ML20141J082: Difference between revisions

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4' 4 -
From: "Barry Siegel" ("SIEGELB9MIRLINK.WUSTL.EDU")
To:      . sxs49nrc. gov                                                  r
              -Date: Wednesday, June 7, 1995 11:56 pm
 
==Subject:==
.    .#164# 35.75 (SMTP-Id#: 57852) 16 @    [b $
Stewart:
1.have reviewed the FRN you sent this afternoon, and still have a few comments / concerns / questions.
: 1. First, referring to my e-mail note of 3 June, I am still not certain why the " annual" and " single-administration" modifiers of the dose limit have been
              . eliminated in the current draft (bby comparison with the 20 April draft).
: 2. In several- placas, the FRN refers to the existing release criterion of a measured dose rate of less than 5 millirems per hour at a distance of one meter. I don't have a copy of Part 35 at home (which is where I am writing.
this) to check to see what the current rule actually says, but shouldn't this be in units of milliroentgens (mR), since that is what is actually being                          jm _
measured.                                                                                                  i
: 3. The section title "RECORDKEEPING FOR ADMINISTRATIONS AB0VE 1.MILLISIEVE T                      4M (0.1 REM)" would be more accurate if:it were "RECORDKEEPING FOR                                -
Qinh-l              ADMINISTRATIONS RESULTING IN DOSES ABOVE 1 MILLISIEVERT (0.1 REM)".                                          [
: 4. In the Discussion of the Final Rule Text, there is the following paragraph"                        '
L "In the case of breast-feeding women where the dose to the infant is likely to exceed 1 millisievert (0.1 rem), there is no specific requirement. to maintain a record indicating that breast-feeding status was determined prior to the release of the patient. However,:the NRC would find it acceptable to demonstrate compliance with the requirement to provide instructions if the                                    4 determination of breast-feeding status is made part of the licensee's procedural routine-for patient release."
l Doesn't.this second statement constitute the indirect introduction of a new regulatory requirement by way of the Statements of Consideration?
Alternatively, is-it assumed by NRC that in order for. licensees to comply with
                #164# 35.75 (a) and #164# 35.75-(d), they obviously have to develop procedures                                .t to-determine whether female patients are breast-feeding?
      % 5.          .When will-the new draft RG be available?                    I would very much like to review it.
p g 4 gg ,
: 6. Have you given any thought yet to comments #7 and #8 in my 3 June note (regarding NARM and written breast-feeding instructions, respectivvely)?
BAS CC:            jeg9nrc. gov >, " Larry W.-Camper" <lwc0nrc. gov >,                  ...
  ~ (f 9700140373 970007 PDR    PR 20 62FR4120                                    PDR  u 9Go%l4CN            Odi
 
y,- h , s ' Ch m ts NC Gnwdw .
(t/G% tkoopa A-i c<cc sa ,1,s                &
O O}}

Latest revision as of 00:40, 22 July 2020

Submits Comments,Concerns & Questions Re FRN Review
ML20141J082
Person / Time
Issue date: 06/07/1995
From: Siegel B
NRC
To: Stewart Schneider
NRC
Shared Package
ML20007J296 List: ... further results
References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-017, AE41-2-17, NUDOCS 9708140373
Download: ML20141J082 (1)


Text

._ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ ____ _ _ _

4' 4 -

From: "Barry Siegel" ("SIEGELB9MIRLINK.WUSTL.EDU")

To: . sxs49nrc. gov r

-Date: Wednesday, June 7, 1995 11:56 pm

Subject:

. .#164# 35.75 (SMTP-Id#: 57852) 16 @ [b $

Stewart:

1.have reviewed the FRN you sent this afternoon, and still have a few comments / concerns / questions.

1. First, referring to my e-mail note of 3 June, I am still not certain why the " annual" and " single-administration" modifiers of the dose limit have been

. eliminated in the current draft (bby comparison with the 20 April draft).

2. In several- placas, the FRN refers to the existing release criterion of a measured dose rate of less than 5 millirems per hour at a distance of one meter. I don't have a copy of Part 35 at home (which is where I am writing.

this) to check to see what the current rule actually says, but shouldn't this be in units of milliroentgens (mR), since that is what is actually being jm _

measured. i

3. The section title "RECORDKEEPING FOR ADMINISTRATIONS AB0VE 1.MILLISIEVE T 4M (0.1 REM)" would be more accurate if:it were "RECORDKEEPING FOR -

Qinh-l ADMINISTRATIONS RESULTING IN DOSES ABOVE 1 MILLISIEVERT (0.1 REM)". [

4. In the Discussion of the Final Rule Text, there is the following paragraph" '

L "In the case of breast-feeding women where the dose to the infant is likely to exceed 1 millisievert (0.1 rem), there is no specific requirement. to maintain a record indicating that breast-feeding status was determined prior to the release of the patient. However,:the NRC would find it acceptable to demonstrate compliance with the requirement to provide instructions if the 4 determination of breast-feeding status is made part of the licensee's procedural routine-for patient release."

l Doesn't.this second statement constitute the indirect introduction of a new regulatory requirement by way of the Statements of Consideration?

Alternatively, is-it assumed by NRC that in order for. licensees to comply with

  1. 164# 35.75 (a) and #164# 35.75-(d), they obviously have to develop procedures .t to-determine whether female patients are breast-feeding?

% 5. .When will-the new draft RG be available? I would very much like to review it.

p g 4 gg ,

6. Have you given any thought yet to comments #7 and #8 in my 3 June note (regarding NARM and written breast-feeding instructions, respectivvely)?

BAS CC: jeg9nrc. gov >, " Larry W.-Camper" <lwc0nrc. gov >, ...

~ (f 9700140373 970007 PDR PR 20 62FR4120 PDR u 9Go%l4CN Odi

y,- h , s ' Ch m ts NC Gnwdw .

(t/G% tkoopa A-i c<cc sa ,1,s &

O O