RULES AND REGULATIONS
Title 25—ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[ 25 PA. CODE CHS. 215—221, 223—228, 230, 232 AND 240 ]
Radiological Health
[48 Pa.B. 6791]
[Saturday, October 27, 2018]The Environmental Quality Board (Board) amends Chapters 215—221, 223—228, 230, 232 and 240 to read as set forth in Annex A. This final-form rulemaking amends Article V (relating to radiological health) to include clarification and guidance regarding radiation safety, update the standards for protection against radiation and amend requirements for radon certification.
This final-form rulemaking was adopted by the Board at its meeting on June 19, 2018.
A. Effective Date
This final-form rulemaking will be effective 90 days after publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact the Bureau of Radiation Protection, P.O. Box 8469, Rachel Carson State Office Building, Harrisburg, PA 17105-8469, (717) 787-2480; or Robert Schena, Assistant Counsel, Bureau of Regulatory Counsel, P.O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 783-8072. This final-form rulemaking is available on the Department of Environmental Protection's (Department) web site at www.dep.pa.gov (select ''Public Participation,'' then ''Environmental Quality Board (EQB)'').
C. Statutory Authority
The amendments to Chapters 215—221, 223—228, 230 and 232 are authorized under sections 301 and 302 of the Radiation Protection Act (35 P.S. §§ 7110.301 and 7110.302) and section 1920-A of the Administrative Code (71 P.S. § 510-20).
The amendments to Chapter 240 (relating to radon certificiation) are authorized under sections 12 and 13 of the Radon Certification Act (63 P.S. §§ 2012 and 2013), section 302 of the Radiation Protection Act and section 1920-A of the Administrative Code.
D. Background and Purpose
Significant technological advances in the use of radiation sources prompted the need to amend the radiological health regulations. This final-form rulemaking establishes and maintains appropriate radiation protection standards and oversight. The Board last updated its radiological health regulations in 2009.
This final-form rulemaking includes amendments based on standards set by recognized accrediting bodies and national organizations such as the National Council on Radiation Protection and Measurements and the Conference of Radiation Control Program Directors.
The radon certification regulations in Chapter 240 were first promulgated in 1991 and have not been significantly amended since. This final-form rulemaking amends the radon certification application requirements and the reporting requirements for certified radon service providers to add clarity to both processes. The amendments to the testing and mitigation protocol requirements and the quality assurance (QA) and quality control (QC) requirements provide greater detail regarding how these programs should be designed and what goals they should accomplish.
This final-form rulemaking was presented to and reviewed by the Radiation Protection Advisory Committee (RPAC) on October 19, 2017. The RPAC represents various stakeholders, including radioactive materials licensees, radiation-producing machine registrants, radon service providers and the general public. The RPAC endorsed moving forward with this final-form rulemaking.
E. Summary of Changes to the Proposed Rulemaking
Sections 224.11(6), 226.5(5), 230.4(5) and 232.3(4) are revised in this final-form rulemaking to delete Agreement State transition language. These deletions were inadvertently omitted in the proposed rulemaking.
The term ''business days'' is added throughout this final-form rulemaking for time requirements based on public comments received.
The word ''individual'' is revised to ''individual(s)'' throughout Chapter 240 due to an amendment in this final-form rulemaking that no longer requires only one certified individual per radon testing, mitigation or laboratory firm. Other grammatical changes were also made where necessary throughout this final-form rulemaking.
The Board amends the following sections of the proposed rulemaking based on public comments, unless otherwise noted.
Chapter 215. General provisions
The title of § 215.41 (relating to address) is changed to ''contact information'' and the telephone number and web address were added in this final-form rulemaking.
Chapter 216. Registration of radiation-producing machines and radiation-producing machine service providers
In § 216.3 (relating to exemptions) the word ''centimeter'' is changed to ''centimeters'' in this final-form rulemaking.
Chapter 217. Licensing of radioactive material
In § 217.143 (relating to certain measuring, gauging or controlling devices), the units of radiation doses were reversed. For example, 37 MBq (1 mCi) in the proposed rulemaking was changed to 1 mCi (37MBq) in this final-form rulemaking, to be consistent with national standards.
Chapter 218. Fees
In § 218.11(e) (relating to registration, renewal of registration and license fees), ''check payable'' was changed to ''payment'' in this final-form rulemaking to account for future payment options.
Chapter 219. Standards for protection against radiation
In § 219.3 (relating to definitions), the proposed definition of ''medical reportable event for radiation-producing diagnostic or interventional X-ray procedures'' contained specific dose criteria. The dose criteria for an unintended peak skin dose to the same area in a single procedure has been increased from the proposed 3 Gy (300 rad) to 1500 rad (15 Gy) in subparagraph (i) of this final-form rulemaking based on public comments. The proposed dose criteria in subparagraphs (ii) and (iii) were changed from 0.5 Gy (50 rad) to 50 rad (0.5 Gy) in this final-form rulemaking to be consistent with national standards.
The title of § 219.229 (relating to other medical reports) is revised in the final-form rulemaking to ''diagnostic or interventional procedure medical reports'' to avoid confusion and to clarify the types of reportable events that are covered by this section.
In § 219.229(b), (b)(1), (b)(2) and (b)(4), the proposed term ''medical event'' is changed to ''medical reportable event'' in this final-form rulemaking for consistency with the definitions in § 219.3.
Chapter 220. Notices, instructions and reports to workers; inspections and investigations
In § 220.2(c) (relating to posting of notices to workers), a typographical error in a document number is corrected in this final-form rulemaking.
Chapter 221. X-rays in the healing arts
In § 221.2 (relating to definitions), a change is made in the proposed definition of ''high-risk procedure'' to the skin dose levels to change ''200 rads'' to ''200 rad (2.0 Gy)'' to be consistent with national standards and correct a typographical error. The term ''high-risk'' was added to the proposed definition of ''FGI—fluoroscopic guided interventional procedures'' in this final-form rulemaking in response to comments regarding the scope of this definition. The term ''therapy'' in subsection (iii) of the ''FGI'' definition is changed to ''the procedure'' in this final-form rulemaking for clarity.
In § 221.11(b)(1) (relating to registrant responsibilities), the proposed phrase ''. . .including certification or registration. . .'' is changed to ''. . .which may include certification or registration. . .'' in this final-form rulemaking based on public comments. In subsection (c)(2), the term ''film'' is replaced with ''image receptor'' in this final-form rulemaking based on comments from the RPAC.
Proposed § 221.35a(c) (relating to fluoroscopic x-ray systems) is revised in this final-form rulemaking to improve clarity based on public comments expressing confusion with the proposed language. Subsection (c) is also revised to add ''or digital acquisition'' modes in paragraph (3) and separate the two types of beam evaluations into paragraphs (5) and (6) to differentiate between the two tests.
In proposed § 221.35a(d)(4) the proposed phrase ''. . .all of the following information. . .'' is changed to ''. . .other information. . .'' in this final-form rulemaking to clarify the information necessary to estimate radiation dose to the skin. Additionally, the proposed phrase ''or the following, as necessary'' is changed to ''or one or more of the following'' for clarity.
Proposed § 221.57 (relating to facilities using CR or DR) is renumbered as § 221.50 in this final-form rulemaking for proper placement in the regulation.
In proposed § 221.64(a) and (a)(2) (relating to CBCT), the phrase ''or QE'' is added in this final-form rulemaking along with the QMP for responsibilities outlined in the subsection and paragraph. Also in subsection (a)(2), the proposed timeframe of ''12 months'' is changed to ''14 months'' for performance evaluation intervals of CBCT units for consistency throughout the rulemaking. Subsection (c) was revised in this final-form rulemaking to clarify that CBCT systems are exempt from the requirements in § 221.202(a) (relating to equipment requirements), which relates to accreditation. Similar changes are made in this final-form rulemaking in § 221.65(1) and (3) (relating to x-ray attenuation systems) to exempt CT systems from §§ 221.202(a) and 221.204(a)(4)(xi) (relating to performance evaluations, routine QC and surveys).
In § 221.201 (relating to definitions), the proposed definition for CTDIw is amended in this final-form rulemaking to further clarify dose measurements.
In § 221.204(c)(1), the proposed language is amended in this final-form rulemaking to ''CT X-ray systems shall have a survey performed at the time of installation. . .'' to clarify when a survey is required.
Chapter 223. Veterinary medicine
Proposed Section 223.31(d) (relating to registrant responsibilities) is amended in this final-form rulemaking to specify the distance within which appropriate persons required for a medical procedure or training may be during the radiographic exposure. The amendment changed ''in the room'' to ''within 2 meters of the device.''
Chapter 240. Radon certification
Section 240.2(a) (relating to scope) is amended in this final-form rulemaking to clarify that Chapter 240 applies to ''a person except when the person is'' performing one of the enumerated activities listed in section (a)(1)—(6). For example, if a person is conducting both commercial radon testing and testing for radon contamination in a building that the person owns or occupies, Chapter 240 would apply in the former circumstance but not in the latter circumstance. Wording was changed in Section 240.2(a)(6) to conform with those changes.
Section 240.2(a)(4) is revised in this final-form rulemaking to delete the proposed addition of ''Department-approved,'' and the proposed § 240.2(a)(5)(ii) is revised by adding ''activated charcoal, liquid scintillation, or alpha track'' to further clarify the types of radon testing devices. Section 240.2(a)(6)(iii) is added in this final-form rulemaking for clarity and specifies that radon testing must be performed in accordance with the device manufacturer's instructions.
Section 240.3 (relating to definitions) is revised in this final-form rulemaking by removing the proposed definition of ''ALARA.'' The proposed term ''blind study'' is also removed in this final-form rulemaking and, instead, is explained in § 240.203(a)(5) (relating to conditions of certification). The method for analyzing activated charcoal has been added to the definition of ''AC—activated charcoal'' in this final-form rulemaking, and the method for analyzing liquid scintillation has been added to the definition of ''LS—liquid scintillation.'' Also, the proposed definition of ''spiked measurement or spike'' is revised in this final-form rulemaking to clarify that the measurement must be conducted in an approved chamber.
Sections 240.101(b), 240.102(b), 240.112(b) and 240.122(b) are revised in this final-form rulemaking to remove the proposed requirement that only one person in a firm can be certified. The term ''person'' is replaced with ''individual'' in this final-form rulemaking in Sections 240.101(b) and 240.111(b) (relating to requirements for radon testing certification; and requirement for radon mitigation certification) for consistency.
The proposed requirement in §§ 240.102(b)(2), 240.112(b)(2) and 240.122(b)(2) (relating to prerequisites for radon testing certification; prerequisites for radon mitigation certification; and prerequisites for radon laboratory certification) that the firm's certified individual may not also be a firm employee is removed in this final-form rulemaking and the paragraphs were renumbered accordingly.
Proposed sections 240.102(b)(4)(ii) and 240.112(b)(4)(i) are revised in this final-form rulemaking to change the notification requirements from 5 days to 10 business days.
The proposed requirement that a testing firm in § 240.102(b)(4) and a mitigation firm in § 240.112(b)(5) may list a maximum of five firm employees at one time is removed in this final-form rulemaking.
Proposed §§ 240.102(b)(6)(iii) and 240.112(b)(6)(iii) are changed in this final-form rulemaking from requiring proof of passing the appropriate Department-approved course or exam to requiring certification that firm employees hired after the effective date of the rulemaking received initial training under new subsection (b)(6) of the respective sections. Initial training under subsection (b)(6) may be provided by the firm's certified individual or by a third party. Proposed subsection (b)(6) is renumbered as subsection (b)(4) in each section. A new subsection (b)(6)(iv) is added to both sections in this final-form rulemaking to require each testing firm applicant to submit proof of completion of continuing education as required by new subsection (b)(7), if applicable. A new subsection (b)(6) is added to both sections in this final-form rulemaking specifying the initial training requirements for a firm employee.
Sections 240.103(a)(3), 240.113(a)(3), and 240.123(a)(3) (relating to radon testing application contents; radon mitigation application contents; and radon laboratory application contents) are amended in this final-form rulemaking to remove the proposed date of birth requirement. A new paragraph in subsection (a) of each section is added in this final-form rulemaking to specify that the applying firm must submit a demonstration that the certified individual will maintain adequate span of control over the employees. These subsections are added in this final-form rulemaking because of the removal of the proposed requirements in §§ 240.102 and 240.112 that would have allowed only five firm employees. This span of control requirement will allow the Department to ensure that certified individuals in responsible charge of firm activities are adequately training firm employees.
Section 240.111(b) (relating to requirements for radon mitigation certification) is amended in this final-form rulemaking to delete the proposed requirement that a certified firm may only have one certified individual in responsible charge of a firm at a time.
Section 240.121(b) (relating to requirement for radon laboratory certification) is amended in this final-form rulemaking to add language to specify that there can be more than one certified individual in a laboratory firm.
Subsection 240.122(b)(4) (relating to prerequisites for radon laboratory certification) is amended in this final-form rulemaking to clarify submittal requirements for each laboratory firm employee for individual certification for laboratory analysis. A new subsection (b)(6) was added to clarify the initial training requirements of firm employees, and a new subsection (b)(7) was added specifying the continuing education requirements for a firm employee.
Section 240.133(a)(3) (relating to certification application contents) is amended in this final-form rulemaking to remove the proposed date of birth requirement.
Proposed § 240.141 (relating to withdrawal of applications and certifications) is amended in this final-form rulemaking to allow for a withdrawn certification application to be reinstated prior to the expiration of the current certification instead of requiring a new application to be submitted along with the appropriate fee.
Proposed § 240.142 (relating to testing and mitigation identification cards) is amended in this final-form rulemaking to remove the proposed requirement for individuals identified in subsection (a) to wear the Department-issued identification card while performing radon-related activities due to the possibility of losing badges when working in tight spaces such as crawlspaces and attics.
Section 240.203(a)(5) is amended in this final-form rulemaking to explain what a blind study is.
Section 240.302(a) (relating to required client information) is amended in this final-form rulemaking to delete the phrase ''for the general public'' to provide clarity in the notice to clients.
Section 240.303(1)(i) (relating to reporting of information) is amended in this final-form rulemaking to add ''as available'' to the end of the subsection. This revision is made in response to a comment regarding the lack of control laboratories have over what information clients provide to the laboratory.
Section 240.303(2)(i) is amended in this final-form rulemaking to replace the word ''of'' with ''after'' to clarify when mitigation reporting should occur.
Section 240.303(3) is amended in this final-form rulemaking to add that the owner or occupant of the building in addition to the client is to receive test results and that the results must be reported within 10 business days. Also, the proposed phrase ''secondary tester'' is changed to ''certified tester'' and the proposed phrase ''certified individual'' to ''certified laboratory'' to clarify reporting responsibility to the client.
Section 240.303(4) is amended in this final-form rulemaking to remove the proposed requirement for a test to be performed prior to a mitigation system installation. Paragraph (4) is also revised to clarify that results of the postmitigation test must be reported in accordance with this section unless the postmitigation test is performed by someone other than the mitigator and the client does not provide the postmitigation test results to the mitigator.
Section 240.305 (relating to health and safety program) is amended in this final-form rulemaking to remove the language relating to ALARA and to specify ways to protect certified individual and firm employees from exposure to radon.
Section 240.306 (relating to continuing education program) is amended in this final-form rulemaking to remove duplicative continuing education requirements that had been proposed.
Section 240.308 (relating to radon mitigation standards for detached and attached residential buildings three stories or less in height) contains several amendments in this final-form rulemaking:
• The proposed heading is amended to ''Radon mitigation standards for detached and attached residential buildings three stories or less in height.''
• A new subsection (a) is added to require the certified individual to conduct a thorough visual inspection of the building prior to initiating any radon mitigation work. With this addition, the subsections are renumbered accordingly.
• Proposed subsections (a)(2) and (a)(3) are removed.
• Proposed subsection (a)(6) is renumbered as subsection (b)(5) and is amended to clarify that the termination point must be at least 5 feet horizontally from a vertical wall that extends above the roof or higher than the vertical wall. Proposed subsection (a)(7) is renumbered as subsection (b)(6) and expanded to clarify that the termination point must be at least 12 inches above the surface of the roof for vent pipes that penetrate the roof and at least 10 feet from any openings of conditioned spaces in the structure.
• A new subsection (b)(1) is added to specify what the termination point must be, and proposed subsection (a)(1) is amended as final-form subsection (b)(2) to specify that a 45-degree elbow is permitted.
• Proposed subsection (b)(1) is renumbered as subsection (c)(1) and is amended to specify that a radon fan used in active soil or block wall depressurization may not be installed in a window well or egress window well or in the conditioned space of a building.
• Proposed subsection (c)(1)(iii) is renumbered as subsection (d)(1)(iii) and is amended to change the sealing of ''openings or cracks in the foundation or at. . .'' to ''expansion or control joints.'' Subparagraphs (iv) and (v) are added to clarify sealing requirements for openings in the foundation and sump pits. Proposed subsection (c)(3) is renumbered as subsection (d)(3). This provision pertains to when a mitigator may leave areas unsealed and must provide written information to the homeowner. Paragraph (3) is amended in this final-form rulemaking to remove ''. . .or that openings or cracks are inaccessible. . .''; paragraph (3)(i) is changed from heating and cooling ''penalty'' to ''costs''; and paragraph (3)(ii) is changed from ''decrease the efficiency'' to ''reduce the effectiveness.''
• Proposed subsection (d) is renumbered as subsection (e). Subsection (e)(1)(ii) and (iii) are changed in this final-form rulemaking to include reference to the firm or the certified individual on the system description label affixed to the mitigation piping system.
• Proposed subsection (e)(1) is removed as unnecessary.
• Proposed subsection (f) is renumbered as subsection (g) and is amended to delete reference to the EPA for source material.
Proposed § 240.309 (relating to testing protocols) is renumbered in this final-form rulemaking as § 240.310 due to a recently promulgated rulemaking that added § 240.309 (relating to radon mitigation system fee). (47 Pa.B. 6482, October 21, 2017). Subsection (a)(4)(v)(G) and (a)(11)(ii) are expanded in this final-form rulemaking to clarify that the client must be notified immediately if a permanently installed radon mitigation system is not functioning during the test period. Subsection (a)(4)(vii) is amended in this final-form rulemaking to correct a grammatical error. The word ''sustained'' is changed to ''unusually'' in this final-form rulemaking in relation to describing storms and winds. Subsection (a)(6)(i), on the use of anti-tampering devices to guard against movement of test devices, is amended in this final-form rulemaking for clarity. Subsection (a)(7) is amended in this final-form rulemaking to correct a document reference number. Subsection (a)(8) is added in this final-form rulemaking to address multifamily building mitigation, and the remainder of the subsection is renumbered. Subsection (a)(11), formerly (a)(10), is amended in this final-form rulemaking to clarify the required testing timeframe applies when no unforeseen circumstance is prohibiting the test from being performed such as when an owner or occupier refuses or ignores requests to complete the postmitigation test. Subsections (b)(1) and (2) are amended in this final-form rulemaking to add ''as available'' with regard to the inclusion of information in the Result Report Form and to change ''10 working days'' to ''10 business days''.
In this final-form rulemaking, § 240.604(a)(6) (relating to QA requirements for testing using primary devices), 240.605(a)(5) (relating to QA requirements for testing using secondary devices), and 240.605(b)(3), the term ''radioactive check source'' is amended to ''check source'' to account for electronic check sources.
In this final-form rulemaking, the requirement in §§ 240.604(c)(2)(ii) and (c)(3)(v)(C) and 240.605(c)(1)(ii) and (c)(2)(v)(C) to include electret chamber serial number(s) is removed from the proposed rulemaking because including both electret and chamber serial numbers on the form tracking electret custody is unnecessary. Proposed §§ 240.604(c)(3)(iv), 240.605(c)(2)(iv) and (d)(2)(iv), and 240.606(c)(3)(iv) (relating to QA requirements for laboratories), (d)(4)(iv) and (e)(3)(iv), pertaining to control and warning levels associated with spikes, are removed because predetermined control limits are already in place for these devices. Proposed §§ 240.604(c)(5) and 240.606(c)(5), pertaining to electret voltage drift, are removed because the manufacturer performs voltage drift checks prior to shipment of the device. All affected subsections were renumbered appropriately.
F. Summary of Major Comments and Responses on the Proposed Rulemaking
The proposed rulemaking was adopted by the Board on October 18, 2016, and published at 47 Pa.B. 2722 (May 13, 2017). Public comments on the proposed rulemaking were accepted through June 26, 2017. A webinar was presented for the proposed radiation-producing machines and radiation source regulations on May 31, 2017. A separate webinar was presented on May 31, 2017, for the proposed radon certification regulations. The Board received comments from 23 commentators during the public comment period and the Independent Regulatory Review Commission (IRRC). These comments were considered and are addressed in the comment and response document that accompanies this final-form rulemaking. All comments are available on the Department's web site at http://www.ahs.dep.pa.gov/eComment/. A summary of the major comments and responses is set forth as follows.
General IRRC comments
IRRC noted that the preamble to the proposed regulation did not include all amendments and did not explain why certain amendments are needed. IRRC also cited differences between the preamble and the Regulatory Analysis Form regarding compliance costs and asked the Board to amend these sections of the two documents in this final-form rulemaking and include explanations that were omitted. Based on these concerns, the Board has clarified the inconsistencies in these final-form rulemaking documents.
With regard to IRRC's comment about differences in the preamble and the Regulatory Analysis Form, an error was made by including the cost of certification of a qualified medical professional (QMP) in the proposed rulemaking, which is not applicable to these regulations. Any costs inadvertently included in the preamble and Regulatory Analysis Form have been corrected in this final-form rulemaking.
IRRC recommended the Board reconsider the regulatory scheme of prescriptive requirements, provide flexibility to accommodate advances in technology, and consider more reliance on the QMP, based on other comments that were submitted. In general, the Board notes that this rulemaking embodies the theory that regulatory clarity and codification of best practices can improve the quality of services to the public, instead of ratcheting numerical standards in a command-and-control fashion. The industry had moved ahead of the Commonwealth regulations in technology and safety. The Department engaged with the business community, learned about practices that had already become standard, and is codifying them in this final-form rulemaking. This process ensures that the requirements are not an unfair surprise to the industry. Some requirements are required of operators by insurance companies (including Medicare and Medicaid), and most others are standards from national organizations, such as the Joint Commission, or are contained in technical guidance documents. The Board notes that the Department's authority in § 215.31 (relating to granting exemptions) to grant exemptions from Article V provides for flexibility to address advances in technology. Additional sections in Article V also address emerging technologies. For example, § 218.11 (relating to registration, renewal of registration and license fees) requires Department safety review and § 221.16 (relating to training, competency and continuing education) necessitates registrants to be knowledgeable with emerging technologies. The Department strives to write regulations as performance based; however, certain requirements, such as basic operations, are not likely to change. Regarding reliance on QMPs as technology advances, the Department anticipates that the previously discussed waiver requests will necessitate QMP involvement to ensure new technologies are being implemented safely.
IRRC questioned why the answer to Question 13 of the Regulatory Analysis Form did not include citations to the Department of Health (DOH) regulations that address radiology, and how the development of this regulation was coordinated with DOH. The Board notes that DOH has regulations regarding radiation sources in 28 Pa. Code Chapters 51, 127, and 565 (relating to general information; radiology services; and laboratory and radiology services) that could be affected by this rulemaking. DOH is currently working on a regulatory update. The Department and DOH have held several meetings and have been working together to ensure DOH's regulations are consistent with the Department's regulations.
IRRC noted that several commentators identified terms that are defined but not used. IRRC recommends reviewing all proposed definitions to eliminate terms not used in the body of the regulation and ensure that defined terms are used consistently. The Board responds the defined phrase ''medical reportable event for radiation-producing diagnostic or interventional X-ray procedures'' remains in this final-form rulemaking to distinguish the difference between the two types of reportable events that are discussed in Chapter 219. One type is for radiation-producing machine therapy and the other is for diagnostic or interventional procedures. ''Medical reportable event for radiation-producing machine therapy'' is defined in existing § 219.3 and applies to sections that are not part of this final-form rulemaking. The definition of ''medical reportable event for radiation-producing diagnostic or interventional X-ray procedures'' clarifies § 219.229. Section 219.229 is included in this final-form rulemaking and only covers diagnostic or interventional procedures. The title of § 219.229 has be revised in this final-form rulemaking to ''diagnostic or interventional procedure medical reports'' to avoid confusion and to clarify the types of reportable events that are covered by this section. The proposed term ''blind study'' is a common term used in all types of scientific studies, but has been removed from the definitions proposed in § 240.3 and is explained in § 240.203(a)(5) in this final-form rulemaking. The proposed term ''ALARA'' in § 240.3 has been removed in this final-form rulemaking. Instead, the substance of how to pursue ALARA is discussed in § 240.305. The Department reviewed all of the proposed definitions to make sure terms are used consistently in the body of the regulation and to consider which definitions should be removed from the rulemaking.
IRRC comments and public comments
One commentator questioned why this final-form rulemaking is effective upon publication. The Board acknowledges this concern and has made this final-form rulemaking effective 90 days after publication in the Pennsylvania Bulletin.
Chapters 215—230
Several commentators suggested that the proposed dose of 3 Gy in the definition of ''Medical reportable event for radiation-producing diagnostic or interventional X-ray procedures'' in § 219.3 is too low. IRRC asked the Board to explain why 3 Gy is the appropriate dose. The Board considered the comments and changed the dose to 15 Gy in this final-form rulemaking based on recommendations of The Joint Commission—a national health care accreditation body—and the Department's discussions with the RPAC.
IRRC and the American Association of Physicists in Medicine (AAPM) commented that the proposed definition of QMP in § 221.2 is insufficient to ensure that individuals providing the designated medical physics services are qualified to do so, and they suggest using AAPM's or CRCPD suggested State regulations' definition. The Board notes that AAPM's definition is a restricted definition and, further, that the individuals providing the medical physics services are already qualified to do so. The Department solicited advice from the RPAC and other organizations in determining appropriate qualifications. The Board believes it would not be reasonable to say the individuals that have already been performing these services are not qualified to do so. Therefore, the proposed definition has not been changed in this final-form rulemaking and will allow equivalent qualifications.
Two commentators questioned whether American Registry of Radiologic Technologists (ARRT) (CT) certification is required in relation to operators subject to § 221.16(a)(2), or whether other certification such as by the Nuclear Medicine Technology Certification Board (NMTCB) would be acceptable for operators of hybrid imaging devices where CT is only used for attenuation correction and localization. The Board notes that ARRT certification in Radiology is required when operating a CT that is only used for attenuation correction. Individuals certified in NMTCB must have post-primary certification in CT to perform CT procedures.
One commentator questioned whether Physician Assistants can no longer be trained to use fluoroscopy due to changes to § 221.35a(b)(1). The Board notes that Physician Assistants are licensed by the Department of State. Subchapter G (relating to medical doctor delegation of medical services) of 49 Pa. Code Chapter 18 permits all duties specified in written agreements between the supervising physician and the Physician Assistant to be performed. If those duties include fluoroscopic procedures, the Physician Assistant is permitted to perform them.
Two commentators suggested that the proposed § 221.11(c), which references protocol information in the vicinity of the control panel, include an allowance for the electronic storage of pre-programmed techniques. The Board confirms that electronic storage of protocols complies with the regulation. No change has been made in this final-form rulemaking, however, because there are numerous older models in use that still print protocols and post them near the control panel.
One commentator disagrees with proposed § 221.35a(c), which states, ''At a minimum, evaluations shall include all of the following.'' Instead of requiring a full evaluation after any maintenance, the commentator recommended that the QMP be allowed to make a determination to evaluate components affected. The Board notes that, if the QMP determines that maintenance did not affect the exposure rate, then no further evaluation is necessary. However, a full evaluation is still required within 14 months from the date of the prior evaluation. Therefore, no change was made in this final-form rulemaking.
One commentator recommended eliminating low-risk fluoroscopic-guided interventional procedures (FGI) from proposed § 221.35a(d). The Department discussed this comment with the RPAC and amended the definition of FGI in this final-form rulemaking to only include high-risk fluoroscopic-guided interventional procedures.
One commentator is concerned that an inspector would interpret proposed § 221.63(a) (relating to therapy imaging guidance systems) as the site being expected to follow all QA procedures described in a document published by a national organization and by the device manufacturer. The commentator believes the QMP should develop QC procedures and tolerances for therapy imaging guidance systems and states that the same should apply to proposed § 221.64(a)(2) and (3). The Board notes that this final-form rulemaking stipulates that it is the QMP's responsibility to develop QC procedures, and the Department will only inspect against those procedures—not against procedures described elsewhere.
Chapter 240
IRRC and another commentator believe the proposed definition of ''ALARA'' in Chapter 240 is vague and unreasonable because it sets a standard of ''making every reasonable effort'' to limit exposure and ''taking into account economic considerations and other societal concerns.'' The Board has considered these comments and deleted the proposed term ''ALARA'' from Chapter 240 in this final-form rulemaking. Instead, the substance of how to pursue ALARA is discussed in § 240.305 in this final-form rulemaking.
Several commentators and IRRC recommended not limiting the number of firm employees in §§ 240.102(b)(4) and 240.112(b)(5). The Board agrees and has deleted this proposed requirement from this final-form rulemaking.
One commentator questioned whether, if bidding on a large job such as a school or nursing home, the proposed regulation in § 240.310 states that they cannot test the number of locations specified by the client. The Board responds that this final-form rulemaking requires testing practices under which protocols require a certain number of tests to be placed in specific locations. The client cannot dictate how many or where the test kits will be placed.
One commentator recommended that the certification program require adherence to all Commonwealth home improvement contractor requirements and require each certified individual to work under a certification firm. The testing reporting should include a requirement that the certified individual responsible be included in the report, and the firm should be required to have a Home Improvement Contractor license. The Board notes that requiring certified individuals to work under a certified firm is not necessary. The name, street address and telephone number of the tester is required in the report under § 240.303(1). The main purpose of a firm is to allow firm employees without certification to perform the work under the direction of a certified individual as a cost savings measure to the industry, because it is more expensive to require all employees to be certified. If a certified individual has no employees, the individual is not required to apply for firm certification. The individual can form a business entity if required by the Home Improvement Contractor program. Therefore, no change was made in this final-form rulemaking.
One commentator observed that the radon industry was not properly represented on the RPAC because none of the members are certified testers or mitigators. The Board notes that, while there is one member on the RPAC who represents the radon industry, RPAC formed a radon subcommittee and engaged that subcommittee in developing this final-form rulemaking.
Two commentators noted the proposed requirement in §§ 240.604(c)(3)(iv), 240.605(c)(2)(iv), (d)(2)(iv), 240.606(c)(3)(iv), (d)(4)(iv) and (e)(3)(iv) for ''. . .control and warning levels identified in. . .shall be adjusted when the RPE of at least 20 spike results has been calculated'' may be too burdensome. The Board agrees and has amended these sections in this final-form rulemaking accordingly.
One commentator noted that there is no place to report data about passive system installations and failures. The Board clarified that there are codes for reporting passive systems into Greenport, the Department's web-based method to report radon activities. The Department will consider adding a code to Greenport for failures.
Several commentators recommended eliminating an exception for new construction in § 240.2 because new construction homes should be built in accordance with radon resistant new construction (RRNC) standards. The commentators stated that data indicates a 40% failure rate when builder RRNC pre-pipe is activated, which occurs because builders are not certified under these regulations to install RRNC correctly. The Board will explore removing this exemption in a future rulemaking, to allow public comment from all stakeholders.
One commentator questioned whether § 240.2(a)(5) means that a real estate agent that buys and distributes but does not place or retrieve secondary devices is exempt from the regulations, and whether a home inspector placing and retrieving secondary devices and getting the lab's report is not exempt. The Board notes that § 240.2(a)(5) does not apply to a real estate agent, but it does apply to the home inspector.
One commentator and IRRC questioned why a certified individual cannot also be a firm employee in proposed §§ 240.102(b)(2) and 240.122(b)(2). The Board has deleted the proposed language that would have prohibited a certified individual from being a firm employee in this final-form rulemaking.
Several commentators questioned what training course or exam the Department requires for new radon firm employees in proposed §§ 240.102(b)(4)(iii) and 240.112(b)(4)(iii). The Board has removed the requirement for firm employees to pass a Department-approved radon course. This requirement has been replaced in this final-form rulemaking with initial training requirements that can be given by the firm's certified individual or through a Department-approved course.
Two commentators noted that the requirement for laboratories to report the status of a radon mitigation system is burdensome because it is difficult to get the required information from the consumer. The Board recognizes this concern and has added ''as available'' at the end of § 240.303(1) in this final-form rulemaking so that the report forms contain all information available to the lab.
One commentator and IRRC noted that the proposed provision in § 240.309(a)(4)(v)(G) states that the mitigation system must be functioning during the test period. They recommended that the final regulation address the situation in which a mitigation system is not functional. The Board notes that § 240.309 was renumbered as § 240.310 in the final-form rulemaking and subsection (a)(4)(v)(G) was amended by adding, ''If the system is not functioning, the client must be notified immediately.''
One commentator suggested changing § 240.309(a)(7) to ANSI/AARST MAMF-2017 instead of ANSI/AARST MSMF-2010. The Board appreciates the correction and has made the suggested change in the final-form rulemaking. In the final-form rulemaking, § 240.309 is renumbered as § 240.310.
One commentator questioned why DEP does not use all of the more current ANSI/AARST Standards instead of relying on several antiquated standards. The commentator does not see how most of the proposed regulation will aid in the effort to save lives, as was the intention of the EPA and the Department in 1987. The Board believes that the standards used in this regulation are not antiquated and provide the necessary protections to test for and mitigate radon exposure. The intent of the regulations is to ensure that radon service providers are properly trained and qualified, and the standards are being followed to reduce the public's risk to radon exposure. Therefore, no change was made in this final-form rulemaking.
G. Benefits, Costs and Compliance
Benefits
As set forth in this final-form rulemaking, users of radiation sources will be required to comply with radiation protection standards that will not only protect and benefit employees but will also protect and benefit the general public. This final-form rulemaking will ensure that trained professionals are operating these radiation sources so that both the patient and the operator are adequately protected.
The amendments to the radon certification regulations in this final-form rulemaking add clarity to the application and reporting requirements, making it easier for the regulated community to understand what is required during each process. The amendments to the testing and mitigation protocols and QA and QC requirements ensure that the radon services provided to the public will protect public health and welfare from the dangers of radon. The QA and QC requirement amendments also benefit the regulated community by eliminating certain equipment check requirements when the equipment is not used. They also remove cross-checks and duplicate tests for testers who use continuous monitors and continuous working level monitors. This final-form rulemaking will eliminate the requirement to have 1 year of radon testing experience prior to certification as a radon tester. This will benefit the regulated community by simplifying and shortening the process for an individual to become certified to test for radon.
Residents of this Commonwealth; including those who have tested their homes for radon and subsequently taken action to reduce high levels with a certified radon mitigation contractor, will benefit from continued strong regulatory oversight of the radon industry, by assuring that testing is done properly and that mitigation systems are installed according to Department standards.
Compliance costs
Minor costs may be experienced regarding the amendments in this final-form rulemaking to Chapters 215—221, 223—228, 230 and 232 if businesses are not following the standard industry practices codified therein. Some requirements in the final-form rulemaking are already required by insurance companies (including Medicare and Medicaid) or are contained in technical guidance documents. Therefore, because these standards are already implemented by the regulated community, the Board does not foresee increased costs resulting from this final-form rulemaking.
The amendments to Chapter 240 in this final-form rulemaking pertaining to reinstating previously withdrawn certifications will decrease costs for, and will benefit, the regulated community which will no longer need to pay certification fees to reinstate a withdrawn certification. Depending upon the type of certification, this amendment will save a firm or individual $450 to $1,125 when a firm or individual seeks to reinstate a withdrawn certification. See Chapter 240, Appendix A (relating to radon certification fee schedule). The standards codified in this final-form rulemaking are already common practice in the radon industry. Some minor business costs may be experienced if firms are not already following these standards. Therefore, because these standards are already implemented by the regulated community, the Board does not foresee increased costs resulting from this final-form rulemaking.
Compliance Assistance Plan
Outreach and support will be provided by regional inspectors and technical staff of the Department's Radiation Control and Radon Divisions. The majority of amendments clarify references; definitions are self-explanatory. Assistance will be offered to explain acceptable requirements for addressing new technologies.
Paperwork requirements
This final-form rulemaking amends various records retention requirements to a 5-year period. This change was suggested by the RPAC to promote consistency throughout the radiological health regulations. These records need not be in paper format and may be stored electronically.
This final-form rulemaking adds requirements for certified radon firms and radon firm employees to document continuing education for firm employees. Continuing education records are required to be retained for 5 years. This requirement was added to this final-form rulemaking because the proposed requirement to limit certified firms to 5 employees, which was aimed at addressing span of control issues, was removed based on comments from IRRC and the public. Requiring this documentation will allow the Department to ensure that certified individuals in responsible charge of firm activities are adequately training firm employees. These records need not be in paper format and may be stored electronically.
H. Pollution Prevention
Pollution prevention is not applicable to this rulemaking.
I. Sunset Review
The Board is not establishing a sunset date for these regulations because they are needed for the Department to carry out its statutory authority. The Department will continue to closely monitor these regulations for their effectiveness and recommend updates to the Board as necessary.
J. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on April 21, 2017, the Department submitted a copy of the notice of proposed rulemaking, published at 47 Pa.B. 2722 (May 13, 2017), to IRRC and the Chairpersons of the House and Senate Environmental Resources and Energy Committees for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing this final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act, on August 15, 2018, this final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on August 16, 2018, and approved this final-form rulemaking.
K. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201 and 1202) and regulations promulgated thereunder at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of the proposed rulemaking published at 47 Pa.B. 2722 (May 13, 2017).
(4) These regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this final-form rulemaking.
L. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapters 215—221, 223—228, 230, 232 and 240, are amended by adding §§ 221.16, 221.50, 221.63, 221.64, 221.65, 223.31, 230.15, 240.141—240.143, 240.310, 240.601—240.606, Appendix B and Appendix C, deleting §§ 217.133, 218.11a, 240.304, 240.501 and 240.502, and amending §§ 215.12, 215.14, 215.22, 215.24, 215.31, 215.41, 216.1, 216.2, 216.2a, 216.2b, 216.3, 217.1, 217.131, 217.132, 217.142, 217.143, 217.152, 217.162, 217.172, 217.182, 217.202, 218.1, 218.11, 219.3, 219.6, 219.229, 220.2, 220.10, 221.1, 221.2, 221.11, 221.21, 221.25, 221.35a, 221.61, 221.71, 221.201, 221.202, 221.204, 221.205, 223.1, 223.22, 224.11, 225.3a, 225.4a, 225.81, 226.5, 227.11a, 228.11a, 228.21a, 228.35, 228.36, 228.61, 228.72, 228.73, 228.75, 230.4, 232.3, 240.1—240.3, 240.101—240.104, 240.111—240.114, 240.121—240.124, 240.132, 240.133, 240.201—240.205, 240.301—240.303, 240.305—240.308 and 240.401 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson of the Board shall submit this order and Annex A to IRRC and the Senate and House Environmental Resources and Energy Committees as required by the Regulatory Review Act (71 P.S. §§ 745.1—745.14).
(d) The Chairperson of the Board shall certify this order and Annex A, as approved to legality and form, and deposit them with the Legislative Reference Bureau, as required by law.
(e) This order shall take effect 90 days after publication in the Pennsylvania Bulletin.
PATRICK McDONNELL,
Chairperson(Editor's Note: Chapters 224, 226 and 232 were not part of the proposed rulemaking. Amendments to §§ 224.11, 226.5 and 232.3 are included in this final-form rulemaking.)
(Editor's Note: Proposed § 221.57 is renumbered as § 221.50 in this final-form rulemaking.)
(Editor's Note: Section 240.309 was added in the final-form rulemaking published at 47 Pa.B. 6482 (October 21, 2017). Therefore, proposed § 240.309 is renumbered as § 240.310, in this final-form rulemaking.)
(Editor's Note: See 48 Pa.B. 5576 (September 1, 2018) for IRRC's approval order.)
Fiscal Note: Fiscal note 7-499 remains valid for the final adoption of the subject regulation.
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
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 for facilities of use identified in a license or registration issued under this article.
(b) Rights of the Department. The Department and its agents and employees will:
(1) Have access to, and require the production of, books, papers, documents and other records and physical evidence pertinent to a matter under investigation.
(2) Require a registrant or licensee to make reports and furnish information as the Department may prescribe.
(3) Enter the premises of a licensee or registrant for the purpose of making an investigation or inspection of radiation sources and the premises and facilities where radiation sources are used or stored, necessary to ascertain the compliance or noncompliance with the act and this chapter and to protect health, safety and the environment.
(4) Secure or lock-down a device if a radiation source is abandoned or poses a threat to public health, safety or the environment.
(c) Inspections and investigations by the Department. 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.
(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.
The following Department records will not be disclosed to the public or to a litigant absent a court order 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:
(1) Trade secrets or secret industrial processes customarily held in confidence.
(2) A report of investigation which would disclose the institution, progress or results of an investigation undertaken by or at the direction of the Department or other governmental agency.
(3) Personnel, medical and similar records, the disclosure of which would be reasonably likely to result in a substantial and demonstrable risk of physical harm to or the personal security of an individual.
(4) Location, identification, safeguards, security measures or other security-related information relating to a radiation source.
(5) A record designated as classified by a Federal or State authority.
(6) A record exempt from disclosure under any Federal or State law or regulation, or judicial order or decree.
(7) Any other record maintained by the Department, the disclosure of which may endanger or threaten public health, safety or preparedness.
PROHIBITIONS AND RESTRICTIONS § 215.22. Prohibited uses.
(a) No person may operate or maintain within this Commonwealth devices or machines which use X-ray or radiologic technology for human nonmedical use without prior written approval of the Department.
(1) A person requesting the Department to approve the nonmedical human use of radiation shall submit written information describing the proposed use to the Department for evaluation.
(2) The Department will consider efficacy of the device or procedure as a factor when evaluating the proposed nonmedical human use of radiation.
(b) Hand-held fluoroscopic screens may not be used.
§ 215.24. Human use.
* * * * * (b) Auxiliary personnel employed by a licensed practitioner of the healing arts at the location at which the licensed practitioner practices or employed by a health care facility may use radiation sources in the healing arts provided those individuals comply with the applicable requirements of 49 Pa. Code Part I, Subpart A (relating to professional and occupational affairs), located in the following chapters:
* * * * * (7) Chapter 33 (relating to the State Board of Dentistry).
(c) Subsection (b) notwithstanding, human use of radiation sources is permitted by individuals enrolled in clinical training programs that satisfy the related accreditation requirements of the boards in subsection (b) and who are under the supervision of a licensed practitioner of the healing arts or of auxiliary personnel authorized under subsection (b) to use radiation sources in the healing arts.
EXEMPTIONS § 215.31. Granting exemptions.
(a) The Department may grant exemptions from this article on its own initiative or upon application from a licensee when the Department determines that the exemptions do not result in significant risk to the health and safety of the public and safeguards that provide equivalent levels of protection in this article are implemented.
(b) The Department will not grant exemptions to the fee requirements in § 218.11 (relating to registration, renewal of registration and license fees).
COMMUNICATIONS § 215.41. Contact Information.
Communications and reports concerning this article and applications filed under it shall be addressed to the Bureau of Radiation Protection, Department of Environmental Protection, Post Office Box 8469, Harrisburg, Pennsylvania 17105-8469; (717) 787-2480; www.dep.pa.gov.
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) or a person performing electronic brachytherapy as defined in § 221.2 (relating to definitions) is exempt from the requirements of § 216.2 (relating to registration of radiation-producing machines).
(1) Accelerators are licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators).
(2) Electronic brachytherapy operations are licensed under Chapter 221 (relating to X-rays in the healing arts) and must comply with §§ 221.71—221.76 (relating to therapeutic X-ray systems with energies less than 1 MeV).
(c) License fees are specified in § 218.11(d) (relating to registration, renewal of registration and license fees).
§ 216.2. Registration of radiation-producing machines.
(a) A person possessing a radiation-producing machine shall:
(1) Register with the Department within 30 days after acquisition. Registration shall be completed on forms furnished by the Department and shall contain information required on the form and accompanying instructions.
(2) Designate on the registration form an individual to be responsible for radiation protection.
(3) Notify the Department in writing within 30 days of a change in name, address, owner or the individual designated under paragraph (2) to be responsible for radiation protection.
(4) Maintain a written inventory to include, at a minimum, the type and location of all radiation-producing devices.
(5) For registrants offering mobile services, have a current schedule, including the date and location where services are to be performed, available for inspection by the Department.
(b) The registration becomes valid upon receipt of the properly completed registration form and the fee required under Chapter 218 (relating to fees).
* * * * * § 216.2a. Registration of radiation-producing machine service providers.
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(k) (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(k) has been paid.
(4) X-ray registrants who employ in-house service providers are exempt from this section but are subject to the requirements of 21 CFR 1020.30 (relating to diagnostic X-ray systems and their major components).
§ 216.2b. Reporting and recordkeeping requirements for registered radiation-producing machine service providers.
* * * * * (b) Services performed 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).
* * * * * (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.
(e) A radiation-producing machine service provider shall comply with the requirements of Chapter 219 (relating to standards for protection against radiation).
§ 216.3. Exemptions.
The following radiation-producing machines or equipment are exempt from registration:
(1) Electrical equipment that produces radiation incidental to its operation for other purposes, if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 mrem (0.005 mSv) per hour at 5 centimeters from an accessible surface. The production, testing or factory servicing of the equipment are not exempt. Electron beam welders and electron microscopes are not exempt.
(2) Radiation-producing machines while in transit in the possession of a transport carrier.
(3) Radiation-producing machines in the possession of vendors, installers or persons engaged in the service or repair of the machines, if applicable persons who have these machines register their activities with the Department under § 216.6 (relating to transfer and disposal obligations).
(4) Accelerators, which are 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 service providers).
(5) Electronic brachytherapy operations, which are licensed under Chapter 221 (relating to X-rays in the healing arts) and comply with §§ 221.71—221.76 (relating to therapeutic X-ray systems with energies less than 1 MeV).
CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 217.1. Purpose and scope.
* * * * * (c) The use of radioactive material in this Commonwealth under a license issued by the NRC is exempt from the licensing requirements of this chapter.
Subchapter B. GENERAL PROVISIONS FOR RADIOACTIVE MATERIAL § 217.131. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 30.5, 30.6, 30.8, 30.21(c), 30.34(d), (e)(1) and (3), 30.41(b)(6), 30.55, 30.63 and 30.64 are not incorporated by reference.
§ 217.132. Effect of incorporation of 10 CFR Part 30.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 30 as follows:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
§ 217.133. (Reserved).
Subchapter C. GENERAL LICENSES FOR RADIOACTIVE MATERIAL § 217.142. Effect of incorporation of 10 CFR Part 31.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 31 (relating to general domestic licenses for byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 31 as follows:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
§ 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 1 mCi (37 MBq) or more of cobalt-57, cadmium-109, iron-55 or accelerator-produced material, as determined on the date of manufacture, or 0.1 mCi (3.7 MBq) or more of radium-226 shall also comply with all of the following:
* * * * *
Subchapter D. SPECIFIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL § 217.152. Effect of incorporation of 10 CFR Part 32.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 32 as follows:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
Subchapter F. SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR RADIOACTIVE MATERIAL § 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 (relating to specific domestic licenses of broad scope for byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 33 as follows:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
Subchapter G. LICENSING OF SOURCE MATERIAL § 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:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
Subchapter H. LICENSING OF SPECIAL NUCLEAR MATERIAL § 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:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
Subchapter J. RECIPROCITY § 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 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:
* * * * * (5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
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).
(2) Is an applicant for or holder of a radioactive material license issued under Chapter 217 (relating to licensing of radioactive material).
(3) Is an applicant for or holder of an accelerator license issued under Chapter 228 (relating to radiation safety requirements for particle accelerators).
(4) Is an applicant for or holder of an electronic brachytherapy license issued under Chapter 221 (relating to X-rays in the healing arts).
PAYMENT OF FEES § 218.11. Registration, renewal of registration and license fees.
(a) Annual registration fees for radiation-producing machines are the sum of an annual administrative fee and an annual fee for each X-ray tube or radiation generating device and shall be paid as follows:
* * * * * (c) Annual license fees for radioactive material shall be paid as set forth in Appendix A (relating to fees for radioactive material licenses).
* * * * * (e) An initial application for a license or reciprocity shall be accompanied by a payment 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 shall be paid 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.
(f) The Department will not accept an initial application for a license prior to payment of the fees required by subsections (c) and (d).
(g) If the registration involves more than one of the facilities in subsection (a), or if a license involves more than one of the categories in subsection (c), the highest applicable fee applies.
(h) The fee schedule in subsection (a) is not applicable to accelerators, emerging technology devices or electronic brachytherapy.
(i) Electronic brachytherapy devices are licensed under Chapter 221 (relating to X-rays in the healing arts). The annual fee is $1,000 for the first unit (controller) at the facility plus $100 for each additional unit at that facility.
(j) Emerging technology devices require Department safety review and approval prior to use. The registrant shall pay a fee equal to the full cost of Department staff time, as specified in Appendix A, for the review and approval process.
(k) A radiation-producing machine service provider shall pay an annual registration fee of $140.
(l) The Department will review the adequacy of the fees established in this section at least once every 3 years and provide a written report to the EQB. The report must identify any disparity between the amount of program income generated by the fees and the costs to administer these programs, and must contain recommendations to increase fees to eliminate the disparity, including recommendations for regulatory amendments to increase program fees.
§ 218.11a. (Reserved).
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS § 219.3. Definitions.
The following terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Medical reportable event for radiation-producing diagnostic or interventional X-ray procedures—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 unintended peak skin dose to the same area in a single procedure greater than 1500 rad (15 Gy).
(ii) An unintended dose, other than skin dose, in a single procedure exceeding five times the facility's established protocol and 50 rad (0.5 Gy) to any organ.
(iii) A dose to the wrong patient, or wrong site for the entire procedure, and exceeding 50 rad (0.5 Gy) to any organ.
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, wrong treatment site or using a treatment delivery intended for another individual.
(ii) An administration of a dose for therapy identified in a written directive that differs from the prescribed dose for the treatment site or any other organ from the intended prescribed dose, by one of the following:
(A) More than 20% of the total prescribed dose.
(B) Exceeds 30% of the weekly prescribed dose.
(C) Exceeds 50% of a single fraction dose of a multifraction plan.
§ 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:
* * * * * (7) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department, except as required under 10 CFR 20.2206 (relating to reports of individual monitoring).
(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.
Subchapter M. REPORTS § 219.229. Diagnostic or interventional procedure medical reports.
(a) Within 30 days of the determination by a physician of either actual or suspected acute or long-term functional damage to an organ or a physiological system of a patient exposed to radiation from a diagnostic or interventional procedure 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 organ or a physiological system that was an expected outcome when the causative procedures were prescribed.
(b) Upon discovery of a medical reportable event, the registrant or licensee shall:
(1) Notify the Department regarding the medical reportable event within 1 business day.
(2) Provide a written report, including the analysis of the medical reportable event, by the qualified medical physicist, as defined in § 221.2 (relating to definitions), to the Department within 15 business days.
(3) Provide a clinical summary to the prescribing physician and patient within 15 business days.
(4) Maintain a record of the medical reportable event as part of the patient's permanent medical record.
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 2900-FM-BRP0003, ''Notice to Employees,'' shall be posted by a licensee or registrant as required by this article.
* * * * * § 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; inspection and investigations), the following words and phrases shall be substituted for the language in 10 CFR Part 19 as follows:
* * * * * (4) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department.
CHAPTER 221. X-RAYS IN THE HEALING ARTS
GENERAL PROVISIONS § 221.1. Purpose and scope.
This chapter establishes requirements for the use of X-ray equipment by or under the supervision of a licensed practitioner of the healing arts. A registrant or licensee who uses X-rays in the healing arts shall comply with this chapter. This chapter is in addition to, and not in substitution for, other applicable provisions of this article.
§ 221.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
AAPM—American Association of Physicists in Medicine.
Air kerma—Kerma in air.
Air kerma rate—Air kerma per unit time.
Aluminum equivalent—The thickness of type 1100 aluminum alloy—the nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper—affording the same attenuation, under specified conditions, as the material in question.
Automatic exposure control—A device which automatically controls one or more technique factors to obtain at preselected locations a desired quantity of radiation.
Beam axis—A line from the source through the centers of the X-ray fields.
Beam-limiting device—A device providing a means to restrict the dimensions of the X-ray field.
CBCT—Cone beam computed tomography—A digital volume tomography method used in some imaging applications using two-dimensional digital detector arrays and a cone-shaped X-ray beam, instead of fan-shaped, that rotates around to generate a high-resolution 3D image with high geometric accuracy. Reconstruction algorithms can be used to generate images of any desired plane.
CINE—Cineradiography—A motion picture record of successive images appearing on a fluoroscopic screen.
CR—Computed radiography—A digital X-ray imaging method in which a photo-stimulable phosphor is used to capture and store a latent image. The latent image is read out by stimulating the phosphor with a laser. CR systems may use cassettes to house the phosphor or it may be integrated into a DR system.
CT—Computed tomography—The production of a tomogram by the acquisition and computer processing of X-ray transmission data.
Cephalometric device—A device intended for the radiographic visualization and measurement of the dimensions of the human head.
* * * * * Control panel—The part of the X-ray control upon which are mounted the switches, knobs, pushbuttons and other hardware necessary for manually setting the technique factors.
DDR—Direct digital radiography—An X-ray imaging method in which a digital sensor, usually incorporating a thin-film transistor, is used to capture an X-ray image. Some DDR systems use a scintillator to convert X-rays to light and a photodiode array to convert light to charge, while others use a photoconductor to convert X-rays directly to charge, which is stored on the thin-film transistor.
DR—Digital radiography—
(i) An X-ray imaging method (or radiography) which produces a digital rather than film projection image.
(ii) The term includes CR and DDR.
DRL—Diagnostic reference level—An investigational level, set as a standard by a recognized body (for example, the American College of Radiology, the American Association of Physicists in Medicine, the National Council on Radiation Protection and Measurements or similar), used to identify unusually high radiation doses for common diagnostic medical X-ray imaging procedures. DRLs are suggested action levels above which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses. DRLs should not be applied to an individual patient.
Dead-man switch—A switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.
Dental panoramic system—A device intended to produce a radiographic image of both dental arches on one film.
Diagnostic source assembly—The tube housing assembly with a beam-limiting device attached.
Diagnostic X-ray system—An X-ray system designed for irradiation of a part of the human body for the purpose of diagnosis or visualization.
Direct supervision—A licensed practitioner of the healing arts who exercises general supervision and is present in the facility and immediately available to furnish assistance and direction throughout the performance of the procedure. The licensed practitioner does not have to be present in the room when the procedure is being performed.
Dose length product—The indicator of the integrated radiation dose from a complete CT examination. It addresses the total scan length by the following formula:
DLP (mGy − cm) = CTDIvol (mGy) × scan length (cm)
Electronic brachytherapy—A modality of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage. X-ray devices specifically designed and solely used to treat skin cancer lesions are not considered electronic brachytherapy devices under this definition and must meet the applicable parts of this title pertaining to registration and use.
Emerging technology—An innovative medical technology that uses an ionizing radiation source.
Entrance exposure rate—The exposure in air per unit time at the point where the center of the useful beam enters the patient.
FGI—Fluoroscopic-guided interventional procedures—An interventional diagnostic or therapeutic HIGH-RISK procedure performed by means of percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to do all of the following:
(i) Localize or characterize a lesion, diagnostic site or treatment site.
(ii) Monitor the procedure.
(iii) Control and document the procedure.
Field emission equipment—Equipment using an X-ray tube in which electrons are emitted from the cathode solely by the force between an electric field and the electrons.
Filter—Material placed in the useful beam to modify the spectral energy distribution and flux of the transmitted radiation and preferentially absorb selected radiation.
Filtration—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.
Fluoroscopic imaging assembly—A subsystem in which X-ray photons produce a fluoroscopic image. The term includes the image receptors such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
Fluoroscopic system—See fluoroscopic imaging assembly.
Focal spot—The area projected on the anode of the X-ray tube by the electrons accelerated from the cathode and from which the useful beam originates.
General supervision—The overall direction and control of a licensed practitioner of the healing arts. The licensed practitioner is not required to be present during the performance of the procedure.
HVL—Half-value layer—
(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.
Health physics—An application of physics concerned with protection of people and the environment from the biological effects of radiation.
High-risk procedure—Any radiologic procedure that uses energies of less than 1 million electron volts that could exceed skin doses of 200 rad (2.0 Gy).
IORT—Intraoperative radiation therapy—A modality of therapy in which therapeutic levels of ionizing radiation are applied to a target area, such as a cancer tumor, while the area is exposed during surgery.
Image intensifier—An image receptor with electronic amplification, installed in its housing, which instantaneously converts an X-ray pattern into a corresponding light image of higher energy density.
Image receptor—A device, such as a fluorescent screen or radiographic film, which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.
Intensifying screen—A fluorescent screen which transforms incident X-ray photons into a visible image.
Intraoral dental radiography—A modality of dental radiography in which the image receptor is placed inside a patient's oral cavity.
kV—Kilovolts
kVp—Peak tube potential (see kilovolts peak).
Kerma—A measure of energy transferred from radiation to matter and means kinetic energy released per unit mass. It is related to, but not the same as, absorbed dose. Unit of measure is gray.
Kilovolts peak (kVp)—The maximum value of the potential difference across the X-ray tube during an exposure.
* * * * * Line-voltage regulation—The difference between the no-load and the load line potentials expressed as a percent of the load line potential calculated using the following equation:
Percent line-voltage regulation = 100 (Vn − V1)/V1
where
Vn = No-load line potential and
V1 = Load line potential.
Low-risk procedure—Any radiologic procedure that is not a high-risk procedure.
mA—Milliampere.
mAs—Milliampere second.
mR—Milliroentgen.
Maximum line current—The root-mean-square current in the supply line of an X-ray machine operating at its maximum rating.
Medical physics—An application of physics that addresses the needs of medicine or health care. Subfields of medical physics include the following:
(i) Therapeutic medical physics.
(ii) Diagnostic medical physics or imaging.
(iii) Nuclear medical diagnostic or molecular imaging and therapy.
(iv) Medical health physics or radiation protection.
Mobile X-ray system—See X-ray equipment.
Patient—An individual subjected to healing arts examination, diagnosis or treatment.
Peak tube potential—The maximum value of the potential difference across the X-ray tube during an exposure.
Performance phantom—A device specifically approved by the QMP or QE for evaluation of operational conformance with tolerances established by the QMP, QE or manufacturer.
Personal supervision—A licensed practitioner of the healing arts who exercises general supervision and is present in the room or adjacent control area during the performance of the procedure.
Phototimer—A method for controlling the radiation exposures to an image receptor by measuring the radiation which reaches a radiation monitoring device. The radiation monitoring device is part of an electronic circuit which controls the duration of time the tube is activated.
* * * * * Protective barrier—A barrier of radiation absorbing material used to reduce radiation exposure. The term includes the following types:
(i) Primary protective barrier—Material used to reduce radiation exposure from the useful beam.
(ii) Secondary protective barrier—Material used to reduce exposure from stray, leakage or scattered radiation.
QE—Qualified expert—The term as defined in § 215.2 (relating to definitions).
QMP—Qualified medical physicist—An individual who is competent to independently provide clinical professional services and practices only in health or radiological physics, or in the subfields of medical physics.
(i) A QMP meets all of the following credentials:
(A) Certified in the field of medical physics, radiological physics, medical health physics or health physics by an appropriate national certifying body recognized by the Department.
(B) Complies with the certifying body's requirements for continuing education and recertification.
(C) Provides clinical professional services and practices only in health/radiological physics or in one or more of the subfields of medical physics, consistent with the individual's training and experience, and in accordance with the individual's respective certifying body's code of ethics.
(ii) An individual who does not meet the requirements of subparagraph (i) shall meet each of the following credentials to qualify as a QMP:
(A) Has earned a master's or doctoral degree, or both, in physics, medical physics, biophysics, radiological physics, health physics or equivalent disciplines from an accredited college or university.
(B) Has 3 years of documented relevant clinical training and experience in each of the subfields in the definition of ''medical physics,'' under the supervision of a QMP who is qualified to practice in the same subfield, for each of the areas in which the individual intends to practice.
(C) Completes the continuing education requirements of an applicable certifying body of health/radiological physics or in one or more of the subfields of medical physics in which the individual practices.
(iii) An individual who has been practicing as a QMP in health/radiological physics or in one or more of subfields of medical physics for at least 5 years prior to January 24, 2019, is exempt from the requirements of subparagraphs (i) and (ii). Documentation of at least 5 years of practicing as a QMP in health/radiological physics or in one or more of the subfields of medical physics must be maintained for each of the fields or subfields, or both, in which the individual practices. As of January 24, 2019, an individual who qualifies as a QMP under this subparagraph shall meet the continuing education requirements in subparagraph (ii)(C).
Radiation therapy simulation system—A radiographic or fluoroscopic X-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
Radiograph—An image receptor on which an image is created directly or indirectly by an X-ray pattern and results in a permanent record.
Radiographic imaging system—A system whereby an image is produced on an image receptor by the action of ionizing radiation.
Radiological physics—See health physics.
Rating—The operating limits specified by the component manufacturer.
Registrant—A person who is legally obligated to register with the Department under this article and the act.
Research—One of the following:
(i) Theoretical analysis, exploration or experimentation.
(ii) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental testing of models, devices, equipment, materials and processes. The term includes the external administration of X-ray radiation to human beings for diagnostic or therapeutic purposes or in an equivalent manner as a diagnostic or therapeutic procedure.
SID—Source-image receptor distance—The distance from the source to the center of the input surface of the image receptor.
SRDL—Substantial radiation dose level—An appropriately selected dose used to trigger additional dose-management actions during a procedure and medical follow-up for a radiation level that might produce a clinically relevant injury in an average patient.
SSD—The distance between the source and the skin of the patient.
Scattered radiation—Radiation that, during passage through matter, has been deviated in direction.
* * * * * Tube housing assembly—The tube housing with the X-ray tube installed. The term includes high-voltage or filament transformers, or both, and other appropriate elements when contained within the tube housing.
Unintended dose—A radiation dose in diagnostic or interventional X-ray resulting from an error in procedure or equipment malfunction.
Useful beam—The radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.
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