Section 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 radiation sources. 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 radiation sources.

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.

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.

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) 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.

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, device, equipment, radiation-producing machine 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.

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 x 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.

The provisions of this § 215.2 amended 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 May 16, 2008, effective May 17, 2008, 38 Pa.B. 2243. Immediately preceding text appears at serial pages (304405) to (304408).

Notation

Authority

The provisions of this § 215.2 amended under sections 301 and 302 of the Radiation Protection Act (35 P. S. § § 7110.301 and 7110.302); section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20); and the Radon Certification Act (63 P. S. § § 2001—2014).

Cross References

This section cited in 25 Pa. Code § 221.201 (relating to definitions); and 25 Pa. Code § 236.2 (relating to definitions).