PROPOSED RULEMAKING
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CHS. 215, 217, 219, 220, 224--226, 230 and 232]
Radiological Health
[28 Pa.B. 881] The Environmental Quality Board (Board) proposes to amend Chapters 215, 217, 219, 220, 224--226, 230 and 232. The proposed amendments update the standards for protection against radiation.
This proposal was adopted by the Board at its regular meeting on December 16, 1997.
A. Effective Date
These proposed amendments will be effective immediately upon publication in the Pennsylvania Bulletin as final rulemaking.
B. Contact Persons
For further information, the contact persons are Stuart R. Levin, Chief, Division of Radiation Control, Bureau of Radiation Protection, 13th Floor, Rachel Carson State Office Building, P. O. Box 8469, Harrisburg, PA 17105-8469, (717) 787-3720; and Mary Lou 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.
C. Statutory Authority
These amendments are proposed under the authority of the following statutes:
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 delegates to the Board the power to adopt the regulations of the Department of Environmental Protection (Department) to implement the act.
Section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20), which authorizes and directs the Board to adopt regulations necessary for the proper performance of the work of the Department.
D. Background and Purpose
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 United States Nuclear Regulatory Commission (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 proposed amendments are necessary for the Commonwealth to acquire Agreement State status from the NRC. Under section 201 of the act, the Governor of the Commonwealth is authorized to enter into agreements with the NRC transferring regulatory authority to the Commonwealth for radiation protection. Presently, Pennsylvania 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 of the Commonwealth to discontinue NRC regulatory authority with respect to most by-product materials, source materials and special nuclear materials in amounts insufficient to form a critical mass.
The proposed amendments are based on the current NRC radiation protection regulations at 10 CFR Parts 19--71.
As required by section 301(c)(14) of the act (35 P. S. § 7110.301(c)(14)) 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. The proposal was provided to the Committee for review on August 20, 1997. The Committee provided oral and written comments at the meeting.
E. Summary of Regulatory Requirements
The proposed amendments revise current radiation protection regulations to reflect compatibility with NRC radiation protection regulations. The revisions are requisite to the Commonwealth's attainment of Agreement State status from the NRC. A description of the proposed amendments is provided as follows:
Chapter 215, General Provisions
§ 215.2. Definitions. The definitions of ''A1,'' ''A2,'' ''misadministration,'' ''prescribed dosage,'' ''prescribed dose,'' ''radiological physicist'' and ''written directive'' were deleted. The following definitions were updated to be compatible with the NRC: ''member of the public,'' ''NRC,'' ''occupational dose'' and ''public dose.'' A new definition for ''reclaiming'' was added.
§ 215.12. Inspections. The target inspection frequency for major medical facilities was changed from every 2 years to every 3 years.
§ 215.32 Exempt qualifications. The new Chapter 232 was added to the list of chapters.
Chapter 217. Licensing of Radioactive Material
§ 217.1 (purpose and scope) and § 217.2 (address) were updated to include the new Chapter 232 and the new Department mailing address.
§ 217.42(d) was amended by adding additional requirements for general licenses.
§ 217.58 (financial assurance arrangements for reclaiming sites) is a new section which provides for site cleanup money for certain licensees and is compatible with the NRC regulation.
§ 217.65 (specific licenses for the use of sealed sources in industrial radiography) was updated to be compatible with the NRC regulations.
§ 217.84 (licensing the manufacture and distribution of measuring, gauging or controlling devices) was amended to be compatible with the NRC regulations.
A new Appendix E (quantities for use with § 217.58), and a new Appendix F (criteria relating to use of financial tests and self guarantees of providing reasonable assurance of funds for decommissioning) were added to support the new § 217.58.
Chapter 219, Standards for Protection Against Radiation
§ 219.3 (definitions) was amended by adding a definition for, ''constraint (dose constraint).''
§ 219.21(a) (radiation protection programs) was amended to clarify the scope of the required radiation protection program.
§ 219.21(f) was added for compatibility with the NRC requirement for a constraint on air emissions for radioactive material.
§ 219.51(a)(1) (dose limits for individual members of the public) was amended to be compatible with the NRC.
§ 219.51(a)(2) was deleted and § 219.51(a)(3) was renumbered as (2).
§ 219.51(a)(2) ... (2). The new 219.51(a) was updated for compatibility with the NRC regulations.
§ 219.114 (further restrictions on the use of respiratory protection equipment) was added for compatibility with the NRC.
§ 219.223(2)(vi) was added to the list of reports in § 219.223 (reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits). The phrase ''ALARA constraints'' was added to 219.223(b)(1)(iv).
Chapter 220. Notices, Instructions and Reports to Workers; Inspections
§§ 220.2 and 220.3 were updated for compatibility with the NRC.
§ 220.8 was updated to reflect the Department's name change from Environmental Resources to Environmental Protection.
Chapter 224. Medical Use of Radioactive Material
§ 224.2 (definitions) was amended by adding definitions for ''authorized nuclear pharmacist,'' ''diagnostic clinical procedures manual,'' ''prescribed dosage,'' ''prescribed dose,'' ''recordable event'' and ''written directive.'' The definition of ''medical use'' was amended to add ''human research subjects under the supervision of an authorized user.'' The definition of ''misadministration'' was updated.
§§ 224.6(2) (license amendments) and 224.7 (notifications) were amended by adding the phrase, ''or authorized nuclear pharmacist'' A new subsection (b) was added to § 224.6 to be compatible with 10 CFR 35.15 (relating to exemptions regarding Type A specific licenses of broad scope).
§ 224.9 (specific exemptions) was amended by changing the name of the advisory committee from Advisory Committee on Medical Uses of Radioactive Material to Radiation Protection Advisory Committee.
§ 224.10 (provisions for research involving human subjects) and § 224.11 (FDA, other Federal, State requirements) were added for compatibility with the NRC regulations.
§ 224.53(2)(ii) (radiation safety committee) was amended by adding the phrase ''an authorized nuclear pharmacist.''
§ 224.55 (a) (supervision) was amended by adding two sections regarding the authorized use of radioactive material by auxiliary personal.
§ 224.60 (suppliers) was reworded to be compatible with the NRC regulations.
§ 224.61 (quality management program) was added for compatibility with the NRC regulations.
§ 224.101(b)(3) (possession, use, calibration and check of dose calibrators) was added for compatibility with the NRC regulations.
§ 224.103(1), (2), and (3)(iii) (measurement of pharmaceutical dosages) was amended for compatibility with the NRC regulations.
§ 224.104(1) (authorization for calibration and reference sources) was amended to include 25 millicuries each of accelerator produced material.
§ 224.108(e) (surveys for contamination and ambient radiation exposure rate) was amended for compatibility with the NRC regulations.
§ 224.109 (release of patients containing radiopharmaceuticals or permanent implants) was rewritten to be compatible with the NRC regulations.
§ 224.112 (decay-in-storage) was amended to allow sealed sources of accelerator produced radioactive material with a physical half-life of up to 300 days to be held for decay-in-storage.
§ 224.113 (possession, use, calibration, and check of instruments to measure dosages of alpha- or beta-emitting radionuclides) was added for compatibility with NRC regulations.
§§ 224.151, 224.201, and 224.251 which involve the use of radiopharmaceuticals for diagnosis and therapy were amended for compatibility with NRC regulations. The radiopharmaceutical may be obtained from a licensed manufacturer, licensed preparer or from an authorized nuclear pharmacist. References to NDA's (''New Drug Application'') and IND's (''Notice of Claimed Investigational Exemption for a New Drug'') were deleted.
§§ 224.152 and 224.204 regarding the possession of survey instruments was updated for compatibility with NRC regulations.
§§ 224.252, 224.253, 224.305, 224.306, 224.352, 24.406 and 224.408 were updated for compatibility with the NRC regulations.
Subchapter J (training and experience requirements) was amended in two main areas. First, additional certifying bodies were added. They are: the American Board of Medical Physics, the Royal College of Physicians and Surgeons of Canada, American Osteopathic Board of Radiology, and the American Osteopathic Board of Nuclear Medicine. Also, § 224.454(2)(ii)(F) was added for compatibility with the NRC regulations and § 224.465 (recentness of training) was amended for compatibility with NRC regulations.
Second, two new sections, § 224.466 (training for an authorized nuclear pharmacist) and § 224.467 (training for experienced nuclear pharmacists) were added for compatibility with the NRC regulations.
Subchapter K (enforcement) was deleted because it is obsolete.
Chapter 225. Radiation Safety Requirements for Industrial Radiographic Operations
Chapter 225 was renamed ''Radiation Safety Requirements for Industrial Uses and Radiographic Operations.''
§ 225.1 (purpose and scope) was amended to include industrial radiographic operations as well as traditional industrial radiography.
§ 225.2 (definitions) was amended by updating and adding some definitions. Updated definitions are: ''cabinet X-ray system,'' ''radiographer,'' ''radiographer's assistant'' and ''temporary job site.'' New definitions are: ''annual refresher safety training,'' ''associated equipment,'' ''certifying entity,'' ''collimator,'' ''control cable,'' ''control drive mechanism,'' ''crank-out device,'' ''exposure head,'' ''guide tube (projection sheath),'' ''individual's certification,'' ''lock-out survey,'' ''personal supervision'' and ''radiographic operations,'' ''S-tube,'' ''source assembly,'' ''storage facility'' and ''transport container.''
A new § 225.10 (application for a specific license or registration) was added which requires a person using X-ray machines for industrial radiography to get Department approval before commencing operations.
The heading, ''Sealed Source Requirements,'' was deleted and §§ 225.11 and 225.12 were brought under the heading, ''General Provisions.'' § 225.11 (storage position radiation level limits) was rewritten as ''reciprocity'' requirements. Section 225.12 (radiation source locks) was rewritten as a prohibition against using radiation sources regulated by Chapter 225 for human use.
§§ 225.13--225.18, 225.21--225.23, 225.31--225.33 and 225.41--225.44 were deleted because they were obsolete.
The heading, ''Precautionary Procedures,'' was replaced by ''General Administrative Requirements.'' Section 225.51 was renamed as ''Duties of Personnel.'' This new section describes the duties of the radiation safety officer, radiographer, radiographer's assistant and radiography trainee.
New §§ 225.71 and 225.72 describe the training and testing requirements for radiographers and radiographer assistants. A new § 225.73 describes the required audits and safety reviews of radiographers and radiographer assistants. A new § 225.74 describes the reporting requirements including those for incidents involving radiographic equipment.
A new heading, ''General Technical Requirements,'' includes requirements for certification of personnel, requirements for an independent certifying organization, requirements for certification programs, requirements for written examinations, permanent radiographic installation, operating requirements, records required at temporary job sites, and operating and emergency procedures. These requirements are in §§ 225.101--225.108 respectively.
A new heading, ''Radiation Survey Instrument and Personnel Monitoring,'' includes requirements for radiation survey meters, radiation survey meter calibration, personnel monitoring control and personal alarm rate meters. These requirements are in §§ 225.151--225.154.
A new heading, ''Radiation Producing Machine Requirements,'' includes requirements for cabinet X-ray systems, shielded room X-ray machine radiography, field site radiography, surveys and survey records, utilization logs, bomb detection and baggage X-ray systems and X-ray calibration systems. These requirements are in §§ 225.201--225.207.
The existing heading, ''Sealed Source Requirements,'' containing §§ 225.11--225.225.18 is replaced with a new group of §§ 225.251--225.261 which are compatible with the NRC radiography regulations. These sections include requirements for performance of radiography equipment, limits on levels of radiation for radiographic exposure devices, locking and relocation of exposure devices, storage precautions, leak testing of and replacement of sealed sources, physical inventories, inspection and maintenance of exposure devices, utilization logs, radiation surveys and records, supervision of radiographer's assistants, and radiographic operations, security and posting.
Chapter 226. Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies
Chapter 226 was renamed ''Radiation Safety Requirements for Well Logging.''
§ 226.1 (purpose and scope) was generally updated and revised to include persons using uranium sinker bars.
§ 226.2 (definitions) was amended by revising, adding and deleting some definitions. Definitions that were revised are: logging supervisor, personal supervision, radioactive marker and well logging. New definitions are: fresh water aquifer, logging assistant, logging tool, safety review, subsurface casing for protecting fresh water aquifers, temporary jobsite, uranium sinker bar and well. Deleted definitions are: mineral logging and wireline service operation.
Other minor revisions were made to §§ 226.3, 226.11--226.17, 226.19, 226.21--226.23, 226.31, 226.33--226.34, 226.41--226.43 and 226.51 for compatibility with NRC regulations.
A new § 226.20, ''radioactive markers and uranium sinker bars,'' is added for compatibility with the NRC regulations.
Appendix B, ''Example of Plaque for Identifying Wells Containing Radioactive Material Abandoned Downhole,'' was deleted.
Chapter 230. Packaging of and Transportation of Radioactive Material
§ 230.2 (definitions) was amended by revising, adding, and deleting some definitions. Definitions that were revised are: ''A2,'' ''exclusive use,'' ''fissile material,'' ''low specific activity material'' and ''transport index.'' New definitions are: ''containment system,'' ''conveyance,'' ''low toxicity alpha emitters,'' ''maximum normal operating pressure,'' ''natural thorium,'' ''surface contaminated object (SCO)'' and ''uranium (natural, depleted, enriched).'' Deleted definitions are: ''closed transport vehicle'' and ''fissile material package.''
§ 230.12 and Appendix A were updated for compatibility with NRC regulations.
§§ 230.25 and 230.26 were deleted. Section 230.41 (fissile material: assumptions as to unknown properties) was deleted and replaced as the section for ''applicability of operating controls and procedures'' for compatibility with NRC regulations.
A new § 230.48 (opening instructions) was added for compatibility with NRC regulations.
Tables I-IV were deleted and replaced with new Tables A-1 and A-2 for compatibility with NRC regulations.
Chapter 232. Licenses and Radiation Safety Requirements for Irradiators
Chapter 232 is a new chapter which is compatible with 10 CFR Part 36, ''Licenses and Radiation Safety Requirements for Irradiators.''
Subchapter A (general provisions) contains the sections for ''purpose and scope'' and ''definitions.''
Subchapter B (specific licensing requirements) contains requirements for addressing application for a specific license, specific licenses for irradiators, start of construction, applications for exemptions and request for written statements.
Subchapter C (design and performance requirements for irradiators) contains requirements for addressing performance criteria for sealed sources, access control, shielding, fire protection, radiation monitors, control of source movement, irradiator pools, source rack protection, power failures, design requirements, and construction monitoring and acceptance testing.
Subchapter D (operation of irradiators) contains requirements for addressing training, operating and emergency procedures, personnel monitoring, radiation surveys, detection of leaking sources, inspection and maintenance, pool water purity, attendance during operation, entering and leaving the radiation room, and irradiation of explosive or flammable materials.
Subchapter E (records) contains requirements for addressing records and retention periods, and reports.
F. Benefits Costs and Compliance
Executive Order 1996-1 requires a cost/benefit analysis of the proposed 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 employes but will also protect the general public.
Compliance Costs
There are no compliance costs because the licensees are currently complying with these proposed amendments by virtue of their NRC licenses.
Compliance Assistance Plan
Compliance assistance is available to all existing holders of a license through the use of NRC guidance which they use currently.
Paperwork Requirements
The proposed amendments will not change paperwork requirements because the licensees are already complying with the identical NRC requirements.
G. Sunset Review
These amendments will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the amendments effectively fulfill the goals for which they were intended.
H. Regulatory Review Act
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 20, 1998, the Department submitted a copy of the proposed amendments to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the Senate and House Environmental Resources and Energy Committees. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department. A copy of this material is available to the public upon request.
If the Committee have objections to any portion of the proposed amendments, they will notify the Department within 20 days of the close of the public comment period.
If IRRC has any objections to any portion of the proposed amendments, it will notify the Department within 10 days of the close of the Committees' comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review by the Department, the Governor and the General Assembly before final publication of the regulations.
I. Public Comments
Written Comments--Interested persons are invited to submit comments, suggestions or objections regarding the proposed amendments to the Environmental Quality Board, P. O. Box 8477 Harrisburg, PA. 17105-8477 (express mail: Rachel Carson State Office Building, 15th floor, 400 Market Street, Harrisburg, PA 17101-2301). Comments submitted by facsimile will not be accepted. Comments, suggestions or objections must be received by the Board by April 15, 1998 (within 60 days of publication in the Pennsylvania Bulletin). Interested persons may also submit a summary of their comments to the Board. The summary may not exceed one page in length and must be received by April 8, 1998 (within 60 days following publication in the Pennsylvania Bulletin). The one-page summary will be provided to each member of the Board in the agenda packet distributed prior to the meeting at which the final-form regulation will be considered.
Electronic Comments--Comments may be submitted electronically to the Board at RegComments.dep.state. pa.us and must also be received by the Board by April 8, 1998. A subject heading of the proposal and a return name and address must be included in each transmission. If an acknowledgment of electronic comments is not received by the sender within 2 working days, the comments should be retransmitted to ensure receipt.
JAMES M. SEIF,
ChairpersonFiscal Note: 7-335. 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
GENERAL PROVISIONS
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§ 215.2. Definitions.
The following words and terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:
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[A1--The maximum activity of special form radioactive material permitted in a Type A package.]
[A2--The maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Chapter 230, Appendix A (relating to packaging and transportation of radioactive materials), Table I, or may be derived in accordance with the procedure prescribed in Chapter 230, Appendix A.]
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Member of the public--An individual [in a controlled or unrestricted area. An individual is not a member of the public during any period in which the] except when that individual [receives] is receiving an occupational dose.
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[Misadministration--The administration to a human being of:
(i) A radiopharmaceutical dosage greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131 under one of the following conditions:
(A) Involving the wrong patient or wrong pharmaceutical.
(B) When both the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage and the difference between the administered and prescribed dosage exceeds 30 microcuries (1.11 MBq).
(ii) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131 under one of the following conditions:
(A) Involving the wrong patient, wrong radiopharmaceutical, or wrong route of administration.
(B) When the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage.
(iii) A gamma stereotactic radiosurgery radiation dose under one of the following conditions:
(A) Involving the wrong patient or wrong treatment site.
(B) When the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(iv) A teletherapy radiation dose under one of the following conditions:
(A) Involving the wrong patient, wrong mode of treatment or wrong treatment site.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.
(v) A brachytherapy radiation dose under one of the following conditions:
(A) Involving the wrong patient, wrong radioisotope, or wrong treatment site--excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site.
(B) Involving a sealed source that is leaking.
(C) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure.
(D) When the calculated administered dose differs from the prescribed dose by more than 20% of the prescribed dose.
(vi) A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131, when the conditions in clauses (a) and (b) apply:
(A) Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration or when the administered dosage differs from the prescribed dosage.
(B) When the dose to the patient exceeds 5 rem (50 mSv) effective dose equivalent or 50 rems (0.5 Sv) dose equivalent to any individual organ.
(vii) An X-ray therapy dose (with energies less than 1 MeV) under one of the following conditions:
(A) Involving the wrong patient, wrong mode of treatment, wrong treatment site, wrong tube potential or wrong filtration.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.
(viii) A radiation therapy dose using X-rays or electron beams with energies of 1 MeV and above under one of the following conditions:
(A) Involving the wrong patient, wrong mode of treatment, wrong treatment site, wrong photon or electron beam energy, wrong applicator or wrong treatment geometry.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.]
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NRC--United States Nuclear Regulatory Commission or its authorized representatives.
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Occupational dose--The dose received by an individual in [a restricted area or in] the course of employment in which the individual's assigned duties involve exposure to sources of radiation, whether in the possession of the licensee, registrant or another person. The term does not include dose received: from background radiation, as a patient from medical practices, from exposure to individuals administered radioactive material and released in accordance with § 224.109 (relating to release of patients containing radiopharmaceuticals or permanent implants), from voluntary participation in medical research programs or as a member of the public.
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[Prescribed dosage--The quantity of radiopharmaceutical activity as documented in one of the following methods:
(i) In a written directive.
(ii) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
Prescribed dose--One of the following:
(i) For gamma stereotactic radiosurgery, the total dose as documented in the written directive.
(ii) For teletherapy, X-ray therapy, and electron beam therapy, the total dose and dose per fraction as documented in the written directive.
(iii) For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.]
Public dose--The dose received by a member of the public from exposure to [sources of radiation either within a licensee's or registrant's controlled area or in unrestricted areas] radiation sources under the control of the licensee or registrant. The term does not include occupational dose, dose received from background radiation, dose received as a patient from medical practices, from exposure to individuals administered radioactive material and released in accordance with § 224.109, or dose from voluntary participation in medical research programs.
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[Radiological physicist--An individual who complies with one of the following:
(i) Is certified by the American Board of Radiology in therapeutic radiological physics, radiological physics or x- and gamma-ray physics.
(ii) Has a bachelor's degree in one of the physical sciences or engineering and 3 years full-time experience working in therapeutic radiological physics under the direction of a physicist certified by the American Board of Radiology. The work duties shall include duties involving the calibration and spot checks of a medical accelerator or a teletherapy unit.
(iii) Has a master's or a doctor's degree in physics, biophysics, radiological physics, health physics or engineering; has had 1 year's full-time training in therapeutic radiological physics; and has had 1 year's full-time work experience in a radiotherapy facility where that person's duties involve calibration and spot checks of a medical accelerator or a teletherapy unit.]
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Reclaiming--Returning property to a condition where the property no longer presents a public health or safety hazard or threat to the environment. The term includes but is not limited to those activities necessary to decommission the licensed facility (that is, to remove the facility safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of the license).
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[Written directive--An order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in subparagraph (vi), containing the following information:
(i) For any administration of quantities greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131: the dosage.
(ii) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage and route of administration;
(iii) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern and total dose.
(iv) For teletherapy: the total dose, dose per fraction, treatment site and overall treatment period.
(v) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site and total dose.
(vi) For all other brachytherapy the following apply:
(1) Prior to implantation: the radioisotope; number of sources; source strengths; and number, type and size of applicator.
(2) After implantation but prior to completion of the procedure: the radioisotope; treatment site; and total source strength and exposure time (or, equivalently, the total dose).
(vii) For X-ray therapy at potentials less than 1 MeV: the total dose, dose per fraction, treatment site, field size, tube potential and filtration and overall treatment period.
(viii) For X-ray and electron beam therapy at energies of 1 MeV and above: the total dose, dose per fraction, treatment site, field size, beam type and energy, applicator, use of beam blocking or shaping devices, treatment geometry and overall treatment period.]
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RIGHTS AND RESPONSIBILITIES OF THE DEPARTMENT § 215.12. Inspections.
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(c) Inspections by the Department.
(1) The Department, its employes and agents may conduct inspections of the facilities of registrants of radiation-producing machines and licensees of radioactive material at the following frequencies:
(i) For major medical facilities, including hospitals, at least once every [2] 3 years.
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EXEMPTIONS § 215.32. Exemption qualifications.
The following sources, uses and types of users are exempt from Chapters 216--[230] 232:
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CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 217.1. Purpose and scope.
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(b) A licensee is subject to Chapters 215, 219 and 220 (relating to general provisions; standards for protection against radiation; and notices, instructions and reports to workers; inspections). A licensee engaged in industrial radiographic operations is subject to Chapter 225 (relating to radiation safety requirements for industrial radiographic operations). A licensee using radioactive material for human use is subject to Chapter 224 (relating to medical use of radioactive material). A licensee using sealed sources in well logging is subject to Chapter 226 (relating to radiation safety requirements for [wireline service operations and subsurface tracer studies] well logging ). A licensee using irradiators is subject to Chapter 232 (relating to licenses and radiation safety requirements for irradiators).
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§ 217.2. Address.
An application for a license, license renewal and license amendments and other communications under this chapter shall be addressed to the Bureau of Radiation Protection, Department of Environmental [Resources] Protection, Post Office Box [2063] 8469, Harrisburg, Pennsylvania [17120] 17105-8469.
Subchapter C. LICENSES
GENERAL LICENSES: MATERIAL OTHER THAN SOURCE MATERIAL § 217.42. Certain measuring, gauging or controlling devices.
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(d) A person who owns, receives, acquires, possesses, uses or transfers radioactive material in a device under the general license in subsection (a):
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(10) Shall conduct a physical inventory every 6 months to account for all sources or devices, or both, received and possessed under subsection (a) and do the following:
(i) Maintain the physical inventory records for 3 years from the date of each inventory.
(ii) Furnish a report to the Department annually showing to the extent practical, the make, model, serial number, isotope, source activity and location of each device. The report shall list an individual to contact regarding questions about this report.
(11) For portable devices, shall also comply with the following:
(i) A person who initiates acquisition of a portable device and does not already hold a license under subsection (a) shall notify the Department within 15 days of their action.
(ii) Portable devices may only be used by or under the direct supervision of individuals who have been instructed in the operating and emergency procedures necessary for ensuring safe use.
(iii) For each individual that the licensee permits to use a portable device, the licensee shall maintain a record showing the type of device use permitted and the basis for that authorization such as training certificates. An individual's record shall be kept for at least 3 years after the individual terminates association with the licensee.
(iv) Portable devices shall be secured against access by unauthorized personnel when not under the direct surveillance of an individual authorized to use the device.
(v) The licensee shall maintain current logs, which shall be kept available for inspection by the Department for 3 years from the date of the event, showing for each portable device the following applicable information:
(A) The model and serial number of the device.
(B) The name of the assigned user.
(C) Locations and dates of use.
(vi) Emergency instructions shall accompany each portable device taken off the premises of the licensee.
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SPECIFIC LICENSES--GENERAL CONDITIONS § 217.58. Financial assurance arrangements for reclaiming sites.
(a) Each applicant for a specific license authorizing the possession and use of unsealed radioactive material of half-life greater that 120 days and in quantities exceeding 105 times the applicable quantities set forth in Appendix E (relating to quantitites for use with § 217.58) shall submit a decommissioning funding plan as described in subsection (e). The decommissioning funding plan shall also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1 (unity rule), where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Appendix E.
(b) Each applicant for a specific license authorizing possession and use of radioactive material of half-life greater than 120 days and in quantities specified in subsection (d) shall do one of the following:
(1) Submit a decommissioning funding plan.
(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by subsection (d) using one of the methods described in subsection (f). For an applicant, this certification may state that the appropriate assurance shall be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirement of subsection (f) shall be submitted to the Department before receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the Department, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of subsection (f).
(c) Each holder of a specific license shall do one of the following:
(1) If the license was issued on or after _____ (Editor's Note: The blank refers to the effective date of adoption of this proposal), which is of a type described in subsection (a) or (b), the licensee shall provide financial assurance for decommissioning in accordance with the criteria set forth in this section.
(2) If the license was issued before _____ (Editor's Note: The blank refers to the effective date of adoption of this proposal) and of a type described in subsection (a), the licensee shall submit, on or before _____ (Editor's Note: The blank refers to a date 1 year after the effective date of adoption of this proposal) a decommissioning funding plan as described in subsection (e) or a certification of financial assurance for decommissioning in an amount at least equal to $750,000 in accordance with the criteria set forth in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in an application for license renewal.
(3) If a specific license was issued before _____ (Editor's Note: The blank refers to the effective date of the adoption of this proposal), and of a type described in subsection (b) the licensee shall submit, on or before _____ (Editor's Note: The blank refers to a date 1 year after the effective date of adoption of this proposal), a decommissioning funding plan as described in subsection (e), or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this section.
(d) If the required amounts of financial assurance for decommissioning by quantity of material is:
(1) Greater than 104 but less than or equal to 105 times the applicable quantities of Appendix E in unsealed form (for a combination of isotopes, if R, as defined in subsection (a), divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1), the required amount is $ 750,000.
(2) Greater than 103 but less than or equal to 104 times the applicable quantities of Appendix E in unsealed form (for a combination of isotopes, if R, as defined in subsection (a), divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1), the required amount is $150,000.
(3) Greater than 1010 times the applicable quantities of Appendix E in sealed sources or plated foils (For a combination of isotopes, if R, as defined in subsection (a), divided by 1010 is greater than 1), the required amount is $75,000.
(e) Each decommissioning funding plan shall contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning from subsection (f), including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. The commissioning funding plan shall also contain a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning and a signed original of the financial instrument obtained to satisfy the requirement of subsection (f).
(f) Financial assurance for decommissioning shall be provided by one or more of the following methods:
(1) Prepayment. Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets so that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities in a form approved by the Department.
(2) A surety method. A surety method, insurance or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix F (relating to criteria relating to use of official tests and self guarantees of providing reasonable assurance of funds for decommissioning). A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this section. A guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Appendix F. A guarantee by the applicant or licensee may not be used in combination with any other financial methods to satisfy the requirements of this section or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning shall contain the following conditions:
(i) The surety method or insurance shall be open-ended or, if written for a specified term, such as 5 years, shall be renewed automatically unless 90 days or more prior to the renewal date, the issuer notifies the Department, the beneficiary and the licensee of its intention not to renew. The surety method or insurance shall also provide that the full face amount be automatically paid to the beneficiary prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the Department within 30 days after receipt of notification of cancellation.
(ii) The surety method or insurance shall be payable to a trust established for decommissioning costs. The trustee and trust shall be acceptable to the Department. An acceptable trustee includes an appropriate State or Federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a Federal or State agency.
(iii) The surety method or insurance shall remain in effect until the Department has terminated the license.
(3) An external sinking fund. An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit or deposit of government securities in a format approved by the Department. The surety or insurance provision shall be as stated in subsection (f)(2).
(4) Statement of intent. In the case of Federal, State or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on subsection (d), and indicating that funds for decommissioning will be obtained when necessary.
(5) Alternate financial assurance arrangements. Alternate financial assurance arrangements not listed in this section may be accepted by the Department, provided the alternate arrangements are submitted to the Department in writing and approval for the alternate arrangement is granted by the Department in writing.
(g) Each person licensed under this article shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with §§ 217.51--217.57 (relating to specific licenses--general conditions), licensees shall transfer all records described in this subsection to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the Department considers important to decommissioning consists of:
(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records shall include any known information on identification of involved nuclides, forms and concentrations.
(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, or both, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.
(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after a leak) or radioactive material having only half-lives of less than 65 days, a list contained in a single document and updated every 2 years, of the following:
(i) All areas designated and formerly designated restricted areas as defined in § 215.2 (relating to definitions).
(ii) All areas outside of restricted areas that require documentation under paragraph (1).
(iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under § 219.209 (relating to records of waste disposal).
(iv) All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under § 219.182 (relating to method of obtaining approval of proposed disposal procedures).
(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of funding method used for assuring funds if either a funding plan or certification is used.
(h) the following specific licensees are required to make financial surety arrangements:
(1) Major processors.
(2) Waste handling licensees.
(3) Former United States Atomic Energy Commission or NRC licensed facilities.
(4) All others except persons exempt under subsection (i).
(i) The following persons are exempt from the requirements of subsection (a):
(1) Persons authorized to possess no more than 1,000 times the quantity specified in Appendix B (relating to exempt quantities).
(2) Persons authorized to possess radioactive noble gasses in sealed sources with no radioactive daughter product with half-live greater than 30 days.
§ 217.65. Specific licenses for the use of sealed sources in industrial radiography.
In addition to the requirements of § 217.52 (relating to general requirements for the issuance of specific licenses), a specific license for use of sealed sources in industrial radiography will be issued if:
(1) The applicant has an adequate program for training radiographers and radiographer's assistants and submits to the Department a schedule or description of the program which specifies the following:
(i) Initial training.
(a) After May 28, 1999, an applicant need not describe its initial training and examination program for radiographers in the subjects outlined in Appendix A, Chapter 225 (relating to radiation safety requirements for industrial uses and radiographic operations).
(b) From ____ (Editor's Note: The blank refers to the effective date of adoption of this proposal) to May 28, 1999, an applicant may affirm that all individuals acting as industrial radiographers will be certified in radiation safety by a certifying entity before commencing duty as radiographers. This affirmation substitutes for a description of its initial training and examination program for radiographers in the subjects outlined in Appendix A, Chapter 225 (relating to radiation safety requirements for industrial uses and radiographic operations).
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(vi) The procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.
(vii) The inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed 6 months, as described in § 225.73 (relating to audits and safety reviews of radiographers and radiographers' assistants).
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(5) The applicant who desires to conduct the required leak tests of sealed sources or of exposure devices containing depleted uranium personally has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the Department a description of the procedures to be used including the following:
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(8) The applicant identifies and lists the qualifications of the individual designated as the radiation safety officer under § 225.51(a) (relating to radiation safety officer for industrial radiography) and potential designees responsible for ensuring that the applicant's radiation safety program is implemented in accordance with approved procedures.
(9) If the applicant intends to perform ''in-house'' calibrations of survey instruments, the description of the methods to be used and the relevant experience of the individual who will perform the calibrations. Calibrations shall be performed according to the procedures described and at the frequency described in § 225.152 (relating to radiation survey meter calibration requirements).
(10) The applicant identifies and describes the locations of all field stations and permanent radiographic installations.
(11) The applicant identifies the locations where all records required by this article and Chapter 225 (relating to radiation safety requirements for industrial uses and radiographic operations) will be maintained.
§ 217.84. Licensing the manufacture and distribution of measuring, gauging or controlling devices.
(a) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under § 217.42 (relating to certain measuring, gauging or controlling devices) or equivalent regulations of the NRC, an agreement state or a licensing state will be approved if:
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(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions and potential hazards of the device to provide reasonable assurance that:
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(ii) Under ordinary conditions of handling, storage and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that a person will receive in a period of [one calendar quarter] 1 year [a dose in excess of 10% of the limits specified in the table in § 219.11(a) (Reserved)] a dose in excess of 10% of the annual limits specified in § 219.31 (relating to occupational dose limits for adults).
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(Editor's Note: Appendices E and F are proposed to be added. They are printed in regular type to enhance readability).
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