ML20136E266
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MAY 2 01982 MEMORANDUM FOR:
William J. Walker Material Licensing Branch Division of Fuel Cycle & Material Safety, NMSS G. K. Tomlin Chief kd THRU:
Regulatory Analysis Branch Division of Risk Analysis, RES
~FROM:
J. J. Henry Regulatory Analysis Branch Division of Risk Analysis, RES
SUBJECT:
PERIODIC AND SYSTEMATIC REVIEW 0F'10 CFR PART 30:
IMPACT OF PROPOSED REVISION OF 10 CFR PART 35 As the Task Leader for the periodic and systematic review of 10 CFR Part.30 under the TMI Action Plan Task IV.G.2, I try to monitor various proposed actions that might have an impact on the content, quality, clarity, or structure of 10 CFR Part 30.
In my role as Task Leader / monitor, I have had an occasion to see a draft of a proposed revision of 10 CFR Part 35.
.My immediate concern is that the proposed revision of 10 CFR Part 35, its periodic and systematic' review, and its value/ impact analysis recognize no_ relationship to other existing regulations. Some of the changes proposed for revised 10 CFR Part 35 will, in my view, have significant impacts on 10 CFR Part 30. My concerns can best be set out in the following detailed comments.
'is issued under sec.161(b) proposed 10 CFR Part 35 states that 5 35.14(b)
The authority citation for 1.
68 Stat. 948, as amended (42 U.S.C. 2201(b).
However 5.35.14(b) would no longer exist in proposed 10 CFR Part 35. This has an impact on 10 CFR 30.34(g) that cross-references 5 35.14(b)(1) through (iv).
2.
Proposed 5 35.15 would revise the definition of " physician". The term
" physician" is defined in 10 CFR 30.4(1) to be identical with the term in 10 CFR Part 35 because of the identical use of the terms in both parts.
Good regulatory practice would call for a conforming amendment of 10 CFR 30.4(1).
3.
Proposed 5 35.16 would require that applications for licenses must be sub-mitted'only by mail.
In this regard, proposed 5 35.16 is not consistent with 10 CFR 30.6 that permits delivery in person. Also, I note that existing 5~30.6(b)(1)(i) includes in the regional licensing program all licenses for 82Wo$2p$2Yf Y
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W. J. Walker i the medical use of radioisotopes except teletherapy sources and nuclear powered pacemakers, rather than a license for human use except for a tele-therapy unit, as proposed in new 5 35.16.
If the intent is to modify the scope of the regional licensing program, you should propose a conformir.g amendment of 10 CFR 30.6(b)(1)(i).
4.
Proposed 5 35.49(a) contains a cross-reference to "10 CFR 55 30.32".
In the interest of quality, I recommend that the cross-reference be revised to accepted Federal Register format, i.e., "... pursuant to 5 30.32... of this chapter.... " only if there is a requirement that proposed 5 35.49(a) apply to a license issued pursuant to-10 CFR 30.32, Application for specific license.
In fact, I am concerned about the precedent of attempting to establish a single section in 10 CFR Part 30 for issuance of a specific license.
Com-monly, regulatory text in 10 CFR Chapter I uses the format of "a license
. issued pursuant to Part xx of this chapter." Accordingly, I suggest that the latter part of proposed 5 35.49(a) be revised to read "... pursuant to the regulations in Part 30 or 55 32.70,.32.72, 32.73, or 32.74 of this chap-ter or equivalent regulations of an Agreement State."
5.
Proposed 5 35.200 lists molybdenum-99/ technetium-99m generators and proposed 5 35.204 sets out the permissible molybdenum-99 concentration in a radio-phannaceutical.
In so doing, you have eliminated existing.10 CFR 35.14(b)(4)(1) through (iv), reduced the permissible molybdenum-99 concen-tration, and reduced the record retention peri.od.
In10CFR30.34(g),
however, nuclear pharmacy licensees and broad medical licensees would still be required to perform molybdenum breakthrough tests pursuant to no-longer existing regulations. Good regulatory practice would call for a conforming amendment of 10 CFR 30.34(g) so nuclear pharmacy licensees and broad medical licensees will have an opportunity to coment on the new requirements.
6.
Proposed 535.641(b)(2)containsa' cross-referenceto"...aspecificexemp-tion as provided for at 10 CFR 30.11."
How would a specific exemption gran-ted by the Comission pursuant to 10 CFR 30.11 differ from a specific exemp-tion granted by the Commission pursuant to proposed 5 35.297 If proposed 5 35.29 cannot be used to grant a specific exemption under proposed i
535.641(b)(2),whencanitbeused?
If you desire the cross-reference to remain, I recommend that the quoted phrase be revised to "... a specific exemption granted by the Commission pursuant to 5 30.11 of this chapter."
-In the interests of maintaining consistency in the Commission's regulations, I suggest that a comprehensive review be undertaken of the relationship of proposed L
revised 10 CFR Part 35 to other existing or proposed regulations or policies.
Wh J6mes J. Henry i
Regulatory Analysis branch Division of Risk Analysis, RES
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