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Two other states, as well as the NRC's own Advisory Committee o the Medical Uses of Isotopes ( ACMUI), recommended keeping the 30-D f | Two other states, as well as the NRC's own Advisory Committee o the Medical Uses of Isotopes ( ACMUI), recommended keeping the 30-D f | ||
, millicurie limit for all radiopharmaceuticals, not just 1-131. And as tl notice of proposed rulemaking did mention, 21 Agreement States, meeting in 1992, recommended keeping the 30-millicurie limit for I-131 while relaxing it for other radiopharmaceuticals. TM Finally, it will be recalled that Dr. Carol Marcus, the author of one of the petitions before the NRC, originally proposed retaining the 30-millicuriu standard for I-131, but climinating it for all other radiopharmaceuticals.' In a November 9,1992, letter to the docket, kgb she used the word " ludicrous" to describe the contention of the American College of Nuclear Medicine that doses of 400 millicuries of ('(itd I-131 could safely be administered on an outpatient basis, pqd t | , millicurie limit for all radiopharmaceuticals, not just 1-131. And as tl notice of proposed rulemaking did mention, 21 Agreement States, meeting in 1992, recommended keeping the 30-millicurie limit for I-131 while relaxing it for other radiopharmaceuticals. TM Finally, it will be recalled that Dr. Carol Marcus, the author of one of the petitions before the NRC, originally proposed retaining the 30-millicuriu standard for I-131, but climinating it for all other radiopharmaceuticals.' In a {{letter dated|date=November 9, 1992|text=November 9,1992, letter}} to the docket, kgb she used the word " ludicrous" to describe the contention of the American College of Nuclear Medicine that doses of 400 millicuries of ('(itd I-131 could safely be administered on an outpatient basis, pqd t | ||
p9_, . | p9_, . | ||
In short, the concerns that I was expressing about I-131 in October 1992 turn out to be utterly mainstream: standard conservative practico. | In short, the concerns that I was expressing about I-131 in October 1992 turn out to be utterly mainstream: standard conservative practico. | ||
| Line 1,541: | Line 1,541: | ||
In my earlier comments, I also pointed out that anyone who has been treated with a therapeutic dose of I-131 is already severely hypothyroid (by design), and that this condition may impair the person's ability to follow safety guidelines for the protection of family members and other members of the public. (Judith Brown of ACMUI raised essentially the same issue in a 1992 ACMUI discussion of the proposal, when she asked how patients felt after receiving a treatment. ) This comment also was not dealt with in the notice of proposed rulemaking. | In my earlier comments, I also pointed out that anyone who has been treated with a therapeutic dose of I-131 is already severely hypothyroid (by design), and that this condition may impair the person's ability to follow safety guidelines for the protection of family members and other members of the public. (Judith Brown of ACMUI raised essentially the same issue in a 1992 ACMUI discussion of the proposal, when she asked how patients felt after receiving a treatment. ) This comment also was not dealt with in the notice of proposed rulemaking. | ||
Nor was there any response to my suggestion that although the NRC staff was justifying its proposal on grounds of the supposed psychological benefit to patients and their families, it might be more comforting to patients to know that they were minimizing the radiation | Nor was there any response to my suggestion that although the NRC staff was justifying its proposal on grounds of the supposed psychological benefit to patients and their families, it might be more comforting to patients to know that they were minimizing the radiation | ||
* I gather from Dr. L rcus's July 11, 1994, letter to the docket that her position on this point may since have changed. In case I have misunderstood her | * I gather from Dr. L rcus's {{letter dated|date=July 11, 1994|text=July 11, 1994, letter}} to the docket that her position on this point may since have changed. In case I have misunderstood her | ||
) views, however, I suggest that the NRC and other interested persons read her aubmissions for themselves. | ) views, however, I suggest that the NRC and other interested persons read her aubmissions for themselves. | ||
i l | i l | ||
Latest revision as of 10:04, 12 December 2021
| ML20141J113 | |
| Person / Time | |
|---|---|
| Issue date: | 11/29/1995 |
| From: | Siegel B NRC |
| To: | Stewart Schneider NRC |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-024, AE41-2-24, NUDOCS 9708140405 | |
| Download: ML20141J113 (135) | |
Text
{{#Wiki_filter:- __ _ __ _ __ - _ . A G '//-O - I ,') From: Barry Siegel <siegelb@mirlink.wustl.edu> V To: Stewart Schneider <sxs4@nrc. gov > Date: 11/29/95 3:44pm
Subject:
RE: Patient Release Rule i j Any reactions to my message from Saturday? BAS
)
From: Barry Siegel on 25 Nov 1995 11:19
Subject:
Patient Release Rule To: Stewart Schneider Cc: Josephine M. Piccone; Larry W. Camper Stewart: i I have reviewed the draft Commission Paper you sent to me by fax on 11/21. I offer the following comments.
- 1. The document indicates, on page 5, that the ACMUI objected to the word
" consequences" largely because explaining the " consequences" of low dose radiation (e.g., from Tc-99m radiopharmaceuticals) "cannot always be explained
- to the patient without causing unjustified alarm." Further, the document i indicates that ACMUI felt that " . . . physicians cannot explain with certainty the effects of low doses of radiation . . ."
This is a misstatement of the ACMUI position. Our principal concern is that there is NO SCIENTIFIC EVIDENCE to support a discussion of consequences from
/ ,N doses in the range from 100 to 500 mrem. The ACMUI strongly believes in
(~ / maintaining exposures ALARA, but not because there are documentable consequences to INDIVIDUAL subjects of failure to do so. The word " rationale" allows the physician to discuss ALARA practices without ever implying that there will be consequences from many of these potential exposures (I-131 excepted, of course) if the patient chooses to ignore the physicain's instructions. I suggest you follow the ACMUI's recommendation.
- 2. The ACMUI did not finally recommend deleting the phrase " . . an activity other than the activity administered." We made that initial recommendation on the first day, but then changed the recommendation on the second day after reviewing the draft regulatory guide, and recommended that the phrase should be
. . . the retained activity rather than the activity administered." The staff plan to use the phrase " . . . less than the activity administered" is potentially acceptable, but is not nearly as explicitly clear as the ACMUI recommendation. As I pointed out at the meeting, the "less than" phrase theoretically allows me to release a patient if I say to myself "let's pretend I only gave this patient 15 mci instead of 150 mci." This is patently ludicrous, but is incorporated with the staff's less explicit wording. I suggest you follow the ACMUI's recommendation as being the scientifically more precise way to say what NRC intends.
These recommendations are well explained in the minutes of the last ACMUI
, meeting.
i n. ('") I will be out of town until Wednesday 11/29, but will be back in my office that afternoon if you have any questions. 9700140405 970807 PDR PR 20 62FR4120 PDR Ct GD%lMC5 '" h
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4 PATIENT RELEASE 10 CFR Parts 20 and 35 u O Agreement State Mmger's Workshop 37 1 rysz 199<
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e Status
/ Proposed rule issued June 15,1994 (59 FR 30724) l
/ Draft Regulatorv Guide. DG-8015, "Rel ease of Patients Administered Radioactive Materials," issued June 30,1994 (availability, 59 FR 30627)
/ NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Materials,"
issued May 1994
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- Major Provisions
/ Modify the application of the public dose limit in 10 CFR l
20.1301(a)(1) and (a)(2) to exclude the dose received from patients released under the provisions of 10 CFR 35.75
/ Modify 10 CFR 35.75 to specify a 500 mrem (5 mSv) annual Total Effective Dose Equivalent dose limit criterion for the individuallikely to receive the greatest dose Agreement State Manager's WMeop 39 uy n. im i
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- Major Provisions
/ Modify 10 CFR 35.75 to require that when the dose to an individual is likely to exceed 100 mrem (1 mSv) from any patient release:
> Licensees provide written information on methods for reducing the exposure ofindividuals
> Licensees keep a record of the release for 3 years Agreement Ssare Marunger's Workshop 40 jaar 1z.1994 u________ - - -
- - - --- .~ - - . .. . - - .
l 1 United States
,,,,,/ Nuclear Regulatory Commission i
- Major Provisions
/ Draft Regulatory Guide provides:
> Table ofradionuclides with activity needed to achieve exposures of 100 mrem and 500 mrem (1 mSv and 5 mSv)
> Acceptable methodology for calculation of case specific dose estimates
> Information on the acceptable contents of written information
> Information on records necessary to demonstrate compliance Agreement State Manager's Workshop $$ July 12,1994
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,,,,) Nuclear Regulatory Commission e Schedu!s
/ Comment period for the proposed rule, draft regulatory guide, and NUREG-1492 expires August 29,1994 Agreensent State Manager's Worts /wp O jury 12, g994 l
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/ Proposed rule issued June 15,1994 (59 FR 30724)
/ Draft Reaulatory Guide, DG-8015, " Release of Patients Administered Radioactive Materials," issued June 30, 1994 (availability, 59 FR 30627)
/ NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Materials,"
issued May 1994 July 11.19N
?
.p- ~s.,
f a , ,y United States
\,,,,fi Nuclear Regulatory Commission Major Provisions
/ Modify the application of the public dose limit in to CFR 20.1301(a)(1) and (a)(2) to exclude the dose received- from patients released under the provisions of 10 CFR 35.75
/ Modify 10 CFR 35.75 to specify a 500 mrem (5 mSv) annual Total Effective Dose Equivalent dose limit criterion for the individual likely to receive the greatest dose July IL 19N j
l . . - - m, __
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\,,,,,,} Nuclear Regulatory Commission Major Provisions
/ Modify 10 CFR 35.75 to require that when the dose to an individual is likely to exceed 100 miem (1 mSv) from any ;
l patient release:
> Licensees provide written information on methods for reducing the exposure ofindividuals
> Licensees keep a record of the release for 3 years 2dy IL 19N 4
l L .-
p* ~ % , i 1 United States
\,,,,,f/ Nuclear Regulatory Commission l
- Major Provisions
/ Modify 10 CFR 35.75 to delete the 5 miem per hour release restriction in 35.75(a)(1) and (b)
/ Modify 10 CFR 35.75 to delete the 30 mci patient release restriction in 35.75(a)(2) 1 3 9 n. m 5
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! , ~ ,g United States
\,,,,,,/ Nuclear Regulatory Commission
- Major Provisions
/ Draft Regulatory Guide published with the Proposed Rule
./ Draft Regulatory Guide provides:
> Table of radionuclides with activity needed to achieve exposures of 100 mrem and 500 mrem (1 mSv and 5 mSv)
> Acceptable methodology for calculation of case specific dose estimates
> Information on the acceptable contents of written information
> Information on records necessary to demonstrate compliance My IL 1m 6
- p. ~ m,,,
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\,,,,ll Nuclear Regulatory Commission Schedule l
/ Comment period for the proposed rule, draft regulatory guide, and NUREG-1492 expires August 29,1994 ,
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/ Comment period for the proposed rule, draft regulatory guide, NUREG-1492 expired August 29,1994 ,
/ Proposed rule. 52 comments
/ Draft Regulatorv Guide. 4 comments
/ NUREG-1492.1 comment 2 Sove= der R. IN
f ~~%.,, { s United States
\,,,,,,) Nuclear Regulatory Commission
- Major issues
/ Exclusion ofpatient release fmm 10 CFR 20.1301(a)
/ Activity-based vs. dose-base release limit
/ Release quantities
/ Recordkeeping for administrations ruove 100 mrem
/ Written instructions to patients 3 sera.krn.1m
l 1 United States Nuclear Regulatory Commission e Exclusion of patient release from 10 CFR 20.1301(a)
/ Almost all commenters appmve deletion from Part 20
/ Restore the 500 mrem dose limit for alllicensed activities (one commenter)
/ No exposure to a member of the public who has not consented freely to the dosage (one commenter, activist group) 4 separ ser 2s, sw L .. _ . . . _ .
p'~'N 4 l United States
\,,,,)1 Nuclear Regulatory Commission e Activity-based vs. dose-base release limit
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/ Maintain status quo of 10 CFR 35.75 (a number of commenters)
/ Dose-basedlimit willcause confusion andpotential problems; calculational approach requires MD to ask many personal questions (a few commenters)
/ One commenter said:
> Dose estimates would be inaccurate; unreliable method of predicting the time / proximity to others
> Increased cost of treatment due to calculation /recordkeeping
> Probably no significant decrease in radiation exposure 5 seremser2s. sm 1
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- Release quantities
/ Some commenters do not think release should be pennitted with quantities > 30 mci 6 saperusern, nn
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l
- Recordkeeping (summing dose) for administrations > 0.1 rem
/ The strongest opposition to the proposed rule (many ,
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/ Excessive costs in time, effort, and money to findprevious administration records
/ NRC underestimated the cost of record generation (many commenters) 7 samum
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- Written instructions to patients 4
/ Instructions do not need to be written, oralinstructions should be permissible (many commenters)
/ A major health maintenance organization strongly supported the requirement that the instructions be written
/ A sizable fraction ofpatients willnot behave as instructed (several commenters) 8 wn. Im
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United States
'%,,,,,/ Nuclear Regulatory Commission l
e Carol Marcus Comment Letter
/ Approves deletion from 10 CFR 20.1301(a)
/ Liked the dose-based approach and 500 mrem limit
/ Adamantly against dose records (cost burden)
/ Commented on the details of the calculational methodology 9 .sperneer n ,19 N
p ~ r,,
! 1 United States
\,,,,,) Nuclear Regulatory Commission I e Peter Crane Comment Letter
/ Approves deletion from 10 CFR 20.1301(a)
/ Maintain status quo of 10 CFR 35.75
/ Concerned about internal contamination if patients released with > 30 mci
/ Claims FRN misrepresented the opinions of the Agreement States and ACMUI 10 snn m eer n ,z m
~*g i
( 1 United States j
,,,,) Nuclear Regulatory Commission
- Suggested Changes
/ Finalrule
> Exclude requirement to keep a record of the dose for non-calculationalreleases 1
> Exclude requirement to sum dose from alladministrations over a year
> Permit oralinstructions l
11 s w n.Im
Mr United States ( ;
\,, ) Nuclear Regulatory Commission 1
- Suggested Changes
/ Regulatory Guide
> Review assumptions for methodology for calculation of case specific dose estimates
> Set parameters for calculated dose (e.g., exposure factor)
/ NUREG-1492
> Modify to exclude the cost of recordkeeping for non-calculationalreleases (i.e., thyroid ablation for hyperthyroidism,15-30 mci, 50,000 administrations /yr) n Account for physical and biological decay for duration of retention per therapeutic procedure (reduced hospital days) 12, serender28, im
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! 1 United States
*%,,,,,) Nuclear Regulatory Commission e Schedule ;
i i
/ Meet with NMSS September 29,1994
/ Meet with ACMUI Subcommittee during October 1994
/ Meet with ACMUI during November 1994 n en. zm
g; copa ff' ~'*%, e fd/b / United States l&wll.:Q Nuclear Regulatory Commission A S~~ N ~ D f PATIENT RELEASE 10 CFR Parts 20 and 35 39 1+mm, A Marnap's www &fc g c c 'q,/
- c. _ _ _ . - _ _ . - .__________ _______- __.______ _______________ _______ -_____- - __-__
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l United States
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- Status
/ Comment period for the proposed rule, draft regulatory guide, NUREG-1492 expired August 29,1994 x
/ Proposed rule. S comments
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/ NUREG-1492.1 comment w-s-u , waw to , ~ ru~
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e Major Provisions
/ Modify the application of the public dose limit in 10 CFR 20.1301(a)(1) and (a)(2) to exclude the dose received from patients released under the provisions of 10 CFR 35.75
/ Modify 10 CFR 35.75 to specify a 500 mrem (5 mSv)
Sn.ia?> Total Effective Dose Equivalent dose limit criterion for iWe individuallikely to receive the greatest dose
,n .,, u , wm a ~~rn. zm Ofi 4yO,
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/ Activity-based vs. dose-base release limit
/ Release quantities
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/ Written instructions to patients sa-s, , u an, wm 42 wum U#0 5'-:es'/
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- Activity-based vs. dose-based release limit
/ Large majority af commenters favored the 0.5 rem
\ dose-based limit
- Release quantities
/ Some commenters do not think release should be permitted with quantities > 30 mci
> Concern about the risks of contamination andinternal exposure to individuals
> 30 mCirelease limit proven safe and effective; no demonstrated reason to permit releases with larger quantities
.p ~, ! 1 United States \,. . ..O. Nuclear Regulatory Commission l
l e Recordkeeping (summing dose) for administrations > 0.1 rem l
/ The strongest opposition to the proposed rule
/ Excessive costs in time, effort, and money to findprevious administration records
/ NRC underestimated the cost of record generation
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*%,,,ff Nuclear Regulatory Commission l
l
- Status
/ Comment period for the proposed rule, draft regulatory guide, NUREG-1492 expired August 29,1994
/ Proposed rule. 55 comments
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/ Draft Regulatorv Guide. 4 comments
/ NUREG-1492,1 comment 2 mm. sm
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/ Written instructions to patients 3 wn. im
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i e Activity-based vs. dose-based release limit
/ Large majority of commenters favored the 0.5 rem dose-based limit
/ Maintain status quo of 10 CFR 35.75 (several commenters)
/ Dose-basedlimit willcause confusion andpotential problems; calculational approach requires physician to ask many personal questions (a few commenters)
/ One commenter said:
> Dose estimates would be inaccurate; unreliable method of predicting the time / proximity to others
> Increased cost of treatment due to calculation /recordkeeping
> Probably no significant decrease in radiation exposure 5 a ssa 20.s m L - -- -
p ~%.,,
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- Release quantities
/ Some commenters do not think release should be permitted with quantities > 30 mci
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- Recordkeeping (summing dose) for administrations > 0.1 rem ;
/ The strongest opposition to the proposed rule
/ Excessive costs in time, effort, and money to findprevious administration records
/ NRC underestimated the cost of record generation wn. zm L__________
p" ~ %., l w . ,5 United States
's,,,,,,,fi Nuclear Regulatory Commission
- Recordkeeping (summing dose) for administrations > 0.1 rem Basis for Recordkeeping I
I I Tracking for Release Based on Multiple Administrations Case-Specific Calculation (Thyroid Ablation-Hyperthyroidism) (Thyroid Cancer / Implants) 50,000 adm./ year" 12,000 adm./ year'
" NUREG-1492; Table 4.6.
8 wn. im
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- Written instructions to patients
/ Instructions do not need to be written, oralinstructions should be permissible
/ A major health maintenance organization strongly supported the requirement that the instructions be written
/ A sizable fraction ofpatients willnot behave asinstructed 9 wn. sm
V p* ~%. ,
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e Questions for the ACMUI
/ Require written instructions?
t
/ Records
> Retrieval of records for multiple administrations; done enough to be considered?
> Record of releases not based on Table 2 of regulatory guide?
/ Did the FRN misrepresent the opinions of the ACMUl?
/ Include non-byproduct materialin Table 2 of regulatory guide?
/ Assumptions for methodology for calculation of case-specific dose estimate?
/ Provide more examples of calculations in regulatory guide?
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11 wn. im I
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\, ff Nuclear Regulatory Commission
- Carol Marcus Comment Letter
/ Approves deletion from 10 CFR 20.1301(a)
/ Liked the dose-based approach and 500 mrem limit
/ Adamantly against dose records (cost borden)
/ Commented on the details of the calculational methodology 12 mze,im
W '
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*%,,,,) Nuclear Regulatory Commission
- Peter Crane Corament Letter
/ Approves deletion from 10 CFR 20.1301(a)
/ Maintain status quo of 10 CFR 35.75
/ Concemed about intemal contaminatican if patients released with > 30 mci
/ Claims FRN misrepresented the opinions of the Agreement States and ACMUI n wn.zm
/ ~%.s 1 United States **,,....!. ! Nuclear Regulatory Commission l
- Suggested Changes
/ Final rule
> Exclude requirement to keep a record of the dose for non-calculationalreleases (Regulatory Guide; Table 2)
> Exclude requirement to sum dose from alladministrations over a year
> Permit oralinstructions H answ20, sm
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/ Regulatory Guide
> Review assumptions for methodology for calcula6on of case specific dose estimates (e.g., retendon factors)
> Set parameters for calculated dose (e.g., expcsure factor)
/ NUREG-1492
> Modify to exclude the cost of recordkeeping for non-calculationalreleases (i.e., thyroid ablation for hyperthyroidism, 15-30 mci, 50,000 administra6ons/yr)
> Account for physical and biological decay for dura 6on of retention per therapeu6c procedure (reduced hospital days) is nn. im I--.----
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- Schedule
/ Meet with NMSS September 29,1994
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/ Meet with ACMUI dudng November 19942 16 wn. im
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/ Inclusion of the dose to breast-feeding infants i t
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/ Recordkeeping requirement for doses > 100 mrem r
/ Management of patients released with radioactivity and remaining in the hospital for other medical care !
4 I 2 sm ser s. aps
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- Cost-Benefit Analysis for 9 Diagnostic Procedures With i Consideration to the Breast-Feeding infant (BFI)
/ 3 procedures result in doses > 500 mrem to BFI t
+ Significant benefit compared to the cost
> Estimated doses (EDE): 6.8, 41.8, and 5.5 rem
/ 6 procedures result in doses < 500 mrem to BFI
> Some benefit compared to the cost
/ Cost based on asking CBA patients, "Are you breast-feeding?" and issuance of written instructions and recordkeeping
/ Benefit based on the dose averted at $1,000 person-rem and no cessation of breast-feeding 3 sa s. im 4
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\,,,,,,/ Nuclear Regulatory Commission i
i e issues for Future Consideration in the Cost-Benefit Analysis
/ Alternative diagnostic procedure (s)
/ Postponing diagnostic procedure (s)
/ Additional hospitalization
/ Cessation af breast-feeding
/ Changes to home environment
\ / Psychological cost l
' 4 Neer=6er 9,1994
S WIG CONSIDERATION TO THE FiREAST FEEDIV; (NFA f8ENEFIT E M MATES OF VARIOUS DIAGNOSTIC PRO COST BENEFIT RADIATION DOSE INFORMATION I c.., .r ..... r... i m. toe .
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28,710. dose <1 mSv 28,710. 24,300. Bra : /, 740 (20 mci) 450,000 4.2E-5 9.03 (0.003) Tc-99m DTPA 8,100
- 68. 28,710. 243,000. 271,710. 55,080,000.
Brain- 740. (20 mci) 450,000 0.092 (6.8) Tc-99m 0, 8,100 5;.sE-5 128,000. dose <1 mSv 128,000. 144,504. Bone- 740. (20 mci) 2,007,000 0.0f (0.004) Tc-99m HMDP 36,126 2.8 55,600. 470,340. 525,940. 4,389,840. ! Lung 185. (5 mci) 871,000 0.015 (0.28) Jerfusion- 15,678
.c-99m MAA 418. 4,785. 40,500. 45,285. 56,430,000.
Thyroid - 3.7 (0.1 m:i) 75,000 113.0 (41.8) I-131 1,350 90,450. 4,785. 75,000 0.06 0.67 (0.067) 4,785. dose <1 mSv Thyroid- 11.1 (0.3 mci) 1-12.3 1,350 ~ 10,020. dose <1 mSv 10,020. 8,478. Renal- 740. (20 mci) 157,000 4.2E-5 0.03 (0.003) Tc-99m DTPA 1 8 2,826 13,500. dose <1 mSv 13,500. 15,192. Cardio- 740. (20 mci) 211,000 5.3E-5 0.04 (0.004) vascular- 3,798 Tc-99m HMDP 55.5 8,600. 72,360. 80,960. 13,300,000. Tumor- 111. (3 mci) 134,000 0.5 (5.5) Ga-67 2,412 citrate
^ All figures f rom NUREG-1492. i.e., RIA for patient release rulemaking.
** Estimated No. patients breast-feeding based on 0.018 multiplier in NUREG/CR-6238. Da t., twe Analysis and Recorrendations," Nuclear Medicine 9 All figures f rom Mounford & Coakley, "A Retew of the secretion of Radioactivity in Human Breast Milk:
Cc-v, uni c at i ons 10, 15-27 (19S9).
- Assumes $2,00 cost for each time the questior. is asked.
Estimated No. patients CBA based on 0.032 multiplier in NUREG/CR-6238
" ..ssumes $30.00 cost to provide written instruct' ans/recordkeeping.
.w,,- -
x _,__~ v j
,7~N Cost Benefit \
I i i
's _/ Abbreviations in the Tat,14; of Section 4:
WD1,2,3 Written Directives, Categories 1,2, and 3 NWD No Written Directives Diag. Pharm. Diagnostic Pharmaceutical Application Th. Pharm, Therapeutic Pharmaceutical At$ plication Teleth. Teletherapy - Brach. Brachytherapy Table 4,2.1 Calculation of Number of Potentially Pregnant or Breast Feeding Patients Per Year Patients Fraction Pregnant Breast-Patients Fraction Female Total Pregnant' Patients Faading Females Patients CBA CBA Per Year' 'ts Fraction 2,244,502 0.0534 119,807 3 126,996 NWD, Diag. 7,000,000 0.55' 3,871,000 0.58' Pharm. 24,540 0.58' 14,229 0.0534 760 POS WD1, Th. 30,000 0.82 3 Pharm 9,000 0.0007 6,1 n/a WD2, 100.000 0.50' 50,000 0.18' f Teletherapy j 6,600 0.0007 4.5 4.7 WD3, 50,000 0.66' 33,000 0.20'
'~'t Brachytherapy
,x_')
' Federal Register,1990 8 NCRP Commentary No 7,1991 8 Werner,1962
- Flynn,1993
- Statistical Abstracts,1992 l
<~
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- Tome to soif.nt per umt .AN%AC
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- I ns s umal mgc>tsms t % Effc.*rwlmalf itfc th y admmestered mansmum wnumum i Iil 1.* te M<ne tksun
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d 12 - I arc".p M5A I [26l 1 5410 ' Nat
/
"j f/ 40 - I 0 H6% - -
O Un 7 c"-gluoeheptonate 1 ll4] 51 15 41 1 O S 10 ' ed t) I t' ti l) D 025
/- it llll 11 Ol h C 444 -
2 NEP
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' *] { {$ A 71 '82 183 4 (29 -32l 4h 25 331(1) 18 1 W'ln=hde (2) 14' 2 24 N 111
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"'in leucorytes u on o di nf' !! 5 "Cr EDI A 3 [J 3.22l
*1ime altet admitmtratum **t radnamtstaty h5 rneither t urveteent. IV. .rwitse m fl. Interruptum susi(wnts.st,11. erstrrruptum t..r perbid in adja,4 nt (+4umn, lit, enterrtpthe w at i meh Jihengsmesutal do av pResults are los 72 h af ter adnumstratum. dv.
Table 4.2 Estimated Radiopharmaceutical Use for Diagnostic Procedurrs la the U.S. In 1993") Average Activity Total No. of Exansination Type per Examination Examinations (Radiopharmaceutical) (MHq (mCl)) (x 1,000) Brain 4 Tc-99m DTPAm 740 (20) 450 Pr 4Tc4P9en Oc* 740 (20) 450 Beriatobiliary Tc-99m IDAm 185 (5) 198
) Liver - Tc-99m sulfur colloid 185 (5) 1,578 B '"7 d oneTc-99m phosphate llAty 740 (20) 2,007 Lung Perfusion k *9tu99m MAAC 185 (5) 871
, Lune Ventilation I
% Xe 133 370 (10) 449 Thyroid .
' . 185 (5) 600 kM 0%1 -Tod i,dJ2., 3.7 (0.1) 75
,)-I-123 -{-jQ,g 11.1 (03) 75 c 99m DTPA 740 (20) 157 y- I 131 hippuran 93 (0.25) 105 Cardiovascular
%- Tc-99m RBCS 740 (20) 421 M. TI-201 chloride til (3) 421 J. Tc-99m phosphate \1%Df 740 (20) 211 Tumor
,) -Go 67 citrate 111 (3) 134 Total 8,202
- Based on ME85; and personal communication, F. A. Mettler, March 1993, but adjusted for the 1993 U.S.
population.
- DTPA is diethylene-triamine pentacetic acid; IDA is imino diacetic acid; M AA is macro aggregated albumin, i and RBC is red blood tells.
(v) 1 5 NUREG-1492
[% - . ( ) From: "Barry Siegel" ("SIEGELB9MIRLINK.WUSTL.EDU")
\.d To: _
.. sxs49nrc. gov Date:-Thursday,-November 3, 1994 5:05 pm
Subject:
Multiple administrations (SMTP Id#: 56019) Stewart: The following are the data for Hallinckrodt Institute of Radiology for the 1-year period from 1 July 1993 to 30 June _1994.
- 1. A _ total _ of 266 patients received 1-131 doses for which a written directive was required, as follows:
39 Thyroid Cancer _ Rx (doses usually 100-200 mci) 140 Hyperthyroidism Rx (doses ranging from 5 to 30 mci; t avg. about 10 mci)
-99 Whole-body imaging (dose 5 mci)
-These numbers add to more than 266, because 12 patients had more than one TYPE of procedure (see below).
- 2. .A total of 16 patients (6%) had more than one 1-131 administration in the year, as follows:-
11 thyroid cancer Rx + whole body-imaging
'l thyroid cancer Rx + (whole body imaging x2)-
3 whole body imaging x2 , I hyperthyroidism Rx x2
/T 'Hence, if. the rule _is tied to a procedure requiring a-written directive and if
) any record-keeping requirement is triggered only by the second administration, the burden MIGHT not~ be unacceptably high. Note that I make this -tatement in a highly provisional fashion.
BAS' CC: jeg0nrc. gov >, " Larry W. Camper" <1wc@nrc. gov >, ... 4 U
O O O~~
~
Db ('~ > y...Y } States United p)E-4/..f
%,;,,,,/ Nuclear Regulatory Commission Suws rat Amos metria M-18LM 3
i( m m :1 10 CFR PARTS 20 and 35 l Patient Release Criteria
. ?
Donald Cool, Stewart Schneider, and Stephen McGuire Radiation Protection and Health Effects Branch Office of Nuclear Regulatory Research i
~ %,,
United States l(r < l],1
\ .. f Nuclear Regulatory Commission b i e Status l 1
/ Comment period for the proposed rule, draft regulatory guide, NUR'~G-1492 expired August 29,1994
/ Proposed rule, 56 comment letters
> Over 80% from physicians or medicalgroups, Agreement States-4, Other-4
/ Draft Regulatory Guide. 6 comment letters
/ NUREG-1492.1 comment letter ACAIUI Afecting 2 Ye w"b" 18.I M l
g - %,, ~ i m 1 United States
\,;,jhi Nuclear Regulatory Commission e Major Provisions of Proposed Rule
/ Modify the application of the public dose limit in 10 CFR 201301(a)(1) and (a)(2) to exclude the dose received from patients released under the provisions of 10 CFR 35.75
/ Modify 10 CFR 35.75 to specify a 500 mrem (5 mSv) Totai Effective Dose Equivalent dose limit criterion for the individuallikely to receive the greatest dose r
4 3 x<nemser is, isst AC3!UI bleeting
O O O'" y%, , g, ~, United States lkW{}1 Nuclear Regulatory Commission i e Major Provisions of Proposed Rule
/ Modify 10 CFR 35.75 to require that when the dose to an l individualis likely to exceed 100 mrem (1 mSv) from any patient release:
> Licensees' provide written information on methods for reducing the exposure ofindividuals
> Licensees keep a record of the release for 3 years (to provide basis for summing doses)
A November 18,1994 ACAIUI Alreting
'~
United States l\, w?.1
.... I Nuclear Regulatory Commission
- Major issues Raised by Commentors and NRC Staff i
)
/ Recordkeeping for doses > 100 mrem
/ Written instructions to patients
/ How should exposure to a breast-fed infant / child be addressed?
ACMUI Meeting S N" ember 18. HH
O O O'~ 1 United States
\,,h:i Nuclear Regulatory Commission i
l
- Comments on Recordkeeping -for Doses > 100 mrem
/ The strongest opposition to the proposed rule
/ Commenters asserted that excessive costs in time, effort, and money to findprevious administration records
/ Commenters asserted that NRC underestimated the cost of record generation and retrieval AC3tri Afteting 6 November 18.1994
~
O O O
- 7. ....,.
! ,~ 1 United States a
\,...../ Nuclear Regulatory Commission !
t-
- Options Being Considered to Reduce Recordkeeping Burden
/ No requirement-for recordkeeping in the finalrule; performance based
- v. Address compliance in Regulatory Guide only
> Guidance cover issues such as potential for multiple administrations
/ Require records for releases based on case-specific calculations but not for use of tables l November 18.1994 ACAICI Sleeting
O O O~~ l va } United States
\,,;fl Nuclear Regulatory Commission e Comments on Written Instructions to Patients 4
/ Instructions do not need to be written; oralinstructions should be sufficient
/ A major health maintenance organization strongly supported the requ ~ement that the instructions be written
/ A sizable fraction of patients willnot behave as instructed AChit!! Afecting 8 N sember 18,1994
- - _. __________-____-_-______-D
O O O~~ United States l(g<hi
\"R 1
Nuclear Regulatory Conunission
- Options Being Considered on Written Instructions issuo
/ Provide oralinstructions only
/ Provide written instructions as proposed
/ Address degree of patient compliance in the Regulatory Guide 9 Nesember 18,1994 AC3!UI Aleeting
( _ . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . , .,, . . . . . . . - . . . . . . . . . . . . .. . . . . . . . . .
~ O O O~~
,s~s s ' r < ~3 United States \, ,,,
y Nuclear Regulatory Commission e How should exposure to a breast-fed infant / child be addressed?
/ The 500 mrem / year limit might be exceeded if breast-feeding continued for some diagnostic tests (e.g.,
Tc99m as pertechnetate for brain scans and 1-131)
/ Although clearly identified in the proposed rule notice, few comments.
> One commenter viewed the breast-fed infant / child as a special case that she ' 'd not be considered in complying with the annuallimit
> One stated that the breast-fed infant / child should be addresesd as a part of patient-physician decision to co.a.suct the procedure 10 Number H,1994 AChlCI Aftesing
s s United States
\...../ Nuclear Regulatory Commission ;
1 e Breast-Feeding infant / Child Protection - Generic Policy issue
/ Radiation protection standpoint; focus on consistent protection ofindividuals
-/ Patient-physician standpoint; focus on balancing all factors
.and maximum flexibility 11 Numbe 18,1994
\ ACAIUI Aftering
O ry - - pd V V United States
!g)/ \.W,,,
1 Nuclear Regulatory Commission e Breast-Feeding Infant / Child - Radiation Protection Rationale for Treating infant / Child as Individual
/ The infant / child is physically separated
/ Infants / children may never breast feed, so inequitable protection
/ No clear break point since breast-feeding times vary over wide range
/ Optimization considerations: 1) before study, mother could pump breast and store enough milk in freezer for feeding the infant / child and 2) standard medical practice for radioactive and nonradioactive pharmaceuticals is to consider interupting breast-feeding 12 November IS,1994 ACAICI Steering
O O . O~' l i .1 United States
',\ ,,,,fi Nuclear Regulatory Commission l
e Breast-Feeding infant / Child - Problems under Proposed Rule if Considered as Individual
/ Does not include preventative action before administration.
/ Difficulty in calculating doses
/ Couldlimit decisions by physician andpatient
/ Potential for patient confinement in many more cases (i.e.,
diagnostic procedures) ACSIUI hireting 53 Nove**b!' 18.1994
O O O~'
- gi United States ,
kylI Nuclear Regulatory Commission l e Resolution Under Consideration by RES
/ Rule: No change
/ Regulatory Guidance:
> Include discussion of preventive measures in introduction to but not position of guide
- Limit consideration of nursing to specified dosages and radiopharmaceuticals
- Provide a table of acceptable times to resume nursing i
> Clarify that reliance on instructions to breast-feeding women in the regulatory guide is acceptable
$$ November 18, !994 ACSICI hireting ,
-.s.,
l m y United States
+,
, }I . Nuclear Regulatory Commission e Schedule ,
/ Final rule and Regulatory Guide to the Commission summer of 1995 15 Nnember 18,1M AChfCl Alerting
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( United States g_ y, 3
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10 CFR PARTS 20 and 35 i Patient Release Criteria l l John E. Glenn, Stewart Schneider, and Stephen McGuire Radiation Protecti'on and Health Effects Branch Office of Nuclear Regulatory Research
lg~s, ~t
~
United States
\,;,,,{I Nuclear Regulatory Commission
- Major Provisions of Final Rule !
/ Modify the application of the public dose limit in 10 CFR 20.1301(a)(1) and (a)(2) to exclude the dose received from patients released under the provisions of 10 CFR 35.75
/ Modify 10 CFR 35.75 to specify a 500 mrem (5 mSv) Total I Effective Dose Equivalent dose limit criterion for the individual (including a breast-feeding infant) likely to receive the greatest dose ACAICI Afecting 2 Afarch 12,1995 I
... j g,<} United States *%,,,/ Nuclear Regulatory Commission I
e Major Provisions of Final Rule l
/ Modify 10 CFR 35.75 to require that when the dose to an individualis likely to exceed 100 mrem (1 mSv), licensees provide written information on methods for reducing the exposure ofindividuals
/ Modify 10 CFR 35.75 to require that licensees keep a record of the release for 3 years if the release is based on:
> Biological elimination rather thanjust the physical half-life of the radionuclide
> Occupancy factor other than 0.25 at one meter
> Consideration of attenuation of radiation by the patient's. body tissue .
ACMUI Meeting 3 uarcs 12. nss
-l
,(~ %,, ~
t . United States
*% ,,ll Nuclear Regulatory Commission o- Regulatory Guide
/ Provide a table of activities and dose rates for anthorized patient release and giving instructions
/ Provide a table'of instructions for breast-feeding mothers that includes cessation periods based on ORISE performed dosimetry calculations
/ Provide an additional example on administration of I-131 for hyperthyroidism ACAIUI bletting 4 hierch 12,1995
!\ y United States s, ,,,,) Nuclear Regulatory Commission d
e Schedule
/ Finalrule and Regulatory Guide to the Commission summer of 1995 AChlCI hinting 5 Afarth 12,1995
9D2 -
/ .... ,g n6-4/v
~
igy United States
\?,.W...l. l Nuclear Regulatory Commission w.
10 CFR PARTS 20 and 35
. Patient Release Criteria John E. Glenn, Stewart Schneider, and Stephen McGuire Radiation Protection and Health Effects Branch Office of Nuclear Regulatory Research I
I r
' +,, -S k* 8 e- . *
*
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n w".e ,_,4 ' ,' * ' g gr , eg ,,
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* [f [
=s s. r .w.. r2 .
{kWy'W United States Nuclear Regulatory Commission i RECORDKEEPING ,
/ Require a record of the basis for the release if the quantity administered exceeds the quantity in the default release table in the Regulatory Guide.
/ Require a record if instructions are given, including instructions to potentially breast-feeding women.
ARE THESE RECORDKEEPING REQUIREMENTS APPROPRIATE? , i Afay 12.1995 >
.AChil:1 Ateering 2
I
{ ~ ') United States
\,,,,'fA Nuclear Regulatory Commission Activities for Authorizing Patient Release Activity Below Which Patients May Be Released Radionuclide (mci (GBq))
Ga-67 240 (8.7) 1-123 160 (6.01 I-125 (implant) 8.7 (0.32) I-131 33 (1.2) In-111 65 (2.4) Pd-103 40 (1.5) Tc-99m 760 (28. l b A'*? 'I I" ACAfUI Aferring
{ ~lD, United States
\., .....
I Nuclear Regulatory Commission i WRITTEN INSTRUCTIONS , Is there any objection to requiring:
... instructions, including written instructions, on how to maintain doses to other indi Fduals as low as reasonably achievable."
4 Stay 12,1995 ACAf t:I Steering I i
f .. .,,, United States Q~ ^\ {Qbfi, Nuclear Regulatory Commission INSTRUCTIONS Should the requirements for instructions in s 35.315 and 5 35.415 be deleted? . 5 35.315 Safety precautions.
"(6) Provide the patient or human research subject with radiation safety guidance, if required by H 35.75(b), that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient or human research subject."
5 """'"" mu ur,s.,,
.~
?. - ). United States
%, , ,, ,) Nuclear Regulatory Commission 1
BIOLOGICAL FACTORS MAXIMUM LIwELY DOSES TO EXPOSED INDIVIDUALS FROM THERPEUTIC 10 DINE-131 PROCEDURES BASED ON THE PATIENT'S BIOLOGICAL RETENTION AND ELIMINA? ION Extrathyroidal Thyroidal Component Component External Dose to an Individual Biological Biological Disease Fraction Hal f-Li fe Fraction Hal f-Li fe' After 8 Hours' Total Dose' (Administered Activity) f, T,, (day) F, T ,(day) (rem) (rem) Hyperthyroidism / 0.10 0.33 0.90 10 0.164 0.902 Thyroid Ablation 0.160 0.941 0.20 0.33 0.80 15 (100 mci) 0.30 0.33 0.70 20 0.155 0.910 0.40 0.33 0.60 20 0.150 0.805 0.50 0.33 0.50 25 0.146 0.734 O.60 0.33 0.40 40 0.141 0.662 0.70 0.33 0.30 65 0.137 0.567 Thyroid Cancer 0.95 0.33 0.05 80 0.186 0.305 (150 mci)
' Personal comunic etion, M. Follycove, M.D., Visiting Medical Fellow, U.$. Nuclear Regulatory Comission. Rockville, Md, May 1995. 'Occup-:r.cy f actor x 1.0 at a distance of 1 meter for the first 8 hours. ' Total dose = (dose for the first 8 hours) + (dose f rom 8 hours to total decay); where the occupancy factor = 0.25 at a dtstance of I meter for the second term.
ACHUI Sleeting 6 Sfay 12. l**$ I
- p. .. .
(* ys< \ United States Ab.Ml[,.... A Nuclear Regulatory Commission BIOLOGICAL FACTORS 1 t is there any concern for immediate releases > 30 mci of I-131?- j i
/ Possibly hold the patient overnight. .
3 t f f I ACMCI .% ferring y May 12,1995 - - -- _.y ---
~
,pa- . ,
United States lQ~{I,1
\.W,,,,,I Nuclear Regulatory Commission INSTRUCTIONS FOR BREAST-FEEDING WOMEN j / The information we have is shown in the attached table. It is l based on ORISE performed dosimetry calculations
/ What is the best approach for presenting this information?
I I ACAIUI Steering
1
.p. m,,,
l> ~\ United States
\,,,,,,/ Nuclear Regulatory Commission INSTRUCTIONS FOR BREAST-FEEDING WOMEN Dose to Infant If No Interruption Recommendation on Radio- Administered of Breast Instructions Interruption of pharmaceutical Activity' Feeding' Required?' Breast Feeding' (mci (MBq)) (mrem) 1-131 Nal 150 (5550) 60,000- yes Complete cessation 40,000,000 is necessary to avoid thyroid ablation in the infant 60 no None 1-123 Nal 0.4 (14.8) 4-30 no None 1-123 OlH 2 (74)
I-123 mIBG 10 (370) 300 yes Interruption for about 24 hours 0.2 no None I-125 OIH 0.01 (0.37) 3-20 no None I-131 OIH 0.3 (11.1) Tc-99m DTPA 20 (740) 0.3-6 no None Tc-99m MAA 4 (148) 4-300 yes Interruption for about 6 hours Tc-99m 30 (1110)- 200-800 yes Interruption for pertechnetate about 24 hours 4-20 no None Tc-99m DISIDA 8 (300) 2-5 no None Tc-99m 20 (740) glucoheptonate 20-50 no None Tc-99m HAM 8 (300) 1-10 no None Tc-99m MIBI 30 (1110) 4-5 no None Tc-99m MDP 20 (740) 5-20 no None Tc-99m PYP 20 (740) Tc-99m RBC's in 20 (740) 0.3-100 yes Interruption for vivo labeling about 6 hours 9 Alay il b95 ACMl'l Alerting
^
^
?DL .
R & VI- y [g"~y.,~< .
; United States
's . ] Nuclear Regulatory Commission i
l l 10 CFR PARTS 20 and 35 i Patient Release Criteria John E. Glenn, Stewart Schneider, and Stephen McGuire Radiation Protection and Health Effects Branch ; Office of Nuclear Regulatory Research
g %,,, i >~ 1 United States
\,,,,h:i Nuclear Regulatory Commission
- Petitions for Rulemaking
/ Petitioners ,
4
> Dr. Carol S. Marcus (PRM-20-20, 2/6/91)
> American College of Nuclear Medicine (PRM-35-10,1/14/92; PRM-35-10A, 4/21/92, Amended Petition)
> American Medical Association (PRM-35-110, 4/20/94)
/ Requests
> Dose limits in 10 CFR 20.1301 should not apply to individuals exposed to releasedpatients
> Amend 10 CFR 35.75 to provide a 500 mrem (5 mSv) dose limit to individuals exposed to releasedpatients
~" ~ w. nonks uming ^ 2 1m!y5.I995
~
i. y United States
!\,,,, ,h Nuclear Regulatory Commission
- Major Provisions of Final Rule
/ Modify the application of the public dose limit in 10 CFR 20.1301(a)(1) and (a)(2) to exclude the dose received from patients released under the provisions of 10 CFR 35.75
/ Modify 10 CFR 35.75 to specify a 500 mrem (5 mSv) Total Effective Dose Equivalent (TEDE) dose limit criterion for the individual (including a breast-feeding infant) likely to receive the greatest dose
/ Modify 10 CFR 35.75 to require that when the dose to an individualis likely to exceed 100 mrem (1 mSv), licensees provide written information on methods for reducing the exposure ofindividuals l
Dr. Morrison Meeting 3 1.tr5.tres I
- - - . . . . . . e - - - -- - --i --4-- .m- - -
- -- .. -- . . . . . . . . . .i.i---
i ,<1 United States
*%,f)
Nuclear Regulatory Commission
- Major Provisions of Final Rule
/ Modify 10 CFR 35.75 to require licensees to keep a record of the release for 3 years if the release is based on:
\
> Biological elimination rather thanjust the physical half-life of the radionuclide
> Occupancy factor other than 0.25 at one meter
/ Modify 10 CFR 35.75 to require licensees to keep a record of the release of a breast-feeding woman for 3 years if the dose to a breast-feeding childis likely to exceed 500 mrem (5 mSv) TEDE, assuming no interruption of breast-feeding l l
- . . ~ < ,. s. ,,,, \
, ~s,,,
.1 United States
!'s.,, <b. i Nuclear Regulatory Commission
- EDO Comment
/ Concem rule allows nursing infant or children to receive 500 mrem (5 mSv) i I
l Dr. blonken hinting 5 NU 5' #5
; <1 .
United Svtes
'%,,,,) Nuclear Regulatory Commission
)
- Options
- 1. Maintain finalrule status quo
- 2. Minor revision to finalrule to put emphasis on ALARA and limiting dose to children
- 3. Major revision to final rule to reduce dose limit to 100 mrem (1 mSv) to maximally exposed individual i
l Dr. Morrison Merring 6 July 5,1995
'I i--
, .. u,
'*\ United States
{', ff
*%,,, Nuclear Regulatory Commission
- Recommendation for Final Rule KEEP:
- 1. Release based on 500 mrem (5 mSv) TEDE to maximally exposed individual
- 2. General ALARA instructions if TEDE may exceed 100 mrem (1 mSv)
- 3. Record of calculation if not based on conservative assumptions i
l l Dr. Morrison Meeting 7 hly 5,1H3
/
p ~%,
- i. 1 United States
) . Nuclear Regulatory Commission
- Recommendation for Final Rule (Continued)
ADD:
- 1. Specific ALARA instructions if minors in household or breast feeding child and the TEDE may exceed 100 mrem (0.1 mSv) 1
- 2. Record ofInstruction i
l
&. Mo%en Meesing 8 ,,,,,,y, I
'1 United States
%....../ Nuclear Regulatory Commission COSTS OF PROPOSED OPTIONS FOR THE PATIENT RELEASE FINAL RULE Estimated Cost Imposed Collective Dose Per Year $ Per Person-REM Options (person-rem) ($ millions) Avoided i
- 1. Status Quo; As proposed 72,000 13.0 0
- 2. Minor Revisions: ALARA 61,000 14.0 $200
- 3. Major Revisions; 100 mrem - All 19,000 148.0 $3,000 Dr. Morrblon Meeting 9 July S.1995
!. 1 United States
%, ,,,,) Nuclear Regulatory Commission COST ANALYSIS
, COSTS OF PROPOSED OPTIONS FOR THE PATIENT RELEASE FINAL RULE Collective Dose Cost Estimates Hospital Value of Records & To Other Cost Lost Time Instructions Psych. From BF Individuals $ $ $ Cost Option (person-rem) (person-rem) (millions) (millions) --- (millions) (relative) Comments ammmmiusmann - . 1 540 60,400 10 0.6 2.5 Low Status Quo
- 1. Dose 1imit 0.5 rem.
- 2. Ins > 0.1 rem (indiv.).
- 3. Rec > 0.5 rem (indiv.).
- 4. Ins > 0.1 rem (BFI w/ inter.).
- 5. Rec > 0.5 rem (BFI w/o inter.).
l 2 540 60,400 10 0.6 3.5 Low Minor Rev: Em.hasire AL ARA & l Limiting Dose to Children l 1. Dose limit 0.5 rem. 2-5 Status Quo
- 6. Rec Ins > 0.1 rem (EFI); added.
- 7. Rec Ins > 0.1 rem (Minors);
added.
- 8. Additional ALARA Ins BFI/ Minors; added.
b40 18,400 140 8.4 0 High MaSor Rev: Raduce Dose timit 3 1. Dese limit 0.1 rem (part 20).
- 2. Rec / Ins net needed above 0.1 rem
- 3. No special consideration for BFI ACMUI Meethrg 10 May 12.1995
+
l,,.e..,,)
- e United States
....*/ Nuclear Regulatory Commission COST ANALYSIS COSTS OF PROPOSED OPTIONS FOR THE PATIENT RELEASE RULEMAKING
~
1 Collective Dose Cost Estimates Hospital Value of Records & To Other Cost Lost Time Instructions Psych. 1 From BF Individuals $ $ $ Cost (relative) Comments Option (nerson-rem) (person-reru) (millions) (millions) (millions) , u- umummmmmmmmmmmmmaammmmmmmmme BFI 1.077 JEG 6/23; similar to Alt 3. 1 540 60,400 10 0.6 Low Rec / Ins to all BFI (added).
},5 Rec / Ins > 0.5/0.1 rem (same).
BFI 1.077 High JEG; strict 0.1 rem limit (Alt 1). ! 2 540 18,400 140 8.4 Rec / Inst to all BFI (added). T
"'*I'"' " * " " *'d * " " *** ' "'
0 (same as current rule package). BFI 1.077 Moderate JEG; 2 dose limits 0.1/0.5 rem, but 3 540 .51,400 20 1.2 cnly a loose 0.1 considered here. j g Same as Alt 2. 1 Rec / Inst to all BFI (added). ! l
}.4 Instructions > 0.1 rem Exisiting pt 35 has no recordkeeping
- .a-+
11 May 12,1995 ACMUI Meeting
!.f,. ,,\ United States
,,,../ Nuclear Regulatory Commission I
4 540 55,900 15 0.9 BFI 1.077 Somewhat JEG; sinillar to Alt 3 LOW Rec / Inst to all ECI (added). i Rec / Ins > 0.1/0.1 rem.for all releases exp sing children; 2*2 80% cf homes (added). og-tine > n 5 tn 1 er Final rule text l l 12 May 12,1995 ACMUIMeeting I
142 f ~%,,, g__ t/ /-o '
!1 1 United States
*%,,,,) Nuclear Regulatory Commission 10 CFR PARTS 20 and 35 Patient Release Criteria David L. Morrison, Director !
Office of Nuclear Regulatory Research ! Carl J. Paperiello, Director ! Office of Nuclear Material Safety and Safeguards
/ ~% ,
^
1 United States
%.....} Nuclear Regulatory Commission e Major Provisions of Final Rule .
/ Modify public dose limit in 10 CFR 20 to exclude the dose received from patients released under 10 CFR 35.75
/ Modify 10 CFR 35.75 to...
1
> Specify a 500 mrem TEDE dose limit
> Require written instructions when the dose is > 100 mrem
> Require a record for 3 years if the release is based on:
- Tissue attenuation
- Biological elimination
- Point source geometry
- Occupancy factor other than 0.25 at one meter l i
> Require a record for 3 years if the dose to a breast-feeding child, assuming no interruptien, is likely to exceed 500 mrem TEDE i
2 Jady 17, IMS EDO Meentet
p- ~s.,,
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1 United States
*% ....l. }Nuclear Regulatory Commission l o EDO Comments
/ Concern rule...
> Allows a nursing infant to receive 500 mrem
> A wkward rule language for recordkeeping requirements ,
l 3 July it, IHs EDO Meedat
; ~ %,,
i < United States
*% ..... l}.1 Nuclear Regulatory Commission e' Options
- 1. Maintain finalrule status quo
- 2. Minor revision to finalrule to put emphasis on ALARA to include limiting dose to children
- 3. Major revision to finalrule to reduce dose limit to 100 mrem to maximally exposedindividual l
EDO Merdng 4 July IT. IM5
!(~< ,1 United States
\,,,,,,./ Nuclear Regulatory Commission e Staff Recommendations for Final Rule
/ Keep:
- 1. Release based on 500 mrem TEDE to maximally exposedindividual
- 2. General ALARA instructions if TEDE may exceed 100 mrem
- 3. Record of calculation if not based on conservative assumptions l
/ Emphasize:
1
- 1. Specific ALARA instructions if minors or breast feeding childin household and the TEDE may exceed 100 mrem o Associated risks and consequences e Actions to keep dose to minors ALARA e Guidance on interruption of breast-feeding
/ Delete:
- 1. The phrase " including a breast-feeding child" from paragraph (a)
- 2. The list ofitems from paragraph (c) soo una., s n n. ms
- f. ..s, i i United States
*%,,,,) Nuclear Regulatory Commission _
l l l ANNUAL COSTS OF PROPOSED OPTIONS FOR THE PATIENT RELEASE FINAL RULE. Collective Dose Cost Estimates-Hospital - Value of Records & From To Other Cost Lost Time Instructions Breast-Feeding Individuals $_ _$ - $
' Option (person-rem) (person-ren) (millions) (millions). (millions)
- 1. Status Quc; As proposed 540 60,400 10 0.6 2.5 l
- 2. Major Revision; 100 arem dose Ifait 540 18,400 140 8.4 0 l
I 6 May n.1995 ACMut Meeting x __ _
,,s ~ %,,
i j United States
*%,,,,,/ Nuclear Regulatory Commission o Petitions for Rulemaking
/ Petitioners
> Dr. Carol S. Marcus (PRM-20-20, 2/6/91)
> American College of Nuclear Medicine (PRM-35-10,1/14/92; PRM-35-10A, 4/21/92, Amended Petition)
> American Medical Association (PRM-35-110, 4/20/94)
/ Requests
> Dose limits in 10 CFR 20.1301 should not apply to individuals exposed to released patients
> Amend 10 CFR 35.75 to provide a 500 mrem dose limit to individuals exposed to released patients i
ACMUI Meerbeg 7 MarH.IMS
l(w~%. ,y United States '
\...../ Nuclear Regulatory Commission Need For Hospitalization Dose Limit Type of 500 TGL Procedure (mrem) (mrem]
Diagnostic No Yes (some cases) Therapy Hyperthyroidism No Yes Other Therapy Yes Yes ACMUI Needert 8 MayILI M
f - %,,
! 1 United States
\,,,,,,) Nuclear Regulatory Commission COSTS OF ALL THE PROPOSED OPTIONS FOR THE PATIENT RELEASE FINAL RULE Estimatea Cost Imposed Collective Dose- Per Year $ Per Person-REM Options (person-res) ($ millions) Avoided
- 1. Status Quo; As proposed 61,000 13.0 0
- 2. Minor Revisions; ALARA 61,000 13.0 $200
- 3. Major Revisions; 100 mrem - All 19,000 148.0 $3,000 9 uar n,Im Acut:1 uraa.e
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y United States
\...../ Nuclear Regulatory Commission COST ANALYSIS COSTS OF PROPOSED OPTIONS FOR THE PATIENT RELEASE FINAL RULE Collective Dose Cost Estimates Hospital Value of Reccrds &
To Other Cost Lost Time Instructions Psych. From BF Individuals $ $ $ Cost Option (person-rem) (person-rem) (millions) (millions) (millions) (relative) Comments 1 540 60,400 10 0.6 2.5 Low Status Quo
- 1. Dose limit 0.5 rem.
- 2. Ins > 0.1 rem (indiv.).
- 3. Rec > 0.5 rem (indiv.).
- 4. Ir s > 0.1 rem (BFI w/ inter.).
- 5. Rec > 0.5 rem (BFI w/o inte .).
2 540 60,400 10 0.6 3.5 Low " W # m E % W e ALA24 & Limit W De e to Chtid e
- 1. Dose Ilmit 0.5 rem.
2-5 Status O w
- 6. Rec Ins > 0.1 rem (BFI); added. i
- 7. Rec Ins > 0.1 rem (Minors);
a&ted.
- 8. Additier.a1 AUUtA Ins BFI/ Minors; addad.
3 540 18,400 140 8.4 0 High Faw 8 v: 8-*ce Dese tw t 8 Dose Itmit 0.1 rem (part 20).
- 2. Eac/ Ins not reeded above 0.1 rem
- 3. No special considaration for BFI I
Acutir weretag 10 my n, Isss 1
. f %,,
y e United States
'%...../ Nuclear Regulatory Commission !
COST ANALYSIS COSTS OF PROPOSED OPTIONS FOR THE PATIENT RELEASE RULEMAKING Collective Dose Cost Estimates Hospital Value of Records & To Other Cost Lost Time Instructions Psych. . From BF Individuals $ $ $ Cost Option (person-rem) (person-res) (millions) (millions) (millions) (relative) Coussents 1 540 60,400 10 0.6 BFI 1.077 Low A G 6/z3: st=ilar to Alt 3. Rec / Ins to all EFI (added). 1.5 ""/ Ins > o.s/o.1 = (s==1 2 540 18,400 140 8.4 BFI 1.077 High AG: strict 0.1 re= lt=it (M t 11 Rec / Inst to all BFI (added). O "'*#I"'"**""d'd " 'I "- (sa m as current rule packaoe). ! i 3 540 51,400 20 1.2 BFI l.077 Moderate A G: 2 dese itsits 0.1/o.5 re=. but enly a loose 0.1 considered here. Same as Alt 2. Rec / Inst to all EFI (added). ; l.4 Instructions > 0.1 rem Entsting pt 35 has no recerckeeping i i Acuer Merttas 1I May 12,Ises i
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, UPDATE ON RULEMAKING/ GUIDANCE ,l Atm@ nqEEmug Not ocro&M 6/ A% - (faeepa s)61 Sam dbd25) um
Demn A RELEASE OF PATIENT (Sectiorn 35.75) CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIALS e
~~
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_C-CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIALS PROPOSED FINAL RULE LANGUAGE:
"(a) The licensee may authorize the release from its control any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).'"
PREVIOUS PROPOSED FINAL RULE LANGUAGE:
"(a) A licensee may authorize release from licensee control any individual administered radiopharmaceuticals_or permanent implants containing radioactive material if the total etTective dose equivalent to any other individual (including a
. breast-feeding infant) from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem)." l
' Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials" (1995), describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem).
,a .
. CRITERIA FOR. THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIALS PROPOSED FINAL RULE LANGUAGE:
"(b) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals ALARA if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no intprgon o{
breast feeding, the instructions shall also include (1) guidanceon# di8 mterrugitibn m_ d "4of breast-feeding ..-d'* '2) ~=E.. 2%e es t'.; ca_.m M T;I!=- B-- fe!Sw th gui& = e=" -% s .%s L -+< %%mk-PREVIOUS PROPOSED FINAL RULE LANGUAGE:
"(b) If the total effective dose equivalent to any individual other than the released individual is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration, upon release the licensee shall provide the released individual with instructions, including written instruction, on how to maintain doses to other individualsi as low as reasonably achievable."
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p. CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACnVE MATERIALS l!Od PROPOSED FINAL RULE LANGUAGE: /
"(c) The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years fler the date of release, if the total effective dose equivalent is calculated (I using an activity other than the activity administereg (2) using an occupancy factor other than 0.25 at I meter, (3) using the biological- Q
- or effective half-life, or (4) considering the shielding by tissue."
oxf }a a
~ PREVIOUS PROPOSED FINAL RULE LANGUAGE: 41v f
"(c) If the release of the individual is' t ased on biological elimination rather than just the physical half-life of the radionuclide or an occupancy factor other than 0.25 at one meter, or includes consideration of the attenuation of radiation by body' tissue, the licensee shall maintain, for three years, a record of the released individual and the calculated total effective dose equivalent to another individual likely to receive the highest dose."
i S
..p-1 CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACTIVE MATERIALS PROPOSED FINAL RULE LANGUAGE:
"(d) The licensee shaII maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the; infant or child from continued breast-feeding could result in a total effective dose equivalent eSceeding 5 millisieverts (0.5 rem)."
\
PREVIOUS PROPOSED FINAL RULE LANGUAGE: No previous langu\ e. ,
\
a.Milonhap , v 4- %.ak 4 h, 9[ 1 l l
inu mmun en mi 91: ^ Troe. ' j~'%, g ,,,,g g,,,,, %- 41 A
\ {} Nuclear Regulatory Commission 10 CFR PARTS 20 and 35 ;
Patient Release Criteria ; 1 Stewart Schneider and Stephen McGuire Radiation Protection and Health Effects Branch Office of Nuclear Regulatory Research
p ~%,,, a United States f\W,,,,[ yt w ]1Nuclear Regulatory Commission
- Status
/ Commission approved the finalrule during October 1996.
- Schadule
/ Final rule to be published around February 1997 1
/ Effective date is 120 days following publication in the l Federal Register
/ Regulatory Guide to be published at the same time as the rule 2 sm n. im
l%f United States
\, ,,,
y Nuclear Regulatory Commission e The Final Rule as approved by the Commission
/ Clarifies that 10 CFR Part 35 governs patient release
/ Permits a maximum likely TEDE of 500 mrem (5 mSv) to an individuai exposed to a released patient
/ Includes instructions for women who are breast-feeding infants or children (Regulatory Guide)
I l I i 3 Kevender 15,1796
. A E-41-a;u,
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l: 1 United States
\.,;,,,$/ Nuclear Regulatory Commission INSPECTION GUIDANCE FOR FINAL ,
PATIENT RELEASE RULE November 15,1996 Joseph E. DeCicco Division ofIndustrial and Medical Nuclear Safety U.S. Nuclear Regulatory Commission , Washington, D.C. 20555 i k i l
,# ~%.
United States ign{',,i
\., ,~,, l Nuclear Regulatory Commission & 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
35.75(a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive materialif the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).' i
' Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," describes methods for :
calculating doses to other individuals and contain tables of activities not likely to cause doses exceeding 5 millisieverts (0.5 rem). i 1
[C\kn+; United States
*% ,-,,,,/ Nuclear Regulatory Commission s 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
f 35.75(b) The licensee shall provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem). O G l i 2
,p %,
! United States
- {'*\
\,,,,} Nuclear Regulatory Commission 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
35.75(b) (con't)
. . . If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include (1) guidance on the interruption or discontinuation of breast-feeding and (2) -
information on the consequences of failure to follow the guidance. I 3 J
__- _ _____--__ ____ . ._ _ _ . . - - -= _ - .. -
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\,z,,,/ Nuclear Regulatory Commission
% 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
s 35.75(c) 1 The licensee shall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, ~ if the total effective dose equivalent is calculated (1) using the retained activity rather than the activity administered, (2) using an occupancy factor less than 0.25 at 1 meter, (3) using the
; biological or effective half-life, or (4) considering the shieldin, of tissue.
l
l.~ . United States
\,,,,-y Nuclear Regulatory Commission
& 35.75 Release of individuals containing j radiopharmaceuticals or permanent implantsc 35.75(d)
The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem). l I 5
~'
y United States l(-l's
\;,- } Nuclear Regulatory Commission Performance Based Inspection Against ! 35.75(a) .
Ask licensee to describe how it demonstrates compliance with , authorizing release of patients administered radiopharmaceuticals Is there a process to determine if TEDE to other individuals not likely to exceed 5 millisieverts? Is there a process to determine if maximally exposed individual is a breast-feeding infant or child? Is there a process to determine the dose to the breast-feeding infant or child? l 6 I
~ ~~
f ~%,, l 1 United States
\,;,,-l} Nuclear Regulatory Commission Performance Based Inspection Against Q 35.75@)
Review instructions provided to the released individual any ' other individual likely to exceed 1 millisievert (0.1 rem) TEDE Is there an instruction written or a sample of the written instruction available? Is there instruction available for the individual that is breast-feeding an infant or child if dose to infant or child could exceed 1 millisievert (0.1 rem)? Is there guidance on interruption of breast-feeding and the consequences of failure to follow the guidance? W 7
! . t United States l .1
\.,;,}} Nuclear Regulatory Commission L Performance Based Inspection Against ! 35.75(c)
Review samples of maintained records that indicate the basis for
- authorizing release of individual when retained activity, i occupancy factor less than 0.25 at 1 meter, biological or l effective half-life, or shielding by tissues is used Is there a record available?
; Are the records documented to ascertain the basis for authorizing release?
Are the (non-medical) assumptions used in the basis for authorizing release reasonable? i 8 ; j ,
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,p %,
j'w ^) United States
*%, ;,)
Nuclear Regulatory Commission Performance Based Inspection Against ! 35.75(d) Review samples of maintained records that indicate instructions were provided to a breast-feeding woman if dose to the infant or child from uninterrupted breast-feeding could result in a TEDE exceeding 5 millisieverts i Is there a record available? Are the records documented to ascertain that the licensee has provided instructions? I 9
00CKElED . 1 hUMBER l' s
$~[3 SED RULE _h SO8 25 l 94 10; 26 E08 (JW12. 3 J ov/ ,
4809 Drummond Avenue 7DI-OffIl40 9. . gp Chevy Chase, MD 20815 @q p///_ g _ - 00CKL11% > a1RVICpugust 25,1994 - John Hoyle, Acting Secreta @N U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch
Dear Mr. Hoyle:
The following are comments on the proposed rule on " Criteria for the Release of patients Administered Edioactive Material," published for comment at 59 F.R. 30724 (June 15,1994). They are submitted in my private capacity as an interested member of the public, not in my official capacity as Counsel for Special Projects at the U.S. Nuclear Regulatory Commission. My concerns in this area stem from my own experience as the recipient of a number of therapeutic and diagnostic doses of radioactive iodine-131, totaling some 800 millicuries. Each of these meant taking precautions to minimize radioactive contamination of family members and members of the public. Knowing the hazards posed by I-131, I am deeply troubled by an NRC staff proposal, taken in the face of strong opposition from the responsible health authorities of many states, that could significantly increase radiation doses to the families of persons treated with this particularly dangerous radiopharmaceutical. At the outset, however, I should say that the NRC staff has done a conscientious job of attempting to calculate the actual dose that members of the public are likely to receive from patients treated with radiopharmaceuticals. Dr. Patricia Holahan, a radiation biologist in the NRC's Office of Nuclear Materials Safety and Safeguards, worked on those calculations, and although, to paraphrase an old song, I don't know much radiation biology, I do know Trish Holahan, and I have no doubt that her calculations are flawless. My concerns are directed to a quite different issue: how the notice of proposed rulemaking dealt with public comments, my own and those of ethers, regarding the particular hazards of I-131. For as I understand it, the dose calculations in the proposed rule are based on the probable external radiation dose to family members and other members of the public from a patient a given distance away. My comments, on the other hand, in focusing on the special daks posed by I-131, stressed the potential for internal contamination, by skin contact, inhalation, and ingestion. (See my commants of October 31, 1992, hereby incorporated.) In particular, I emphasized the risk of contamination from vomiting if, as not infrequently happens, a i therapeutic dose of I-131 induces nausea.
- These were comments filed in response to the NRC's announcement of the receipt of petitions for rulemaking. 57 F.R. 21043 (May 18,1992).
0
, , '" m QQ0 ) \~ C%
2 Numeroua other commenters, including health authorities of six states (Illinois, New York, Colorado, Alabama, Texas, and North Carolina) raised the same concern about I-131, though you would not know this from the notico of proposed rulemaking. The individual states cautioning about I-131 were the following: 4
-- New York.
The New York State Department of Health said of I-131: " At - dosages greater than 150 millicuries nausea and the likelihood of vomiting are more likely and present a risk of extensive contamination." (New York was willing to consider outpatient Qd treatment above 30 millicuries of I-131, but to a maximum of 80 9 millicuries, and then only under special circumstances.) C{L6C
-- Texas.
The Texas Department of Health observed that I-131 is "the most g radiotoxic byproduct material used for medical use," warranting especially close controls, }hgg
, -- Colorado.
The Colorado Deparment of Health commented that while a .- relaxation of the current 30-millicurie limit might be appropriate for [w mk "certain other isotopes," it did "not feel this is justified for patients ' l receiving lodine-131." % fp c coi .og b g , 9gg i - Illinois. The State of Illinois Department of Nuclear Safety likewise expresed' concerns, "especially in light of the request to release patients containing up to 400 mci (millicuries) of I-131." DMN
-- Alabama, %tE f *g The Alabama Department of Public Health expressed support for relaxing current release criteria for some radiopharmaceuticals, but g M,,
[vn6 declared itself "gpoosed to the petitivn in that it supports release of patients from hospital (institution) confinement whose body burden of Y W4 todine exceeds 30 millicuries,
-- North Carolina. . even as A4
& umy high as 400 The North Carolina Department of Environment, Health, and Natural Resources stated that while the "30 millicurie limit is indee \ry
.' arbitrary in that it has been generically applied to all gM1L radiopharmaceuticals," patients dosed with I-13Leould caus3 4 Jignifimnt radiation doses to " family members, coworkers and othe F ~peifsons they encounter," both from external gamma radiation and Vf@@
internal dose, gg
%MTS O d m ni5~titFx l MTb WUT#I c m p u t cs roAw1h bgd % b" d 1
yd b d1,M A N T* Q (dC M d W&ggWgb9 g,, w . goivp D [+ 3 (4. Two other states, as well as the NRC's own Advisory Committee o the Medical Uses of Isotopes ( ACMUI), recommended keeping the 30-D f
, millicurie limit for all radiopharmaceuticals, not just 1-131. And as tl notice of proposed rulemaking did mention, 21 Agreement States, meeting in 1992, recommended keeping the 30-millicurie limit for I-131 while relaxing it for other radiopharmaceuticals. TM Finally, it will be recalled that Dr. Carol Marcus, the author of one of the petitions before the NRC, originally proposed retaining the 30-millicuriu standard for I-131, but climinating it for all other radiopharmaceuticals.' In a November 9,1992, letter to the docket, kgb she used the word " ludicrous" to describe the contention of the American College of Nuclear Medicine that doses of 400 millicuries of ('(itd I-131 could safely be administered on an outpatient basis, pqd t
p9_, . In short, the concerns that I was expressing about I-131 in October 1992 turn out to be utterly mainstream: standard conservative practico. Nor are these concerns about 1-131 trifling. As I mentioned in my October 1992 comments, the transcript of a 1992 ACMUI meeting shows the Committee's chairman, Dr. Barry Siegel, worrying about the hazard to family members posed by diacmostic doses of 'is little as 5 millicuries of I-131. But although one commenter after another, as well as the states mentioned above, pointed to the special hazards associated with I-131, the notice of proposed rulemaking never mentioned this, nor did it suggest that one of the key issues in the rulemaking was whether I-131 should be in a class by itself for regulatory purposes. Nor is the issue of patient vomiting over mentioned. In my earlier comments, I also pointed out that anyone who has been treated with a therapeutic dose of I-131 is already severely hypothyroid (by design), and that this condition may impair the person's ability to follow safety guidelines for the protection of family members and other members of the public. (Judith Brown of ACMUI raised essentially the same issue in a 1992 ACMUI discussion of the proposal, when she asked how patients felt after receiving a treatment. ) This comment also was not dealt with in the notice of proposed rulemaking. Nor was there any response to my suggestion that although the NRC staff was justifying its proposal on grounds of the supposed psychological benefit to patients and their families, it might be more comforting to patients to know that they were minimizing the radiation
- I gather from Dr. L rcus's July 11, 1994, letter to the docket that her position on this point may since have changed. In case I have misunderstood her
) views, however, I suggest that the NRC and other interested persons read her aubmissions for themselves.
i l
4 dose to others by remaining in the hospital in radioactive isolation. Speaking from the experience of five inpatient treatments, radioactive isolation is unpleasant, but worrying that one is putting others at risk may be even less pleasant. My experience in that regard is not unique. Several moaths ago, I asked an NRC staff member, recently released from the hospital ae.er 23 hours confinement to receive a 100-millicurie dose of I-131, the following question: "If you had been given a choice between getting i the treatment as an outpatient and as an inpatient, which would you have chosen, do you think?" She replied: I personally would have preferred to stay in the hospital for the full three days (originally projected) until the thyroid was well below 29.9 [ millicuries] vice getting out with thyroid at 50 millicuries. If I had lived alone it might not have been a significant issue. I think, especially with children at home, the argument to bring patients home is ridiculous, too risky, too hard to keep isolated. I think my kids were more frightened that I was home, in a sequestered state, locked away upstairs as it were, taking my meals alone on paper plates, not being able to kiss them good night than they would have been had I stayed in the hospital for three days. We had a chair in the living room with masking tape marking a large X as well as one in the kitchen. Those were the only two place I could sit when I did come downstairs briefly. My husband slept on the couch for five days and used the boys' bathroom downstairs, 1tc. . . . That such concerns are not frivolous is confirmed by the American Journal of Public Health article (" Contamination of the Home Environment by Patients Treated with I-131: Initial Results"), placed in the docket by a commenter. It suggested that in-home contamination by patients dosed with I-131 could double family-members' risk of developing thyroid cancer. The same study found that of 12 adults studied, none was "willing to adjust living habits with their spouses because of the radiation therapy." (By contrast, they were willing to take steps to protect their children.) I suspect that with a larger sample, this finding would not hold up -- all the thyroid cancer patients I have known have been, like the NRC staff member just quoted, careful to protect their spouses from radiation - but this is nevertheless a data point that needs to be considered. If even a sizable fraction of patients will not follow radiation safety guidance to protect their own spouses, what reason is their to think that they will be rigorous about protecting total strangers, such as fellow passengers on public transportation, or the _ _ _ _ _ _ _ - - - _ _ _ _ _ _ _ _ -- _J
5 shoppers in the grocery store? (For example, a person dosed with I-131 who handles a piece of in11t and then does not buy it may leave behind a residue of contamination that may wind up in the thyroid gland of whoever later eats that pieca of fruit.) Consider also the observation of the North Carolina Department of Environment, Health, and Natural Resources that many thyroid cancer patients treated with I-131 are otherwise healthy, and "[r]eleasing such patients with the expectation that they will go home and lock themselves in a room for two or three days with limited contact with family and friends is not realistic." To be sure, the notice of prcposed rulemaking acknowledges North Carolina's commant, in the context of concluding -- sensibly -- that remaining at home does not constitute " confinement" for regulatory purposes. But that is not enough. The whole point of the proposed rule is to make it possible for the licensee to dispense with ccnfinement altogether if the calculated dose to any member of the public falls below certain limits. If a patient is single and lives alone, , and is given instructions for minimizing radiation dose to others, it may be easy to demonstrate that the criteria are met, but whether the public is actually protected will then depend entirely on whether the patient abides by the restrictions. The key issue, then, is whether it is reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others, and on this point the proposed rule is silent, despite the comments of states and others. Why has the NRC embarked on this novel course, in the face of such strong and unified opposition from health authorities in so many states, as well as its own ACMUI? Dr. Marcus has explained that the immediate occasion for her petition was a change in 10 CFR Part 20,
" Standards for Protection Against Radiation," that reduced allowable doses to members of the public from NRC-licensed activities by a factor of five. It appears that at the time that rule change was put into place, the issue of its applicability to the release of patients with radioactivity in their systems had not been thought through. As a result, the new rule, by dropping the maximum allowable dose to members of the public from .5 rem to .1 rem, could theoretically have been read to require many procedures that are normally performed on an outpatient basis to become inpatient procedures.
If this was the problem, there could have been a quick and easy fix. It would have been a relatively simple and non-controversial matter to propose a rule to make clear that the new Part 20 was not intended to alter the status quo for the release of patients. (The comments make clear that there is a consensus in favor of the .5 rem standard. ) But what the NRC has done is go much further, and propose a rule under which procedures that formerly were handled only on an inpatient basis could become outpatient procedures. Thus having first lurched (unintentionally) in the direction of imposing new and unnecessary conta 91s, the NRC has reacted by lurching in the opposite direction, to eliminate valuable, time-tested radiation
- _ _ _ _ _ _ _ _ _ _ - - . - - )
e v.;.: 1. 6 protection measures, over the objection of individual states, the Agreement. States as a group, and other commenters. No one should have the illusion that this rule change would simply give patients and doctors a choice between inpatient and outpatient
- treatment. -In practice, the pressure to contain costs would probably mean that insurance companies would pay only for the cheapest possible option, creating pressure on practitioners to find a way to justify out-patient treatments. In such cases, patients will not realistically have a choice, unless they are able to pay for I-hospitalization out of their own pockets. Most, whether they like it or not, will be outpatients, living at home, and their. families will be getting unnecessary radiation doses, so long as it is possible to -
calculats, on paper, a set of restrictions by which doses can be kept to .5 rem. In conclusion, I will frankly admit that as a commenter, I am disappointed that the notice of proposed rulemaking has not done more to come to grips with the issues raised in the public comments._- If commenters are not to_ be discouraged from participating in NRC-processes, the NRC owes it to the public (which in this case includes state health authorities) to offer.more evidence that it has so far_ given that it reads and thinks openmindedly about the comments that are filed. Whenever an agency fails to respond to major concerns rdsed in public comments on a rulemaking, there is a risk that members of-the public and others will view the notice-and-comment process as no
- more than a pro forma exercise, in which the conclusion is
' foreordained.' Moreover, agencies cannot expect reviewing courts to accord them the deference they normally receive on technicalissues
-when there is no articulated technical judgment to which to point.-
. Inf sum, the proposed rule is ill-advised, at least.with regard to I-131. The consensus of responsible health authorities on this point is clear, and the NRC should heed it.
Sincerely, Pete G. Crane The need to demonstrate that the agency has not prejudged the outcome, and is openminded ,with respect to views submitted by public_ commenters, is especially strong in the present case, given Dr. Marcus's repeated assertions, in
= letters filed in the public docket (gdt,., the letter of November 9,1992), that her petition-for rulemaking was filed at the request -- indeed, the insistence - of a then member of the' staff. E As I suggested in my earlier comments, I believe that the 'NRC _should clear the air and indicate one way or the other whether this rulemaking has been,'in Dr. Marcus's own phrase (in the November 1992 letter, in reference to an earlier rulemaking in which she was a petitioner), "an inside job
' from the start."-
', Th ff r+6 4 l-D-f Notes for Meeting on Patient Release Rule Major Issues: 4 Rule language: D( It should be noted that the MEb$ tis the dose to decay, not the $ cp' '), annual dose - this should belpelled out in rule language f(M Breast feeding infant - RES indicates 127,000 (SOC state ~ 70,000) patients undergoing NM procedures are breastfeeding - this number should be verified - furthermore, the determination of breastfeeding status and provision of - instructions will have a major impact on reg. analysis and should be clearly spelled out pe t +p Recordkeeping - no records required unless release is based on licensee calculations - should reconsider the need for records ed ,cd g' to demonstrate compliance with the rule, even if onlyo$,V,J reference that table was used - inspection implications p# T, U 35.75(c) - provides specific exceptions for which calculations are acceptable - recommend a general exception to conservative tables e.g., b}} If the release of the individual is based on ov '* factors other physical half-life and an occupancy (',.(F w for factor of 0.25 ata 1record three years, m, theof licensee the shall released maintain, M,<M',' v 7 equivalent g the highest to dose.another individual likely to receive g pg,(
+
Instructions - RES is still considering whether the d requirement a cost-benefit to provide written instructions is justified from perspective
'p[
recommend that written instructions are necessary for ALARA considerations
+
Reg. Analysis not completed - recommend waiting for Reg. Analysis to determine impact on rule before providing 0 concurrence - NMSS should review the revised Reg. Analysis
- 35. 315 (a) (6) and 3 5. 415 (a) (6) -
the recommended ' conforming i change makes these requiremente redundant - they should be eliminated
&5 Regulatory Guide D( h q
ACMUI recommended that a table should be included based on biological elimination as this represents a more realisticT case (otherwise licensees will be more likely to do case by case calculations)Wth~ ~ e argument for not being concerned with n multiple administrat' ions is based on biological cogiderations ,hv and yet we don't usetthem. '
- k. i A A f , .k
E .. 4 g Note: If effective half-life is used, the issue of internal dose being a consideration should be $ addressed. Also, this would argue for a record keeping requirement to indicate whether'the release was based on the table and if internal dose was a factor q g^ Reg. Guide does not reference NCRP Commentary for which NRC Npb issued a grant with the specific intent of getting 6 recommendations on this issue ,9 g
+
Table on Breastfeeding Infants - no statement of uncertainty N[ppb ' or that these are recommendations 91 , Activity tables are being revised with NRC generated nuutbers no gamma constants available for some isotopes such as Ir-192, P-32, etc. therefore RES believes that all tables should O9/} t' 0 be generated by calculational method kY recommend that published data should be used where available Minor Issues pD Need to make 'dLcision whether to- refer to patient as Id
' individual' or ' patient or human research subject' V
Consistency with wrong patient rule - e.g., identified as individual, changes to Part 20 definitior.s patient is tf
+
P17, SOC - statement that no routine nuclear- medical practice p 0-results in TEDE > 5 mSv due to multiple administrations is , misleading because this is based on realistic numbers and the d'4 Cp' tables provided are based on conservative numbers - furthermore, this is based primarily on personal opinions, it should be confirmed SI units should be used throughout
+
0d a, 3h ! f
~ fJ /Vts5 7Rg gg-gl- A
~
UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 September 29, 1994
..NRC-INFORMATION NOTICE 94-70: ISSUES ASSOCIATED WITH USE OF STRONTIUM-89 AND OTHER BETA EMITTING RADI0 PHARMACEUTICALS Addressees All U.S. Nuclear Regulatory Commission Medical Licensees.
Purpose The U.S. Nuclear Regulatory Commission is issuing this information notice to 3 alert its licensees of the following: A. special considerations for assaying pure beta emitting radiopharmaceuticals; B. safety considerations for managing patients who have been treated with therapeutic dosages of beta emitting radiopharmaceuticals; and C. physician training and experience requirements for the therapeutic use of radiopharmaceuticals other than 1-131 (i.e., strontium-89, rhenium-186, samarium-153). It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate. However, suggestions contained in this information notice do not represent new NRC requirements; therefore, no specific actions or written response is required. Descriotion of Circumstances The use of therapeutic quantities of pure beta emitting' radioisotopes may pose special technical difficulties. These difficulties include assaying of the radiopharmaceutical dosages and determining the isotope burden of the patient. Furthermore, opening of the body cavity or exposure to body fluids encountered in surgery, autopsy, embalming, or cremation may require special precautions to limit the possible spread of contamination from the radioisotope present in the patient. Strontium-89 (Sr-89) Metastron has an approved New Drug Application (NDA) from the Food and Drug Administration (FDA) for use in therapeutic amounts to reduce bone pain from raetastatic bone lesions. Other beta emitting radionuclides such as rhenium-186 (Re-186) and samarium-153 (Sm-153) are currently under review by the FDA for similar approval. Section 35.300 of 809218110 s
IN 94-70 September 29, 1994 Page 2 of 5 10 CFR Part 35 authorizes the therapeutic use of Sr-89 Metastron since an i10A has been approved by the FDA. However, the physician training and experience requirements for the use of Sr-89 or other pure beta emitting rt.dtonuclides are not explicitly addressed in 10 CFR Part 35. Therefore, this document explains the training and experience criteria for the therapeutic use of radiopharmaceuticals, other than 1-131. Discussion Assavino Dosaaes: Subpart C of 10 CFR Part 35 does not require the use of a dose calibrator to measure patient dosages of radiopharmaceuticals containing pure beta emitters. However, it is our understanding that the manufacturer of Sr-89 Metastron has participated in intercomparisons with the National Institutes of Standards and Technology (NIST) in the calibration of its beta measurement instruments. Therefore, until appropriate measuring instruments and standards are developed and available, reliance on the manufacturer's stated activity of the unit dosage may be the most accurate means, and an acceptable method, of determining the activity of the patient dosage. A licensee may use a dose calibrator to accurately measure the patient dosage containing pure beta emitters; however, there are inherent technical difficulties to overcome. These difficulties include, but are not limited to, dependence upon geometry, lack of an industry standard for the materials used in the manufacture of both vials and syringes, and a lack of a suitable Sr-89 calibration standard from NIST. For example, if there is a need to administer an activity different from the unit dosage supplied by the manufacturer, the licensee should perform either a volumetric adjustment based on the manufacturer's stated specific activity, or use the appropriate setting on a dose calibrator specifically designed and calibrated to measure beta activity. If the latter method is used, you should assay patient dosages in the same type of vial and geometry as used to determine the correct dose calibrator settings. The use of different vials or syringes may result in measurement errors due to the variation of bremsstrahlung created by interaction between beta rays and the differing dosage containers. Licensees are reminded that beta emitters should be shielded using a low-atomic-numbered material to minimize the production of bremsstrahlung, followed by a high-atomic-numbered material thick enough to attenuate the bremsstrahlung intensity. NRC recently became aware of a case where a licensee inz.dvartently administered a therapeutic dose of Sr-89 to a patient when a diagnostic dose of a different radiopharmaceutical was intended. Licensees may want to develop a method for distinguishing between therapy and diagnostic doses, such as physical separation or using a different colored label. If the procedures in your Quality Management Program (QMP) state that you will measure radiopharmaceuticals for therapy in a dose calibrator, you shobld either continue to measure the dosage in the dose calibrator after determining the appropriate dose calibrator setting or modify the QMP to state that you l l
-IN 94-70 September 29, 1994 Page 3 of 5 will rely on the manufacturer's calibration for unit dosages. Licensees are reminded-that modificatior,s to the QMP must be furnished to the appropriate NRC Regional Office within 30 days after the modification has been mad,e
[ (535.32(e)). , In addition, the proposed radiopharmacy rule published in the Federal Reaister, June 17,'1993, would require medical use licensees to measure dosages of alpha- and beta-emitting radionuclides, except for unit dosages obtained from the manufacturer or commercial nuclear pharmacy. Also, the proposed rule would allow a licensee to use a combination of measurements and calculations to determine the dosage of alpha- or beta-emitting radionuclides. It is anticipated that the final rule, which is scheduled to be approved by the Commission prior to issuance, will be published by early 1995. Manaaina Patients: Due to the long half-life of some alpha- or beta-emitting radionuclides, contamination of hospital or funeral home personnel and facilities, in the ' event of-surgery or death following administration of these radiopharmaceuticals, is possible. Licensees administering radiopharmaceuticals containing Sr-89, or other long lived isotopes, may wish to review NCRP Report No. 37, Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides, for guidance in managing these patients. Although the report does not specifically address Sr-89, it does provide a guide for persons concerned with care of patients who have received therapeutic dosages of radionuclides. Copies of this publication can be obtained by writing: National Council on Radiation Protection and Measurements 7910 Woodmont Avenue , Bethesda, MD 20814 i or, by phoning the NCRP at (301) 657-2652. Currently, the price is 520.00 plus 53.00 postage, fy gr) @ Q t
- The main source of exposure to workers h ndling deceased patients who have been administered Sr-89 (half-life of 50.5 days) is contamination from contact with body fluids. Using extremely conservative assumptions, an estimated skin dose to workers handling deceased patients was calculated by NRC staff. The calculations were based on the typical administered dosage of 4.05 mci-(150 MBq). Assuming that all of the activity was in the blood and the patient died 1mmediately, the skin dose to a worker not wearing gloves was estimated to be 447 mrads (4.47 x 10'3 Gy)perhour/-Assumingtheworkerwas contaminated with body fluids and worked for 4 hours with the patient, the skin dose would be about 1.8 rad (0~.18-Gy)'.,3 If the worker wears gloves, the skindoseisreducedto,180mrads11.8-x~10 Gy) per hour, which gives a skin dose of 720 mrad '(7,.2 Gy) when handling a patient for 4 hours. These skin doses are within egulatory limits; however, all necessary precautions should
~
betakentominimletthedoseasmuchaspossible. In fact, most patients do not die immediately After receiving Sr-89, and the Sr-89 is rapidly taken up in the extracellular luid and intracellularly, primarily in the skeleton with less than 1 percent- the dosage'present in the blood at 140 hours (about 6 k i M _ _ __..__
( IN 94-70 September 29, 1994 Page 4 of 5 days).' Therefore, any skin doses to a worker should actually be much lower than the ones estimated previously. Licensees should use typical precautions, e.g. use of gloves and protective clothing, in preventing contamination when using Sr-89 and other beta emitting radioisotopes for therapy. Workers should wash their hands and change into clean gloves and laboratory coats / gowns if the protective clothing becomes contaminated. The National Radiological Protection Board in the United Kingdom has performed a radiological assessment to estimate the impa people who have received treatment with Sr-89.ptThe nf cremating calcuistions corpses were basedof on an assumption that the entire dose of 4.05 mci (150 MBq) was present in the ash. The maximum dose to a crematorium worker would be about 0.01 mrem (0.1 pSv) (effective) from inhalation of ash, and about 0.02 mrem (0.2 vSv) (effective) from ingestion of ash. Again, these estimates were calculated using conservative assumptions. Normal precautions should be taken in handling the ash as with any other cremation. Workers typically wear protective clothing including barrier face masks or respirators when handling ash. Trainina and Experience: If a physician is currently authorized for the therapeutic use of radiopharmaceuticals, (10 CFR 35.300) and requests authorization for therapeutic use of radiopharmaceuticals other than 1-131 (i.e., P-32 or Sr-89), no additional authorization by license amendment from NRC is required. If a physician is NOT currently so authorized by NRC, the training and experience requirements described in 35.930 would apply, i.e., board certification by the American Board of Nuclear Medicine or the American Board of Radiology in radiology or therapeutic radiology; or 80 hours didactic training and supervised clinical experience with 3 case studies involving the radiopharmaceutical for which authorization is requested.
'Intemational Commission on Radiological Protection, No. 20," Alkakne Earth Metabolism in Adult Man,* Table 29, page 205.
2 Contract Report for the National Radiological Protection Board, United Kingdom: Cooper, J.R.; Waimsley, A.; and Charles, D.;
- Individual and Collective Doses from the Release of "Sr into the Environmeni Following Medical Administration: Assessment of the Radiological impact of the Cremation of Corpses Containing "$r;*
reproduced by A. Wright. 4
4 - IN 94-70 September 29, 1994 Page 5 of 5
. This information notice requires no specific action or written response. If you have-questions-about the information in this notice, please contact the technical contact listed below or the appropriate regional ,qffice. <
) tnfu Carl J. PaperiMio, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical contact: Torre Taylor, NMSS (301) 504-1062 Attachments:
-1. List of Recently Issued NMSS Information Notices
- 2. List of Recently issued NRC Information Notices i
Attachment 1
. IN 94-70 September 29, 1994 Page 1 of 1 LIST OF RECENTLY ISSUED NMSS INFORMATION NOTICES Information Date of -
Notice No. Subject Issuance Issued to 94-65 Potential Errors in 09/12/94 Al U.S. Nuclear Regulatory Manual Brachytherapy Commission medical Dose calculations licensees. Generated Using a Computerized Treatment Planning System 94-64 Reactivity Insertio;. 08/31/94 All holders of Ols or cps Transient and Accident for nuclear power reactors Limits for High Burnup and all fuel fabrication Fuel licensees. 04-47 Accuracy of Information 06/21/94 All U.S. Nuclear Regulatory Provided to NRC during Commission Material the Licensing Process Licensees. 94-39 Identified Problems in 05/31/94 All U.S. Nuclear Regulatory-Gamma Stereotactic Commission Teletherapy Radiosurgery Medical Licensees. 94-38 Results of a Special NRC 05/27/94 All holders of OLs or cps Inspection at Dresden for NPRs and all fuel cycle Nuclear Power Station and materials licensees Unit 1 Following a Rupture authorized to possess spent of Service Water Inside fuel. Containment 94-37 -Misadministration Caused 05/27/94 All U.S. Nuclear Regulatory by a Bent Interstitial Commission Medical Licensees Needle during Brachy- authorized to use brachy-therapy Procedure therapy sources in high , medium , and pulsed-dose-rate remote afterloaders, i
- s-
- Attachment-2=
.,-. IN 94-70' September- 29, 1994 Page 1 of 1 LIST OF RECENTLY ISSUED NRC INFORMATION NOTICES
-Information -
Date of- . Notice N:. Subject Issuance Issued to 94-69' Potential Inadequacies 09/28/94 All holders of Ols or cps Lin the Prediction of Torque for nuclear power reactors. Requirements for and Torque-Output of-Motor-0perated Butterfly Valves 94-68 Safety-Related Equip- 09/27/94 . All holders of Ols or cps ment Failures caused-by for nuclear power reactors. -l Faulted Indicating Lamps
'94-67 Problem with Henry 09/26/94 All holders of Ols cr cps Pratt Motor-Operated -for nuclear power reactors.
Butterfly Valves 94-66l _0verspeed of Turbine- 09/19/94 All holders of OLs or cps Driven Pumps Caused by " for nuclear power reactors. Governor Valve Stem = Bindir.g 94-65 Potential Errors-in 09/12/94 All U.S. Nuclear Regulatory Manual Brachytherapy _ Commis ..n medical Dose Calculations - licensees. Generated Using.a Computerized Treatment Planning. System-l94 Reactivity Insertion 08/31/94 . All holders of Ots or cps-for nuclear power reactors-Transient and Accident- , Limits for High Burnup and all fuel fabrication i Fuel licensees. 94-63 Boric-Acid Corrosion of 08/30/94 - All holders of Ols 'or cps - Charging Pump Casing- - _ for pressurized water Caused by_ Cladding Cracks -reactors, 94 Operational : Experience -08/30/94 All' holders of OLs or cps on Steam Generator Tube for pressurized water-Leaks and Tube Ruptures -reactors. 194-61 Corrosion of William 08/25/94 All holders of OLs or cps-Powell Gate Valve Disc - for nuclear power reactors.
-Holders- -
OL-~=.0perating License
.CP:= Construction Permit-
,nAtS a B PM~- 41 +
7 NEETING ON: PATIENT RELEASE l 9/19/94; Attendeos: Schneider, McGuire, Glenn, Camper, Holahan, Polycove)C 4hy Slide 9: Change "permissib, ' to " sufficient". Polycove said that instructions must be both written and oral. Slide 10: Polycove said that the records are no cost burden. Discussion and Summary:
- 1. Did a State ask for accelerator-produced isotopes? If so, this could be a basis for including in Table 2.
- 2. The ACMUI subcomittee meeting is schedulaed for October 20 in'the i afternoon, 3, 0001 and Paperiello agreed there is no need for recordkeeping.
- 4. An alternative is to require a record if the release is not based on the default ' values in Table 2.
A
- N ms occumn ~4 '?DE
- - - - &Ei W
. PATIENT RELEASE CRITERIA Major outstanding issues:
- 1. Should the breastfeeding infant / child-be addressed under this rule?
o Decision to administer to mother is patient-physician decision and not based on regulatory requirement to limit dose. Voluntary standards are available for use by physicians. IMPORTANT: The second statement of the medical Policy Statement says that "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate." - We recognize that the baby is not a patient. Is the baby a member of the public or part of a " medical unit" with the mother? o it is not a direct approach to limit the dose by tieing it to the patient release rule. [Does not address inpatients.) Breastfeeding should be addressed under a pregnancy / breastfeeding rule. Also recommended by ACHUI-subcommittee on 10/20/94. Data on the TEDE to a breastfed child is not well substantiated-due to the large number of unknown variables such as intake volume, activity in the milk, frequency of feeding o This rule may result in mothers being sequestered from their offspring.
- 2. Should the 100 millirem " threshold" be eliminated from the rule, i.e., written instructions and records required only at 500. millirem
-threshold?
o ACMUI subcommittee recommended to delete 100 millirem action level and to require written instructions as required by 35.315 and 35.415. (10/20/94 meeting) o Strongest opposition in the public comments was the recordkeeping-burden associated with the proposed ruie.
-Note, the bulk of the recordkeeping burden is associated with records generated for patients _ that exceed the 100 millirem threshold.
W Nm65 , L%cf3 To th OtScA%s5L D pT RF WM5 IWSTt ear % % m & u n dson S y b
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- I NIWitslTY OF CAllH)llNIA LOS ANGEL.ES UCLA DGGK, A o r 't , m.s
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January 24, 1995 F 6 ED -2 D I
'"* UCLA SCHOOL OF MEDICINE
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F ~ '95 m.15 PoTM '
"moC uc" "'o'c^t Ctsm The Honorable Ivan Selin, Ph.D.
DOCW. ""[NCSsTo sin $ Chairman . .
;; TorumCE. cAurosum a US Nuclear Regulatory doim,i'ssion 11555 Rockville Pike Rockville, MD 20852 DOCKET NUMBERea w PROPOSED RULE TR Em
Dear Chairman Selin:
f5Mocm4) ._ The purpose of this letter is to inquire about the reason for the puzzling delay concerning the " Patient Discharge Rule". This is NRC's rule which is supposed to state that the most exposed contact of a patient treated with radionuclide therapy should remain at the 500 mrem maximum, and that the methode. logy published by the National Council for Radiation Protection and Measurements (NCRP) in 1970 (NCRP no. 37) should be employed for estimating such doses. This would end needless and expensive hospitalizations. As a representative of the Society of Nuclear Medicine (SNM) and the American College of Nuclear Phycicians-(ACNP), I met with you on the subject of poor performance by NRC on this Proposed Rule
... published in the Federal Register on 15 June 94 (Criteria for the Release of Patients Administered Radioactive Material, RIN 3150-AE41, 59FR 30724-30732, and associated analysis and regulatory guidance).- our meeting was held in your office the third week of Sept. 1994, and dealt with the points made in my 18-page letter to NRC pointing out its serious scientific, mathematical, and medical mistakes. You agreed with my points, stated that NRC "had not done its homework", and vowed that it would ne repaired.
Given the fact that I did all the physics, math, pharmacokin-ethics, and pathophysiology for NRC, and contributed model calculations, model language and the pertinent references, one would assume that it would require no more than about an hour of NRC time to complete the rule. After all, it was NRc that asked 1 ne to write a' petition on the subject in the first place, in December of 1990. The reason for pushing for progress on this rulemaking is very simple. NRC is frivolously wasting medical dollars for no good reason at all. Let us see what NRC's delays are costing those who pay for health care in this country. According to NRC's estimates in the regulatory analysis of this rule, we treat about 50,000 patients y a year for hyperthyroidism. In my experience, about 20% require k total administered activities of NnI-131 greater than 30 mci, ' your present outpatient limit. As my experience is skewed by working in a public hospital whose patients often present with advanced disease, let us say that only 10% nationally require - areat than In additien, about 9 RQ$e.RIV230aci,or5000 (\' i Bey =u _patients w / year. 't
.I' bcnunry-'24, 199'd* Q)F s Tho H:nsroblo-Ivan Salin, Ph.D.
'Page ,
10,000 patients a year are treated with NaI-131 for thyroid cancer,, virtually.all of whom-require more than 30 aCl per therapy. Lot-us say that the average inpatient hospital cost for the hyperthyroid patient is $3000, and that the average cost for a thyroid cancer patient is $2000. .That is (3000)(5000)+(2000) (10,000)=15,000,000+20,000,000=$35 million per year, of unnecessary expenses. For 25 years, NRC has failed to understand NCRP no. 37, and these costs, in 1995 dollars, amount to about $675 million (assuming a mean population of 200 million) . For 4 years NRC has delayed my Petition, at a patient' cost of $140-million and a User Fee of Perhaps $0.5-1 million. For 6 months, all NRC had to do was copy my comment letter but instead cost patients $17.F million. During the 4 months after our meeting, NRC has cost America's patients about $12 million. While many. physicians "get around" NRC's "30 aci" rule, mainly for hyperthyroid patients, by breaking up administered activity into 30 aci chunks or less, no radiation dose is saved by the public, inpatient costs are avoided, but the patient may be ill for several extra months. It is not ethically acceptable that NRC should impose several extra monthe of-illness on patients who need to avoid costs that result from a scientifically unrespectable and foolish NRC regulation'in i
/ .the first placa.
I recommend that you rectify this situation immediately. If your- j Ataff.and management still-find it too difficult to accosplish, ' then-perhaps you could either copy my recommendations or those of an intolligent Agreement state, such as California. Tnank ycu.for your attention and consideration. Eincerely, [. ff7ktrn47 Carol S. Marcus, Ph.D., M.D. Director, Nuclear Med. Outpt. Clinic and Professor of Radiological-Sciences-UCLA,- Vice-President, Society of Nuclear Medicine and President, American College of-Nuclear Physicians, California Chapter Phone: (310) 222-2845 FAX: (310)-533-7159 cc: -Commissioner E. Gail:de Planque Hugh Thompson, Deputy EDO David Nichols, ACNP/SNM Conjoint Office}}