RULES AND REGULATIONS
Title 25--ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CHS. 215--221, 223--228,
230 AND 240]
Radiological Health
[34 Pa.B. 3823] The Environmental Quality Board (Board) amends Chapters 215--221, 223--228, 230 and 240. The final-form rulemaking is necessary to improve the clarity, coherency and effectiveness of the requirements for the safe use of radiation sources. The final-form rulemaking describes requirements in more detail, provides flexibility for compliance where possible and corrects cross references to other parts of the regulations and the regulations of the United States Nuclear Regulatory Commission (NRC). The final-form rulemaking also addresses equity in the collection of fees to support program activities.
This order was adopted by the Board at its meeting of April 20, 2004.
A. Effective Date
The final-form rulemaking is effective upon publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact Louis Ray Urciuolo, Chief, Division of Radiation Control, P. O. Box 8469, Rachel Carson State Office Building, Harrisburg, PA 17105-8469, (717) 787-3720; or Scott Perry, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Persons with a disability may use the AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This final-form rulemaking is available on the Department of Environmental Protection's (Department) website: www. dep.state.pa.us.
C. Statutory Authority
This final-form rulemaking is being made under the authority of sections 301 and 302 of the Radiation Protection Act (act) (35 P. S. §§ 7110.301 and 7110.302), which directs 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 to implement the act, and 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 of the Amendments
In 2001, the Board updated chapters of its radiological health regulations to provide for compatibility with other states and to serve as a basis for the Commonwealth to assume authority from the NRC for radioactive material licensees in this Commonwealth under the Agreement State program. These updates were published at 31 Pa.B. 5239 (September 15, 2001) and 31 Pa.B. 6280 and 6282 (November 17, 2001), and they incorporate by reference certain Nationally recognized radiation safety standards of the NRC. Incorporating by reference results in a single, consistent set of standards applicable to the radiological safety of not only radioactive materials, but radiation-producing machines as well.
As a result of the revisions, many sections in Article V (relating to radiological health) now reference text that no longer exists and appear as ''reserved.'' The final-form rulemaking replaces the orphaned references with the corresponding regulations incorporated by reference and imposes no new requirements. Other amendments address the recent changes to the NRC regulations that are incorporated by reference, most notably the comprehensive revision to 10 CFR Part 35 (relating to the medical use of by-product material). Licensees of this Commonwealth are already subject to these requirements by virtue of their radioactive material licenses and incorporation by reference to 10 CFR (relating to energy). Several amendments clarify the wording of existing regulations and their requirements, in most part involving radiation-producing machines. Section 216.6(c) (relating to transfer and disposal obligations) requires persons involved in certain commercial and service activities involving radiation-producing machines to register their activities with the Department. There is a new § 216.2a (relating to registration of radiation-producing machine service providers), along with the provision for registration fees and reporting requirements in § 216.2b (relating to reporting and recordkeeping requirements for registered radiation-producing machine service providers). In Chapter 218 (relating to fees), a new annual fee of $100 covers the activities and costs regarding §§ 216.2a and 216.2b. The omission of a fixed fee in the previous rulemaking has been corrected to cover the activities and costs related to licenses issued under fee category 3Q in Chapter 218, Appendix A (relating to fees for radioactive material licenses). Overall, the final-form rulemaking improves the clarity and effectiveness of the regulations, corrects cross references and adds flexibility for compliance where possible.
As required by section 301(c)(14) of the act, the Department provided the Radiation Protection Advisory Committee (RPAC) with an opportunity to review the proposed and final-form rulemakings and to advise the Department prior to submittal to the Board. On October 24, 2002, and November 20, 2002, the RPAC reviewed the proposed rulemaking and endorsed it at the latter meeting.
The Department also met with staff of the Department of Health (DOH) to discuss their role in assisting the Department in reviewing applications to perform ''healing arts screening.'' Changes were made to § 221.13(b) (relating to information to be submitted by persons requesting approval to conduct healing arts screening) to better define the role of the DOH in providing assistance to the Department.
The proposed rulemaking was adopted by the Board on July 15, 2003, and published with a 30-day public comment period at 33 Pa.B. 4393 (August 30, 2003). A single comment was received from the Independent Regulatory Review Commission (IRRC). This comment has been addressed in the final-form rulemaking and is described in Section E.
On November 13, 2003, the RPAC reviewed the draft final-form rulemaking and the response to IRRC's comment on the proposed rulemaking. The RPAC endorsed the final-form rulemaking for presentation to the Board.
E. Summary of Changes to the Proposed Rulemaking
§ 215.24 (relating to human use)
The current reference in subsection (b) to 49 Pa. Code Part I, Subpart A (relating to professional and occupational affairs) spans over 30 chapters, not all of which have requirements that are relevant to radiological health professionals. IRRC requested that the relevant chapters be listed. This was done in the final-form rulemaking.
In light of the change to subsection (b) and at the recommendation of the RPAC, the reference to Departmental approval in subsection (d) of the proposed rulemaking was replaced by reference to Department of State (DOS) accreditation requirements in the final-form rulemaking, since the DOS has accreditation requirements for professional training.
The RPAC also noted that trainees would require authorized supervision. As a result, subsection (d) in the final-form rulemaking also clarifies the requirement for supervision of trainees.
§ 216.4a (relating to expiration and termination of certificates of registration)
A typographical error was corrected in subsection (c)(1) by removing an extra hyphen.
§ 219.228 (relating to reports of medical reportable events for radiation-producing machine therapy)
In subsection (a)(3), a legacy reference to ''misadministration'' was discovered. This concept no longer exists having been replaced by ''medical event.'' The reference to ''misadministration'' was deleted in the final-form rulemaking as it had been from the rest of this article.
§ 227.14 (relating to personnel requirements)
In subsection (a)(3), instruction and competence in emergency procedures was added. The preamble to the proposed rulemaking described this amendment, but the wording failed to appear in Annex A of the published text of the proposed rulemaking.
F. Summary of Comments and Responses on the Proposed Rulemaking
There was only one comment to the proposed rulemaking. This was from IRRC regarding specification of the applicable chapters of the DOS regulations referenced in § 215.24. The Department implemented that recommendation as discussed in Section E of this preamble.
G. Benefits, Costs and Compliance
Benefits
The primary benefit of the final-form rulemaking is to correct cross references that are no longer accurate as a result of changes in previous rulemakings and changes in the regulations of the NRC incorporated by reference. This is part of a comprehensive effort to provide additional clarity to the regulations for radiological health to benefit the regulated community. Existing requirements are clarified in many areas, including: registration, licensing, fee assessment, radiation-producing machine service providers, healing arts screening and human research, determination of competence for auxiliary medical personnel, filtration, radiation safety committees, medical event reporting and radiation therapy simulators. The new requirement for concurrence by the DOH for approval of certain healing arts screening provides additional health protection by bringing in a competent independent third-party regulator. There are also additional benefits to the regulated community in more flexible requirements for personnel exposure to X-rays, quality assurance programs, leak testing of sealed sources, general licenses for sealed source devices, cabinet radiography and shielded room radiography operations. Eligibility for lower fees for general license devices has been extended. In fairness to registrants and the recovery of fees to support this program, the time that an X-ray machine from outside this Commonwealth may be operated before being subjected to registration and payment of associated fees is reduced. Radiation-producing machine service providers are assessed a registration fee to cover the cost of oversight of their activities and a minimum annual fee for accelerators greater than 50 MeV is created.
Compliance Costs
The majority of amendments represent clarifications, as opposed to changes in requirements, so there is no additional cost to comply. Implementing the more flexible requirements for personnel exposure to X-rays, quality assurance programs, leak testing of sealed sources, general licenses for sealed source devices, cabinet radiography and shielded room radiography operations will add no additional costs and generally reduce existing costs. The fixed category 3Q annual general license fee of $315 is identical to what should have been set by formula in footnote 3, Chapter 218, Appendix A, but was omitted from the previous rulemaking that set the current fees in Chapter 218, Appendix A and is less than what the formula based fee will be without this final-form rulemaking. The final-form rulemaking will also permit extension of this fee to certain current category 3P licensees resulting in a fee decrease for about 70 licensees who currently pay $750 annually. There is also a new annual fee of $100 for registration of radiation-producing machine service providers. To the regulated community as a whole, the savings from switching some category 3P licenses to category 3Q is expected to be offset in an equal amount by the new radiation-producing machine service provider registration fee. These fees will cover the cost of administering the program, as required by section 401 of the act (35 P. S. § 7110.401).
Compliance Assistance Plan
The majority of amendments clarifying references and definitions are self-explanatory. They are being made as part of compliance assistance. Guidance is being prepared to explain acceptable alternate methods of determining personnel exposure to X-rays and acceptable X-ray quality assurance programs. Outreach and assistance will be provided by regional inspectors and technical staff of the central office Radiation Control Division.
Paperwork Requirements
Amendments dealing with clarification of existing regulations add no additional paperwork beyond the original requirements. Regulations made more flexible may or may not result in a decrease in recordkeeping requirements depending on what options the registrant or licensee chooses. Persons providing radiation-producing machine services will be required to file a registration of activities form provided by the Department. Paperwork for reporting the details of actual services being provided is already being filed with the Commonwealth through United States Food and Drug Administration Form 2579. The application form for new general license category 3Q replaces the current license application, which requires less supporting documentation than any current category and will constitute a reduction in paperwork over the current alternative licenses.
H. Sunset Review
The final-form rulemaking 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 20, 2003, the Department submitted a copy of the notice of proposed rulemaking, published at 33 Pa.B. 4393, to IRRC and the Chairpersons of the House and Senate Environmental Resources and Energy Committees for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on June 9, 2004, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on June 10, 2004, and approved the final-form rulemaking.
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 at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law, and all comments were considered.
(3) These amendments do not enlarge the purpose of the proposal published at 33 Pa.B. 4393.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this order.
K. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapters 215--221, 223--228, 230 and 240, are amended by amending §§ 215.1, 215.2, 215.12, 215.14, 215.24, 215.28, 215.32, 216.1, 216.2, 216.3, 216.4a, 216.6, 216.7, 217.136, 217.141, 217.143, 217.171, 217.201, 217.202, 217.203, 218.1, 218.11, Appendix A, §§ 219.3, 219.6, 219.61, 219.228, 219.229, 220.2, 221.2, 221.11, 221.13, 221.15, 221.25, 221.29, 221.36a, 221.38a, 221.61, 221.73--221.75, 221.202, 221.204, 221.205, Appendix A, §§ 223.21, 223.22, 224.10, 224.22, 224.23, 225.1, 225.4a, 225.71, 225.73, 225.82, 225.83, 225.101--225.103, 226.3a, 227.11a, 227.12a, 227.13a, 227.14, 228.2, 228.11a, 228.12, 228.21a, 228.23a, 228.31a, 228.32a, 228.34a, 228.35, 228.37--228.39, 228.41a, 228.43, 228.44, 228.61, 228.75, 228.76, Appendix A, §§ 230.3 and 240.2; by adding §§ 216.2a, 216.2b and 219.8; and by deleting § 224.21 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson 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.
KATHLEEN A. MCGINTY,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 34 Pa.B. 3078 (June 12, 2004).)
Fiscal Note: Fiscal Note 7-387 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 § 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 and 150.20 of the CFR are 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 31.4 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, 35.4001 and 35.4002 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), 40.33, 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, 71.51, 71.52, 71.53, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, 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 (relating to energy) 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:
* * * * * License--Permission issued by the Department in accordance with this article to possess and use radiation sources. Types of licenses are as follows:
* * * * * (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 radiation sources.
* * * * * Major X-ray system component--A tube housing assembly, X-ray control, X-ray high voltage generator, X-ray table, cradle, film changer, fixed cassette holder, beam limiting device, fluoroscopic or digital radiographic imaging assembly, spot film device, image intensifier or cephalometric device.
* * * * * Qualified expert--
(i) For radiation protection, 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) For radiation therapy calibrations, an individual having, in addition to the qualifications in subparagraph (i), training and experience in the clinical applications of radiation physics to radiation therapy.
(iii) For diagnostic X-ray performance evaluations, an individual having, in addition to the qualifications of subparagraph (i), training and experience in the physics of diagnostic radiology.
* * * * * Radioactivity--The transformation of unstable atomic nuclei accompanied by the emission of radiation.
Registrant--A person who is legally obligated to register with the Department under this article and the act.
* * * * *
RIGHTS AND RESPONSIBILITIES OF THE DEPARTMENT § 215.12. Inspections and investigations.
(a) Maintenance of records. Licensees and registrants shall maintain records under this article and have these records available for inspection by the Department at permanent sites or facilities of use identified in a license or registration issued under this article.
(b) Rights of the Department. The Department and its agents and employees will:
(1) Have access to, and require the production of, books, papers, documents and other records and physical evidence pertinent to a matter under investigation.
(2) Require a registrant or licensee to make reports and furnish information as the Department may prescribe.
(3) Enter the premises of a licensee or registrant for the purpose of making an investigation or inspection of radiation sources and the premises and facilities where radiation sources are used or stored, necessary to ascertain the compliance or noncompliance with the act and this chapter and to protect health, safety and the environment.
(c) Inspections and investigations by the Department. The Department, its employees and agents may conduct inspections and investigations of the facilities and regulated activities of registrants of radiation-producing machines and licensees of radioactive material necessary to demonstrate compliance with the act or this article.
(d) Additional inspections and investigations. The Department, its employees and agents may conduct additional follow-up inspections and investigations if violations of the act or regulations promulgated thereunder were noted at the time of the original inspection, or if a person presents information, or circumstances arise which give the Department reason to believe that the health and safety of a person is threatened or that the act or this article are being violated.
§ 215.14. Availability of records for public inspection.
The following Department records are not available for public inspection, unless the Department determines that disclosure is in the public interest and is necessary for the Department to carry out its duties under the act:
(1) Trade secrets or secret industrial processes customarily held in confidence.
(2) A report of investigation, not pertaining to safety and health in industrial plants, which would disclose the institution, progress or results of an investigation undertaken by the Department.
(3) Personnel, medical and similar files, the disclosure of which would operate to the prejudice or impairment of a person's reputation or personal safety.
PROHIBITIONS AND RESTRICTIONS § 215.24. Human use.
(a) No human use of radiation sources may be permitted except under this article, and the following:
(1) Medical Practice Act of 1985 (63 P. S. §§ 422.1--422.45).
(2) The Osteopathic Medical Practice Act (63 P. S. §§ 271.1--271.18).
(3) The Chiropractic Registration Act of 1951 (63 P. S. §§ 601--624).
(4) The Dental Law (63 P. S. §§ 120--130g).
(5) The Podiatry Practice Act (63 P. S. §§ 42.1--42.21c).
(b) Auxiliary personnel employed by a licensed practitioner of the healing arts at the location at which the licensed practitioner practices may use radiation sources in the healing arts provided those individuals comply with the applicable requirements of 49 Pa. Code Part I, Subpart A (relating to professional and occupational affairs), located in the following chapters:
(1) Chapter 5 (relating to the State Board of Chiropractic).
(2) Chapter 16 (relating to the State Board of Medicine--general provisions).
(3) Chapter 17 (relating to the State Board of Medicine--medical doctors).
(4) Chapter 18 (relating to the State Board of Medicine--practitioners other than medical doctors).
(5) Chapter 25 (relating to the State Board of Osteopathic Medicine).
(6) Chapter 29 (relating to the State Board of Podiatry).
(7) Chapter 33 (relating to the State Board of Dentistry).
(c) Auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government may only use radiation sources in the healing arts in accordance with written job descriptions and employee qualifications.
(d) Subsections (b) and (c) notwithstanding, human use of radiation sources is permitted by individuals enrolled in clinical training programs that satisfy the related accreditation requirements of the boards in subsection (b) and who are under the supervision of a licensed practitioner of the healing arts or of auxiliary personnel authorized under subsections (b) and (c) to use radiation sources in the healing arts.
§ 215.28. Improper use of a monitoring device.
The deliberate exposure of, failure to use, or improper use of, an individual monitoring device or area monitoring device by an individual is prohibited.
EXEMPTIONS § 215.32. Exemption qualifications.
The following sources, uses and types of users are exempt from Chapters 216--221, 223--228, 230, 232 and 240:
(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 216. REGISTRATION OF RADIATION-PRODUCING MACHINES AND RADIATION-PRODUCING MACHINE SERVICE PROVIDERS § 216.1. Purpose and scope.
(a) This chapter establishes requirements for the registration of radiation-producing machines and radiation-producing machine service providers. A person who possesses a radiation-producing machine or provides services described in this chapter shall comply with this chapter.
(b) A person possessing an accelerator as defined in § 228.2 (relating to definitions) is exempt from the requirements of § 216.2 (relating to registration of radiation-producing machines). Accelerators are licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators) and license fees are specified in § 218.11(d) (relating to registration, renewal of registration and license fees).
§ 216.2. Registration of radiation-producing machines.
(a) A person possessing a radiation-producing machine shall:
(1) Register with the Department within 30 days after acquisition. Registration shall be completed on forms furnished by the Department and shall contain information required on the form and accompanying instructions.
(2) Designate on the registration form an individual to be responsible for radiation protection.
(3) Notify the Department in writing within 30 days of a change of address, owner or radiation safety officer or number of machines.
(b) The registration becomes valid upon receipt of the properly completed registration form and the fee required under Chapter 218 (relating to fees).
(c) A certificate of registration will be issued by the Department to a person whose registration becomes valid under subsection (b).
(d) A registrant shall have the currently valid certificate of registration available for inspection by the Department.
(e) A certificate of registration issued under this chapter may not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, to any person without submitting a written request by the registrant to the Department.
§ 216.2a. Registration of radiation-producing machine service providers.
After July 17, 2004, a person who engages in the business of assembling or installing radiation-producing machines or who offers to assemble or install radiation-producing machines or who is in the business of furnishing or offering to furnish radiation-producing machine servicing or services or who is in the business of selling, leasing or lending radiation-producing machines in this Commonwealth shall apply for registration of the activities with the Department prior to furnishing or offering to furnish those services.
(1) Registration is for 12 months and is renewable.
(2) An application for registration or renewal will not be accepted unless accompanied by the appropriate fee specified in § 218.11(h) (relating to registration, renewal of registration and license fees). Fees are not refundable after issuance of a registration.
(3) An application for registration shall be submitted on forms provided by the Department. The Department will issue a certificate of registration for radiation-producing machine services to the applicant when the application is complete, contains all the information required by the Department and when the appropriate fee specified in § 218.11(h) has been paid.
(4) A person who, on July 17, 2004, is currently in the business of providing radiation-producing machine services shall apply for registration by September 15, 2004.
§ 216.2b. Reporting and recordkeeping requirements for registered radiation-producing machine service providers.
(a) A radiation-producing machine service provider who installs, services, sells, leases or otherwise transfers a radiation producing-machine or major X-ray system component in this Commonwealth shall submit information to the Department and maintain records as described in this section.
(1) The following information shall be submitted in writing to the Department within 15 days of the action:
(i) The date of installation, service or transfer.
(ii) The name, address, telephone number and registration number, if registered, of the client facility.
(iii) The type of radiation-producing machine, the manufacturer's name, model number and control panel serial number of each radiation-producing machine, or major X-ray system components involved in the transaction.
(iv) A contact name of the individual for the service action.
(2) A copy of the assembler's report on United States Food and Drug Administration (FDA) Form 2579, prepared in compliance with the Federal diagnostic X-ray standard (21 CFR 1020.30(d)(1) (relating to diagnostic x-ray systems and their major components)), when completed in full and submitted to the Department within 15 days following the service, satisfies the requirements of paragraph (1) and subsection (d) for services provided under the assembler's report.
(b) Services performed under preventative maintenance that do not involve replacement or refurbishing of major X-ray system components are exempt from the reporting requirements specified in this section except subsection (d).
(c) A radiation-producing machine service provider shall maintain a log or other record of radiation-producing machines installed or serviced in this Commonwealth. The record shall be maintained for 5 years for inspection by the Department and shall list the following information:
(1) The date the machine was installed or service provided.
(2) The name of the customer, address, telephone number and customer's State registration number.
(3) The type of radiation-producing machine, the manufacturer's name, model number and control panel serial number of each radiation-producing machine or major X-ray system component involved.
(4) The name of the individual performing the service.
(d) A radiation-producing machine service provider who services a radiation-producing machine in a radiation installation in this Commonwealth that is not registered shall report the service to the Department. The report shall be submitted in writing within 15 days after the services and contain the following information:
(1) The date service was provided.
(2) The name, address and telephone number of the client.
(3) The type of radiation-producing machine, the manufacturer's name, model number and control panel serial number of each radiation-producing machine or major X-ray system component.
(4) The name of the individual performing the service.
§ 216.3. Exemptions.
The following radiation-producing machines or equipment are exempt from registration:
(1) Electrical equipment that produces radiation incidental to its operation for other purposes, if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed .5 mrem (.005 mSv) per hour at 5 centimeter from an accessible surface. The production, testing or factory servicing of the equipment are not exempt. Electron beam welders and electron microscopes are not exempt.
(2) Radiation-producing machines while in transit in the possession of a transport carrier.
(3) Radiation-producing machines in the possession of vendors, installers or persons engaged in the service or repair of the machines, if applicable persons who have these machines register their activities with the Department under § 216.6 (relating to transfer and disposal obligations).
(4) Accelerators are exempt from registration. Accelerators shall be licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators). Accelerator service providers are not exempt from registration of services under § 216.2a (relating to registration of radiation-producing machine service providers).
§ 216.4a. Expiration and termination of certificates of registration.
(a) A certificate of registration expires on the date specified on the certificate of registration. Expiration of the certificate of registration does not relieve the registrant from the requirements of this article.
(b) When a registrant decides to terminate all activities involving radiation-producing machines under the certificate of registration, the registrant shall notify the Department immediately, in writing, and request termination of the certificate of registration. This notification and request for termination of the certificate of registration shall be in accordance with subsection (c).
(c) If a registrant does not submit a renewal for a certificate of registration under § 216.4 (relating to renewal of certificate of registration), the registrant shall, on or before the expiration date specified in the certificate of registration, do the following:
(1) Terminate use of all radiation-producing machines subject to registration under § 216.2 (relating to registration of radiation-producing machines) or cease all radiation-producing machine services subject to registration under § 216.2a (relating to registration of radiation-producing machine service providers).
(2) Transfer or dispose of all radiation-producing machines subject to registration under § 216.2 in accordance with § 216.6 (relating to transfer and disposal obligations).
(3) Remit any outstanding registration or renewal of registration fees owed to the Department under § 218.11 (relating to registration, renewal of registration and license fees).
(4) Request termination of the certificate of registration in writing to the Department.
§ 216.6. Transfer and disposal obligations.
(a) A person, distributor, retailer or other agent who, by selling, leasing, lending or gifting, transfers possession of radiation-producing machines or major X-ray system components in this Commonwealth that are not otherwise reported under § 216.2b (relating to reporting and recordkeeping requirements for registered radiation-producing machine service providers), shall notify the Department within 30 days of the following information:
(1) The name and address of persons who have received the machines or components.
(2) The manufacturer, model and serial number of a machine or component transferred.
(3) The date of transfer of a radiation-producing machine or major X-ray system component.
(b) A person who disposes of a radiation-producing machine shall notify the Department within 15 days of the method of disposal used.
§ 216.7. Out-of-State radiation-producing machines.
(a) If a radiation-producing machine is brought into this Commonwealth for temporary use, the person proposing to do so or an authorized agent shall give written notice to the Department at least 2 working days before the machine enters this Commonwealth. The notice shall include the type of machine, the nature, duration and scope of use and the exact location where the machine is to be used. In addition, the person shall:
(1) Comply with this title.
(2) Supply the Department with other information as the Department may reasonably request.
(3) Not operate within this Commonwealth on a temporary basis in excess of 60 calendar days per year.
(b) If for a specific case, the 2-working-day period would impose an undue hardship, the person, upon application to the Department, may receive a waiver of this requirement.
(c) When a radiation-producing machine is brought into this Commonwealth for temporary use exceeding 60 days per year, a person possessing the machine shall register with the Department under § 216.2 (relating to registration of radiation-producing machines) within 15 days after the 60th day.
CHAPTER 217. LICENSING OF
RADIOACTIVE MATERIAL
Subchapter B. GENERAL PROVISIONS FOR RADIOACTIVE MATERIAL § 217.136. Exempt concentrations.
In addition to the parts of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material) 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 specific domestic licenses of broad scope for radioactive material), 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 CONCENTRATIONSNote: 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.
Element
(atomic number)Isotope Column I
Gas concentration
µCi/mlColumn II
Liquid and solid
concentration
µCi/mlActinium (89) Ac-228 9E-04 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
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