ML20141J091
| ML20141J091 | |
| Person / Time | |
|---|---|
| Issue date: | 07/27/1995 |
| From: | Siegel B NRC |
| To: | Stewart Schneider NRC |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-020, AE41-2-20, NUDOCS 9708140385 | |
| Download: ML20141J091 (6) | |
Text
_ _ _ _ _ _ _ -
FrE-hlI-b i/^s From: "Barry Siegel" ("SIEGELB9MIRLINK.WUSTL.EDU")
\\b)
To:
sxs49nrc. gov Date: Thursday, July 27, 1995 5:52 pm
Subject:
Patient Relea.se Criteria -(SMTP Idf: 52215)
Stewart: The 35.75 language you sent me today is acceptable.
I have some minor concerns with the clarity of (c)(1), about which I left you a voice-mail message. Also, (a) is worded a bit awkwardly, but I'm not sure how to fix.
BAS CC:
lwc9nrc. gov l-VOICE MAIL FROM BARRY A. SIEGEL (Received'after e-mail message) 1.
Language is quite fine.
2.
However, some of the grammar is odd.
K Paragraph "a" text is awkward. No Ch e $ bM d
40 W O c h m ed fA M (3 Paragraph "c" text is not clear.
Specifically, "blologica17r effective half-life" or " factor that considers shielding by tissue"p gb,% a is unrelated to the preceding phrase on " occupancy factor" and may(
(
be related to the other than, so you might want to separate each of L these items as subitems in the paragraph or use ";" to show clearly
~
they are absolutely distinct.
(x 9708140385 970807 20 6 4120 PDR L
ene(ans
P DP-
/9614// c;L i
f ORM 386 U.S. NUCLEAR REGULATORY COMMCSION DATE I
'b 3
pg fqq -
TELECOPlER TRANSMITTAL TIME h '. DM fW) 1 WARNING: fAost facsimile machines produce copies on thermal paper. The Image produced is highly
)
unstable and will deteriorate significantly in a few years. Reproduce copies onto plain paper prior to filing as arecord.
l 10 l
T ELEPHONE NAM k 3
A / [v')
Jt C g o NAME AND LOCATION OF COMPANY (If other than NRC) fbl.d.//NCll1j'[a/~)[
.()
CJ h < gc3 911, W1, M o.
d,),
TELECOPY NUMBER VERIFICATION NUMBER
]L 3hl-bb FROM NAME TELEPHONE MAIL STOP
&QW DLY EL 64 /V Q \\ r) "V L ff a j l{ /[
(, ?7 i TELECOPY DATA NUMBER OF PAGES PRIORITY IMMEDIATE THIS PAGE +
PAGES =
TOTAL OTHER (Specify)
SPEC %L INST RUCTIONS g th 4 / t' V}
jMO s d q con ") (ornnodi pn WGg Uy,
')(A fd c'h
-k h4 Cl 1(/v f
([h
- C@ \\h zu
& acnA % p,. c
,4
}u& e yd
( c le n s c y w %,;y (gv7h 4A
%ng PROBLEMS DISPOSITION OF ORIGINAL If Cny problems occur or if you do not recewe all the pages, call:
After telecopy has been sent, process the original as requested below. (W none are checked. the original will be discarded)
RETURN TO SENDER EPHONE CALL AND SENDER WILL PICK UP DISCARD PROCESSED BY (INf7JALS)
VtERIFIED BY (INmALS) mig FOEN 386 (12 02)
PHINTED ON 5(CYCLCD PAPLR
n.,-
' C' requested by the licensee on a case-by-case basis under i 35.19 "
exemptions."
RECO'RDKEEPING l
The strongest opposition to the proposed rule was to the proposed i
requirement to maintain a record of the released patient and the calculated total effective dose equivalent to the individual likely to receive the highest dose if the dose to that person is likely to exceed 1 mil 11 sievert I
(0.1 rem).
Under the proposed rule, if a patient had or might have had one or more administrations within the same year, it would be necessary for the licensee to use the records to determine the dose from the previous administrations so that the total dose to an individual exposed to a patient from all administrations would not exceed 5 millisieverts (0.5 Comment.
Many commenters indicated that this requirement would cause excessive costs in time, effort, and money to track down records of previous i
administrations, to perform calculations, and to keep records of all the wor and asked that the requirements to make calculations and keep records be removed.
The commenters believed that the work would not produce an increased level of safety, that the NRC greatly underestimated the cost, and that the recordkeeping would be unnecessary, inappropriate and-impractical.
Some commenters said that multiple administrations that would result in a total
. effective dose equivalent greater than 1 mil 11 sievert (0.1 rem) are not don to the same patient routinely. Other commenters said that there are decad es of experience unencumbered by any paperwork burden at all with no evidence
((
18
num W 1
/
("/that a lack of paperwork has resulted in any additional problems.
One commenter said that if 0.5 rem is acceptably safe, why have the 0.1 rem level with all the documentation required.
Another commenter said that it cannot be the licensco's responsibility 4
to know the details of a radionuclide therapy performed by another licensee in i
iIi terms of which members of the public rnci*ta the most radiation dose due to that other licensee's therapy procedure.
One commenter said that the excessive recordkeeping cost would be a nonreimbursable cost and the burden will cause many physicians to stop offering iodine therapy and force patients to travel to large medical facilities in cities and cause problems with patient access in sparsely i
p:pulated areas.
(O Response.
Upon reconsideration, the NRC has decided to delete the W e)quirement to keep records when the dose to the most highly e j
individual-is likely to exceed 1 mil 11 sievert (0.1 rem). The requirement was proposed so that it would be possible to account for the dose from multiple administrations in the same year to assure that the total dose to an individual exposed to the patient did not exceed 5 millisieverts (0.5 rem).
The NRC hac an advisory committee (the Advisory Committee on the Medical Uses of 120 topes or "ACHUI"), which advises the NRC on rulemakings and other initiatives related to the medical use of byproduct materials.
The NRC also hts a visiting medical fellows pregram that recruits selected physicians or s
pharmacists to work for the NRC for a period of 1 to 2 years.Both the ACMUI k
and the current Visiting Medical fellow, Myron Pollycove, M.D., provided advice to the NRC during the development of this rule.
In addition,
,Os 19
' il
r+8*EL > at4Welf8*NA arry A. Siegel, M.D., Chairman, ACMUI, reviewed the patient records at his medical facility for the 1-year period from July 1, 1993 to June 30, 1994 (Hallinckrodt Institute of Radiology, St. Louis, Missouri).
Urs. Siegel and Pollycove concluded that no routine nuclear medicine practice, be it 1
1 diagnostic, therapeutic, or a combination of the two, results in multiple l
large administrations that would be likely to cause the 5-mil 11 sievert j f (0.5-rem) dose limit to be excLeded because of multiple administrations in a a
10 year.
i c While the proposed requirement to maintain a record of the dose to l
another individual if the dose is likely to exceed 1 mil 11 sievert (0.1 rem)
{
has been deleted, a recordkeeping requirement with a reduced impact has been retained as discussed under the heading, "VI. Discussion of final Rule Text."
Comment. Several commenters said that those who pay for health care will put great pressure on physicians to optimize calculations to reduce i
in-patient days and to justify out-patient treatments.
U sl l
Response. There is no objection to optimizing calculations to reduce in-patient days as long as the 5-mil 11 sievert (0.5-rem) limit in 10 CFR 35.75
_1 1
is met.
Regulatory Guide 8.39, " Release of Patients Administered Radioactive l_
Materials " describes examples of calculations that are acceptable to the NRC.
.i
)
d 20 Attachment I f
TRANSMISSION REPORT 08.18.1995 17:08 HRC-PESDR4/RPHEB m
DHTE 11NE DukA130H REM 01E ID MODE PAGES RESUL1 08.18 17886 92'19" 13143622806 G3 e
0.6.
l l
l f
i o
...