ML18236A300

Alabama Response to NRC 122716 Letter

ML18236A300
Person / Time
Issue date:	08/21/2018
From:	Office of Nuclear Material Safety and Safeguards
To:
Beardsley M
Shared Package
ML18236A295	List: ML18236A296 ML18236A298 ML18236A299 ML18236A300 ML18236A302 ML18253A164 ML18253A178
References
Download: ML18236A300 (3)

Text

NRC Letter dated 12/27/2016 ORC NRC RATS Category Subject and Comments ORC Actions Section Section ID 420-3 32.72 2007-1 B Manufacture, preparation, or transfer No actions.

.02(10)(t) 2007-3 for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35.

AL omits an equivalent regulation to 10 CFR 32.72(b)(3). AL needs to add an equivalent regulation to 10 CFR 32.72(b)(3) to 420-3-26-.2(10)(t) to meet the requirements of a compatibility category B designation.

AL omits no later than 30 days after the date that the licensee allows, under paragraphs 420-3-26-.02(10)(t)(2)(ii)(I) and (III), the individual to work as an authorized nuclear pharmacist from the end of 420-3-26-.02(10)(t)(5)(v).

AL needs to make the above changes in order to meet the compatibility category B designation assigned to 10 CFR 32.72.

COMMENT STANDS FROM NRC LETTER DATED AUGUST 19, 2016 Note: AL provided a rationale for not addressing this comment in their submitted comment resolution document (ML16314D996).

As written, ALs proposed regulations are not essentially identical to NRCs and as such, cause inconsistency and have transboundary implications. They do not

meet the Compatibility Category B designation assigned to 32.72. For example, ALs proposal to omit the equivalent regulation to 10 CFR 32.72(b)(3) would allow AL to issue license conditions that are less restrictive, which is inconsistent and not essentially identical for compatibility category B designation.

Similarly, ALs proposal for the equivalent regulation to 10 CFR 32.72(b)(5) is more restrictive, which is also not essentially identical for compatibility category B designation 420-3 40.13 2013-2 B Unimportant quantities of source

.02(3) material AL omits the word delivers from 420 delivers was added to 420-3 26-.02(3)(a). .02(3)(a)

AL needs to remove 420-3 420-3-26-.02(3)(c)2.(ii) was deleted in

.02(3)(c)2.(ii) from its regulations. its entirety.

AL needs to add a regulation An equivalent 40.13(c)(2)(ii) was added equivalent to 10 CFR 40.13(c)(2)(ii) as 420-3-26-.02(3)(c)2.(ii)

Piezoelectric ceramic containing not more than 2 percent by weight source material to 420-3-26-.02(3)(c)2.

420-3-26-.02(3)(c)8. was deleted in its AL needs to remove 420-3-26-.02(3)(c)8. entirety. .02(3)(c)9. was renumbered as from its regulations. .02(c)8. for sequential numbering purposes.

AL needs to add a regulation equivalent to An equivalent 40.13(c)(9) was added as 10 CFR 40.13(c)(9) The exemptions in 420-3-26-.02(3)(c)9.

this paragraph (c) do not authorize the manufacture of any of the products described. to 420-3-26-.02(3)(c).

AL lists the incorrect reference in 420 The reference was corrected in 420 26-.02(3)(c)10.(ii). AL needs to reference 26-.02(3)(c)10.(ii).

Section 40.52 instead of Section 40.42.

AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 40.13 (except 10 CFR 40.13(c)(5)(iv) which is a compatibility category NRC).