENERAL LICENSES FOR RADIOACTIVE MATERIAL § 217.141. Incorporation by reference.
* * * * * (b) Notwithstanding the requirements incorporated by reference, [10 CFR 31.3,] 10 CFR 31.4 and 31.14 (relating to [certain devices and equipment;] information collection requirements: OMB approval; and criminal penalties) are not incorporated by reference.
§ 217.143. Certain measuring, gauging or controlling devices.
In addition to the parts of 10 CFR 31.5 (relating to certain detecting measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere) incorporated by reference, general licensees subject to registration under 10 CFR 31.5(c)(13)(i) or possessing general licensed devices containing [370] 37 MBq ([10] 1 mCi) or more of accelerator-produced material, as determined on the date of manufacture, or 3.7 MBq (0.1 mCi) or more of radium-226 shall also comply with the following:
* * * * *
Subchapter G. LICENSING OF SOURCE MATERIAL § 217.171. Incorporation 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), 40.33, 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.
Subchapter J. RECIPROCITY § 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)] 150.20 [(relating to recognition of Agreement State licenses)] are incorporated by reference.
§ 217.202. Effect of incorporation of 10 CFR Part 150.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 150 (relating to exemptions and continued regulatory [authorization] authority in 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:
* * * * * § 217.203. Reciprocity of licenses [of] for byproduct, source, naturally occurring and accelerator-produced radioactive material and special nuclear material in quantities not sufficient to form a critical mass.
(a) Subject to this article, a person who holds a specific license from the NRC or 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, except for areas of exclusive Federal jurisdiction, for a period not in excess of 180 days in a calendar year if:
* * * * * (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, the NRC or by another [licensing] state to receive the material.
* * * * * (b) Notwithstanding the provisions of subsection (a), a person who holds a specific license issued by the NRC or 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:
* * * * * (2) The device has been manufactured, labeled, installed and serviced in accordance with the specific license issued to the person by the NRC or a [licensing] state.
* * * * * (e) Implementation of the requirements of this section regarding byproduct, source and special nuclear material is subject to § 217.133 (relating to persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register).
CHAPTER 218. FEES
GENERAL § 218.1. Purpose and scope.
(a) This chapter establishes fees for registration and licensing and provides for their payment. For the purpose of this chapter, radiation-producing machines under the same administrative control in a single building are registered or licensed as a single facility. Radiation-producing machines under the same administrative control at the same address or in a contiguous group of buildings may be registered or licensed as a single facility if the Department determines that it is appropriate.
(b) Except as otherwise specifically provided, this chapter applies to a person who:
(1) Is required to register or renew registration for radiation-producing machines or radiation-producing machine service providers under Chapter 216 (relating to registration of radiation-producing machines and radiation-producing machine service providers).
* * * * *
PAYMENT OF FEES § 218.11. Registration, renewal of registration and license fees.
(a) Annual registration fees for radiation-producing machines, other than accelerators, are the sum of an annual administrative fee and an annual fee for each X-ray tube or radiation generating device as follows:
Type Facility Annual
Administrative
Fee
Annual Fee per X-ray Tube or
Radiation Generating DeviceDentists,
podiatrists,
veterinarians
$70 $35 Hospitals $520 $35 Other
Facilities
$250 $35 (b) A registrant filing an initial registration under § 216.2 (relating to registration of radiation-producing machines) or an application for renewal of a certificate of registration under § 216.4 (relating to renewal of certificate of registration) shall remit the appropriate fee calculated by using the information on the registration or application form and the fee schedule in subsection (a). Fees for any initial registration under § 216.2 are payable upon the filing of the registration. Fees for the renewal of a certificate of registration are payable upon the submission of an application for a renewal of a certificate of registration. If the number of tubes increases after an initial registration or after an application for renewal has been filed with the Department, no additional fee is required until the time of the next registration. Likewise, if the number of tubes decreases during the year, no refund will be made for that year.
* * * * * (d) Particle accelerators are licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators). [Fees] Annual fees are as follows:
(i) Accelerators, below 50 MeV, other than for ion implantation--$1,500 for the first accelerator at the [site] facility plus $500 for each additional unit [of the same general type] at that [site] facility.
(ii) Accelerators used for ion implantation--$500 plus $50 for each additional unit at the same [site] facility.
(iii) Accelerators above 50 MeV--full cost of staff time to review license applications and conduct inspections as needed. (Hourly rate is $50 per hour) [given in Appendix A)]. For the purpose of anticipating costs and compliance with subsections (e) and (f), a minimum annual fee of $1,500 for the first accelerator at the facility plus $500 for each additional unit is established. Additional invoices shall be issued by the Department at regular intervals at least quarterly when net costs are incurred above the minimum annual fee.
(e) An initial application for a license or reciprocity shall be accompanied by a check payable to the Department in accordance with the fee schedules in subsections (c) and (d). Thereafter, the Department will issue an annual fee invoice in accordance with the appropriate fee schedule at least 2 months prior to the license expiration. Fees are payable by the last day of the license expiration month as shown on the license fee invoice. This provision is not applicable to full cost recovery licenses specified in Appendix A.
* * * * * (h) A radiation-producing machine service provider shall pay an annual registration fee of $100.
APPENDIX A
Fees for Radioactive Material Licenses
Fee Category Description [Proposed Pa]
Annual Fee
($)1, 2, 3, 4, 7
1C [SNM] Special Nuclear Material Sealed Source Gauges [(XRF)] (X-Ray Fluorescence) 875 1D [SNM] Special Nuclear Material--Other 2,475 2B Source Material as Shielding 450 2C Source Material--Other (not 11e2) 8,650 3A1 [MFR & Distr.] Manufacturing & Distribution Commercial Broad Scope--10 CFR 30, 33 19,875 3A2 [MFR & Distr.] Manufacturing & Distribution Commercial Broad Scope--NARM Only 4,000 3B1 [MFR & Distr.] Manufacturing & Distribution Commercial Specific [Lic.] License--10 CFR 30 4,650 3B2 [MFR & Distr.] Manufacturing & Distribution Commercial Specific [Lic.] License--NARM Only 2,000 3C1 [MFR & Distr.] Manufacturing & Distribution Pharmaceuticals--10 CFR 32.72--32.74 11,650 3C2 [MFR & Distr.] Manufacturing & Distribution Pharmaceuticals--NARM Only 4,000 3D1 Pharmaceuticals--Distribution Only--10 CFR 32.7x 2,825 3D2 Pharmaceuticals--Distribution Only--NARM Only 2,000 3E Irradiator--Shielded Source 2,575 3F Irradiator--Unshielded < 10kCi 4,300 3G Irradiator--Unshielded >= 10kCi 10,750 3I [Distr.] Distribution As Exempt--No Review of Device 3,525 3J [Distr.] Distribution--SSD Devices to Part 31 GLs 1,550 3K [Distr.] Distribution--No Review-Exempt Sealed Source 1,300 3L1 [R & D] Research & Development Broad Scope 8,300 3L2 [R & D] Research & Development Broad Scope--NARM Only 2,000 3M1 [R & D] Research & Development 3,650 3M2 [R & D] Research & Development--NARM Only 750 3N Services [Not Leak Test, Waste Disp. Calib.] other than Leak Testing, Waste Disposal or Calibration 3,875 3O Radiography 10,850 3P1 Other Byproduct Material 1,900 3P2 NARM Licenses not covered elsewhere 750 3Q Generally licensed devices under § 217.143 (relating to certain measuring, gauging or controlling devices) 315 4A Waste Storage, Processing[,] or Disposal Full Cost * 4B Waste Packaging or Repackaging 8,175 4C Waste Receipt of Prepackaged for Disposal 6,125 5A Well Logging & Non Field Flood Tracers 7,500 5B Well Logging Field Flood Tracer Studies Full Cost * 6A Nuclear Laundry 14,250 7A Human Use--Teletherapy 11,275 7B1 Human Use--Broad Scope (except Teletherapy) 19,975 7B2 Human Use--Broad Scope (except Teletherapy)--NARM Only 2,000 7C1 Human Use--Specific License (except Teletherapy) 4,300 7C2 Human Use--Specific License (except Teletherapy)-NARM Only 750 8A1 [Civil Defense] Specifically licensed sources used in static eliminators, nonexempt smoke detectors, fixed gauges, dew pointers, calibration sources, civil defense uses or in temporary (2 years or less) storage 875 8A2 Specifically licensed NARM sources used in static eliminators, [non-exempt] nonexempt smoke detectors, fixed gauges, dew pointers, calibration sources, civil defense uses[,] or in temporary (2 years or less) storage. 200 14 Decontamination, Decommissioning, Reclamation or Site Restoration[, Special] Full Cost * 16A Reciprocity (180 days/year) 900 16B Reciprocity--NARM (180 days/year) 300 SB15 Small Business--Category 1 2,100 SB26 Small Business--Category 2 400 [PF Professional Fees (Hourly Rate) for full cost items $50 per hour] 1A license may include as many as four [non-contiguous] noncontiguous sites at the base fee. Sites that are within 5 miles of the main Radiation Safety Office where the license records are kept will be considered contiguous. An additional fee of 25% of the base fee will be added for each noncontiguous site above four.
2All fees for NARM licenses will be effective upon publication of the final rules in the Pennsylvania Bulletin. The fees for NRC licenses that are transferred to the Commonwealth will be effective on the next license anniversary date. NARM licenses will be changed to the corresponding category of [by-product] byproduct material license on the next license anniversary date after achievement of Agreement State status and fees adjusted at that time. The NARM license categories will cease to exist one year after Agreement State status is achieved.
3Annual fees for categories of NRC licenses that are not included in this table will be calculated as follows: PA Fee = 0.7 (NRC Annual Fee + 0.10 NRC Application or Renewal fee).
4Annual fees charged to holders of transferred NRC licenses with multiple sites will not exceed the fees charged by the NRC for the same licenses in the year of transfer, provided the number of [non-contiguous] noncontiguous sites remains constant.
5Small Businesses Not Engaged in Manufacturing, and Small Not-For-Profit Organizations with Gross Annual Receipts of more than $350,000 and less than $5 million; Manufacturing Entities that have an average of 35--500 employees with Gross Annual Receipts of more than $350,000 and less than $5 million; Small Government Jurisdictions (including publicly supported, [non-medical] nonmedical educational institutions) with a population between 20,000 and 50,000; and [non-medical] nonmedical Educational Institutions that are not state or publicly supported and have 35--500 employees.
6Small Businesses Not Engaged in Manufacturing, and Small Not-For-Profit Organizations with Gross Annual Receipts of less than $350,000; Manufacturing Entities that have an average of less than 35 employees and less than $350,000 in Gross Annual Receipts; Small Government Jurisdictions (including publicly supported nonmedical educational institutions) with a population less than 20,000; and nonmedical Educational Institutions that are not state or publicly supported and have less than 35 employees.
7Full cost recovery licensees and licensees required to provide financial assurance for decommissioning are not eligible for reduced fees under category SB1 or SB2.
* Full cost recovery consists of a professional fee, to cover the activities and support of Department personnel, and any other additional incidental charges incurred, such as related contracted services or laboratory costs. The professional fee component (Hourly Rate) is $50 per hour. Other costs are recovered at 100% of actual cost. Invoices shall be issued by the Department at regular intervals but at least quarterly when net costs are incurred.
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS
GENERAL PROVISIONS § 219.3. Definitions.
The following term, when used in 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:
* * * * * (iii) A total dose delivered to the treatment site identified in a written directive for therapy that is outside the prescribed dose range or 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%.
§ 219.6. 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:
* * * * * (8) 10 CFR Part 20, notwithstanding, exposures involving the use of X-rays may be weighted, in a manner specified by the Department, so that, with Department approval, the effective dose equivalent may be substituted for the deep dose equivalent in determining compliance with occupational exposure limits for specified groups of individuals.
§ 219.8. Requirement for a Radiation Safety Committee.
The requirements of 10 CFR 35.24 (relating to authority and responsibilities for the radiation protection program) apply to registrants as well as licensees. For the purpose of this requirement, facilities that utilize two or more modalities in which patients are likely to receive, or will receive a dose to an organ in excess of 200 rads (2.0 gray), shall have a radiation safety committee.
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:
* * * * * (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 specified in the Sealed Source and Device Registry approved by the Department [under §§ 217.81--217.93 (Reserved)], 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 specified in the Sealed Source and Device Registry approved by the Department [under §§ 217.81--217.93 (Reserved), an agreement state], a [licensing] state or the NRC[, except that the maximum interval between leak tests may not exceed 3 years].
* * * * * (b) A licensee need not perform tests for leakage or contamination on the following sealed sources:
* * * * * (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.]
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Subchapter M. REPORTS § 219.229. Other medical reports.
Within 30 days of the [discovery] determination by a physician of either actual or suspected acute or long-term functional damage to [tissue] an organ or a physiological system 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 reports of medical reportable events for radiation-producing machine therapy) and any functional damage to a patient [tissue] organ or a physiological system that was an expected outcome when the causative procedures were prescribed.
CHAPTER 220. NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS § 220.2. Posting of notices to workers.
* * * * * (c) Department Form [ER-BRP-3] 2900-FM-RP0003, ''Notice to Employees,'' shall be posted by a licensee or registrant as required by this article.
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CHAPTER 221. X-RAYS IN THE HEALING ARTS
GENERAL PROVISIONS § 221.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Filter--[aterial] Material placed in the useful beam to [absorb the less penetrating radiation.] modify the spectral energy distribution and flux of the transmitted radiation and preferentially absorb selected radiation.
Filtration--[Material placed in the useful beam to absorb the less penetrating radiation.] The amount of material placed in the useful beam to modify the radiation's characteristics, typically expressed in terms of millimeters of aluminum or copper equivalent.
* * * * * Half-value layer (HVL)--
(i) The thickness of specified material which attenuates the exposure rate by 1/2 when introduced into the path of a given beam of radiation. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
(ii) The term is used to describe the penetrating ability of the radiation.
Healing arts screening--The testing of human beings using X-ray machines for the detection or evaluation of health indications when the tests are not specifically and individually ordered for the purpose of diagnosis or treatment by a licensed practitioner of the healing arts legally authorized to prescribe the X-ray tests [for the purpose of diagnosis or treatment].
* * * * * [Qualified expert--An individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs. For example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the preceding qualifications, training and experience in the clinical applications of radiation physics to radiation therapy. For example, individuals certified in therapeutic radiological physics or X-ray and radium physics by the American Board of Radiology, or radiation oncology physics by the American Board of Medical Physics; or those having equivalent qualifications.]
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