ML20137Q644

Comments on Draft Proposed Rev to 10CFR35 to Codify Current Suggestions on Calibr of Equipment,Storage & Measurements, Per Reg Guide 10.8

ML20137Q644
Person / Time
Issue date:	03/04/1982
From:	Mills W NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Webb Patricia Walker NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
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References
FRN-50FR30616, RTR-REGGD-10.008, RULE-PR-35 AA73-1, NUDOCS 8509230144
Download: ML20137Q644 (2)

Text

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MEMORANDUM FOR: William Walker, Chief Material Licensing Branch, NMSS FROM : William A. Mills, Chief Health Effects Branch, RES

SUBJECT:

COMMENTS ON DRAFT REVISION OF PART 35 I am struck by the detailed requirements placed on the licensee by the present draft revision. Subpart C on General Technical Requirements contains signif-icantly more operational and administrative requirements than is in the current 10 CFR Part 35. I understand that the reason for this is to codify current suggestions (Regulatory Guide 10.8) on calibration of equipment, storage, measurements, etc. With codification, the licensing process is intended to be shortened in time and other "moderization" of the regulations attained.

I assume that the " Statement of Consideration" for the proposed rule will adequately address the need for these increased requirements by drawing upon NRC's licensing and inspection experiences as well as the experiences of the Agreement States. It appears that a significant loss in licensee flexibility will take place if the present draft becomes final.

Specific Comments

1. Define " dose" as it is used on page 6 to mean the amount of material admini-stered. Likewise radiation dose needs to be defined because on page 8 the ALARA program requires consideration of " individual and collective dose".

2. On page 8, provide the title for form NRC-313-AR.

3. Section 35.30(b)(4) (top of page 9). If you require an active ALARA program and monitoring of that program by the Comittee, the establishment of

" investigational levels for occupational" exposures seems unnecessary. In-vestigational and reference levels tend to become lower standards; rely on the Committee and the RS0 to provide the radiation protection needed. Does the requirement mean that NRC will pass judgement on the selection of the levels?

4. Section 35.31(b). Should this requirement not be at the end of the require-ments for the Committee?

5. Section 35.32. Why is the RS0 charged to establish " policy for disposal?

Is this not a responsibility of the Committee? In(c)and(d)therequire-

ments to " establish" are unnecessary.

g92gl44850916 35 50FR30616 PDR

William Walker 6. Section 35.34. Regarding the " visiting physician" requirements, should not (a)(1) and (a)(2) be an "either-or"? In line 2 of (3), " physician" I assume refers to the " visiting physician". With references to visiting physicians could not Section 35.17 (b)(c) and (d) be combined into a requirement that says get a license amendment when the designated RS0 and the listing of authorized users, including visiting physicians, is changed.

7. Section 35.630. Is there agreement on the alternative of an intercom-parison check between 1 1/2 and 21/2 yrs as a substitute for the present

> 2 yrs as a response to the AAPM petition? Are there reasons why a longer period of time would not be adequate based on NRC's experiences? Does the alternative address the broader problem of the need for comparison to a primary NBS standard? Perhaps a viable alternative is to rely solely on the calibration factor not changing by more than 2 percent without a mandated time for recalibration.

8. Page35,(d),line3. Substitute " radioactive" for " physical".

9. Subpart J. Is it really necessary to mandate what the training consists of, e.g. discussion groups on the subject areas with the number of hours in each?

In 35.910(c), for example, what is lost by deleting all details beyond the first complete sentence that requires 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training. Will NRC reject as an authorized user a physician with only 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of training in radiation protection? I suspect not.

I recognize the large effort devoted by a competent task group to draft a revision of Part 35 that provides adequate radiation protection and is meaningful in its implementation. To fully satisfy these goals NRC should make sure that needed changes are warranted and again reasons provided in the Statement of Considerations.

y!

William A. Mills, Chief Health Effects Branch i

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