RULES AND REGULATIONS
Title 25--ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CHS. 215, 217, 219, 220, 224--226, 230 AND 232]
Radiological Health
[31 Pa.B. 5239] The Environmental Quality Board (Board) by this order amends Chapters 215, 217, 219, 220, 224--226 and 230, and adds new Chapter 232. The amendments update the standards for protection against radiation to meet compatibility requirements for the Commonwealth to become an agreement state with the United States Nuclear Regulatory Commission (NRC). This order was adopted by the Board at its regular meeting on June 19, 2001.
A. Effective Date
These amendments will be effective immediately upon publication in the Pennsylvania Bulletin as final rulemaking.
B. Contact Persons
For further information, the contact persons are Louis Ray Urciuolo, Chief, Licensing Section, Bureau of Radiation Protection, 13th Floor, Rachel Carson State Office Building, P. O. Box 8469, Harrisburg, PA 17105-8469, (717) 787-3720; and Marylou Barton, Assistant Counsel, Bureau of Regulatory Counsel, Rachel Carson State Office Building, 9th Floor, 400 Market Street, P. O. Box 8464, Harrisburg, PA 17105-8464, (717) 787-7060. This proposal is also available electronically through the Department of Environmental Protection's (Department) website (www.dep.state.pa.us).
C. Statutory Authority
This final-form rulemaking is being made under the authority of sections 301 and 302 of the Radiation Protection Act (act) (35 P. S. §§ 7110.301 and 7110.302), which, respectively, direct the Department to develop and conduct comprehensive programs for the registration, licensing, control, management, regulation and inspection of radiation sources and radiation source users, and delegate to the Board the power to adopt the regulations of the Department to implement the act.
Section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20) authorizes and directs the Board to adopt regulations necessary for the proper performance of the work of the Department.
D. Background and Summary
In 1995, the Board updated its radiological health regulations to provide for compatibility with other states and to serve as a basis for the Commonwealth to assume authority from the NRC for radioactive material licensees in this Commonwealth as an agreement state. These updates were published at 25 Pa.B. 5088 and 5206 (November 18, 1995). Technological advances in the use of radioactive material and the need to establish and maintain radiation protection standards at least as stringent as the NRC standards provide the basis for these revisions to the existing radiological health regulations.
The amendments are necessary for the Commonwealth to acquire agreement state status from the NRC. Under section 201 of the act (35 P. S. § 7110.201), the Governor is authorized to enter into agreements with the NRC transferring regulatory authority to the Commonwealth for radiation protection. Presently, the Commonwealth is responsible for the regulation of naturally occurring and accelerator-produced radioactive material (NARM) and radiation producing equipment. Under the Atomic Energy Act of 1954 (42 U.S.C.A. § 2021), the NRC is authorized to enter into an agreement with the Governor to discontinue NRC regulatory authority with respect to most byproduct materials, source materials and special nuclear materials in amounts insufficient to form a critical mass.
The amendments are based on the current NRC radiation protection regulations in 10 CFR Parts 19--150.
As required by section 301(c)(14) of the act (35 P. S. § 7110.301), the Department provided the Radiation Protection Advisory Committee (Committee) with an opportunity to review the proposed amendments and to advise the Department prior to submittal to the Board. On March 1, 2001, the Committee met and reviewed the draft final rulemaking. The chairperson announced by letter dated March 1, 2001, the Committee's concurrence to send the draft final rulemaking to the Board.
A description of the amendments is provided as follows:
Chapter 215. General Provisions
Section 215.1 (relating to purpose and scope) is expanded to clarify the scope of incorporation by reference and list any exceptions. Subsections (e) and (f) provide notification that this does not relieve a person from complying with Pennsylvania law nor does it expand the scope of authority already granted the Department under statute. Locations are listed in new subsection (g) for the purchase of copies of the Code of Federal Regulations (Title 10 Chapter I) to be incorporated by reference. An electronic version is also available on the United States Government Printing Office world wide web site at http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title= 199910. New subsection (h) describes the relationship between certain commonly used terms of the Department and the NRC.
Section 215.2 (relating to definitions) The following definitions were deleted because they are incorporated by reference: ''ALARA,'' ''A1,'' ''A2,'' ''absorbed dose,'' ''agreement state,'' ''airborne radioactive material,'' ''airborne radioactivity area,'' ''background radiation,'' ''becquerel,'' ''byproduct material,'' ''calendar quarter,'' ''collective dose,'' ''committed dose equivalent,'' ''committed effective dose equivalent,'' ''controlled area,'' ''curie,'' ''deep dose equivalent,'' ''depleted uranium,'' ''dose,'' ''dose equivalent,'' ''dose limits,'' ''effective dose equivalent,'' ''embryo/fetus,'' ''exposure,'' ''exposure rate,'' ''external dose,'' ''extremity,'' ''eye dose equivalent,'' ''generally applicable environmental radiation standards,'' ''gray,'' ''high radiation area,'' ''individual monitoring,'' ''individual monitoring devices,'' ''internal dose,'' ''licensed material,'' ''lost or missing licensed or registered source of radiation,'' ''member of the public,'' ''minor,'' ''misadministration,'' ''monitoring,'' ''normal form,'' ''occupational dose,'' ''personnel monitoring equipment,'' ''prescribed dosage,'' ''public dose,'' ''rad,'' ''radiation area,'' ''radiopharmaceutical,'' ''rem,'' ''research and development,'' ''restricted area,'' ''sealed source,'' ''SI,'' ''shallow dose equivalent,'' ''sievert,'' ''site boundary,'' ''source material,'' ''special form,'' ''special nuclear material,'' ''special nuclear material in quantities not sufficient to form a critical mass,'' ''survey,'' ''TEDE,'' ''unrefined and unprocessed ore,'' ''unrestricted area,'' ''week,'' ''whole body,'' ''worker,'' ''working level,'' ''working level month'' and ''year.''
The following definitions are updated: ''NRC,'' ''qualified expert'' and ''roentgen.'' The definition of ''prescribed dose'' is changed to ''prescribed dose for therapy using radiation-producing machines'' because references to radioactive material modalities now covered by incorporation by reference have been removed. Likewise, the definition of ''written directive'' is changed to ''written directive for therapy using radiation-producing machines'' following the deletion of references to radioactive material. It is clarified that electron and other particle beams are included in addition to X-ray. Although the term ''misadministration'' has been deleted, a similar concept called ''medical event'' that is restricted to radiation producing machine therapy is newly defined in § 219.3 (relating to definitions).
Section 215.3 (relating to units of exposure and dose) is amended to delete units of dose already incorporated by reference in 10 CFR 20.1004 (relating to units of radiation).
Section 215.4 (relating to units of activity) is deleted because it is replaced by incorporation by reference of 10 CFR 20.1005 (relating to units of radioactivity).
Section 215.5 (relating to effect of incorporation of the Code of Federal Regulations) is added for clarification.
Section 215.11 (relating to records) is amended to clarify the separate record keeping requirements of licensees and registrants.
Section 215.12 (relating to inspections) is amended to change the target inspection frequency for major medical facility X-ray operations from every 2 years to every 3 years.
Section 215.15 (relating to additional requirements) was amended by incorporating the requirements of the rescinded § 219.73 (orders requiring furnishing of bioassay services).
A new § 215.25 (relating to deliberate misconduct) is added for compatibility with the NRC.
A new § 215.26 (relating to employee protection) is added for compatibility with the NRC.
A new § 215.27 (relating to vacating premises) contains the provisions of § 219.241 (relating to vacating premises), which is relocated to this chapter. The requirement is extended to all licensees and is in addition to the decommissioning requirements of 10 CFR 30.36 (relating to expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas) that are incorporated by reference under Chapter 217 (relating to licensing of radioactive material).
A new § 215.28 (relating to deliberate exposure of a monitoring device) is added to prohibit using a monitoring device to indicate falsely high or low doses to individuals.
Section 215.32 (relating to exempt qualifications) is amended to add the new Chapter 232 (relating to licenses and radiation safety requirements for irradiators) to the list of chapters.
Chapter 217. Licensing of Radioactive Material
Subsection 217.1(b) is amended to include references to Chapters 218, 230 and 232 (relating to fees; packaging and transportation of radioactive material; and licenses and radiation safety requirements for irradiators).
Section 217.2 (relating to address for communications) is updated with the new Department name and address.
Sections 217.11--217.18, 217.21--217.24, 217.31, 217.32, 217.41--217.49, 217.51--217.57, 217.65, 217.71--217.74, 217.81--217.93, 217.101, 217.121 and 217.122, Appendices A, B and D are deleted and replaced by new sections and new tables for NARM and renamed subchapters that incorporate applicable portions of 10 CFR Parts 30, 31, 32, 33, 40, 70 and 150 by reference.
A new Subchapter B (general provisions for radioactive material) is created to incorporate 10 CFR 30 (relating to rules of general applicability to domestic licensing of byproduct material).
Sections 217.131 and 217.132 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 30) explain incorporation by reference.
Section 217.133 (relating to persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register) is the existing § 217.24, which is deleted.
Section 217.134 (relating to filing application for specific licenses) is the existing § 217.51(d) and alerts the applicant for a license that a fee is required.
Section 217.135 (relating to renewal of licenses) is similar to the existing § 217.55 and is amended to alert the licensee to the Department's renewal requirements.
Section 217.136 (relating to exempt concentrations) and Table 1 replaced the existing requirements of § 217.12 and Appendix A for NARM isotopes, which are not incorporated by reference.
Section 217.137 (relating to exempt quantities) and Table 2 replace the existing requirements of § 217.13 and Appendix B for NARM isotopes, which are not incorporated by reference.
A new Subchapter C (relating to general licenses for radioactive material) is created to incorporate 10 CFR 31 (relating to general domestic licenses for byproduct material).
Sections 217.141 and 217.142 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 30) explain the incorporation by reference.
Section 217.143 (relating to certain measuring, gauging or controlling devices) incorporates 10 CFR 31.5 and adds some Department requirements that are not included in the incorporation by reference for sources subject to registration under 10 CFR 31.5(c)(13)(i) and certain NARM sources.
Section 217.144 (relating to incidental radioactive material produced by a particle accelerator) is the existing § 217.48, amended to include a Department requirement regarding disposal that is not included in the incorporation by reference.
A new Subchapter D (relating to specific licenses to manufacture or transfer certain items containing radioactive material) is created to incorporate 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) and to also include NARM radioactive material.
The requirements of existing Subchapter D (relating to transfer of radioactive material) are moved to new Subchapter I with the same title.
Sections 217.151 and 217.152 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 32) explain the incorporation by reference.
Section 217.153 (relating to licensing the incorporation of NARM into gas and aerosol detectors) is the existing § 217.83, amended to include a Department requirement for using radium-226 that is not included in the incorporation by reference.
Section 217.154 (relating to special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226) is the existing § 217.86, amended to include a Department requirement for using radium-226 that is not included in the incorporation by reference.
Section 217.155 (relating to manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license) is the existing § 217.88, amended to include Department requirements for using NARM that are not included in the incorporation by reference.
A new Subchapter F (relating to specific domestic licenses of broad scope for radioactive material) is created to incorporate 10 CFR Part 33 (relating to specific domestic licenses of broad scope for byproduct material). This replaces deleted §§ 217.71--217.74 and Appendix D for licenses of broad scope.
Sections 217.161 and 217.162 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 33) explain the incorporation by reference.
Section 217.163 (relating to types of specific licenses of broad scope) and Table 3 replace the existing requirements of §§ 217.71--217.73 and Appendix D for NARM isotopes, which are not incorporated by reference.
A new Subchapter G (relating to licensing of source material) is created to incorporate 10 CFR Part 40 (relating to domestic licensing of source material).
Sections 217.171 and 217.172 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 40) explain the incorporation by reference.
A new Subchapter H (relating to licensing of special nuclear material) is created to incorporate 10 CFR 70 (relating to domestic licensing of special material).
Sections 217.181 and 217.182 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 70) explain the incorporation by reference.
A new Subchapter I (relating to transfer of radioactive material) replaces existing Subchapter D. New § 217.191 (relating to transfer of material) incorporates 10 CFR 30.41 (relating to transfer of byproduct material) by reference, expands the scope to include NARM and replaces existing § 217.101.
A new Subchapter J (relating to reciprocity) is the existing Subchapter F amended to incorporate 10 CFR 150.1 (relating to purpose), 10 CFR 150.2 (relating to scope), 10 CFR 150.3 (relating to definitions), 10 CFR 150.11 (relating to critical mass) and certain sections of 10 CFR 150.20 (relating to recognition of Agreement State licenses).
Sections 217.201 and 217.202 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 150) explain the incorporation by reference.
Section 217.203 (relating to reciprocity of licenses of naturally occurring and accelerator-produced radioactive material) is the existing § 217.122.
Chapter 219. Standards for Protection Against Radiation
Section 219.3 (relating to definitions) deletes all existing definitions because of the incorporation by reference of 10 CFR Part 20 (relating to standards for protection against radiation) in this chapter. A new definition of ''medical reportable event for radiation-producing machine therapy'' is created to replace, in part, the definition of ''misadministration'' in § 215.2 which has been deleted following incorporation by reference of the definitions in 10 CFR 35.2 (relating to definitions).
Section 219.4 (relating to implementation) is deleted because it is obsolete.
Sections 219.5 and 219.6 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 20) are added to clarify the differences between Chapter 219 and 10 CFR Part 20.
Section 219.7 (relating to effect of incorporation of 10 CFR 20.1403) is added to clarify license termination under restricted conditions.
Sections 219.21 and 219.31--219.38 are deleted because of incorporation by reference of 10 CFR Part 20.
Existing Subchapter D (relating to radiation dose limits for individual members of the public) consisting of §§ 219.51 and 219.52 is amended as follows.
Section 219.51 (relating to dose limits for individual members of the public) is rewritten in its entirety to incorporate by reference 10 CFR Part 20, Subpart D (relating to dose limits for individual members of the public). The result includes the elimination of current § 219.51(a)(2) that allows individual members of the public in unrestricted areas to receive exposures up to 0.5 rem per year from medical diagnostic radiation producing machines.
Section 219.52 (compliance with dose limits for individual members of the public) is deleted because of the incorporation by reference of 10 CFR Part 20.
Existing Subchapter E (relating to testing for leakage or contamination of sealed sources) consists of § 219.61 which is amended to include incorporation by reference of 10 CFR Part 20 as an additional requirement.
Existing Subchapter F (relating to surveys and monitoring) is deleted. Sections 219.71 and 219.72 are deleted because of incorporation of 10 CFR Part 20 by reference. The current § 219.73 is deleted and the requirements are moved to § 215.15 (relating to additional requirements).
Existing Subchapter G (relating to control of exposure from external sources in restricted areas) consisting of §§ 219.91--219.93 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter H (relating to respiratory protection and controls to restrict internal exposure in restricted areas) consisting of §§ 219.111--219.113 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter I (relating to storage and control of licensed or registered sources of radiation) is amended so that existing §§ 219.131 and 219.132 now apply only to radiation-producing machines, while incorporation of 10 CFR Part 20 by reference applies to radioactive material.
Existing Subchapter J (relating to precautionary procedures) is amended as follows:
Sections 219.151--219.158 were deleted because of incorporation of 10 CFR Part 20 by reference.
Section 219.159 (relating to posting of radiation producing machines) is amended by changing the words ''The registrant'' at the beginning of the first sentence to ''The registrant or licensee'' because accelerators are now licensed.
Section 219.160 (relating to exceptions to posting requirements) is amended by deletion of those sections for radioactive materials that are superceded through incorporation by reference of 10 CFR Part 20.
Sections 219.161 and 219.162 (relating to exemptions from labeling requirements; and procedures for receiving and opening packages) are deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter K (relating to waste disposal) with §§ 219.181--219.186 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter L (relating to records) with §§ 219.201--219.211 is deleted because of incorporation of 10 CFR Part 20 by reference.
Existing Subchapter M (relating to reports) consists of §§ 219.221--219.228.
Section 219.221 (relating to reports of stolen, lost or missing licensed or registered sources of radiation) is amended by deletion of those sections for radioactive materials that are superseded through incorporation by reference of 10 CFR Part 20.
Section 219.222 (relating to notification of incidents and reportable events) is renamed and amended by replacing the current text with incorporation by reference of the specific requirements for the notification of incidents under 10 CFR Part 20. The scope of the reference is also expanded to apply to radiation producing machines and NARM.
Sections 219.223--219.226 are deleted as a result of incorporation by reference of 10 CFR Part 20.
Existing § 219.227 (relating to reports of leaking or contaminated sealed sources) is retained.
Section 219.228 (relating to reports of misadministrations) is renamed to ''reports of medical reportable events for radiation-producing machine therapy.'' References to ''misadministration from X-ray'' are replaced by ''medical reportable event from radiation-producing machine therapy.''
New § 219.229 (relating to other medical reports) is added to require reporting of certain harmful exposures to patients that are not reported under § 219.228.
Existing Subchapter N (relating to additional requirements) which consists of § 219.241 (relating to vacating premises) is deleted. The conditions are transferred to new § 215.27 and expanded to apply to all licensees.
Chapter 219, Appendices A--C (relating to protection factors for respirators; annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage; and quantities of licensed or registered material requiring labeling) are deleted by incorporation by reference of 10 CFR Part 20.
Chapter 220. Notices, Instructions and Reports to Workers; Inspections and Investigations
Because of incorporation by reference of 10 CFR Part 19, the title of Chapter 220 has been expanded to include ''Investigations.''
Section 220.2 (relating to posting of notices to workers) is updated for compatibility with the NRC.
Sections 220.3--220.8 are deleted because of incorporation by reference of 10 CFR Part 19.
Sections 220.9 and 220.10 (relating to incorporation by reference; effect of incorporation of 10 CFR Part 19) are added to clarify the differences between Chapter 220 and 10 CFR Part 19.
Chapter 224. Medical Use of Radioactive Material
Sections 224.2--224.9 are deleted because of incorporation by reference of 10 CFR Part 35.
New §§ 224.10 and 224.11 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 35) are added to clarify the differences between Chapter 224 and 10 CFR Part 35.
Subchapter B (relating to general administrative requirements) is renamed ''other requirements.''
New § 224.21 (relating to supervision) clarifies which auxiliary personnel may handle radioactive material. It replaces current § 224.55 (supervision) that is deleted by incorporation by reference of 10 CFR Part 35.
New § 224.22 (relating to authorization for calibration and reference sources) allows sealed sources up to 1,110 MBq (30 mCi) apiece of radioactive material. It replaces current § 224.104 that is deleted because of incorporation by reference of 10 CFR 35.57 (relating to authorization for calibration and reference sources).
New § 224.23 (relating to decay-in-storage) allows sealed sources of radioactive material with a physical half-life of up to 300 days to be held for decay-in-storage. It replaces current § 224.112 (relating decay-in-storage) that is deleted by incorporation by reference of 10 CFR 35.92 (relating to decay-in-storage).
Current §§ 224.51--224.60 are deleted because of incorporation by reference of 10 CFR Part 35. The requirements of current § 224.55 (relating to supervision) are now found in new § 224.21 (relating to supervision).
Current §§ 224.101--224.112 comprising all of Subchapter C are deleted because of incorporation by reference of 10 CFR Part 35. The requirements of current § 224.104 (relating to authorization for calibration and reference sources) are now found in new § 224.22 (relating to authorization for calibration and reference sources). The requirements of current § 224.112 (relating to decay-in-storage) are now found in new § 224.23 (relating to decay-in-storage).
Sections 224.151--224.501 comprising all of Subchapters D--K are deleted because of incorporation by reference of 10 CFR Part 35.
Chapter 225. Radiation Safety Requirements for Industrial Uses and Radiographic Operations
Chapter 225 is split into two subchapters: Subchapters A and B (relating to general provisions; and radiation producing-machines). The chapter title is expanded to include industrial uses.
Existing § 225.1 (relating to purpose and scope) is expanded upon. An addition to subsection (a) clarifies applicability. New subsection (b) is added to exempt persons using only radiation-producing machines from the requirements of 10 CFR Part 34 incorporated by reference except as may be noted in Subchapter B. New subsection (c) is added to clearly indicate that Chapter 225 does not apply to medical diagnosis or therapy.
Existing §§ 225.2, 225.11--225.18, 225.21--225.23, 225.31--225.33, 225.41--225.44 are deleted because of incorporation by reference of 10 CFR Part 34.
Existing §§ 225.51--225.53 are deleted because of incorporation by reference of 10 CFR Part 34 with the requirements of existing § 225.52 (relating to security) being transferred to new § 225.87 (relating to security) and existing § 225.53 (relating to posting) being transferred to new § 225.88 (relating to posting).
Existing Appendix A is retained.
New §§ 225.2a and 225.3a (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 34) are added to clarify the differences between Chapter 225 and 10 CFR Part 34.
Section 225.4a (relating to radiation safety programs) is added for radiation-producing machine users only. This section includes a requirement that a person using radiation-producing machines for industrial radiography shall have Department approval before commencing operations.
Section 225.5a (relating to reciprocity) is added to alert out-of-State users of radiation-producing machines to the requirements of § 216.7 (relating to out-of-State radiation producing machines).
Section 225.6a (relating to prohibitions) is added to clarify that the use of radiation-producing machines covered under this chapter is not permitted for diagnosis or therapy on humans or animals.
New Subchapter B (relating to radiation-producing machines) requirements are added to apply to those persons who only have radiation-producing machines because radiation-producing machines do not fall under the requirements of sealed source radiography incorporated through reference of 10 CFR Part 34.
Subchapter B begins with a new undesignated center heading, ''General Administrative Requirements,'' that includes new §§ 225.71--225.76. The new sections in this subchapter provide for definition of terms, duties of personnel, training of personnel, specification of training and testing, audits and safety reviews of radiographers and radiographer assistants, and reporting requirements of incidents and overexposures.
The definitions introduced in § 225.71 (relating to definitions) are ''cabinet radiography,'' ''cabinet X-ray system,'' ''certified cabinet X-ray system,'' ''DRD--direct reading dosimeter,'' ''industrial radiography,'' ''permanent radiographic installation,'' ''personnel dosimeter,'' ''personal supervision,'' ''radiation safety officer,'' ''radiographer,'' ''radiographer's assistant,'' ''radiographer trainee,'' ''radiographic operations,'' ''shielded room radiography'' and ''temporary job site.''
A new heading, ''General Technical Requirements,'' includes §§ 225.81--225.88. The new sections provide requirements for permanent radiographic installations, operation outside of permanent radiographic installations, records at temporary job sites, general operating and emergency procedures, surveys and survey records, utilization logs, security, and posting.
A new heading, ''Radiation Survey Instrument and Personnel Monitoring,'' includes §§ 225.91--225.93 (relating to radiation survey meter requirements; radiation survey meter calibration requirements; and personnel monitoring control). These new sections specify the use of operable calibrated survey meters, personnel dosimeters and direct reading dosimeters, survey meter calibration requirements, and associated records.
A new heading, ''Radiation Producing Machine Requirements,'' includes §§ 225.101--225.104.
Section 225.101 (relating to cabinet X-ray systems and baggage/package X-ray systems) replaces and updates existing § 225.21 (relating to cabinet x-ray systems).
Section 225.102 (relating to shielded room X-ray machine radiography) replaces and updates existing § 225.22 (relating to shielded room radiography).
Section 225.103 (relating to temporary jobsite radiography) replaces and updates existing § 225.23 (relating to other radiography).
Section 225.104 (relating to X-ray detection systems for explosives, weapons and illegal items) is new and provides for special requirements for the use of X-ray in the search for contraband.
Chapter 226. Licenses and Radiation Safety Requirements for Well Logging
Current Chapter 226 is renamed as ''Licenses and Radiation Safety Requirements for Well Logging'' to parallel 10 CFR Part 39 (relating to licenses and radiation safety requirements for well logging).
Section 226.1 (relating to purpose and scope) is generally updated and revised to include persons using uranium sinker bars.
Section 226.2 (relating to definitions) is deleted because of incorporation by reference of 10 CFR Part 39.
Current § 226.3 (relating to prohibition) is deleted. It is replaced by new § 226.3a (relating to abandonment of a sealed source) to incorporate by reference 10 CFR Part 39 and to add a reference to § 78.111 (relating to abandonment).
Sections 226.4 and 226.5 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 39) are added to clarify the differences between Chapter 226 and 10 CFR Part 39.
A new undesignated center heading ''Particle Accelerators'' is created.
The provisions of § 226.34 (relating to particle accelerators) are reworded and renumbered to § 226.61, and a reference to licensing provisions of Chapter 228 (relating to radiation safety requirements for particle accelerators) is added.
Sections 226.11--226.51 and Appendixes A and B are deleted because of incorporation by reference of 10 CFR Part 39.
Chapter 230. Packaging and Transportation of Radioactive Material
Sections 230.2, 230.11, 230.12, 230.14, 230.21--230.26, 230.41--230.46, 230.51, Appendix A and Tables I--IV are deleted because of incorporation by reference of 10 CFR Part 71 (relating to packaging and transportation of radioactive material).
In Subchapter A (relating to scope and definitions), the phrase ''and definitions'' is dropped from the title because of the deletion of § 230.2 (relating to definitions).
Sections 230.3 and 230.4 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 71) are added to clarify the differences between Chapter 230 and 10 CFR Part 71.
Section 230.5 (relating to communications) is added to ensure that communications are sent to the Department's address.
Section 230.13 (relating to transportation of licensed material) is amended to include only the requirements of existing § 230.13(b) and incorporation by reference of 10 CFR Part 71.
Section 230.47 (relating to advance notification of transport of nuclear waste) is amended to ensure that the Governor or the Governor's designee and the Department will receive the required notifications and information.
Chapter 232. Licenses and Radiation Safety Requirements for Irradiators
Chapter 232 is a new chapter that is compatible with 10 CFR Part 36 (relating to licenses and radiation safety requirements for irradiators).
Section 232.1 (relating to purpose and scope) explains that this chapter applies only to the use of radioactive material in sealed sources to irradiate objects or materials with gamma radiation.
Sections 232.2 and 232.3 (relating to incorporation by reference; and effect of incorporation of 10 CFR Part 36) clarify the differences between Chapter 232 and 10 CFR Part 36.
E. Summary of Comments and Responses on the Proposed Rulemaking
The notice of proposed rulemaking was published at 30 Pa.B. 4503 (August 26, 2000) and included a 30-day comment period that ended on September 25, 2000. The Board received five responses during the comment period. The Independent Regulatory Review Commission (IRRC) also provided comments on the proposed rulemaking through a letter dated October 26, 2000.
The Department prepared a comment and response document that summarizes and responds to the aforementioned comments. A copy of the comment and response document is available upon request from the contact person listed in Section B of this Preamble.
A summary of the comments received and the Department's responses follow. The revisions that resulted from the comments as well as those made on the initiative of the Department are described thereafter.
The comments are of two kinds, those that address a specific reference and those that refer to the format of incorporation by reference in general.
One comment was suggested that to improve clarity, more specificity be provided in defining the linkage to regulations incorporated by reference. It was suggested that a list of either each provision incorporated by reference or each provision not incorporated by reference be cited. Because listing the individual regulations incorporated by reference is lengthy and therefore impractical, the Department chose to list the exceptions to incorporation.
Section 215.1(e) lists by part, rather than section, the NRC regulations incorporated by reference, except for Part 150. A part in the NRC regulations is roughly equivalent to a chapter in Title 25 of the Pennsylvania Code. The reference has been augmented to list each section or subunit of a referenced part of the NRC regulations that is not incorporated by reference. References to all the NRC regulations incorporated by reference are displayed in § 215.1. However, for convenience of the reader, each chapter displays a list in modified format that is limited to the NRC regulations corresponding to the subject of the chapter.
Section 215.1(h) is added to enhance clarity by showing the relationship between certain commonly used terms in the Code of Federal Regulations and their counterparts in these regulations. The applicable relationships are repeated in each chapter for convenience. Section 215.1(h)(5) is repeated in §§ 217.132(5), 217.142(5), 217.152(5), 217.162(5), 217.172(5), 217.182(5), 217.202(5), 219.6(7), 220.10(4), 224.11(6), 225.3a(5), 226.5(5), 230.4(5) and 232.3(4).
Section 215.2 as proposed is modified. Since a definition of ''misadministration involving radioactive materials'' has been incorporated by reference, under proposed rulemaking the existing definition of misadministration was to be renamed and redefined as ''misadministration (medical event) from X-ray'' to treat events involving X-ray separately from those involving radioactive material. However, a commentator noted that the purpose of the definition was to support a reporting requirement, and the definition should therefore appear in Chapter 219 instead of Chapter 215. It was also commented that in light of incorporation by reference of a similar term, the name given to the definition was confusing and also inaccurate. For these reasons, the definition of ''misadministration'' is deleted from § 215.2 at final rulemaking, and a new definition, ''medical reportable event for radiation-producing machine therapy,'' has been added in § 219.3. This is explained further under the discussion of § 219.3. At final rulemaking, the term ''prescribed dose for X-ray therapy'' has been changed to ''prescribed dose for therapy using radiation-producing machines,'' to show that electron as well as other particle beam therapy is included in addition to x-ray. For the same reasons, the proposed term ''written directive for X-ray therapy'' has been clarified to read ''written directive for therapy using radiation-producing machines.'' The definition of ''worker'' has also been deleted in the final-form rule since an applicable definition of ''worker'' is incorporated by reference.
Sections 215.12 and 215.26 show an editorial change of ''employe'' and ''employes'' to ''employee'' and employees.''
Section 215.27 refers to the requirements for vacating premises that contained areas where access was restricted due to the presence of radioactive material. One commentator suggested that acceptable criteria for decontamination be stated in the regulation. The regulation is not changed. The Department does not believe it is wise to lock in values for acceptable levels of residual contamination in the regulation. In some cases it may not always be possible to satisfy a given limit. License termination plans are subject to as low as reasonably achievable (ALARA) and are addressed on a case-by-case basis. The matter of limits is addressed through guidance to provide the flexibility necessary to handle diverse conditions.
Section 215.28 is changed for clarity. Objection was taken to the use of the word ''deceptive.'' ''Deceptive exposure of a monitoring device'' is changed to ''Deliberate exposure of a monitoring device'' for the purpose of ''falsely'' rather than ''deceptively'' indicating the dose to an individual.
Section 217.1(b) was amended to show the descriptions of the referenced chapters as an editorial correction for clarity.
Sections 217.132(4), 217.142(4), 217.172(4), 217.182(4), 217.202(4) and 224.11(3) change ''the definition of licensed material'' to ''a reference to byproduct material'' as an editorial correction since the corresponding parts of the CFR refer to byproduct material rather than licensed material. Similarly, the sentence ''The definition of licensed material includes NARM'' has been deleted from §§ 217.152(4) and 217.162(4) as the phrase ''licensed material'' is not found in the corresponding parts of the CFR.
A correction to § 217.143 changed the NRC reference from 10 CFR 30.5 to 10 CFR 31.5. The scope of the regulation was also clarified by adding that the additional requirements contained in the section apply only to generally licensed sources that are subject to registration under 10 CFR 31.5(c)(13i) and certain specified NARM sources.
Section 217.191 (relating to transfer of material) has been amended at final-form rulemaking. The existing text is replaced by incorporation by reference of 10 CFR 30.41 because the CFR is equivalent. Three concerns were raised to items in this section. One objection related to the provision for verification of a licensee's authority to receive material by using data supplied from parties other than the Department or the licensee. Another commentator felt even more strongly that direct contact with the licensee should be the only form of permissible verification. The Department disagrees with the first two comments because they were based on the misconception that the transferor was accountable for not allowing the transferee's inventory to exceed the transferee's license possession limits. The transferor need only verify that the material to be transferred does not exceed the limits listed in the transferee's license. The transferee is responsible for ensuring that current inventory (which may fluctuate on a day-to-day basis) never exceeds the license limits. The third concern questioned what constituted ''verbal'' certification. These regulations are not new, and the requirements are not being altered. They are currently in force and are identical to the CFR. They have been in place for a sufficient time for the Department to note that there is no indication that the regulated community has a problem understanding or complying with the regulations, and no significant problems have arisen that could be attributed to defects in the regulations. No one has approached the Department as yet to compile a third-party verification service. If this did happen, it would have to be approved by the Department. Verbal certification has no special legal definition and must be followed up in writing anyway. In summary, the Department has not changed the existing requirements. However, the text of these requirements is now 10 CFR 30.41, incorporated by reference.
A commentator also asked for clarification on three parts of § 217.191 that also apply to 10 CFR 30.41. First, regarding § 217.191(a)(3), the regulation should indicate who would be exempt and how an exemption is granted. As discussed in the comment and response document, the Department believes the description of exempted parties and the provision for exemptions is adequately addressed in the regulation, so no change has been made. Second, in § 217.191(a)(4), the commentator asked what documents in other jurisdictions are equivalent to general and specific licenses. The regulation was not modified because there is no one-to-one relationship that holds for all jurisdictions. An equivalent authorization may go by different names, such as a permit or a registration, and the regulatory equivalency does not hold to begin with. Some jurisdictions may require the equivalent of a general license for what is specifically licensed in another jurisdiction. It is up to the licensee to uncover the requirements before transferring radioactive material. Third, under § 217.195(a)(5), the commentator asked who would be subject to being ''otherwise authorized in writing by the Department.'' This rule is not changed because it cannot be elaborated further. It is a catch-all provision for unspecified situations. For example, under § 217.22 a requirement for prior authorization in writing may be invoked, if deemed appropriate, before transfer of ownership of radioactive material is allowed during a corporate merger.
Section 219.3 (relating to definitions) is retained at final-form rulemaking for the purpose of the new definition, ''medical reportable event for radiation-producing machine therapy.'' The new definition is the renamed successor to the definition of ''misadministration'' for events not involving radioactive material. Several additional concerns were raised regarding the definition. These concerns involved clarity of scope, interpretation and limits. The resolution of these issues resulted in a significant rewrite of the proposed regulation. The proposed regulation closely followed the anticipated form of the NRC's new definition of medical event, with the exception of being slanted toward invasive therapy. The final rule is closer to the traditional form of the Council of Radiation Control Directors Suggested State Regulations for teletherapy. The result is a rule that better addresses the comments and provides more flexibility to the regulated community. The rule was simplified by removing such issues as wrong site, errors of precision, wrong beam energy, wrong mode or wedge factor. The criteria is that controllable exposures to areas inside or outside the treatment volume do not exceed a certain percentage of the prescription regardless of the cause. The percentage is based upon the total dose and, as suggested by a commentator, the weekly dose rather than an individual dose fraction.
In the final-form rulemaking, the issue of harmful events arising from exposure to diagnostic radiation and unintended functional damage to tissue, diagnostic or therapeutic, is addressed by removing them from the definition of medical reportable event for radiation-producing machine therapy and creating new § 219.229 (relating to other medical reports). This simplified the definition of medical reportable event for radiation-producing machine therapy yet retained the proposed requirement for reporting any unintended functional damage from medical radiation. The Department considers it unnecessary and overly prescriptive to set limits for these events or to specify who makes the determination of a reportable event or who submits the report of an event. The licensee or registrant is responsible and the determination of a reportable event is a medical judgment made by physicians and medical physicists using generally accepted clinical protocol and is reported under the administrative structure of the licensee or registrant.
Section 219.7 is added at final-form rulemaking to clarify the requirements of incorporation by reference of 10 CFR 20.1403 (relating to license termination under restricted conditions) for license termination under restricted conditions. This is a regulatory option of last resort that the Department would not exercise without scrutiny, so the existing requirements were more fully detailed.
Section 219.222 is renamed at final-form rulemaking to ''Notification of Incidents and Reportable Events'' to more clearly describe the content. The specific references to the CFR are clarified as well as the linkage to a 30-day reporting requirement.
Section 219.228 is renamed in final-form rulemaking to ''Reports of Medical Reportable Events for Radiation-Producing Machine Therapy'' for clarity and consistency. Previous references to ''misadministration'' are replaced with ''event.''
Section 219.229 (relating to other medical reports) is new at final rulemaking. The reporting requirements for certain events of interest involving unintended harm from medical radiation that had been proposed under the definition of ''medical event'' have been moved here for the reasons described previously in the discussion of ''medical event.''
Section 220.2(a)(3) relating to posting of procedures was questioned. A commentator believed that certain procedures, such as activities involving wet chemistry, could be too complex to post. The Department believes the commentator misinterpreted the requirement. Safe working procedures, not analytical procedures, must be posted. In any case, there is an option to post the location at which the procedures can be found rather than the procedures. For these reasons, no change has been made.
Section 220.10(3) is added at final rulemaking to clarify the applicability to registered sources of radiation.
Chapter 224 relates to the incorporation by reference of 10 CFR 35 for the medical use of radioactive material. One commentator did not express confidence in the NRC's handling or general competence in regulating this area and suggested the Department formulate its own regulations. The Department recognizes the tension that has historically existed between the NRC and the medical community. However, the Department is committed to incorporation by reference as the best method to insure compatibility. Some latitude exists in the degree of compatibility required for specific regulations, and the Department has and will continue to make use of that latitude as practical to make incorporation by reference viable.
In § 225.71 (relating to definitions), definitions of ''direct reading dosimeter'' and ''personnel dosimeter'' have been added at final rulemaking in response to confusion expressed over the inconsistent use of names used to describe terms for individual monitoring devices. A commentator also took exception to including the words ''An RSO shall have the authority to suspend or terminate radiographic operations'' in the definition of ''RSO.'' The Department concurred and removed this language in the final rulemaking because it is a substantive requirement that already exists in § 225.72 (relating to duties of personnel).
Regarding § 225.74 (relating to training and testing), a commentator requested that minimum hours of training be specified and standardized tests be required. The Department disagrees. The rule is written for flexibility, and training requirements and times vary with the complexity of the operation and the ability of the student. In any case, the program will be subject to review upon inspection by the Department or prior to the issuance of a license.
In § 225.76, general references to Chapter 220 are replaced by specific references for clarity. The applicability to licensees is also clarified in subsection (b), as well as the requirement to provide a 30-day follow-up letter under subsection (c) for information ''to the extent known.''
In §§ 225.82(c)(3) and (4), 225.83(5) and 225.84(5), the new terms ''direct reading dosimeter'' and ''personnel dosimeter'' described previously are substituted for references to other devices used by individuals requiring monitoring.
Section 225.85 is amended at final-form rulemaking to limit retention of surveys used to determine personnel exposure to the period in which a license or registration is active. This is in response to a comment questioning when the Department would authorize their disposition.
Section 225.91 is clarified in the final rulemaking to show that adequate radiation survey instrumentation is required by licensees as well as registrants.
Section 225.93 at final-form rulemaking changes references to various individual monitoring devices to the newly defined terms ''direct reading dosimeter'' and ''personnel dosimeter,'' as appropriate, and the requirements were further clarified to include licensees as well as registrants. Under § 225.93(d)(1), it was questioned what was meant by recharging a direct reading dosimeter daily and at the start of each work shift. In response, the requirement was reduced and rewritten to rezero the dosimeter at the start of each work shift. An editorial change was made to subsection (d)(3) changing the required accuracy of response for direct reading dosimeters from 30 % to 20 %.
Section 225.101(b) is amended at final-form rulemaking. One commentator was not sure of the intent of the phrase ''It may not be possible to energize.'' This was rewritten to clarify that a cabinet X-ray machine may not be energized when the operating conditions necessitate the area surrounding it to be restricted to maintain radiation exposure levels that are appropriate for members of the public. An editorial correction was also made to § 225.101(d) changing the reference from 10 CFR 20.1201 to 10 CFR 20.1301.
A commentator objected to the wording that requires safety and warning devices to be repaired ''in a timely manner,'' preferring that a specific time limit be set in § 225.104 (relating to X-ray detection systems for explosives, weapons and illegal items). The Department disagrees and has not changed the final rulemaking. The activity engaged in is inherently more dangerous than the risk of exposure to radiation. The regulation recognizes this and provides additional flexibility to the regulated community.
Section 230.13 (relating to transportation of licensed material) is amended at final-form rulemaking to elaborate on the parts of the Federal and Commonwealth transportation agency regulations that are referenced. A commentator believed the provision to be vague, and the Department concurred and made additional clarification.
F. Benefits Costs and Compliance
Executive Order 1996-1 requires a cost/benefit analysis of the final-form amendments.
Benefits
As set forth in this proposal, users of radioactive material will be required to comply with radiation protection standards that will not only protect employees but will also protect the general public. The Commonwealth will also be able to continue pursuit of agreement state status with the NRC that will lead to an overall reduction in license fees for NRC licensees of this Commonwealth. The regulation will also generally reduce the records retention requirement from 5 years to 3 years for registrants and licensees of the Department.
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