ML20136E295

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Forwards Comments on Proposed Rev to 10CFR35 Re Medical Licensing
ML20136E295
Person / Time
Issue date: 09/01/1982
From: Klucsik J
NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD)
To: Webb Patricia Walker
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20136D915 List: ... further results
References
FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8210130110
Download: ML20136E295 (5)


Text

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'~ r, o atog 49 'o UNITED STATES

~k NUCLEAR REGULATORY COMMISSION

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-g  : j WASHINGTON, D. C. 20555

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September 1, 1982 MEMORANDUM FOR: William J. Walker, FCML FROM: John F. Klucsik, ELD,(

SUBJECT:

PROPOSED REVISION OF PART 35 FEDERAL REGISTER NOTICE In my note to you of August 31, 1982, I promised additional comments on the Commission paper, Federal Register preamble and rule. Attached are comments'on the Federal Register preamble and rule. The comments noted with asterisks are of a legal nature and must be resolved. Other comments are of an editorial nature and should be addressed.

Attachment:

Comments cc: W. Olmstead T. Dorian

i CONTACT

X-43295 0Elh l0 &llhhh 59-

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ATTACHMENT A COMMENTS ON FEDERAL REGISTER PREAMBLE AND RULE

-s PROPOSED PART 35 (MEDICAL LICENSING)

Preamble

p. 8 MIS could reduce review time by an additional 10 days.

What is the anticipated' reduction in review time without the MIS? How do these reductions relate to the reductions claimed in the value impact statement?

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p. 9 The summary of the scope section is too narrow.

The regulations apply to supervised but unlicensed t persons.

  • p. 14 S 35.31. The rulemaking on the Radiation Safety Committee is not complete until a final rule is published. If the staff's intent is to incorporate this rulemaking into the Part 35 rulemaking, a clearer statement of that intent is 4

needed. See Note to Cook from Klucsik, April 14, 1982, Attachment B.

p. 18 S 35.51. Spell out GM in first reference. The rule does not specifically mention the GM device.

This preamble summary should explain'which part of the rule applies to the GM device.

p. 22 S 35.92. The term " interim burial" seems a little peculiar here since the material is unlikely to ne

.ll buried. Perhaps the words " disposal" or n " permanent storage" are better suited to the meaning you intend.

  • p. :23 S 35.200. If the Taplin petition rulemaking is to be incorporated into the Part 35 rulemaking, a

/~L+ statement as to how comments will be treated is necessary. See Note to Cook from Klucsik, April 14, 1982, Attachment D.

  • p. 37 See comments on Reg. Flex certification.
Rule
  • p. 42 'In.the fourth line of the authority citation, L insert " (e) (1)" af ter S 35.59 (a)-(c) .

Sections 35.17 and 35.606 should be listed under 161b, not 161o. Section 35.204 (b) , listed under 161o, should be 35.204 (c) .

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p. 43 S 35.1. The phrase "in order to provide for the protection of the public health and safety" may be deleted.
  • p. 43 S 35.8(b). Sections 35.17 and 35.606 should be deleted. They are not reporting requirements.

They are requirements for a license (instructions respecting possession and use) under 161b and 81.

p. 44 The definit' ion of mobile service does not include the actual use of material at a location not identified on-a license. It covers only the

.,. transportation of the materials. Transportation L'>

is covered by other parts of the NRC regulations and by DOT regulations. Revise to read:

" Mobile service" means the transportation and use of byproduct material for human use and

[its use] for checks and tests of equipment used in conjunction with human use by the licensee at a location other than the licensee's principal place of human use.

p. 46 S 35.17. Paragraph (f) is still a little vague.

What is the licensed program referred to?

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p. 47 S 35.29. The phrase "the requirements of" may be deleted.

p.-47 S 35.30 (d) (4) . This item does not accomplish the purpose set out for it in the preamble. Revise as follows:

(4) . Personnel exposure investigational levels which when exceeded will initiate a prompt investigation of the cause of-the exposure and [a consideration of]

action [s] [that might be taken] to reduce the probability of recurrence.

  • p. 50 S 35.34(b). Delete.the word "such" and insert at the end of the sentence "as provided in paragraph.(a) of this section."

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p. 56 S 35.58. As written this section would not permit unlicensed techicians to use check sources.

Revise to read:

Any person [ licensed for human use of byproduct material] authorized by license or

3 S 35.2(b) to use byproduct material for human i use may receive, etc.

p. 60 S 35.90. This section:may be streamlined. "The licensee shall;[ prevent the unintended exposure of individuals to] store volatile radiopharmaceuticals and radioactive gases [by storing such byproduct material] in a fume hood, etc.
p. 65 S 35.405(b). Delete " maintain records to show compliance with the."
p. 66 S 35.606 (c) . Typo. Teletherapy.

(g). Insert " license" after

" licensee's."

p. 67 S 35.620 (b) . Typo. Licensee.
p. 68 S 35.630 (a) (2) . This paragraph is still a little unclear.- Revise to read:

(2) The system must have been calibrat.cd within the previous four years;

[two years thereafter (plus or minus six months) ] and, within 18 to 30 months after calibration, the system must have been intercompared etc.

p. 75 S 35.900 (b) . Typo. Officer's.

(e). The meaning of " continuing involvement in medical radiation safety" is unclear.

  • p. 75- S 35.910(c). "
  • p. 78- S 35.920(c). "
p. 83 S 35.961. The word " neophyte" is unnecessary,
p. 84 Some distinction needs to be made between the text of the proposed Part 35 and the introduction to the Part 30 amendments. The Part 40 amendment appears to be out of order.

S-30.34(g) needs a clearer statement of what records are required. Suggest (1) require test; then~ (2) require record of test results.

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  • p. 85 S 32.72(a) currently refers to SS 35.14 and 35.100. These references will be incorrect if the proposed rule is adopted.

S 32.73(a)

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