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L,y pDe UNITED STATES g
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e WASHINGTON, D.C. 20$$!WXX)1
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May 31,=1995-
'i MEMORANDUM TO:
Carl J. Paperiello, Director Office of Nuclear Material Safety & Safeguards Richard L. Bangart, Director Office of State Programs Martin G. Malsch, Deputy General Counsel Office of the General Counsel Walter E. 011u, Acting Chief Rules Review and Directives Branch Office of Administration Gerald F. Cranford, Director Office of Information Resources Management James Lieberman, Director
-/
Office of Enforcement Office of Nuclear Regulatory Research /NNI,
'O FROM:
David L. Morrison, Director 4
7-0' C '
SUBJECT:
OFFICE REVIEW AND CONCURRENCE:
DRAFT FINAL RULE - CRITERIA FOR-THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIALS Your assistance is requested in reviewing the attached rulemaking package and providing me with your commeni.s and concurrence.
.The following is a summary of this request.
1.
Title:
Final-Rule on Criteria for the Release of Individuals Administered Radioactive Materials 2.-
RES Task leaders:
Stewart Schneider, 415-6225, and Stephen A. McGuire, 415-6204 3.
Coanizant Individuals:
NMSS - Patricia Holahan, Cathy Haney 000 - Bradley Jenes SP
- Lloyd Bolling 4.
Reauested Action: Review, comment, and provide concurrence.
k
-5.
Reauested Completion Dat_q: June 7, 1995.
9708150166 970807 PDR PR 20 62FR4120 PCR c p o g (5,2 'i c lo v$t
e C. J. Paperiello, et al. 6.
Background:
A working group was formed to develop the draft final rule.
The members of the working group are:
Stephen McGuire, Stewart Schneider, Sam Jones, Cathy Haney, Patricia Holahan, and Bradley Jones.
Note that the associated Regulatory Guide will be sent to the Commission as a working draft for their information, not their approval.
Do not comment on the guide at this time.
The guide will be sent for Office concurrence review at a later date.
No additional resources are anticipated to implement the rule. A copy of this concurrence package has been forwarded to the Office of the Controller for coordination of resource issues per the ED0 memorandum of June 14, 1991.
Attachment:
Rulemaking Package cc w/atts.:
R. M. Scroggins, OC D.
c.. Williams, IG W. Beecher, PA D. K. Rath'oun, CA 3
sesisMissimuuminismiim iiii i.
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FOR:
The Commissioners FROM:
James M. Taylor Executive Director for Operations
SUBJECT:
FINAL AMENDMENTS T0 10 CFR PARTS 20 AND 35 ON CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIAL PURPOSE:
To obtain Commission approval to publish a notice of final rulemaking in the Federal Register.
BACKGROUND:
Each. year in the United States, radioactive pharmaceuticals or radioactive
-implants are administered to approximately 8 to 9 million patients for the diagnosis or treatment of disease. These people can expose others around them ta radiation until the radioactive material has been excreted from their bodies or has decayed away.
NRC's current patient release criteria are contained in 10 CFR 35.75, " Release of patients or human research subjects containing radiopharmaceuticals or permanent implants." That section states: "(a) A licensee may not authorize release from cor.finement for medical care any patient or human research subjects administered a radiopharmaceutical until either:
(1) The measured dose rate from the patient or human research subject is less than 5 millirems per hour at a distance of 1 meter; or (2) The activity in the patient or human research subject is less than 30 millicuries; (b) A licensee may not authorize release from confinement for medical care of any patient or human research subject administered a permanent implant until tha measured dose rate is less than 5 millirems per hour at a distance of 1 meter."
CONTACTS:
Stewart Schneider, RES 415-6225 Stephen A. McGuire, RES 415-6204 DRAFT:
May 26, 1995
e The Commissionert 2
On May 21, 1991 (56 FR 23360), the NRC published a final rule that amended 10 CFR Part 20, " Standards for Protection Against Radiation." The rule contained a dose limit of 1 millisievert (0.1 rem) total effective dose equivalent (TEDE) for members of the public in 10 CFR 20.1301(a). When 10 CFR Part 20 was issued, there was no discussion in the supplemental information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.
Because some licensees were uncertain about what effect the revised 10 CFR Part 20 woulci have on patient release criteria, three petitions for rulemaking were received on the issue.
To resolve this uncertainty, two steps were taken.
The short-term resolution was to inform licensees of the NRC's position that 10 CFR 35.75 governed patient release.
The Commission was informed in SECY-94-01 of the staff's recommendation that 10 CFR 35.75 govern patient release.
The Commission allowed publication of an information notice explaining the interim staff position (Staff Requirements Memorandum (SRM) dated January 28, 1994).
Information notice No. 94-09 was issued on February 3, 1994, to inform licensees of this position.
The longer term resolution was through rulemaking.
Thus, the NRC '
ished a proposed rule for comment on h ne 15, 1994 (59 FR 307?b.
DISCUSSION:
The final amendments (Attachment 1) represent a partial granting of the regulatory relief requested by the petitioners.
The rule takes into consideration the recommendations of the ACMUI and the Agreement States, as well as the comment letters received on the proposed rule and the petitions.
In all, 232 comment letters were received on the three petitions, and 60 comment letters were received on the proposed rule.
The rule was also discussed with the Advisory Committee on Medical Uses of Isotopes (ACMUI) at several public meetings, the last on May 11, 1995.
The following summarizes the main features of the amendments:
1.
The amendments make it clear that patient release is governed by 10 CFR 35.75 rather than 10 CFR 20.1301(a). There was very broad agreement with this position in the comment letters, with the ACMul, and with the Agreement States.
2.
The amendments revise the criteria for release of patients administered radioactive material for medical use under 10 CFR 35.75 to permit a maximum likely total effective dose equivalent, excluding background or any occupational exposure, to an individual exposed to the patient of 5 millisieverts (0.5 rem).
DRAFT: May 26, 1995
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The Commissioners 3
Specifying the release criterion in terms of dose requires that the NRC provide an acceptable method to relate the quantity of radioactivity administered to that dose. That relationship will be provided in a regulatory guide. A working draft of that guide is attached (Attachment 2); the guide is still under staff review, but will be published in active form before the final rule becomes effective.
The guide provides two methods to relate dose to quantity of radioactivity administered.
The first method is the use of a default table of release quantities and release dose rates based on conservative assumptions.
For the radioactive material of greatest significance, iodine-131, the default table is essentially equivalent to the release criteria in the current regulations.
The second method is to perform a case-specific dose calculation using the method described in the guide.
The case-specific method can be less conservative than the default table because it permits a more realistic estimate of how quickly the radioactive material leaves the body. Thus, use of this method would, in some cases, permit the release of patients containing several times more radioactive material than the current regulations permit. Under certain circumstances, such as a long half-life and no biological excretion, the default table and the case-specific dose calculation may be more restrictive than the current release criteria.
Overall, a substantial majority of all comments supported a dose limit of 0.5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material.
In addition, the ACMUI and the Agreement States supported the criterion based on a dose limit. A few commenters opposed the new criterion because they thought that the present criteria were working well and were adequate. These commente s opposed allowing release with quantities of radioactive material' greater than permitted under the current regulations.
3.
The proposed rule proposed to require licensees to maintain, for 3 years, a record of the basis for the patient's release and the total effective dose equivalent if any individual is likely to receive a dose in excess of 1 millisievert (0.1 rem) in a year from a single administration. The purpose of this requirement was so that records would be available to calculate the dose if there were multiple admir.istrations in a year.
This proposed requirement generated a great deal of opposition.
Commenters were especially concerned about having to retrieve records of previous administrations, sometimes from another hospital. Upon reconsideration, it was decided to delete this requirement because a review of nuclear medicine procedures indicated that there was not DRAFT: May 31, 1995
c4 o-g 4
The Commissioners 4
significantLlikelihood of exceeding al 5 millisieverts (0.5-rem) annual dose because of. multiple administrations.
4.
The amendments require that the patient be given written instructions on how to maintain doses to others as low-as reasonably achievable if the
- dose to an individual is likely to exceed 1 millisievert (0.1 rem).
In general, most commenters agreed with this requirement, although a few did not think that instructions should necessarily have to be written.
5.
.The amendments make it clear that the limit on dose in unrestricted areas under 10 CFR 20.1301(a)(2) does not include dose contributions
=from patients administered radioactive material and released in p'
accordance with'10 CFR 35.75. The: purpose-of this change is to clarify.
that licensees are not responsible for doses outside of their restricted areas from radiation sources not under their control. The comments -
supported this position.
6.
- The amendments explicitly include nursing infants as individuals whose dose must be limited. There was relatively little opposition.to this, but some commenters wanted information on when-instructions would have
- to be given and what the instructions should say about interruption or cessation of breast feeding. The information requested will be included in the rmulatory guide (Attachment 2).
RESOURCES:
Resources needed to conduct and implement this rulemaking are included in the FY 1995-1999 Five-Year Plan.
COORDINATION:
The Office of the General Counsel has no legal objection to this paper.
RECOMMENDATION:
That the Commission:
- 1.
- Approve the notice of final rulemaking for publication-(Attachment 1).
2.
Certify that this rule will not haveia negative economic. impact on a substantial-number of small entities to satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
3.
Note:
The rulemaking will become effective 90 days after publication in
-a.
the Federal Register; DRAFT: May 26, 1995 l
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b.
A final-regulatory analysis will be available 'in the Fublic
. Document' Room (Attachment 3);
c.
A final environmental assessment and a finding of no significant impact have been prepared =(Attachment 4);
d.
The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act; The rule contains information collection requirements that are subject to review by OMB. Upon Commission approval, the OMB supporting statement (Attachment 7) will be submitted to 0MB for approval.
f.
The appropriate Congressional Committees will be informed (Attachment 5);
g.
A public announcement will be issued (Attachment 6); and-h.
Copies of the Federal Register notice of final rulemaking and the associated regulatory guide will be distributed to all Commission medical-licensees and each Agreement State.
The notice will be sent to other interested parties upon request.
James M. Taylor Executive Director for Operations Attachments: As Stated (7) a l
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ATTACHMENT 1 FEDERAL REGISTER NOTICE
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[7590-01)-
NUCLEAR REGULATORY COMMISSION 10 CFR. Parts 20 and 35 RIN 3150-AE41 Criteria for the Release of Individuals Administered Radioactive Material AGENCY: Nuclear Regulatory Commission.
ACTION:'- Final rule.
SUMMARY
- The Nuclear. Regulatory Commission (NRC) 'is amending its regulations -
concerning the criteria for the release-of patients administered radioactive material. 'The new criteria for patient release are based on potential. dose to other individuals exposed to the patient, including nursing infants.
The new criteria are consistent with the' reconnendations of the National-' Council on Radiation Protection and Measurements (NCRP).and the International Commission on Radiological Protection (ICRP). This final rule requires the. licensee to q
-provide written-instructions to. patients on how to maintain the doses to others as-low as -reasonably achievable if the total effective dose equivalent to any other indi'idual exposed to the released patient is likely to exceed v
.1: Oillisievert (0.1 rem).
This final rule responds to three petitions for rulemaking'regarding the criteria for release of patients 1 administered radioactive material.
EFFECTIVE DATE:
(90 days-following publication in the Federal Register).
DRAFT: May 19, 1995 1
e a
ADDRESSES: -Copies of the public record, including t'ne final Regulatory Guide 8,39, " Release of Patients Administered Radioactive Materials," the final regulatory analysis and the public comments received on the proposed rule, may be examined and copied for a fee in the Commissions's Public Document Room at 2120 L Street, NW. (Lower Level), Washington DC.
FOR FURTHER INFORMATION CONTACT:
Stewart Schneider or Stephen A. McGuire, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6225.
SUPPLEMENTARY INFORMATION:
Table of Contents I.-
Background
II.
Publication of the Proposed Rule III. : Public Comments
-- I V.
- Coordination with NRC Agreement States
-- V.
Coordination with the Advisory Committee on Medical _Uses of Isotopes VI.
Discussion of Final Rule Text -
VII.
Consistency with 1979 Medical Policy Statement VIII. Issue of Compatibility for Agreement States IX.
Finding of No Significant Environaental Impact: Availability X.
Paperwork Reduction Act Statement XI.
Regulatory Analysis XII.
Regulatory Flexibility Certification XIII. Backfit Analysis-.
XIV.
List of Subjects DRAFT: May 19,-1995-2 Attachn.ent 1
-___-_____A
XV.
Text of-Final Regulations I.
Background
Each year in the United States, radioactive pharmaceuticals or radioactive implants -are administered to approximately 8 to 9 million individuals for the diagnosis or treatment of disease.
These individuals to whom radioactive materials have been administered are hereinafter referred to as " patients." These patients can expose others around them to radiation until the radioactive material has been excreted from their bodies or the radioac'.ivity has decayed away.
NRC's current patient release criteria in 10 CFR 35.75, " Release of patients or human research subjects containing radiopharmaceuticals or permanent implants," are as follows:
"(a) A licensee may not authorize release from confinement for medical care any patient or human research subject administered a radiopharmaceutical until either:
(1) The measured dose rate from the patient or human research subject is less than 5 millirems per hour at a distance of one meter; or (2) The activity in the patient or human research subject is less than 30 millicuries; (b) A licensee may not 5
authorize release from confinement for medical care of any patient or human research subject administered a permanent implant until the measured dose rate
.is less than 5 millirems per hour at a distance of one meter."
On May 21,1991 (56 FR 23360), the NRC published a final rule that amended 10 CFR part 20, " Standards for Protection Against Radiation." The rule contained limits on the radiation dose for members of the public in 10 CFR 20.1301. However, when 10 CFR part 20 was issued, there was no DRAFT: May 19, 1995 3
i
discussion in the supplementary information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.
Because sone licensees were uncertain about what effect the revised 10 CFR part 20 wculd have on patient release criteria, two petitions for rulemaking were received on the issue. On June 12, 1991 (56 FR 26945), the NRC published in the Federal Register a notice of receipt of, and request for comment on, a petition for rulemaking (PRM-20-20) from Dr. Carol S. Marcus.
In addition, Dr. Marcus submitted a letter dated June 12, 1992, further characterizing her position.
On March 9, 1992 (57 FR 8282), the NRC published a notice of receipt and request for comment in the Federal Register on another petition for rulemaking (PRM-35-10) on patient release criteria from the American College of Nuclear Medicine (ACNM). On May 18, 1992 (57 FR 21043), the NRC published in the Federal Register notice of an amendment submitted by the ACNM to its original petition (PRM-35-10A),
in addition, a third petition (PRM-35-11) dealing, in part, with these same issues was submitted by the American Medical Association (AMA). That petition was noticed in the Federal Register on July 26, 1994 (59 FR 37950)._
The main point of the petition was that the radiation dose limits in I
10 CFR 20.1301 should not apply to individuals exposed to-the patient and that the dose limit to the individuals should be 500 millirems per year.
The AMA believed that 10 CFR 20.1301 would have an adverse impact on.the availability and the cost of treatment of thyroid disease, which would outweigh the advantages of reduced radiation exposure to the public.
The AMA stated-that treatment of up to 10,000 cancer patients annually for thyroid carcinoma would require the hospitalization of the patients under the revised regulation DPAFT: May 19, 1995 4
I i
e (10 CFR 20.1301), reducing both early release of patients and the treatment of patients at home.
II.
Publication of the Proposed Rule On June 15, 1994, the NRC published a proposed rule on criteria for the release of patients administered radicar+1ve material in response to the first two petitions (59 FR 30724).
The Federal Register Notice for the proposed rule discussed the public comment letters received on the first two petitions.
Three additional comment letters were received on the third petition (PRM-35-11) These letters each supported the petition but did not contain any additional information not covered by the letters on the first two petitions.
The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically state that the dose to individual members 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 was to clarify that the Commission's policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301.
The NRC proposed to amend 10 CFR 20.1301(a)(2) to specifically state that the limit on dose in unrestricted areas does not include dose contributions from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose was to clarify that licensees are not required to control areas, such as a waiting room, simply because of the presence of a patient released pursuant to 10 CFR 35.75.
If a patient has been released from licensee control, pursuant to 10 CFR 35.75, licensees are no+ required to limit the radiation dose to members of the public DRAFT: May 19, 1995 5
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o (e.g., visitor in a waiting room) from a patient to 0.02_millisievert (2 millirems) in any one hour.
Patient waiting rooms or hospital rooms need only be controlled for those patients not meeting the release criteria in 10 CFR 35.75.
The NRC proposed to adopt a now 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 millisievert (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 one year to an individual from exposure to a released patient. A dose-based limit providas a single limit that can be used to provide an equivalent level of risks from all radionuclides. Also, the proposed changes are supported by the recommendations of the ICRP and the
' National Council on Radiation Protection and Measurements (NCRP) that an individual can be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where 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 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 one 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 100,000
-individuals who are breast-feeding and administered various diagnostic and DRAFT: Nay 19, 1995 6
s
_o therapeutic radioactive materials. The purpose of the instructions is to maintain doses to individuals exposed to patients as low as reasonably achievable.
The NRC proposed to adopt a new 10 CFR 35.75(b)(2) to require that licensees maintain,- for three years, a record of the released patient and the calculated total effective dose equivalent to the individual likely to receive the highest dose if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration.
The major purpose was to provide a record to allow licensees to assess the need to control the dose to individuals exposed to a patient who may receive more than one administration 4
in a year.
Finally, the NRC proposed to amend its requirements on instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5).
These regulations already required instructions (not necessarily written) in certain cases, but the pnras:: "if required by 5 35.75(b)" was added to each. The purpose of this change vas as a conforming change within part 35 on when instructions must be given.
In-addition,- the NRC issued concurrently for public comment an associated draft regulatory' guide and supporting draft regulatory analysis.
The_dra'ft_ regulatory guide, DG-8015, " Release of Patients Administered-Radioactive Materials," provided guidance on determining the potential doses to an individual likely to receive the highest dose from exposure to a patient and established appropriate activities and dose rates for release of a
. patient..The draft guide also provided guidelines on instructions for patients on how to maintain doses to other individuals as low as reasonably achievable and described recordkeeping requirements. The draft regulatory DRAFT:.May 19, 1995 7
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i analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of
{-
Patients-Administered Radioactive _ Material," examined the benefits and impacts I
of theLproposed rule _ considered by the NRC.
l-1 111.
Public. Comments on the Proposed Rule a
i A total of 62 comment letters were received on the proposed rele, the
[
draft regulatory guide, and the draft regulatory analysis. A majority of the l
comment letters were from medical practitioners and medical organizations, but i
F there were also comment letters from regulatory agencies in Agreement States, i
private individuals,-and public-interest groups.
Overal), the majority of all comment letters supported a dose-limit of 5 millisteverts (0.5 rem) for y
individuals exposed _ to patients released with radioactive material.
- However, j
about one-fourth of all commenter letters opposed the proposed recordkeeping a
-requirement. The significant comments are discussed below, arranged by subject.
EXCLUSION OF PATIENT RELEASE FROM 20.1301(a)
All of=the_commenters except one supported governing patient release by the regulations in 10 CFR 35.75 and 4xcluding the dose to individuals exposed-to a released patient from 10 CFR 20.1301(a).
Consent: One commenter, a public-interest group, objected to any exposure of a member of the general public who has not consented freely to tl.e DRAFT: May 19, 1995 8
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' dosage.
They said that such exposure would lead to widespread morbidity.and mortality.
i Response: -In its' previous rulemaking on 10 CFR part 20-(56 FR 23300;-
l May 21, 1991), the NRC determined that, while doses should be_ maintained as low as reasonably achievable, a dose limit of 1 millisievert (0.1 rem), or a
' dose l'imit' of 5 millisieverts (0.5 rem) in certain special circumstances,
[
'provides adequate protection.- 10 CFR Part 20 is based, in part, upon-the
-recommendations of the. International Commission on Radiological Protection l(ICRP) and the recommendations of the National Council on Radiation Protection l
and Measurement's (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. 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 millisievert (0.5 rem) is acceptable provided that it is of relatively short duration and that steps are
-taken to reduce the dose to as low as reasonably achievable. The NRC reaffirms its-previous determination in_this rulemaking.
Consent: 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 offers adequate protection and is a-dose'that has no-proven effects.
DRAFT: May;19,f1995 9
3 f:
-Response:- This issue of the general public dose limit is outside the scope of this rulemaking The-issue was dealt with when 10 CFR part 20 was j
recently a:aended (56 FR 23360; May 21,1991).
That.rulemaking explained the NRC's rationale for. adopting the 1-millisievert (0.1-rem) dose limit in 1
i_
t 1
ACTIVITY-BASED VS, DOSE-BASED RELEASE LIMIT i
i -
The issue is whether to retain the current patient release limit in 10 CFR 35.75 expressed as an activity limit together with an alternative but approximately equivalent limit on dose-rate at I meter or to express the I
i release limit as a dose to an individual exposed to the patient.
The majority of commenters supported the dose-based limit.
However, some commenters opposed the dose-based _ approach.
Comment: A number of commenters said that 10 CFR 35.75 should not be changed and that the 30 millicurie or 5 millirems per hour release criteria should be retained because they are working well.
Some commenters said that a dose-based release limit:as proposed would cause confusion and potential problems. One commenter said that the part 20 revision was not intended to alter the status quo for patient release. Commenters-objected to the dose-based release limit because they thought the dose estimates to the public would be.very inaccurate as they are based on the unreliable method of predicting the anticipated time and proximity to others.
Commenters also said Lthat dose estimation and the subsequent recordkeeping would be time consuming DRAFT: May 19, 1995 10
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and would add.to the cost of treatment with probably no significant decrease
- in radiation exposure.-
a Response: The NRC is adopting a dose-based limit rather than an
. activity-based limit because the dose-based limit better expresses the NRC's j
- primary concern for_ the public's health and safety. A single activity 3
requirement was not retained because the doses received from a released patient are difrerent for different radionuclides that have the same activity.
Also, a single dose rate requirement for all radionuclides was not retained because one value is not a uniform indicator of the total dose which depends on'the effective half-life of the radioactive material in the body of the y
patient and other factors which will vary for different materials.
For these reasons, the NRC is establishing for each patient release a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual from exposure'to the released patient. This dose limit-is consistent with the underlying risk basis of the' current 10 CFR 35.75 (50 FR 30627), the recommendations of the NCRP and the ICRP, and the provisions in 10 CFR 20.1301(c), pertaining to temporary situations in which there is
]
. requisite justification for a dose limit higher than 1 millisievert (0.1 rem).
The NRC believes that the dose-based release limit _ can and will work
_ ell because the associated Regulatory Guide 8.39, " Release of Patients w
Administered Radioactive Materia.ls," can be used to relate the dose to the quantity of activity in the patient. The guide provides conservative
-estimates of activities for commonly used radionuclides and their
[
corresponding dose rates with which a patient may be released in compliance with the dose limits in the final rule.
The approach used in the regulatory DRAFT: May 19, 1995 11 Attachment I
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. guide is based on NCRP Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."'
The supporting regulatory ani. lysis contains a detailed examination of the benefits and impacts of the final rule that includes dose estimation, recordkeeping and radiation exposure. Single copies of the final regulatory I
analysis and Regulatory Guide 8.39, " Release of Patients Administered i
j Radioactive Materials," are available as indicated in the ADDRNES heading.
i j
[
Comment:
A commenter said that the calculational approach in the rule would require the physician to ask many personal questions of the patient.
4 Response: The commenter is incorrect in believing that the dose-based approach will generally require personal information from the patient. The i
NRC anticipates that nearly all patients will be released based on the defaalt table of activities provided in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." The' table of release quantities i
approach, based on standard conservative assumptions, does not require any personal information from the patient.
Personal information might only be necessary for certain patient-specific cases.
t Comment: One commenter said that it should continue to be acceptable to release patients based on the dose rate at 1 meter.
' National Council on Radiation Protection and Measurements (NCRP),
" Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37 (October 1, 1970).
(Available for sale-from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 4
20814-3095.)
-DRAFT: May 31, 1995 12
i s
v Consent: One commenter said that it should continue to be acceptable to release patients based on the dose rate at 1 meter.
Response: The rule authorizes release of patients based on the dose rate at'I met.er. The table of release quantities in Regulatory Guide 8.39,
" Release of Patients Administered Radioactive Materials," specifies the dose rate at 1 meter of commonly used radionuclides that allow licensees to authorize patient release.
RELEASE QUANTITIES Going to a dose-based system based on a dose to the most highly exposed individual of 5 millisieverts (0.5 rem) would, in some circumstances, allow patient release with more than 1,110 megabecquerels (30 mil 11 curies) of activity.
Some commenters were. opposed to allowing release with higher activities than now permitted.
Coasent: Several commenters said that the release uf patients with more
.than 30 millicuries of iodine-131 should not be permitted because of concerns about the risk of internal exposure. One commenter said that doses to family--
members-due to patient vomiting were not adequately considered.
-Response:
Theconcernovercontaminationisnotjustifiedbythe radiation doses that are likely to be caused by the contamination.
Measurements have shown that a relatively small proportion of the radioactive material administered will appear as contamination. The large majority will DRAFT: May 31, 1995 13
e either decay away within the patient's body or will be excreted in the patient's urine and flushed down the toilet. The proportion that will be deposited as contamination on accessible surfaces will be small. Doses to
' individuals exposed to the patient from pathways other than direct external exposure (e.g., internal exposure due to intake of radionuclides from vomited matter, sweat, etc.) have been measured and have been found to be relatively low compared to direct external exposure.
(The intake from the milk in l
breast-feeding infants is dealt with in the regulations as a special case.)
These measurements'are discussed in the supporting regulatory analysis and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." In addition, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No. II,
" Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, "Thus, a contamination incident that could lead to a significant intake of radioactive material is very unlikely."'
Comment: One commenter said that the Federal Register Notice for 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.
Response
In commenting on the petitions, the States did express concerns about releasing patients administered relatively large quantities of
' 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 Wooc'mont Avenue, Suite 800, Bethesda, MD 20814-3095.)
DRAFT: May 31, 1995 14
1 iodine-131. However, the Agreement States were generally favorable to the approach that was-contained 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.
Coasent: 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 it might be beneficial and acceptable to family members in some cases. 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 provides a basis for allowing individuals to receive annual doses up to
' International Commissien 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 form the NCRP, 7910 Woodmont-Avenue, Suite 800, Bethesda, MD 20814-3095.
DRAFT: May 31, 1995 15
O o-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 to b millisieverts (0.5 rem) in a given year in situations where_ exposure to radiation ir act 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. The NRC believes that if the dose to another individual is likely to exceed 5 millisteverts (0.5 rem), the patient should remain under l
the control of the licensee.
Licensee control is necessary to provide adequate protection to the individuals exposed to the patient.
RECORDKEEPING FOR ADMINISTRATIONS AB0VE 1 MILLIS1 EVERT (0.1 REM)
The strongest opposition to the pr<> posed rule was to the proposed requirement to maintain a record of the released patient and the calculated total effective dose equivalent to the _ individual likely to receive the highest dose if the dose to that person is likely to exceed 1 millisievert (0.1 rem).
Under the proposed rule, if a patient had or might have had one or more administrations within the same_ year, it would be necessary for the licensee to use the records to determine the dose fron; the previous administrations so that the total dose to an individual exposed to a patient from all administrations would not exceed 5 millisieverts (0.5 rem).
Comment: Many commenters indicated that this requirement would cause excessive costs in time, effort, and money to track down records of previous administrations, to perform calculations, and to keep records of all the work and-asked that the requirements to make calculations and keep records be DRAFT: May 31, 1995 16 Attachment I
9 d
removed. The comenters believed that the work would not produce an increasta level of safety and that the NRC greatly underestimated the cost, and that therefore the recordkeeping would be unnecessary, inappropriate and impractical. Some commenters said that multiple administrations that would result in a total effective dose equivalent greater than 1 mil 11 sievert (0.1 rem) are not done to the same patient routinely. Other commenters said that there are decades of experience unencumbered by any paperwork burden at all with no evidence that a lack of paperwork has resulted in any additional problems. One commenter said that if 0.5 rem is acceptably safe, why have the 0.1 rem level with all the documentation required.
Another commenter said that it cannot be the licensee's responsibility
[
to know the details of a radionuclide therapy performed by another licensee in terms of which members of the public receive the most radiation dose due to that other licensee's therapy procedure.
One commenter said that the excessive recordkeeping cost would be a nonreimbursable cost and the burden will cause many physicians to stop offering iodine therapy and force patients to travel to large medical facilities in cities and cause problems with patient access in sparsely populated areas.
Response: Upon reconsideration, the NRC has decided to delete the requirement to keep records when the dose to the most highly exposed individual is -likely to exceed 1 mil 11 sievert (0.1 rem). The requirement was proposed so that it would be possible to account for the dose from multiple administrations in the same year, to assure that the total dose to an individual exposed to the patient did not exceed 5 millisieverts (0.5 rem).
DRAFT: May 31, 1995 17
s a
The NRC has an advisory committee (the Advisory Committee on the Hedical Uses_of Isotopes or "ACMVI"), which advises the NRC on rulerakings and other initiatives related to the medical use of byproduct materials.
The NRC also has a visiting medical fellows program that recruits selected physir.ians or pharmacists to work for the NRC for a period of 1 to 2 years.
Both the ACMVI and the current Visiting Medical Fellow, Myron Pollycove, M.D., provided advice to the NRC during the development of this rule.
In addition, l
Barry A. Siegel, M.D., Chairman, ACMUI, reviewed the patient records at his medical facility for the 1-year period from July 1,1993 to June 30, 1994 (Mallinckrodt Institute of Radiology, St. Louis, Missouri).
Drs. Siegel and Pollycove concluded that no routine nuclear medicine practice, be it diagnostic, therapeutic or a combination thereof, results in multiple large administrations that would be likely to cause the 5-mil 11 sievert (0.5-rem) dose limit to be exceeded because of multiple administrations in a year.
While the proposed requirement to maintain a record of the dose to another individual if the dose is likely to exceed 1 m1111 sievert (0.1 rem) has been deleted, a recordkeeping requirement with a reduced impact has been 1
retained, as discussed later.
Consent: Several commenters said that those who pay for health care will put great pressure on physicians to optimize calculations to reduce inpatient days and to justify out-patient treatments.
Response: There is no objection to optimizing calculations to reduce impatient days as long as the calculations are realistic and the 5-mil 11 sievert (0.5-rem) limit in 10 CFR 35.75 is met.
Regulatory Guide 8.39, DRAFT: May 31, 1995 18
" Release of Patients Administered Radioactive Materials," describes examples of calculations that are acceptable to the NRC.
WRITTEN INSTRUCTIONS TO PATIENTS In general, there was little objection to providing instructions to
-patients on how to minimize the dose to others, but there was significant opposition to the proposed requirement that the instructions would have to be i
i written.
Comment: -One commenter said that the Statement of Considerations for
-the proposed rule was in error in stating that the existing regulations already required that the instructions to patients be written.
Response: The commenter is correct. The Statement of Considerations was in error on that point. The existing regulations do not specify that instructions have to be in written form.
Consent: A number of commenters said that instructions should not need to be written and that oral instructions should be permissible.
Some of these coumenters said that oral instructions are more effective and that how the instructions should be given is within the province of the doctor-patient relationship and that the NRC and its regulations should not interfere with that relationship. Another commenter said that the standard written instructions require too much time explaining how each patient varied from the standard instruction sheet. However, one Agreement State and a major health DRAFT: May 31, 1995 19
e maintenance organization strongly supported the requirement that the I
instructions be written.
I Response: The NRC believes that providing written instructions has a significant value because often patients will not remember all of the instructions given orally.
In addition, written instructions can be read by other family members. The requirement to provide the instructions in written form was also supported by the ACMUI.
This regulation allows the licensee to determine the form of the written l
instructions. The NRC believes that for the majority of releases requiring written instructions, the written instructions can be prepared in a generic t
form.
For example, the Society of Huclear Medicine ha; prepared a brief pamphlet, " Guidelines for Patients Receiving Radioiodine Treatment," which can oe given to patients at nominal cost (less than $1 per patient).
- However, oral instructions may also be provided in all cases.
Consent: Several commenters said that dictating to a physician how and what he or she must tell a patient is not the purview, mandate, or competence of the NRC, and interferes with an essential part of medical practice, which is communication between physician and patient.
Response
In a policy statement published on February 9,1979 (44 FR 8242), entitled " Regulation of the Medical Uses of Radioisotopes; Statement of General Policy," the NRC made three specific statements.
The third statement of the policy states that, "The NRC will minimize intrusion into medical judgements affecting patients and into other areas traditionally DRAFT: May 31, 1995 20
t
.O considered to be a part of the practice of medicine." The final rule is consistent with this statement because it does not specify the details of what the physician must say verbally or include in the contents of the written instructions. However, Regulatory Guido 8.39, " Release of htients Administered Radioactive Materials," includes recommended contents of the written instructions.
Single copies of Regulatory Guide 8.39 are available as
~
indicated in the ADDRESSES heading.
Further discussion of the 1979 Medical Policy Statement is presented i
under the heading, "VIII. Consistency with 1979 Medical Policy Statement."
l Comment: Several commenters asked whether written instructions were appropriate if the patient was blind, illiterate, or did not read English.
Another commenter said that the instructions should be both written and oral and should-be in the primary language of the patient.
Response: The NRC believes that written instructions are useful and should be required.
If the patient is blind, illiterate, or does not read English, it is likely that someone else will be able to read the instructions for the patient. NRC considers it too much of a burden to require that the instructions be given in the primary language of the p'tient, although the a
regulations do not preclude foreign language written instructions if the -
licensee chooses to provide them.
In most situations, it will be possible to 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.
DRAFT: May 31, 1995 21
o Consent: 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
.about protecting total strangers. This commenter also asked whether it is 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 is voluntary for the patient.
With regard to compliance with the instructions, surveys of patients and their spouses 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 physir. ally distant from their spouse for prolonged periods of time.
In this situation these couples would be making their own informed decision on what is reasonable or acceptable.
Coasent: 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 DRAFT: May 31, 1995 22
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 tny instructions that he or she considers desirable.
l CONFINEMENT OF PATIENTS Comment: 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 r.annot 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 if the patient were to leave "against medical advice."
Consent: One commenter asked if a patient that was releasable but was still hospitalized for other reasons would still be considered under the licensee's control.
Response
Once the licensee has authorized the release of the patient, there is no need to keep the patient under licensee control for radiation protection purposes if the patient remains hospitalized for other reasons. However, good health physics practice would be to continue to make DRAFT: May 31, 1995 23
-i-efforts to maintain doses to people at the facility as low as reasonably achievable.
Consent: Commenters also asked how a patient can be confined to his or her house.
Response: These commenters misunderstood the conrept of confinement.
As explained in the Statement of Considerations for the proposed rule (59 FR 30724), the term " confinement" no longer applies to the revision to 10 CFR 35.75.
Instead, the rule language uses the phrase " licensee control" which the NRC believes more clearly reflects the NRC's intent.
The URC believes that there is a distinct difference between a patient being under license 6 control in a hospital or other licensee facility (e.g., a hospice or nursing home) and being at home.
In a hospital or other licensee facility, the licensee has control over access to the patient as well as having trained personnel and instrumentation available for making radiation measurements not typically available at the patient's home.
In addition, while uMer licensee control, a licensee has control over the dose by limiting the amount of time that individuals are in close proximity to the patient. A patient who goes home is released from licensee control.
Consent: One commenter thought that the rule should define the term
" release."-
DRAFT: May 31, 1995 24
s Response: The NRC thinks the term " release from licensee control " when read in context, clearly-refers to radiation protection considerations and is sufficiently clear and that there is no need to define the term.
MISCELLANEOUS COMMENTS ON THE RULE' Coasent: Several commenters said that the rule should not be a matter of Agreer.ent 5 tate compatibility at any level.
l Response: The NRC does not agree.
NRC conducts an assessment of each proposed requirement or rule to determine what level of compatibility will be assigned to the rule. These casa-by-case assessments are based, for the most part, on protecting public itealth and safety.
Consent: Several commenters said that the nursing infant should not be considered as an individual exposed to the patient for the purposes of determining if patient release may be authorized. These'commenters said that consideration of the nursing infant should be under the jurisdiction of the physician,- that the issue is a medical issue rather a regulatory issue, and that the NRC should not interfere in medical issues.
Response: The NRC does not agree. The NRC has.a responsibility to protect public health and safety and that responsibility extends to all individuals exposed to a patient administered licensed radioactive materials, including the nursing infant.
DRAFT: -May 31, 1995 25
-Attachment 1-
Coarent: One commenter said that the Federal Register Notice on the proposed rule _did not-accuratcly represent the position of the Advisory Committee on Medical Use of Isotopes.
Response: -_A review of the transcript for the ACMUI meeting =in May, 1992, shows that the Federal Register Notice provided an accurate description of the ACMUI position. The final rule was discussed with the ACMUI on May 12,
. 1995, and the ACMUI supported the rule, i
Consent: One commenter said that its facility treated many foreign l
patients with therapeutic pharmaceuticals. These patients frequently may leave the hospital and immediately board a plane to return home. Thus,-there exists a limit as to the amount of control that a licensee has over the patient.
I Response: The NRC recognizes that the licensee has no control over the patient after the patient has been released. The quantities listed in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," for normal release were calculated using conservative assumptions (for example, by not taking credit for biological elimination by using the.
physical half-life of the radioactive material rather than the more realistic biological half-life). Thus, the NRC considers it unlikely that the dose to an individual in real circumstances would approach 5 millisieverts (0.5 rem).
If the release is based on a more realistic case-specific calculation.
- it may be necessary to consider and evaluate'special situations, such as when a released patient would immediately board an airplane flight and would DRAFT: May 31, 1995 26
-r
o e
therefore be in close contact with another individual.
But once the patient is released, the responsibility for following the instructions is entirely-the patient's, not the licensee's.
l COMMENTS ON THE DRAFT REGULATORY GUIDE Coments were also requested on the draft regulatory guide associated with this rulemaking.
Because tha guide is associated with the rule, the coments received on the draft guide are discussed here. Most of the coments concerned the method and the assumptions used to calculate dose to the individual likely to receive the highest dose.
Consent: Several comenters said that the calculational methodology in the draft guide is too complex and that the assumptions are too conservative.
As an example, several comenters said that the assumed 24-hour non-voiding assumption used in calculating doses is too conservative. As evidence that the calculations are too conservative, several comenters said that the doses measured using dosimeters were much lower than doses calculated using the models in the draft guida.
Response: While the calculations can sometimes be complex, it will rarely be necessary to do a calculation. Almost all releases can be done using the table of release quantities in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials."
If a case-specific calculation is appropriate, it is possible to do a generic calculation that would represent a condition such as treatment for thyroid cancer for all patients.
DRAFT: May 31, 1995 27
s This calculation could be done once and placed on file. A separate calculation would not have to be done for each patient.
With regard to the comments that the methodology is too conservative and l
that measured values are lower than calculated by the methodology, the methodology in the table giving default release quantities is intended to be conservative. The NRC believes it is appropriate and prudent to be conservative when providing generally-applicable reletse quantities that may be used with little consideration of the specific details of a specific patient's release. A review of published information, as described in the regulatory analysis (NUREG-1492), finds that the measured doses were well below those predicted by the methodology used to calculate the table of default release quantities. Thus, the default release quantities are conservative as the NRC intended. However, the licensee is give.i the option to do case-specific calculations that may be less conset vathe.
The NRC agrees that the assumption used in the draft guide of 24-hour non-voiding in the thyroid cancer example is too conservative.
The revised example uses an excretion half-time of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> as recommended by the ICRP in ICRP Publication 53, " Radiation Dose to Patients from Radiopharmaceuticals.'
Comment: -One commenter said that the exposure factor (generally assumed to be 0.25 at 1 meter) should not be left to the discretion of the licensee because low exposure factors could easily be justified by providing strict safety instructions without any verification that the instructions will be followed. Another commenter liked the flexibility provided by being able to
' International Commission on Radiological Protection (ICRP), " Radiation Dose to Patients from Radiopharmaceuticals," ICRP Publication No. 53 (March 1987). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.
DRAFT: May 31, 1995 2o
r adjust the exposure factor, but wanted to be know if other considerations ar allowed and if it is acceptable to use values lower than 0.125.
4 Response: Exposure factors less than 0.125 may be difficult to justify C
because it is generaly'}\\ot realistic to assume that the patient can avoid all contact with others[ This view is expressed in Regulatory Guide 8.39,
" Release of Patients Administered Radioactive Materials." However, lower values for the exposure factor are not prohibited by the regulation, but must be justified in the record of the calculation, as the record will be subject to inspection.
i Comment: Several commenters said that the iodine-131 retention fraction of 0.3 used in the draft guide for treatment of thyroid cancer is too large and that the correct value should be 0.05 or less. Another commenter said that the biological half-life of extrathyroidal iodine should be 0.5 day for both the euthyroid and hyperthyroid condition. One commenter said that the values from ICRP Publication No. 53 should be used instead.
(The value used in the draft guide for the euthyroid condition was 0.21 day.)
Response: The NRC agrees that the comnienters raised valid points.
Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," has been appropriately revised.
Comment: One commenter said the table of rel 'se quantities in the draft guide should be expanded to include beta emitters such as strontium-89 and phosphorous-32. Another commenter said that the table should be expanded DRAFT: May 31, 1995 29
v T
to include:
chromium-51,-selenium-75, ytterbium-90 tin-117m, and
~ iridium-192.-
Response: -Values for the beta emitters, strontium-89 and phosphorous-32 have been added to the table'of release quantities in Regulatory Guide 8.39,
" Release of Patients Administered Radioactive Materials." The table of release quantities was also expanded to add values for chromium-51, selenium-75, ytterbium-90, tin-ll7m, _and iridium-192.
ll Comment: The table of releases quantities in the draft regulatory guide should be expanded to include accelerator-produced radioactive materials as an-
-1
- aid to Agreement States, i
Response: Several accelerator-produced materials were added to
-Regulatory Guide 8.39, " Release of Patients Administered Radioactive Material s. "
-Comment: One commenter said that the regulatory guide should have a table of release quantities based on biological half-life rather than only the
- physical half life.
-Response: - Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," now provides increased information on release
. quantities for iodine-131 based on biologica1' half-lives.
DRAFT: May 31, 1995 30
a Comment: One commenter said that the factor of 10" used in the draft guide to rstimate internal dose is not well supported for nonoccupational exposures. Another commenter said that the calculation of dose to individuals exposed to the patient. ignores the potential of radiation dose from the excretion of radioactive material from the patient and this could present a significant radiological hazard to family members.
Response
It is true that there is not a great deal of information on the use of the factor in nonoccupational settings, but measurements (described in NUREG-1492) have been made in which iodine uptake was measured in people exposed to a patient. These data suggest that the fraction uptake of the administered activity will be on the order of 10".
Since iodine is among the most soluble and volatile radiopharmaceuticals, it can be expected that the transfer to others of less soluble and less volatile radiopharmaceuticals i
would less than that of iodine.
Thus, the NRC considers use of the factor appropriate on a general basis.
In addition, the NCRP recently concluded that for individuals exposed to radionuclide therapy patients the risks of external irradiation and potential contamination are minor from a public health viewpoint; therefore a significant intake from a contamination incident is very unlikely.'
Comment: A medical organization commented that the draft guide is not complete and does not provide sufficient comprehensive examples to assist licensees in complying with the rule.
DRAFT: May 31, 1995 31
i
Response
Expanded examples now given in Regulatory Guide 8.39,
" Release of Patients Administered Radioactive Materials." The example on thyroid cancer was revised to include more realistic assumptions and an additional example on hyperthyroidism was added.
The NRC believes that the five examples provided illustrate the techniques sufficient to perform the whole range of potential calculations.
i l
Coasent: One commenter said that the draft regulatory guide did not l
provide enough information on when and for how long nursing of infants should be stopped.
Response: Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," has been greatly expanded with respect to information on the breast-feeding infant, including a table on interruption of i
)
breast-feeding for specific radiopharmaceuticals.
Consent: One commenter said that the sample instructions in the draft guide concerning implants should include a picture of an implant seed.
Response: The sample instructions were not expanded to include this due to graphics limitations, but licensees may add photos if desired.
Comment: Several ccmmenters asked whether multiple individual calculations have to be specifically done or if a generally-applicable calculation could be done once and used for many patients.
DRAFT: May 31, 1995 32 Ll
Response: The NRC would expect that if a case-specific calculation were done by a licensee, it could be done for a class of patients.
The record of the basis for a particular patient's release could then reference the calculation done for the class of patients.
Comeent: One commenter said that the discussion on radiolabeled antibodies in the draft guide was wrong because iodine-131-labeled antibodies will be deiodinated in the body and the iodine will behave like other iodine.
None of the radiolabeled antibodies now being developed or planned for the future should have an internal dose hazard for the general public.
Response: The NRC agrees with this comment.
Statements in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," are now modified.
COMMENTS ON THE REGULATORY ANALYSIS (NUREG-1492)
Comment: One commenter said that the value of a person-rem should be
$40 rather than $1,000 as used in the regulatory analysis for the purpose of evaluating the costs and benefits of the rule.
The commenter cited a Health Physics Society position paper.
Response: The NRC does not believe that the value of $40 per person-rem recommended by the Health Physics Society is appropriate.
The NRC continues (-
to believe that for the purposes of this evaluation a value of $1,000 per DRAFT:
May 31, 1995 33
n person-rem is appropriate. Use of this value is standard practice in conducting NRC cost-benefit analyses.
Coseent: One commenter said ' hat the benefits of the rule were overestimated because the length of time that a thyroid patient would have to remain in the hospital was overestimated and the cost of a hospital room was
-overestimated, being M50 per day rather than $1,000 per day as assumed in the draft regulatory analysis.
Response: 1he ecme' sr is correct that the benefits of the rule were overastimated.
The estku.tes of days of nospitalization required did not include biological elimination of the radioactive material.
Only radioactive decay was considered. As a consequence, the estimetes of the periods of time that patients would need to be retained under licensee control were too long, and therefore the costs of patient retention were too high.
The final regulatory analysis corrects the estimates.
The NRC believes that the current cost of $1,000 per day for a hospital room is not an overestimate.
Under 10 CFR 35.315(a)(1), for each phtient receiving radiopharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75, licensees are required to provide a private room with a private sanitary facility.
Considaring this NRC requirement and the recent reference cited in the finti regulatory analysis on the cost of hospitalization, $1,000 per dav 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 i=ference cited.
DRAFT:
May 31, 1995 34
i i
[
l
- esponse: The commenter is correct.
An incorrect reference was given.
The final regulatory analysis provides the correct reference.
1 IV. Coordination with NRC Agreement States 1
I l
The NRC staff discussed the status of this rulemaking effort at two i
public meetings; the Agreement State Managers Workshop held on July 12-14, 1
1994 and at the All Agreement States Heeting held on October 24-25, 1994.
The Agreement States expressed no objections to the approach in this rule.
I I
V.
Coordination with the Advisory Committee on Medical Uses of Isotopes a
l The Advisory Committee on Medical Uses of Isotopes (ACMul) is an j
advisory body established to advise the NRC staff on matters that involve the administration of radioactive material and radiation from radioactive t
material. The NRC staff presented a sumnary of the comments on the proposed l
.ule to the ACHUI during a public meeting held in Rockville, Maryland, on l
November 17 and-18 -1994.
Drafts of the final rule and regulatory guide were discussed with ACMUI in Rockville, Maryland, on May 12, 1995.
The ACMul was generally supportive of the approach in this rule.
Transcripts of the meetings have been placed in and are available for examination at the NRC Public Document Roov, 2120 L St. NW. (Lower Level), Washington, DC.
3 4
d i
DRAFT:l May 31,-1995 35 Attachment I r.
?
.., ~
.,,,,.m.,,
_,;.....,_..._...._,~..,,,....-..___-_.--.,,,-,_.,....
s a
VI.
Discussion of Final Rule Text This section summarizes the final rule.
The NRC is amending 10 CFR 20.130)(a)(1) to specifiU 1y state that the dose to individual members 1
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 is a clarifying change to make clear that the Commission's policy is that 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 i 20.1002, " Scope," in i 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 specifically state that the limit on dose in unrestricted areas does not include dose contributions from patients 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 NRC is adopting a new 10 CFR 35.75(a) to chnge the patient release criteria from 30 millicuries 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 DRAFT: May 31, 1995 36
o e
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 can be allowed to 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 nil 11 sievert (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 l
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.
The new 10 CFR 37.75(a) explicitly. states that the 5-mil 11 sievert (0.5-rem) release criteria also applies to breast-feeding infants due to radiopharmaceuticals contained in the breast milk of a woman who received an administration.
Realistically, a woman would not be denied release because of the potential transmission of radioactive materials in breast milk.
- Instead, the woman would be given instructiot.s (as required by 10 CFR 35.75(b), which is described below) to cease or to interrupt breast feeding.
The release could then be authorized on the basis that the woman would cease or interrupt breast feeding as instructed.
The NRC is adopting a new 10 CFR 35.75(b) to require that the licensee provide released patients with instructions, including written instructions, on how to maintain doses to other individuals as low as 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).
This requirement also requires giving instructions to breast feeding women if the DRAFT: May 31, 1995 37 O
s
o a
dose to the infant is likely to exceed 1 millisievert (0.1 rem) if there were no interruption of breast feeding.
A requirement for instructions for certain patients was already contained in 10 LFR 35.315(a)(6) and 35.415(a)(5), but the modified requirement adds approximately 50,000 patients per year who are administered r
N indinn-mghe treatment of hyperthyroidism and another 70,000 patients)
( {who are breast-feedi
~~
The purpose of the written instructions-is to '
\\
N mainttifr d6ies to individuals exposed to patients as low as reasonably i
achievable.
The instructions may be either written plus oral or written only.
The NRC believes that written instructions are necessary so that the patient and the patient's family and friends will have a document to refer to rather than having to rely solely on the patient's memory and understanding of the instructions.
The NRC is adopting a new IJ CFR 35.75(c) to require that the licensee maintain, for three years, a record of the basis for authorizing the release if the administered activity is in excess of the activity considered not likely to result in a total effective dose equivalent to another individual, exceeding 5 millisieverts (0.5 rem) based on standard > m ervative assumptions.
For the purposes of this requirement, those assumptions are:
the individual retains the initial administered activity, a point-source geometry, the physical half-life of the radionuclide, an occupancy factor of 0.25 at one meter, and no attenuation of radiation in tissue.
For the convenience of the licensee, the administered activities far which a record would be required are tabulated and presented in Table 1 of Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials."
DRAFT: May 31, 1995 38
8$!N$k b
t 4
l This recordkeeping requirement is a modification of that in the proposed rule.
The proposed rule would have required that a record be maintained of the basis for the patient's release, including all calculations performed, if the total effective dose equivalent to any other individual other than the released patient is likely to exceed 1 mil 11 sievert (0.1 rem) in a year from a single administration.
Under the proposed rule, the major purpose of the record was to prtvide the basis for controlling the dose to 5 millisieverts (0.5 rem) to individuals exposed to a patient who may receive more than one administration in a year.
Upon reconsideration, based on public comments and consultation with the ACMUI, an NRC medical consultant, and the NRC Visiting Medical Fellow, the NRC has decided to delete this requirement.
A review of medical treatment practices revealed no routine practice that would result in exceeding the 5-mil 11 sievert (0.5-rem) limit because of multiple l
aoministrations in the same year. Without the need to account for the dose from multiple administrations, maintaining records for the tens-of-thousands of patient releases where the dose to an individual is likely to exceed l
l 1 mil 11 sievert (0.1 mil 11 sievert) becomes an unnecessary burden, and therefore has been deleted.
Each patient release is to be treated as a separate event upon which licensee knowledge of previous administrations is unnecessary.
The NRC is adopting a new 10 CFR 35.75(d) to require that the licensee maintain for 3 years a record of the instructions given to a breast feeding woman if the administered activity would be likely to result in a total effective dose equivalent to the breast feeding child exceeding 5 millisieverts (0.5 rem), assuming no interruption of breast feeding.
- Thus, the NRC is requiring record of the instructions given for only the more significant radiopharmaceutical administrations. The activities of D4 AFT: May 31, 1995 39
t radiopharmaceuticals that require this record are tabulated in Regulatory Guide 8.39, "Ciiteria for the Release of Patients Administered Radioactive Material s. "
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.
VII.
Consistency with 1979 Medical Policy Statement l
On February 9,1979, the NRC published a Statement of General Policy on the Regulation of the Medical Uses of Radioisotopes (44 FR 8242). The first statement of the policy states, "The NRC will continue to regulate the medical uses of radioitotopes as necessary to provide for the radiation safety of workers and the general public." The rule is consistent with this statement because its purpose is to provide for the safety of individual members of the public exposed to patients administered radioactive materials.
The second statement of the policy states, "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."
This statement is not relevant to the rule because the rule does not affect the safety of patients themselves. The rule instead affects the safety of individuals exposed to patients.
The third statement of the policy states, "The NRC will minimize intrusion into medical judgements affecting patients and into other areas traditionally considered to be a part of the practice of medicine." The rule is consistent with this statement because it places no requirements on the DRAFT: May 31, 1995 40
t administration of radioactive materials to patients and because the release of patients administered radioactive materials has long been considered a matter of regulatory coaccrn to protect _ members of the public rather than solely a matter of medical judgement.
Thus, the final rule is considered to be consistent with the 1979 medical policy statement.
l Vill.
Issue of Compatibility for Agreement States l
l The NRC believes that the definitions contained in i 20.1003 and text in il 20.1002 and 20.1301(a) that are modified by this rulemaking are Division 1 levels of compatibility. These definitions and sections must be the same for all NRC and Agreement State licensees so that national consistency can be maintained.
Additionally, 6 35.75, is a Division 2 level of compatibility because the patient release criteria required by the rule are the minimum requirements necessary to ensure adequate protection of the public health and safety. The Agreement States will be allowed to establish requirements that are more stringent than the NRC's requirements, but not less stringent.
IX.
Finding of No Significant Environmental Impact: Availability The NRC has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR part 51, that-the amendments are not be a major Federal action significantly affecting the quality of the human environment, and therefore an DRAFT: May 31, 1995 41
t environmental impact statement is not required.
The final amendments clarify the pertinent regulatory language to reflect explicitly the relationship between 10 CFR part 20 and part 35 with respect to release of patients, and revise the release criteria for patients receiving radioactive material for medical use from an activity-based standard to a dose basis.
It is expected that there will be relatively little change in radiation dose to the public or to the environment as a result of the revised regulation.
The final environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental assessment and the finding of no significant I
impact are available as indicated in the FOR FURTHER INFORMATION CONTACT heading.
7.
Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
These requirements were approved by the Office of Management and Budget, approval number 3150-0010.
The public reporting burden for this collection of information is estimated to average 0.42 hours4.861111e-4 days <br />0.0117 hours <br />6.944444e-5 weeks <br />1.5981e-5 months <br /> per response, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information.
DRAFT: May 31, 1995 42
l XI. Regulatory Analysis The NRC has prepared a final regulatory analysis (NUREG-1492) on this regulation. The analysis examines the benefits and impacts considered by the NRC. The final regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC.
Single copies are available as indicated under the FOR FURTHER INFORMATION CONTACT heading.
Xil. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
the NRC certifies that this rule will not have a significant economic impact on a substantial nember of small entities. This rule affects medical use of byproduct material licensees. As a result of the final rule, the impact will not be significant because the final rule basically represents a continuation of current practice.
XIII.
Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this rule and, therefore, that a backfit analysis is not required for this rule, because these amendments-do not involve any provisions which impose backfits as defined in 10 CFR 50.109(a)(1).
l DRAFT: May 31, 1995 43
e XIV. List of Subjects 10 CFR part 20 Byproduct material Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and-recording requirements, Special nuclear material, Source material, Waste treatment and disposal.
10 CFR part 35 Byproduct material, Criminal penalty, Drugs, liealth facilities, Health professions, incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553; the NRC is adopting the following amendments to 10 CFR parts 20 and 35.
l l
DRAFT: May 31, 1995 44
e XV.
Text of Final Regulations PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION 1.
The authority citation for part 20 is revised to read as follows:
Authority:
Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 2073, 2093, 2095,
)
2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as amended, 202, 206, 88 Stat.
1242, as amended, 1244, 1246 (U.S.C. 5841, 5842, 5846).
Section 20.408 also issued under secs. 135, 141, Pub. l.97-425, 96 Stat. 2232, 2241 (42 U.S.C.
10155,10161).
2.
Section 20.1002 is revised to read as follows:
I 20.1002 scope.
The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under parts 30 through 35, 39, 40, 50, 60, 61, 70, or 72 of this chapter._ The limite in this part do not apply to_ doses due to background radiation, to exposure of patients to radiation for the purpose 'of medical diagnosis or therapy, tsleihiissNits]fsdjjjduals[sdal6DiefedZradifictl1WeitO]i196d' EilissidIKsiss#iicGith15;ssus; or to voluntary participation in medical research programs.
DRAFT: May 31, 1995 45
Note to reviewers:
Another ongoing final rule is also amenC.ng 20.1002.
If that rule goes to the Commission first, the wording shown here will be changed to reflect the wording in the other rule.
3.
In i 20.1003, the definitions of occupatfonal dose and public dose are revised to read as follows:
E 20.1003 Definitions.
Occuoatfonal dose means the dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include dose received from background radiation, as a patient from medical practices, from.Lexp'osure tejindividualsisdministerediradioactivelmaterial;'and r_eleased in accordance
~
With;;l 35;75] from voluntary participation in medical research programs, or as a member of the public.
Pubife dose means the dose received by a member of the public from exposure to radiation and to radioactive material released by a licensee, or to anothe, source of radiation either within a licensee's controlled area or in unrestricted areas.
Publicid6se' does not include occupational dose or DRAFT: May 31, 1995 46
s doses received from background radiation, as a patient from medical practices, fromTexpossrel.tolindividualsladministered; radioactive material andLreleased in bedrdance;Vith?,lT35?75i or from voluntary participation in medical research programs.
I Note to reviewers: Two other final rulemakings are amending the
. definitions of occupational dose and public dose.
The wording will be changed to reflect those rulemakings if they go to the Commission before this rule.
4.
In i 20.1301, paragraph (a) is revised to read as follows:
5 20.1301 Dose limits for individual members of the public.
(a)
Each licensee shall conduct operations so that--
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year, exclusive of the dose contributions from background-radiation,.; fromfsxposure ofiindividuQsitoradiationforithefpurposeofmedica1Tdiagno'sisioi;;theracyl froml expo s ure;;to]i nd i v i du al slade_i ni s t e redirad i o act i v e; ma t e r i a1 T and T rel e a s ed i i n iccofdsn;ce[wi th Ell 35 ; 75[ fron'; vol uht aryl pai ti ci pat i6nii nf med i ~c al. re se arch progFans, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 6 20.2003, and (2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with 6 35.75, does not exceed 0.002 rem (0.02 mSv) in any one hour.
DRAFT: May 31, 1995 47
r Note to reviewers: One other final rulemaking is changing 20.1301.
If that rulemsking goes to the Commission before this rule, the wording of l
this rule will be changed appropriately.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL 5.
i,te authority citation for part 35 continues to read as follows:
Authority:
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
6.
In Section 35.8, paragraph (b) is revised to read as follows:
E 35.8 Information collection requirements:
OM8 approvs1.
(b) The approved information collection requirements contained in this part appear in il 35.12, 35.13, 35.14, 35.21, 35.22, 35.23, 35.27, 35.29, 35.13, 35.50, 35.51, 35.53, 35.59, 35.60, 35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636, 35.641, 35.643, 35.645, and I
35.647.
DRAFT: May 31, 1995 48 J
o 7.
Section 35.75 is revised to read as follows:
)
i 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
(a) The licensee may authorize release from licensee control any individual administered radiopharmaceuticals or permanent implants containing l
radioactive material if the total effective dose equiulent 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).
(b) The licensee shall provide the released individual with instructions, including written instructions, on how to maintain doses to other individuals as low as reasonably achievable if the total effective dose l
equivalent to any other individual is likely to exceed 1 mil 11 sievert (0.1 rem).
(c) The licensee 'shall maintain, for 3 years, a record of the basis for authorizing the release if the administered activity is in excess of the activity considered not likely to result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem) calculated based on standard conservative assumptions.
For the purposes of this requirement, standard conservative assumptions are:
the individual retains the initial administered activity, a point-source geometry, the physical half-life of the radionuclide, an occupancy factor of 0.25 at one meter, and no attenuation of radiation in tissue.
(d) The licensee shall maintain for 3 years a record of the basis for k
authorizing the release'of a breast feeding woman if immediate release with the administered 3ctivity-would be likely to result in a total effective dose DRAFT: May 31, 1995 49 Attachment I
e e
i equivalent to the breast feeding child exceeding 5 millisteverts (0.5 rem),
assuming no interruption of breast feeding.
8.
InSection35.315, paragraph (a)(6)isdeleted l
)
i 35.315 Safety precautions.
(a)
I (6) Deleted.
o 9.
In Section 35.415, paragraph-(a)(5) is deleted:
5 35.415 Safety precautions.
(a)
(5) Deleted.
Dated at Rockville, Maryland, this day of
, 1995.
For the Nuclear Regulatory Commission.
Shmuel J. Chilk, Secretary of the Commission.
DRAFT: May 31, 1995 50
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ATTACHMENT 2 DRAFT ACTIVE REGULATORY GUIDE 4
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o NOTE TO COMMISSION This guide is a working draft rather than a final draft, it does not have Office cancurrence, and it has not yet undergone final editing.
It is thus subject to change before publication, but it is expected that the changes will be relctively minor. There should be no difficulty in publishing the final guide at about the same time that the final rule is published.
l REGULATORY GUIDE 8.39 (Draft was issued as DG-8015)
RELEASE OF PATIENTS ADMINISTERED RADI0 ACTIVE MATERIALS j
A.
Il[IRQDUCTION
)
l Section 35.75, " Release of individuals containing radiopharmaceuticals l
or permanent implants," of 10 CFR Part 35, " Medical Use of Byproduct Material," permits licensees to " authorize release from licensee control any individual administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective 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)."
In addition, Section 35.75 requires that if "the total effective dose equivalent to any individual other than the released individual is likely to exceed 1 millistevert (0.1 rem) from a single administration, upon release the licenset shall provide the released individual with instructions, including written instructions, on how to maintain doses to other individuals as low as reasonably achievable."
Section 35.75 also requires that the licensee maintain, for 3 years, a record of the basis for authorizing the release if the administered activity is in excess of the activity considered not likely to result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem) calrulated based on standard conservative assumptions.
For the purposes of this requirement, DRAFT: June 1,1995
staMard conservative issumptions are:
the individual retains the initial administer # activity, a point-source gecmetry, the physical half-life of the radionuclide, an occupancy factor of 0.25 at one meter, and no attenuation of radiation in tissue.
Hereaftar in this geide the individual to whom the radioactive material has s wa administered will be known as the patfent.
This guide is being developed to provide guidance on determining the potential dosos te 14. Wividual likely to receive the highest dose from exposure to the releasef patient, to establish appropriate ictivities and dose rates for release, to provide guidsnce on instructions for patients on how to I
maintain doses to other individuals as low as reasonably achievable, and to describe recordkeeping requirements.
The information collections contained in this regulatory guide are covered by the requirements in 10 CFR 35.75, which have been app.oved by the l
Office of Management and P-iget, Approval No. 3150-0010.
B.
DISCUSSION This guide lists activities for commonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dose limits in Section 35.75.
The activities were calculated by using, as a starting point, the method discussed in National Council on Radiation Protection and Measurements (NCRP)
Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."'
NCRP Report No. 37 uses the following equation to calculate the exposure until time t at a distance r from the patient:
- 34. 6 f Q,T, (1-e """')
D(t) =
(Equation 1) r'
' National Council on Radiation Protection and Measurements, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," Report No. 37, 1970.
DRAFT: June 1, 1995 2
O.
e Where D(t) = accumulated exposure at time t, in roentgens, i
- 34. 6 +. conversion factor of H hrs / day times the total l
integration of decay (1.44),
i i
f=
specific camma ray constant for a point source, R/ mci h at 1 cm, 5
Q. = initial activity of the point source in mil 11 curies, j
at the time of the release, j
T, = physical-half-life in days, i
r-distance from the point source to the point of-interest in centimeters,
]
t-exposure time in days, i
This guide uses the NCRP equation (Equation 1) in the following manner i
to calculate the activities at which patients may be released.
e The dose to en individual likely to receive the highest dose from exposure to the patient is taken to be the dose to total decay.
Therefore, (1-e'""U) is set equal to 1.
e It is assumed that I roentgen is equal to I rem.
e The doses are calculated using the physical half-life of the radionuclides A and do not acco;at for the biological half-life of the radionuclide.
The gamma ray constants and half-lives for radionuclides typically o
used in nuclear medicine and brachytherapy procedures are given in Appendix A to this guide, e
For radionuclides with half-lives greater than 1 day, it is assumed that the individual likely to receive the highest dose from exposure to the patient would receive a dose of 25 percent of the dese to total decay (0.25 in Equation 2) at a distance of 100 centimeters. Selection of 25 percent of the dose to total DRAFT: June 1, 1995 3
O O
1 l
decay for estimating the maximal likely exposure is a judgement based on time-distance combinations believed to occur when instructions to spend as little time as possible near the patient are given.
For radionuclides with half-lives less than 1 day, the factor 1.0 is used in Equation 3 because the assumption that the time that individuals will spend near the patient will be limited may not be valid when relatively long-term averaging of behavior cannot be assumed.
Thus, for radionuclides with a half-life greater than 1 day:
34.6 rQ T,(0.25)
D(=) =
(Equation 2)
(100cm)'
For radionuclides with a half-life less than 1 day:
34.6 rQ,T, D(=) =
(Equation 3)
(100cm)'
Equations 2 and 3 calculate the dose from external exposure to gamma radiation. The equations do not account for internal intake by household members and members of the public because the dose from intake by other individuals is normally expected to be small (less than a few percent) relative to.the gamma dose (see Appendix B, Section 3.2).
Further, the equations above do not apply to the release of breast-feeding mothers if they continue to breast-feed.
Breast feeding must be considered separately as described below.
DRAFT: June 1, 1995 4
1-
O c
C.
REGULATORY POSIT 10!(
l.
ACTIVITY LEVELS 1.1 Activities for Release of Patients Licensees may demonstrate compliance with the dose limit in Section 35.75 for release of patients from licensee control if the amount of the radionuclide in the patient's body at the time of release is less than the value in Column 1 of Table 1 or if the dose rate at 1 meter (from the patient L
centerline) is less than the value in Column 2 of Table 1 for that-radionuclide. The release of mothers who might breast feed after release may also be based on Columns 1 and 2 of Table 1, but Columns 3 and 4 cannot be used to determine when instructions must be given. The instructions that must be given _to women who might breast feed are discussed later in this guide.
1.2 Activities Reauirina Instructions l
Licensees may use tho values in Column 3 or Column 4 of Table 1 to determine when instructions must be given to patients who are not breast feeding. Column 3 provides activities above which an individual could receive a dose of 1 mil 11 sievert (0.1 rem) or more.
Column 4 provides corresponding dose-rates at 1 meter, based on the activities in Column 3.
If the released patient is a woman who will be breast-feeding after release, licensees may also use Tabic 2 to determine when additional instructions on the cessation period must be given to the patient to meet the requirements in Section 35.75(b).
DRAFT: June 1, 1995 5-
Table l' Activities and Dose Rates for Authorizing Patient Release and Giving h tructions' Column 1 Column 2 Column 3 Column 4 Activity Below Dose Rate at Activities Dose Rates at Whit.h Patients 1 meter at Requirir!1 1 meter May Be Which Instruct'ons Requirin!1 Released Patients May Instruct'ons Be Released Radio-nuclide (ares /hr)
(mci (GBq)
(ares /hr)
Ag-111 500 (20) 8 100 (4) 2 Au-198 90 (3) 20 20 (0.7) 4 Cr-51 100 (4) 2 20 (0.8) 0.4 Cu-64 200 (9) 30 40 (2) 5 Ga-67 200 (9) 20 40 (2) 4 1-123 160 (6) 20 30 (1) 4 1-125 8.7 (0.32 1
1.7 0.06 0.2 (implant) 1-125 7
(0.2) 1 1.4 (0.5) 0.2 1-131 30 (1,2) 7 6
(0.24 1.4
)
In-111 60 (2) 20 10 (0.4) 4 Ir-192 1,6 (0.06 0.8 0.3 (0.01 0.1
)
)
P-32 100 (4)
NA 20 (0.8)
NA Pd-103 40 (1.5) 3 7.9 0.29 0.7 implants Re-186 900 (30) 10 200 (7) 2 Re-188 600 (20) 20 100 (4) 4 Sc-47 300 (10) 10 50 (2) 3 Se-75 2
(0.07
.5
.4 (0.01 0.1
)
)
Sm-153 700 (30) 30 100 (5) 6 Sn-ll7m 30 (1) 4 6
(0.2) 0.8
' Values rounded to one significant figure, except in a few instances where it was considered appropriate to use two si tificant figures.
The details of the calculations are shown in NUREG-1492, Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material,1995.
DRAFT:
June 1, 1995 6
o I
Sr-89 100 (4)
NA 20 (0.8)
NA Tc-99m 700 (30) 50 100 (6) 10 T1-201 400 (10) 20 80 (2) 4 Y-90 100 (4)
NA 20 (0.8)
NA Yb-169 10 (0.4) 2 2
(0.07 0.4
)
i l
1 DRAFT: June 1, 1995 7
o I
l l
l 1.3 Calculations Based on Case-Soecific Factort Licensees may calculate the maximum likely dose to an individual exposed j
to the patient on a case-by-case basis to account for factors specific to a patient.
In such cases, licensees may be ab;e to rolease a patient with
-radioactive material in excess of the activity listed in Table 1 and still demonstrate compliance with the annual dose limit.
Licensees may take into account the effective half-life of the radioactive w'aterial and other factors that may be relevant to the particular case.
I Appendix B provides procedures for performing case-specific dose calculations, and it describes how various factors may be considered in the calculations.
2.- INSTRUCTIONS 2.1 Instructions for patients to be Released If the total effective dose equivalent to an individual exposed to a patient is likely to exceed 1 mil 11 sievert (0.1 rem), Section 35.75(b) requires that the released patient be given instructions, including written instructions, on how to maintain doses to other individuals as low as reasonably achievable.
The instructions should be specific.to the type of treatment given, such as permanent implants or radiciodine for hyperthyroidism or' thyroid carcinoma, or they may include additional information for individual situations.
The instructions should include a contact and phone number in case the patient has any questions.
Instructions should include, as appropriate, the need.for Maintaining distance from individuals, including sleeping arrangements and minimizing use of public transportation, Minimizing time-in public places (e.g., grocery stores, shopping e
centers, theaters, restaurants, and sporting events),
e Maintainii.g good hygiene to reduce contamination, and DRAFT: June 1, 1995 8
e i
e The length of time precautions should be taken.
The Society of Nuclear Medicine published a pamphlet in 1987 that l
provides information for patients receiving treatment with radiciodine.'
This pamphlet was prepared jointly by the Society of Nuclear Me<iicine and the NRC. The NRC considers the instructions in this pamphlet to be acceptable instructions for patients, provided specific information is given to patients regarding any case-specific factors. However, licensees may develnp their own instructions, addressing the items discussed above as appropriate.
Sample instructions for patients who have received permanent implants are given in Appendix C.
2.2 Additional Instructions for Release of Women Who Could be Breast-FeediD2 after Release i
If the patient to be released is a women who could be breast-feeding after release, Table 2_ provides acceptable instructions on the cessation period for the radionuclides currently used in medical diagnosis and treatment. The instructions are appropriate for the normal dosage ranges shown but if the activity administered is outside of the range the instructions may not be appropriate and may have to be modified.
8 " Guidelines for tients Receiving Radiciodine Treatment," Society of Nuclear Medicine, 1987.
This pamphlet may be obtained from the Society of Nuclear Medicine, 136 Madison Avenue, New York, NY 10016-6760.
DRAFT: June 1, 1995 9
o Table 2 Instructions for Breast-feeding Women Dose to infant if no Administered interruption Recommendation on Radio-Activity
- of breast Instructions interruption of pharmaceutical mci (MBq) feeding
- Required?'
breast feeding' mrem 1-131 Nat 150 (5550) 60,000-yes Complete cessation 40,000,000 is necessary to avoid thyroid ablation in the infant I-123 Nat 0.4 (14.8) 60 no None l
I-123 OlH 2 (74) 4-30 no None l
I-123 mlBG 10 (370) 300 yes Interruption for about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 1-125 OIH 0.01 (0.37) 0.2 no None I-131 OlH 0.3 (11.1) 3-20 no None
- Maximum activity normally administered.
I
' Doses are calculated for the maximum administered activities shown in Column 2.
If a smaller activity were administered, the doses would be proportionally smaller.
The doses are calculated for newborns; doses to a one-year-old would be less than half the doses shown.
If a dose range is shown, the range is due to individual variability and measurement variability as indicated by different measurements of concentrations in breast milk. The doses include internal doses only; external doses due to close contact during nursing were found to be small relative to the maximum of the internal dose range. The details of the calculations are shown in NUREG-1492. " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material."
' The decision on whether instructions are required by 6 35.75(b) is based on the maximum value of the dose range for the newborn exceeding 0.1 rem.
' The duration of interruption is selected to reduce the maximum dose to a newborn infant to less than 0.1 rem.
The actual doses that would be received by most infants would be far below 0.1 rem.
The physician may use discretion in the recommendation, increasing or decreasing the duration of interruption somewhat depending on the mother's concerns about radioactivity or interruption of breast feeding.
DRAFT: June 1, 1995 10
e
-Tc-9_9m DTPA 20 (740) 0.3-6 no None Tc-99m MAA 4 (148) 4-300 yes Interruption for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> Tc-99m 30 (1110) 200-800 yes Interruption for pertechnetate about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> Tc-99m DISIDA 8 (300) 4-20 no None Tc-99m 20 (740) 2-5 no None glucoheptonate Tc-99m HAM 8 (300) 20-50 no None Tc-99m MIBI 30 (1110) 1-10 no None Tc-99m MDP 20 (740) 4-5 no None Tc-99m PYP 20 (740) 5-20 no None Tc-99m RBC's in-20 (740) 0.3-100 yes Interruption for vivo labeling about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> Tc-99m RBC's in 20 (740) 1-2 no None vitro labeling Tc-99m sulfur 12 (444) 9-100 yes Interruption for colloid about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> Tc-99m DTPA 1 (37) 0.02-0.5 no None j
aerosol Tc-99m MAG 3 10 (370) 0.2-2 no None Tc-99m WBC's 5 (185) yes Interruption for about 247 hours0.00286 days <br />0.0686 hours <br />4.083995e-4 weeks <br />9.39835e-5 months <br /> Ga-67 citrate 5 (185) 300-10,000 yes Complete cessation Cr-51 EDTA 0.05 (1.85)
<0.01 no None In-111 WBC's 0.5 (18.5)20-100 yes Interruption for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> T1-201 3 (111)
DRAFT:
June 1, 1995 11
3.
RECORDS There is no recordkeeping requirement for patient releases based on Table 1.
However, if the release of the patient is based other than the standard conservative assumptions on which Table 1 is based, Section 35.75(c) requires that the licensee maintain, for three years, a record of basis for the release.
Records should include (1) the patient's name (2) the radioactive material, (3) the administered activity, (4) the date and time of administration, (5) the date and time of release, (6) the case specific factors thatLwere used in calculating the dose to the individual, and (7) the estimated dose to an individual exposed to the patient.
in those instances for which a case-specific calculation applies to more than one patient release, the calculation need not be performed again.
D.
IMPLEMENTATION The purpose of this section is to provide information about the NRC staff's plans for using this regulatory guide.
Except in those cases in which a licensee uses an acceptable alternative method for complying with 10 CFR 35.75, the method described in >ais guide will be used in the evaluation of a licensee's compliance with Section 35.75.
)
3-DRAFT: June 1, 1995 12 i
i 1
i
___J
APPENDIX A Table A-1.
Half-Lives-and Exposure Rate Constants of Radionuclides Used in Medicine Hal f-Exposure Hal f-Exposure Radio-Life Rate Constant' Radio-Life Rate nuclide (days)*
(R + cm*/ mci h) nuclide (days)'
Constant' (R cm'/ mci h i
)
Ag-lll 7.45 0.150 Pd-103 16.97 0.86' (implants)-
Au-198 2.696 2.36 Re-186 3.777 0.168 Cr-51 27.704 0.177_
Re-188 0.7075 0.337 Cu-64 0.5292 1.10 Sc-47 3.351 0.626 Ga-67 3.261 0.753 Se-75 119.8 2.60 I-123 0.55 1.61 Sm-153 1.9458 0.425 I-125 60.14 1.42 Sn-ll7m 13.61 1.48 I-125 60.14 1.11' Sr-89 50.5 NA' (implanu)
I-131 8.040 2.20 Tc-99m 0.2508 0.756 In-lll 2.83 3.15 T1-201 3.044 0.447 Ir-192 74.02 4.69 Y-90 0.1329 NA' P-32
'14.29 NA' Yb-169 32.01 1.83 1-
- Keith F. Eckerman, Anthony B. Wolbarst, and Allan C. B. Richardson, Eederal Guidance Report No. 11. Limitina Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation. Submersion. and L
Inaestion, Report # EPA-520/1-88-020, Office of Radiation Programs, U. S.
Environmental Protection Agency, Washington, DC,1988.
' The exposure rate factor includes gamma rays and x rays with an energy above 11.3 kev. The 11.3 kev cutoff is the one used in NCRP Report No. 41,
" Specification of Gamma-Ray Brachytherapy Sources," 1974. The exposure rate constant was calculated from the following equation:
>T *
- (1.332 x 10" mci hr )(4n(100 cm)* ) 1 f,E,( p gm cm-' )
x mci hr 9"
erg
( 87.6 erg)(1.6 x 10..
MeV)
DRAFT: June 1, 1995 13
-Where E,.-
the energy of the-gama ray or x ray 1 in Mev.
f, - the probability of decay of gama rays or x rays with energy E, per disintegration. Values for E, and f, were taken from:
-Bernard Shleten, The Health Physics and Radioloaical Health liandbook, Revised Edition, Scinta, Inc., 1992, pages 294-334.
For Re-186, Re-188, and Sn-ll7m the values for E, and f, were taken from:
Laurie M. Unger and D. K. Trubey, Specific Gama-Rav Dose Constants for Nuclides Imoortant to Dosimetry and Radio'loaical Assessment, ORNL/RSIC-45/R1, 1982.
p.,, - the linear energy absorption coefficient in air of photons of energy E,, taken from Radioloaical Health Handbook, U. S.
Department of Health, Education, and Welfare,1970, page 135.
p = the density of air at standard temperature and pressure, taken to be 0.0012929 gm/cm'.
The details of the calculation of the exposure rate factors are shown in Table A-2, Appendix A of NUREG-1492.
- R. Nath, A.S. Meigooni, and J.A. Meli, " Dosimetry on Transverse Axes of '"I and '"Ir Interstitial-Brachytherapy Sources," Medical Physics, Volume 17, Number 6, November / December 1990. The exposure rate constant given is a measured value averaged for several source models and taking into account the attenuation of gama rays within the implant capsule itself.
- Ravinder Nath, Yale University School of Medicine, letter to Dr. U. Hans Behling dated March 31, 1993. The exposure rate constant given is a measured value that takes into account the attenuation of gama rays within the implant capsule itself.
- Not applicable (NA) because release quantities based on beta emission rather than gama emission.
DRAFT: June 1, 1995 14
APPENDIX B PROCEDURES FOR CALCULATING DOSES BASED ON CASE-SPECIFIC FACTORS There may be situations in which a licensee may release a patient with an activity higher than the values listed in Table 1-for a specific radionuclide.
Licensees may calculate potential doses to individuals exposed to patients receiving treatment with radioactive material on a case-by-case basis to account for certain factors specific to an individual.
Section-35.75 requires that a record of the basis _for the release of the patient if the release of the patient is based on other than standard conservative assumptions.c For the purposes of this requirement, standard conservative assumptions are:
the individual retains the initial administered activity. a point-source-geometry, the physical half-life of the radionu < ide,
)
an occupancy factor of 0.25 at one meter, and no attenuation of radiation in l
tissue. 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 of the released individual.
The following equation is generally used to calculate doses:
34.6 TQ,T,E 0(t) -
(Equation B-1)
(r)'
3 DRAFT: June 1, 1995 15
e Where D(t) - dose to total decay, l
34.6 - conversion factor of 24 hrs / day times the total integration of decay (1.44),
f=
specific gamma-ray constant, Q, - initial activity at the start of the time interval, i
T, - physical half-life, E-exposure factor that accounts for the different occupancy times and distances when an individual is around a patient.
This value is typically 0.25 when the distance is 100 cm.
r-distance.
This value is typically 100 cm.
1.
EFFECTIVE HALF-LIFE l
A licensee may take into account the effective half-life of the radioactive material to demonstrate compliance with the dose limits to members of the public stated in Section 35.75. The effective half-life is defined as:
T.,,
(Equation B-2)
T + T, Where T, - biological half-life of the radionuclide, T, - physical half-life of the radionuclide.
Using the effective half-life, Equation B-1 becomes:
34.6 f Q,T,,E D(t) =
(Equation B-3) with the factors defined as above and T,,, is the effective half-life.
For radioiodine, the effective half-life comprises the effective half-life of extrathyroidal iodide (i.e., existing outside of the thyroid) and the effective half-life of iodide following uptake by the thyroid.
The DRAFT: June 1, 1995 16
o-
-c; effective half-life for-the_ extrathyroidal and thyroidal fractions (i.e., F i
- and F,, respectively) can be calculated with the following equations:
T,3 x T, T,,, =
(Equation B-4) i
, T,3 + T, T,,,,
=
(Equation _B-5)
T., + T, Where T, = biological hal'f-life for extrathyroidal iodide, l
T,, = biological half-life of iodide following-uptake by the thyroid, T, = physical half-life of iodine-131.
I i
Thyroid Cancer Ex= ale: Calculate the maximum likely dose to an individual exposed to a patient who has;been administered 100 millicuries (3,700 megabecquerals) of iodine-131, 3 to 4 weeks after thyroid cancer surgery, for the. treatment of thyroid remnants-and metastases. The occupancy factor is 0.25 at one meter.
Solution:. In this example, we will account for elimination of iodine-131 from the-bod' y by using the biological half-lives appropriate for thyroid-cancer to calculate-the dose. -It is generally recognized-that after. surgical removal of therthyroid, the uptake of. iodine-131 by the thyroidal remnants'and n.etastases-does not exceed $ percent of the administration.
It will be necessary to consider the different biological half-lives for thyroidal and extrathyroidal iodine..The following assumptions are made in this example:
DRAFT: June 1, 1995 17
10 DINE-131 PARAMETERS FOR THYROID CANCER EXAMPLE Physical half-life of Iodine-131, T, 8.0 days Extrathyroidal fraction, F......................
0.9S' Biological half-life of extrathyroidal fraction, T,3 0.33 day' Effective half-life of extrathyroidal fraction, T.,
0.3 day-i Thyroidal fraction, F,
................,......0.05' Biological half-life of thyroidal fraction, T,,
80 days' Effective half-life of thyroidal fraction, T,,,,
7.3 days Specific gamma ray constant, f 2.2 R cm'/ mci h
' Personal communication, M. Pollycove, M.D., Visiting Medical Fellow, U.S.
Nuclear Regulatory Commission, Rockville, MD, April 1995.
' International Commission on Radiological Protection (ICRP), " Radiation Dose to Patients from Radiopharmaceuticals," ICRP Publication No. 53 (March 1987).
The total dose comprises the doses from the extrathyroidal and thyroidal fractions. The equation is:
34.6 iF Q,T,y (0.25)(1-e*""I*")
i i
D(t) =
+
(Equation B-6) 34.6 f F,0,T,,y (0.25) (1-e*""'4*")
(100 cm)*
Substituting the values from above, the dose to total decay is 34.6(2.2 R cm'/ mci h)(0.95)(100 mci)(0.3 d)(0.25)
(100 cm)'
34.6(2.2 R cm'/ mci h)(0.05)(100 mci)(7.3 d)(0.25)
(100 cm)*
D(m) =
0.054 + 0.069 D(m) =
0.124 rem (1.24 mSv)
DRAFT: June 1, 1995 18 I......
U
Therefore, thyroid cancer patients administered 100 millicuries (3,700 megabecquerels) of iodine-131 or less would not have to remain under licensee control and could be released under Section 35.75, assuming that the foregoing assumptions can be justified for the individual patient's (.ase and the patient is given instructions.
In the example above, the thyroidal fraction, F, = 0.05, is a conservative assumption.
For those individuals who have had surgery to remove thyroidal tissue, F, is typically sn11er and, in some cases, F, is known for a specific individual.
l HyperthyroidhELExample: Calculate the maximum likely dose to an individual l
exposed to a patient who has been administered 33 millicuries (1,200 megabecquereis) of iodine-131 for the treatment of hyperthyroidism l
(i.e., thyroid ablation). The occupancy factor is 0.25 at one meter.
Solution:
In this example, we will cccount for elimination of iodine-131 from the body by using the biological half-lives appropriate for hyperthyroidism to calculate the dose.
It will be necessary to consider the different biological half-lives for thyroidal and extrathyroidal iodine. The following assumptions are made in this example:
10 DINE-131 PARAMETERS FOR HYPERTHYROIDISM EXAMPLE Physical half-life of Iodine-131, T,,
8.0 days Extrathyroidal fraction, F
.....................0.45' 3
Biological half-life of extrathyroidal fraction, T,i 0.33 day *'
Effective half-life of extrathyroidal fraction, T.,,
0.3 day i
Thyroidal fraction, F,
.......................0.55' Biological half-life of thyroidal fraction, T,2 21 days' Effective half-life of thyroidal fraction, T,,,,
5.8 days' Specific gamma ray constant, f 2.2 R cm'/ mci h
' Personal communication, M. Pollycove, M.D., Visiting Medical Fellow, U.S.
Nuclear Regulatory Commission, Rockville, MD, April 1995.
DRAFT: June 1, 1995 19 l
t--
' International Commission on Radiological Protection (ICRP), " Radiation Dose
--to Patients from Radiopharmaceuticals," ICRP Publication No. 53 (March 1987).
The total-dose comprises the doses from the extrathyroidal and -
thyroidal fractions.- The equation is:
l
- 34. 6 iF QeT.,, (0. 25) (1-e'* '"'""")
3 i
D(t) =
+
(Equation 8-6)
(100 cm)'
3 4. 6 i F, Q.T,,,, (0. 2 5) ( 1-e * '"'"**")
(100cm)'
Substituting the values from above, the dose to total-decay is
?4.6(2.2R cm'/ mci h)(0.45)(33 mci)(0.3 d)(0.25)
[
D(*) =
+
l (100 cm)'
i-34.6(2.2R cm'/ mci h)(0.55)(33 mci)(5.8_ d)(0.25)
(100 cm)'
D(=) =
0.008 + 0.200 D(=) =
0.208 rem (2.08 mSv)
Therefore, hyperthyroid patients administered 33 millicuries (1,200 megabecquerels) of iodine-131 or less would not have to remain under licensee cont'rol and could be released under Section 35.75.
2.
EXPOSURE FACTOR The distance and the time that other individuals will spend in the
- proximity of the patient may occasionally be taken into account when determining the dose to an individual.
If the patient is living alone, will have_few if any-visits by family or friends, will not be returning to work immediately, and will be generally isolated from other people, the exposure factor can be decreased by a--factor of two (for example, from the general value of 0.25 to 0.125). This would allow an individual to be relea::ed with DRAFT: June 1,-
1995 20
an activity that is higher than that specit ?ed in Table 1 in the regulatory guide. On the other hand, if the patient needs extensive care at home, the exposure factor will have to be increased to account for the increased exposure of the individual caring for the patient.
In general, the NRC does not believe that the exposure factors should be
-l 1ess than 0.125 because it is not possible to avoid someone being exposed to the patient at all times.
Lower values for the exposure factor are not specifically prohibited by the regulation, but must be justified in the record of the calculation, as the record will be subject to inspection.
Example: Calculate the maximum likely dose to an individual exposed to a l
patient who has received 10 mil 11 curies (370 megabecquerels) of iodine-131, The patient lives alone and will not be working.
Solution: The dose is calculated using Equation B-1:
34.6 FQ,T,E D(t) =
r' Since the patient lives alone and will not be returning to work, and therefore will not be around the public, the exposure factor can be reduced to 0.125:
34.6(2.22 R cm'/ mci hr)(10 mci)(8.05 d)(0.125) g g),
(100 cm)'
D = --0.077 rem (0.77 mSv)
Since the dose is less than 1 millisievert (0.1 rem), the patient may be released and instructions to the patient are not required.
Because the administered activity would indicate instructions and a record to be maintained based on the values in Table 1, it is recommended that a record of the calculation be maintained to ensure compliance with the dose limits in Section 35.75.
DRAFT: June 1, 1995 21
Example: Calculate the maximum likely dose to an individual exposed to a patient who has received 10 mil 11 curies (370 megabecquerels) of iodine-131.
The patient requires extensive care because of other medical conditions.
solution: Since the pr ient needs extensive care, the exposure factor will l
have to be increased to count for the increased time the primary caregiver will spend near the patient. An exposure factor of 0.5 is used in this i
example:
1 34.6(2.2 R cm'/ mci hr)(10 m01)(8.05 d)(0.5) 0-l (100 cm)*
D=
0.304 rem (3.04 mSv)
Since the dose exceeds 1 mil 11 sievert (0.1 rem), the licensee must provide the patient with written instructions, and a record of the released patient is required.
3.
OTHER FACTORS 3.1 Attenuation of the Radiation in the Body Licensees may take into account attenuation of the radiation by the patient. The fraction of the dose that results after attenuation by the body may be calculated using the following equation:
D=
D e ""
(Equation B-8)
Where D = dose after attenuation, D = dose before attenuation,
= linear attenuation coefficient of tissue, x = thickness of tissue covering the implant.
Also, the dose before attenuation is, from Equation 2 in the guide:
DRAFT: June 1, 1995 22
34.6 r Q.T,(0.25)
D,,
(Equation B-9) l (100 cm)*
{
Substituting Equation B-9 for D in Equation B-8, the dose after attenuation becomes-1 34.6 00,T,(0.25) (e*')
D=
(Ecuation B-10)
Example: Calculate the maximum likely dose to an individual exposed to a patient who has received a pern.anent implant of 60 mil 11 curies l
(2,220 megabecquerels) of iodine-125. The following factors apply:
i = 1.11 R.cm'/ mci hr, T, = 60.2 days,
= 0.387/cm (Ref. B-1),
5 HVLs = 9 cm (assume 5 Half Value Layers in soft tissue; 1 Half Value Layer for iodine-125 = 1.9 cm).
There is a significant reduction in the exposure rate from the shielding effects of the source capsule. The i of 1.11 R.cm'/ mci h for iodine-125 already accounts for the reduction in exposure rate from attenuation by the source capsule.
Based on empirical assessment involving patients with implants, soft tissue shielding for iodine-125 is likely to exceed 5 or more half value layers (Reference B-1).
Solution: The dose is calculated using Equation B-10:
(
""4 / mci hr)(60 mci)(60.2 d)(0.25)(e " *!*""' **')
d D=
(100 cm)'
D=
0.107 rem (1.07 mSv)
DRAFT: June 1, 1995 23
e Therefore, a patient who has received a permanent implant of 60 millicuries (2,220 megabecquerels) of iodine-125 may still be authorized for release.
The licensee must provide the patient with instructions and maintain a record that documents the validity of the foregoing assumptions in the individual patient's case.
3.2 Internal Dose Internal dose may be a consideration with certain radiopharmaceuticals now being developed, such as radiolabeled antibodies, or those that are developad in the future. Many of the radionuclides used in radiolabeled antibodies are predominantly beta or alpha emitters, which emit few gammas.
One way of evaluating the internal dose is to compare the internal dose with the annual limit on intake (ALI) value in 10 CFR Part 20. A rule of I
thumb is to assume that the individual likely to receive the highest dose from exposure to the patient will receive an internal dose of 1-millionth of the activity that is in the patient. This rule of thumb was developed in Reference B-2 for cases of worker intakes during normal workplace operations, worker intakes from accidental exposures, and public intakes from accidental j
airborne releases from a facility, but it does not specifically apply for cases of intake by an individual exposed to a patient. However, two studies (Refs. B-3 and B-4) regarding the intakes of individuals exposed to patients administered iodine-131 indicated that internal doses are negligible compared to external doses and that intakes were of the magnitude of one 1-millionth of the quantity in the patient.
In addition, the NCRP addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Comentary No. II, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, "Thus, a contamination incident that could lead to a significant intake of radioactive material is very unlikely."(B-5).
For additional discussion on the subject, see Reference B-1.
DRAFT: June 1, 1995 24 Attachme..t 2
A rough estimate of the effective dose equivalent can be calculated from
.the following equation:
Q (5 rems) (10).
D, =
(Equation B-ll).
ALI Where D-the internal effective dose equivalent to the individual i
exposed to the patient in rems, Qw the activity in the patient at time of release in microcuries, ALI - the occupational inhalation annual limit on intake from Appendix B of Part 20, 5 rems - the dose from an intake of one ALI, 10 - the assumed fractional intake.
For example, assume that 30 millicuries (30,000 microcuries) of iodine-131 was administered to a patient.- If 1-millionth of the administered activity'is taken in by another individual, the activity would be 0.03
-microcuries. The stochastic ALI for iodine-131, 200 microcuries, corresponds to an effective dose equivalent of 50 millisieverts (5 rems). Thus; the individual would receive a dose of about 75 microsieverts (0.75 millirem).
In this case, the internal dose would be considerably less than 1 percent of the assumed 5 millisieverts (0.5 rem) external gamma dose.
Internal doses may be ignored in' the calculations if they are'likely to be less than 10 percent of the external dose since they would be significantly less than the uncertainty in' the external dose.
t DRAFT: June 1, 1995 25
e REFERENCES FOR APPENDJX B B-1.
Stewart Schneider and stephen A. McGuire, " Regulatory Analysis or, Criteris for the Release of Patients Administered Radioactive Material," NUREG-1492 (Final Report), NRC, 1995.*
B-2.
A. Brodsky, "Resuspension Factors and Probabilities of Intake of Material in Process (Or 'Is 10 a Magic Number in liealth Physicsi'),"
Health Physics, Volume 39, Number 6, 1980.
B-3.
R.C.T. Buchanan and J.M. Brindle, "Radioiodine Therapy to Out-patients -
The Contamination Hazard," British Journal of Radioloay, Volume 43, 1970.
B-4.
A.P. Jacobson, P.A. Plato, and D. Toeroek, " Contamination of the Home f
Environment by Patients Treated with Iodine-131," American Journal of Publim Health, Volume 68, Number 3, 1978.
B-5.
National Council on Radiation Protection and Measurements, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," Commentary No. 11, February 28, 1995.
- Requests for single copies of drafts should be made in writing to the U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
Distribution and Mail Services Section. Requests for drafts will be filled as long as supplies last. Copies of drafts are also available for inspection and copying for a fee from the NRC Public Document Room at 2120 L Street NW.
(Lower Leveli, Washington, DC.
The PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; telephone (202)634-3273; fax (202)634-3343.
DRAFT: June 1, 1995 26
APPENDIX C SAMPLE INSTRUCTIONS FOR PATIENTS RECEIVING PERMANENT IMPLANTS
- A small radioactive source has been placed (implanted) inside your body. The source is actually many small metallic pellets or seeds, which are about 1/3 to 1/4 of'an inch long, similar in size and shape to a grain of rice. To minimize exposure to radiation to others from the source inside your body and to yourself if the source falls out or comes out, you should do the following:
Stay at a distance of feet from for days / weeks.
Minimize time with children and pregnant women for days / weeks.
e l
e Do not hold or cuddle children for days / weeks.
e Avoid public transportation for days / weeks.
l Examine any bandages or linens that come into contact with the implant e
site for any pellets or seeds that may have como out of the implant
- site, Take the following action if you find a seed or pellet:
e Do not handle it with your fingers.
Use something like a e
(
spoon or tweezers to place it in a jar or other container that you can close with a lid.
Place the contaitier with the seed / pellet in a location away from people, e Notify
, at (ohone number) for further instructions as soon as possible.
If you have any questions, contact the following individual (s):
.Name Phone number
-Beeper number Name Phone number Beeper number DRAFT: June 1, 1995 B-1
s l
l I
l ATTACHMENT 3 l
FINAL REGULATORY ANALYSIS
Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material Final Rt..- et l
Prepared by:
Stewart Schneider and Stephen A. McGuire Omce of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission Washington, D.C. 20555 F
June 1,1995 NUREG-1492
-s.
i ABSTRACT The Nuclear Regulatory Commission (NRC) has limit of 5 millisleverts (0.5 rem) for patient received threc petitions to amind its regulations release. The evaluation demonstrates that
'in 10 CFR Parts 20 and 35 as they apply to doses diagnostic procedures are unaffected by the choice received by members of the public exposed to of alternative. Only some therapeutic administra+
patients released from a hospital after they have -
tions of radioactive material could be affected by been administered radioactive material. While the the choice of alternative. The evaluation indicates
- three petitions are not identical, they all request that Alternative 1 would cause a large increase in
- that the NRC esublish a dose limit of 5 milli-the national health care cost from retaining sieverts (0.5 rem) per year for individuals exposed patients in a hospita! !onger and would cause l
to patients who have been administered significant personal and psychological costs to -
l' radioactive materials. This Regulatory Analysis patients and their families. The choice of evaluates three alternatives. Alternative 1 is for Alternatives 2 or 3 would affect only thyroid-the NRC to amend its patient release criteria in cancer patients treated with iodine 131. For those 10 CFR 35.75 to use the more stringent dose limit patients, Alternative 3 wculd result in less of 1 millisievert (0.1 rem) per year in hospitalization than Alternative 2, Alternative 3 10 CFR 20.1301(a) for its patient release criteria.
has a potential decrease in national health care
- Alternative 2 is for the NRC to continue using the cost of $10,000,000 per year but would increase existing patient release criteria in 10 CFR 35.75 of the potential colbetive dose from released therapy 1,110 megabecquerels (30 millicuries) of activity patients by about 9,000 person-rem per year, or a dose rate at one meter from the patient of mainly to family members. Alternative 3 would 0.05 millislevert (5 millirems) per hour, also have personal and psychological benefits for Alternative 3 is for the NRC to amend the patient the patients and their families.
release criteria in 10 CFR 35.75 to specify a dose l
i i
i lii NUREG-1492
'6?
s CONTENTS
-I
- A B ST RA CT............................................................,....,. iii '
l-ACKNOWLEDGEMENTS...............
.....................................vii l
i
\\.
?
1 STATEM ENT OF TH E PRO BLEM............................................. I 2 OBJ ECTIVES OF TH E RULEMAKING.....,....................................
1 3 ALTE R NATI VES <........................................................... 2 1
l-l 4 CO NS EQ U ENCES....,...................................................... ' 2
- 4.1 Current Uses of Radiopharmaceuticals......................................... 2
. 4.1.1 Diagnostic Administrations............................................... 3 4.1.1.1 Estimates of the Number of Diagnostic Procedures Performed............... 3 4.1.1.2 Age and Sex Distribution of Patients................................. 3
[
4.1.2 Therapeutic Administrations............................................ 4
- 4.1.2.1 Radiopharmaceuticals Used in Therapy............,.................. 6 4.1.2.2 Radioactive Materials Used in Permanent implants (Brachytherapy)........
10 z 4.1.23 Summary of Therapeutic Administrations............................ ~. 11
- 4.2 Assessment of Doses to Individuals Exposed to Patients Administered Radioactive Materials
.............................................................. 11 4.2.1 Methodology for Calculating External Gamma Dose........................... 12 4.2.1.1 Occupancy Factor............................................... 6 4.2.1.2 Exposure Rate Constant.......................................... 6 4.2.1.3 Effective Half-Life..............................................., 6 4.2.1.4 Internal Exposure............................................... 1 6 4.2.1.5 Tissue Shielding for Permanent Implants...............,,,............ 6
- 4.2.2 Estimate of Maximum Likely Dose to Individuals Exposed to Patients.............. 13 4.2.2.1 Diagnostic Procedures........................................... 18-4.2.2.2 Therape utic Procedures.......................................... 19-
. 4.2.3 - Assessment of Doses to Breast. Feeding Infants...........,................... 15 4.23. I ' I nternal Dose.................................................. 15 4.2.3.2 External Dose................................................ - 15 4.2.4 Collective Dose....................................................
22 v
NUREG.1492
e c
4 3 Value Impact Analysis.................................................... 22 43.1 Estimates of the Potential Costs.......................................... 22 43.1.1 Estimates of the Direct Costs of Patient Retention.....................22 43.1.2. Derivation of Indirect Costs......................................
24 43.13 Evaluation of Psychological Costs................
................24 43.2 Cost Comparison of Alternatives.......................................... 25 4.4 Evaluation Of The Alternatives With Respect to Accept:d Radiation Protection Principles...............
25 5 D ECISI ON RATIONALE...................................................
25 6 t h1 P LE h1E NTATI O N.......................................................
26 R E PE R EN C ES...............................................................
27 APPENDIX A - Parameters and Calculations for Determining Release Ouantities and Dose Rates for Radionuclides Used in hiedicine.........................
27 APPENDIX B - Parameters and Calculations for Determining Instructions to Breast-Feeding Women....................................
....................27 Tables 4.1 Estimated Number of Diagnostic Radiopharmaceutical Procedures Performed in the U.S.
between 1972 and 1982.................................................... 4 4.2 Estimated Radiopharmaceutical Use for Diagnostic Procedures in the U.S. in 1993........ 5 43 Age and Sex Distribution of Patients Having Nuclear hiedicine Examinations...........,. 6 4.4
- Number of Annual Therapeutic Administrations in the U.S. (significant gamma-emitting r adionuclid es only)......................................................
12 4.5 Family Doses from Patients Treated with lodine-131 for Thyroid Carcinoma............. 14 4.6 hiaximum Likely Doses to Total Decay to Exposed Individuals from Diagnostic Procedures.. 16 4.7 hfaximum Likely Doses to Total Decay to Exposed Individuals from Thera Assuming No Hospitalization.................................peutic Procedures 12 4.8 Estimates of Collective Dose from Therapeutic Radiciodine Procedures for Alternative 1:
Annual Limit of 1 millislevert (0.1 rem).......................................
21 4.9 Estimates of Collective Dose from Therapeutic Radioiodine Procedures for Alternative 2:
Limit of 1,110 megabecquerels (30 millicuries) or 0.05 millisievert (5 millirems)/hr......... 21 4.10 Estimates of Collective Dose from Therapeutic Radiciodine Procedures for Alternative 3:
- Annual Limit of 5 millisievert (0.5 rem).............
-- NUREG.1492 vi
O 4.11 Duration of Retention per Therapeutic Procedure (to the nearest day)...
23 4.12 Costs of Alternatives 1, 2, and 3..........................
25 A1 Italf Lie, and Exposure Rate Constants of Radionuclides Used in Medicine............
25 A2 Calculations of Exposure Rate Factors, Release Ouantities, and Release Dose Rates 25 B1 Potential Doses to Breast Feeding infants from Radiopharmaceuticals Administered to the Mother if NO Interruption of Breast Feeding.......,......
25 B-2 Maximum Likely External Doses to an Infant During Breast Feeding with Administered Activity and Interruptioa as Specified in Table B-1.......................
r B-3 Biokinetic Parameters for Radiopharmacueticals Excreted in Breast Milk....
B-4 Calculated doses to Newborn and 1 Year Old Infants from ?.laximum Administered Dosages of Radiopharmacueticals as a Function of Breast Feeding Interruption Time.................
l vii NUREG-1492
o ACKNOWLEDGEMENTS l
Much of the statistical and technicalinformation M. Pollycove, ht.D., Visiting Medical required for this analysis is not available in the Fellow, U.S. Nuclear Regulatory l
open literature. In such instances, information Commission, Rockville, MD l
was obtained directly from technical experts. The following indhiduals are acknowledged for their G.E. Powers, PhD, OfGee of Nuclear cooperation and contribution of technical Regulatory Research, U.S. Nuclear information and data.
Regulatory Commission, Rockville, MD R. Atcher, PhD, Radiation and Cellular M. Rosenstein, PhD, Food and Drug Oncology Department., University of Administration, Center for Devices and Chicago, Chicago, IL Radiology Health, Rockville, MD l
D. Flynn, M.D., (NRC Advisory Committee B.A. Siegel, M.D., (Chairman, NRC l
on Medical Use of Isotopes) Massachusetts Advisory Committee on Medical Use of l
General llospital, Boston, MA Isotopes) Director, Dhision of Nuclear l
Medicine, Mallinckrodt Institute of W.R. Hendee, PhD, Dean of Research, Radiology, Washington University Medical Medical College of Wisconsin, Milwaukee, Center, St. Louis, MO WI
(
J. St.Germain, Radiation Safety Officer, C. Jacobs, President, Theragenics, Memorial Sloan Kettering, New York City, Norcross, GA NY F.A. Mettler, M.D., Department of M.G. Stabin, PhD, CHP, Radiation !nternal Radiology, University of New Mexico, Dose Information Center, Oak Ridge School of Medicine, Albuquerque, NM Institute for Science and Education, Oak Ridge, TN K.L. Miller, CHP, Professor of Radiology and Director, Division of Health Physics, D. Steidley, PhD, CHP, Medical Health Milton Hershey Medical Center, Hershey, Physicist, Department of Oncology, St.
PA Barnabas Medical Center, thingston, NJ R. Nath, PhD, Professor of Yale University, J. Stubb, PhD, Radiation laternal Dose School of Medicine, and President of the Information Center, Oak Ridge Institute for American Association of Nuclear Physics, Science and Education, Oak Ridge, TN New Haven, CT K. Suphanpharian, PhD, President, Best M.P. Nunno, PhD, CHP, Cooper Hospital, Industries, Springfield, VA University Medical Center, Camden, NJ R.E. Toohey, PhD, Director, Radiation P. Paras, PhD, Food and Drug Internal Dose Information Center, Oak Administration, Center for Devices and Ridge Institute for Science and Education, Radiology Health, Rockville, MD Oak Ridge, TN vii NUREG.1492
C o
1 STATEMENT OF THE (2) Amend 10 CFR 35.75(a)(2) to retain the PROBLEM
.*dme 131 (1 131),b*'9"" *' (3**!I"'"'i*) "*h I"
- 8 io but prm1de an activity limit for other radionuclides consistent with the calculational methodology employed in Each year in the U.S., radioactive pharmaceuticals the National Council on Radiation Protection or radioactive implants are administered to and hicasurements (NCRP) Report No. 37, roughly 8 to 9 million patients for the diagnosis or
" Precautions in the hianagement of Patients treatment of disease. These people can expose Who llave Received Therapeutic Amounts of others around them to radiation until the Radionuclides" (NCRP70).
radioactive material has been excreted from their bodies or has decayed away.
(3) Delete 10 CFR 20.1301(d) which requires licensees to comply with prosisions of EPA's NRC's patient release criteria in 10 CFR 35.75, environmental regulations in 40 CFR Part 190
- Release of patients containing radiopharma.
in addition to complying with the require-ceuticals or permanent implants," are as follows:
ments of 10 CFR Part 20.
- (a) A licensee may not authorize release from confio ment for medical care any patient The second petition, submitted by the American admin stered a radiopharmaceutical until either:
College of Nuclear hiedicine (ACNht) i (1) The measured dose rate from the patient is (PRht-35-10,57 FR 8282, as revised by less than 5 millirems per hour at a distance of PRht 35-10A,57 FR 21043), requested that the 1 meter; or (2) The activity in the patient is less NRC:
I than 30 millicuries; (b) A licensee may authorize the release of a patient administered a permanent (1) Adopt a dose limit of 5 millisieverts (0.5 rem) implant only if 'the measured dose rate is less for individuals exposed to patients who have than 5 millirems per hour at a distance of been administered radiopharmaceuticals.
I meter."
(2) Permit licensees to authorize release from On hiay 21,1991, the NRC published a final rule hospitalization any patient administered a that amended 10 CFR Part 20, "S;andards for radiopharmaceutical even if the activity in the Protection Against Radiation'(56 FR 23360).
patient is greater than 1,110 megabecquerels The rule contained limits on the radiation dose (30 millicuries) by defining " confinement" to for members of the public in 10 CFP. 20.1301.
include confinement in a private residence.
110 wever, when 10 CFR Part 20 was issued, there was no discussion in the supplemental information A third petition (PRht 35-11,59 FR 37950) on whether or how the provisions of dealing, in part, with these same issues was 10 CFR 20.1331 were intended to apply to the submitted by the American hiedical Association release of patients, thereby creating the need to (Ah1A). The main point of the petition is that address this issue, the radiation dose limits in 10 CFR 20.1301 should not apply to individuals exposed to the Because some licensees were uncertain what patient.
effect the revised 10 CFR Part 20 would have on patient release criteria, three petitiens for rule-Since the petitions submitted by Dr. h1 arcus, the making were received on this issue. The first ACNht, and the Ah1A all address the patient petition, submitted by Dr. Carol S. h1 arcus release criteria in 10 CFR 35.75, the NRC decided (PRht 20-20,56 FR 26945), requested that the to resolve these petitions in a single rulemaking.
NRC:
(1) Raise the annual radiation dose limit in 10 CFR 20.1301(a) for individuals exposed to radiation from patients receiving radiophar-maceuticals for diagnosis or therapy from 1 millisievert (0.1 rem) to 5 millisieverts (0.5 rem).
a 2 OBJECTIVES OF THE controlling requirement for determining when RULEMAKING a patiert may be released from the licensee's control.
- Alternative 3: 5 millisieverts (0.5 rem) total The objective of this rulemaking is to re.spond to effective dose eauivalent) the three petitions for rulemaking by amending, as deemed appropriate, the patient release criteria in This alternative evaluates a dose limit of 10 CFR 35.75.
5 millisieverts (0.5 rem) to an individual exposed to a patient as the limiting factor for determining when a patient may be released from the licensee's control.
3 ALTERNATIVES 4 CONSEQUENCES i
As the petitions and the public comments that were submitted to the Commission on the petitions made clear, some licensees were To evaluate the impacts of the three alternauves, uncertain sbout whether dose limits imposed by it is necessary to determine which current 10 CFR 20.1301(a) or the patient release criteria procedures invohing the administration of i
l.
established by 10 CFR 35.75 govern patient radiopharmaceuticals or permanent implants release. In the Commission's view,10 CFR 35.75 might be affected by the imposition of a 1 milli-governs patient release as explained in the Notice sicvert (0.1 rem) total effective dose equivalent of Proposed Rulemaking (59 FR 30724). The dose limit for indhiduals exposed to released public comments received on the three petitions patients. For convenience, procedures invohing and the Notice of Proposed Rulemaking also the administration of radioactive materials to made it clear that the majority of commenters patients may be classified as; 1) diagnostic favored an annual dose limit of 5 millisiuerts procedures invoMng administration of (0.5 rem). Given that 10 CFR Part 35 was radiopharmaceuticals to obtain information about deemed to be the controlling regulation, the normal and pathological processes in the patient; Commission was faced with the decision regarding or,2) therapeutic procedures invohing the regulatory approach to be pursued in administration of radiopharmaceuticals or 10 CFR 35.75. To evaluate the issues raised by implantation of a radioactive source to destroy the petitioners and those who commented on the diseased tissue in the patient, requests made by the petitioners cad the Notice of Proposed Rulemaking, the NRC determined that the following alternatives should be 4.1 Current Uses of
- I" **d; Radiopharmaceuticals e Alternative 1: 1 millislevert (0.1 rem) total effective dose eauivalent Radiopharmaceuticals can be defined as " drugs" that are radioactive and because of this property In this alternative, a 1 millisievert (0.1 rem) are used to (1) obtain information about normal dose limit is evaluated as the controlling and pathological processes in human organisms or criteria for determining when a patient may (2) destroy tissue. The first group of compounds be released from the licensee's control.
represents diagnostic and the latter therapeutic radiopharmaceuticals. Although radiopharma-o Alternative 2: < 1.110 mecabecouerels ceuticals, diagnostic or therapeutic, may be (30 millicuries) or < 0.05 millisievert classified as drugs, it should be noted that (5 millirems)/hr at 1 meter radiopharmaceuticals are not given for the purpose to exert any pharmacological action.
In this alternative, the current patient release criteria in 10 CFR 35.75 is evaluated as the NUREG-1492 2
l
o Radiopharmaceuticals are generated from two reflect about 90 percent of the total diagnostic sources: nuclear reactors and accelerators.
imaging examinations. Additional studies werc Nuclear reactors can produce radionuclides conducted by the BRH for the years 19S0,1981, through neutron capture reactions (e.g., (n, y),
and 1982. The hospital-based survey was called i
(n, p), and (n, a)), as well as by nuclear fission the Radiation Experience Data (RED 1 and RED (n, f). Other radiopharmaceuticals are accelerator 2 studies) (h1E85). The RED 1 study examined produced, in which a highly pure target material is the computer billing records of 81 hospitals. Data bombarded with protons, deuterons, or alpha for the subsequent RED 2 study reflect informa-particles. hiany have relatively short half lives.
tion obtained by mail survey from 500 hospitals.
Some radiopharmaceuticals may be produced by either reactor or accelerator (e.g., palladium-103, Data for 1982 were also provided by Parker, et al.
iodine-125). The choice in production method is (PA84) in which a randomized sample of 10 per-dictated by cost considerations and vendor access cent of the U.S. hospitals was surveyed. Although to a high neutron flux reactor facility. While most his survey was specifically directed to thyroid iodine-125 has in the past and continues to be examinations, survey data also prosided estimates produced by reactors, the production of of total examinations, palladium-103 has shifted from reactor to accelerator (personal communication, C. Jacobs, All of the studies mentioned above are August 1993).
summarized in Table 4.1 and represent hospital data only. However, the exclusion of non-hospital 4.1.1 Diagnostic Adtninistrations facilities should not significantly affect the accu.
I racy of estimates since less than 1 percent of all 4.1.1.1 Estimates of the Number of Diagnostic nuclear medicine procedures are performed out-Procedures Performed side hospitals (JOS3). Inspection of Table 4.1 reveals severalimportant trends. While the total Estimates regarding the frequency and total number of diagnostic procedures has shown a number of diagnostic nuclear medicine rocedures general increase, the number of specific proce-I have been reported over the years in several dures has in some cases dramatically increased or l
studies reviewed and analyzed by hiettler, et al.
decreased. By 1982, there were fewer radionu-l (h1E85). Among the earliest data reported was a clide brain imaging examinations than in 1972, study supported by the American College of undoubtedly due to replacement by computerized Radiology (ACR75), which reflects data collected tomography (h1E85). For the same period, liver in 1972 by J. Lloyd Jchnson Associates. Addition.
imaging increased tenfold. The largest percent al data for the years 1973 and 1975 were obtained increase involves cardiovascular imaging, which in a similar fashion and also published in the increased from an estimated 25,000 procedures in American College of Radiology hianpower Survey 1972 to about 950,000 in 1982. Other procedures (ACR82).
such as renal, lung, and tumor imaging have experienced only modest increases in numbers.
in 1975, the Bureau of Radiological Health (BRH; now the Center for hiedical Devices and A search of the open literature revealed no recent Radiological Health, CDRH) of the U.S. Food comprehensive studies to assess more current U.S.
and Drug Administration initiated a pilot study use of radiopharmaceuticals It is generally that surveyed information reported by six hospitals thought, however, that the i.equency and usage of to the hiedically Oriented Data System (h10DS).
radiopharmaceuticals have stabilized because of This project was later expanded to includ-26 the competing technologies of computerized stratified hospitals that prosided data for 1977 and tomography, magnetic resonance imaging, and 1978 (FDA85).
gray-scale ultrasound (personal communication, F A. hiettler, h1 arch 1993). For this report, the Comprehensive data on 1980 diagnostic imaging most recent RED 2 frequency distribution and the procedures were obtained by J. Lloyd Johnson cumulative frequency of 16 diagnostic nuclear Associates by mail questionnaire using a stratified medicine procedures per one thousand population 6 random sample of general hospitals and selected will be used to estimate current usage. Table 4.2 office practices in the U.S. (JO83). The sample provides frequency estimates of diagnostic pro-included 6,109 hospitals and was estimated to cedures adjusted to reflect the 1993 U.S.
0 e
i population, which is projected at 256,466,000 by the U.S. Bureau of the Census.
Table 4.1 Estimated Number of Diagnostic Radiopharmaceutical Procedures Performed in the U.S.
betweer M72 and 1982 Year 1972 1973 1975 1978 1980 1980 1981 1982 1982 Source Examination Type ACR ACR ACR MODS Johnson RED 1 RED 2 RED 2 Parker Brain 1260'"
1510 2120 1546 870 1176 1038 812 109 179 Heratobiliary 26 Liver 455 535 676 1302 1180 1399 1445 1424 Bone 81 125 220 1160 1270 1307 1613 1811 Respiratory 332 417 597 10.53 830 898 1095 1191 Thyroid 356 460 627 699 650 506 664 677 533 Urinary 108 122 154 205 200 164 402 236 125 121 Tumor 10 14 22 166 130 Cardiovascular 25 33 49 160 580 558 708 950 Other 686 294 338 120 120 368
^
Total 3339 3510 4803 6411 5830 6374 7199 7401 7690 (16)*
(17)
(22)
(29)
(26)
(28)
(31)
(32)
(33)
Soune: MERS.
"' Numben not in parenthesis indicate number of examinations x 1,000.
- Numbers in parenthesis indicate number of examinationall,000 pcpulation.
The identity, chemical form, and average quantity use iodine-131 or iodine 123 (1 123), and about of radionuclides used for diagnostic in-vivo 2 percent use gallium-67 (Ga-67).
procedures are cited in Table 4.2 and reflect values cited by Mettler, et. al. (ME86). It can be 4.1.1.2 Age and Sex Distribution of Patients assumed that the average quantity per examina-tion has not significantly changed since the time of The age and sex distribution of the U.S.
original publication (personal communication, population that underwent nuclear medicine F.A. Mettler, March 1993).
examinations in 1980, as cited by Mettler, et. al.
a' (ME86),is shown in Table 4.3. For the period of As the results in Table 4.2 indicate, there are observation, more than three-fourths of all nuclear approximately 8.2 million diagnostic examinations medicine examinations were performed on employing radiopharmaceuticals performed amiu-persons over the age of 45; nearly 40 percent of ally in the U.S. Of these, more than 85 percent these patients were 64 years and older. With the use technetium 99m (Tc-99m) as the label, about exception of the youngest age category, the 5 percent use xenon-133 (Xe-133), about 5 per-percentage of females exceeded males.
cent use thaliium-201 (TI-201), about 3 percent NUREG-1492 4
o e
Table 4.2 1:stimated Radiopharmaceutical ll>e for I)lagnostic l'rocedures in the ll.S.
In 1993'"
Agerage Actliity Total No. of 1:sainination Tyle ger I'tamination 1:taminations (Radiopharmaceuticall (Milq (mCl))
(t 1,(KKI) jlrain T(-Wm DTI'A 740 (20) 450 Tc Wm O.
740 (20) 450 liepatobiliary Tc-Wm IDA 185 (5) 198 Iiver
- Tc Wm sulfur colloid 185 (5) 1,578 Ilone Tc 99m phosphate 740 (20) 2,lK17 J,unc l'erfusion Tc Wm MAA 185 (5) 871
.laint Ventilation Xc.133 370 (10) 449 11wroid Tc 99m O.
185 (5) 600 I 131 3.7 (0.1) 75 l123 11.1 (0.3)
'i5 Jitnj Tc 99m DTI'A 740 (20) 157 1 131 hippuran 9.3 (0.25) 105 Cardiovascular Tc Wm RilC 740 (20) 421 Tc Wm phosphate 740 (20) 211 TI 201 chloride 111 (3) 421 Tumor Ga 67 citrate til (3) 134 Total 8,202
'" Based on ME86; and personal communication. F. A. Mettler. March 1993, k't adjusted for the 1993 U.S.
population.
c e
Table 4.3 Age and Ses Distribution of Patients liasing Nuclear hiediclue Esaminations h1 ale remale Total Age Fr)
FT,)
pr) e
< 15 0.9 0.7 1.6 15 29 3.3 4.9 8.2 30 - 44 5.2 8.7 13.9 45 64 15.8 21.6 37.4
> 64 17.0 21.9 38.9 Source: hir86.
4.1.2 Therapeulle Administrallons flyperthyroidism is characterized by an increased production of thyroid hormone. Ilyperthyroidism Therapeutic use of radioactive materials involves is most commonly associated with Graves' two distinct approaches. The first involves the Disease. Graves' Disease is an autoimmune e al, intravenous, or intracavity administration of disease in which the body's own immune system is a radiopharmaceutical that may subsequently be directed against cellular and secretary products of distributed, concentrated, retained, and climinated the thyroid gland.11yperthyroidism can also be by physical, chemical, and metabolic actions the result of excessive hormone production by a occurring within the body. The second approach
- r. ingle *toxie" nodule, thyroid carcinomas, and involves the implantation of radioactive sources medications inciusive of potassium iodide.
(i.e., seeds) directly into a solid tumor, While both temporary and permanent implants are 11yperthyroidism is not a condition reportable to performed, all patients receiving temporary public health agencies. As a result, data on rates implants are hospitalized until the linplants are of occurrence and treatment must be inferred.
remond. Thus, only permanent implants are incidence of hyperthyroidism is reported at 3 per potentially affected by this rulemaking.
10,000 adults per year, with peak incidence occurring between 30 and 50 years of age (DG79).
4.1.2.1 Radiopharmaceuticals Used in Therapy t' rom the most recent data (1990) available from The in-vivo use of radiopharmaceuticals in therapy the U.S. !!ureau of the Census, it can be assumed is based on the t'.ility to differentially deliver that about 75 percent of the U.S. population lethal radiation doses to the selected target tissue.
(approximately 191,500,000 persons) is 18 years of age or older. Thus,it can be estimated that about The choice of radionuclides is based on specific
$7,500 individuals per year require medical physical characteristics. hiost desirable are beta treatment for hyperthyroidism, emitters that can deliver intense irradiation of target cells while sparing the surrounding tissues, Although medical treatment may in some cases s
in contrast to diagnostic procedures for which the involve the use of anti-thyroid drugs or surgery,it gamma emission is essential, the emission of may be assumed that about 85 percent of the energetic gammas is undesirable for therapeutic cases of hyperthyroidism are treated with i
l purposes since it results in unwanted irradiation of therapeutic doses of iodine 131 (personal surrounding healthy tissues and doses to communication, bl. Pollycove, November 1993),
indhiduals in close proximity to the patient. The The resulting estimatt is about 50,000 treatments more significant therapeutic applications are per year, described below, in the past, therapeutie quantities of iodine-131 flyperthyroidism for treatment of hyperthyroidism tended to be of l
r 1
I
a magnitude that would seduce the hormone There is no nationwide cancer registry that production of the hyperactive thyroid gland to accurately dennes the number of new cases of normallevels. Ilowever, experience demonstrated cancer diagnosed each year.110 wever, the that over a period of yearri the therap3 induced American Cancer Society (ACS) annually euthyroidal (normal or healthy thyroid) condition publishes data on cancer incidence and patient deteriorated to one of hypothyroidism requiring sunival based on information provided by the thyroid hormone replacement therapy. As a National Cancer institute's Surveillance, result, hyperthyroid the:apy today involves Epidemiology, and End Results (SEER) program.
hblation of the thyroid using doses of iodine 131 in the range of $50 to 1.100 megabecquerels The ACS estimates of U.S. cancer cases (15 to 30 millicuries). Such doses quickly result in diagnosed for 1992, are based on age specine the totalloss of thyroid function and the patient is incidence rates from the SEER program for given hormone replacement therapy from the 1961988 applied to the Census Bureau's popula-onset (personal communication, F.A. hiettler, tion projections for 1992. The ACS's estimate of htarch 1993).
new thyroid cancers in 1992, is 12,500 (ACS93).
This report assumes that about 10.000 cases per Thytold Nodules year will be treated with therapeutic doses of iodinc.131.
Single or multiple nodules of sufficient site may cause obvious enlargement of the thyroid. A T he quantitles of lodine 131 used in thyroid nodule (s) refers to a replacement of the normal cancer therapy depend upon the type of cancer, homogeneous cytostructure of the thyroid with a the status of the cancer, and the degree of uptake histologic pattern ranging from colloid filled cysts and retention of iodine-131 by residual cancerous and colloid adenomas to follicular adenomas, thyroid tissue. As a result, current therapeutic Since the incidence is 4 to 5 times as great ir-doses range from 1,850 to 11,100 megabecquerels women as in men, and since it develops and (50 to 300 millicuries) (personal communications, progro,sively increases in site during life, it is F.A. hiettler and K.L hiiller, h1 arch 1993),
most frequently found in females 50 to 70 years of age it is not uncommon for nodules to remain Therapy for Polyc)themia Vera undetected until a post mortem examination.
Since the introduction of radiophosphorus in 1936, Small nodules in euthyroid subjects require no patients with polye>themia vera have been treated therapy. If the gland is grossly enlarged and successfully with this radioisotope to control causes a cosmetic problem or tracheal rather than cure this disease. Polycythemia vera compression, treatment may be indicated along is a relatively rare disease that is characterized by with thyroid hormone replacement therapy.
an autonomous proliferation of marrow cells leading to an over production of red blood cells, A small percentage of th> Told nodules tend to white bhiod cells, and platelets. Typically, produce thyroid hormones uncontrollably and in phosphorous 32 (P-32) is administered excess (i.e., the nodule is not under the replatory intravenously in doses of 110 to control of the pituitary giard and is c!inhall) 185 megabecquerels (3 to 5 millicuries) per referred to as toxic nodular goiter). The presence treatment over a period of time with average of these autonomously funuiomng thyroid aodules cumulative quantities of 740 megabecquerels leads to hyperthyroiuhm (dy.otoxicosis).
(20 millieuries) per patient.
Toxic nodular goiter, like Gi.nys' Dicase, may be Bone Therapy treated surgically (thyroidectomy) at by therapeutic dose (s) with radioactive iodinu.
Since the use of radioactive strontium for the Estimates of the frequency of radioactive iodine treatment of bone metastases was first described treatment for this condition are included under in early 1942 (PE42), bone therapy has included the estimates for hyperthyroid treater,ent abwe.
other radionuclides. Bone therapy may involve the treatment of primary bone tumors such as Thyroid Cancer osteosarcoma (BL87) in which bone seeking radiopharmaceuticals are in fact tumor secking.
l l
7 NUREG 1492 l
l
e o
F lione therapy may also be the tseatment of painful Intracavitar) Tumor lherapy skeletal metastases, which may be palliated by bone seeking radionuclides. Although the For tumors that are spread over the serosal literature references ti,e palliative and tumor linings of the body casilies or for ascites tumors, therapeutic use of these radionuclides one approach to delivering therapeutic doses of (phosphorous 32: Cil80, RO77; Strontium-89 radiation is to inject the radiopharmaceutical (St 89): IMM, KL87, ROS7, ROE 90, S185; di,ectly into the body cavity. For this approach, rhenium 186 (Re 186): RE87, htA88, SC90; colloids, chelates, and, more recently, monoclonal Samarium 153 (Sm 153): LA90, TU89), there are antibodies labelled with gold 198 (Au 198),
no data bases and no studies have been phosphorous 32, yttrium 90, or iodine 131 can be performed that would allow quantitative estimates used.
regarding the number of patients given bone therapy with radiopharmaceuticals. These other Initially, gold.198 colloids were used, but therapies are performed so seldom that they have phosphorous 32 is now preferred due to its longer negligible impact in comparison with the half life, more energetic beta particles, and the radioiodines.
absence of gamma radiation. Intracavitary radionuclide therapy with phosphorous 32 in 1herapy with Radiolabelled Cells quantities of 185 to 370 megabecquerels (5 to 10 millicuries) has been applied to malignancies For lymphoid cell malignancies, the tumor cells invohing the pleural, pericardial, and peritoneal (i.e., lymphoc)tes) may retain their ability to cavitier, (JA81, KA81, hiA78),
migrate and recirculate into the lymphoretkular tissues (i.e., spleen, liver, bone marrow, and lymph More recently, iodine 131. or yttrium 90-labelled nodes). The harvesting, labelling, and reinjection tumor associated monoclonal antibodies have of lymphocytes has been demonstrated to deliver been used in intracavitary therapy (F189, PEM6, therapeutie levels of radiation doses to tumors of Rl90) in doses of 740 to 2,220 megabecquerels the lymphoreticular system (CO87). Indium !14 (20 to 60 millicuries). Superiority of monoclonal i
labelled lymphocytes have a potential therapeutic antibodies over colloids is expected due to the role in the management of lymphoma, and clinical enhanced affmity of the labelled antibody for the studies are underway. Ilecause use of this new target cells. At present, these therapies are rarely therapy is not widespread, its im,,act may be used and thus have no impact in comparison with omitted in the analysis, but it should be noted that radioiodines.
use of a dose-based methodology provides a means to determine the quantities for which Radioimmunotherapy release may be authorized.
Radioimmunotherapy involves the use of radio-Intra Arterial'Iherapy labelled antibodies directed against tumor-specific antigens such as the carcinoembryonic antigen Some primary tumors as well as metastatic lesions (CEA) and ferritin. Only a very limited number are highly vascularized. Direct arterialinjection of cancer patients have been treated experimen-with insoluble radiolabelled particulates that lodge tally with radiolabelled antibodies in combination in arterioles and capillaries of the tumor is the with chemotherapy and external beam irradiation.
basis of this form of therapy (Ell 87, Zl84).
Among cancers treated are hepatomas, llodgkin's insoluble carriers of radionuclides that have been disease, and non llodgkin's lymphoma (LE85, clinically tested include iodine 131 labelled oil NE90, OR85). In the past, radioimmunotherapy contrast medium, iodine 131 lipoidal or -ethiodol involved the use ofiodine-131 and 1trium 90-3 (PAS 7), yttriurm94 glass microspheres (11E88),
labelled polyclonal antibodies raised against and yttrium 90 (Y 90) resin particles (ROE 90).
tumor associated antigens in a variety of animal Since these therapies are so seldom used, their species. Ilased on avidity of tumor cells and impact may be ignored in this analysis, exposure considerations of the bone marrow, sir.gle doses of 370 to 1,110 megabecquerels (10 to 30 millieuries) have been used.
The development of the hybridoma technique by (Pd 103). Less frequently used radionuclides Kohler and Milstein (KO75) has caused significant indude gold 198 and tterbium 169 (Yb 169).
3 shift in radioimmunotherapy. The hybridoma i
technique allows the developrnent of monoclonal The most frequently used radionuclide m j
antibodies against tumor associated antigens. At permanent implants is iodine 125, which has the this time, however, the use of radiolabelled mono-advantage of an extremely low energy (27 lev) donal antibodies for therapeutic applications has photon and a half life of 60 days. liesides been limited to experimebtal treatments. At minimizing dose to surrounding healthy tissue, the present, these therapies are rarely used and thus low photon energy also limits doses to hospital have no impact in comparison with radioiodines.
personnel and others when compared to temporary implants with Iridium 192 or J
4.1.2.2 Radioacthe hlaterials Used in Permar,ent permanent implants with gold 198 (CIA 9, RU92).
Implants dirach therapy)
Although iodine 125 implants are most commonly 3
used to treat cancer of the prostate (DE86, FU91, in situ radiotherapy may involve permanent ilE82, MOSS, PR92, Wil88), they have also been implants or brachytherapy.11rach) therapy has used on a very limited basis for brain tumors been around almost since the discovery of X rays.
(AG92, OS92, SC92), carcinomas of the panercas tirath) therapy can be divided into temporary (MO92), non oat cell lung carcinomas (FL92),
implantation using high activity sources or per-breast cancers (RU92), and tumors of the head, manent brachytherapy using the interstitial neck, and eye.
implantation of encapsulated radioactivity. In 1911, Pasteau seported the first treatment of Palladium 103 seeds were developed for use in prostate cancer by brachytherapy using radium brach> therapy to reduce some of the problems inserted through a urethral catheter (Pall).
associated with iodine 125. Its average photon Currently, iridium 192 (Ir 192) is the radionuclide energy of 21 lev is lower than iodine 125, but, of choice for temporary implantation. For tempo-given its shorter 17 day half life, it has a higher rary implantation, patients may be retained in the initial dose rate. Recently, palladium 103 seeds hospital for reasons that are independent of have been developed with the same physical radiological considerations. Radionuclides used parameters as iodine-125 seeds to ensure for temporary implants are, therefore, of r.o compatibility with the brachytherapy tubes and concern to this report and will not be discussed templates used for iodine implantation (ME90).
further.
Ytterbium 169 has been hailed as a replacement Over the past 20 years, several radionuclides have for iodine 125 in brachytherapy. Compared to been introduced to brachytherapy, allowing for the iodine-125 and palladium 103,it has a slightly permanent implantation of radioactive
- seeds
- higher initial dose rate, and its average 93 lev Seeds are miniature capsules that are strategically beta energy allows for a more favorable dose inscried within a solid tumor and over the period distribution and negligible tissue self attenuation of their decay deliver a letLal dose of radiation to (PO90), flowever, its use as a permanent implant tumor cells within a short distance of the implant.
is nominal due to the presence of a small (less The major advantage of brachytherapy over than 3 percent) average photon peak at 300 lev, externalirradiation in the treatment of solid that can significantly impact radiation doses to tumors is the favorable ratio of dose delivered to individuals in proximity to the patient.
tumor cells versus normal tissue. This is particularly true of prostate cancer where the Gold 198 implants have been used in a few surrounding normal tissue includes the bladder, instances of prostate cancer (CASS, FR88). The rectum, and urethra. The presence of these potential advantage of delivering a high dose normal tissues limits the dose of external beam within a relatively short time, however, is offset by radiation therapy that can be administered safely its energetic gamma emissions, which has caused to the prostate.
its use in recent years to fall into disfavor and be used only rarely (CA87).
The radionuclides primarily used in permanent implants are iodine 125 (1125) and palladium 103 A thorough search of the literature and personal communications with several prominent members 9
e of thc medical and scientific community (see 8.2 Assessnient of Doses to Acknowledgements) indicates that there is no published data available to quantify the annual IndlViduals Exposed to number of cancer patients receiving permanent Patients Administered implaat$-
Radioactive Materials The v.cientific literature and consensus opinion among the experts identified in the adnowledg-To identify the potential impacts associated with l
ments to this report does, however, support the cach of the alternatives, it is necessary to know following:
the magnitude of doses that could be reccaved by an individual exposed to a patient who has been 1.
permanent implants are currently considered administcred radioactive materials. White an appropriate treatment for only a few sites exposurc can occur via any of the climinat,mn of solid tumors; pathways by which radionuclides are removed from the body (e.g., exhalation, feces, raliva, 2.
among the cancer sites for which permanent sweat, urine, and possibly vomit), experience implants are currently employed, prostate indicates that for lodme 131 and other gamma cancer represents the overwhelming majority; emitters, these pathways will generally be msigmficant in relation to the doses that can 3.
among the 132,000 annual new cases of result from exposure to the direct gamma prostate cancer (ACS93), only a small radiation from the patient, with the exception of fraction is treated with permanent implantr.;
intake from the milk in breast feeding infants,
- and, This section of the report assesses the external and internal doses to individuals, including a 4.
for the purposes of this analysis, implants breast feeding infant, exposed to patients who invohing gold 198 (largely discontinued) and have been administered radioactive materials.
ytterbium 169 (isolated use only) may be ignored.
4.2.1 Methodology for Calculating External Gamma Dose in the absence of documented clinical data, information was sought from the implant vendors The methodology for calculating the external on numbers of administrations and typical gamma dose from exposure to the released activities of radioactive material used per patient is fully described in the associated administration. Currently, there are only three regulatory guide for the final rule (NRC95). The vendor sources. Vendor supplied data suggests methodology is based on the one employed in the that approximately 2,000 implants invohing National Council on Radiation Protection and iodine 125 are performed annually, at activities Measurements (NCRP) Report No. ??,
ranging from 1,110 to 1,8'.0 megabecquerels (30
- Precautions in the Management of Patients Who to 50 millicuries). For palladium 103, approx-llave Received Therapeutic Amounts of imately 1,500 implants are performed annually, at Radionuclides" (NCRP70),
aethities ranging from 2,775 to 4,625 mega.
becquerels (75 to 125 millicuries).
4.1.2 3 Summary of Herapeutie Administrations Table 4Asummarizes the estimates of the quantities of gamma emitting radioactive materials used in therapeutic administrations and the numbers of each therapy currently performed
- annually, J
NUREG 1492 10
4 e
Table 4.4 Number of Annual Herapeutic Administrations in the U.S. (significant gamma emitting rr.dionuclides oni))
Activity per Estimated No, of Therapeutic Radionuclide Administration Administrations Procedure Employed (Mity (mCil)
(per year)
Thyroid Ablation for 1131 370 1,1Hf" (10 30) 50,(KK) liyperthyroidism Thpold Cancer 1131 1,850 11,HKf" (50 300) 10,000 Permanent implant 1125 1,110 1,85(f" (30 50) 2,000 Pertaanent implant Pd 103 2,775 4,625"'
(75 125) 1,500
~
Total 63,5(K)
"' liened on personal communication, F. A. Mettler, Merd 1993.
- llaned on personal communkstions, T. A. Mettler and K t_ Miller, March !99).
- 11aned on information supphed tiy implant vendors. August 1993.
limited is not valid when most of the dose is To calculate the dose to total decay D(oo), the delivered in a relatively short time.
regulatory guide uses for radionuclides with a half life greater than I day Doses among individuals who may come in contact with a released patient are highly variable p(,,), 34.6PQ,T,(0.25)
(1) and reflect the crucial, but difficult to define, (100 cm)2 parameters of time, distance, and shiciding.
13ased on time and distance considerations, it is reasonable to conclude that for the overwhelming and for radionuclides with a half life less than majority of released patients, the maximally 1 day exposed indhidual is likely to be the primary care.
prosider, the family, or any other indhidual who p(,,), 34.6 PQ, E (2) spends significant time close to the patient, (100 rm)3,
11ased on time, distance, and shielding factors, which describe oormal lifestyles of the U.S.
where P = exposure rate constant for a population, it is highly unlikely that doses equal to point source, R/ mci h at I cm, spending 100 percent of time at a distance of I meter from a patient would result to any G, - initial aethity of the point source in indhidual including a patient's spouse. As a millicuries, at the time of release, standard medical practice, patients undergoing therapeutic treatments with radiopharmaceuticals T, - physical half life in days.
are ghen firm instructions, both verbally and in writing, regarding basic principles on how to 4.2.1.1 Occupancy Factor minimize doses to other indhiduals.
Equation 1 assumes, for radionuclides with Given all considerations, a realistic estimate of the half lives greater than 1 day, that the indhidual maximal likely dose to an indhidual exposed to a likely to receive the highest dose from exposure to patient is 25 percent of the dose to-total decay at the patient would receive a dose of 25 percent of a distance of I meter. The selection of an the total dose to decay (0.25 in Equation 1) at a occupancy factor of 25 percent at I meter for
?
distance of 100 cm (1 m). For radionuclides with estimating maximal likely exposure is based on the half lives less than 1 day, the factor 1.0 is used in authors' professional judgment of time-distance Fquation ;! because the assumption that the time combinations that are believed likely to occur that indhiduals will spend near the patient will be when instructions to spend as little time close to 11 NUREG-1492
the patient as possible are given. The value is purposes of this analysis. Ilowever, under the also supported by empirical data. liarbert and final rule a licensee could authorirs release on a Wells (llA74) monitored family members of three case by case basis based on the biological half life patients for external exposure. Table 4.5 rather than only the physical half life of the summarires the Ley parameters of patient radiopharmaceutical.
treatments for thyroid carcinoma using iodine 131 and the associated measured doses to family 4.2.1.4 Internal Exposurr members. The last column of Table 4.5 provides dose estimates that would have been predicted Upon oral administration or direct injection into based on the 25 percent occupancy factor in the circulating blood, the normal processes of Equation 1. Since the actual doses are well below absorption, distribution, and excretion tale place, the calculated doses for an occupancy factor of 25 Removal of radionuclides from the body may percent, the model provides a conservative follow the pathways of urine, fcces, sweat, saliva, estimate of the dose.
exhaled air and vomitus.
4.2.1.2 Exposure Rate Constant Urine. Radionuclide excretion in the urine is the dominant and almo t universal climination The expasure rate constant P expresses the dose
- pathway, rate per hour at I cm in air for a 37 megabecquerel (1 millicuric) point source of l'eces Radiopharmace iticals retained or a given radionuclide. The exposure rate constants catabollied by the liver may be secreted into and the physical half lives of radionuclides used in the gastrointestinallumen sia the bile. Ilitiary medicine are shown in Table A 1 of Appendix A.
Secretion of a radionuclide may be followed by intestinal reabsorption.
For permanent implants, a significant reduction in the dose and dose rate occurs from the shielding Sweat. Radionuclides present in the extracellular effects of the source capsule. For iodine 125 and fluid will tend to be excreted in the sweat in palladium 103 implants, the dose to total decay at accordance with the fraction that is unbound in 1 meter was calculated using an exposure rate the plasma.
constant corrected for capsule shielding as shown in Table A 1 of Appendix A. The physical Salha. Salivary excretion of radionuclides is also characteristics of other radionuclides used in proportional to the unbound or diffusible fraction permanent implants (e.g., gold 198 and in the plasma, llowever, salivary excretion is ytterbium 169) are given in Appendix A.
seldom an important climination route, since nearly all saliva is swallowed rather than 4.2.lJ Effecthe flatf Ilic expectorated.
A licensee may replace T,in Equations (1) and lircast Milk. Radionuclide excretion via the (2) with the effective halflife T,of the mammary gland constitutes a potential exposure radioactive material to demonstrate compliance pathway to the breast fed infant or child. This with the dose limit in the revised 10 CFR 35.75.
can be a very important pathway after the T,is characterited by T, and the biological administration of radiciodines. Relatively small half life T, of the radionuclide according to the administrations of radioiodine to a breast feeding equation:
mother can cause very large doses to the thyroid of the infant. Thus, precautions must be taken T'.
(3) against breast feeding after the administration of T, = T, + T, radiomdines.
Eshaled Air. Exhalation is the principal pathway for the climination of radioactive gases such as The biological retention and climination xenon 133, which is used for lung ventilation tests.
(i.e., biological half life) of the Through passive diffusion, unbound iodide in the radiopharmaceutical by the patient following circulating blood may also be exhaled.
administration is generally not considered for the NUREG 1492 12
O p
Table 4.5 l'amily Doses from Patients Treated with lodine.131 for nyroid Carcinoma hicasured Predicted Total Hodyllurden Doses to Dose Itased on I
Arthily at Time of l'amily Occupanc) l' actor of Administered Discharge Member 257c at 1 intter Patient (mCh (mCO (mrem)
(mrem) 1 210 25.2 80,70,30 3S6 2
311 26.4
$0,20,20 404 3
209 18.4 80,40 282 h rte: itA71 20 millicuries) per patient. Of the 39 patients,28 were instructed to take precautionary measures to Vomitus. Itadionuclide excretion by vomiting is minimite exposure to family members. Eleven seldom an important climination route, since patients volunteered to disregard special orally administered radiopharmaceuticals such as precautions against contamination and minimiting iodinc.131 are rapidly absorbed, within a half spousal and family exposure. On the basis of one hour, by the gastrointestinal system. Ilowever, a measurement per family, subject thyroid burdens significant portion of the administered ranged from less than 37 to 1,110 becquerels (1 to radionuclide could be excreted if vomiting occurs 30 nanocuries) with an average of 259 becquerels immediately following the administration.
(7 nanocuries). Thus, the uptake of radiolodine by family members was only about 1 one millionth The potential for contamination by patients of the administered quantity, and the dose from treated with radioiodine which may serve as a the uptake was less than 1 millirem committed source for internal exposures to others have been effective dose equivalent.
assessed for various excreta pathways (HL71, MA73, NI8O), Maximum excretion rates are In a 1978 study by Jacobson, et.al. (JA78), seven observed shortly after an administered dose, families were studied in which one family mcmber Excretion rates decline rapidly thereafter due to had been treated with iodine 131 doses ranging renal clearance and thytoidal uptake. Almost all from 2% to 5,500 megabecquerels (8 to the excreted actiiity is excreted in the urine.
150 milicuries). Non patient family members Contamination through urinary excretion may be were assessed for external exposures by means of readily coutrolled by cautious but reasonable thermoluminescent dosireters (TLDs) worn at hygiene practices, the wiist for the full duration of exposure, internal exposure (l.c., thyroid burden) was In a thorough study of two patients treated for determined at discrete time intervals by means of thyroid carcinomas, Nishizawa, et.al. (NIS0) a pair of 30-inch Nai crystals. Although all family observed maximum excretion rates of iodine in members proximal to the patient had measurable exhalation, perspiration, and saliva of thyroid burdens, dose estimates in nearly all cases 3.2 x 10*/hr,2.4 x 10*/hr, and 6.3 x 10'/hr of the indicate that external expo ures substantially administered dose, respectively. Thus, the exceeded internal thyroid dose equivalents, amounts in exhalation and perspiration were very Moreover, the investigators also concluded that it small. The amount in saliva is larger, but transfer
... appears certain from our study of these of saliva to other people is likely to be limited, subjects that for spouses, there is a relation between thyroid activity and ictimacy. Of the 12 Buchanan and Bridle (HU70) estimated thyroid husbands and wives questioned.... none were radioiodine activity in 39 subjects who, as family willing to adjust living habits with their spouses members, were associated with patients treated because of the radiation therapy. Most, however, for hyperthyroidism. Administered quantities are concerned for their children and are willing to ranged from 148 to 740 megabecquerels (4 to 13 NUltEG 1492
listen to Suggestions which minimite exposure to for the purposes of this analysis, implants will be their child:en.*
cvaluated cornidering Shielding by tissue equivalent to $ half value layers.
Thus, the Studies on internal esposures suggest that internal doses from intake of contamination 4.2.2 Estittiate of Masiniutu Likely are likely to be much Smaller than doses from Doses to Individuals Exposed to external rad 4 tion and much smaller than the Pallents public dos dirnit. Therefore, internal exposures will not be considered in this analysis.
Assessments were made of the doses that couhl resu horn exposun to a padent OcaW wM 4.2.1.5 Tinue Shiriding for Permanent implants cach of the radionuclides used.
In addition to the Shielding effects of the source C2.1 Divoule Pmdms capsule (see 4.2.1.2 Exposure Rate Constant), a significant reduction in the dose and dose rate also occurs from the insue surrounding the Tk tmla of the calculations for diagnostic implant. I or a prostate implant, tissues that Serve pocedures are summarized in Table 4.6.
to reduce photon flux about the patient m, clude Table 4.6 indicates that, except for some the soft and bone tissues of the thighs, pehas, procedures using iodine 131 to detect thyroid buttocks, abdomen, etc. The linear attenuation cancer, none of the other diagnostic procedures coefficient and corresponding soft tissue halfaalue currently being performed have the potential to ddiver a 1 millislevert (0.1 rem) dose to an layer for the 27 lev photon of iodme 125 are 0.387 cm' and 1.8 cm, and for the 21 lev photon indhidual exposed to a patient, llowever, in the case of lodinco31, the effective half life of the of palladium 103,0.770 cm and 0.9 cm*
estrathroidal component is much shorter than the respectively (J01183),
physicallife used to calculate doses. Therefore, To assess the impact of tissue shiciding by the the dose would be mu$h lower than the value down in taw u Mncc die hes in au cases patient, the medical health physicist of the Memorial Sloan Kettering Cancer Center was an muqi below I milk,s, evert (0.1 rem),
i consulted (personal communication, J. St.
agnosue procedures will not be considered any Germain, March 1993). Ilased on empirical further in th,is analpis, assessment invohing patients with prostate implants, tissue 6hiciding for iodine-125 is likely to exceed 5 or more half value layers (llVLs), which would reduce the dose and dose rate by a factor of at least 32. For palladium 103 implantr., in which the llVL in tissue is less than one centimeter, the shielding afforded by the patient's tissue is even more extensive. For other implants invohing the lungs, brain, pancreas, etc., tissue shiciding values of similar magnitude can be assumed for an aduit male and female. For certain implants invohing primary cancers of the neck and head, overlying tissues may provide less than 5 IIVLs of attenuation in such instances,it is standard practice to provide the patient with a small portable '6hield" which effectively attenuates all emissions (personal communications, C. Jac,bs, August 1993, and R. Nath, J. St.
Germain and K. Suphanpharian, March 1993). A shield coraists of a vinyl sheet impregnated with lead and molded to fit the anatomical surface over the implant.
NUREG 1492 14
e l
i I
Table 4.6. Masimum lAtly Doses to Total Decay to Dposed Individuals from Diagnostic Procedures Attleity per 1:samlaation Type 1:samination"'
Gamina Dose *
(l(adiopharinaceutical)
(Mity (mCl))
(inst (rein))
l Diagnostic Procedures l
Ilraln Tc 99m DTPA 740 (20) 0.13 (0.013)
Tc Wm O, 740 (20) 0.13 (0.013) j!cpatobiliary Tc Wm IDA 185 (5) 0.03 (0.003)
.Iivcf
- Tc 99m sulfur colloid 185 (5) 0.03 (0.003) lione Tc Wm phosphate 740 (20) 0.13 (0.013) l-unt Perftision Tc Wm MAA 185 (5) 0.03 (0.0C3)
Thmild Tc Wm On 185 (5) 0.03 (0.003) 1 131 3.7 (0.1) 0.02 (0.002) l 131 (maximum) 370 (10) 1.5 (0.15)
Dediovasfuljg Tc Wm l(IIC 740 (20) 0.13 (0.013)
Tc Wm phosphate 740 (20) 0.13 (0.013)
TI 201 chloriae til (3) 0.04 (0.(K)4)
Itenal Tc 99m DTPA 740 (20) 0.13 (0.013) l 131 hippuran 9.3 (0.25) 0.04 (0.004)
"' The activity is the average per admuustration (see Table 4
). He masimum diagnostic activity of I-131 la shown bwouse it yields gamma dosee exceeding i nullisievert (0.1 rem).
- Calculations assunw no biological ehmination and no anenuation of gumnw rays in air or body of patient.
15 NUREG 1492
e 4.2.2.2 Therapeutic Procedurn Therefore, the decision to require instructions, as shown in Table 111, is based on the maximum Table 4.7 prosides the maximum likely doses to value in the dose range for the newborn inf ant indhiduals from current therapeutic procedures exceeding I millisievert (0.1 rem). The duration based on physical ball life only and assuming of tbe interluption shown in Table 111 is selected immediate release of the patient by the licensee to reduce the maximum dose to a newborn infant (i.e., no hospitalitation). Only the therapies to less than 1 millisievert (0.1 rem). The actual invohing radioiodine would be affected by any of doses that would be re(ched by most infants for the alternatives under consideration.
the recommended interruption periods shown should be a small fraction of 1 millislevert 4.2.3 Assessment of Doses to Ilreast.
(0.1 rem).
Fowling Infants in reviewing Table 111, it was concluded that the if a radiopharmaceuticalis administered to a recomniendations on interruption of breast woman who is breast feeding, a fraction of the feeding to reduce the dose to the infant to len quantity administered will be deposited in the than I millisievert (0.1 rem) are practical and breast milk and will be transferred to the breasi-prudent, that the overwhelming majority of feeding infant. In considering the dose to the women would follow instructions, and that there is individuallikely to receive the highest dose from no reason for doses to nursing infants exceeding exposure to a patient who has been administered I millisievert (0.1 rem). f^or example, the internal a radiopharmaceutical, it is necessary to consider dose to the breast feeding infant from iodine 131 both the internal and external dose to a breast, sodium iodide diagnostic and therapeutic feeding infant.
procedures could exceed 5 millisieverts (0.5 rem) with no cessation of breast feeding. Ilowever, in 4.2.3.1 Internal Dose these cases the licensee would instruct the woman to cease breast feeding as a condition for The potentialinternal dose to the breast feeding authorizing release. Consequently,it is reawnable to assume that there would be no infant was calculated for the maximum normally administered quantities of commonly used internal dose to the infant. Therefore, the issue diagnostic and therapeutic radiopharmaceuticals of internal dose to breast feeding infants does not affect the choice of alternatives and it can be assuming no interruption in breast feeding. The results of the calculations are shown in climinated from further consideration.
Appendix 11.
The doses can be represented as a range where the range covers the minimum and the maximum transfer from published data The range is due to individual variability and measurement variability as indicated by concentrations measured in breast milk. The doses were calculated for newborn and one-year old infants. Since the doses for newborn infants are the highest, those doses were used in the analysis. The dose ranges for commonly used radiopharmaceuticals assuming no interruption of breast feeding are shown in Table 11-1 (see Appendix II) Ti.e radionuclides in the table that are not regulated by the NRC (e.g., Ga 67) are omitted from further consideration in this analysis.
The proposed rule would require that instructions on maintaining the doses to other indhiduals as low as reasonably achievable be given to the released patient if the dose to another indhidual is likely to execed I millisievert (0.1 rem).
NUREG 1492 16
0 e
Table 4.7 Mastmum IJLely Doses to Total Deca) to Esposed Indhiduals from herapeutic Procedures Assuming No Hospitalization heragwutie Procedure Aethily Adminittered Masimum Likely Dose ("
(Radionuclide)
(Milq (mCID (mSt (remn J)vroid Ablation (Hvoerthroidkm) iodine 131 370 (10) 1.5 (0.15) 740 (20) 3.0 (0.30) 1,110 (30) 4.6 (0.46)
Thyroid Cancer iodine 131 1,850 (50) 7.6 (0.76) 3,700 (100) 153 (1.53) 7,400 (200) 30.6 (3.06)
Permanent Imolant*
iodine 125 1,110 (30) 0.54 (0.054) 1,480 (40) 0.72 (0.072) 1,850 (50) 0.90 (0.090)
. palladium 103 2,775 (75) 0.29 (0.029) 3,700 (100) 0.39 (0.039) 4,625 (125) 0.49 (0.(M9)
"* Menimum hbly done bewd on physical half-bre on.y.
- Rene values account for the $ HVLa of tLaue shielding by the patient end. therefore, are equal to the point source dose in air divided by 32.
4.2.4 Collective Dose 4.2.4.2 Esternal Dose To evaluate each alternative, it is also necessary To determine a realistic estimate of the external to estimate not only the dose to the maximally dose to total decay to the infant during breast exposed individual, but also the collective dose to feeding, an occupancy factor must be selected that other individuals who may be exposed to patients r.pecifically reflects the variables involved, it can administered radioactive materials. To calculate be assumed that the average infant feeds for a precisely the collective dose that would be period lasting 30 minutes every 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />, resulting received under any of the alternatives would in an occupancy factor of 16 percent. Since require detailed information of a highly diverse Srcast feeding requires close contact, the analysis group of patients relative to lifestyles, living uses 20 centimeters as the distance between the arrangements, work emironments, social activities, infant and the source. For permanent implants, etc. This information does not esist and is capsule shielding and tissue attenuation by the essentially impouible to precisely determine, in woman's body are considered. Also, since only place of a precise estimate we have made a rough the physical half life is considered, the analpis is estimate of the collective dose per procedure conservative. The results are shown in Table H0, which we believe is adequate for the purposes of it can be seen that in some cases, external dose this relemaking, can be significant. Thus, for some radiopharmaceuticals, the recommended Based on considerations of the written instructions interruption period in Table B 1 had to be provided patients, the demographics of the patient adjusted to take external dose into consideration.
population (see Table 43), and time, distance, and shielding factors, we estimate that the collective dose per procedure is 3 times the maximal dose. This 3 times factor could occur in 17 NUREG 1492
e
,he following manner, based upon intuitive collective dose is 3 times the indhidual dose or assu nptions al.out a typical family and friends. In 9 millisleverts (0.9 rem). The collective dose per addition to the person recching the maximal dose, procedurs for iodine 125 implants was calculated who is likely to be the primary care provider in the same manner assuming no hospitallration.
there could be 2 other people who will average For thyroid cancer, hospitalization is assumed about half as much time near the patient. There until the aethity remaining in the patient's body is might also be about 4 other people who will 1,110 megabecquerch (30 millicuries). The average about a quarter as much time near the estimated total effc(tive dose equivalent to the patient as the maximally exposed indhidual. The maximally exposed indhiduals from a patient sum of the collective dose to all these people is leaving the hospital after 2 days who has been 3 times the dose to the maximally exposed indhid-scleased with 1,110 megabecquerels ual. This situation could represent a typical (30 millicuries) is estimated to be 2 millisleverts family and friends. Of course some patients will (0.2 rem) considering biological excretion.
spend more time near other people, but other patients will srend less. A collective dose of 3 times the dose to the maximally exposed indhidual is thus a reasonable average representation.
+
Finally, as data are not available on the distri-
~
bution of the quantities of radionuclides adminis.
tered for each procedure, the estimates of collective dose for each alternative are based on the mid. point values within the ranges of the activities administered.
4 Tables 4.8,4.9, and 4.10 present the estimates of the collective doses for Alternatives 1,2, and 3, respectively for therapeutic administrations that could be affected by choice of alternathe.
Implants using palladium 103 are not included because doses to exposed indhiduals are always 1
i less than I millislevert (0.1 rem).
In Table 4.8, the collective dose per procedure was determined in the following manner. For all types of procedures in the table, the average aethity administered was used. It was assumed that all patients would remain hospitalized until the dose dropped to 1 millisievert (0.1 rem) or less for iodine-125 implants. Thus, the dose to i
the most exposed indhidual would be 1 millisievert (0.1 rem). The collective dose per procedure is then assumed to be 3 times the dose to the most exposed indhidual.
In Table 4.9, the collective dose per procedure was calculated in the following manner. For thyroid ablation, no hospitalization is required because the administered aethity is less than 1,110 mega becquerels (30 millicuries). From Table 4.7, the dose to the most exposed indhidual from an administration of 740 megabecquerels (20 millicuries) is 3 millisieverts (0.3 rem). The NUREG-1492 18
Table 4.H Estimates of Collectlie 1)ose from 1herapeutic Radiolodine Procedures for Alternalise 1:
Annual !Jmit of 1 millislesert (0.1 rem)
Astrage Attiilly Collettlir I:stimated Total "Iherapeutic Administered Dose /l'nicedure Procedures Collecilie Dose Procedure (hlity (mCD)
(mSt (rem))
per Year (person Sv (rem))
4 Thyroid Ablath!,o iodine 131 740 (20) 3.0 (0.3) 50,(KO 150 (15,(W10)
Thyroid Cancer iodine 131 3,700 (100) 3.0 (0.3) 10,(XK) 30 (3,(XXI)
Permanent implan,J
. iodine 125 1,4M0 (40) 2.2 (0.22) 2,(XX) 4.4 (440)
All Therapeutic Procedures 624K10
!!,4.4 (18,440) i Table 4.9 1:stimates of Collectise Dose from Therapeutle Radiolodine Procedures for Alternelige 2:
Limits of 1,110 megabecquerels (30 millicurles) or 0.05 millisinert (5 millirems)/hr Aserage Acthily Collectise Estimated Total lherapeutic Administered Dose /Pnicedure Procedures Collecthe Dose Procedure (hllig (mCl))
(mSt (rem))
per Year (person Sv (rem))
Thyroid Ablatigi) iodine.131 740 (20) 9.0 (0.9) 50,(XX) 450 (45,000)
_ Thyroid Canegt iodine 131 3,700 (100) 6.0 (0.6) 10,(XX) 60 (6,(KX))
Permanent implant
- iodine 125 1,480 (40) 2.2 (0.22) 2,000 4.4 (440)
All Therapeutic Procedures 62,(KK) 514 (51,400) 19 NUREG 1492
e Table 4.10 1:stimates of Collecthe Done from nerapeutle Radiolodine Procedurts for Alternathe 3:
Annual Limit of $ millisleserts to.5 rem)
Astrage Activity Collecthe Estimated Total Herapeutic Administered Dose / Procedure Prmedures Collecthe Dose Procedure (Mily (mCO)
(mSt (rem))
per Year tperson.Sv Or m))
Thstoid Ablation lodinc.131 740 (20; 9.0 (0.9) 50,(KK) 450 (45,(KK1)
Tinvoid Cancer
. iodine 131 3,700 (100) 15 (1.5) 10,(KK) 150 (15,(xx))
J'crmanent implant lodine 125 1,480 (40) 2.2 (0.22) 2.(X10 4.4 (440)
All Therapeutic Procedures 62,(KN' 604 (60,440)
In Table 4.10, the collective dose per procedure dose to the hospital staff and other patients in the for thyroid cancer is estimated by assuming hospi.
hospital. Ilowever, the increase in dose to the talization for one day until the maximum dose to hospital staff is expected to be low relative to a an individual would be 5 millisleverts (0.5 rem).
patient going home earlier beecuse of the precau.
The collective dose is therefore 15 millisleverts tions taken during hospitalization; e.g., patients (1.5 rems), using the previously described are isolated and the hospital staff rarely enters the assumption that the collective dose will be 3 times patient's room, the dose to the maximally exposed indhidual.
In the analysis that follows, these costs are calculated assuming that all retained patients will 4.3 Value Impact Analysis be hospitalized. While retention costs might be less for non hospital locations, no attempt is made 4.3.1 Estimates of the Potential Costs 4.3.1.1 Estimates of the Direct Costs of Patient The analysis in Section 4.2 indicates that the Retention 1 millisievert (0.1 rem) per year dose limit imposed by Alternative I would result in the Durations of Patient Retention smallest collective dose to individuals exposed to released patients. The benefit of smaller doses Estimates of the periods of time that patients estimated for Alternative 1 will only be achieved if would need to be retained under licensee control the patients to whom the radioactive materials for each of the alternatives are presented in have been administered are retained under the Table 4.11. These estimates employ the midpoint control of licensees for longer periods of tirne, activities used for a given medical procedure and The impact of retaining patients must be auessed are based on realistic estimates of the retention in in terms of the patient, family, and society as a the body using the effective halflike rather than whole At a m%imum, the economic cost must the physical halflife, consider the direct cost of medical resources requ. red to retain the patient in a hospital and the Cost of Patient Retention indirect cost resulting from the loss of human resources. Additional consideration should be To estimate the annual dollar costs for these given to the psychologicalimpact of retention on periods of retention, one needs only multiply the the affected individual and family members, llospitalization will also cause an increase in the NUREG 1492 20
e Table 4.11 I)uration of Retention per Therapeutic Procedure (to the nearest day)
Alternatise 1 Alternatine 2 Alternalise 3 (dap)
(dap)
(days)
Midpolnl Actisity E
E E
1herapeutic Administered per procedures per piecedures per procedures Procedure (MHg (mCl))
procedure (x 10(Kl) procedure (x 1(NXI) procedure (x 1(KM))
Thyroid Ablation 1 131, 50,(XX) procedurcs// car 740 (20) 2 1(K) 0 0
0 0
Thyroid Cancer 1 131,10,tXX) procedures /ycar 3,700 (100) 4 40 2
20 1
10 Permanent implant, i 125, 2,(XX) procedurcs/ year 1,480 (40) 0 0
0 0
0 0
Total for All Therapeutic 140 20 10 Procedures 21 NUREG 1492
e number days required for cath procedure by the achieved by means of the gross national product number of procedures per year arid the average (GNP). The GNp is considered the trost cost per day of hmpitalization. In lWO, the comprehemite measure of the country's economic average cost per day in a community hospital aethity and includes the market value of all goods was $687 (SA92). The per diem cost at the and senices that have been bought for final use beginning of IW5 is estimated to be $4K).
during a year. From the GNP of about llowever, as the current regulations require that
$5,(dK) billion in IWI, the gross average annual patients who are hospitalized from a therapeutic per capita income of about $22,tKKIis derived.
3 administration of radiopharmaceuticals to be The value of $22,(KK) per year corresponds to l
placed in a private room, the $4K1 per day
$(41 per day and can be used to determine the estimate is adjmted to $1,(KKI per day. Using this equivalent dollar value for the number of days lost figure, the potential costs of retaining patients due to retention of an indhidual. The valu, of under Alternative 1 are estimated to be $402 mil-the days lost is shown in Table 4.16.
l lion. Under Alternative 2, the estimated cost is l
$60 million. And, under Alternative 3, the 4.3.1.3 1:tatuation of Paghological Costs l
estimated cost is $30 million.
Retsntion of patients in a hospital by design Costs of Prmiding Recordkreping necessitate 6 that the patient be " isolated" and that human contact, inclusive of family me nbers, is The currently emisioned proposed rule associated either avoided or minimlied. Such isolation may with Alternative 3 imposes additional paperwork bring about numerous changa and impositions in and recordkeeping requirements on the estimated the lives of the patient and fan,ily members that 1,350 licenseen (NRC. and Agreement State-may in part be linked to, but are not reflected in, licensed) that provide therapeutic administrations the direct and indirect economic cmts identified of radiopharmaceut:cals or permanent radioactive above. The wide variety of deterioration in the implants. For therapeutic administrations where quality of life brought on by illness are frequently where releases are not based on the default table referred to as psychological costs. For thyroid in Regualtory Guide 839, a record must be cancer or dysfunction requiring therapeutic doses maintained for three years.
of iodine 131 for example, a deterioration in the quality of life may be precipitated by the loss of it is estimated that approximately 10,000 thera.
bodily function, a lifetime dependence on medica-peutic procedures per year would be subject to tion, hormonal instability, uncertainty of normal these requirements. A cost of $33 per patient is life-expectancy, disruption of normal daily estituated. This resuhs in an annual estimated routines, and reduced financial security related to cost of approximately 103 million.
employment, lost earnings, and medical expenses.
4.3.1.2 Derivation of Indirect Costs While some of these elements of psychological costs are the result of the disea3e itself, others las of Time such as disruption of normal routines, social isolation, and enhanced financial strain are clearly Indirect costs principally reflect the time and elements of psychological costs that are directly output lost or forfeited by the patient while related to patient retention, in characterizing retained in a controlled emironment. Indirect psychological costs, Thomas llodgson (11084) costs may also be incurred by indhiduals other chief economist for the Department of IIcalth and than the patient who may forego economic Iluman Senices' Offices of Analysis and activities to accommodate a family member's Epidemiology states: '... The emironment hospital retention. Economic activities include created by illness often induces anxiety, reduced occupational work that is lost to either the patient self esteem and feelings of well being, resentment, or his or her employer as well as non-occupation-and emotional problems that often require al (e.g., domestic) work which must be nerformed by someone else -' the expense of the patient.
The conversion of time lost from economic aethities to equivalent dollars is most fairly NUREG 1492 22
l l
Table 4.12 Costs of Alternathen I,2, and 3 Cost Estimates llospitalization value of Record llospital cost lost time Lecping Psyhological Colletthe Dose Retention S
5 tut Alternathe
.t person. rem)
(dap)
(millions)
(millions)
(millione (relathe) 1 18,4(K) 140,(KK) 140 H.4 0
liigh 2
51,400 20JKK) 20 1.2 0
Moderate 3
60,400 10.000 10 0.6 0.3 low psychotherapy. Problems of thing arrangements allowing indhideals to receive annual doses up to may develop, leading to family con 0ict, antisocial 5 millisieverts (0.5 rem) under certain circum-behavior and suicide.... The combination of stances. Iloth ICRP and NCRP recommend that financial strain and psychological problems can be an indhidual be allowed to receive a dose up to especially devastating.'
5 millisleverts (0.5 rem) in a given year in temporary situations whuc exposure to radiation 4.3.2 Cost Comparison of Alternatives is not expected to result in doses above 1 milli-sievert (0.1 rem) for long periods of time. The Table 4.12 summarites the most relevant da:a recommendations of the ICRP and NCRP are pertaining to the costs of the three alternatives based on their finding that annual doses in excess under consideration. Quantitative values are of 1 millisievert (0.1 rem) to a small group of bawd on the midpoint aethity values of iodine.131 people, provided that they do not occur often to used in the therapeutic treatments of hyperthy.
the same group, need not be regarded as roidism and thyroid neoplasms and lodine 125 especially hazardous. Although the risk is seeds which are used in permanent implants for potentially greater under Alternative 3,it is still treatment of select solid tumors. Due to the within the range of acceptablo risk for radiation subjective nature of psychological costs, exposure accepted by the NRC (as implemented comparison is provided on a relative scale.
under the revised 10 CFR Part 20).
4*4 Evaluation Of The Alternatives M,ith Respect To 5 DECISION RATIONALE Accepted Radiation Protection Principles 1.
All of the Alternatives are acceptable according to generally accepted radiation Selection of the 5 millisieverts (0.5a:m) total protection principles, as those expressed by effective dose equivalent pc year criterion is con-NRC, NCRP, and ICRP, as discussed in sistent with: the Commission :. provision in Section 4.4.
10 CFR 20.1301(c) for authorizing a licensee to operate up to this limit; the recomraendations of 2.
Alternative 1 is considerably more expensive the International Commission on Radiological to the public compared to Alternative 2 (the Protection (ICRP) in ICRP Publication 60, *1990 status quo) or Alternative 3. Even neglecting Recommendations of the International Commis-the psychological costs, which have not been sion on Radiological Protection;" and the recom-expressed in dollar terms, the additional cost mendations of the NCRP in NCRP Report of Alternative 1 relative to Ahernative 2 is No.116,' Limitation of Exposure to lonizing about $126,000JXK) per year, mostly in Radiation.' Each of these provide a basis for increased national health care costs. The 23 NUREG 1492 n
e value of the dose savings at a value of $1,(KK) lead to the delhery of more effective health per person rem is $33,tMK),(KKI per year. In care.
view of this, Alternative 1 may be dismissed.
j 3.
Alternative 3 sciative to Alternative 2 has a value of sloaxum per year, mostly in lower 6 IMPLEMENTATION heahh care costs at a collective dose cost of
$9,tKI,(xt) per year. Alternative 3 also has psychological benefits to patients and their families. Thus, Alternative 3 appears cost No impediments to implemertation of the recom-effective in comparison with Alternative 2.
mended alternative have been identified. The staff is prrparing a Regulatory Guide for licensees 4.
liasing the patient release criteria in which will provide, in part, simple methods to 10 CFR 35.75 on the dose to indhiduals evaluate the dese to the individual reember of the exposed to a patient provides a wnsistent, public likely to neceive the highest dose from the scientific basis for such decisions that treats released patient. This will enable licensees to all radionuclides on a risk equivalent basis, determine when a patient may be released from The dose delivered by an initial methity of their control.
30 millicuries or a dose rate at 1 meter of 5 millitems per hour saries greatly from one I
radionuclide to another. Thus, while the values in the current 10 CFR 35.75 may be appropriate for iodinc.131, they are too high for some other radionuclides and too low for others.
5.
A dose based rule no longer restricts patient release to a specific aethity, and therefore would permit the release of patients with aethities that are greater than currently allowed. This is especially true when case-specific factors are evaluated to more accurately assess the dose to other indhiduals. For the case of thyroid cancer,in those cases occasional where multiple administrations in a year of 1,110 millisieverts (30 millieuries) or less of iodine 131 are now administered to a patient, it may be possible to give all of the acthity in a single adminis-tration. This would reduce the potential for repeated exposures to hospital staff and to those providing care to the released patient.
Additionally, this would provide physicians with the flexibility to not have to fractionate doses to avoid hospitalization to meet the current requirements, which may lead to a more effective treatment.
6.
Shorter hospital stays provide emotional benefits to patients and their families. Allow-ing earlier reunion of families can improve the patient's state-of mind, which in itself may improve the outcome of the treatment and NUREG 1492 24
1 l
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- Dosimetry of Palladium 103 Watanabe,1980, ' Monitoring of I Brachytherapy Sources for Perma-Exetetions and Used Materials of 27 NUREG 1492
O l
Patients Treated with I.131,* Ilealth PL86 PectaJdes, D., S. Stewart, N.
)-
Physics 38(e):467.
Courtenay Luck, R. Rampling, A.J.
i Munro, T. Kraust, H. Dhokia, D.
l NRC95 Nuclear Regulatory Commission, Snook G. Ilooker,11. Ourbin, J.
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Oncol. 3:1573.
PR92 Priestly, J.ll Jr., D.C. Heyet.1992 OS92 Ostertag C.H., F.W. Kreth,1992,
- Guided lirachytherapy for Treat.
- lodine 125 Interstitial irradiation ment of Confined Prostate Cancer,*
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Neurochi (Austria) 119(1 4):53, Freiburg University, Federal RI90 Riva, P., S. Larzari, M. Agostini, G.
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Sarti, G. Moscatelli, G. Franceschi, A. Spinelli, G. Vecchietti, R. Tassin),
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D. Tirindelli,' 1990, ' intracavitary Lee, D.I. Kim, B.S Kim,1987, Radioimmunotherapy Trails in
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Nucl. Med. Commun. 8:1075.
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Pall Pasteau. O.,1911, "Traitment du 2:64.
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1990, Superselective 90Y resin Embolization Therapy of Solid NUREG 1492 23
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Tumors.* European Journal of Wil88 Whitmore, W.P.,1988, ' Interstitial Nuclear Medicine 16:439, implaalation of the Prostate: 10 Year Results, Brachytherapy RU92 Rustig, S.N., S.S. Ilahn,1992, Update,1988,* In: Proceedings of
' Advantages of using liigh Activity 1 the Memorial Sloan Kettering 125 Seeds in Temporary Interstitial Cancer Center Course on Breast implants,' Med. Dosim.
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17(4):217.
Z184 Ziessman, ii.A., J.ll. Thrall, PJ.
SA92 -
Statistical Abstracts of the U.S.,
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SC92 Scharfen, C.O., P.K. Sneed, W.M.
Wara, D.A. Larson, T.L Phillips, M.D. Prados, K.A. Weaver, M.
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29 NUREG 1492
o APPENDIX A. PARAMETERS AND CALCULATIONS FOR DETERMINING RELEASE QUANTITIES AND DOSE RATES FOR RADIONUCLIDES USED IN MEDICINE.
Table A l. Italf Lhes and Esposure Rate Constants of Radionuclides Used in Medicine i
llatf.
Esposure llalf.
Exposure Radio.
Life Rate Constant 8 Radio.
Life Rate Constant 8 nuclide (days)'
(R.cm /mCl h) nuclide (days)8 (R cm /mCl h) 8 8
Ag.111 7.45 0.150 Pd 103 implant 16,97 OR/
Au 198 2.696 2.36 Re.186 3.777 0.168 Cr 51 27.704 0.177 Re.188 0.7075 0.337 Cu 64 0.5292 1.10 Sc.47 3.351 0.626 Ga 67 3.261 0.753 Sc.75 119.8 2.60 1123 0.55 1.61 Sm.153 1.9458 0,425 1125 60.14 1,42 Sn 117m 13.61 1.48 1125 irnplant 60.14 1.118 St89 50.5 NA8 l131 8.040 2.20 Tc-99m 0.2508-0.756 In 111 2.33 3.15 TI 201 3.044 0.447 Ir.192 74.02 4.69 Y 90 0.1329 NAS i
P.32 14.29 NAS Yb-169 32.01 1.83 8 Keith P. Eckerman, Anthony B, Wolbarst, and Allan C. B. Richardson, Federel Guidance Reoort No.11.
- Limitine Values of Radionuclide intake and Air Concentration and Dose Conversion Factors for Inhalation.
Submersion. and incestion. Report # EPA 520/188-020, Office of Radiation Programs, U. S. Emironmental Protection Agency, Washington, DC,1988.
8 The exposure rate factor includes gamma rays and x rays with an energy above 11.3 kev. The 11.3 lev cutoff is the one used in NCRP Report No. 41,' Specification of Gamma Ray Brachytherapy Sources," 1974.
The exposure rate constant was calculated from the following equation (as shown in Table A 2):
NUREG 1492 26
o mR cm' dis 1
- p.,, c m 2 (1.332 x 10"
)4(rr (100 cm)' ) E f,E,(
)
r
=
x mci hr mci hr p gm cm
gm mR
( 87.6 erg)(1.6 x 10..
erg )
MeV Where E, - the energy of the gamma ray or x ray i in Mev.
f, -
the probability of decay of gamma rays or x rays with energy E, per disintegration. Values for E, and f, were taken from: Bernard Shicien, The llealth Physics and Radiolocica]
Ilealth llandbook. Revised Edition, Scinta, Inc.,1992, pages 244-334. For Re 186, Re 188, and Sn.117m the values for E, and I, were taken from: Laurie M. Unger and D. K. Trubey, SpeciGe Gamma Ray Dose Constants for Nuclides impot: ant to Dosimetry and Radiolocical Assesi, ment. ORNL/RSIC 45/R1,1982.
.., =
the linear energy absorption coef6cient in air of photons of energy E, taken from i
J1.pdiolonical llcalth llandbook. U. S. Department of 11calth, Education, and Welfare,1970, page 135.
p=
the density of air at standard temperature and pressure, taken to be 0.0012929 gm/cm'.
The details of the calculation of the exposure rate factors are shown in Table A.2.
- R. Nath, A.S. Meigooni, and J.A. Meli, ' Dosimetry on Transverse Axes of *l and '"It Interstitial llrachytherapy Sources," Medical Physics. Volume 17, Number 6, November / December 1990. The es posure rate constant given is a measured value averaged for several source models and taking into account the attenuation of gamma rays within the implant capsule itself.
- Ravinder Nath, Yale University School of Medicine, letter to Dr. U.11ans Behling dated March 31,1993.
The exposure rate constant given is a measured value that takes into account the attenuation of gamma rays within the implant capsule itself.
- Not applicable (NA) because the release quantity is based beta emissions.
27 NUREG 1492
G p
Tcble A 2. C:Icul ti:ns cf Erposure Rate Factorr., Rel:ase Qu:ntities, end R Ins) D:se Rites.
Gamma Dose Factor Leculations j j
i i
half-life in days linear absorption coeff Q, based on.5 rem mrem /hr R/hr Ci R/hr-mci @
@ 1 m for Isot:pe Tig fraction / dis E(Mev)
U,n(1/m) Mev/cm/ dis.@ 1 m 1cm Q,(mCl)
Q,(MBq)
Q,(GBq)
Q.
Ag-111 0 000245 0 022984 4 30E-02 2 42E-09 3 63E-05 3 63E-04 0.000*62 0.023174 4 00E-02 4 28E-09 6 42E-05 6.42E-04 0 000151 0 0261 2.80E 02 1.10E-09 1.65E-05 1.65E 04 0 001202 0 09675 3 00E.03 3 49E-09 5 23E-05 5 23E-04 0 012291 E24539 3 665-03 1.09E-67T65t-03 1.65E-02 0 0668 0.34213 3 80E-03 8 68E-07 1.30E-02 1.30E-01 0 000559 065472 3 80E-03 1.39E-08 2.09E-04 2=09E-03 7 45_
TOTAL 1.50E-02 1.50E-01 5.16E+02 1.91 E + 04 1.91 E+ 01 7.76E+00 Au-198 0 008053 0.068895 3 50E-03 194E-06 2 91E-04 2 91E-03 0 013695 0 070819 3 45E-03 3 35E-08 5 02E-04 5 02E-03 0 006024 0.0803 3 25E-03 1.57E-08 2.36E-04 2.36E-03 0.9551 0 4118 3 90E-03 1.53E-05
- 2. 30E-01
- 2. 30E+ 00 0 010602 0 67589 3.80E 03 2.72E-07 4.08E-03 4 OBE 02 0.002292 1.0877 3 55E 03 8 85E-08 1.33E-03 1.33E 02 2 696 TOTAL 2 36E-01 2.36E+00 9 07E+01 3 36E+03 3 36E+00
_2.14 E+ 01 Cr 51 0 0983 0 32008
,3 75E-03 1.18E-06 1.77E 02 1.7_7E-01 4 30E+03 4 36E+00 2.00E+00 27.704 j
TOTAL 1.77E 02 1.77E-01 1.10E+ 02 i
Cu-64 0.00489'$
1.3459 3 35E-03 2.21 E-07 3 31E-03 3.3fET02 Occupancy Factor = 1 0 3574 0 511 3.90E-03 7.12E-06 1.07E 01 1.07E+00 0.52920833 TOTAL 1.10E-01, 1.10E + 00 2.48E + 02 9.18E+03 9.18E+ 00 2.73E+01 Ga-67 0 02856 0 091266 3 00E-03 7.82E-08 1.17E 03 1.17 E-02 0.357 0.093311 2 95E-03 9 83E-07 1.47E-02 1.47E 01 0.19700 0.18458 3 40E-03 1.24 E-06 1.85E-02 1.85E-01 0.02242 0.20895 3.50E-03 1.64E-07 2A6E 03 2 46_E-02 0.15994 0.30022 3.75E-03 1.80E-06 2.70E-02 2.70E-01 0.044768 0.39353 3 90E-03 6 87E-07 1.035!d2 1.03E-01
~
0.001385 0.88769 3 65E 03 4 49E-08
- 6. 73E-04 6.73E-03 0.001247 0.62941 3.85E 03
__3 02E-08 4.53E-04 4.53E-03 3 26083333 TOTAL 7.53E 02 7.53E 01 2.35E+02 8 71E+03 8 71E+00 1.77E+ 01 0.02f5027 2 60E-02 1.74 E-06 2.61 E-02 2 61E-01 1-123 0 24631 "0.027475~YiC5~~6I' 3 16s!66'T73562l 4 7'3E-01 0.45954 0.15952 0 031 1.73E-02 8.56E-07 1.28E-02 1.28E-01
~
~ 565!63 4 38E-06 6 565!65' 6 56$!6U 0.834 0 159 3
0.001259 0 34635 3 80E-3 1.66E-08T2.48E-04 2 48E 05i 0 004587 0 44002 3.90E-03 7.36E-08 1.10E 65 1.105T62 T
l 0.003161 0.50533 3 855-03 6.15's 08 9 22E-04 9 225! 3 0 013928 052896 3.85E 03 2.84 E-07 4.25E-03 4.25E-02 j
0.00382 0.53854 3 85E-03 7.92E-08 1.19E-03 1.19E-02 Occupancy Factor = 1 0.004763 0 49444 3 90E-03 9.18E-08 1.3BE-03 1.38E-02 0.55 TOTAL 1.61E 01 1.61 E + 00 1.63E + 02 6.04 E+ 03 6.04E+ 00 2.63E+ 01 A3 i
0 i
Tcbl3 A-7 C:lcut:tions of Exposurs R:t3 Factors, R;l: $1 Quentiti:s, and R:l:ast D:s3 Rates.
Garr 2 % tor Calculations j j
j Wute in days knear absorption coeff O. based on.5 rem mrem /hr
[
j R/hr-Ci R/hr mci @
@ 1 m for b.gTo fraction / dis E(Mev)
U (1/m) Mev/cm/ dis {lp i m icm Q.(mCl)
Q.(MBq) 0.(GBq)
Q.
h-125 0 39233 0.027202 2 60E-02 2.77E-06 4.16E-02 4.16E-01 0.73196 0.027472 _
2 50E-02 5 03E-06 7.54E-02 7.54E 01
~
O25409 0 031 1.73E 02 1.36E-06 2.04E-02 2.04E-01 0 0649 0.035492 1.20E-02 2.76E-07 4.14E-03 4.14 E-02 60.14 TOTAL 142E-01 1.42E+00 6.79E+00 2 51E+02 2 51E-01 9.61 E-01 4
1-131 0 013468 0.029458 1.95E-02 7.74E-08 1 16E-03 1.16E-02 0.024987 0.029779 1.90E-02 141E-07 2.12E 03 2.12E-02 0.008883 0.0336 1.30E 02 3 88E-08 5.82E-04 3.82E-03 D.026182 0.080183 3.25E-03 6 82E-08 1.02E-03 1.02'E-62
~~
0.002648 0.17721 3.35E-03 1.57E-08 2.36E-04 2.36E-03 0.060521 0.2843 3.68E-03 6.33E-07 0 49E-03 9 49E-02 0.002507 0.32578 3.75E-03 3.06E-08 4 59E-04 4 59E-03 0.81164 0 36448 3 80E-03 1.12E-05 1.69E-01 1.69E+00 0.003605 0 50299 3 85E-03 6.98E-08 1.05E 03 1.05E-02 0.072605 0.63697 3.80E-03 1.76E-06 2.64 E-02 2.64E-01 0.002195 0 6427 3 80E-03 5 36E-08 8.04E-04 8.04E-03 0.018025 0.72289 3 75E-03 4.89E-07 7.33E-03 7.33E-02 0.002304 0.32939 3 76E-03 2.85E-08 4 27E-04 4.27E-03 8 04 TOTAL 2.20E-01 2.20E+00 3.27E+01 1.21E+03 1.21 E+00 7.19E+ 00 l
_1 In.111 0 23628 0.022984 4.30E-02 2.34E-06 3.50E-02 3.50E-01 0 44581 0.023174 4.00E-02 4.13E-06 6.20E-02 6.20E 01 0.14597 0 0261
? 80E-02 1.07E-06 1.60E-02 1.60E-01 0.9024 0.17128 o.35E-03 5.18E-06 7.76E-02 7.76E-01 0.94 0.24539 3.60E-03 M OE-06 1.25E 01 1.25Et00 4
0 000028 015081 3.25' e 1
- E-10 2.06E-06 2.06E-05 2.83 hL 315E-01 315E+00 6 48E+01 2.40E+03 2.40E+00 2.04E+01 Ir 192 ~
0.011323 0.061487 3.90E 03 2.72E-u3 4.07E 04 4.07E-03
^
0019555 0.063001 3.85E-03 4 74E-08 7.11E-04 7.11ET03 0.008399 0.0714_
3 45E-03 2.07E-08 3.10E 04 3.10E-03 0.004674 0.20131 3 45E-03 3.25E-08 4.87E-04 4.87E-03 0.032873 0.2058 3.50E-03 2.37E-01 3.55E-03 3.55E-02 0 002615 l0.28326 3.70E-03 2.74E-08 4.11E-04 4.11 E-03 0.00f264 'O.37448 3 80E-03 1.03E-07 1.55E-03 1.55E-02 0.031628 0.48458 l 3 00E-03 5 98E-07 8.96E-03 8.96E-02 0.003989 0 48906 3 90E 0 7.61E-08 1.14E-03 1.14 E-02 0.000797 0.42307 3 90E-03 1.32E-08 1.97E-04 1.97E-03 0.02635 0.065122 3.70E-03 6.35E-08 9.52E 04 9.52E-03 0.045197 0.066832 3.60E-03 1.09E-07 1.63E-03 1.63E-02 0.019675 0 0757 3 35E-03 4 99E-08 7.48E-04 7.48E-03 0.001806 0.13635 3 20E-03 7.88E-09 1.18E-04 1.18E-03 0.29015 0.29596 3.75E-03 3.22E-06 4 83E-02 4.83E-01 0.29678 0.30846 3.80E-03 3.48E-06 5.22E-02 5.22E-01 0.82853 0.31651 3.80E-03 9.97E-06 1.49E-01 1.49E+ 00 0.006645 0.41646 3.90E-03 1.08E-07 1.62E-03 1.62E-02 0 48055 0.46807 3.90E-03 8 77E-06 1.32E-01 1.32E+00 A-4
.. ~
O 1
Tcbb A 2. C:lcut:tions of Exposura R ts Factors, R:Iscse Quantiti:s, and R l: ass Doss Rates.
Osmma Dose Factor Calculat6ons I j
1[
~
i half hfe in days linear absorption coeff Q based on.5 rera mrom/hr Isotope Tm R/hr-Ci R/hr mci @
@ 1 m for fraction / din E(Mev)-
U.n(1/m) Mev/cm/ dis @ 1 m 1cm Q.(mCl)
Q.(MBq)
Q.(GBq)
_ Q.
0.045735 0.58858-3.85E-03 1.04E-06 1.55E 02 1.55E-01 0.082024 0 60441 3.85E-03 1.91E-06 2.86E-02 2.86E-01 O 053357 0.61246 3.85E-03 1.26E-06 1.89E-02 1.89E-01 0.003016 0.88451 3.65E-03 9.74E-08 1.46E-03 1.46E-02 0.000986 0.87173 3.60E-03 3.09E-08 4.64E-04 4.64E-03 74 02 TOTAL 4.69E-01 4.69E+00 1.66E+00 6.16E+ 01 6.16E-02 7.81 E-01 4
Re-186 0.016 0.058 4.20E-03 3.90E 08 5 84E-04 5.84E-03 0.0278 0.0593 4.00E-03 6.59E-08 9.89E-04 9.89E-03 0.0118 0.0672 3.60E-03 2.85E-08 4.28E 04 4.28E-03 O.007 0.1223 3.10E-03 2.65E-08 3.98E 04 3.98E-03 0.0116 0.0615 3.90E-03 2.78E 08 4.17E-04 4.17E-03 j
0.2 0.063 3.85E-03 4.85E 07 7.27E-03 7.27E-02 O.0086-0.0714 3.45E-03 2.12E-08 3.18E-04 3.18E-03 0.0952 0.1372 3.15E-03 4.11 E-07 6.17E-03 6.17E-02 3
0.0006 0.7022 3.80E 03 1.00E-08 2.40E-04 2.40E-03 3.77666667 TOTAL 1.68E-02 1.68E-01 9.10E+02 3.37E+04 3.37E+01 1.53E+01 1
4 l
'~R2-188 0.0136 0.0615 3.90E-03 3.26E 08 4.89E-04 4.89E-03 0.2%
0.063 3 85E-03 5.70E-07 8.55E-03 6.55E 02 DIGI "
0.0714 3 45E-03 2 49E-08 3.73E-04 3.73E-03 4Ib 0.155 3 25E 03 7.54E-07 1.13E-02 1.13E-01
^
0 C ":#i 0.478 3.90E-03 1,96E-07 2.93E-03 2.93E-02 0.0A 0.6331 3.80E-03 3.61E 08 5.41 E-04 5.41 E-03 0.0011 0.6725 3 80E-03 2.81E 08 4.21 E-04 4.21 E-03 0.0041-0.8295 3.70E-03 1.26E-07 1.89E-03 1.89E-02 0.0056 0.9313 3.70E-03 1.93E-07 2.89E 03 2.89E 02 Occupancy Factor = 1 1
0.0072 1.134 3.55E 03 2.90E 07 4.35E-03 4.35E-02 0.7075 TOTAL 3.37E 02 3.37E-01 6.05E+02 2 24E+04 2.24E+01 2.04E+01 Sc-47 '
O.68 0.15939 3.85E-03 4.17E 06 6.26E-02 6.26E 01 3.351 TOTAL 6.26E-02 6.26E-01 2 '6E+02 1.02E+04 1.02E+01 1.72E+01 S)-75 0.07269 0.0117 4.25E-01 3.61E 06 5.42E-02 5.42E-01 0.010226 0.06605 3.65E-03 2.47E-08 3 70E 04 3.70E-03 0.034086 0.096733 3.00E-03 9.89E-08 1.48E-03 1.48E-02 0.16744 0.12112 3.10E-03 6.29E-07 9.43E-03 9 43E-02 0.59202 0 136 3.20E-03 2.58E-06 3.86E-02
- 3.86E-01 0.014472 OJ86 3.50E-03 1.01E-07 1.51E-03 1.51 E-02 0.598 -
0.26465 3.65E-03 5,78E-06 8.66E-02 8 66E-01 0.25236 0.27953 3.70E-03 2.61E-06 3.91E-02 3.91 E-01 0.013216 0.30391 3.75E 03 1.51E-07 2.26E-03 2.26E-02 0.11422 0.40065 3 90E-03 1.78E-06 2.68E-02 2.68E-01 119.8 TOTAL 2.60E-01 2.60E+00 1.85E+00 6.8SE+01 6.86E-02 4.82E-01 A5
v i
Tebt) A-2. Cticul:tions of Exposura R t) Fectors, R:liase Quantitiis, cnd R: tass Doss Rit:s.
camma Dose Factor Calculations i j
l half-life in days linear absorption coeff Q. based on.5 rem mrem /hr jR/hr-Ci R/hr-mCl @
@ 1 m for Isot:pe To fraction / dis F(Mev)
U (1/m) Mev/cm/ dis @ 1 m 1cm Q (mCl)
Q (MBq)
Q (GBq)
Q.
Sm-153 0.17263 0.040002 7.70E-03 5.44E-07 8.15E-03 8.15E-02 0 31218 67041542 7.30E-03 9 47E-07 1.42E-02 1.42E-01 0.12217 0.047 4.60E-03 2.64E-07 3 96E-03 3.96E-02 0.0517 0.069672 3 45E-03 1.24E-07 1.86E-03 1.86E 02 0.00194 0.075422 3 35E-03 4.90E-09 7.35E-05 7.35E-04 0.002 0 083355~~3.20E-03 5 34E-09 8 00E-05 8.00E-04 0.00158 0.089484 3.00E-03 4.24E-09 6.36E-05 6.36E-04 0.00718 0.09743 3.00E-03 2.10E-08 3.15E-04 3.15E-03 0.283 0.10318 3 00E-03 8.76E-07 1.31 E-02 1.31 E-01 0.002775 0 42266 3 85E-03 4.52E-08 6.77E-04 6.77E-03 1.94583333 TOTAL 4.25E-02 4.2SE-01 6.99E+02 2.59E+ 04 2.59E+01 2.97E+01 Sn-117m 0.1873 0.025 3.35E-02 1.57E-06 2.35E-02 2.35E-01 0 3514 0.0253 3.30E-02 2.93E-06 4.40E-02 4.40E-01 0 1185 0 0285 2.25E-02 7.60E-07 1.14E-02 1.14 E-01 0 0211 0.156 3 25E-03 1.07E-07 1.60E-03 1.60E-02 0.864 0 1586 3.30E-03 4 52E-06 6.78E-02 6.78E-01 13.61 TOTAL 1.48E-01 1.48E+ 00 2.86E+01 1.06E+03 1.06E+00 4.25E+00 Sr-89 0,00015 0.9091 3.65E-03 4.98E-09 7.46E-05 7.46E-04 50.5 TOTAL 7.46E-05 7.46E-04 1.53E+04 5 67E+05 5.67E+02 1.14E+00 Tc-99m 0.021021 0.018251 7.90E-02 3.03E-07 4.54 E-03 4.54E-02 0.040194 0.018367 7.90E-02 5.83E-07 8.74E-03 8.74 E-02 0.012059 0.0206 5.90E-02 1.47E-07 2.20E-03 2.20E-02 0.8907 0.14051 3.20E 03 4.00_E-06. 6.00E-02 6.00E-01 Occupancy Factor = 1 0.000214 0.14263 3.20E-03 9.77E 101 1.46E-05 1.46E-04 0.25083333 TOTAL 7.56E-02 7.56E-01 7.63E+02 2.82E+04 2.82E+01 5.76E+01 TI-201 0.0022 0.0306 1.80E-02 1.21 E-08 1.82E-04 1.82E-03 0.27357 0.068895 3 45E-03 6.50E-07 9.75E-03 9.75E-02 0 46525 0.070819 3.40E-03 1.12E-06 1.68E-02 1.68E-01 0.20465 0.0803 3.20E-03 5.26E-07 7.88E-03 7.88E-02 0.0265 0.13534 3 20E-03 1.15E-07 1.72E-03 1.72E-02 0.0016 0.16588 3.30E-03 8.76E-09 1.31 E-04 1.31E-03 0.1 0.16743 3.30E-03 5.53E-07 8.28E-03 8.28E-02 3.044 TOTAL 4.47E-02 4 47E-01 4.24E+02 1.57E+04 1.57E+01 1.90E+01 A-6
g Tcble A-2. Ccicutti:ns of Exposure Rate Fcetors, R:l:ase Quantiti:s. cnd RII:ast Dos) Rate:.
Gamma Dose Factor Calculations l l
l hilf-hfe in days knear absorption coeff Q. based on.5 rem mrem /hr R/hr-Ci R/hr-mci @
@ 1 m for Isot:pe Tm fraction / dis E(Mev)
U.,,(1/m) Mev/cm/ dis @ 1 m 1cm Q.(MCI)
Q.(MBq)
Q.(GBq)
Q.
Yb-169 0.002134 0 02075 6.00E-02 2.66E-08 3.98E-04 3.98E-03 0 52777 0 049773 5.25E-03 1.38E-06 2.07E-02 2.07E-01 0.93411 0.050742 5.05E-03 2.39E-06 3.59E 02 3 59E-01 0.38301 0.0575 4 25E-03 9.36E-07 1.40E-02 1.40E-01 0 43747 0.063119 3.75E-03 1.04 E-06 1.55E-02 1.55E-01 0.020578 0.093613 3.05E-03 7.59E-08 1.14 E-03 1.14E-02 0.17363 0.10978 3.05E-03 5.81 E-07 8.72E-03 8.72E-02 0.018818 0.11819 3.10E-03 6.89E-08 1.03E-03 1.035-02 0.11058 0.13052 3.20E-03 4.62E-07 6.92E-03 6 92E-02 0 21437 0.17721 3 40E-03 1.29E-06 1.94E-02 1.94E-01 0.3492 0 19705 3 60E-03 2 49E-06 3 73E-02 3.73E-01 0.001222 0.2403 3 60E-03 1.06E-08 159E-04 1.59E-03 0.017654 0.2610'7
- 3. 65E-03 1.68E-07 2 52ET03 2.52El2 0.10806 0.30773 3.75E-03 1.25E 06 1.87E-02 1.87E-01 0.001843 0.34406 3.80E-03 2 41E-08 3.61 E-04 3.61 E-03 32.01 TOTAL 1.83E-01 1.83E+00 9 88E+00 3 66E+02 3 66E-01 1.81 E+00 A-7
s APPENDIX H. PARAMETERS AND CALCULATIONS FOR DETERMINING INSTRUCTIONS TO HREAST FEEDING WOMEN.
iable B 1. Potential Doses to Hreast Feeding infants from Radiopharmaceuticals Administered to the Mother if No Interruption of Breast Feeding.
4 Dose to infant if Masimum no interruption of 5
Administered breast feeding Recommendation on Radio.
Activity' mrem Instructions interruption of breast S
pharmaceutical MCI (MBq)
Required?
feeding' l 131 Nat 150 (5550) 60,000-40,000,000 yes Complete cessation is necessary to avoid thyroid ablation in the infant 1123 Nal 0.4 (14.8) 60 no None 1-123 OlH 2 (74) 4-30 yes Interruption for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />' l-123 mlBG 10 (370) 300 yes Interruption for about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 1-125 OlH 0.01(037) 0.2 no None 1-131 OlH 0 3 (11.1) 3 20 no None Tc-99m DTPA 20 (740) 0.3-6 no None i
Tc-99m MAA 4 (148) 4-300 yes Interrupt!on for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> f
5 Maximum activity normally administered.
2 Doses are calculated in Table B-4 for the maximum administered activities shown in Column 2. If a smaller activity were administered, the doses would be proportionally smaller The doses are calculated for newborn infants; doses to one year-old infants would be less than half the doses shown. If a dose range is shown, the range is due to individual variability and measurement variability as indicated by different measurements of concentrations in breast milk as shown in Table B-3. The doses include internal doses only; external doses due to close contact during nursing were found to be small relative to the maximum of the internal dose range as shown in Table B-2.
5 The decision on whether instructions are required by 6 35.75(b) is based on the maximum value of the dose range for the newborn infant exceeding 0.1 rem.
- The duration of interruption is selected to reduce the maximum dose to a newborn infant to less than 0.1 rem, The actual doses that would be received by most infants would be far below 0.1 rem. The physician may use discretion in the recommendation, increasing or decreasing the duration ofinterruption somewhat depending on the mother's concerns about radioactivity or interruption of breast feeding.
i 5 Dose from external radiation during breast feeding, as shown in Table B-2, was considered in developing
. the recommendation.
29 NUREG 1492
e Tc-99m pertechnetate 30 (1110) 200-800 yes Interruption for about 24 l hours
! None Tc-99m DISIDA 8 (300) 4 20 no Tc-V)m 20 (740) 25 no None glucohep;onate Tc-99m IIAM 8 (300) 20-50 no None Tc-99m MIBI 30 (1110) 1 10 no None Tc-99m MDP 20 (740) 4-5 no None Tc-99m PYP 20 (740) 5-20 no None Tc 99m RBC's in 20 (740) 0.3-100 yes Interruption for about 6 vivo labeling hours Tc-99m RBC's in 20 (7 t'))
1-2 no None vitro labeling Tc-99m sulfur colloid 12 (444) 9-100 yes Interruption for about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> Tc-99m DTPA 1(37) 0.02-0.5 no None aerosol Tc-99m MAG 3 10 (370) 0.2-2 no None Tc-99m WBC's 5 (185) yes Interruption for about 24?
hours Ga 67 citrate 5 (185) 300-10,000 yes Complete cessation Cr-51 EDTA 0.05 (1,85)
<0.01 no None In 111 WBC's 0.5 (18.5)20-100 yes Interruption for about 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> 5 TI-201 3 (111)
NUREG-1492 30
Table B 2. Maximum Likely Esternal Dnses to an Infant During Hrrast Feeding with Administered Acthity and Interruption as Specified in Table B-1 Dose to infant Administerd with Interruption Radio.
Activity' interruption of Breast Feeding 2
pharmaceutical (mci (MBq))
of Breast Feeding (rem (mSv))
1 123 0111 2
(74) 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> 0.123 (1.23) 1 125 0111 0.01 (0.37)
None 0.012 (0.12) 1131 OlH 0.3 (11.1) 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> 0.073 (0.73)
Tc-99m 30 (1,110) 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> 0.01 (0.1) pertechnetate Cr-51 EDTA 0.05 (1.85)
None 0.003 (0.03)
In 111 WBC's 0.5 (18.5) 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> 0.06 (0.6)
TI201 3
(111)
None 0.056 (0.56)
' Prom Table B-1.
2 Based on an occupancy factor of 0.16 and an effective distance from source to receptor tissue of 0.2 meter.
o-Table B-3.' Biokinetic Parameters for Radiopharmaceuticals Excreted in Breast milk.
E 1 0 ra il 2 2. l le_G lS n*
"?M_A L T *' ? P
- HiQhe**
] ' f. :
hj f e re.C t 03-67 Citrate.
9.5E-5 17:)
21f T: ban
. 7ll 5 (3G; 3.
- 8"
% 4ag3 g;.;g3 g.,gt;w 5.65 5 (96)
Larson
. 0E 4 (66; Greener 4.3E-5 (41; w..ier e
3.15E-255 9.9E-255 20-390 Rubow94 Tc 99m OTPA 7.2E-7 (2.2) 15 Mount 84 t'. 0 E - 7 (2.8) 15 Mounts 5 5.0E-455 2.4E-355 6.5 30 Rutcw94
-5.DE 7
(- 3 )
9.6 Ahlgren Tc-9 9m MM 1 4E-4 (2.2) 20 MountB4 7.1E 6 t')
3.1C 4 (?)
5.2-45 F4ttsson 2.4E-5 (4) 5.3 Eerke 1,4E 4 (3.5) 12'*
Cranage 7.0E-6 ff; 12 Heaton 4 0E-355 5.2E-2Si 7.3-18 JE gren Tc 99m pertechnetate
-5.7E-6 iG.5' Ru mb'.e 2.(
-5 (10:
( 4K-E l0?
t-AA Wyburn 1.4E 4 J22) 20 Vagenakis
-1.3E-F
!3:
Pittard
' 19E-3 (2.4) 1.73-2 (2 ogunleyet
-5.0E-4 l-5) 6.9 Ahlgren 1,tK-*
to.:)
6 Houn:07 1.4E-4 (-3) 5.2 NedrickB6 I 131 NaI 1,4E 5 (24) 4.0E 5 (6)
-9.9 Nurncerger 6.7E 4 (6)
Weaver 6.6E-4
-12 vyaet (2 tw y 1.6E-5 526 model)
+
3 oE 2 (191
-5.1 TLucow
-5.0E-4 14 Robinson 11 Rooinson (2 cw.p 235 model 2.3E-iS$
11' Rubow94 2.EE-155 4 6E-155
- 7. 6 - 1 *'
Mountes
_ib cretion Freet to:m L eleoten :v:
perors,m a
dass B
- c'49 T t!1.43eD t T W (see ref) g Cr-51 EDTA 1.5E-4$$
6.5E 455 5.0-7.0 Ahlgren Tc-99m DISIDA 1.0E-355 2.BE-355 10-13.litt xucewss Tc-99m gluccheptonate 1.et-395 0.0 Rdowpa i
2.6E 6 12 M0untB7 i
Tc-99T. tW1 8.BE-355 1.1E-255
- 6. 0- t 7. 0) tt Rubow94 Tc.99m MIBI 1.4E-6 (3.3)
U R ulsvu 91 1.0E 455 2 DE-455 18-(6.7)tt Rubow94
..T 09m M0P/HDP
~1.6E-6 (-4: a.4 34 Ahlgren NUREG-1492 32 I
I
p 0
'.5E-351 4.4E-j$$
e,4.'s s,*T E,h;chs TO-99m iTF Te-5)m FLC - : n e r.m t.Jz-35; I c!-253
("
"'t?
nos- 00
- 4. ? E ? ii' iS.9?tt R0se9';
'r '
4.'
=7:+t
-Ahl;ren 3 ;;-gy.3 T P ~ 4 :* FI Z
/;t n 2-455
' E - i ; r, rp
- v+
Tc-9fm Sulphat 0011c1: 1 45-Jii SE-23:
35
+f.3'**
E.:b. 94 4
In-131 h*BO 3.3E ' !13) (65.3)t*
Maur.tB5
' 3E 7 (16) (140)11 Heselewood6B 2.4E-7 (00)
Batt I-223 Nai 2. o r. - ; s s Ic.$
Heartex 6.!E 5 1C.4 Hedrich I-123 OIH 6.0E-$
4.8 Moune.85 1.2E 0:55 3.5E-255 S.1 '0 2 Rose 1.55-4 (4) 6.3 Rose 1-;;3 mI33 r.2:-6 (e) 85 nettle 2.1E 255 4.8 Ak*pran 1.2? OIM I 131 o1M 1 9E-2SE 4.3E *iC5
- .6.0 Ahlgren T1-03; Cnloride 2.2E-(
43 Murphy 89 (2 :oT-1 SI-7 (3c;)tt partment model) 5.9E '
13 Johnston !
- m-1 1E f
('d4177 partnent modell class 0 T: 99m ETTA Aercrol tractica of admiainteaa' aercasi assumed t e s cach bloodstream (0.436) treeted as T -99m OTTA Tc-99m MAG?
Trested as Tc-99m OTPA (renal agent for which data exist)
Tc-9im kBC Treated as T:-99m pertechnetate. 5g :raetten et frey Tc-P?m is highly variable Xe-133 gas See text Feak fra:tton per ml of milk.
All values corrected to the time of activity adminis t r a-ion. The numbet in parenthes;s is una time in' at which th1=
msxinum was observed.
"Lewest' is the lowest concentration cbserved at peak, anc "nighest" as the highest concent:ntion observed as peak, in an Individual patient.
- f data frcm enly one patient are reported, they are given under the "Eighest* column.
- Pooled data free 4 patients t Patient adr.itted for study of enlarged thyroid.
Conserva-ive value chosen due to anecdotal report (neu data Conservative value chosen due to irregularities in reported (n 1) 533 total fraction excreted - milk ccocentrations not given (t)tt Ef fective half-time > T, :ndicates continued activity accumulation
- Specia:Lon tests indica-Ai that the activity excreted was most likely in the form of NAI, ngi mIBG.
6 Table B-4. Calcdated Doses to Newborn tnd 1-Ye:r-Old Infants from M _ximum Administered Dosages of
-l Radiopharmaceuticals as a Function of Breast reeding Incruption Time.
2U 9l 5' mci, min concentration. t 1/2.
inj DOS E ( b) -
- 2. 72E+02 mrem DCSI(1)
- 1. e4E+ 02 etrem Ga-67 Ci t rat e, Mc)
=
9.17E-01% of 3 tr, IffTAKE =
4.09E-02 nCi
=
INTERR.
- TIME
- 1. 098+0 2 mrem des 3t1) -
1.16E*01 mres z
ItiTERR. TIME =
24 tr, If1TAKE =
1,64E-02 sfi 3.20E-01% of in) COSE ( tt)
=
- 3. 8 4 E+01 m&se DOS 3(1)
- 1. 4 7E+01 au em 1.15E-011 of inj DOSE ( G)
IFREPR. TIME =
48 tr, INTAE =
5.77E-03 oCi
=
4.7GE+00 mrem DOS 3f1) 1.G2EaOO mrce l
e 1.43E-021 of inj DOS E ( 0 )
=
7 14E-04 mci
=
I!frERR. TIME =
96 tr, JNTAKh
=
1.67E+co prem DOSItt) -
6.42E-01 wrae 5.03E 03% of inj DOSElo) 2.51E-04 mei IffTE1H. *11ME = 320 f.t.
INTAKE
=
2.07E-01 mrem DOSI(15 7 95E - 0 2 mreen 6.23H-04% of i n,-
DOSE ( 0 )
3.11E-05 eCi
=
INTERP. TIME = 160 ir, INTAKE
=
5.32E-C5 mrer e
1.19 E- 0 4 mtem DOS 3(1) 4 17R-07% of inf DOSE (0)
=
2.00E-08 mei r
INTERR. TIME = 336 tr.
IttTAKE
=
6.17E-11 mrem DOSM1)
- 2. 3T-t 3 mrem
- 1. 85H-1 M of in-DOS E (c)
INTEPR. *11ME, 672 tr, TNTAKE -
9.278-15 eCi
=
=
'l'.
J' 5 mci, m n concen ration, t1/2:
Ga-67 Citrate, Mc )
08E+0* ent em 1.33Ee04 miem KY3M ( 1 ) -
=
- 3. 98E+ 0 h of i n, LWJS E t o )
=
3 hr, IfEAKE r 1.99E*00 sci e
1.06Fe04 mrem DOSZ41) 4 OG403 mrem INTET@. TIME
=
3.18Ee01% of is DOS E ( 0)
DUEPR. TIME =
24 hr, IfCAKE =
- 1. WE+ 0D TW.i
=
=
i IV +C f mne
= 2 4 7E * *> 1 % of in-InSE (C )
S.21E403 mrem DJS:(1) 4 1.23E+00 ed
=
48 tit,
INTAKE IrTTERR. TIME =
96 hr, I!iTAIG.
- 7. 4 0E- 01 wCi J.48E+01% of a n.
DOS E ( 0) --
4.93Fe03 mr+n r W (*1 p % 91 maem e
IITTEPR.
- I I M H 3.82Ee03 mrmu DOSE 41) t.16E + 0 3 n rem 5.73E-01 mCA
- 1 ISF+ nit ni i n, IX6 E ( 0 )
=
IITTE15. TIME - 120 hr, INTAFE 2.29E+03 mrem DOSE (t!
8.78EeD2 mrem 6 88E+0CT of ina DOSE (0)
INTEPP. TIME = 168 hr, INTAKR 8 44F-01 wCi
=
3.83E+02 mrem DOSE (1) 1 4 7E +02 mrem 1.35E+0r4 of iny DOSE ( 0)
INTERP TTME :-
16 hr,
. INTAKE s
- 5. 76 E-02 wCi
=
=
1.07E+)1 mrem DOSEt16 4 12E+0D mrem 3 2 M-On of in: DOS S ( 0)
INTEFR. TIMH = 672 hr, INTAEE -
1.61E-03 wCi
=
=
20 nCi, min con 2entration, t1/2:
Tc-99m DTPI.,
A(o)
- 3. 2 3E-31 mrr;m DOSC(li -
1 43E-02 mtem
=
- 1. 29E -03 of is,,
DOSE ( 0) 2.57E-03 mci
=
IffrRFR. TIME =
3 lir,
IffTAKE
-=
1.22E On of inj DOSEto) -
3.06E-33 mrem DOSR(11 1 1 W -n 3 m +=n
=
JNTE5R. TIME -
24 hi, IfGAME = 2 4 3 E- 05 mci
=
- 1. 49E-% mrem DOSE (1) -
6.57E-06 mrem 3rrTEFR. TIME =
40 hr.
INTAKE =
1.19E-07 roCi
- 5. 9 22 - O% of ini DOSR(0)
=
e 1 SSE-It. mren 3.52E-10 mrem DOSE (1) 1 4CE-11% of inj DOSEic) 1NTElm TIME -
96 br, INTAFS -
- 2. g nF-12 mri u
=
6. 8 C E - J 4 *. of ini DOSE (0) -- L. 71E-L2 rm em DOSE (1) - 1 55E-13 mrem INTEER. TIME e
.20 br.
INTAKE =
- 1. 36E-14 stCi
=
0 OCE+00% of inj DOSE (0) -
0.00E+30 mrem DOSE (1) 0.00E+00 mrem
=
0.00E+00 trCi INTEFR. TIME,
".68 ht, INTAKE
=
0.00E+30 mrem DOSEtt) u.ouE+00 mrem
=
- 0. OCE+ 00% of ini DOSE t e)
INTETJ. 7IME = 336 br, INTAKE -
- 0. 00E+00 mC1
=
=
O.10 E + 30 mr e m DOSE (1)
U. GOE+ 00 v tr on 0.OCE+001 of in) DOSli(C)
- 0. DOE +00 mC1 w
IITTEF R. TIME, 672 hr, INTAKE
=
= 20 cCi, mu couant r eit. ion, t1/2:
Tc-99m DTPA, A(o) 2.35E-01% of in) DOS E (0) -
6.32E40 mrem I'OeF. ( 1 1 f. 86E e GO mrm INTERR. TIME =
3 la r,
IfrTAKE -
4.708 02 enCi
=
3.29E-31 mrere DOSEil! -
I 45E-01 mrm
- 2. 61 E-0 3 mci - 1 31R.02% of in) DOSEid)
=
IrrTERP. TIME a 24 hr, IffT'tKE 4.7;E-OM of in) DOSE (On -
1.19E-02 mr ets DOSEtt)
- r. 24E -01 mtm
- 9. 41E- 05 mci INTEPD. IME -
49 hr, irrTAFE e.
6.14E-OM of in) DOSE (0) -
1.35E-05 rrrem DOSEll). r3:E46mrm
=
INTEPD. "IME =
96 hr, ItTTAKE e 1.23E-07 mci
=
5.58B-07 mrcts DOSH(1) 4G 07 nrm IITTERR. "IME = 120 hr, IttTAKE =
4.43E-09 mci 2.2 E-Ot% of iny DOSE (0)
=
- 7. ME - 10 mrem IoSE(at 3 /eE 10 mrm 2.89E-I a of inj DOS E ( 4 )
5.77E-12 mci e
If7 TERR. TIME = 168 hr, INTAFE
=
O. "JO E +0 0 mi em Dose (14 0.f;oE+no mrem
=
- rrTERR. TIME = 336 hr.
INTAKE =
0.00E+00 mC1
- U. 00t.+ 00% o' inj D3SE M) e 0.30E600 mrcm DOCE 41 )
0 001:*39 mrm 0.00E+001 o' inj IV)S E i H
- 0. OOE+ 00 rnC i
- NTEPR. "IME - 02 hr, Irr17# R
=
=
//
Te-99m MAA I. f o) - 4 mci, min c:mermtration. t1/2-4 19E*00 mrem DOSE (1) 1.t011 00 mrs_*
frTERR. TIME =
3 hr, IffTAKE -
6.66R-D'sM i 1 6AE-02% of ini (MSE t i) a 2.26E-02 mrem DOSE (1) 9 WE - U t arern 9.00H-OM of in) DOS E (-))
=
_ttrERR. TIME =
24 ir, INTAKE =
L60H-05 mC)
=
5.91E-05 mrem DOSE (1) 2 KR
.y, mretu 2.31E-OM of inj DOSE (Te INTERR. TIME -
48
.ir, INTAKE -
9.23F-08 nCi
=
=
3.92E-10 mrem DOSE (1) 1 *W t o mi m 1.52E-11%
o_*
inj DOSE (1)
IFTTERR. TIMH =
96 3r, INTAKE =
6.07E-13 mci
=
=
9.59E-13 mrem DOSE (1) 3 9 % 11 mr ee 3.85E in of inj WS E ( 3)
=
INTEPR. TIME = 120.ir, INTAKE =
1.54E-15 mci
=
.. ~- -
--.-~ ~.-.
, -. - - ~.. -. -.., _ - - - - - - -.
O
.s uh hh hhhhh h.hkhhhhh h.u h hh h
h h
h.
khh uwwwwu
~
-8 u
a
~~~u.euw.
unusFWfE EEED$EEE EEEE6 EEL 66EEEOE5
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INTAKE.
0.00E-00 ' nCi
=
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9.33E,00 mreau DOS 8: 11:
4 ME* cc mt em
=
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3 br, IfTTAKE
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=
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2.11E-02 miem DOM (1)
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24 hr,
' INTISH
=
=
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=
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2 Oul+*1U mten f
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=
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INTERR. TIME = 672 he,-
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12' mci, max concentration, t1/2:
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7.26F+01 mrtw DOSI(1) -
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3.0SE-02 mci
=
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24 1.s,
INTAKE
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48 t. r, ' INTAKE -
4.12 E-0 3 mci ' -
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5.53E-02 m:em DOSU11
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96 f.r.
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3.65E-0 3 tares
' INTEFR. TIME e 120 hr,.
If7TAKE =
1.OIE-05 inci
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=
tr.64E-m mr en
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=
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1.48E-13 TCi
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6.21E 04 nCi 1.24E-031,;l i ni; te:R(01 t-i L.72H+31 mrem DOSE (1)
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-24 hr,
'INTAFE -
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48 hr.
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4.30E-04 mci
=
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5.8 E-02% of in: DOSE (0)
INTEPR. '"TME =
96 hr.
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=
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=
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=
e
=
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' 5. _t ?R - 111. mree
[
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4. J L E- % mC t.
4 4aC n2 er.m l
=
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i INTERR. "1ME = 612 hr.
IHTAKE -
2.66E-06 mci
=
I
=
i In-111 wec Atot
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7 l
INTEPR. TIME -
I hr, IrrrAK E =- 3 10E-o f raCi ' -
6.19E-03 ol inj DOSE Hf -
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[
9.19E+G1 surets DOSE (1)
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4 ATTACHMENT 4 FINAL ENVIRONMENTAL ASSESSMENT l
c-ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT ON AMENDMENTS OF 10 CFR PARTS 20 AND 35 ON
" CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADI0 ACTIVE MATERIAL" Stewart Schneider and Stephen A. McGuire Office of Nuclear Regulatory Research V. S. Nuclear Regulatory Commission May, 1995 1.
THE PROPOSED ACTION The Nuclear Regulatory Commission (NRC) is amending its regulations in 10 CFR Parts 20 and 35 concerning criteria for the release of patients administered radioactive material. The amen.dments permit licensees to authorize the release from licensee control of patients administered radiopharmaceuticals or permanent implants only if the dose to total dacay to an individual exposed to the released patient is not likely to exceed 5 millisieverts (0.5 rem).
II.
NEED FOR THE RULEMAKING ACTION This action is necessary to respond to three petitions for rulemaking.
The petitions were submitted by Dr. Carol S. Marcus, by the American College of Nuclear Medicine (ACNM), and by the American Medical Association (AMA).
NRC's current patient release criteria in 10 CFR 35.75, " Release of patients containing radiopharmaceuticals or permanent implants," are as follows:
"(a) A licensee may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either:
(1) The measured, dose rate from the patient is less than 5 millirems per hour at a distance of one meter; or (2) The activity in the patient is less than 30 millicuries; (b) A licensee may not authorize release from confinement for medical care of any patient administered a permanent implant until the measured dose rate is less than 5 millirems per hour at a distance of one meter."
On May 21,1991 (56 FR 23360), the NRC published a final rule that amended 10 CFR part 20, " Standards for Protection Against Radiation." The rule contained a dose limit of 1 millisievert (0.1 rem) (total effective dose equivalent) for members of the public in 10 CFR 20.1301(a). When 10 CFR part 20 was issued, there was no discussion in the supplemental information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.
DRAFT: May 26, 1995 1
o i
Because some licensees were uncertain about what effect the revised 10 CFR part 20 would have on patient release criteria, three petitions were received on the issue. On June 12, 1991 (56 FR 26945), the NRC published in the Federal Reaister a notice of receipt of, and request for comment on, a petition for rulemaking (PRM-20-20) from Dr. Carol S. Marcus.
The petition requested the NRC to amend the revised part 20 and 10 CFR 35.75 to raise the annual radiation dose limits to members of the public from 1 millisievert (0.l' rem) to 5 millisieverts (0.5 rem) from patients administered radioactive materials.
In addition, Dr. Marcus submitted a letter dated June 12, 1992, further characterizing her position. On March 9, 1992 (57 FR 8282), the NRC published a notice of receipt and request for comment in the Federal Reaister for a similar-petition for rulemaking (PRM-35-10) from the ACNN. On May 18.1992 (57 FR 21043), the NRC published in the Federal Reaister r.otice of an amendment submitted by the ACNM to its original petition (PTE-35-10A).
In addition, the ACNM submitted two letters dated September 24, 1991, and October 8, 1991, on the issues in their petition.
On July 26, 1994 (59 FR 37950) the NRC published in the Federal Register a petition from the AMA requesting that patient release be regulated by Part 35 rather than Part 20.
On June 15, 1994, the NRC published a proposed rule on criteria for the release of patients administered radioactive material in response to the petitions (59 FR 30724). The Federal Register Notice for the proposed rule discussed the public comment letters received on the first two petitions.
l Three comment letters, each supporting the petition, were received on the third petition (PRM-35-11), but these letters did not contain any additional information not covered by the letters on the first two petitions.
The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically state that the dose to individual members 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 was to clarify that the Commission's policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301.
III. ALTERNATIVES CONSIDERED To evaluate the issues raised by the petitioners and the members of-the public who commented on the requests made by the petitioners and the proposed rule,.the NRC has determined that the following alternatives merit evaluation:
e Alternative 1:
1 millisievert (0.1 rem) total effective dose equivalent In this alternative, the 1 millisievert (0.1 rem) per year dose limit in 10 CFR 20.1301(a) is evaluated as the controlling criteria for determining when a patient may be released from the licensee's control.
e - Alternative 2:
< l.110 megabecauerels (30 millicuries) or
< 0.05 millisievert (5 millirems)/hr at I meter In this alternative, the existing patient release' criteria in DRAFT: May 26, 1995 2
o 10 CTR 35./5 are evaluated as the controlling requirement for determining when a patient may be released, e Alternative 3:
5 millisieverts (0.5 rem) total effective dose eauivalent)
In this alternative, a dose limit of 5 millisieverts (0.5 rem) for determining when a patient may be released is evaluated.
IV.
ENVIRONMENTAL IMPACTS OF THE PROPOSED ACTION AND TllE ALTERNATIVES The alternatives were evaluated in the regulatory analysis done for the rulemaking (Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Materials, Final Report, Stewart Schneider and Stephen A. McGuire, NRC report NUREG-1492, 1995).
The regulatory analysis found that there would be no need to retain patients due to any diagnostic procedure under any of the alternatives. Only about 62,000 therapeutic procedures per year, mostly using iodine-131, would be potentially affected.
The costs of the alternatives for the affected therapeutic procedures are presented in Table 1.
For details of how the results were calculated, the regulatory analysis should be consulted.
Table 1 impacts of Alternatives 1,2, and 3 Cost Estimates Hospitalization Value of Hecord Collective Hospital cost lost time kuping Psycholo0 cal l
Dose Retention 4
4 cost Alternative (person rem)
(days)
(millions)
(millions)
(millions)
(relative) 1 18,400 140,000 140 8.4 0
High 2
51,400 20,000 20 1,2 0
Moderate 3
60,400 10,000 10 0.6 0.3 Low As set forth in more detail in the Regulatory Analysis, Alternative 3 is favored for the following reasons:
1.
All of the Alternatives are acceptable according to generally accepted radiation protection principles, as those expressed by NRC, NCRP, and ICRP, as discussed in Section 4.4 of the Regulatory Analysis.
2.
Alternative 1 is considerably more expensive to the public compared to Alternative 2 (the status quo) or Alternative 3.
Even neglecting the psychological costs, which have not been expressed in dollar terms, the additional cost of Alternative 1 relative to Alternative 2 is about
$126,000,000 per year, mostly in increased national health care costs.
The value of the dose savings at a value of $1,000 per person rem is DRAFT: May 26, 1995 3
e-o.
i
$33,000,000 per year.
In view of this, Alternative 1 may be dismissed.
3.
Alternative 3 relative to Alternative 2_has a_value of $10,300,000 per year, mostly in lower health care costs at a collective' dose cost of
$9,00,000 per year. Alternative 3 Liso has psychological benefits to-patients and their families. 'Thus, Alternative 3 appears cost effective in comparison with Alternative 2.
4.
Basing the patient release criteria in 10 CFR 35.75 on the dose to individuals exposed to a patient provides a consistent,- scientific basis for such decisions that treats all radionuclides on a risk-equivalent basis. The dose delivered by an initial-activity of 30 millicuries or a dose rate at_1 meter of 5 millirems per hour varies greatly from one radionuclide to another. Thus, while the values _in_ the current 10 CFR 35.75 may be appropriate for iodine-131, they are too high for some l
other radionuclides and too low for others.
5.-
A dose-based rule no longer restricts patient release to a specific l
activity, and therefore would permit the release of patients with activities that are greater than currently allowed. This.is especially true when case-specific factors are evaluated to more accurately assess the dose to other individuals.
For the case of thyroid cancer, in those a
i cases occasional where multiple administrations in a year of 1,110 millisieverts (30 millicuries) or less of iodine-131 are now administered to a patient, it may be-possible to give all of the activity in a single administration. -This would reduce the potential for repeated exposures to hospital staff and to those providing care to i
the released patient. Additionally, this would provide physicians with the flexibility to not have to fractionate doses to avoid hospitalization to meet the current requirements, which.may lead-to a 4
more effective treatment, i
6.
Shorter hospital. stays provide emotional benefits to patients and their i
families. Allow-ing earlier reunion of families can improve the patient's state-of-mind,- which in itself may improve the outcome of the treatment and lead to the delivery of more effective health care.
For the purpose of evaluating the environmental impact of the proposed
-action,.the proposed action (Alternative 3) is compared to the impact of the existing patient release criter_ia, the status quo (Alternative 2).. The impacts can be-seen. in Table 1 above. The estimated change in the collective dose-is balanced by decreased hospitalization costs and psychological benefits to the patient and the patient's family. The environmental impact of the preferred Alternative 3 is not considered significant because the change is small: relative to the existing impact (under Alternative 2) and the change is balanced by the' benefits.
DRAFT: May 26, 1995 4
V.
FINDING 0F NO SIGNIFICANT IMPACT The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of
(
10 CFR Part 51, that the amendments are not a major Federal action I
significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required. The Commission believes these amendments would result in benefits for patient care while coe.inuing to adequately protect public health and safety.
As can be seen a Table 1, there will be no significant change in radiation exposure to the public or to the environment due to the proposed Alternative 3 beyond the exposures currently resulting from the medical use of radioactive material (Alternative 2).
VI.
LIST OF t.GENCIES AND PERSONS CONSULTED The NRC has held public meetings concerning the release criteria for patients receiving radioactive material for medical use. Appropriate suggestions from the meetings have been incorporated in the proposed amendments. The following table lists the date, location, and the groups represented at each meecing.
Public Meetinas Held Date location Groups Represented 07/15/92 Atlanta, GA Agreement States: AL, AR, AZ, CA, 00, FL, 07/16/92 GA, IL, KS, KY, LA, MD, NC, ND, NE, NH, NV, NY, OR, SC, TX, UT, WA, and NY City 10/24/92 Tempe, AZ Agreement States: AL, AR, AZ, CA, 00, FL, 10/25/92 GA, IA, IL, KY, LA, MD, MS, NC, ND, NE, 10/26/92 NH, NV, OR, RI, SC, TN, TX, UT, WA, and 10/27/92 NY City 10/94 Portland, ME Agreement States 10/22/92 Rockville, MD Advisory Committee on the Medical Uses of 10/23/92 Isotopes (ACMUI) 05/03/93 Bethesda, MD 05/04/93 11/01/93 Reston, VA 11/18/04 Rockville, MD 05/12/95 Rockville, MD Much of the statistical and technical information required for this assessment is not available in the open literature.
In such instances, information was obtained directly from technical experts.
The following individuals are acknowledged for their cooperation and contribution of technical information and data:
R. Atcher, PhD, Radiation and Cellular Oncology Department., University DRAFT: May 26, 1995 5
9
'o of Chicago,-Chicago, IL D. Flynn, M.D.,- (NRC Advisory Committee on Medical Use of Isotopes)
Massachusetts General Hospital,-Boston, MA W.R. Hendee, PhD, Dean of Research, Medical College of Wisconsin, Milwaukee, WI C. Jacobs, President, Theragenics, Norcross, GA F.A. Mettler, M.D., Department of Radiology, University-of New Mexico, School of Medicine, Albuquerque, NM K.L. Miller, CHP, Professor of Radiology and Director, Division of Health Physics, Milton Hershey Medical Center, Hershey, PA R. Nath, PhD, Professor of Yale University, School of Medicine, and President of the American Association of Nuclear Physics, New Haven,.CT M.P. Nunno, PhD, CHP, Cooper Hospital, University Medical Center, Camden, NJ-P. Paras, PhD, Food and Drug Administration, Center for Devices and Radiology Health, Rockville, MD M. Pollycove, M.D., Visiting Medical Fellow, U.S. Nuclear Regulatory Commission, Rockville, MD' G.E. Powers, PhD, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Rockville, MD M. Rosenstein PhD, Food and Drug Administration, Center for Devices and Radiology Health, Rockville, MD B. A. Siegel, M.D.,
(Chairman, NRC Advisory Committee on Medical Use of i
Isotopes) Director, Division of Nuclear Medicine, Mallinckrodt Institute-of Radiology, Washington University Medical Center, St. Louis, M0 J. St.Germain, Radiation. Safety Officer, Memorial Sloan Kettering, New i
York City NY
.M.G. Stabin, PhD, CHP, Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, 0ak Ridge, TN D. Steidley, PhD, CHP,. Medical Health Physicist, Department of Oncology, St. Barnabas Medical Center, Livingston, NJ J. Stubb, PhD, Radiation Internal Dose Information Center, Oak Ridge-Institute for Science and Education, Oak Ridge, TN-
.K. Suphanpharian, PhD, President, Best Industries, Springfield, VA DRAFT: May 26, 1995 6
o R.E. Toohey, PhD, Director, Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, Oak Ridge, TN DRAFT: May 26, 1995 7
o k
i ATTACHMENT 5 DRAFT CONGRESSIONAL LETTERS
DRAFT CONGRESSIONAL LETTER
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a public annouacemant and a final amendment to 10 CFR Parts 20 and 35 dealing with criteria to: the release of patients administered rcdioactive materials.
Mughly 8 to 9 million medical diagnostic and therapeutic administrations of radioactive material are performed in the United States each year.
The rule is largely in response to three petitions-for-rulemaking that were submitted by the medical community because of concerns that the NRC's recent amendments of its regulations in Part 20, " Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus increase national health care costs.
The rule mLkes it clear that the release of patients administered radioactive materials continues to be regulated by the requirements in NRC's Part 35, Ndical Use of Byproduct Naterial." khile the comments of the medical cc a. unity on the proposed rule wers generally supportive, they objected strongly to one of the recordkeeping requirements contained in the proposed rule.
Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary to provide for adequate protection of public health and safety.
Sincerely, Dennis K. Rathbun Director Office of Congressional Affairs
Enclosures:
1.
Public Announcement 2.
Federal Register Notice cc:
Representative g
DRAFT:
April-20, 1995 Attschment 5
1 o
ATTACHMEi1T 6 DRAFT PUBLIC ANNOUNCEMENT l
l l
i o
DRAFT PUBLIC ANNOUNCEMENT NRC REVISES REGULATIONS ON RELEASE OF PATIENTS ADMINISTERED BYPRODUCT MATERIAL The Nuclear Regulatory Comission (NRC) is amending its regulations governing the release of patients from a hospital or other licensed medical facility after they have received radioactive material for treatment or d
diagnostic purposes. The revisions respond to three petitions received on this subject.
Radioactive pharmaceuticals or radioactive implants are administered to approximately 8 to 9 million patients in the United States each year for diagnosis or treatment of disease. These patients can expose other persons around them to radiation until the radioactive material has been excreted from their bodies or has become less intense due to radioactive decay.
Under the final rule, licensees may not atthorize the release of patients if the estimated dose, to the individual 'ikely to receive the highest dose from exposure to the patient, is likely to be greater than 500 millirems in any one year.
(Typical natural background radiation in the United States is 300 millirems per year.) The t.ew criteria are consistent with the recomendations of the National Council on Radiation Protection and Measurements and the International Comission on Radiological Protection.
Current NRC requirements on release of patients containing radioactive material are contained in Part 35 of the Comission's regulations. Medical licensees'are not permitted to authorize the release of patients to whom nuclear material has been administered until either (1) the measured dose rate DRAFT:
June 1, 1995
from the patient is less than 5 millirems per hour at a distance of 1 meter or (2) the radiopharmaceutical content of the patient is less than 30 millicuries.
l In addition, the Commission's previously issued new radiation protection 1
standards, which are contained in Part 20, limit the dose to individual members of the public from an NRC-licensed operation to 100 millirems per year. However, when the new Part 20 was issued, there was no discussion on whether or how it was intended to apply to the release of patients, in adopting the new Part 20, the Commission did not intend it to supersede the medical use regulations in Part 35.
This rule therefore amends Part 20 to exclude doses to individuals exposed to released patients.
Release of patients containing radioactivity is instead governed by the more explicit requirements of a revised Part 35, which include, in addition to the 500-millirem per year limit, a requirement that, if the annual dose to an individual exposed to the patient is likely to exceed 100 millirems, the licensee would have to provide the patient with written instructions on how to maintain doses to other individuals as low as reasonably achievable.
The revisions partially grant three petitions for rulemaking on criteria for release of patients who have been administered radioactive material.
On June 12, 1991 March 9, 1992, May 18, 1992, and July 26, 1994, the NRC published Federal Register notices concerning receipt of the petitions from Dr. Carol S. Marcus, the American College of Nuclear Medicine, and the American Medical Association.
The final rule reflects public comments received on the proposed rule.
The rule will be effective 90 days after publication in the Federal Register.
DRAFT: May 17, 1995
I 9
4 l
4 ATTACHMENT 6 DRAFT PUBLIC ANNOUNCEMENT 4
C 0
DRAFT PUBLIC ANNOUNCEMENT NRC REVISES REGULATIONS ON RELEASE OF PATIENTS ADMINISTERED BYPRODUCT MATERIAL The Nuclear Regulatory Commission (NRC) is amending its regulations governing the release of patient:. ?ti < hospital or other licensed medical facility after they have received 6.;;4tive material for treatment or diagnostic purposes. The revisions respond to three petitions received on this subject.
Radioactive pharmaceuticals or radioactive implants are admini'stered to approximately 8 to 9 million patients in the United States each year for diagnosis or treatment of disease.
These patients can expose other persons around them to radiation until the radioactive material has been excreted from their bodies or has become less intense due to radioactive decay.
Under the final rule, licensees may not authorize the release of patients-if the estimated dose, to the individual likely to receive the highest dose from exposure to the patient, is likely to be greater than 500 millirems in any one year.
(Typical natural background radiation in the United States is 300 millirems per year.) The new criteria are consistent with the recommendations of the National Council on Radiation Protection and Measurements and the International Commission on Radiological Protection.
Current NRC requirements on release of patients containing radioactive material are contained in Part 35 of the Commission's regulations. Medical licensees are not permitted to authorize the release of patients to whom nuclear material has been administered until either (1) the me m red dose rate DRAFT:
June 1, 1995
4 from the patient is less than 5 millirems per hour at a distance of 1 meter or (2) the radiopharmaceutical content of the patient is less than 30 millicuries.
In addition, the Commission's previously issued new radiation protection standards, which are contained in Part 20, limit the dose to individual members of the public from an NRC-licensed operation to 100 millirems per I
year. However, when the new Part 20 was issued, there was no discussion on whether or how it was intended to apply to the e of patients.
v in adopting the new Part 20, the Commissi
^ not intend it to supersede the medical use regulations in Eart 35.
This rule therefore amends l
Part 20 to exclude doses to individuals exposed to released patients.
Release of patients containing radioactivity is instead governed by the more explicit requirements of a revised Part 35, which include, in addition to the 500-millirem per year limit, a requirement that, if the annual dose to an individual exposed to the patient is likely to exceed 100 millirems, the licensee would have to providc the patient with written instructions on how to maintain doses-to other individuals as low as reasonably achievable.
The revisions partially grant three petitions for rulemaking on criteria for release of patients who have been administered radioactive material. On June 12, 1991, March 9, 1992, May 18, 1992, and July 26, 1994, the NRC published Federal Register notices concerning receipt of the petitions from Dr. Carol S.- Marcus, the American College of Nuclear Medicine, and the
- American Medical Association.
The final rule reflects public comments received on the proposed rule.
The rule will-be effective 90 days after publication in the federal Reoister.
DRAFT: May 17, 1995
0 o
l l
l ATTACHMENT 7 OMB SUPPORTING STATEMENT
[7590-01)
NUCLEAR REGULATORY COMMIS$10N 09cuments Containing Reporting or Recordkeeping Requirements; Office of Management and Budget (OMB) Review l
AGENCY': Nuclear Regulatory Commission (NRC).
ACTION: Notice of the OMB review of information collection.
SUMMARY
The Nuclear Regulatory Commission has recently submitted to OMB for review the following proposal for collection of information under the provisions of the Paperwork Reduction Act of 1980 (44 U.S.C. Chapter 35).
1.
Type of submission, new, revised, or-extension:
Revision.
2.
The' title of the information collection:
Final amendments of 10 CFR 35.75, " Criteria for the Release of Individuals Administered Radioactive Material."
3.
The. form number if applicable:
Not applicable.
DRAFT: May 26, 1995-
-0 e
t 4.
How often is the collection required: On occasion; when the release of a patient is-based on other than standard assumptions or requires-interruption of breast feeding to meet the 5 mil 11 sievert (0.5 rem) dose limit.
5.
Who will be required or asked to report:
Medical licensees administering radiopharmaceuticals and permanent implants and releasing patients under the provisions of 10 CFR 35.75.-
6.
An estimate of the number of respondents:
Approximately 1,350 NRC and Agreement State licensees.
7.
An estimate of the number of hours annually needed to complete the requirement or request:
29,036 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> (includes NRC and Agreement State licensees).
8.
The average annual burden per respondent:
22.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />.
9.
An indication of whether Section 3504(h), Pub. L.96-511
' applies: Applicable.
10.
Abstract: The Nuclear Regulatory Commission (NRC).is amending the criteria for release of individuals administered radioactive material under 10 CFR Part 35.
The amendment requires the licensee to provide the patient with written instructions'on how to maintain doses to other DRAFT:
May 26, 1995 D
a.
individuals as low as reasonably achievable and to maintain a record of the released patient and the calculated total I
effective dose equivalent to the individual likely to j
receive the highest dose if the release is authorized using other than standard assumptions or requires interruption of breast feeding.
These requirements are necessary to ensure adequate protection of the public health and safety and that doses to other individuals are maintained as low as l
reasonably achievable, i
Copies of the submittal may be inspected or obtained for a fee from the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Comments and questions can be directed by mail to the OMB reviewer:
Troy' Hillier Office of Information.and Regulatory Affairs (3150-0010)
NE08-3019 Office of Management and Budget Washington, DC 20503 Comments may also be communicated by telephone at (202) 395-3084.
The NRC Clearance Officer is Brenda Jo. Shelton, (301) 415-7232.
i i
DRAFT:. May 26, 1995 i
s
(e o
i l
l l
Dated at Rockville, Maryland, this day of
, 1995, i
l for the Nuclear Regulatory Commission.
l Gerald f. Cranford, Designated Senior l
Official for Information Resources Management.
DRAFT: May 26, 1995
r e c> _
OMB SUPPORTING STATEMENT FOR 10 CFR PART 35,
" Criteria for the Release of Individuals Administered Radioactive Material" (3150-0010)
Description of Information Collection
'This clearance package covers the recordkeeping-and reporting requirements of amendments to 10 CFR Part 35, " Medical Use of Byproduct Material," 5 35.75, i
+
" Release of individuals containing radiopharmaceuticals or permanent l
t implants." The existing i 35.75 contains no information collection -
requirements. The revision to i 35.75 incorporates the information collection 1
required below.
[
t The information collection requirements in the proposed rule were submitted to 0MB and approved under 0MB control number 3150-0010. The entire collection is being resubmitted at the final rule stage because of some minor changes in the information collections.
S A.
JUSTIFICATION The amendment of i 35.75 revises the criteria for authorizing the release of patients administered radioactive material for medical use under DRAFT: May 26,'1995 i
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10 CFR Part 35 to permit a maximum annual dose of 5 millisieverts (0.5 rem) to an individual member of the public, requires written instruction on how to maintain doses to other as low as is reasonably achievable is the dose to an individual exposed to a released patient is likely to exceed 0.1 rem, and establishes recordkeeping requirements when the release is authorized using other than standard assumptions or requires interruption of breast feeding.
l.-
Need for the Collection of Information The information collection requirements of the amendments to 10 CFR Part 35 are identified below, n 35.75 Release of oatients containina radiopharmaceuticals or permanent implants.
Paragraph (b) of this section requires licensees to provide, upon release, the patient with written instructions on how to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 mil 11 sievert (0.1 rem).
The instructions should be specific to the type of treatment given and may include additional information regarding individual situations. The instructions should include a contact and phone num!:er in case the patient has any questions.
Instructions should include, as appropriate:
(1) maintaining distance from individuals, including sleeping arrangement: and the need to avoid public transportation; (2) the need to stop breast feeding; (3) minimize time in public places (such as grocery stores, DRAFT: 'May 26, 1995 2
i I
shopping centers, restaurants, and sporting events); (4) hygiene; and (5) the length of time precautions should be taken.
Written instructions are needed I
to provide a reference'available after the patient's release, if questions regarding patient care arise and to reduce the chance of misunderstanding the licensee's instructions as verbal instructions may not be properly conveyed to persons not present at the time of release.
The written instructions are also necessary to permit the NRC to verify the type of instructions given to patients.
Paragraph (c) of this section requires licensees to maintain, for three years, a record of the released patient and the calculated total effective dose equivalent to the individual likely to receive the highest dose if the release
'is authorized using other than standard assumptions.
The records are necessary so that the NRC inspector can review the method for calculating the i
dose to determine that the method is acceptable to the NRC.
)
Paragraph (d) of this section requires licensees to maintain for_3 years, a record of the instructions given to a breast-feeding woman if the administered activity would-be likely to result in a total effective dose equivalent to the breast-feeding child exceeding 5 millisieverts (0.5 rem),-assuming no interruption of breast feeding.. The records are necessary so that the NRC inspector can verify the type of instructions given to the breast-feeding woman to determine that the interruption time is acceptable to the NRC.
DRAFT:
May 26, 1995 3
(4 l
2.
agency Use of Information i
Records kept, and written instructions provided by the licensee, will be used by NRC inspectors to evaluate compliance with NRC regulations to assure that
-the public health and safety are protected.
3.
Reduction of Burden Throuah information Technoloav l
NRC encourages licensees to utilize any technology which would reduce the burden of recordkeeping and reporting. Archival storage of (1) surveys and prospective evaluations and (2) the content of written instructions lend themselves readily to the use of automated information technology.
4.
Effort to identify Duolication
-The Information Requirements Control Automated System (IRCAS) was searched for dup 1_ication, and none_was found.
5.
Effort to Use Similar Information There is no similar information available to the NRC.
l 6. --
Effort to Reduce Small Business Burden DRAFT: _May 26, 1995 4
The NRC believes that there is no way to reduce the burden on small businesses by less frequent or lesh complete records while maintaining the required level of safety.
7.
Consecuences of less Freauent Collection The consequences of less frequent recordkeeping and reporting would be that there would be no basis for demonstrating compliance with the required level of safety through the NRC inspection program.
8.
Circumstances Which Justify Variation from OMB Guidelines There are no variations from OMB guidelines.
9.
Consultation Outside the Aaency A public meeting to discuss the concepts and approaches of a previous version of the proposed rule with representatives of the Agreement States was held in July 1992 and October 1993.
In addition, a draft rule package was sent to the Agreement States for their review and comment in July 1993.
The final rule was discussed with the States at a meeting in October, 1994.
The proposed rule was also discussed with the Advisory Committee on Medical Uses of isotopes (ACMul) during public meetings held in October 1992. May 1993, and November 1993. The final rule was discussed with the ACMV1 in November,1994 and May, 1995.
The Agreement States and the ACMUI were generally supportive of the approach in the rule.
DRAFT: May 26, 1995 5
10.
Confidentiality of information No information normally considered _ confidential is requested.
11.-
Justification of Sensitive information q
No sensitive information is requested under these regulations.
{
12.-
Estimated Annual Cost:to the Federal Government p
l The estimated burden-on the NRC to review records is estimated to be 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> per.NRC licensee per year, or 450 hours0.00521 days <br />0.125 hours <br />7.440476e-4 weeks <br />1.71225e-4 months <br /> for all NRC licensees. At-a cost of $132 per hour, the annual cost to NRC is $59,400 annually. This cost is fully recovered through fee assessments to NRC licensees pursuant _to 10 CFR Part 171.
13.
Estimate of Burden The total burden to provide instructions and maintain release records is estimated to be about 22.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per licensee annually, or a total of approximately 29,036 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> annually _for.all 1,350 NRC and Agreement State medical-use of_ byproduct material licensees.
See attached table for details.
14.
Reasons for Chance in Burden DRAFT: May 26, 1995 6
u
l The amendment adds recordkeeping and reporting requirements to 10 CFR 35.75 to protect individuals likely to be exposed to patients administered radiopharmaceuticals or permanent implants, for demonstrating compliance with the annual limit for individuals due to the release of patients administered radioactive material.
15.
Publication for Statistical Use There is no application to statistics in the information collected.
There is no publication of this information.
B.
00llt'CT10NS OF INFORMATION EMPl.0VING STATISTICAL HETH005 Not applicable.
DRAFT: May 26, 1995 7
Table 1.
Reporting Requirements No. of Procedures I
Requiring Written Instructions Hours Per Total Burden Section Per Year Procedure Hours 35.75(b) exceeding default table 62,000 0.17 10,333 breast-feeding mothers 58.000' O.17 9.860 l
Recordkeeping Requirements No. of Procedures Hours Per Total Burden Section Per Year Licensee Hours 35.75(c) 5,000' l.00 5,000 35.75(d) 15.370 '
O.25 3.843 r
Total burden - 29,036 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> or 22.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per licensee (29,036 + 1,350) at a cost of $3,832,752 ($132 x 29,036).
NCOi f
28,000,000 administrations x 0.5 female fraction x 0,58 child-bearing agex0.05 breast-feeding (58,000.
' Assuming 50% of iodine for thyroid cancer patients released on the basis of case-specific calculations.
'(60,000 iodine + 1,000,000 Tc-99m pertechnetate, x 0.5 female x 0.58 I
child-bearing age x 0.05 breast feeding = 15,370.
DRAFT: May 26, 1995 8
i
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