[30 Pa.B. 4503]
[Continued from previous Web Page] Minor--An individual under 18 years of age.]
Misadministration (medical event) from X-ray--The administration to a human being [of:], except for administrations resulting from the 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) [A radiopharmaceutical dosage greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131 under one of the following conditions:
(A) Involving the wrong patient or wrong pharmaceutical.
(B) When the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage, and the difference between the administered and prescribed dosage exceeds 30 microcuries (1.11 MBq).
(ii) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131 under one of the following conditions:
(A) Involving the wrong patient, wrong radiopharmaceutical, or wrong route of administration.
(B) When the administered dosage differs from the prescribed dosage by more than 20% of the prescribed dosage.
(iii) A gamma stereotactic radiosurgery radiation dose under one of the following conditions:
(A) Involving the wrong patient or wrong treatment site.
(B) When the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(iv) A teletherapy radiation dose under one of the following conditions:
(A) Involving the wrong patient, wrong mode of treatment or wrong treatment site.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the total prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.
(v) A brachytherapy radiation dose under one of the following conditions:
(A) Involving the wrong patient, wrong radioisotope or wrong treatment site--excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site.
(B) Involving a sealed source that is leaking.
(C) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure.
(D) When the calculated administered dose differs from the prescribed dose by more than 20% of the prescribed dose.
(vi) A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131, when the conditions in clauses (A) and (B) apply:
(A) Involving the wrong patient, wrong radiopharmaceutical, wrong route of administration or when the administered dosage differs from the prescribed dosage.
(B) When the dose to the patient exceeds 5 rem (50 mSv) effective dose equivalent or 50 rems (0.5 Sv) dose equivalent to any individual organ.
(vii) An X-ray therapy dose (with energies less than 1 MeV) under one of the following conditions:
(A) Involving the wrong patient, wrong mode of treatment, wrong treatment site, wrong tube potential or wrong filtration.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.
(viii) A radiation therapy dose using X-rays or electron beams with energies of 1 MeV and above under one of the following conditions:
(A) Involving the wrong patient, wrong mode of treatment, wrong treatment site, wrong photon or electron beam energy, wrong applicator or wrong treatment geometry.
(B) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than 10% of the prescribed dose.
(C) When the calculated weekly administered dose is 30% greater than the weekly prescribed dose.
(D) When the calculated total administered dose differs from the total prescribed dose by more than 20% of the total prescribed dose.]
An administration of a dose to the wrong individual.
(ii) An administration of a dose that results in or is likely to result in functional damage to tissue unless the damage is an expected outcome of the prescribed procedure or the damage can not be avoided without compromising the efficacy of the procedure.
(iii) An administration of a dose for therapy to the wrong site or by the wrong treatment mode (photon versus electron), wrong effective energy, wrong applicator or wrong treatment geometry when one of the following applies:
(A) The deviation results in a dose to an area outside of the intended treatment site that exceeds 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin.
(B) The result is an increase in the total expected treatment doses inside the area of the intended treatment site (other than the primary treatment target), for organs, tissue or skin that exceeds the larger of 20% of the expected dose or 0.5 Sv (50 rem).
(iv) A total dose delivered to the treatment site identified in a written directive for therapy that differs from the prescribed dose by more than 20%, or for a fractionated dose, any individual dose fraction that differs from the prescribed single fraction dose by more than 50%.
[Monitoring--The measurement of radiation levels, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this article, ''radiation monitoring'' and ''radiation protection monitoring'' are equivalent terms.]
* * * * * NRC--United States Nuclear Regulatory Commission or its authorized representatives.
* * * * * [Normal form--aterial in any form that does not qualify as ''special form.''
Occupational dose--The dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to sources of radiation, whether in the possession of the licensee, registrant or another person. The term does not include dose received: from background radiation, as a patient from medical practices, from voluntary participation in medical research programs or as a member of the public.]
* * * * * [Personnel monitoring equipment--See the definition of ''individual monitoring devices.'']
* * * * *
[Prescribed dosage--The quantity of radiopharmaceutical activity as documented in one of the following methods:
(i) In a written directive.
(ii) Either in the diagnostic clinical procedures manual or in an appropriate record in accordance with the directions of the authorized user for diagnostic procedures.]
Prescribed dose for X-ray therapy--[One of the following:
(i) For gamma stereotactic radiosurgery, the total dose as documented in the written directive.
(ii)] For [teletherapy,] X-ray therapy and electron beam therapy, the total dose and dose per fraction as documented in the written directive.
[(iii) For brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive.
Public dose--The dose received by a member of the public from exposure to sources of radiation either within a licensee's or registrant's controlled area or in unrestricted areas. The term does not include occupational dose, dose received from background radiation, dose received as a patient from medical practices or dose from voluntary participation in medical research programs.]
Qualified expert--[An individual having the knowledge, training and experience to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs. Examples include relevant certification by the American Board of Health Physics, the American Board of Radiology, or the equivalent.]
(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.
[Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 gray).]
* * * * * [Radiation area--An area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from a surface that the radiation penetrates.]
* * * * * [Radiopharmaceutical--A pharmaceutical containing radioactive material.]
* * * * * [Rem--The special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 sievert).
Research and development--One of the following:
(i) Theoretical analysis, exploration or experimentation.
(ii) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. The term does not include the internal or external administration of radiation or radioactive material to human beings.
Restricted area--An area to which access is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. The term does not include areas used for residential quarters, although a separate room in a residential building may be set apart as a restricted area.]
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 [exposure] § 215.3 (relating to units of exposure).
[Sealed source--Radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.
SI--The abbreviation for the International System of Units.
Shallow dose equivalent (Hs), which applies to the external exposure of the skin or an extremity--The dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm) averaged over an area of 1 square centimeter.
Sievert (Sv)--The SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).
Site boundary--That line beyond which the land or property is not owned, leased or otherwise controlled by the licensee or registrant.
Source material--Uranium or thorium, or a combination thereof, in a physical or chemical form or ores which contain by weight .05% or more of uranium, thorium or a combination thereof. The term does not include special nuclear material.
Special form--Radioactive material which satisfies the following conditions:
(i) The material is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule.
(ii) The piece or capsule has at least one dimension not less than 5 millimeters (.197 inch).
(iii) The material satisfies the test requirements of regulations of the United States Department of Transportation 49 CFR 173.469. Special form encapsulations designed in accordance with the requirements of 49 CFR 173.389(g) in effect on June 30, 1983, and constructed prior to July 1, 1985 may continue to be used. Special form encapsulations either designed or constructed after June 30, 1985 shall meet the requirements of this subparagraph.
Special nuclear material--Plutonium, uranium 233, uranium enriched in the isotope 233 or the isotope 235; material artificially enriched in plutonium, uranium 233, uranium enriched in the isotope 233 or the isotope 235. The term does not include source material.
Special nuclear material in quantities not sufficient to form a critical mass--Uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or a combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of the ratios for all of the kinds of special nuclear material in combination may not exceed ''1'' (i.e., unity). For example, the following quantities in combination would not exceed the limitation:
175 (grams contained U-235) + 50 (grams U-233) + 50 (grams Pu) = 1 _________________ ______ ______ 350 200 200
Survey--An evaluation of the production, use, release, disposal or presence of radiation sources under a specific set of conditions to determine actual or potential radiation hazards. When appropriate, the evaluation includes, but is not limited to, tests, physical examinations and measurements of levels of radiation or concentrations of radioactive material present.
TEDE--Total effective dose equivalent--The sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.]
* * * * * [Unrefined and unprocessed ore--Ore in its natural form prior to processing, such as grinding, roasting, beneficiating or refining.
Unrestricted area--An area to which access is neither limited nor controlled by the licensee or registrant. For purposes of this article, ''uncontrolled area'' is an equivalent term.]
* * * * * [Week--Seven consecutive days starting on Sunday.
Whole body--For purposes of external exposure, the head, trunk including male gonads, arms above the elbow, or legs above the knee.]
* * * * * [Working level (WL)--A combination of radon-222 daughters in one liter of air which will result in the ultimate emission of 1.3 x 105 million electron volts of alpha particle energy.
Working level month (WLM)--The exposure resulting from inhalation of air containing a radon daughter concentration of 1 WL for 170 working hours.]
Written directive for X-ray therapy--An order in writing for a specific patient, dated and signed by an authorized user or licensed practitioner prior to the administration of [a radiopharmaceutical or radiation, except as specified in subparagraph (vi), containing the following information] an X-ray therapy treatment:
(i) [For the administration of quantities greater than 30 microcuries (1.11 MBq) of either sodium iodide I-125 or I-131: the dosage.
(ii) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage and route of administration.
(iii) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern and total dose.
(iv) For teletherapy: the total dose, dose per fraction, treatment site and overall treatment period.
(v) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site and total dose.
(vi) For other brachytherapy the following apply:
(1) Prior to implantation: the radioisotope, number of sources; source strengths; and number, type and size of applicator.
(2) After implantation but prior to completion of the procedure: the radioisotope; treatment site; and total source strength and exposure time (or, equivalently, the total dose).
(vii)] For X-ray therapy at potentials less than 1 MeV: the total dose, dose per fraction, treatment site, field [size] sizes, tube potential and filtration, and overall treatment period.
[(viii)] (ii) For X-ray and electron beam therapy at energies of 1 MeV and above: the total dose, dose per fraction, treatment site, field size, beam type and energy, applicator, use of beam blocking or shaping devices, treatment geometry and overall treatment period.
[Year--The period of time beginning in January used to determine compliance with this article. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant if the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.]
§ 215.3. Units of exposure [and dose].
[(a)] 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 x 10-4 coulomb per kilogram of air. One milliroentgen (mR) is equal to 1/1000 Roentgen.
[(b) As used in this article, the units of dose are:
(1) Gray (Gy), which is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).
(2) Rad, which is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 Gy).
(3) Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).
(4) Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).
(c) As used in this article, the quality factors for converting absorbed dose to dose equivalent are shown in Table I.
TABLE I
QUALITY FACTORS AND
ABSORBED DOSE EQUIVALENCIES
TYPE OF RADIATION Quality Factor (Q) Absorbed Dose Equal to a Unit Dose Equivalenta X, gamma, or beta radiation and
high-speed electrons1 1 Alpha particles, multiple-charged
particles, fission fragments and
heavy particles of unknown
charge20 0.05 Neutrons of unknown energy 10 0.1 High-energy protons 10 0.1 ______
a Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem.
(d) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in subsection (c), 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of this article, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.
TABLE II
MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE
EQUIVALENT FOR MONOENERGETIC NEUTRONS
Neutron Energy Quality Factors Fluence per Unit Fluence per Unit (MeV) (Q) Dose Equivalentb Dose Equivalentb (neutrons cm-2 rem-1 (neutrons cm-2 Sv-1) (thermal) 2.5E-8 2 980E+6 980E+8 1E-7 2 980E+6 980E+8 1E-6 2 810E+6 810E+8 1E-5 2 810E+6 810E+8 1E-4 2 840E+6 840E+8 1E-3 2 980E+6 980E+8 1E-2 2.5 1010E+6 1010E+8 1E-1 7.5 170E+6 170E+8 5E-1 11 39E+6 39E+8 1 11 27E+6 27E+8 2.5 9 29E+6 29E+8 5 8 23E+6 23E+8 7 7 24E+6 24E+8 10 6.5 24E+6 24E+8 14 7.5 17E+6 17E+8 20 8 16E+6 16E+8 40 7 14E+6 14E+8 60 5.5 16E+6 16E+8 1E+2 4 20E+6 20E+8 2E+2 3.5 19E+6 19E+8 3E+2 3.5 16E+6 16E+8 4E+2 3.5 14E+6 14E+8 ______
a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.
b Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.]
§ 215.4. [Units of activity] (Reserved).
[For purposes of this article, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of airborne curie (Ci), or their multiples, or disintegrations or transformations per unit of time.
(1) One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).
(b) One curie (Ci) = 3.7 x 1010 disintegrations or transformations per second (dps or tps) = 3.7 x 1010 becquerel (Bq) = 2.22 x 1012 disintegrations or transformations per minute (dpm or tpm).]
§ 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.
RIGHTS AND RESPONSIBILITIES OF THE DEPARTMENT § 215.11. Records.
[Licensees and registrants shall maintain records showing the receipt, transfer and disposal of radiation sources.]
(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.
* * * * * (c) Inspections by the Department.
(1) The Department, its employes and agents may conduct inspections of the facilities of registrants of radiation-producing machines and licensees of radioactive material at the following frequencies:
(i) For major medical facilities, including hospitals, at least once every [2] 3 years 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.
* * * * * § 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. Employe 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 relinquishingpossession 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. Deceptive exposure of a monitoring device.
Exposure of a personnel monitoring device or area monitoring device to deceptively 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--[230] 232:
* * * * *
CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 217.1. Purpose and scope.
* * * * * (b) A licensee is subject to Chapters 215, [219], 218--220 and 230 [(relating to general provisions; standards for protection against radiation, and notices, instructions and reports to workers; inspections]. 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 [wireline service operations and subsurface tracer studies] 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).
* * * * * § 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 [Resources] Protection, Post Office Box [2063] 8469, Harrisburg, Pennsylvania [17120] 17105-8469.
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to delete the existing text of §§ 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 and 217.122 and Appendices A, B and D which appear at 25 Pa. Code pages 217-2--217-76, serial pages (203810)--(203832), (249215)--(249244) and (203863)--(203884). The existing subchapters are renamed and the following regulations are new and printed in regular type to enhance readability.)
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 (relating to interpretations), 10 CFR 30.6 (relating to communications), 10 CFR 30.8 (relating to information collection requirements: OMB approval), 10 CFR 30.63 (relating to violations) and 10 CFR 30.64 (relating to criminal penalties) 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) The definition of ''licensed material'' includes NARM.
§ 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 doesnot 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.
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
