ML20141J078
| ML20141J078 | |
| Person / Time | |
|---|---|
| Issue date: | 06/05/1995 |
| From: | Siegel B NRC |
| To: | Stewart Schneider NRC |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-016, AE41-2-16, NUDOCS 9708140368 | |
| Download: ML20141J078 (3) | |
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![ 44 9a wsmt bumms Wh{ % s 4/ S From: "Barry Siegel" ("SIEGELB@MIRLINK.WUSTL.EDU") ; l' V ' To: .. - ,. sxs49nrc. gov (
- Date: Monday,rJune:5;31995 ml0:50,amc
Subject:
" -FW: Proposed 35.'75 (SMTP so#: 54219) , Did you receive? BAS "- l i l To: Stewart Schneider i Cc: John E. Glenn; Larry W. Camper From: Barry Siegel on 3 Jun 1995 15:25
Subject:
Proposed 3S.75 Stewart: I have a few concerns with the proposal (and with some of the associated > material in ths RG) for-your consideration. 4
- 1. In the 20 April draft, #164#35.75(b) included the phrase "in a year from a single administration" as a modifier of TEDE. Why was th t phrase eliminated in the 1 June draft?+ mWW co W h m m 4.r+Cms
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- 2. When I noticed the change above, it also became obvious to me that the "in 9 b9@ b a year" modifier is missing throughout #164#35.75; sho ldn't it be included -
explicitly? 7taoE a ls, o- i ep t hs, A vh 04 cc \ h wAT 50yh. u m M m W CNmb (' 3. 'In #164#35.75(c), the new language refers to "... authorizing the release if ( N the N administered Rt ty it in excess..." Consider a hypothetical situation where the administered ac is too much to permit Jamediate release under any circumstances and the pat is confined ov3rnight. The next day the patient is released based on a measure of to arbody activity, but still has more retained activity than would be al for release based on conservative assumptions. In this case the re se eQtes to calculations performed on the basis of RETAINED activity ra r than on t asis of ADMINISTERED activity. Does the phrase in questio eed to be altered " ... authorizing the release if the administered ac ty (or the retained act at the time of release) is in excess..."??? ' t
- 4. The table distributed at the ACMUI Meeting includes confusing information regarding instructions for patients who are breast feeding and regarding the need to interrupt breast feeding. I think the table should include the .
following columns for each entry: 4 g 4, d t J s Leilo 6 % c)w & j
- a. Radiopharmaceutical
- b. Dose to infant per mci administered to mother if no interruption of breast feeding.
- c. Maximum administered dose for infant dose of 100 mrem if no interruption of breast feeding. -(Threshold for requiring instructions) m
-l i d. Maximum administered dose for infant dose of 500 mrem if no interruption V of breast feeding. (Threshold for requiring cessation or interruption) 9708140368 970807 PDR PR 20 62FR4120 PDR &
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v [ ) e. Usual administered dose for a particular diagnostic or therapeutic v procedure,
- f. Instructions required (because dose >100 mrem)? (Yes or No)
- g. Period of interruption REQUIRED to maintain dose <500 mrem?
- h. Period of interruption RECOMMENDED to maintain dose <100 mrem?
If this seems too confusing, could break into two separate table consisting of (a) through (d) and of (a) + (e) through (h), respectively.
- 5. The final column in the current breast-feeding table is confusing because it is based on interrupting to keep the dose below 100 mrem. This certainly is ALARA, but not necessarily good medicine and not required by the intent of revised #164#35.75. Hence both columns (g) and (h) recommended above are needed in the table.
- 6. The total number of records related to breast feeding following diagnostic nuclear medicine studies is an imponderable number, but could be large. Thus the record-keeping bursen could be substantial. Hence, I am curious to know
' what type of record you have in mind in #164#35.75(d). In the case of something
iat requires a written directive, it will be relatively easy to modify the written directive form to indicate that the issue of breast feeding has been ,&
addressed, that instructions have been given, and that cessation of breast pN q i i feeding (or interruption for some specific period of time) has been recommended // to the patient by the authorized user. Ideally, similar information also will'
'd be recorded in the medical record by the prudent physician. In the case of'a study for which no written directive is required, but which could require i interruption tg kqep the dose <500 mreq, was it your notion that some new form
! Would W b T de u t A l' d A / W U lo ( b N d [ f N / , / Y havetobecreatedandstoredforeasy[etrievaltoallowforNRCinspectio (6-Alternatively, the physician could make the record as part of the diagnostic report, but it would be much harder for NRC to find these records (e.g., need &6 to review 10,000 reports to find 4 or 5 such circumstances). -h mig y( In the final analysis, I am quite uncertain exactly how NRC proposes to use D4% these records as an inspection or enforcement tool. Except for the I-131 catastrophes, which very likely would come to light on their own, NRC really has no way of ever knowing if a patient who was breast-feeding got a dose of a y 'I radiopharmaceutical for which instruction or interruption was required, but not done. This might lead the overly cautious regulator to the " logical" 04td. conclusion that a signed statement must be obtained from every woman undergoing a nuclear medicine procedure (and maintained for NRC inspection) attesting to the fact that she is not breast feeding (and, next " logical" conclusion, that she is not pregnant--better yet, you could require a pregnancy test!!!). Sarcasm aside, I remain most troubled about this component of the rule. Since bM compliance depends so much on licensees' honest efforts to attempt to identify,A o' p) theat-risksubjects(buttheeffectivenessoftheseeffortsisnotlikely)why be measurable by NRC without a major escalation in the regulatory burden), ( not drop the record requirement related to breast feeding (except possibly for O' those radiopharmaceuticals that require a written directive) and inspect to see _ _ _ _ _ _ _ _ ~
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N that licensees ha radehiiHe procedures to protect breast fed infants?? For example, the inspector could look to see what kinds of signs are posted in the [N d p' department, could ask the technologists whether they routinely ask female patients about breast feeding, and could review the written instructions given to those breast feeding patients identified. (If you read between the lines, you'll realize that what I am in part saying is that the cart has gotten before the horse--we reall'y needed the pregnancy and breast feeding rule already completed or being developed in tandem with the breast feeding component of 4
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I presume the table will need to show for the NARM 'radiopharmaceuticals that the information is being provided for the ben'efit'of 1.icensees (as part of the spirit of ALARA), but there is no requirement to! follow (#164#35.75 for these }Q$ radiopharmaceuticals?? Qcp ((y g i 8. Theexistingpatient-instructionpamphlets(whichweredesignedwithI-lbP T "in mind and, thus, indicate that breast feeding must be terminated) do not S adequately address the breast feeding instruction / interruption issue. Should
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NRC in the RG) be to developing fill this void? a pamphlet or suggested instruction 5 language (fo I thought this was going to be a brief note, but it has turned into a treatise. I hope you find my comments helpful. f Did you solicit input from any other ACMUI members? If so, I would like to see their comments. If not, I suggest that it would be valuable to send the 1 June draft rule, along with my comments, to several members of the Committee. At p(V! the least, I would send to Swanson and Wagner (who unfortunately is on (*, _ vacation, which may conflict with your time requirements). Barry owd A Go M wcw,w ,pu3.q% a at su a eta p +budq , be ed f%sg Nik ne% S
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