ML20216D113
| ML20216D113 | |
| Person / Time | |
|---|---|
| Issue date: | 08/29/1995 |
| From: | Cordes J NRC |
| To: | Bradley Jones NRC |
| Shared Package | |
| ML20013H248 | List: |
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-089, AE41-2-89, NUDOCS 9804150186 | |
| Download: ML20216D113 (28) | |
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rQ Lll Q NOTE TO BRAD JONES August 29, 1995 trad --
The patient release package is full of technical detail and findings that should make it rather difficult to attack successfully, given the usual deference the judiciary gives to agency technical expertise.
Even so, in view of Peter Crane's expressed intent to file a suit challenging the rule, I would suggest that the agency elaborate a bit on its responses to some of Peter's points:
1.
In response to the point that husbands and wives undergoing treatment "might not keep physically distant from their spouse," the FR Notice simply says that these couples "would be making their own informed decision."
This sounds a bit cold to me.
Shouldn't the FR Notice add some of the flavor of the Regulatory Analysis, which (insofar as I understand it) apparently concludes that there is virtually no risk even if
" stay apart" instructions are disregarded?
Couldn't the FR Notice also make the point that American medical practice routinely depends on patients following instructions, such as instructions when and how to take medications?
Whatever might be said, I think that the FR would do well to avoid the implication that risk-creating or self-destructive behavior is likely, but is no concern of ours.
2.
One of Peter's letters rather elaborately points to many states that opposed relaxing the release criteria for patients receiving doses of I-131.
The FR Notice says that states "did express concerns," but " Agreement States were generally favorable to the [ proposed rule's) approach."
To me this is entirely too Did the states that "did express concern" later abandon vague.
their concern?
What was their concern?
Did the Agreement States' " generally favorable" reaction extend to the I-131 issue?
When we say " Agreement States" are we talking about an organization, or individual states?
How many states?
Our response to Peter's point should make these things more clear.
It would be far better, in my view, to acknowledge (if true) that some states opposed the NRC's proposed I-131 approach, and then explain why in our expert judgment those states' objections are mis'placed.
Or perhaps, as the rulemaking developed, the state opposition evaporated.
If that is so, we should say it.
If Peter sues us, he is sure to stress any examples of the NRC mischaracterizing or ignoring opposing views.
An agency failure l
to explain itself clearly or to respond to comments is far more likely to lead to trouble in the courts that a forthright resolution of technical or policy disagreements.
9804150186 980402 1
't 3.
Peter lays heavy stress on alleged process problems during the rulemaking, particularly inside influence by Carol Marcus.
I suggest saying something brief about the process issue, if only to deny the charge of insidious influence.
Didn't the EDO issue.something cautioning the Staff on how much help it could provide rulemaking petitioners?
Is there anything in the rulemaking docket describing the Selin-Marcus conversations?
Perhaps something could be derived from these materials to defang Peter's process complaint.
Silence in the face of a strongly-worded attack leaves me a little uncomfortable.
Thanks for showing me the rulemaking material.
John Cordes 1
e Leo's Addendum to note to Brad Jones--
1.
I agree with John's comments, especially the comment about the need for more specificity regarding the Agreement States' views on I-131. Also, Peter apparently claims that the ACMUI opposed the rule.
The staff's answer is:
"The ACMUI was generally supportive of the approach in this rule." Like the Agreement State response, this is too vague.
... generally supportive of the approach..." leaves open the possibility that the ACMUI did not support the specifics of the rule as it applies to I-131.
2.
The response to commenters' concerns about risks of internal exposure needs to be more detailed, in my view. As written, the response simply says that the " proportion" of the administered radioactive material that winds up as accessible contamination will be "small," and doses from contamination will be "relatively low compared to direct external exposure." The comparison between direct external exposure radiation doses and internal doses from I-131 may not be very meaningful, as Peter is very likely to argue.
In the case of I-131 external exposure (presumably, whole body dose from gamma radiation emitted by I-131 inside the patient's body) probably has little health significance for innocent bystanders compared to the thyroid dose from any I-131 that might be ingested.
1-131 is, I think, of major health concern only when it gets inside you, whereupon it concentrates in your thyroid.
Thus the possibility that a family member or innocent bystander could ingest I-131 from contact with contaminated material that the patient has excreted through sweat, spit, tears, vomitus, or whatever could have much more health significance than external exposure.
Peter specifically makes this point in the Letter numbered 25, where he discounts external radiation doses and stresses "the potential for internal contamination, by skin contact, inhalation, and ingestion."
I think our response should take special note of the difference between concerns about external radiation dose and internal contamination and explain (if it can) why neither one is a serious problem at the levels the rule permits. There does seem to be plenty of evidence in the NUREG that sweat and vomit from released patients. don't contain a significant amount of I-131, but we should be explicit about this.
Citing the NUREG, the response gives what seems to be an adequate answer to Peter's concerns about vomiting.
The response should also say something about Peter's other examples of contamination risks-- the released patient who handles fruit or picks up toys in the dime ~ store or hangs from a strap in the subway, thereby (according to Peter) depositing through sweat a significant amount of 1-131 that other people will pick up and absorb to their potential detriment.
NUREG-1492 has some numbers that seem to show that very little I-131 actually gets into sweat. These should be quoted and related in a fairly quantitative way to Peter's sweaty examples. We'll be seeing these examples again in any brief Peter might happen to file.
Also, on page 2 of Letter 54 Peter describes the extensive precautions that the hospital takes to deal with " contamination through bodily fluids of all kinds." This kind of thing will make its way into a Statement of Facts in a brief.
If contamination is the relatively insignificant problem the response says it is, why do the hospitals do all this?
I presume it is because the radioactivuv has not yet diminished to levels at which patient release would be contemplatt.d even under the new rule.
The notice should be explicit about
this and be fairly clear about the timing, so that we will have something to point to in court.
4.
Th'e Notice of Final Rulemaking frequently characterizes dose limits 'as the dose "an individual (should) be allowed to receive." P. 9 for example. This language is appropriate when dealing with occupational exposure, but it is quite inappropriate here. No one is requesting permission to receive radiation doses from released patients.
The limits should be described as "the maximum dose to which persons other than the patient may be exposed," or something along that line.
5.
On P. 9 we say."it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 1 millisievert more than once in a l i fetime. "
Is this really unlikely? What about the families of patients, like Peter, who get repeated doses of I-131 year after year in an extended course of treatment?
Also, on p 9 it says that "Section 20.1301(c) provides that an annual dose of up to 5 millisievert is acceptable provided that it is of relatively short duration...."
Section 1301(c) doesn't say anything about doses of "short duration," whatever that might mean. A dose is a dose.
1301(c) seems to be talking about the duration of the activities that might give rise to the dose. What is the rationale underlying the.5 rem exception in 1301(c) and why'is it relevant here?
6.
P. 15. OK, so I'm ignorant.
What is a " gray"?
7.
P. 46, paragraph (2), says that the final rule arants a request to retain the 30 mci limit for I-131.
It does? Then why is Peter complaining?
I thought the rule went to a dose limit standard for all isotopes.
.\\
i 1
I I
PATIENT RELEASE CRITERIA FINAL RULEMAKING REVISIONS TO FINAL RULEMAKING PACKAGE BASED ON OGC/ SOLICITOR COMMENTS DATED 08/29/95 John Cordes:
1.
Followina of instructions: The Federal Register Notice has been revised in accordance with the OGC comments provided. See attached.
2.
Aareement States:
The Federal Register Notice has been revised in accordance with the OGC comments provided.
See attached 3.
Process issue,- Brad Jones, 0GC, is providing a footnote to be included in the Commission Paper that addresses the issue.
Leo Slaggie's Addendum to note to Brad Jones:
1.
More specificity reaardina Aareement States:
See "Following of instructions" above.
i ACMUI onoosed the rule: The Federal Register Notice has been revised in accordance with the OGC comments provided.
See attached 2.
Followina of instructions: The Federal Register Notice has been revised in accordance with the comments provided. See attached.
Examples of contamination risk:
Need to discuss with Brad Jones, 0GC.
3.
Contamination in the hosoital:
Need to discuss with Brad Jones, 0GC.
I 4.
Public dose limit:
The Federal Register Notice has been revised in accordance with the comments provided.
See attached.
5.
Multiole exposures:
The Federal Register Notice has been revised in accordance with the comments provided.
See attached.
6.
Meanina of the term "arav.": The term " gray" no longer appears in the FRN text because the response on the issue of the risk of developing thyroid cancer has been revised.
See attached.
7.
30 mci limit for iodine-131: The Federal Register Notice has been revised in accordance with the comments provided.
See attached.
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find someone who can translate for the patient if necessary.
The requirement that written instructions be given to the patient does not preclude oral instructions.
Comment. Several commenters asked how the NRC would enforce implementation of the instructions given to the patient. Another commenter asked how the licensee could verify that the instructions are followed.
Another commenter said that a sizable fraction of patients may not follow radiation safety instructions to protect spouses and may be even less careful I
about protecting total strangers. This commenter also asked whether it is j
reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others.
Response. The NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's responsibility.
Eollow W 4ha,.
,igs,truc,tiossais2aormal.lyc,thaaresponsibilitysofctheepatient. However Jhtedcas.
endicalvpractice rout W depends;on patients;followingrinstructions,ssuchmass instructionsuon,when4andc.how2to take.,. medications..
n With regard to compliance with the instructions, surveys of patients and their spouses, as discussed. in the supporting regulatory analysis, indicate that most will attempt to follow the instructions faithfully, especially with regard to protecting their children, Alt.hqugh,some patients and their spouses indicated that they might not keep physically distant from their spouse for prolonged periods of time.
Stiedies of-deses-received by1 ndividuals-exposed o t p a(Le[!t s.,jadisaht h atstha,<andel s a usedhthe&araiganar.a))y.
t x conservat iveMove rpred i ct= theido se Ei nt mostt c ases rRThu s rithereli s;;a'.:merg in,
23 Attachment I
ofusafety4 built into the dose.: calculations that allows forxsome: noncompliance withathevinstructions withouttexceeding-the doseslimit.
Consent. One commenter said that instructions should be given for all administrations of radioactive material, regardless of the quantity administered.
Response. The NRC does not agree.
In some cases, particularly in the large number of diagnostic administrations, the potential doses are so small that the burden of requiring instructions cannot be justified. Under the final rule, if the dose to any individual exposed to the patient is not likely to exceed 1 millisievert (0.1 rem), instructions are not required but the physician could give any instructions that he or she considers desirable.
CONFINEMENT OF PATIENTS i
Consent. Two commenters said that patients cannot be confined against their wishes and that the rule provides no penalty for the patient who leaves confinement in the hospital "against medical advice." Another commenter said that the rule seems to require that the licensee have control of the patient's activities after release.
Response. The NRC recognizes that patients cannot be held against their will. The rule deals with the conditions under which the licensee may authorize release. The NRC would not penalize a licensee for the activities 24
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reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others.
Response. The NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's responsibility.
Following of the instructions i h or the patient.
With regard to compliance with the instructions, surveys of patients and their spouses, as discussed in the supporting regulatory analysis, indicate that most will attempt to follow the instructions faithfully, especially with regard to protecting their children.
Some patients and their spouses 1
indicated that they might not keep physically distant from their spouse for prolonged periods of time. EBii!4ilHkWMinlibTn hieTMiWMilRueWAMsakim hidteNitWrentwhateis:reasemeWrN I
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Comment. One commenter said that instructions should be given for all administrations of radioactive material regardless of the quantity administered.
Response.
The NRC does not agree.
In some cases, particularly the large number of diagnostic administrations, the potential doses are so small that the burden of requiring instructions cannot be justified. Under the final rule, if the dose to any individual exposed to the patient is not likely to exceed 1 millisievert (0.1 rem) instructions are not required but the physician could give any instructions that he or she considers desirable.
CONFINEMENT OF PATIENTS 24 Attachment I l
Gl&M&&d eItre.d -tegf OmqwAL TEKF
- reasonable to expect that released patients will alter their behavior and limit their activities for the protection of others.
I Response. The NRC does not intend to enforce patient compliance with the instructions nor is it the licensee's responsibility. Following of the instructions 1 N or the patient.
With regard to compliance with the instructions, surveys of patients and their spouses, as discussed in the supporting regulatory analysis, indicate that most will attempt to follow the instructions faithfully, especially with regard to protecting their children. Some patients and their spouses indicated that they might not keep physically distant from their spouse for prolonged periods of time. WAlfETs~ Multi MnTJJiiie7isimpWigidMGAEWEmekt;$
deb W whateisJanssen%ggM Comment. One commenter said that instructions should be given for all administrations of radioactive material regardless of the quantity administered.
I Response. The NRC does not agree.
In some cases, particularly the large number of diagnostic administrations, the potential doses are so small that the burden of requiring instructions cannot be justified.
Under the final rule, if the dose to any individual exposed to the patient is not likely to exceed I millisievert (0.1 rem) instructions are not required but the physician could give any instructions that he or she considers desirable.
CONFINEMENT OF PATIENTS 24
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In general, the physical reactions (e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare.
Vomiting is seldom an important elimination route for radiopharmaceuticals after the patient has left the medical facility since orally administered radiopharmaceuticals such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system.
Regarding the comment on the doubling of risk of developing thyroid cancer, there is no scientific consensus by the United Nations Scientific Committee on the Effects of Atomic Radiation, ICRP, or NCRP to support the increased risk of thyroid cancer following ingestion of iodine-131.
Therefore, NRC can draw no conclusion with regard to the validity or invalidity of the cited case study.
Comment. One cownenter said that the proposed rule did not adequately address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries.
Response.
In commenting on the petitions, atnumbem edEhStates expressed concerns about releasing patients administered it.8agjgabecquecah.
Mlj9f18Mgf.dWinen% %enezofether pe ti ti onersaroquestad a However, the Agreement States tskat*mntediantthesproposederale,were generally favorable to the approach in the proposed ruleilimitingethesdoseatea WooggotedQ3 jyjg,tyg,@,K5iiETFS
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d generallympermittraleaseslofson.ly;:thosa;patientncontainiP 3
ea14.8;gigabecquftrelsd400rmillicur.ies)tofidodined%g None of the States that 15
commented on the proposed rule indicated that the concerns of the Agreement States were misrepresented.
In fact, one Agreement State commented that it
~
was pleased that the NRC had considered the comments made by the Agreement States at various meetings with the NRC.
Comment. One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member might exceed 0.5 rem becausa the -elease might be beneficial and acceptable to family members. Another commenter ssid that a dose of 0.5 rem to an individual exposed to a patient has so little hazard that the NRC should not be concerned with it.
Response. The NRC does not believe that individuals exposed to a patient should, in general, receive doses in excess of 5 millisieverts (0.5 rem).
This is consistent with the recommendations of the ICRP in ICRP Publication 60,' "1990 Recommendations of the International Commission on Radiological Protection;" and the recommendations of the NCRP in NCRP Report I
No.116,' " Limitation of Exposure to Ionizing Radiation." Each of these recommendations provides a basis for allowing individuals to receive annual doses up to 5 millisieverts (0.5 rem) under certain circumstances.
Both the ICRP and the NCRP recommend that an individual be allowed to receive a dose up
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990).
Available for sale from Pergamom Press, Inc., Elmsford, NY 10523.
' National Council on Radiation Protection and Measurements, " Limitation of Exposure to Ionizing Radiation," NCRP Report No. 116 (March 31, 1993).
Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.
16 i
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Response.
In commenting on the petitions, 6 States
- 4 express concerns about releasing patients administeredhapusussages of
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iodine-131. However, the Agreement States were generally favorable to the approach that was contained in the proposed rule',8 W sone of the States that commented on the proposed rule indicated that the concerns of the Agreement States were misrepresented.
In fact, one Agreement State commented that it was pleased that the NRC had considered the comments made by the Agreement States at various meetings with the NRC.
l Comment. One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member l
might exceed 0.5 rem because it might be beneficial and acceptable to family z
. members in some cases. Another comenter said that a dose of 0.5 rem to an individual exposed to a patient has so little hazard that the NRC should not be concerned with it.
Response. The NRC does not believe that individuals exposed to a patient should, in general, receive doses in excess of 5 millisieverts (0.5 rem). This is consistent with the recommendations of the ICRP in ICRP Publication 60,' "1990 Recommendations of the International Commission on j
Radiological Protection;" and the recommendaticns of the NCRP in NCRP Report
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990). Available for sale from Pergamom Press, Inc., Elmsford, NY 10523.
16
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IV. Coordination with NRC Agreement States The NRC staff discussed the status of this rulemaking effort at two public meetings: the Agreement State Managers Workshop held on July 12-14, 1994 and at the All Agreement States Meeting held on October 24-25, 1994. The Agreement States expressed no objections to the approach in this rule.
V.
Coordination with the Advisory Committee on Medical Uses of Isotopes The Advisory Committee on Medical Uses of Isotopes (ACMUI) is an advisory body established to advise the NRC staff on matters that involve the administration of radioactive material and radiation from radioactive material. The NRC staff presented a summary of the comments on the proposed rule to the ACMUI during a public meeting held in Rockville, Maryland, on November 17 and 18, 1994.
Drafts of the final rule and regulatory guide were discussed with ACMUI in Rockville, Maryland, on May 12, 1995. ThehACM&ls
_ _,, rtrN, r iMitNttii'sfM1 Mutauxpressedecencetfhahoug e.e, Ly% uui uin. Transcripts of the meetings have' been placed in and are available for examination at the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, DC.
VI.
Discussion of Text of Final Rule This section summarizes the final rule. The NRC is amending 10 CFR 20.1301(a)(1) to state specifically that the dose to individual members of the public from a licensed operation does not include doses received by 38
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4
()(?){ N4L T'En'V with 10 CFR 35.75.' Considering this NRC requirement and the recent reference cited in the final regulatory analysis on the cost of hospitalization, $1,000 per day for a hospital room is a reasonable estimate.
Consent. One commenter said that the description of the measured doses received by family members was not consistent with the reference cited.
Response. The comenter is correct. An incorrect reference was given.
The final regulatory analysis provides the correct reference.
IV. Coordination with NRC Agreement States The NRC staff discussed the status of this rulemaking effort at two public meetings: the Agreement State Managers Workshop held on July 12-14, 1994 and at the All Agreement States Meeting held on October 24-25, 1994. The Agreement States expressed no objections to the approach in this rule.
V.
Coordination with the Advisory Committee on Medical Uses of Isotopes The Advisory Committee on Medical Uses of Isotopes (ACMUI) is an 1
advisory body established to advise the NRC staff on matters that involve the j
administration of radioactive material and radiation from radioactive material. The NRC staff presented a summary of the comments on the proposed i
i rule to the ACMUI during a public meeting held in Rockville, Maryland, on November 17 and 18, 1994. Drafts of the final rule and regulatery guide were discussed with ACMUI in Rockville, Maryland, on May 12, 1995.
The ACMU N 37 j
y 7, 7 M supportigof the approach in this rule. Transcripts of the l
meetings.have been placed in and are available for examination at.the NRC
. Publici ocument Room, 2120 L Street' NW. -(Lower Level), Washington,' DC.
D l
VI. Discussion of Text of Final Rule This section summarizes the final rule. The ARC is amending 10 CFR 20.1301(a)(1).to' state-specifically that the dose to individual members i
of the public from a licensed operation does not include doses received by individuals exposed to patients who were released by the licensed operation under the provisions of 10 CFR 35.75. _This is not a substantive change.
It l
is 'a' clarifying change to make clear that the Commission's policy is that J
patient release is governed by_10 CFR 35.75, not 10 CFR 20.1301.
'For the sake of consistency and clarity, the same words are used in l
i 20.1002, " Scope"; in-1 20.1003, " Definitions" (in the definitions.of both public dose and occupational dose); and in i 20.1301, " Dose limits for-
)
individual members of the public." Also for consistency and clarity, the exclusion of dose from background radiation and from voluntary participation in medical research programs that are now included in il 20.1002 and 20.1003 are added to i 20.1301(a).
The NRC is amending 10 CFR 20.1301(a)(2) to state specifically that the limit on dose in unrestricted areas does not include dose contributions from individuals administered radioactive material and released in accordance with 10 CFR 35.75..The purpose of this change is to clarify that after a patient has been-released under 10 CFR 35.75, licensees are no longer required to control radiation from the patient. The regulation uses the term " individual" l
i 38
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" bE\\ll$ [C)N patients dosed with I-131 could double family members' risk of developing thyroid cancer.
Response. The concern over contamination is.not justified by the radiation doses that are likely to be caused by the contamination.
Measurements from several studies, as discussed in the supporting regulatory analysis, have shown that a relatively small proportion of the radioactive material administered will appear as contamination. Doses to individuals exposed to boommesiiuredm4ntsevemL, stadia &d@everyTetseMsgsvtmM99PpurdentM5ElffDMewerle(45-rgiq[
gytA(e{factJve dose equivalentM11mittand'weve'Mit 6ftenklesssthavthper_ecen T
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x v.aishedantlMstaverAtfq.5-rem)3 Jmi}g.I,n,tadditionethednternalvdamas 1
emm3Mae:frasadasjaatj on, we.re.tg ene ral l yyfan,lessg)andhe; extern,al dose, ganlagjihitJgLtgi,.naMontw3s therless;depor.tantisoWeefof:&adtam a
mA4R9mrAerJThpAermeasurementsashow.,thatd9ntamination doetnotgm t
3aiceptablye,hi.ghWesus. These measurements are discussed in NUREGk1492s Also, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No.11,
'? Dose Limits for.
Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, "... a contamination incident that could lead to a significant intake of radioactive material is very unlikely."'
In general, the physical reactions (e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare.
' National Council on Radiation Protection and Measurements, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Commentary No. 11 (February 28,1995).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
14
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y patients dosed with I-131 could double family members' risk of developing thyroid cancer.
Response. The concern over contamination is not justified by the radiation doses that are likely to be caused by the contamination.
Measurements from several studies, as discussed in the supporting regulatory analysis, have shown that a relatively small proportion of the radioactive material administered will appear as contamination.gyspalmsg6 N MadMhlb.^2$12^dhiMI.EG!'Oh%fi M eenianumwatedenashedaeannet netWMw'wertie1***.t=1 mms g g si M M E N Doses to individuals exposed to98Mr patient from7pathwaystether2 thin?d1FnEtriftElkilW e
taxposuggageTyt4 Nave been measured in several studies and f**Merte?MRiitMRPWrRRupsuetMMffiRiiiET6 afreutthe$st44LatmbeenstMeedigthiTdrWWdiiVMHhW69W71RjUtW4dPf-1FF W These measurements are discussed in the supporting regulatory analysis aWatsyy.1Gutde*8739189161WiTd7dEPit4HtVTAddiGW935dppdf
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irr Ag(spas 46 In addition, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No.11. " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, "... a contamination incident that could lead to a significant intake of radioactiva material is very unlikely."'
' National Council on Radiation Protection and Measurements, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Commentary No. 11 (February 28,1995).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
14
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j In general, the physical reactions (e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare.
Vomiting is seldom an important elimination route for radiopharmaceuticals after-.the patient has left the medical facility since orally administered radiopharmaceuticals such as iodine-131 are _ rapidly absorbed, within a half hour, by the gastrointestinal system.
Regarding the comment on the doubling of risk of developing thyroid cancer, there is no scientific consensus by the United Nations Scientific C m ittee on the Effects of Atomic Radiation, ICRP, or NCRP to support the increased risk of thyroid cancer following ingestion of iodine-131.
Therefore, NRC ca.. draw no conclusion with regard to the validity or invalidity of the cited case, study.
Comment. One commenter said that the proposed rule did not adequately address t'he concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of.30 millicuries.
Response.
In commenting on the petitions, a number of States expressed concerns about releasing patients administered 14.8 gigabecquerels (400 millicuries)-of iodine-131, which one of the petitioners requested.
However, the Agreement States that commented on the proposed rule were generally favorable to the approach in the proposed rule limiting the dose to the most exposed individual to 5 millisieverts'(0.5 rem). This limit would generally' permit releases of.only those patients containing much less than 14.8 gigabecquerels (400 millicuries) of iodine-131. None of the States that 15
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q controlled for those patients not meeting the release criteria in 10 CFR'part 35.
The NRC proposed to adopt a new 10 CFR 35.75(a) to change the patient release criteria from 1,110 megabecquerels (30 millicuries) of activity in a patient or a dose rate of 0.05 mil 11 sievert (5 millirems) per hour at 1 meter from a patient to a total effective dose equivalent not to exceed 5 millisieverts (0.5 rem) in any 1 year to an individual from exposure to a released patient. A dose-based limit provides a single limit that could be used to provide an equivalent level of risks from all radionuclides. Also, the proposed changes were supported by the recommendations of the ICRP and the NCRP that an individual can6eceive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations when exposure to radiation is not expected to result in doses above 1 millisievert (0.1 rem) for long periods of time.
The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that the licensee provide released patients with written instructions on how to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem)_in any 1 year. A requirement to give instructions to certain patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the proposed requirement would also require instructions for an additional 50,000 individuals who are administered iodine-131 for the treatment of hyperthyroidism and another 27,000 individuals who are breast-feeding and administered various diagnostic and therapeutic radioactive materials. The purpose of the instructions is to maintain doses to individuals exposed to patients as low as is reasonably achievable.
6
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Consent. One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member might exceed 0.5 rem because the release might be beneficial and acceptable to family members. Another commenter said that a dose of 0.5 rem to an individual exposed to a patient has so little hazard that the NRC should not be concerned with it.
Response. The NRC does not believe that individuals exposed to a patient should, in general, receive doses in excess of 5 millisieverts (0.5 rem).
This is consistent with the recommendations of the ICRP in ICRP Publication 60,' "1990 Recommendations of the International Commission on Radiological Protection;" and the recommendations of the NCRP in NCRP Report No.116,' " Limitation of Exposure to Ionizing Radiation." Each of these recomendations provides a basis for allowing individuals to receive annual doses up to 5 millisieverts (0.5 rem) under certain circumstances.
Both the can ICRP and the NCRP recommend that an individua receive a dose up to 5 millisieverts (0.5 rem) in a given year in situations when exposure to radiation is not expected to result in doses above 1 mil 11 sievert (0.1 rem) per year for a long period of time, as would be the case for doses from released patients.
In NCRP Commentary No.11, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients,"' the NCRP
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990). Available for sale from Pergamom Press, Inc., Elmsford, NY 10523.
' National Council on Radiation Pr6tection and Measurements, " Limitation of Exposure to Ionizing Radiation," NCRP Report No. 116 (March 31, 1993).
Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.
16
3Mwmuna Mded DEL
[
to refer to the individual to whom the radioactive material has been i
l administered rather than " patient" to clarify that the regulation refers to anyone receiving a medical administration.
The NRC is amending 10 CFR 20.1903(b) to use the term " licensee control" rather than " confinement" because the latter term no longer applies to 10 CFR 35.75.
The conforming change is necessary since the term " licensee control" more clearly reflects the NRC's intent in 10 CFR 35.75.
The NRC is adopting a new 10 CFR 35.75(a) to change the patient release criteria from 30 mil 11 curies of activity in a patient or a dose rate of 5 millirems per hour at 1 meter from a patient to a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual j
from exposure to a released patient.
(The dose from the radionuclide involved is taken to be the dose to total decay.) A dose-based limit provides a single limit that can be used to provide an equivalent level of protection from risks from all radionuclides. Also, the changes are supported by the recommendations of the ICRP and NCRP that an individual carn receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where exposure to radiation is not expected to result in annual doses above 1 millisievert (0.1 rem) for many years.
Usually, the only individuals likely to exceed a dose of 1 mil 11 sievert (0.1 rem) will be those who are aware of the patient's condition such as the primary care-giver, a family member, or any other individual who spends significant time close to the patient.
This dose-based rule would, in some instances, permit the release of patients with activities greater than currently allowed.
This is especially true when case-specific factors are evaluated to more accurately assess the dose to other individuals.
The individuals exposed to the patient could 39
'I
W"W % W SL4% I L MrnEg p {
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n bM % o rS III.
Public Comments on the Proposed Rule i
A total of 63 comment letters were received on the proposed rule, the draft regulatory guide, and the draft regulatory analysis. A majority of the comment letters were from medical practitioners and medical organizations, but i
there were also comment letters from private individuals, public-interest groups, and regulatory agencies in Agreement States,. Overall, the majority of comment letters supported a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material. However, about one-fourth of comment letters opposed the proposed recordkeeping requirement. The significant comments are discussed below, arranged by subject.
EXCLUSION OF PATIENT RELEASE FROM l 20.1301(a)
All the commenters except one supported governing patient release by the regulations in 10 CFR 35.75 and excluding the dose to individuals exposed to a
' released patient fron.10 CFR 20.1301(a).
Comment. One commenter, representing a public-interest group, objected to any exposure of a member of the general public who has not consented freely to the dosage. They said that such exposure would lead to widespread j
morbidity and mortality.
Response.
In its revision of 10 CFR part 20 (56 FR 23360; May 21, 1991), the NRC determined that, while doses should be maintained as 8
)
low as is reasonably achievable, a dose limit of 1 mil 11 sievert (0.1 rem), or a dose limit of 5 millisieverts (0.5 rem) in certain special circumstances, provides adequate protection. The revised Part 20 is based, in part, upon the recommendations of the International Commission on Radiological Protection (ICRP) and the recommendations of the National Council on Radiation Protection and Measurements (NCRP). The NCRP recommends public dose limits of 1 mil 11 sievert (0.1 rem) for continuous or frequent exposure and 5 millisieverts (0.5 rem) for infrequent exposure. The ICRP recommends that the limit for public exposure should be expressed as an effective dose of
/
1 at111 sievert (0.1 rem) in a year, except that, in special circumstances, the dose could be higher in a single year provided the average over 5 years does not exceed 1 mil 11 sievert (0.1 rem) per year.
In the case of released patients, it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 1 mil 11 sievert (0.1 rem) more than once in a lifetime lungandeepoifAbsppeptistdesescarawafetyradministened:morec&gs w The revision of Part 20 incorporated the long-term objective as the dose limit and included a provision (20.1301(c)), to allow for alternative limits on an occasional basis.
Section 20.1301(c) provides that. an annual dose of up to 5 millisteverts (0.5 rem) is acceptablenifr4here th a g ed A n
'99f*tnd if steps are taken to reduce the dose to as low as is reasonably achievable. The NRC reaffirms that previous determination in this rulemaking.
Comment. One commenter said that the NRC should change the 0.1 rem dose limit for the public in 10 CFR 20.1301(a)(1) to 0.5 rem for all licensed activities because a dose limit of 0.5 rem offers adequate protection and is a dose that has no proven effects.
9
4EEMMIEipyg dddd i
0/14 g nc A % x f low as is reasonably achievable, a dose limit of 1 millisievert (0.1 rem), or a dose limit of 5 millisieverts (0.5 rem) in certain special circumstances, provicus adequate protection.
Part 20 of Title 10 of the Code of Federal Regulations is based, in part, upon the recommendations of the International Commission on Radiological Protection (ICRP) and the recommendations of the National Council on Radiation Protection and Measurements (NCRP). The recommendations of both of these organizations include both a long term objective to be achieved, and short term limitations on the maximum dose for any one year.
Both the ICRP and the NCRP rjacadmand-that an individual be a%wed to receive a dose up to 5 millisie.verts (0.5 rem) in certain special s
circumstances wnere exposure to radiation is not expected to result in doses averaging above 1 millisievert (0.1 rem) for long periods of time.
For the case of released patients, it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 1 millisievert (0.1 becaw>vAcr^y 4 W- 0 den n % WM rem) more than once in a lifetime The revi:: ion of Part 20 incorporated the N A N
long term objective as the dose limit, and included a provision (20.1301(c)),
to allow for alternative limits on an occasional basis. Section 20.1301(c) provides that an annual dose of up to 5 millisievert (0.5 rem) is acceptable-
@ ; 6 steps are taken to reduce the dose to as low as is reasonably achievable.
The NRC reaffirms that previous determination in this rulemaking.
Comment. One commenter said that the NRC should change the 0.1 rem dose limit for the public in 10 CFR 20.1301(zi)(1) to 0.5 rem for all licensed activities because a dose limit of 0.5 rc;:: of@rs adequate protection and is a dose that has no proven effects.
9
KdSvoNSE 7c, L10 SLWS61e Wi'm t W6 W"*A**"*=* $p 9
b 6N151 o nl In general, the physical reactions (e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare.
Vomiting is seldom an important elimination route for radiopharmaceuticals after the patient has left the medical facility since orally administered radiopharmaceuticals such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system.
Regarding the comment on the doubling of risk of developing thyroid cancerq=4hereedsuneascientificecon sen su s ey'therUni ted dlatj ansJ c,i e n t4fg Radiation,s.lCRP.xr.NCRP...tosuppor11hg Comgme,e,,ggjp,((fec_tsofaAtomic1 o
o
- $$chj@$@766@E$Tdiideffdttppfyinses ti on "of 41 odi ne-131%
Tgeforgd%qartedrawenorconcitrsibntwith~ regard *to the'validityr_sua inulidi)LgLthg.,cileisagttuA Comment. One commenter said that the proposed rule did not adequately address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries.
Response.
In commenting on the petitions, the States did express concerns about releasing patients administered relatively large quantities of iodine-131. However, the Agreement States were generally favorable to the approach in the proposed rule, and none of the States that commented on the proposed rule indicated that the concerns of the Agreement States were misrepresented.
In fact, one Agreement State commented that it was pleased that the NRC had considered the comments made by the Agreement States at various meetings with the NRC.
15 j
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Reg b
lhl O L Nd In general, the physical reactions (e.g., vomiting) that a patient may experience due to the administration of any radiopharmaceutical are rare.
Vomiting, is seldom an important elimination route for radiopharmaceuticals after the patient has left the medical facility, since orally administered radiopharmaceuticals such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system.
Regarding the comment on the doubling of risk of developing thyroid cancer, gg3rifBW591MINR8Fs'fiidf2WsiipffEIbir6HTF2tb"thFliMffGETPF (e scyg gjthe;papegEThCcanceci sT%oEffiElistEfs~!TeVeTdirE6H?thEngey n
aggendggg}thegty 'of Tt'ancer(s )? cons i dered r7sn'dibtfi6F'TrsMsbTeiTMThWifoT r, -
.e-,y
~, y by#the;commenter'cannot'be broadly-a,p,pliid;to-
,,...._.n.
__,_t ted-theFresults ofathe^ study
.allepatientirelease7stidafihnsbThe"dats'on\\.,..yFoiMAE~cWItMatego3 n,,, n,
th jngg sjign g[J odinedMd sti nconcl us151CTheiNCRPlin 7 NCRPIRepurfLiton80 2
gU nd uct i on; p fMhyro.i_d._- C._a.n_ c. e._r;_ by; i o n t zi ng1 Rad iati ocin st ate s.t t. h._a.t_-t h e x, hum _an m.
gdatatWilT56@dENhhdENfSNNfIdN$)ikNNN NbhNIMOTlWDSt%I!Efii2
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the; carcinogen 1ttiEtH61Huehnithirsi@linTiddi t'ibrGNCRP T.RtportMog%
h w,ayww_imate s e ofqi skito the: thyroid 3 thhf @ifeTa7Ti f'EtlimEErb presents est
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wm,f atal _canc..e. r~- ofrA 5 T 10Mrayib f6FIM[A682iifdhrB1Ws'd fiEfW.
1or m.
Comment. One commenter said that the proposed rule did not adequately represent the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries.
,pmen~d, F66 RidiatioERProtecMandan@N(Matet036;9 ~ 2
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- g in" Jk~nOingiRa'diatiohPNCRPlep'orti.NoE80::1 gf foMial eiffpg T
(Av d %, ee - q u 15 I
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administrations of iodine-131). The activities of radiopharmaceuticals that require this record are described in Regulatory Guide 8.39.
Finally, the NRC is deleting its requirements on written instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5) because those paragraphs are redundant now that 10 CFR 35.75 has requirements for instructions.
In addition, 10 CFR 35.415(a) and a(1) are reworded to clarify the original intent of the paragraphs, which was to limit the dose rate at 1 meter from the patient. The ambiguity was introduced when Part 20 was revised and a conforming change was made in 10 CFR 35.415. The conforming change that was made was not fully consistent with the original intended meaning of 10 CFR 35.415(a) and (a)(1).
VII. Disposition of the Petitions for Rulemaking The three petitions for rulemaking submitted by Dr. Marcus (PRM-20-20),
the ACNM (PRM-35-10 and PRM-35-10A), and the AMA (PRM-35-11) requested that the NRC amend the revised 10 CFR part 20 and 10 CFR part 35. These requests and their disposition by this rulemaking are discussed below.
The requests made by Dr..Marcus and thei, disposition may be summarized as follows:
(1) Raise the annual radiation dose limit in 10 CFR 20.1301(a) for individuals exposed to radiation from patients receiving radiopharmaceuticals for diagnosis or therapy from 1 mil 11 sievert (0.1 rem) to 5 millisieverts (0.5 rem). The final rule grants this request.
(2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel (30-mil 11 curie) limit for iodine-131, but provide an activity limit for other
)
radionuclides consistent with the calculational methodology employed in the 45
l l
National Council on Radiation Protection and Measurements (NCRP) Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."' The final rule 6 Regulatory Guide 8.39 uses a calculational methodology based on NCRP Report No. 37 to relate the dose to the quantity of activity in the patient.
6 (3) Delete 10 CFR 20.1301(d), which requires licensees to comply with provisions of the Environmental Protection Agency's environmental regulations in 40 CFR part 190 in addition to complying with the requirements of 10 CFR part 20. The EPA regulations referenced in 10 CFR 20.1301(d) are contained in 40 CFR part 190, which deals only with doses and airborne emissions from uranium fuel cycle facilities.
Part 190 of Title 40 of the Code of Federal Regulations does not apply to hospitals or to the release of i
patients.
Furthermore, 10 CFR 20.1301(d) does not incorporate the EPA's Clean Air Act standards in 40 CFR part.61 that applies to hospitals. The NRC is-separately pursuing actions with the EPA to minimize the impact of dual regulation under the Clean Air Act and to take agreed upon actions that will lead to EPA recision of 40 CFR part 61 for NRC and Agreement State licensees.
Because the reference to EPA regulations in 10 CFR 20.1301(d) has nothing to do with the patient release issue, and therefore, has no impact on the petitioner, the final rule denies this request.
46
w asummans Q qd I
&g l
hAA,g d i6)CC The requests made by Dr. Marcus and their disposition may be summarized as follows:
(1) Raise the annual radiation dose limit in 10 CFR 20.1301(a) for individuals exposed to radiation from patients receiving radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1 rem) to 5 millisieverts (0.5 rem). The final rule grants this request.
(2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel (30-millicurie) limit for iodine-131, but provide an activity limit for other radionuclides consistent with the calculational methodology employed in the National Council on Radiation Protection and Measurements (NCRP) Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."' The final rule pth uses a calculational methodology based on NCRP Report No. 37 to relate the dose to the quantity of activity in the patient.
(3) Delete 10 CFR 20.1301(d), which requires licensees to comply with provisions of the Environmental Protection Agency's environmental regulations in 40 CFR part 190 in addition to complying with the requirements of 10 CFR part 20.
The EPA regulations referenced in 10 CFR 20.1301(d) are contained in 40 CFR part 190, which deals only with doses and airborne emissions from uranium fuel cycle facilities.
Part 190 of Title 40 of the Code of Federal Regulations does not apply to hospitals or to the release of patients.
4 Furthermore, 10 CFR 20.1301(d) does not incorporate the EPA's Clean Air Act standards in 40 CFR part 61 that applies to hospitals. The NRC is separately pursuing actions with the EPA to minimize the impact of dual 45