25 Pa. Code Subchapter D. Specific Licenses To Manufacture Or Transfer Certain Items Containing Radioactive Material

Pennsylvania Code

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 32.1(c)(1), 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, 32.30, 32.31, 32.32 and 32.40 are not incorporated by reference.

Source

   The provisions of this §  217.151 amended September 14, 2018, effective September 15, 2018, 48 Pa.B. 5723. Immediately preceding text appears at serial page (304438).
§ 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 (relating to energy) shall be directed to the Department.

Source

   The provisions of this §  217.152 amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial page (393717).
§ 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.

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