CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL

Subchap. Sec.

A.    GENERAL … 217.1
B.    GENERAL PROVISIONS FOR RADIOACTIVE MATERIAL … 217.11
C.    GENERAL LICENSES FOR RADIOACTIVE MATERIAL … 217.141
D.    SPECIFIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL … 217.151
F.    SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR RADIOACTIVE MATERIAL … 217.161
G.    LICENSING OF SOURCE MATERIAL … 217.171
H.    LICENSING OF SPECIAL NUCLEAR MATERIAL … 217.181
I.    TRANSFER OF RADIOACTIVE MATERIAL … 217.191
J.    RECIPROCITY … 217.201

Authority

   The provisions of this Chapter 217 issued under section 302 of the Radiation Protection Act (35 P. S. §  7110.302); and section 1920-A of The Administrative Code of 1929 (71 P. S. §  510-20); amended under the Radiation Protection Act (35 P. S. § §  7110.101—7110.703); and the Low-Level Radioactive Waste Disposal Act (35 P. S. § §  7130.101—7130.905); amended under sections 301 and 302 of the Radiation Protection Act (35 P. S. § §  7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P. S. §  510-20), unless otherwise noted.

Source

   The provisions of this Chapter 217 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235, unless otherwise noted.

Cross References

   This chapter cited in 25 Pa. Code §  215.27 (relating to vacating premises); 25 Pa. Code §  215.32 (relating to exemption qualifications); 25 Pa. Code §  218.1 (relating to purpose and scope); 25 Pa. Code §  220.1 (relating to purpose and scope); 25 Pa. Code §  224.1 (relating to purpose and scope); 25 Pa. Code §  225.1 (relating to purpose and scope); 25 Pa. Code §  226.1 (relating to purpose and scope); 25 Pa. Code §  228.37 (relating to production of radioactive material); and 25 Pa. Code §  232.1 (relating to purpose and scope).

Subchapter A. GENERAL


Sec.


217.1.    Purpose and scope.
217.2.    Address for communications.

§ 217.1. Purpose and scope.

 (a)  This chapter establishes requirements for the licensing of radioactive material. Persons who use radioactive material shall comply with this chapter. A person may not receive, possess, use, transfer, own or acquire radioactive material except as authorized in a specific or general license issued under this chapter or otherwise provided in this chapter.

 (b)  A licensee is subject to Chapters 215, 218—220 and 230. A licensee engaged in industrial uses and radiographic operations is subject to Chapter 225 (relating to radiation safety requirements for industrial radiographic operations). A licensee using radioactive material for human use is subject to Chapter 224 (relating to medical use of radioactive material). A licensee using sealed sources in well logging is subject to Chapter 226 (relating to licenses and radiation safety requirements for well logging). A licensee using sealed sources in irradiators is subject to Chapter 232 (relating to licenses and radiation safety requirements for irradiators). A licensee for the disposal of low-level radioactive wastes received from other persons is subject to Chapter 236 (relating to low-level radioactive waste management and disposal).

 (c)  The use of radioactive material in this Commonwealth under a license issued by the NRC is exempt from the licensing requirements of this chapter until the Commonwealth becomes an agreement state on the date published in the Federal Register.

Source

   The provisions of this §  217.1 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203809) to (203810).

§ 217.2. Address for communications.

 An application for a license, license renewal and license amendments and other communications under this chapter shall be addressed to the Bureau of Radiation Protection, Department of Environmental Protection, Post Office Box 8469, Harrisburg, Pennsylvania 17105-8469.

Source

   The provisions of this §  217.2 amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial page (203810).

Subchapter B. GENERAL PROVISIONS FOR RADIOACTIVE MATERIAL


Sec.


217.11—217.18.        [Reserved].
217.21—217.24.        [Reserved].
217.31 and 217.32.        [Reserved].
217.41—217.44.        [Reserved].
217.45.        [Reserved].
217.46—217.48.        [Reserved].
217.49.        [Reserved].
217.51.        [Reserved].
217.52.        [Reserved].
217.53—217.56.        [Reserved].
217.57.        [Reserved].
217.61—217.64.        [Reserved].
217.65.        [Reserved].
217.71—217.73.        [Reserved].
217.74.        [Reserved].
217.81—217.83.        [Reserved].
217.84.        [Reserved].
217.85—217.87.        [Reserved].
217.88.        [Reserved].
217.89.        [Reserved].
217.90—217.92.        [Reserved].
217.93.        [Reserved].
217.101.        [Reserved].
217.111—217.114.        [Reserved].
217.121.        [Reserved].
217.122.        [Reserved].
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.

Cross References

   This subchapter cited in 25 Pa. Code §  217.153 (relating to licensing the incorporation of NARM into gas and aerosol detectors); and 25 Pa. Code §  217.203 (relating to reciprocity of licenses of naturally occurring and accelerator-produced radioactive material).

§ § 217.11—217.18. [Reserved].


Source

   The provisions of these § §  217.11—217.18 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203810) to (203817).

§ § 217.21—217.24. [Reserved].


Source

   The provisions of these § §  217.21—217.24 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203819) to (203821).

§ § 217.31 and 217.32. [Reserved].


Source

   The provisions of these § §  217.31 and 217.32 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203821) to (203823).

§ § 217.41—217.44. [Reserved].


Source

   The provisions of these § §  217.41—217.44 amended November 17, 1995, effective November 18, 1995, 25 Pa.B. 5206; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203823) to (203828).

§ 217.45. [Reserved].


Source

   The provisions of this §  217.45 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203829) to (203830).

§ § 217.46—217.48. [Reserved].


Source

   The provisions of these §  217.46—217.48 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; amended 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 pages (203830) to (203832) and (249215) to (249216).

§ 217.49. [Reserved].


Source

   The provisions of this §  217.49 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial page (249216).

§ 217.51. [Reserved].


Source

   The provisions of this §  217.51 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended December 31, 1987, effective January 2, 1988, 18 Pa.B. 11; amended June 19, 1992, effective June 20, 1992, 22 Pa. B. 3135; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial page (249217).

§ 217.52. [Reserved].


Source

   The provisions of this §  217.52 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249217) to (249218).

§ § 217.53—217.56. [Reserved].


Source

   The provisions of these § §  217.53—217.56 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249218) to (249221).

§ 217.57. [Reserved].


Source

   The provisions of this §  217.57 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial page (249221).

§ § 217.61—217.64. [Reserved].


Source

   The provisions of these §  217.61—217.64 adopted December 18, 1987, effective December 19, 1987, 17 Pa. B. 5235; reserved June 19, 1992, effective June 20, 1992, 22 Pa. B. 3135. Immediately preceding text appears at serial pages (123549) to (123556).

§ 217.65. [Reserved].


Source

   The provisions of this §  217.65 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249222) to (249233).

§ § 217.71—217.73. [Reserved].


Source

   The provisions of these §  217.71—217.73 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249223) to (249226).

§ 217.74. [Reserved].


Source

   The provisions of this §  217.74 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial page (249226).

§ § 217.81—217.83. [Reserved].


Source

   The provisions of these § §  217.81—217.83 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249226) to (249230).

§ 217.84. [Reserved].


Source

   The provisions of this §  217.84 amended November 17, 1995, effective November 18, 1995, 25 Pa.B. 5085; amended September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249230) to (249234).

§ § 217.85—217.87. [Reserved].


Source

   The provisions of these § §  217.85—217.87 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249234) to (249235).

§ 217.88. [Reserved].


Source

   The provisions of this §  217.88 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; amended 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 pages (249235) to (249237).

§ 217.89. [Reserved].


Source

   The provisions of this §  217.89 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249237) to (249238).

§ § 217.90—217.92. [Reserved].


Source

   The provisions of these § §  217.90—217.92 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (249238) to (249242).

§ 217.93. [Reserved].


Source

   The provisions of this §  217.93 amended 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 pages (249242) to (249244).

§ 217.101. [Reserved].


Source

   The provisions of this §  217.101 amended November 17, 1995, effective November 18, 1995, 25 Pa.B. 5206; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203863) to (203864).

§ § 217.111—217.114. [Reserved].


Source

   The provisions of these § §  271.111—217.114 reserved November 17, 1995, effective November 18, 1995, 25 Pa.B. 5206. Immediately preceding text appears at serial pages (170357) to (170360).

§ 217.121. [Reserved].


Source

   The provisions of this §  217.121 reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203864) to (203866).

§ 217.122. [Reserved].


Source

   The provisions of this §  217.122 adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; amended December 31, 1987, effective January 2, 1988, 18 Pa.B. 11; reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203866) to (203867).

§ 217.131. Incorporation by reference.

 (a)  Except as provided in this subchapter, the requirements of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material) are incorporated by reference.

 (b)  Notwithstanding the requirements incorporated by reference, 10 CFR 30.5, 30.6, 30.8, 30.21(c), 30.34(d), (e)(1) and (3), 30.41(a)(6), 30.55, 30.63 and 30.64 are not incorporated by reference.

Source

   The provisions of this §  217.131 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.

§ 217.132. Effect of incorporation of 10 CFR Part 30.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 30, the following words and phrases shall be substituted for the language in 10 CFR Part 30 as follows:

   (1)  A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.

   (2)  A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.

   (3)  The definition of ‘‘sealed source’’ includes NARM.

   (4)  A reference to ‘‘byproduct material’’ includes NARM.

   (5)  Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.

Source

   The provisions of this §  217.132 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.

§ 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.

Source

   The provisions of this §  217.133 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.

Cross References

   This section cited in 25 Pa. Code §  217.203 (relating to reciprocity of licenses for byproduct, source, naturally occuring and accelerator-produced radioactive material and special nuclear material in quantities not sufficient to form a critical mass).

§ 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).

Source

   The provisions of this §  217.134 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.

Cross References

   This section cited in 25 Pa. Code §  217.135 (relating to renewal of licenses).

§ 217.135. Renewal of licenses.

 (a)  An application for renewal of a specific license shall be filed under §  217.134 (relating to filing application for specific licenses).

 (b)  If a renewal application is filed prior to 30 days before the expiration of a license, the existing license does not expire until definitive notice has been given by the Department of its action on the renewal application. This subsection also applies to new license applications incorporating other licenses.

Source

   The provisions of this §  217.135 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.

§ 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 CONCENTRATIONS

 Note: Some of the values in Table A-1 are presented in the computer ‘‘E’’ notation. In this notation, a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 102 or 600 and 6E+0 represents 6 x 100 or 6.

Element
(atomic number)
Isotope Column I
Gas concentration
µCi/ml
Column II
Liquid and solid concentration
µCi/ml
Actinium (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

Source

   The provisions of this §  217.136 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial pages (282351) to (282352).

§ 217.137. Exempt quantities.

 In addition to the parts of 10 CFR 30 incorporated by reference, the following requirements apply:

   (1)  A person may receive, possess, use, transfer, own or acquire radioactive material in individual quantities each of which is less than those listed in Table 2 if the person does not produce, package or repackage radioactive material for purposes of commercial distribution or incorporate radioactive material into products intended for commercial distribution.

   (2)  Except under a specific license issued by the Department or the NRC under 10 CFR 32.18 (relating to manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license), a person may not, for purposes of commercial distribution, transfer radioactive material for distribution to persons exempt under paragraph (1) or equivalent regulations of the NRC, an agreement state or licensing state.

TABLE 2


EXEMPT QUANTITIES



Radioactive Material Microcuries
Actinium-228 (Ac 228) 1
Beryllium-7 (Be 7) 10
Bismuth-207 (Bi 207) 10
Cesium-129 (Cs 129) 100
Cobalt-57 (Co 57) 100
Gallium-67 (Ga 67) 100
Germanium-68 10
Gold-195 (Au 195) 10
Gold-196 (Au 196) 1
Indium-111 (In 111) 100
Iodine-123 (I 123) 100
Iodine-124 (I 124) 1
Iridium-190 (Ir 190) 100
Lead-203 (Pb 203) 100
Lead-210 (Pb 210) 0.1
Lead-212 (Pb 212) 10
Phosphorus-33 (P 33) 10
Potassium-43 (K 43) 10
Protactinium-230 (Pa 230) 10
Protactinium-231 (Pa 231) 0.1
Radium-223 (Ra 223) 1
Radium-224 (Ra 224) 1
Radium-226 (Ra 226) 0.1
Radium-228 (Ra 228) 0.1
Radon-220 (Rn 220) 1
Radon-222 (Rn 222) 1
Rhenium-183 (Re 183) 100
Rhenium-187 (Re 187) 100
Rubidium-81 (Rb 81) 10
Scandium-46 (Sc 46) 10
Sodium-22 (Na 22) 10
Technetium-96m (Tc 96m) 100
Xenon-127 (Xe 127) 1,000
Yttrium-87 (Y 87) 10
Yttrium-88 (Y 88) 10

Source

   The provisions of this §  217.137 adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239.

Subchapter C. GENERAL LICENSES FOR RADIOACTIVE MATERIAL


Sec.


217.141.    Incorporation by reference.
217.142.    Effect of incorporation of 10 CFR Part 31.
217.143.    Certain measuring, gauging or controlling devices.
217.144.    Incidental radioactive material produced by a particle accelerator.

Source

   The provisions of this Subchapter C adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

Cross References

   This subchapter cited in 25 Pa. Code §  217.203 (relating to reciprocity of licenses of naturally occurring and accelerator-produced radioactive material).

§ 217.141. Incorporation by reference.

 (a)  Except as provided in this subchapter, the requirements of 10 CFR Part 31 (relating to general domestic licenses for byproduct material) are incorporated by reference.

 (b)  Notwithstanding the requirements incorporated by reference, 10 CFR 31.4 and 31.14 (relating to information collection requirements: OMB approval; and criminal penalties) are not incorporated by reference.

Source

   The provisions of this §  217.141 amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial pages (282354).

§ 217.142. Effect of incorporation of 10 CFR Part 31.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 31 (relating to general domestic licenses for byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 31 as follows:

   (1)  A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.

   (2)  A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.

   (3)  The definition of ‘‘sealed source’’ includes NARM.

   (4)  A reference to ‘‘byproduct material’’ includes NARM.

   (5)  Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.

§ 217.143. Certain measuring, gauging or controlling devices.

 In addition to the parts of 10 CFR 31.5 (relating to certain detecting measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere) incorporated by reference, general licensees subject to registration under 10 CFR 31.5(c)(13)(i) or possessing general licensed devices containing 37 MBq (1 mCi) or more of accelerator-produced material, as determined on the date of manufacture, or 3.7 MBq (0.1 mCi) or more of radium-226 shall also comply with the following:

   (1)  Conduct a physical inventory every 6 months to account for all sources or devices, or both, received and possessed under this section and do the following:

     (i)   Maintain the physical inventory records for 3 years from the date of each inventory.

     (ii)   Furnish a report to the Department annually showing to the extent practicable, the make, model, serial number, isotope, source activity and location of each device. The report shall list an individual to contact regarding questions about this report.

   (2)  For portable devices, also comply with the following:

     (i)   A person who initiates acquisition, transfer or disposal of a portable device shall notify the Department within 15 days of the action. Sending a portable device for calibration, maintenance or source replacement does not constitute transfer.

     (ii)   Portable devices may only be used by or under the direct supervision of individuals who have been instructed in the operating and emergency procedures necessary to ensure safe use.

     (iii)   For each individual that the licensee permits to use a portable device, the licensee shall maintain a record showing the type of device use permitted and the basis, such as training certificates, for that authorization. An individual’s record shall be kept for at least 3 years after the individual terminates association with the licensee.

     (iv)   Portable devices shall be secured from access by unauthorized personnel whenever the device is not under the direct surveillance of an individual authorized to use the device.

     (v)   The licensee shall maintain a current sign out log at the permanent storage location of the portable device. Log entries shall be available for inspection by the Department for 3 years from the date of entry. The following information shall be recorded for each portable device:

       (A)   The model and serial number of the device.

       (B)   The name of the assigned user.

       (C)   The locations and dates of use.

 (vi)  Emergency instructions shall accompany each portable device taken off the premises of the licensee.

Source

   The provisions of this §  217.143 amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial pages (282354) to (282355).

Cross References

   This section cited in 25 Pa. Code Chapter 218, Appendix A (relating to fees for radioactive material licenses).

§ 217.144. Incidental radioactive material produced by a particle accelerator.

 A general license is issued to possess radioactive material produced incidentally to the operation of a particle accelerator. The general license is also subject to the applicable provisions of this chapter and Chapters 215, 219 and 220 (relating to general provisions; standards for protection against radiation; and notices, instructions and reports to workers; inspections and investigations). A licensee may transfer this radioactive material only under Subchapter I and Chapter 230 (relating to transfer of radioactive material; and packaging and transportation of radioactive material). A licensee may dispose of this radioactive material only with Department approval.

Cross References

   This section cited in 25 Pa. Code §  228.37 (relating to production of radioactive materials).

Subchapter D.  SPECIFIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL


Sec.


217.151.    Incorporation by reference.
217.152.    Effect of incorporation of 10 CFR Part 32.
217.153.    Licensing the incorporation of NARM into gas and aerosol detectors.
217.154.    Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226.
217.155.    Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license.

Source

   The provisions of this Subchapter D adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

Cross References

   This subchapter cited in 25 Pa. Code §  217.136 (relating to exempt concentrations).

§ 217.151. Incorporation by reference.

 (a)  Except as provided in this subchapter, the requirements of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) are incorporated by reference.

 (b)  Notwithstanding the requirements incorporated by reference, 10 CFR 32.8, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29 and 32.40 are not incorporated by reference.

§ 217.152. Effect of incorporation of 10 CFR Part 32.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material), the following words and phrases shall be substituted for the language in 10 CFR Part 32 as follows:

   (1)  A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.

   (2)  A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.

   (3)  The definition of ‘‘sealed source’’ includes NARM.

   (4)  A reference to byproduct material includes NARM.

   (5)  Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.

§ 217.153. Licensing the incorporation of NARM into gas and aerosol detectors.

 

 An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under Subchapter B (relating to general provisions for radioactive material) will be approved if the application satisfies requirements equivalent to those in 10 CFR 32.26—32.29. The maximum quantity of radium-226 may not exceed 0.1 microcuries (3.7 kBq).

§ 217.154. Special requirements for license to manufacture calibration sources containing americium-241, plutonium or radium-226.

 In addition to the incorporation by reference of requirements in 10 CFR 32.57 (relating to calibration sources containing americium-241), applicants using plutonium and radium-226 in the manufacture of calibration or reference sources shall comply with 10 CFR 32.57.

§ 217.155. Manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license.

 (a)  In addition to the incorporation by reference of requirements in 10 CFR 32.71 (relating to manufacture and distribution of radioactive material for certain in vitro clinical or laboratory testing under general license), applicants using cobalt-57 shall prepare for distribution the cobalt-57 in prepackaged units that do not exceed 10 microcuries (370 kBq) of cobalt-57.

 (b)  A prepackaged unit shall bear a durable, clearly visible label identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (370 kBq) cobalt-57.

Subchapter F. SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR RADIOACTIVE MATERIAL


Sec.


217.161.    Incorporation by reference.
217.162.    Effect of incorporation of 10 CFR Part 33.
217.163.    Types of specific licenses of broad scope.

Source

   The provisions of this Subchapter F adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

Cross References

   This subchapter cited in 25 Pa. Code §  217.136 (relating to exempt concentrations).

§ 217.161. Incorporation by reference.

 (a)  Except as provided in this subchapter, the requirements of 10 CFR Part 33 (relating to specific domestic licenses of broad scope for byproduct material) are incorporated by reference.

 (b)  Notwithstanding the requirements incorporated by reference, 10 CFR 33.8, 33.21 and 33.23 (relating to information collection requirements: OMB approval; violations; and criminal penalties) are not incorporated by reference.

§ 217.162. Effect of incorporation of 10 CFR Part 33.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 33, the following words and phrases shall be substituted for the language in 10 CFR Part 33 as follows:

   (1)  A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.

   (2)  A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.

   (3)  The definition of ‘‘sealed source’’ includes NARM.

   (4)  A reference to byproduct material includes NARM.

   (5)  Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.

§ 217.163. Types of specific licenses of broad scope.

 In addition to the incorporation by reference of 10 CFR 33.11 (relating to types of specific licenses of broad scope), the following requirements for licensees using NARM also apply:

   (1)  A Type A specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in the license, but not exceeding quantities specified in the license, for purposes authorized by the act. The quantities specified exceed those specified in Column I, Table 3 and are usually in the multicurie range.

   (2)  A Type B specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in Table 3, for an authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column I, Table 3. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: for each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Column I, Table 3, for that radionuclide; the sum of the ratios for radionuclides possessed under the license may not exceed unity.

   (3)  A Type C specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of a chemical or physical form of radioactive material specified in Table 3, for an authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Column II, Table 3. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: for each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in Column II, Table 3, for that radionuclide; the sum of the ratios for radionuclides possessed under the license may not exceed unity.

TABLE 3


LIMITS FOR BROAD LICENSES



Radioactive
Material
Col. I curies Col. II curies
Beryllium-7 10 0.1
Cobalt-57 10 0.1
Radium-226 0.01 0.0001
Scandium-46 1 0.01
Sodium-22 0.1 0.001

Subchapter G. LICENSING OF SOURCE MATERIAL


Sec.


217.171.    Incorporation by reference.
217.172.    Effect of incorporation of 10 CFR Part 40.

Source

   The provisions of this Subchapter G adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

§ 217.171. Incorporation by reference.

 (a)  Except as provided in this subchapter, the requirements of 10 CFR Part 40 (relating to domestic licensing of source material) are incorporated by reference.

 (b)  Notwithstanding the requirements incorporated by reference, 10 CFR 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 by reference.

Source

   The provisions of this §  217.171 amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial page (282359).

§ 217.172. Effect of incorporation of 10 CFR Part 40.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 40 (relating to domestic licensing of source material), the following words and phrases shall be substituted for the language in 10 CFR Part 40 as follows:

   (1)  A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.

   (2)  A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.

   (3)  The definition of ‘‘sealed source’’ includes NARM.

   (4)  A reference to ‘‘byproduct material’’ includes NARM.

   (5)  Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.

Subchapter H. LICENSING OF SPECIAL NUCLEAR MATERIAL


Sec.


217.181.    Incorporation by reference.
217.182.    Effect of incorporation of 10 CFR Part 70.

Source

   The provisions of this Subchapter H adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

§ 217.181. Incorporation by reference.

 (a)  Except as provided in this subchapter, the requirements of 10 CFR Part 70 (relating to domestic licensing of special nuclear material) are incorporated by reference.

 (b)  Notwithstanding the requirements incorporated by reference, 10 CFR 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) and (b)(1), (3) and (4) and (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 by reference.

§ 217.182. Effect of incorporation of 10 CFR Part 70.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 70 (relating to domestic licensing of special nuclear material), the following words and phrases shall be substituted for the language in 10 CFR Part 70 as follows:

   (1)  A reference to ‘‘NRC’’ or ‘‘Commission’’ means Department.

   (2)  A reference to ‘‘NRC or agreement state’’ means Department, NRC or agreement state.

   (3)  The definition of ‘‘sealed source’’ includes NARM.

   (4)  A reference to ‘‘byproduct material’’ includes NARM.

   (5)  Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department and, for NRC licenses, to the NRC until agreement state status is in effect.

Subchapter I. TRANSFER OF RADIOACTIVE MATERIAL


Sec.


217.191.    Transfer of material.

Source

   The provisions of this Subchapter I adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

Cross References

   This subchapter cited in 25 Pa. Code §  217.144 (relating to incidental radioactive material produced by a particle accelerator).

§ 217.191. Transfer of material.

 The requirements of 10 CFR 30.41 (relating to transfer of byproduct material) also apply to NARM.

Subchapter J. RECIPROCITY


Sec.


217.201.    Incorporation by reference.
217.202.    Effect of incorporation of 10 CFR Part 150.
217.203.    Reciprocity of licenses for byproduct source, naturally occurring and accelerator-produced radioactive material and special nuclear material in quantities not sufficient to form a critical mass.

Source

   The provisions of this Subchapter J adopted September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239, unless otherwise noted.

§ 217.201. Incorporation by reference.

 Except as provided in this subchapter, the requirements of 10 CFR 150.1, 150.2, 150.3, 150.11 and 150.20 are incorporated by reference.

Source

   The provisions of this §  217.201 amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial page (282361).

§ 217.202. Effect of incorporation of 10 CFR Part 150.

 To reconcile differences between this subchapter and the incorporated sections of 10 CFR Part 150 (relating to exemptions and continued regulatory authority in agreement states and in offshore waters under section 274), the following words and phrases shall be substituted for the language in 10 CFR Part 150:

   (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.

Source

   The provisions of this §  217.202 amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial page (282362).

§ 217.203. Reciprocity of licenses for byproduct, source, naturally occurring and accelerator-produced radioactive material and special nuclear material in quantities not sufficient to form a critical mass.

 (a)  Subject to this article, a person who holds a specific license from the NRC or a state where the licensee maintains an office, issued by the agency having jurisdiction to direct the licensed activity and to maintain radiation safety records, is granted a general license to conduct the activities authorized in the licensing document within this Commonwealth, except for areas of exclusive Federal jurisdiction, for a period not in excess of 180 days in a calendar year if:

   (1)  The licensing document does not limit the activity authorized by the document to specified installation or locations.

   (2)  The out-of-State licensee notifies the Department in writing at least 3 days prior to engaging in the activity. The notification shall indicate the location, period and type of proposed possession and use within this Commonwealth, and shall be accompanied by a copy of the pertinent licensing document. If for a specific case the 3-day period would impose an undue hardship on the out-of-State licensee, the licensee may, upon application to the Department, obtain permission to proceed sooner. The Department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in this subsection.

   (3)  The out-of-State licensee complies with this title and with the terms and conditions of the licensee’s document, except terms and conditions which may be inconsistent with this title.

   (4)  The out-of-State licensee supplies other information as the Department may request.

   (5)  The out-of-State licensee does not transfer or dispose of radioactive material possessed or used under the general license provided in this subsection except by transfer to a person who is one of the following:

     (i)   Specifically licensed by the Department, the NRC or by another state to receive the material.

     (ii)   Exempt from the requirements for a license for the material under Subchapter B (relating to general provisions for radioactive material).

 (b)  Notwithstanding the provisions of subsection (a), a person who holds a specific license issued by the NRC or a state authorizing the holder to manufacture, transfer, install or service a device described in Subchapter C (relating to general licenses for radioactive material) within areas subject to the jurisdiction of the licensing body is granted a general license to install, transfer, demonstrate or service the device in this Commonwealth subject to the following conditions:

   (1)  The person files a report with the Department within 30 days after the end of a calendar quarter in which a device is transferred to or installed in this Commonwealth. The report shall identify the general licensee to whom the device is transferred by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device.

   (2)  The device has been manufactured, labeled, installed and serviced in accordance with the specific license issued to the person by the NRC or a state.

   (3)  The person assures that labels required to be affixed to the device, under regulations of the authority which licensed manufacture of the device, bear a statement that ‘‘Removal of this label is prohibited.’’

   (4)  The holder of the specific license or his intermediary shall provide a copy of the conditions of general license contained in Subchapter C to the general licensee upon transfer of the radioactive material or installation of a device containing the radioactive material.

 (c)  The Department may withdraw, limit or qualify its acceptance of a specific license or equivalent licensing document issued by another agency, or product distributed under the licensing document, upon determining that the action is necessary to prevent undue hazard to public health and safety or property.

 (d)  When a person is granted a general license under subsection (a) and subsequently exceeds the prescribed 180-day period, the person shall file a license application with the Department under Subchapter B within 30 days after the end of the 180-day period.

 (e)  Implementation of the requirements of this section regarding byproduct, source and special nuclear material is subject to §  217.133 (relating to 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).

Source

   The provisions of this §  217.203 amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial pages (282362) to (282363).

APPENDIX A. [Reserved]



Source

   The provisions of this Appendix A reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203868) to (203873).

APPENDIX B. [Reserved]



Source

   The provisions of this Appendix B reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203874) to (203879).

APPENDIX C. [Reserved]



Source

   The provisions of this Appendix C adopted December 18, 1987, effective December 19, 1987, 17 Pa.B. 5235; reserved June 19, 1992, effective June 20, 1992, 22 Pa.B. 3135. Immediately preceding text appears at serial pages (123598) to (123600).

APPENDIX D. [Reserved]



Source

   The provisions of this Appendix D reserved September 14, 2001, effective September 15, 2001, 31 Pa.B. 5239. Immediately preceding text appears at serial pages (203879) to (203884).



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