ML20137R777
| ML20137R777 | |
| Person / Time | |
|---|---|
| Issue date: | 04/11/1983 |
| From: | Walker B NRC |
| To: | Rehm T NRC |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230645 | |
| Download: ML20137R777 (7) | |
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l'ote to Tom Rehm RESPO!:GE TO C0::'ISSI0l:ER AHEAR!!E OI: SECY 03-02, PROPOSED REVISIO!! 0F
- PART 35 "HUI'AN USE OF BYPRODUCT l'.ATERIAL"
'I an enclosing, as suggested, text for a memorandum to the Co.T.fssioners' Assistants for fort:ctding our brechdcun chcrt on Part 35.
I personclly delivered a copy to Kate Bissell, Jim IMDermott and Spiros Droegitis on April C,1503. If you have any questions or if the Commissioners' Assistants have ar.y questions, I will be pleased to discuss them.
l Bill 1.'alker i
i Enclosurc: As stated t
1 8509230645 850906 PDR PR 35 50FR30616 PDR c 4 c c >-
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MEMORANDUM FOR: Roxanne Goldsmith, Program Analyst, OCM
-Maria Lopez-Otin, Special Assistant, OCM FROM: Thomas Rehm, Assistant for Operations, EDO
SUBJECT:
SECY 83-62, PROPOSED REVISION OF PART 35 " HUMAN USE OF BYPRODUCT MATERIAL" In response to SECY 83-62, proposed revision to Part 35 " Human Use of Byproduct Material", Commissioner Ahearn requested a breakdown of additions, deletions, etc. contrasting existing regulations with the revised Part 35. This was the information Kate Bissell requested at the March 7,1983 briefing with William Walker, NMSS and John Klucsik, ELD.
A copy of the breakdown is attached for your information. William Walker is available to answer any questions you may have about the s . chart. His extention is 74052. .
Thomas Rehm Assistant for Operations, EDO
Enclosure:
As stated
ad 37 dj Changes Made in the Proposed Revision of Part 35 This table first describes the content of major paragraphs in the current Part 35 and the reason for retaining or deleting each one. Then other major source documents are treated in a similar manner.
The following abbreviations are used:
A added in the proposed revision D deleted in the proposed revision C. clarified, frequently with modification, in the proposed revision AU Authorized User RSO- Radiation Safety Officer T&E training and experience Bi'M byproduct material SL; standard license condition; a license condition in'cluded in many licenses RG Regulatory Guide App Appendix
Topic Current Proposed Why the Change was Made A definitions 35.3 35.15 expanded human use and physician clarified Physician, podiatrist, added dentist, mobile service, visiting AU D adequate facilities 35.lle medical care, not radiation safety D hospital access 35.12a 3 medical care, not radiation safety C adequate T&E 35.12a4 35.900, .910, clarify " adequate"
.920, .930,
.940, .941,
.950, .960 C private practitioner in 35.12b2 35.35, .80 redefined as mobile service an institution D institutional clients 35.12b3 more flexibility to hospitals for alternate service suppliers C adequate T1E 35.13b 35.940, .941, clarify " adequate"
.950,.960 D adequate instrumentation 35.14a4 implicit in use and measure-ment requirements C adequate procedures 35.14a5 35.50., .51, clarify " adequate"
.53, .59, .60,
.61, .62, .63,
, .70, .75, .80, l
.90, .92, .204,
.205, .304, l
.404, .405,
.610, .620,
.622, .641,
.642, .645 l
D opening applicator cells 35.14b5ni not allowed by package instructions
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Topic Current Proposed Why the Change was Made t
l D chemical form of radio 35.14b61 " chemical" deleted; would radiopharmaceuticals be a new radiopharmaceutical D facit in vitro license 35.14c line item added to application (31.11)~~ form C teletherapy expert T&E 35.24b 35.961 clarified " minimum" D training expection 35.242 may apply under 35.29 D general in vitro license 35.31 35.100 safety measures similar to those for current 35.100(a)
Group I C uptake dilution excretion 35.100 I 35.100 I-125 as oleic acid or sodium radiopharmaceuticals iothalamate deletion-not used C imaging radiopharma- 35.100 II 35.200 Ag-203 as chlormerodium ceuticals deleted-high patient dose C imaging radiopharma- 35.100 III 35.200 added generators for ceuticals and generators extraction (currently omitted)
A brachytherapy 35.100 VI 35.400 added Ix and Ta wire used in Europe and under US broad license A diagnostic sealed scurces 35.100 VI 35.500 broken from 35.100 VI because hazard, worker dose, AU T&E are different A teletherapy not listed 35.600 makes for complete listing of normal authorized BPM C Mo-99 in Tc-99m 35.14b41ii 35.204 consistency with United States pharmacopeia A Decay-in-storage license 35.92 minimize unnecessary disposal condition by burial C teletherapy timer accuracy 35.21b 35.632b4 & 5 clarify " accuracy" A mobile service client NMSS checklist item 3 35.35b avoids unwanted use of BPM management authorization mobile instrument check NMSS checklist item 5 35.80d ensures instruments are
! working before handling BPM mobile closeout survey NMSS checklist item 6 35.80e ensures that: BPM has not been left behind mobile secure the material NMSS checklist item 7 35.80c ensures curious client employee won't carry off BPM
Topic Current Proposed Why the Change was Made A dosage measurement PRM and 35.53 avoid unnnecessary patient 35.41, .43 dose B syringe and vial shields I&E bulletin 35.60, 35.61 reduce worker exposure A AAPM teletherapy petition 11 35.630 calibration labs can't meet
, instrument calibration 4yr. interval demand, instrument time is L lost in transit, instruments shouldn't be shipped A 12 intercomparisons must be supervised 35.630 ensures that a qualified individual oversees the calibration l 0 13 constancy check currently available constancy check sources are not sufficiently precise over long periods A 14 records 35.630 specifies record retention
! requirement A leaking sealed sources 35.14e 35.59e expands requirements to all sealed sources possess by licensee A release of radioactive SLC-53 35.75 current SLC expressed in mci patients inpatient can't be measured.
mR/hr 0 1m can be measured, is more relevant A visiting authorized user SLC-62 35.34 allows full time and emergency coverage C patient observation during SLC-65 35.622 establishes performance treatment criterion A . radiation and safety SLC-70 35.641, .42 minimize worker and public surveys for new tele- exposure, check safety devices therapy units A changes in teletherapy SLC-71 35.606 minimize worker and public facility exposure C teletherapy applications draft tele- 35.606 clarify " adequate" information therapy RG 4.14 A amendments draft tele- 35.17 & .606 specify when an amendment therapy RG 5. is needed