ML20137R258
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O 1 4 1982 l
HEMORANDIN FOR: Richard E. Cunninghan. Director Division of fuel Cycle and
!!sterial Safety FR0!i:
G.
syne Kerr. Director Office of State Prograns PROF 0 SED REVIS1010F 10 CFR PART 35 St3 JECT:
The effort to revise Part 35 so as to provide for a clear and consolidated set of requiracnts for human use of byproduct cateriel is ccacndable.
Also, we agree with the appr%ach of toving away frou the " customized" We see review toward a c. ore standardized method for ecdical licensing.
no decrease in health and safety provided the entire systen as described-
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We feel that since the preevaluation of in the paper is icplccented.
applicant's equipcent and procedures will be eliminated, it is essential ~
.I that there be an early inspection ~of such licensees to identify aryTh
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significant safety probicas. safety (cature of the regulatory program a y,
In keeping with needed and the icportance of having them available.
what we understand the LRC philospty for regulations to be, we suggest Dctailed that the regulations state performance cbjectives to be cet.
procedures or specifications for testing the objectives, such as how surycy instrucents are to be calibrated, should be addrcssed in regulatory s,'.
Ve have several coments regarding the proposal uhich are prov e
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in the enclosure to this cerorandum.
Since the Part 35 addressed in the raper, we are prepared to concur. revision relates Sta tes.
take it a catter of ccupatibility with the Agreetent l
The prcposed revision has been sent to the Acreccent States for coment.
He expect that the consensus opinion of the Agrept.cnt States will be y
negative because of the shif t from a custom review of each applicatfor(-
N prior to the issuance of a license, to an increased cupshsis on review Uc will continue to fj of base progran data during on-site inspections. provide you
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k D1'istna1 ag n,a y,
g g Wayne r,,,.
G. Wayne terr. Director Office of State Progra:ts Enclosure-As stated 4
4 g92g450850906 35 50FR30616 PDR
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Comm*nts/Qurstions on th? Proposed Ravision of 10 CFR Part 35 r
l 1.
Page 12 of Enclosure 1 It is anticipated that the revision of Regulatory Guide 'l0.8 for medical programs will contain at least one procedure acceptable to the Commission for meeting each of the requirements in the proposed regulations for human use.
It is proposed that licensees who wish
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to use alternative, but equivalent, procedures may do so at their own discretion.
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Comment We believe that alternative procedures should be submitted for review and incorporated into the licensee file.
This would insure that serious consideration was given to such procedures, whether by the licensee or by a consultant.
We feel that too much confidence is being placed on the licensee's discretion.
2.
Page 12 of Enclosure 1 L
Since procedures would no longer be submitted to NRC for review
.... this simplification will permit licensees to modify procedures L
used by their professional staff to meet NRC requirements without
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obtaining a licensee amendment.
Comment L
As noted above, too much is being left to the licensee's discretion.
l The submittal of data will, in our opinion, insure that proper attention is paid to the modification of procedures.
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3.
Page 7 of Enclosure 3, (1) (f) l.
An early on-site inspection of the facility and program for new licensees would be performed by licensing personnel.
Questions l
The above statement needs amplification for the reader to understand i
how the new system will work.
For example, will early on-site
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inspections be performed for all new applications and amendments involving major program changes? What is the timing for these t
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inspections? How early are we inspecting? Will the financial and personnel resources of the Commission and the regions be able to support these extra inspections? We also feel that the staff paper r
should include a cost analysis on the effect of this revision on the materials inspection program f
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Enclosure
4.
Page 41 of Enclosure 1, (a)(1)
Coment Membership of the radiation safety comittee lacks a representative of the nursing staff. This point was covered in the Notice of Final Rulemaking to amend 10 CFR Part 35.11(b), which we concurred in on May 26,1982.
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