Subchapter A. GENERAL PROVISIONS
Sec.
219.1. Purpose.
219.2. Scope.
219.3. Definitions.
219.4. [Reserved].
219.5. Incorporation by reference.
219.6. Effect of incorporation of 10 CFR Part 20.
219.7. Effect of incorporation of 10 CFR 20.1403 ‘‘Criteria for license termi- nation under restricted conditions.’’
219.8. Requirement for a Radiation Safety Committee.
219.11—219.15. [Reserved].
GENERAL PROVISIONS
§ 219.1. Purpose.
(a) This chapter establishes standards for protection against ionizing radiation resulting from activities conducted under licenses or registrations issued by the Department. Licensees and registrants shall comply with this chapter.
(b) The requirements of this chapter are designed to control the receipt, possession, use, transfer and disposal of sources of radiation by a licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter. This chapter does not limit actions that may be necessary to protect health and safety.
Source The provisions of this § 219.1 amended November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085. Immediately preceding text appears at serial page (170385).
§ 219.2. Scope.
Except as specifically provided in other chapters of this article, this chapter applies to persons licensed or registered by the Department to receive, possess, use, transfer or dispose of sources of radiation. The limits in this chapter do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy or to voluntary participation in medical research programs.
Source The provisions of this § 219.2 amended November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085. Immediately preceding text appears at serial pages (170385) to (170386).
§ 219.3. Definitions.
The following terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Medical reportable event for radiation-producing diagnostic or interventional X-ray procedures—The administration to a human being, except for an administration resulting from a direct intervention of a patient that could not have been reasonably prevented by the licensee or registrant, that results in one of the following:(i) An unintended peak skin dose to the same area in a single procedure greater than 1500 rad (15 Gy).
(ii) An unintended dose, other than skin dose, in a single procedure exceeding five times the facility’s established protocol and 50 rad (0.5 Gy) to any organ.
(iii) A dose to the wrong patient, or wrong site for the entire procedure, and exceeding 50 rad (0.5 Gy) to any organ.
Medical reportable event for radiation-producing machine therapy—The administration to a human being, except for an administration resulting from a direct intervention of a patient that could not have been reasonably prevented by the licensee or registrant, that results in one of the following:(i) An administration of a therapeutic radiation dose to the wrong individual, wrong treatment site or using a treatment delivery intended for another individual.
(ii) An administration of a dose for therapy identified in a written directive that differs from the prescribed dose for the treatment site or any other organ from the intended prescribed dose, by one of the following:
(A) More than 20% of the total prescribed dose.
(B) Exceeds 30% of the weekly prescribed dose.
(C) Exceeds 50% of a single fraction dose of a multifraction plan.
Source The provisions of this § 219.3 adopted November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085; amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial pages (304456) to (304457).
Cross References This section cited in 25 Pa. Code § 228.35 (relating to operating procedures).
§ 219.4. [Reserved].
Source The provisions of this § 219.4 adopted November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial page (204037).
§ 219.5. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 20 (relating to standards for protection against radiation) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 20.1006, 20.1009, 20.2206(a)(1), (3), (4) and (5), 20.2401 and 20.2402 are not incorporated by reference.
Source The provisions of this § 219.5 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.
Cross References This section cited in 25 Pa. Code § 227a.22 (relating to radiation protection responsibility).
§ 219.6. Effect of incorporation of 10 CFR Part 20.
To reconcile differences between this chapter and the incorporated sections of 10 CFR Part 20 (relating to standards for protection against radiation), the following words and phrases shall be substituted for the language in 10 CFR Part 20 as follows:
(1) A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.
(2) A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.
(3) A reference to ‘‘licensee’’ includes registrant.
(4) A reference to ‘‘license’’ includes registration.
(5) A reference to ‘‘licensed’’ includes registered.
(6) A reference to ‘‘Department’’ in 10 CFR means the United States Department of Energy.
(7) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR (relating to energy) shall be directed to the Department, except as required under 10 CFR 20.2206 (relating to reports of individual monitoring).
(8) 10 CFR Part 20, notwithstanding, exposures involving the use of X-rays may be weighted, in a manner specified by the Department, so that, with Department approval, the effective dose equivalent may be substituted for the deep dose equivalent in determining compliance with occupational exposure limits for specified groups of individuals.
Source The provisions of this § 219.6 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceeding text appears at serial page (304458).
§ 219.7. Effect of incorporation of 10 CFR 20.1403 ‘‘Criteria for license termination under restricted conditions.’’
The Department will not terminate a license under the conditions of restricted release as provided for in 10 CFR 20.1403 (relating to criteria for license termination under restricted conditions) until a license termination plan (LTP), approved by the Department, has been in effect for a period of time sufficient to demonstrate to the Department that continued implementation of the plan will be effective in maintaining compliance with the required conditions of the plan. The Department may choose to implement the license termination process in one or more of the following steps:
(1) The license is amended to authorize activities necessary to begin decommissioning under the LTP.
(2) After decommissioning activities are complete and the provisions of 10 CFR 20.1403 are in effect under the LTP, the license may be amended to end authorization of licensed activities. The license shall remain in effect for up to 5 years being limited to ownership/possession of the decommissioned material.
(3) At the end of the period prescribed in paragraph (2), the Department will make a determination of the effectiveness of the LTP as enacted. If the LTP has demonstrated the ability to maintain compliance with 10 CFR 20.1403, the license will be terminated subject to the revisitation provision of 10 CFR 20.1401(c) (relating to general provision and scope) regarding new evidence of a significant threat to health and safety. Otherwise, the licensee will be directed by the Department to take corrective actions as necessary to conform to 10 CFR 20.1403 and the process shall revert back to paragraph (2).
Source The provisions of this § 219.7 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.
§ 219.8. Requirement for a Radiation Safety Committee.
The requirements of 10 CFR 35.24 (relating to authority and responsibilities for the radiation protection program) apply to registrants as well as licensees. For the purpose of this requirement, facilities that utilize two or more modalities in which patients are likely to receive, or will receive a dose to an organ in excess of 200 rads (2.0 gray), shall have a radiation safety committee.
Source The provisions of this § 219.8 adopted July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823.
§ § 219.11—219.15. [Reserved].
Source The provisions of these § § 219.11—219.15 reserved November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085. Immediately preceding text appears at serial pages (170386) to (170393).
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