PROPOSED RULEMAKING
ENVIRONMENTAL
QUALITY BOARD
[ 25 PA. CODE CHS. 215—221, 223, 225, 227, 228, 230 AND 240 ]
Radiological Health
[47 Pa.B. 2722]
[Saturday, May 13, 2017]The Environmental Quality Board (Board) proposes to amend Chapters 215—221, 223, 225, 227, 228, 230 and 240 to read as set forth in Annex A. The proposed rulemaking would amend 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 proposed rulemaking was adopted by the Board at its meeting on October 18, 2016.
A. Effective Date
This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact Joseph Melnic, Chief, Division of Radiation Control, P.O. Box 8469, Rachel Carson State Office Building, Harrisburg, PA 17105-8469, (717) 783-9730; or Keith Salador, Assistant Counsel, Bureau of Regulatory Counsel, P.O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 783-8075. Information regarding submitting comments on this proposed rulemaking appears in Section J of this preamble. Persons with a disability may use the AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This proposed rulemaking is available electronically through 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 proposed amendments to Chapters 215—221, 223, 225, 227, 228 and 230 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 of 1929 (71 P.S. § 510-20).
The proposed amendments to Chapter 240 (relating to radon certification) 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 of 1929.
D. Background and Purpose
The Board last updated its radiological health regulations in 2009 to provide for compatibility with the United States Nuclear Regulatory Commission's (NRC) regulations after the Commonwealth became an NRC Agreement State. Since that time, there have been significant technological advances in the use of radiation sources prompting the need to amend the radiological health regulations to establish and maintain adequate radiation protection standards and oversight.
The proposed amendments are based on standards set by the current 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 were first promulgated in 1991 and, other than minor amendments in 2004, 2008 and 2009, have not been significantly amended since that time. The proposed rulemaking would amend the radon certification application requirements and the reporting requirements for certified radon service providers to add clarity to both processes. The proposed amendments to the testing and mitigation protocol requirements and the quality assurance (QA) and quality control (QC) requirements would provide greater detail regarding how these programs should be designed and what goals they should accomplish.
As required under section 301(c)(14) of the Radiation Protection Act, the Department provided the Radiation Protection Advisory Committee (RPAC) with an opportunity to review the proposed rulemaking and to advise the Department prior to submittal to the Board. Beginning in 2014, the Department and the RPAC worked together over five RPAC meetings to develop this proposed rulemaking. On July 23, 2015, the RPAC endorsed the proposed rulemaking for presentation to the Board.
E. Summary of Regulatory Requirements
The following summary outlines the regulatory requirements that will be affected by this proposed rulemaking and describes the basis for the proposed amendments.
Chapter 215. General provisions
Proposed amendments to § 215.12 (relating to inspections and investigations) include a mechanism whereby the Department can secure or lock-down a radiation source device that is abandoned or poses a threat to public health, safety or the environment.
Proposed amendments to § 215.14 (relating to availability of records) clarify the scope of records regarding radiation sources prohibited from public access to protect public health, safety and the environment.
Proposed amendments to § 215.22 (relating to prohibited uses) expand this section's prohibition on use of nonmedical human use devices for the Department to determine efficacy of a procedure.
Section 215.24 (relating to human use) is proposed to be amended to apply the same X-ray operator requirements to all medical facilities for consistency throughout the regulated community.
Proposed amendments to § 215.31 (relating to granting exemptions) add clarity and reaffirm fee requirements to prevent regulatory confusion.
Chapter 216. Registration of radiation-producing machines and radiation-producing machine service providers
The amendment to § 216.1 (relating to purpose and scope) proposes the inclusion of licensing requirements for electronic brachytherapy devices. This is a new modality that was not previously addressed in the regulations.
Proposed amendments to § 216.2 (relating to registration of radiation-producing machines) clarify notification requirements for registrants. Specifically, in the notification requirements, radiation safety officer is proposed to be replaced with the individual responsible for radiation protection. A requirement is proposed to be added to have a written inventory that includes the type and location of all devices, and a current schedule that includes the date and location where mobile services are to be performed.
Proposed amendments to § 216.2a (relating to registration of radiation-producing machine service providers) delete transitional language from when service provider registration went into effect, and exempt in-house service providers.
Proposed amendments to § 216.2b (relating to reporting and recordkeeping requirements for registered radiation-producing machine service providers) clarify that radiation-producing machine service providers are not exempt from the radiation protection requirements in Chapter 219 (relating to standards for protection against radiation).
Proposed amendments to § 216.3 (relating to exemptions) make electronic brachytherapy operations exempt from registration but require licensure. X-ray tubes require registration; however, when tubes are used for electronic brachytherapy, a higher degree of oversight is necessary. This is due to a higher dose being administered in these procedures.
Chapter 217. Licensing of radioactive material
Proposed amendments to a number of sections delete the transitional language used when the Commonwealth became an Agreement State in 2008.
Proposed amendments to § 217.143 (relating to certain measuring, gauging or controlling devices) add three radioisotopes that are not referenced by 10 CFR 31.5 (relating to certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere). The NRC unintentionally omitted these three isotopes.
Chapter 218. Fees
Proposed amendments to § 218.1 (relating to purpose and scope) clarify that this section also applies to electronic brachytherapy license holders. Electronic brachytherapy is a new modality not previously addressed in the regulations.
Proposed amendments to § 218.11 (relating to registration, renewal of registration and license fees) address emerging technologies and include a fee for electronic brachytherapy devices at $1,000 annually for the first unit (controller) at a facility and $100 for each additional unit at that facility.
Section 218.11a (relating to special provisions for calculating fees during agreement state transition period) is proposed to be deleted as it is obsolete.
Chapter 219. Standards for protection against radiation
Proposed amendments to § 219.3 (relating to definitions) clarify the definition of ''medical reportable event for radiation-producing machine therapy'' by including actual criteria. A definition of ''medical reportable event for radiation-producing diagnostic or interventional X-ray procedures'' is proposed to be added.
Proposed amendments to § 219.6 (relating to effect of incorporation of 10 CFR Part 20) exempt the Radiation Exposure Information and Reporting System requirement. This requirement remains the responsibility of the NRC.
Proposed amendments to § 219.229 (relating to other medical reports) include additional requirements for reporting medical events such as interventional radiology, a modality not previously addressed in the regulations.
Chapter 220. Notices, instructions and reports to workers; inspections and investigations
Proposed amendments to § 220.10 (relating to effect of incorporation of 10 CFR Part 19) delete transitional language that is obsolete.
Chapter 221. X-rays in the healing arts
Proposed amendments to § 221.1 (relating to purpose and scope) add licensees to the scope of this chapter.
Proposed amendments to § 221.2 (relating to definitions) add definitions to support the addition of terms in §§ 218.11—221.205, including ''air kerma,'' ''air kerma rate,'' ''CBCT—cone beam computed tomography,'' ''CINE—cineradiography,'' ''CR—computed radiography,'' ''CT—computed tomography,'' ''DDR—direct digital radiography,'' ''DR—digital radiography,'' ''DRL—diagnostic reference level,'' ''dose length product,'' ''electronic brachy-therapy,'' ''emerging technology,'' ''FGI—fluoroscopic-guided interventional procedures,'' ''health physics,'' ''high-risk procedure,'' ''IORT—intraoperative radiation therapy,'' ''kerma,'' ''low-risk procedure,'' ''medical physics,'' ''performance phantom,'' ''QE—qualified expert,'' ''QMP—qualified medical physicist,'' ''radiological physics,'' ''SRDL—substantial radiation dose level'' and ''unintended dose.''
In addition, for clarity, definitions for all forms of supervision are proposed to be added, including ''direct supervision,'' ''general supervision'' and ''personal supervision.'' The definition of ''image intensifier'' is proposed to be amended to define it as an image receptor rather than a device.
Proposed amendments to § 221.11 (relating to registrant responsibilities) clarify continuing education requirements and expand the QA program. This includes clarifying how often continuing education should occur, and adding diagnostic reference levels, image quality and artifacts to be addressed by the QA programs. These amendments will ensure adequate radiation protection.
Proposed § 221.16 (relating to training, competency and continuing education) adds specific training for X-ray operations, competency in the operation, and continuing education requirements for registrants and licensees. Continuing education requirements include biological effects of radiation, QA and QC, and radiation safety.
Proposed amendments to § 221.21 (relating to diagnostic equipment requirements) require that new equipment comply with United States Food and Drug Administration (FDA) requirements, which will prevent a business, foreign or domestic, from selling noncertified devices.
Proposed amendments to § 221.25 (relating to beam quality) update Table II, X-ray tube voltage, to current FDA standards.
Proposed amendments to § 221.35a (relating to fluoroscopic X-ray systems) limit who can operate a fluoroscopic X-ray system for clinical purposes to licensed practitioners, radiologist assistants, registered technologists and students-in-training. Equipment evaluations, such as entrance exposure rates, maximum air kerma rates and high contrast resolutions, are proposed to be added. Requirements for fluoroscopic-guided interventional procedures, such as written procedures, records of policies and procedures, radiation output and peak skin dose, are proposed to be added.
Proposed § 221.57 (relating to facilities using CR or DR) adds QC program requirements for the relatively new imaging methods of computed radiography and digital radiography. These requirements address exposure indicators, image QC program, phantom image evaluation and manufacturer specifications.
Proposed amendments to § 221.61 (relating to radiation therapy simulation systems) clarify the oversight requirements for simulation systems. Requirements for simulation systems are not as arduous as diagnostic systems. Therefore, these systems only need to comply with certain radiological health regulations.
Proposed § 221.63 (relating to therapy imaging guidance systems) adds technical requirements for procedures using this new type of guidance system, such as QC procedures and methods addressing radiation safety.
Proposed § 221.64 (relating to CBCT) adds QC and evaluation requirements for cone beam computed tomography (CBCT) to address radiation safety. Radiation measurements for these units shall be evaluated annually and as soon as practical following any component repair. The operator shall have instructions on performing routine QC.
Proposed § 221.65 (relating to X-ray attenuation systems) clarifies the restrictions needed for this type of computed tomography (CT) system. These systems function differently than diagnostic systems and are required only to comply with §§ 221.202—221.205 unless they are exempted by other means.
Proposed amendments to § 221.71 (relating to equipment requirements) clarify the requirements that apply to electronic brachytherapy. This is a new modality, previously not addressed in the regulations, which is exempt from certain equipment requirements.
Proposed amendments to § 221.201 (relating to definitions) add definitions applicable to CT X-ray systems, including ''alert value,'' ''CT dosimetry phantom,'' ''CTDI100,'' ''CTDIvol,'' ''CTDIw,'' ''dose profile,'' ''Modulation transfer function'' and ''notification value.'' The definition of ''MSAD—multiple scan average dose,'' an obsolete term, is proposed to be deleted. The definition of ''CT number'' is proposed to be realphabetized and amended. The definition of ''CTDI—computed tomography dose index'' is proposed to be amended.
Proposed amendments to § 221.202 (relating to equipment requirements) require accreditation of all diagnostic CT X-ray systems, and safety information necessary for these potentially high-risk systems to be maintained and readily accessible to the operators to address radiation safety.
Proposed amendments to § 221.204 (relating to performance evaluations, routine QC and surveys) delete obsolete requirements, add performance evaluation requirements for CT X-ray systems to be performed by or under the direction of a qualified medical physicist (QMP), change performance evaluation procedures to routine QC procedures and add requirements for radiation protection survey and records management to address radiation safety.
Proposed amendments to § 221.205 (relating to operating procedures) add the requirement for operators to be appropriately trained in the specific techniques and modalities they will be utilizing.
Chapter 223. Veterinary medicine
Proposed amendments to § 223.1 (relating to purpose and scope) clarify that the safety requirements also apply to radiation sources being used in research on animals.
Proposed amendments to § 223.22 (relating to sealed and unsealed sources) add unsealed sources to the scope of this section because unsealed sources are now being used in animal therapy.
Proposed § 223.31 (relating to registrant responsibilities) adds responsibilities of the registrant, including responsibilities such as adequate instruction, written safety procedures, a QA program and continuing education to satisfy radiation safety requirements.
Chapter 225. Radiation safety requirements for industrial radiographic operations
Proposed amendments to § 225.3a (relating to effect of incorporation of 10 CFR Part 34) delete obsolete transitional language.
Proposed amendments to § 225.4a (relating to radiation safety program) add monitoring report requirements. These are individual monitoring reports required under 10 CFR 20.2206(a)(2) (relating to reports of individual monitoring).
Proposed amendments to § 225.81 (relating to permanent radiographic installations) rectify a typographical error in the citation to 10 CFR 34.53 (relating to posting) and require that records of tests performed for permanent radiographic installations be retained for 5 years as opposed to the current 3 years. This proposed change in records retention requirements was suggested by the RPAC to promote consistency throughout the radiological health regulations.
Chapter 227. Radiation safety requirements for analytical X-ray equipment, X-ray gauging equipment, electron microscopes and X-ray calibration systems
Proposed § 227.11a(i) (relating to equipment requirements) adds requirements for hand-held devices to address radiation safety. This is a new modality not previously addressed in the regulations.
Chapter 228. Radiation safety requirements for particle accelerators
Proposed amendments to § 228.11a (relating to licensee responsibilities) add qualification requirements for operators of accelerators used in the healing arts to address radiation safety. This includes operators who need additional instruction including certification in the applicable specialty.
Proposed amendments to § 228.21a (relating to notification and license requirements) delete an outdated requirement and increase the time in which to file an application for a specific license from 30 to 90 days after the initial order is issued to obtain any or all parts of an accelerator.
Proposed amendments to § 228.35 (relating to operating procedures) reduce the requirement for testing interlocks from quarterly to annually. Testing interlocks quarterly can be damaging to the accelerator because it forces a quick shutdown to the machine. The regulated community has recommended the need for no more than an annual test, and the Department's inspection records confirm that an annual test is sufficient to ensure that the interlocks are functioning properly. The proposed rulemaking would also require records to be maintained for 5 years instead of the current 4 years. This proposed change in records retention was suggested by the RPAC to promote consistency throughout the radiological health regulations. In addition, subsection (g)(5) is proposed to be renumbered as subsection (h) and proposed amendments clarify that it refers to both medical and nonmedical accelerator operations.
Proposed amendments to § 228.36 (relating to radiation monitoring requirements) change the annual check to daily testing to reflect current industry practice. The original rulemaking inadvertently required annual testing.
Proposed amendments to § 228.61(b) (relating to leakage radiation to the patient area) change ''[e]xisting equipment shall meet'' to ''[e]quipment manufactured or installed prior to July 17, 2004, must meet.''
Proposed amendments to § 228.72 (relating to selection of radiation type) clarify that this section refers to devices capable of X-ray therapy or electron therapy, or both.
Proposed amendments to § 228.73 (relating to selection of stationary beam therapy or moving beam therapy) clarify that this section refers to devices capable of stationary beam therapy or moving beam therapy, or both.
Proposed amendments to § 228.75 (relating to calibrations) include the addition of flattening filter free mode for calibration of a therapy beam.
Chapter 230. Packaging and transportation of radioactive material
Proposed § 230.15 (relating to packaging and transportation of unlicensed material) addresses unlicensed material, such as technologically enhanced naturally occurring radioactive materials, and the requirement to adhere to United States Department of Transportation regulations.
Chapter 240. Radon certification
A majority of amendments to this section codify current radon testing and mitigation protocols and standards being implemented by radon service providers.
Proposed amendments to § 240.1 (relating to description of regulatory structure) delete the cross-reference to Subchapter F (relating to interim certification), which is proposed to be deleted.
Proposed amendments to § 240.2 (relating to scope) revise certification exceptions from the building that the person occupies to the building in which the person resides for clarity. A new certification exception is proposed to be added to clarify existing requirements for employees of local governments and schools who perform radon testing.
Proposed amendments to § 240.3 (relating to definitions) add definitions applicable to Chapter 240, including ''AC—activated charcoal,'' ''ALARA—as low as reasonably achievable,'' ''AT—alpha track,'' ''alteration,'' ''blind study,'' ''CRM—continuous radon monitor,'' ''CWLM—continuous working level monitor,'' ''calibration,'' ''certification year,'' ''certified individual,'' ''client,'' ''control limit,'' ''diagnostic test,'' ''duplicate measurements,'' ''electret ion chamber,'' ''electret reader,'' ''electret voltage drift,'' ''field blank,'' ''firm employee,'' ''firm owner,'' ''LS—liquid scintillation,'' ''laboratory,'' ''lowest livable level,'' ''MV—measured value,'' ''measurement,'' ''mitigator,'' ''multifamily building,'' ''nonreported test,'' ''pCi/L—picocurie per liter,'' ''QA—quality assurance,'' ''QC—quality control,'' ''RPD—relative percent difference,'' ''RPE—relative percent error,'' ''RV—reference value,'' ''secondary device,'' ''secondary tester,'' ''sigma level,'' ''spiked measurement or spike,'' ''tester,'' ''WLM—working level month,'' ''WLM/yr—working level month per year'' and ''warning level.'' The proposed rulemaking also amends existing definitions for clarity and standardization, including ''firm,'' ''laboratory analysis,'' ''person,'' ''primary device,'' ''primary tester,'' ''test'' and ''WL—working level.''
Proposed amendments to § 240.101 (relating to requirements for radon testing certification) clarify this section, including adding that testers reading/analyzing their own continuous monitors or electrets are not required to become certified in radon laboratory analysis. This requirement is in place because of the ease of reading/analyzing these test devices due to advancements in technology. This also clarifies that prior to performing radon testing activities, a person shall obtain either a radon testing individual certification or Department listing as an employee of a testing firm.
Proposed amendments to § 240.102 (relating to prerequisites for radon testing certification) delete the 1-year radon testing experience requirement as it has proven to be prohibitive to persons becoming certified and is not necessary for the protection of the public. Proposed amendments clarify that it is the firm owner and the certified individual's responsibility to inform the Department of the loss of the certified individual. Proposed amendments clarify that a certified firm may only have one certified individual in responsible charge of a firm at a time to ensure clear lines of responsibility for accountability. Proposed amendments codify the limit on number of testing firm employees to a maximum of five to ensure adequate responsible charge by the certified individual. Proposed amendments specify the requirements for testing firm employee applications to include a completed application form, an identification card photograph, proof of passing an approved exam and the appropriate fee.
Proposed amendments to § 240.103 (relating to radon testing application contents) clarify language and add identification photograph and date of birth to the application requirements to ensure proper identity tracking of testers. Proposed amendments add the requirement to notify the Department of changes to the application within 10 days of each change to ensure compliance with the requirement to perform all radon activities in accordance with the application.
Proposed amendments to § 240.104 (relating to application filing deadline) specify when a testing individual renewal applicant can be assessed a late application fee and clarify that this late fee will not be assessed on any firm renewal applications.
Proposed amendments to § 240.111 (relating to requirements for radon mitigation certification) clarify that a certified firm may only have one certified individual in responsible charge of a firm at a time to ensure clear lines of responsibility for accountability. Proposed amendments also clarify that prior to performing radon mitigation activities a person shall obtain either a radon mitigation individual certification or Department listing as an employee of a mitigation firm.
Proposed amendments to § 240.112 (relating to prerequisites for radon mitigation certification) clarify this section, adding that it is the firm owner and the certified individual's responsibility to notify the Department of the loss of the certified individual. Proposed amendments codify the limit on the number of mitigation firm employees to a maximum of five to ensure adequate responsible charge by the certified individual. Proposed amendments specify the requirements for mitigation firm employee applications to include a completed application form, an identification card photograph and proof of passing an approved exam or course.
Proposed amendments to § 240.113 (relating to radon mitigation application contents) clarify language, add identification photograph and date of birth to the application requirements to ensure proper identity tracking of the mitigators, and add the requirement to notify the Department of any changes to the application within 10 days of each change to ensure compliance with the requirement to perform all radon activities in accordance with the application.
Proposed amendments to § 240.114 (relating to application filing deadline) specify when a mitigation individual renewal applicant can be assessed a late application fee and clarify that this fee will not be assessed on firm renewal applications.
Proposed amendments to § 240.121 (relating to requirements for radon laboratory certification) provide clarifying language. Proposed amendments also clarify that prior to performing radon laboratory activities a person shall obtain either a radon laboratory individual certification or Department listing as an employee of a laboratory firm.
Proposed amendments to § 240.122 (relating to prerequisites for radon laboratory certification) clarify the language, adding that it is the firm owner and the certified individual's responsibility to inform the Department upon the loss of the certified individual. Proposed amendments clarify that a certified firm may only have one certified individual in responsible charge of a firm at a time to ensure clear lines of responsibility for accountability. Proposed amendments specify the requirement for each laboratory firm employee applicant to submit a completed and signed laboratory firm employee application as provided by the Department, and the applicant shall receive written approval prior to conducting radon laboratory activities as a firm employee. Proposed amendments also clarify the limits of each laboratory employee's listing.
Proposed amendments to § 240.123 (relating to radon laboratory application contents) clarify language, add applicant's date of birth to ensure proper identity tracking and add the requirement to notify the Department of any changes to the application within 10 days of each change to ensure compliance with the requirement to perform all radon activities in accordance with the application.
Proposed amendments to § 240.124 (relating to application filing deadline) specify when a laboratory individual renewal applicant can be assessed a late application fee clarifying that this fee will not be assessed on firm renewal applications.
Proposed amendments to § 240.132 (relating to limited radon practice in this Commonwealth) make a grammatical change to clarify language.
Proposed amendments to § 240.133 (relating to certification application contents) clarify this section by adding date of birth requirements for individual applicants and adding the requirement to notify the Department of any changes to the application within 10 days of each change.
Proposed § 240.141 (relating to withdrawal of applications and certifications) specifies the requirements for withdrawing an individual or firm certification application, or both, or an individual certification and the process for reinstating a previously withdrawn individual or firm certification, or both. This includes that certification fees are not refundable for a withdrawal of any certification application. Proposed amendments also specify that previous individual or firm certification, or both, may be reinstated upon written request by the individual for an individual certification and by the firm owner for a firm certification for only the remainder of that certification period at no additional fees.
Proposed § 240.142 (relating to testing and mitigation identification cards) requires each mitigation and testing individual and each mitigation and testing firm employee to obtain a Department identification card. These identification cards are to be worn prominently and presented to a client upon request. This is being added to ensure the public has proper and current proof of certification at all times.
Proposed § 240.143 (relating to adding or removing devices from certification) explains that written requests signed by the certified individual shall be submitted to add or remove testing or lab devices, or both. The Department's written response letter will contain the add or remove date so that all parties are clear on exactly when a device has been added or removed from a certification.
Proposed amendments to § 240.201 (relating to criteria for issuance or denial of certifications or course provider applications) revise the section heading and subsections (a) and (b) to add reference to requirements for course provider's applications to ensure proper accountability and transparency about who is providing this educational service to the certified community.
Proposed amendments to § 240.202 (relating to terms of certification) clarify this section by changing ''other radon-related activity'' to ''laboratory analysis.''
Proposed amendments to § 240.203 (relating to conditions of certification) clarify this section and add the requirement for testing and laboratory individuals to pass blind studies conducted by the Department. This blind testing ensures accurate testing is being performed by the certified community with a percent error of less than or equal to +/- 25% of the reference value.
Proposed amendments to § 240.204 (relating to certification renewal) add that a certification renewal application needs to be submitted at least 30 days prior to the expiration of the current certification, and that the submittal of the renewal application does not extend that expiration date. Proposed amendments add that an individual certification application postmarked prior to 1 year after the expiration of the previous certification is considered a renewal application subject to the late application fee. An individual certification application postmarked 1 year or more after the expiration of the previous certification is considered an initial application subject to the initial application fee, but not the late application fee.
Proposed amendments to § 240.205 (relating to certification modification) clarify this section by adding that certifications may be subject to amendment, revision or modification by the Department for a violation.
Proposed amendments to § 240.301 (relating to advertising) clarify this section and add the requirement to include the valid certification number of the certified individual in advertisements to ensure proper accountability and enforcement capability.
Proposed amendments to § 240.302 (relating to required client information) revise the section heading, clarify this section and add the requirement that the tester, mitigator or laboratory shall present to the client a current Department-issued photo identification card.
Proposed amendments to § 240.303 (relating to reporting of information) clarify what information is to be reported to the Department by the primary certified testing, mitigation or laboratory individual. Proposed amendments also clarify that if radon-related activities are not performed during a 45-day period, a report of no activity shall be submitted to the Department by the end of that 45-day period in a Department-approved format. The Department currently collects this information through Greenport which has greatly minimized tracking and entry time. However, it has shown the data requirements needed to be clarified. Proposed amendments change the requirement of reporting the results in writing within 45 days to 10 days after testing or laboratory analysis to the owner or occupier of the building, and change ''owner or occupier of the building'' to ''client.''
Section 240.304 (relating to quality assurance program) is proposed to be deleted. The language of this section is moved to proposed § 240.603 (relating to QA program).
Proposed amendments to § 240.305 (relating to health and safety program) clarify this section and add requirements for radon mitigators to track exposure and retain these records for 5 years. The requirement for testers and laboratories to track exposure is proposed to be deleted because statistics prove their exposure is not even a fraction of the limit due to the short duration of their exposure. However, there is still the possibility that mitigators may reach or exceed the exposure limits.
Proposed amendments to § 240.306 (relating to continuing education program) clarify this section and specify that continuing education credit hours may only be used for one certification period for each certification activity to prevent the use of continuing education credits being used for more than one certification period.
Proposed amendments to § 240.307 (relating to radon measurement proficiency program) revise the section heading and clarify this section as well as the applicability of this requirement to initial primary tester and laboratory applicants only. This section is proposed to be amended to an initial applicant requirement only. Renewal applicants are not required to repeat this operator's proficiency requirement since they are operating these devices regularly as part of their certification.
Proposed amendments to § 240.308 (relating to radon mitigation standards) provide specific requirements for mitigation system installations including fan/fan discharge location, sealing, labeling and information required to be provided to the client. This section is to provide codification of requirements in the Pennsylvania Radon Mitigation Standards to ensure proper enforcement of these standards.
Proposed § 240.309 (relating to testing protocols) provides specific requirements for radon testing to codify United States Environmental Protection Agency (EPA) guidance to ensure proper enforcement capability—''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, and Radon Measurement in Schools (EPA 402-R-92-014). The following American National Standards Institute (ANSI) standard is included in this section—ANSI/AARST MAMF-2010 Protocol for Conducting Radon and Radon Decay Product Measurements in Multifamily Buildings. These additions include: placement criteria; closed house conditions; short-term, postmitigation, real estate, multifamily, school and commercial building testing; and testing of new construction and buildings under construction. This section will also specify that the result shall be given to the client within 10 working days and the information to be included on the Result Report Form provided to the client. The information on the radon test result report form is the only information the client receives about that test. To fully understand that result data such as location of test, calibration due date, test start and end date and time, type of device used, complete address of test location, the average and individual results of co-located devices, radon health risk information and, if applicable, the name and certification number of the lab must be included to have a meaningful test result. Reporting the result as a number in picocurie per liter is not sufficient or adequate.
Proposed amendments to § 240.401 (relating to inspection) correct minor grammatical errors.
Sections 240.501 and 240.502 (relating to scope; and reapplication when this chapter is adopted as final) are obsolete and proposed to be deleted.
Subchapter G (relating to QA requirements) is proposed to be added.
Proposed § 240.601 (relating to scope) applies QA requirements to testers and laboratories and their devices. This section clarifies that the requirements do not apply to testing performed only for diagnostics, because diagnostic testing is used only for performance of internal QA.
Proposed § 240.602 (relating to general requirements) requires QA records to be retained for 5 years and requires the certified individual to be responsible for the QA requirements regardless of who performs the QA activity.
Proposed § 240.603 is language proposed to be relocated from § 240.304, which is proposed to be deleted.
Proposed § 240.604 (relating to QA requirements for testing using primary devices) specifies all QA requirements for each primary testing device (continuous monitors, electret ion chambers and continuous working level monitors). This section states specific requirements for each of these devices and their frequency, logging requirements and control limits.
Proposed § 240.605 (relating to QA requirements for testing using secondary devices) includes QA requirements for each secondary testing device (activated charcoal, continuous monitor, working level monitors, alpha track detectors and electret ion chambers). This section states the specific requirements for each of these devices and their frequency, logging requirements and control limits.
Proposed § 240.606 (relating to QA requirements for laboratories) specifies QA requirements for each laboratory device (activated charcoal, continuous monitors, working level monitors, alpha track detectors and electret ion chambers). This section states the specific requirements for each of these devices and their frequency, logging requirements and control limits.
Proposed Appendix B (relating to non-interference agreement for real estate radon testing) specifies the minimum requirements for testing noninterference requirements maintained during a real estate transaction. The conditions are necessary to ensure valid radon test results.
Proposed Appendix C (relating to radon exposure tracking record) specifies the template that shall be used by radon mitigation service providers as part of their health and safety program to track radon exposure of employees under § 240.305. Tracking radon exposure is necessary to ensure that employees do not exceed recommended exposure limits.
F. Benefits, Costs and Compliance
Benefits
As set forth in this proposed rulemaking, users of radiation sources would be required to comply with radiation protection standards that would not only protect employees but would also protect the general public. The proposed rulemaking would ensure that trained professionals are operating these radiation sources so that both the patient and the operator are adequately protected.
The proposed amendments to the radon certification regulations would add clarity to the application and reporting requirements, making it easier for the regulated community to understand what is required during each process. The proposed amendments to the testing protocols and QA and QC requirements would ensure that the radon services provided to the public will protect the public's health and welfare from the dangers of radon. The proposed QA and QC requirements also benefit the regulated community by eliminating certain equipment check requirements when the equipment is not used and by removing cross checks and duplicate tests for testers who use continuous monitors and continuous working level monitors. The proposed amendments would eliminate the requirement to have 1 year of radon testing experience prior to certification, which would benefit the regulated community by simplifying and shortening the process for an individual to become certified to test for radon. Lastly, the proposed amendments codify the exemption from laboratory certification for certified primary testers who place, retrieve and analyze continuous monitors or electret ion chambers.
Compliance costs
The proposed amendments to Chapter 221 (relating to X-rays in the healing arts) require a QMP to perform various functions and may increase costs for a small percentage of registrants. A QMP would be required to, among other things, personally evaluate or direct the evaluation of fluoroscopic, CT and CBCT equipment, recommend imaging QC programs, review protocols, perform or direct the performance of radiation surveys, and provide analysis of medical events. The Department is proposing to add these requirements because QMPs are trained and most often certified in health physics disciplines, and their oversight of these functions would ensure adequate radiation protection standards are maintained. The vast majority of the regulated community is already employing QMPs in this capacity as it is standard industry practice, but there may be a small percentage of facilities that employ individuals that do not meet the proposed definition of QMP. The Department is proposing a ''grandfathering'' provision in the definition of QMP, which would further reduce the impact to the regulated community by allowing individuals who meet certain requirements to continue to perform the functions of a QMP as long as they complete continuing education requirements. A QMP typically charges a minimum of $150 per hour for services, and the small percentage of registrants who will be required to obtain the services of a QMP for these functions may see an increase in their costs.
The proposed amendments to the radon certification regulations pertaining to reinstating previously withdrawn certifications would decrease costs for and be a benefit to the regulated community because they will no longer be required to pay certification fees to reinstate a withdrawn certification. Depending upon the type of certification, this proposed amendment would save a firm or individual $300 to $750 when an individual or firm seeks to reinstate a withdrawn certification. See Chapter 240, Appendix A (relating to radon certification fee schedule).
The proposed amendments to the radon certification regulations requiring certified firms to employ one certified individual per five firm employees may increase costs for the regulated community. This proposed amendment would benefit the public because it would ensure that uncertified firm employees are being adequately supervised by the firm's certified individuals. Based on the current fee schedule, this proposed amendment may cost a certified firm an additional $300 every 2 years for each additional certified individual they are required to employ.
Compliance assistance plan
Outreach and support will be provided by regional inspectors and technical staff of the Department's Radiation Control Division. The majority of proposed amendments clarifying references and definitions are self-explanatory. Assistance will be offered to explain acceptable requirements for addressing new technologies.
Paperwork requirements
The proposed rulemaking would amend various records retention requirements to a 5-year records retention period. This proposed change was suggested by the RPAC to promote consistency throughout the radiological health regulations. These records do not need to be in paper format and may be stored electronically.
G. Pollution Prevention
Pollution prevention is not applicable to this proposed rulemaking.
H. Sunset Review
The Board is not establishing a sunset date for these regulations, since 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.
I. 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 this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) which have not been met. The Regulatory Review Act specifies detailed procedures for review prior to final publication of the rulemaking by the Department, the General Assembly and the Governor.
J. Public Comments
Interested persons are invited to submit written comments, suggestions, support or objections regarding the proposed rulemaking to the Board. Comments, suggestions, support or objections must be received by the Board by June 26, 2017.
Comments may be submitted to the Board online, by e-mail, by mail or by express mail as follows.
Comments may be submitted to the Board by accessing the Board's online comment system at http://www.ahs.dep.pa.gov/eComment.
Comments may be submitted to the Board by e-mail at RegComments@pa.gov. A subject heading of the proposed rulemaking and a return name and address must be included in each transmission.
If an acknowledgement of comments submitted online or by e-mail is not received by the sender within 2 working days, the comments should be retransmitted to the Board to ensure receipt. Comments submitted by facsimile will not be accepted.
Written comments should be mailed to the Environmental Quality Board, P.O. Box 8477, Harrisburg, PA 17105-8477. Express mail should be sent to the Environmental Quality Board, Rachel Carson State Office Building, 16th Floor, 400 Market Street, Harrisburg, PA 17101-2301.
PATRICK McDONNELL,
Acting ChairpersonFiscal Note: 7-499. No fiscal impact; (8) recommends adoption.
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.
* * * * * (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.
* * * * * § 215.14. Availability of records [for public inspection].
The following Department records [are not available for public inspection,] 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[, not pertaining to safety and health in industrial plants,] 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 [files] records, the disclosure of which would [operate to the prejudice or impairment of a person's reputation or personal safety] 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 [fitting] devices or machines which use [fluoroscopic,] X-ray or [radiation principles for the purpose of selling footwear through commercial outlets] 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) Auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government may only use radiation sources in the healing arts in accordance with written job descriptions and employee qualifications.
(d) Subsections (b) and (c)] (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 [subsections (b) and (c)] subsection (b) to use radiation sources in the healing arts.
EXEMPTIONS § 215.31. Granting exemptions.
(a) The Department may[, upon application therefor or upon its own initiative,] grant exemptions from this article on its own initiative or upon application from a licensee when the Department determines that [they] 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).
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) [and license].
(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 [of address, owner or radiation safety officer or number of machines] 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.
[After July 17, 2004, a] A person who engages in the business of assembling or installing radiation-producing machines or who offers to assemble or install radiation-producing machines or who is in the business of furnishing or offering to furnish radiation-producing machine servicing or services or who is in the business of selling, leasing or lending radiation-producing machines in this Commonwealth shall apply for registration of the activities with the Department prior to furnishing or offering to furnish those services.
(1) Registration is for 12 months and is renewable.
(2) An application for registration or renewal will not be accepted unless accompanied by the appropriate fee specified in [§ 218.11(h)] § 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(h)] § 218.11(k) has been paid.
(4) [A person who, on July 17, 2004, is currently in the business of providing radiation-producing machine services shall apply for registration by September 15, 2004.] 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 [under preventative maintenance] that do not involve replacement or refurbishing of major X-ray system components are exempt from the reporting requirements specified in this section except subsection (d).
* * * * * (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 .5 mrem (.005 mSv) per hour at 5 centimeter 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 are exempt from registration.] Accelerators [shall be], 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 [until the Commonwealth becomes an agreement state on the date published in the Federal Register].
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(a)(6)] 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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
§ 217.133. [Persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register] (Reserved).
[On the date the Commonwealth becomes an agreement state as published in the Federal Register, a person who possesses a general or specific license issued by the NRC for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass, is deemed to possess a like license issued under this chapter and the act. The license shall expire either 90 days after receipt from the Department of a notice of expiration of the license, or on the date of expiration specified in the NRC license, whichever is earlier.]
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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
§ 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 37 MBq (1 mCi) or more of cobalt-57, cadmium-109, iron-55 or accelerator-produced material, as determined on the date of manufacture, or 3.7 MBq (0.1 mCi) or more of radium-226 shall also comply with 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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
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[, other than accelerators,] 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 [are] 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 check payable to the Department in accordance with the fee schedules in subsections (c) and (d). Thereafter, the Department will issue an annual fee invoice in accordance with the appropriate fee schedule at least 2 months prior to the license expiration. Fees [are payable] 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.
[(h)] (k) A radiation-producing machine service provider shall pay an annual registration fee of $140.
[(i)] (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. [Special provisions for calculating fees during agreement state transition period] (Reserved).
[(a) The fees for the NRC licenses that are transferred to the Commonwealth on the date the Commonwealth becomes an agreement state will be invoiced on the license's next anniversary date.
(b) During the first year after the date the Department attains agreement state status, the annual fee for each NRC license transferred to the Commonwealth will include a proportional amount, based on the schedule of fees in Appendix A, for the period from the date agreement state status is attained until the license's next anniversary date, in addition to the amount assessed for the year following the license's anniversary date.
(c) In the event that the Commonwealth attains agreement state status prior to January 1, 2009, the provisions of this section and § 218.11 and Appendix A (relating to registration, renewal of registration and fees; and fees for radioactive material licenses) will be applied retroactively to NRC licenses transferred to the Commonwealth.]
CHAPTER 219. STANDARDS FOR PROTECTION AGAINST RADIATION
Subchapter A. GENERAL PROVISIONS § 219.3. Definitions.
The following [term] terms, when used in this subchapter, [has the following meaning] 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 3 Gy (300 rad).
(ii) An unintended dose, other than skin dose, in a single procedure exceeding five times the facility's established protocol and 0.5 Gy (50 rad) to any organ.
(iii) A dose to the wrong patient or wrong site for the entire procedure and exceeding 0.5 Gy (50 rad) 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 [when the result is an increase in the total expected doses inside or outside of the intended treatment volume for organs, tissue or skin that exceeds 20% of the total prescribed dose for the intended target volume.] 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.
[(iii) A total dose delivered to the treatment site identified in a written directive for therapy that is outside the prescribed dose range or differs from the total prescribed dose by more than 20%, or for a fractionated dose, when the weekly administered dose differs from the weekly prescribed dose by more than 30%.]
§ 219.6. Effect of incorporation of 10 CFR Part 20.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 20 (relating to standards for protection against radiation), the following words and phrases shall be substituted for the language in 10 CFR Part 20 as follows:
* * * * * (7) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department [and, for NRC licenses, to the NRC until agreement state status is in effect], except as required under 10 CFR 20.2206 (relating to reports of individual monitoring).
* * * * *
Subchapter M. REPORTS § 219.229. Other 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 [therapeutic or diagnostic] 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 event, the registrant or licensee shall:
(1) Notify the Department regarding the medical event within 1 business day.
(2) Provide a written report, including the analysis of the medical 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 event as part of the patient's permanent medical record.
CHAPTER 220. NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS; INSPECTIONS AND INVESTIGATIONS § 220.10. Effect of incorporation of 10 CFR Part 19.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 19 (relating to notices, instructions and reports to workers; [inspections] 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 [and, for NRC licenses, to the NRC until agreement state status is in effect].
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
