[31 Pa.B. 5239]
[Continued from previous Web Page] Compliance Costs
There are no additional compliance costs because licensees either currently comply with these regulations by virtue of their NRC licenses or through licenses issued by the Department which incorporate similar requirements by condition. There is no additional compliance cost for registrants as the generally applicable standards for radiological health already apply to them.
Compliance Assistance Plan
Compliance assistance is available to all existing license holders through the use of a comprehensive set of regulatory guides published by the NRC.
Compliance with the amended regulations should impose no difficulty or costs because they are either essentially unchanged or simplified from present requirements. In addition to the publication in the Pennsylvania Bulletin, notification of the regulatory changes will be enclosed with annual fee invoices to licensees and registrants, and Department inspectors will bring the changes to the attention of licensees and registrants during inspections.
Paperwork Requirements
The final-form regulations will not change paperwork requirements for current NRC licensees because they are already complying with NRC requirements. The retention period for most records will be reduced for registrants and Department licensees.
G. Pollution Prevention
The major purpose of the Bureau of Radiation Protection is to reduce public and occupational exposure to radiation. An educational, compliance assistance approach has been used for many years. However, over 90% of the radiation sources regulated emit controlled beams of photon or particle radiation directed at a patient or object for various medical or industrial purposes. Any unwanted radiation is controlled by shielding, adherence to operational rules, inventory procedures, and the like. Materials licensees working with radioisotopes that are not sealed in liquid and gas tight containers are required to follow Department-approved procedures to ensure that the material is not spilled or otherwise released (hoods, absorbent material in metal trays, and the like) and to frequently survey work areas to detect any contamination. The final-form regulations include risk-based release limits.
H. Sunset Review
These final-form regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
I. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 8, 2000, the Department submitted a copy of the proposed rulemaking to IRRC and the Chairpersons of the Senate and House Environmental Resources and Energy Committees. In compliance with section 5(b.1) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of the comments, as well as other documentation.
In preparing these final-form regulations, the Department has considered the comments received from IRRC and the public. These comments are addressed in the comment and response document and Section E of this Preamble. The Committees did not provide comments on the proposed rulemaking.
These final-form regulations were deemed approved by the House Environmental Resources and Energy Committee on July, 17, 2001, and were deemed approved by the Senate Environmental Resources Committee and Energy Committee on July 17, 2001. IRRC met on July 26, 2001, and approved the final-form regulations in accordance with section 5(c) of the Regulatory Review Act.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and regulations promulgated thereunder in 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law, and all comments were considered.
(3) These regulations do not enlarge the purpose of the proposal published at 30 Pa.B. 4503 (August 26, 2000).
(4) These regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this Preamble.
K. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapters 215, 217, 219, 220, 224, 225, 226, 230 and 232, are amended by amending §§ 215.1--215.3, 215.11, 215.12, 215.15, 215.32, 217.1, 217.2, 219.3, 219.51, 219.61, 219.131, 219.132, 219.159, 219.160, 219.221, 219.222, 219.228, 220.2, 225.1, 226.1, 230.13 and 230.47; adding §§ 215.5, 215.25--215.28, 217.131--217.137, 217.141--217.144, 217.151--217.155, 217.161--217.163, 217.171, 217.172, 217.181, 217.182, 217.191, 217.201--217.203, 219.5--219.7, 219.71--219.73, 219.91--219.93, 219.111--219.113, 219.229, 220.9, 220.10, 224.10, 224.11, 224.21--224.23, 225.2a, 225.3a, 225.4a, 225.5a, 225.6a, 225.71--225.76, 225.81--225.88, 225.91--225.93, 225.101--225.104, 226.3a, 226.4, 226.5, 226.61, 230.3--230.5 and 232.1--232.3; and by deleting 215.4, 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, 217.122, Appendices A, B and D, 219.4, 219.21, 219.31--219.38, 219.52, 219.151--219.158, 219.161, 219.162, 219.181--219.186, 219.201--219.211, 219.223--219.226, 219.241, Appendices A--C, 220.3--220.8, 224.2--224.9, 224.51--224.60, 224.101--224.112, 224.151, 224.152, 224.201--224.204, 224.251--224.254, 224.301--224.306, 224.351, 224.352, 224.401--224.414, 224.451--224.465, 224.501, 225.2, 225.11--225.18, 225.21--225.23, 225.31--225.33, 225.41--225.44, 225.51--225.53, 226.3, 226.11--226.19, 226.21--226.23, 226.31--226.34, 226.41--226.43, 226.51, Appendices A and B, 230.2, 230.11, 230.12, 230.21--230.26, 230.41--230.46, 230.51, Appendix A, Tables I--IV, to read as set forth in Annex A.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of the Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson shall submit this order and Annex A to IRRC and the Senate and House Environmental Resource and Energy Committees as required by law.
(d) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau, as required by law.
(e) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
DAVID E. HESS,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 31 Pa.B. 4503 (August 11, 2001).)
Fiscal Note: Fiscal Note 7-350 remains valid for the final adoption of the subject regulations.
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 § 215.1. Purpose and scope.
(a) This article establishes requirements for the protection of public health and safety as related to radiation sources and implements the requirements of the act.
(b) This article, except as otherwise specifically provided in the act, applies to persons who use, manufacture, produce, transport, transfer, receive, acquire, possess, own or dispose of a radiation source.
(c) A person who, when required, fails to register or obtain a license for radiation sources in the possession or control of the person, shall comply with the act or with this article.
(d) This article does not apply to the extent the person is subject to regulation by the NRC.
(e) Title 10 Chapter I (Nuclear Regulatory Commission) Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 70, 71 and §§ 150.1, 150.2, 150.3, 150.11, 150.20(a)(1), 150.20(a)(2) and 150.20(b) of the CFR is incorporated by reference with the exceptions set forth in paragraphs (1)--(13). Notwithstanding the requirements incorporated by reference, nothing in this article relieves or limits a person from complying with the laws of the Commonwealth, including the act and the Low-Level Radioactive Waste Disposal Act (35 P. S. §§ 7130.101--7130.905).
(1) Sections 19.4, 19.5, 19.8, 19.30 and 19.40 are not incorporated.
(2) Sections 20.1006, 20.1009, 20.2206(a)(1), (3), (4) and (5), 20.2401 and 20.2402 are not incorporated.
(3) Sections 30.5, 30.6, 30.8, 30.21(c), 30.34(d) and (e)(1) and (3), 30.41(a)(6), 30.55, 30.63 and 30.64 are not incorporated.
(4) Sections 31.3, 31.4 and 31.14 are not incorporated.
(5) Sections 32.8, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29 and 32.40 are not incorporated.
(6) Sections 33.8, 33.21 and 33.23 are not incorporated.
(7) Sections 34.5, 34.8, 34.121 and 34.123 are not incorporated.
(8) Sections 35.8, 35.990 and 35.991 are not incorporated.
(9) Sections 36.5, 36.8, 36.91 and 36.93 are not incorporated.
(10) Sections 39.5, 39.8, 39.101 and 39.103 are not incorporated.
(11) Sections 40.6, 40.8, 40.12(b), 40.23, 40.27, 40.28, 40.31(k) and (i), 40.32(d), (e) and (g), 40.38, 40.41(d), (e)(1) and (3) and (g), 40.51(b)(6), 40.64, 40.66, 40.67, 40.81 and 40.82 are not incorporated.
(12) Sections 70.1(c), (d) and (e), 70.5, 70.6, 70.8, 70.13, 70.13a, 70.20a, 70.20b, 70.21(a)(1), (c), (f), (g) and (h), 70.22(b), (c), (f), (g), (h), (i), (j), (k), (l), (m) and (n), 70.23(a)(6), (7), (8), (9), (10), (11) and (12) and (b), 70.23a, 70.24, 70.25(a), 70.31(c), (d) and (e), 70.32(a)(1), (4), (5), (6) and (7), 70.32(b)(1), (3) and (4), (c), (d), (e), (f), (g), (h), (i), (j) and (k), 70.37, 70.40, 70.42(b)(6), 70.44, 70.51(c), (d) and (e), 70.52, 70.53, 70.54, 70.55(c)(1), (2) and (3), 70.56(c) and (d), 70.57, 70.58, 70.59, 70.62, 70.71 and 70.72 are not incorporated.
(13) Sections 71.2, 71.6, 71.13(c) and (d), 71.24, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.47, 71.51, 71.52, 71.53, 71.55, 71.59, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, 71.83, 71.99 and 71.100 are not incorporated.
(f) If a provision of the CFR incorporated by reference in this article includes a section which is inconsistent with this title, this title controls to the extent Federal law does not preempt Commonwealth law. If a provision of the CFR incorporated by reference in this article is beyond the scope of authority granted the Department under statute, or is in excess of the statutory authority, the provisions shall be and remain effective only to the extent authorized by the Pennsylvania law.
(g) Appropriate parts of 10 CFR may be obtained from the following:
(1) The United States Government Printing Office, Book Store, Room 118, Federal Building, 1000 Liberty Avenue, Pittsburgh, Pennsylvania 15222, (412) 664-2721.
(2) The United States Government Printing Office, Book Store, 100 North 17th Street, Robert Morris Building, Philadelphia, Pennsylvania 19103, (215) 597-0677.
(3) The United States Superintendent of Documents, United States Government Printing Office, Washington, D.C. 20402, (202) 783-3238.
(h) To reconcile differences between this chapter and the incorporated sections of Federal regulations and to effectuate their joint enforcement, the following words and phrases shall be substituted for the language of the Federal regulations:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 215.2. Definitions.
The definitions in 10 CFR Chapter 1 Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 70, 71 and 150 are incorporated by reference in this article unless indicated otherwise. In addition, the following words and terms, when used in this article, have the following meanings, unless the context clearly indicates otherwise:
AEC--United States Atomic Energy Commission.
Accelerator-produced material--Material made radioactive by a particle accelerator.
Act--The Radiation Protection Act (35 P. S. §§ 7110.101--7110.703).
Bioassay--The determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of this article, ''radiobioassay'' is an equivalent term.
Brachytherapy--A method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary or interstitial application.
Entrance or access point--An opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed or registered radiation sources. The term includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.
FDA--The Federal Food and Drug Administration.
Human use--The internal or external administration of radiation or radioactive material to human beings.
Inspection--An official examination or observation including, but not limited to, tests, surveys and monitoring to determine compliance with this article, rules, orders, requirements and conditions of the Department.
Ionizing radiation--Radiation consisting of directly ionizing charged particles--such as electrons, protons, alpha particles and the like--having sufficient kinetic energy to produce ionization by collision, or consisting of either indirectly ionizing uncharged particles--such as neutrons--or photons which can liberate directly ionizing particles or can initiate a nuclear transformation.
License--Permission issued by the Department in accordance with this article to possess and use radioactive material. Types of licenses are as follows:
(i) General license--Permission to possess and use radioactive material without the formal review and issuance of documents by the Department.
(ii) Specific license--Written permission to possess and use radioactive material issued by the Department after the Department reviews and approves an application for the possession and use of the radioactive material.
Licensed practitioner of the healing arts--An individual licensed by the Commonwealth to practice the healing arts, which for the purposes of this article shall be limited to medicine, surgery, dentistry, osteopathy, podiatry and chiropractic.
Licensee--A person who is licensed by the Department under this article and the act.
Licensing state--A state that has regulations equivalent to the Suggested State Regulations for Control of Radiation (United States Department of Health and Human Services) relating to, and has an effective program for, the regulatory control of NARM and which has been granted final designation as a licensing state by the Conference of Radiation Control Program Directors, Inc.
NARM--A naturally occurring or accelerator-produced radioactive material. The term does not include by-product, source or special nuclear material.
NORM--Naturally occurring radioactive material--A nuclide which is radioactive in its natural physical state--that is, not man-made--but does not include source or special nuclear material.
NRC--United States Nuclear Regulatory Commission or its authorized representatives.
Person--An individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency or political subdivision of this Commonwealth; another state or political subdivision or agency thereof; and a legal successor, representative, agent or agency of the entities listed in this paragraph. The term does not include Federal government agencies.
Pharmacist--An individual licensed by the Commonwealth to compound and dispense drugs, prescriptions and poisons.
Physician--An individual licensed by the Commonwealth to practice medicine or osteopathy in this Commonwealth.
Prescribed dose for therapy using radiation-producing machines--For X-ray, electron or other particle beam therapy, the total dose and dose per fraction as documented in the written directive.
Qualified expert--
(i) An individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs; for example: individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics or those having equivalent qualifications.
(ii) With reference to the calibration of radiation therapy equipment, an individual having, in addition to the qualifications in subparagraph (i), training and experience in the clinical applications of radiation physics to radiation therapy; for example: individuals certified in therapeutic radiological physics or X-ray and radium physics by the American Board of Radiology, or radiation oncology physics by the American Board of Radiology, or radiation oncology physics by the American Board of Medical Physics or those having equivalent qualifications.
Radiation--Ionizing radiation.
Radiation producing machine--A device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.
Radiation safety officer--An individual who has the knowledge and responsibility to apply appropriate radiation protection regulations.
Radiation source--An apparatus or material, other than a nuclear power reactor and nuclear fuel located on a plant site, emitting or capable of emitting ionizing radiation.
Radioactive material--A material--solid, liquid or gas--which emits radiation spontaneously.
Radioactivity--The transformation of unstable atomic nuclei accompanied by the emission of radiation.
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.
Registrant--A person who is legally obligated to register with the Department under this article and the act.
Registration--The act of registering with the Department under this article.
Roentgen (R)--The special unit of exposure to external X-ray and gamma radiation. One roentgen equals 2.58 × 10-4 coulombs/kilogram of air. See § 215.3 (relating to units of exposure).
Traceable to a National standard--A system which has been calibrated by the National Institute of Science and Technology or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine.
Waste handling licensees--Persons licensed to receive and store radioactive wastes prior to disposal or persons licensed to dispose of radioactive waste.
Written directive for therapy using radiation-producing machines--An order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiation therapy treatment:
(i) For X-ray therapy at potentials less than 1 MeV: the total dose, dose per fraction, treatment site, field sizes, tube potential and filtration, and overall treatment period.
(ii) For X-ray, electron or other particle 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.
§ 215.3. Units of exposure.
As used in this article, the unit of exposure to external X-ray and gamma radiation expressed in standard international (SI) units is the coulomb per kilogram (C/kg) of air. This represents the quotient of dQ by dm where ''dQ'' is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass ''dm'' are completely stopped in air. The ''roentgen'' is a special unit of exposure. One roentgen is equal to 2.58 × 10-4 coulomb per kilogram of air. One milliroentgen (mR) is equal to 1/1000 roentgen.
§ 215.4. (Reserved).
§ 215.5. Effect of Incorporation of the CFR.
(a) Title and name changes. To reconcile differences between this chapter and the incorporated sections of Federal regulations and to effectuate their joint enforcement, the following words and phrases shall be substituted for the language of the Federal regulations as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means ''Department, NRC or agreement state.''
(b) Forms and documents. References to forms in the Federal regulations incorporated by reference will be replaced by the appropriate forms prescribed by the Department.
(c) Notifications, reports and correspondence. Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
RIGHTS AND RESPONSIBILITIES OF THE DEPARTMENT § 215.11. Records.
(a) Registrants shall maintain records showing the receipt, transfer and disposal of radiation producing machines.
(b) Licensees shall maintain records showing the receipt, transfer and disposal of radioactive material as described in 10 CFR 30.51 (relating to records).
§ 215.12. Inspections.
(a) Maintenance of records. Licensees and registrants shall maintain records under this article and have these records available for inspection by the Department.
(b) Rights of the Department. The Department and its agents and employees will:
(1) Have access to, and require the production of, books, papers, documents and other records and physical evidence pertinent to a matter under investigation.
(2) Require a registrant or licensee to make reports and furnish information as the Department may prescribe.
(3) Enter the premises of a licensee or registrant for the purpose of making an investigation or inspection of radiation sources and the premises and facilities where radiation sources are used or stored, necessary to ascertain the compliance or noncompliance with the act and this chapter and to protect health, safety and the environment.
(c) Inspections by the Department.
(1) The Department, its employees 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 3 years for X-ray operations.
(ii) For all other facilities, at least once every 4 years for X-ray operations.
(iii) For licensees, at the frequencies recommended by the NRC.
(d) Additional inspections. The Department, its employees and agents may conduct additional follow-up inspections if violations of the act or regulations promulgated thereunder were noted at the time of the original inspection, or if a person presents information, or circumstances arise which give the Department reason to believe that the health and safety of a person is threatened or that the act or this article are being violated.
§ 215.15. Additional requirements
The Department may impose upon a person requirements additional to those established in this article which it may deem reasonable and necessary to protect the public health and safety. As an example, when necessary or desirable to determine the extent of an individual's exposure to concentrations of radioactive material, the Department may require a licensee to provide to the individual appropriate bioassay services, medical services and the services of a qualified expert and to furnish a copy of the reports of these services to the Department.
PROHIBITIONS AND RESTRICTIONS § 215.25. Deliberate misconduct.
The requirements under 10 CFR 30.10 (relating to deliberate misconduct) are incorporated by reference. This requirement also applies to registrants.
§ 215.26. Employee protection.
The requirements under 10 CFR 30.7 (relating to employee protection) are incorporated by reference. This requirement also applies to registrants.
§ 215.27. Vacating premises.
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 licensee shall notify the Department in writing of intent to vacate at least 30 days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of the licensee's activities. When deemed necessary by the Department, the licensee shall decontaminate the premises as the Department may specify.
§ 215.28. Deliberate exposure of a monitoring device.
The deliberate exposure of an individual monitoring device or area monitoring device to falsely indicate the dose delivered to an individual is prohibited.
EXEMPTIONS § 215.32. Exemption qualifications.
The following sources, uses and types of users are exempt from Chapters 216--232:
(1) A United States Department of Energy contractor or subcontractor and an NRC contractor or subcontractor of the following categories operating within this Commonwealth to the extent that the contractor or subcontractor under contract receives, possesses, uses, transfers, owns or acquires radiation sources:
(i) Prime contractors performing work for the United States Department of Energy at United States Government-owned or controlled sites, including the transportation of radiation sources to or from the sites and the performance of contract services during temporary interruptions of the transportation.
(ii) Prime contractors of the United States Department of Energy performing research in, or development, manufacture, storage, testing or transportation of, nuclear weapons or components thereof.
(iii) Prime contractors of the United States Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government owned vehicle or vessel.
(iv) Other prime contractors or subcontractors of the United States Department of Energy or of the NRC if the Commonwealth and the NRC jointly determine that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety and that the exemption of the contractor or subcontractor is otherwise appropriate.
(2) Federal government agencies.
(3) Electrical equipment that produces radiation incidental to its operation for other purposes if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed .5 mrem (.005 mSv) per hour at 5 centimeters from an accessible surface. The equipment is not exempt when operated without adequate shielding during testing and servicing if radiation levels exceed those specified. Electron beam welders and electron microscopes are not exempt.
(4) Radiation-producing machines in transit or in storage incident thereto.
(5) A material, product or use specifically exempted from licensing requirements by the NRC, the Department or an agreement state or authorized for distribution to persons exempt from license requirements.
CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 217.1. Purpose and scope.
(a) This chapter establishes requirements for the licensing of radioactive material. Persons who use radioactive material shall comply with this chapter. A person may not receive, possess, use, transfer, own or acquire radioactive material except as authorized in a specific or general license issued under this chapter or otherwise provided in this chapter.
(b) A licensee is subject to Chapters 215, 218--220 and 230. A licensee engaged in industrial uses and 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 licenses and radiation safety requirements for well logging). A licensee using sealed sources in irradiators is subject to Chapter 232 (relating to licenses and radiation safety requirements for irradiators). A licensee for the disposal of low-level radioactive wastes received from other persons is subject to Chapter 236 (relating to low-level radioactive waste management and disposal).
(c) The use of radioactive material in this Commonwealth under a license issued by the NRC is exempt from the licensing requirements of this chapter until the Commonwealth becomes an agreement state on the date published in the Federal Register.
§ 217.2. Address for communications.
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 Protection, Post Office Box 8469, Harrisburg, Pennsylvania 17105-8469.
§§ 217.11--217.18. (Reserved).
§§ 217.21--217.24. (Reserved).
§ 217.31. (Reserved).
§ 217.32. (Reserved).
§§ 217.41--217.49. (Reserved).
§§ 217.51--217.57. (Reserved).
§ 217.65. (Reserved).
§§ 217.71--217.74. (Reserved).
§§ 217.81--217.93 (Reserved).
§ 217.101. (Reserved).
§ 217.121. (Reserved).
§ 217.122. (Reserved).
Appendix A (Reserved)
Appendix B (Reserved)
Appendix D (Reserved)
Subchapter B. GENERAL PROVISIONS FOR RADIOACTIVE MATERIAL Sec.
217.131. Incorporation by reference. 217.132. Effect of incorporation of 10 CFR Part 30. 217.133. Persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register. 217.134. Filing application for specific licenses. 217.135. Renewal of licenses. 217.136. Exempt concentrations. 217.137. Exempt quantities. § 217.131. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 30.5, 30.6, 30.8, 30.21(c), 30.34(d), (e)(1) and (3), 30.41(a)(6), 30.55, 30.63 and 30.64 are not incorporated by reference.
§ 217.132. Effect of incorporation of 10 CFR Part 30.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 30, the following words and phrases shall be substituted for the language in 10 CFR Part 30 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 217.133. Persons possessing a license for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass on the date the Commonwealth becomes an agreement state as published in the Federal Register.
On the date the Commonwealth becomes an agreement state as published in the Federal Register, a person who possesses a general or specific license issued by the NRC for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass, is deemed to possess a like license issued under this chapter and the act. The license shall expire either 90 days after receipt from the Department of a notice of expiration of the license, or on the date of expiration specified in the NRC license, whichever is earlier.
§ 217.134. Filing application for specific licenses.
In addition to incorporation by reference, an application for a specific license shall be accompanied by the fee required under Chapter 218 (relating to fees).
§ 217.135. Renewal of licenses.
(a) An application for renewal of a specific license shall be filed under § 217.134 (relating to filing application for specific licenses).
(b) If a renewal application is filed prior to 30 days before the expiration of a license, the existing license does not expire until definitive notice has been given by the Department of its action on the renewal application. This subsection also applies to new license applications incorporating other licenses.
§ 217.136. Exempt concentrations.
In addition to the parts of 10 CFR 30 incorporated by reference, the following requirements apply:
(1) Except as provided in paragraph (2), a person may receive, possess, use, transfer, own or acquire products or materials containing radioactive material introduced in concentrations less than those listed in Table 1 without possession of a license under this chapter.
(2) Except under a specific license issued under Subchapter D (relating to specific licenses to manufacture or transfer certain items containing radioactive material), or the general license under Subchapter F (relating to reciprocity), a person may not introduce radioactive material into a product or material for distribution to persons exempt under paragraph (1) or equivalent regulations of the NRC, an agreement state or licensing state.
TABLE 1
EXEMPT CONCENTRATIONS Note: Some of the Values in Table A-1 are presented in the computer ''E'' notation. In this notation a value of 6E-02 represents a value of 6 × 10-2 or 0.06, 6E+2 represents 6 × 102 or 600 and 6E+0 represents 6 × 100 or 6.
Column II Column I Liquid and solid Element Gas concentration concentration (atomic number) Isotope µCi/ml µCi/ml Actinium (89) Ac-228 9E-04 Cadmium (48) Cd-109 2E-03 Cesium (55) Cs-129 3E-03 Europium (63) Eu-154 2E-04 Gallium (31) Ga-67 2E-03 Germanium (32) Ge-68 9E-03 Gold (79) Au-195 1E-02 Indium (49) In-111 1E-03 Iodine (53) I-123 3E-04 I-124 4E-06 I-125 2E-06 Lead (82) Pb-212 2E-04 Phosphorus (15) P-33 3E-04 Potassium (19) K-43 2E-04 Protactinium (91) Pa-230 2E-03 Radium(88) Ra-223 7E-06 Ra-224 2E-05 Ra-228 3E-07 Radon (86) Rn-220 1E-07 Rn-222 3E-08 Sodium (11) Na-22 4E-04 Technetium (43) Tc-97m 4E-03 Xenon (54) Xe-127 4E-06 Yttrium (39) Y-88 8E-04
§ 217.137. Exempt quantities.
In addition to the parts of 10 CFR 30 incorporated by reference, the following requirements apply:
(1) A person may receive, possess, use, transfer, own or acquire radioactive material in individual quantities each of which is less than those listed in Table 2 if the person does not produce, package or repackage radioactive material for purposes of commercial distribution or incorporate radioactive material into products intended for commercial distribution.
(2) Except under a specific license issued by the Department or the NRC under 10 CFR 32.18 (relating to manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license), a person may not, for purposes of commercial distribution, transfer radioactive material for distribution to persons exempt under paragraph (1) or equivalent regulations of the NRC, an agreement state or licensing state.
TABLE 2
EXEMPT QUANTITIES
Radioactive Material Microcuries Actinium-228 (Ac 228) 1 Beryllium-7 (Be 7) 10 Bismuth-207 (Bi 207) 10 Cesium-129 (Cs 129) 100 Cobalt-57 (Co 57) 100 Gallium-67 (Ga 67) 100 Germanium-68 10 Gold-195 (Au 195) 10 Gold-196 (Au 196) 1 Indium-111 (In 111) 100 Iodine-123 (I 123) 100 Iodine-124 (I 124) 1 Iridium-190 (Ir 190) 100 Lead-203 (Pb 203) 100 Lead-210 (Pb 210) 0.1 Lead-212 (Pb 212) 10 Phosphorus-33 (P 33) 10 Potassium-43 (K 43) 10 Protactinium-230 (Pa 230) 10 Protactinium-231 (Pa 231) 0.1 Radium-223 (Ra 223) 1 Radium-224 (Ra 224) 1 Radium-226 (Ra 226) 0.1 Radium-228 (Ra 228) 0.1 Radon-220 (Rn 220) 1 Radon-222 (Rn 222) 1 Rhenium-183 (Re 183) 100 Rhenium-187 (Re 187) 100 Rubidium-81 (Rb 81) 10 Scandium-46 (Sc 46) 10 Sodium-22 (Na 22) 10 Technetium-96m (Tc 96m) 100 Xenon-127 (Xe 127) 1,000 Yttrium-87 (Y 87) 10 Yttrium-88 (Y 88) 10
Subchapter C. GENERAL LICENSES FOR RADIOACTIVE MATERIAL Sec.
217.141. Incorporation by reference. 217.142. Effect of incorporation of 10 CFR Part 31. 217.143. Certain measuring, gauging or controlling devices. 217.144. Incidental radioactive material produced by a particle accelerator. § 217.141. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 31 (relating to general domestic licenses for byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 31.3, 31.4 and 31.14 (relating to certain devices and equipment; information collection requirements: OMB approval; and criminal penalties) are not incorporated by reference.
§ 217.142. Effect of incorporation of 10 CFR Part 31.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 31 (relating to general domestic licenses for byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 31 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 217.143. Certain measuring, gauging or controlling devices.
In addition to the parts of 10 CFR 31.5 (relating to certain detecting measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere) incorporated by reference, general licensees subject to registration under 10 CFR 31.5(c)(13)(i) or possessing general licensed devices containing 370 MBq (10 mCi) or more of accelerator-produced material, as determined on the date of manufacture, or 3.7 MBq (0.1 mCi) or more of radium-226 shall also comply with the following:
(1) Conduct a physical inventory every 6 months to account for all sources or devices, or both, received and possessed under this section 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 practicable, 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.
(2) For portable devices, shall also comply with the following:
(i) A person who initiates acquisition, transfer or disposal of a portable device shall notify the Department within 15 days of the action. Sending a portable device for calibration, maintenance or source replacement does not constitute transfer.
(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 to ensure 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, such as training certificates, for that authorization. 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 from access by unauthorized personnel whenever the device is not under the direct surveillance of an individual authorized to use the device.
(v) The licensee shall maintain a current sign out log at the permanent storage location of the portable device. Log entries shall be available for inspection by the Department for 3 years from the date of entry. The following information shall be recorded for each portable device:
(A) The model and serial number of the device.
(B) The name of the assigned user.
(C) The locations and dates of use.
(vi) Emergency instructions shall accompany each portable device taken off the premises of the licensee.
§ 217.144. Incidental radioactive material produced by a particle accelerator.
A general license is issued to possess radioactive material produced incidentally to the operation of a particle accelerator. The general license is also subject to the applicable provisions of Chapters 215, 217, 219 and 220. A licensee may transfer this radioactive material only under Subchapter I and Chapter 230 (relating to transfer of radioactive material; and packaging and transportation of radioactive material). A licensee may dispose of this radioactive material only with Department approval.
Subchapter D. SPECIFIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL Sec.
217.151. Incorporation by reference. 217.152. Effect of incorporation of 10 CFR Part 32. 217.153. Licensing the incorporation of NARM into gas and aerosol detectors. 217.154. Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226. 217.155. Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license. § 217.151. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 32.8, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29 and 32.40 are not incorporated by reference.
§ 217.152. Effect of incorporation of 10 CFR Part 32.
To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 32 as follows:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) A reference to byproduct material includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.
§ 217.153. Licensing the incorporation of NARM into gas and aerosol detectors.
An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under Subchapter B (relating to general provisions for radioactive material) will be approved if the application satisfies requirements equivalent to those in 10 CFR 32.26--32.29. The maximum quantity of radium-226 may not exceed 0.1 microcuries (3.7 kBq).
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