ML20141J265
| ML20141J265 | |
| Person / Time | |
|---|---|
| Issue date: | 06/07/1995 |
| From: | St Mary B NRC |
| To: | Mcguire S NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-059, AE41-2-59, NUDOCS 9708150209 | |
| Download: ML20141J265 (212) | |
Text
{{#Wiki_filter:_ _ _ . _ , From: Beth C. St. Mary (BCS) To: SAM 2 Date: Wednesday, June 7,1995 4:03 pm ,
Subject:
RULE CONCURRENCE Steve,
- IRM concurs in the final rulemaking, *Critetia for the Release of Individuals Administered Radioactive Material," subject to the following changes.
( .
, Change the PRAS to the enclosure. The burden reflected in the PRAS also appears to g
l need revision as it currently reflects the burden for the proposed rule and has changed. -- Change section 35.8 to the enclosure. Since the time the proposed rule was published, a final rule has become effective that changes the sections containing information dug collections. I have not yet reviewed the OMB clearance package, but I will send you comments as soon the review is complete. If you have any questions, please e-mail me at BCS or phone me at 415 5878. CC: BJS1 Files: P:\PRAS, P:\OMBPT35
,0 QO'T cfg6, 9708150209 970807 PDR PR 20 62FR4120 PDR ,.
.~
SECY PAPER DISTRIBUTION , Rev. 07/11/95 POLICY- . MEETING SECY RULEMAKING \ AFFIRMATION ADJUDICATORY _ NOTATION Reviewed By NEGATIVE CONSENT NOTE: Classified - (1) to each 4 Comission office, OGC (2), INFORMATION SECY (3), & Central Files (1)
- CLASSIFICATION I
l CHAIRMAN JACKSON (3) (2 for INFO) _ _ EXECUTIVE DIRECTOR FOR OPERATIONS (3) 3 COMMISSIONER ROGERS (3) DEPUTY EXECUTIVE DIRECTORS (2) b COMMISSIONER (3) ADM (1) (2)* COMMISSIONER (3) OC (4)- ' COMMISSIONER (3) IRM (3) (4)* - SECY (10-14) (80 For Mtg) AEOD (5) OGC (17) (7 For ADJ) NRR (12) 5 0FFICE OF CAA (1/4) NMSS (5) .5 OIG (3) RES (12) 5 PA (2) OE (1) l IP (5) OI (2) CA (2) SP (3) ACRS (20) OP (2) ACN'l (10) SBCR (1) ASLBP (4) DOCUMENT CONTROL DESK (1) FILESCENTER(1) I 4 REGIONAL OFFICES: (C&R BRANCH, SECY) RI - King of Prussia (2) RII - Atlanta (2) RIII - Chicago (2) ' RIV - Dallas (2) TOTAL NUMBER OF COPIES
*If Rulemaking RETURN ORIGINAL T0:
9 __ a
pt d MC y- /*, UNITED STATES J- * -]t NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 4 001
/
March 12, 1996 MEMORANDUM 10: Hugh L. Thompson, Jr., Deputy Executive Director for Nuclear Materin13 36Tety, Safeguards l and Operations Support - Office of the Executive Director for Operations FROM: David L. Morrison, Director f .- Office of Nuclear Regulatory Research /
SUBJECT:
' REVISED FINAL RULEMAKING PACKAGE - CRITERIA FOR THE RELEASE 0F INDIVIDUALS ADMINISTERED RADI0 ACTIVE MATERIALS (PARTS 20 AND 35) Attached is the Commission paper and its attachments on the subject final rulemaking. The Regulatory Analysis (RA) has been revised in accordance with the recent changes to the RA guidelines.- Conforming changes have also been made to the Federal Register Notice (FRN) and the Environmental Assessment (EA). There are no changes in the staff paper, except -for adding a footnote on the first page, and other attachments. In the revised RA, the staff used $2,000 per person-rem instead of $1,000. In addition, the staff used effective half-life instead of physical half-life.
~ Since effective half-life includes biological elimination, its use results in more realistic estimates- of exposures to the patient's family members. In fact, these exposures are now estimated to result-in a-collective dose which is about one third of that previously estimated.
Specifically, as compared to the status quo, the savings in hospital costs was estimated at $14 million, whereas the collective dose would be increased by about 2,700 person-rem which-corresponds to a cost of about $5 million based on $2,000 per person-rem. *
-The revised cost-benefit analysis indicates that almost all patients who
-receive rad _iopharmaceutical therapy may be released from the hospital immediately if the physician elected to perform a case-specific calculation to show compliance with the dose-based release criteria. -Any individual -
associated with the patient's family would be unlikely to receive a dose of 500 mrem within a-year. Marked up sheets of the FRN, RA, and EA showing significant changes are attached under " BACKGROUND." Attachments: 1
- 1. Commission paper w/atts &-disk-
- 2. Marked up sheets--
.}. .
u
NUREG.1492 Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material
- Final Report n
l Prepared by: Stewart Schneider and Stephen A. McGuire Omce of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission Washington, D.C. 20555 M cap; C9
- [goed
- li
, y:
r a ,, a '
,+ ~v... t.n_.
April 23,1996 NUREG-1492
d infant (section 4.2.4.3) , 4 _lmoact on breast-teedina woman an Original RA: Some discussion. Revised RA: Expanded discussion. t 2.
- 5. Chanaes in Cost and benefLt estimates Decrease in Hospital Cost increase in Collective Dose __....__._____..........-
person-rem $1,000 $2,000 Original RA: $18M $8M Using physical 9,000 $9M i ,n and $1000 per person-rem l Revised RA*: $5M
$14M Using physical 2,700 $2.7M and BIOLOGICAL To, and $2000 per person-rem
- The revised cost-benefit analysis indicates that almost all.
patients who receive radiopharmaceutical therapy may be release from the hospital immediately if the physician elects to perform a case-specific calculation to show compliance with the dose-based release criteria. Any individual associated with the patient's family would be unlikely to receive a dose of 500 mrem within a year.
SUMMARY
OF MAJOR CHANGES'TO REGULATORY ANALYSIS (CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RA
' l; Costs per oerson-res Original RA: Used $1,000 per person-rem.
' Revised RA: Used $2,000 per person-rem.
- 2. Half-lives of radiocharmaceuticals in body i
Original RA: Used physical half-life. For I-131, T,=8.04 days. Revised RA: Used effective half-life-(biological and physical). For 1-131 in thyroid, T,=20 days- (approximate, it varies slightly with uptake frtction); T,=5.73 days; For 1-131 in whole body (other than thyroid), T,=0.33 days;' T,=0.32 days. (other than thyroid)_
- 3. gp.take fraction for thyroid and the whole body Original - RA: Since physica1' half-life was used, the use of uptake ,
fraction was not_necessary. Revised RA: For thyroid ablation, four uptake-fractions for thyroid and for whole body are used. An average dose is estimated by averaging four doses calculated by each uptake fraction, i For thyroid tancer, uptake fractions for-thyroid of 4 s 0.95 and for whole body of 0.05 are used. 4
)
u
ATTACHMENT 3 REGULATORY ANALYSIS /NUREG-1492 y I
R[,GUlATORY ANALYSIS
" Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Sterial" (NUREG-1492, S. Schneider et al., 1996),
provides the regulatory basis for this guide and examines the costs and benefits. A copy of NUREG-1492 is available for inspection and copying for a fee at the NRC Public Document Room, 2120 L Street NW., Washington, DC. l DRAFT: October 13, 1995 RA-1 4
I l t ) APPENDIX C SAMPLE INSTRUCTIONS FOR PAllENTS RECElVING PERHANENT IMPLANTS The A small radioactive source has been placed (implanted) inside your body. source is actually many small metallic pellets or seeds, which are about 1/3 To to 1/4 of an inch long, similar in size and shape to a grain of rice. minimize exposure to radiation to others from the source inside your body and to yourself if the source f alls out or comes out, you should do the followina for days: e Stay at a distance of feet from _. Maintain separate sleeping arrangements, o Minimize time with children and pregnant women.
- Do not hold or cuddle children.
e Avoid public transportation, o Examine any bandages or linens that come into contact witn the implant site for any pellets or seeds that may have come out of the implant site. e Take the following action if you find a seed or pellet:
- Do not handle it with your fingers. Use something like a spoon or tweezers to place it in a jar or other centainer that you can close with a lid.
- Place the container with the seed / pellet in a location away from people.
- Notify one of the individuals listed below, if you have any questions, contact the following individual (s):
Phone number Beeper number Name Phone number Beeper number __ Name ORAFT: October 13, 1995 C-1 1 1 s
REFERINCIS FOR APP!NDIX B B-1. Stewart Schneider and Stephen A. McGuire, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material " NUREG-1492 (finai Report), NRC, 1996.' B-2. A. Brodsky, "Resuspension Factors and Probabilities of Intake of Material in Process (Or 'Is 10 a Magic Number in Health Physics 7')," Health Physics, Volume 39, Number 6, 1980. B-3. R.C.T. Buchanan and J.M. Brindle, "Radiolodine Therapy to Out-patients - The Contamination Hazard," British Journal of Radiology, Volume 43, 1970. B-4. A.P. Jacobson, P.A. Plato, and D. Toeroek, " Contamination of the Home Environment by Patients Treated with lodine-!31," American Journal of Public 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. B-6 Keith F. Eckerman, Anthony B. Wolbarst, and Allan C. B. Richardson, limitina Values of Radionuclide intake and Air Concentration and Dose Conversion factors for Inhalation. Submersion, and Ingestion, Federal Guidance Report No. II, U. S. Environmental Protection Agency, Washington, 1988.
- Requests for single copies of draft' should be made in writing to the U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
Distribution and Mail Services Section. Requests for draf ts will be filled as long as supplies last. Copies of draf ts are also available for inspection and copying for a fee from the NRC Public Document Room at 2120 L Street NW. (Lower level), Washington, DC. The PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; telephone (202)634-3273; fax (202)634-3343. DRAFT: October 13, 1995 B-14 e
the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No. 11, ' Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients." The NCRP 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, 1 DRAFT: October 13, 1995 B-13
Q = the activity administered to the patient in microcuries, 4 10 the assumed fractional intake. ! DCf = the dose conversion factor to convert an intake in millicuries to an internal committed effective dose equivalent (such as tabulated in Reference B-6). 4
' Equation B-ll uses a value of 10 as the fraction of the activity administered to the patient that would be taken in by the individual exposed-to the patient. A comon rule of thumb is to assume that no more than one 1-millionth of the activity being handled will become an intake to an individual working with the material. 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 airborne releases from a facility, but it does-not specifically apply for cases of intake by an individual exposed to a patient. However, two stJdies ,
(Refs. B-3 and B-4) regarding the intakes of individuals exposed to patients ! administered todino-131 indicated that intakes were generally of the magnitude j of one 1-millionth of the activity administered to the patient and that ! I internal doses were far below external doses. To account for the most highly exposed individual and to add a degree of conservatism to the calculations, a 4
-fractional transfer of 10 has been assumed.
As an example of the use of Equation B-11, assume that 30 millicuries of iodine-131 was administered to a patient. The dose conversion factor DCF for
-the ingestion pathway is 53 rems /millicurie h m Table 2.2 of Reference B-6.
The ingestion pathway was selected since it is likely that most of the intake-would be through the mouth or through the skin, which is most closely approximated by the ingestion pathway. Thus, the maximum internal dose to the individual D, would be calculated to be 0.016 rem. In this case, the internal dose would be about 3 percent of the assumed 5 millisteverts (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 the internal dose would be significantly less than the uncertainty in the external dose.- The conclusion that internal contamination is relatively unimportant in the case of patient release was also reached by the NCRP. The NCRP addressed ORAFT: October 13, 1995 B-12
- Y k hl Based on empirical assessment involving patients with implants, sof t tissue shielding for iodine-125 is likely to exceed 5 or more half value
/ layers (Ref. B-1). l l Solution: The dose is calculated using Equation B-10: 34.6(1.11 R cm'/ mci hr)(60 mci)(60.2 d)(0.25)(e'anw.n. , i) 0" (100 cm)' 0= 0.107 rem (1.07 mSv) Therefore, a patient who has received a permanent implant of 60 millicuries (2,210 megabecquerels) of iodine-125 may still be authorized for release. To meet the requirements of 10 CfR 35.75(b), the licensee must provide the patient with instructions and to meet the requirements of 10 CFR 35.75(c), the licensee must maintain a record of the calculation. [ Although a correction for attenuation may be calculated, it will usually be simpler to measure the dose rate at 1 meter. If the dose rate is no greater than the rate in column 2 of Table 1, the patient may be released and the record of the survey would serve as the record required by 10 CFR 35.75(c). 3.2 Internal Dos _e internal dose may be a consideration with certain radiopharmaceuticals now being developed, such as radiolabeled antibodies, or those that are developed in the future. Some of the radionuclides used in radiolabeled antibodies are predominantly beta or alpha emitters, which emit few gammas. A rough estimate of the maximum likely committed effective dose equivalent from internal exposure can then be calculated from the following equation: (Equation B-ll) D, = Q 10
- DCf Where 0, = the maximum likely internai committed effective dose equivalent to the individual exposed to the patient in rems.
DRAFT: October 13, 1995 B-ll
D= 0, e "' (Equation 8-8) Where D = dose after attenuation, D, . dose before attenuation.
= linear attenuation coefficient of tissue, x = thickness of tissue covering the inplant.
Also, the dose before attenuation is, from Equation 2 in the guide:. 34.6rQ,1,(0.25) D, = (Equation B-9) (100 cm)* , l Substituting Equation B-9 for 0, in Equation B-8, the dose af ter attenuation becomes 34.6 rQ,T,(0.25)(e'"') D= (Equation 8-10) (100 cm)' f Example: Calculate the maximum likely dose to an individual exposed to a patient who has received a permanent implant of 60 millicuries (2,220 megabecquerels) of iodine-125. The following factors apply: J r = 1.11 R cm'/ mci hr,
-T, = 60.2 days,- ;
- = 0.387/cm (Ref 8-1),
4 5 HVLs = S cm (assume 5 Half Value Layers in soft tissue; 1 Half Value Layer for iodine-125 = 1.8 cm). , There is a significant reduction in the exposure rate from the shielding effects of the source capsule. The r of 1.11 R<m'/ mci h for iodine-125 already accounts for the reductior.'in exposure rate from attenuation by the source capsule. ORAFT: October 13, 1995 8-10
0= 0.31 rem (3.1 mSv) Since'the dose is no greater than 5 millistevert (0.5 rem), the patient may be released but instructions to the patient are required. Because an occupancy factor less than 0.25 at 1 meter was used, a record of the calculation must be maintained pursuant to 10 CFR 35.75(c). Example: Calculate the maximum likely dose to an individual exposed to a patient who has received 40 millicuries (1,480 megabecquerels) of iodine-131. The patient requires extensive care because of other medical conditions.
-Solution: Since the patient needs extensive care, the exposure factor will l
have to be increased to account for the increased time the primary caregiver-will spend near the patient. An exposure factor of 0.5 is used in this example: 34.6(2.2 R cm'/ mci hr)(40 mci)(8.04 d)(0,5) 0-(100cm)' 0- 1.22 rem (12.2 mSv) Since the dose exceeds 5 millistevert (0.5 rem), the licensee may not authorize release. However, when the patient is releasable, 10 CFR 35,75(c) requires a record of the release and 10 CFR 35.75(b) requires instructions to the patient if the dose to an individual from the released patient is likely to exceed I millistevert (0.1 rem).
- 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:
ORAFT: October 13, 1995 B-9
- 2. fXP050RE FACTOR The distance and the time that other individuals will spend in the i 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 2 (for example, from the general value of 0.25 to 0.125). This would allow an individual to be released with an activity that is higher than that specified in Table 1 in the regulatory guide. On the other hand, if the patient needs extensive care at home, the exposure factor may 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 less than 0.125 can be easily justified 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 explicitly 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 patient who has received 40 millicuries (1,480 megabecquerols) of iodine-131. The patient lives alone and will not be working. Solution: The dose is calculated using Equation B-1: 34.6rQ,T,E 0(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*/mti hr)(40 mci)(8.05 d)(0.125) D(t) = (100 cm)' DRAFT: October-10, 1995 B-8
Table B-1. Release Times Post Administration for Therapeutic Iodine-131 Procedures Based on Biological Retention and Elimination (To be prepared) B-7 DRAFT: October 13, 1995
34.6(2.2R cm'/ mci h)(0.55)(33 mC1)(5.8 d)(0.25) (100cm)' 0(w) = 0.008 + 0.200 0(=) - 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 control and could be released under 10 CFR 35.75. 1 Release Time Example: Using Equation B-6, it is possible to calculate doses from which release times can be estimated using a graphical method. This is shown in Table B-1 for the maximum quantities normally administered. The values for hyperthyroidism and thyroid ablation are given for various thyroid retention fractions. The licensee's record required by 10 CFR 35.75(b) should indicate the reason for using the assumed thyroid retention fraction. DRAf1: October 13, 1995 B-6 i
\
Solutions in this example, we will account for elimination of iodine-131 from i the body by using the biological half-lives appropriate for hyperthyroidism to l calculate the dose. it will be necessary to consider __the different biological l
- half-lives for thyroidal and extrathyroidal iodine. The following assumptions are made in this example:
100!NE-131 PARAMETERS FOR HYPERTHYROIDISM EXAMPLE 8.0 days Physical half-life of iodine-131. T, ............... Extrathyroidal fraction, F, . . . . . . . . . . . . . . . . . . . . . 0.45' ; 0.33 day'# Biological half-life of extrathyroidal fraction T,, ...... Effective half-life'of extrathyroidal fraction, T,,,, . . . . . . 0.3 day Thyroidal fraction, F, . . . . . . . . . . . . . . . . . . . . . ._. 0.55' 21 days' Biological half-life of thyroidal fraction, T,, ..........
- 5. 8 d ays' Effective half-life of thyroidal fraction, T,,,, . . . . . . . . .
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: 3 4. 6 r F , Q,T ,,,, (0. 2 5) ( 1- e'"""")
+ (Equation B-6)
D(t) = (100 cm)'
- 34. 6 r F,Q,T,,,, (O. 25) ( 1-e '""4*")
(100 cm)' i Substituting the values from aiove, the dose to total decay is 34.6(2.2R cm'/ mci h)(0.45)(33 mci)(0.3 d)(0.25) (100cm)' DRAFT: October 13, 1995 B-5
i i The. total dose comprises the doses from the extrathyroidal and thyroidal fract_ tons. The equa~.fon is: 34.6 r F,Q,T,,,, (0. 25)(1-e """") + (EquationB-6) D(t) - , 34.6 r F,0.T,,,, (0. 2 5) (1-e+"""") (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) D(=) = (100 cm)' 34.6(2.2 R cm'/ mci h)(0.05)(100 mC1)(7.3 d)(0.25) (100 cm)' 0(=) - 0.054 + 0.069 0(=) - 0.124-rem (1.24 mSv) 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 10 CFR 35.75, assuminginat the foregoing assumptions can be justified for the individual patient's case 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 smaller and, in some cases, F, is known for - a specific individual. ~ Hyperthyroidism Example: Calculate the maximum likely dose to an individual exposed to a patient who has been administered 33 millicuries (1,2*)0 megabecquerels) of iodine-131 for the treatment of hyperthyroidism (1.e., thyroid ablation). The occupancy factor is 0.25 at 1 meter. DRAFT:- October 13, 1995 B-4
I i 1 Thyroid Cancer Example: Calculate the maximum likely dose to an individual exposed to a patient who has been administered 100 millicuries (3,700 megabecquerels) of iodine-131, 3 to 4 weeks after thyroid cancer The occupancy surgery, for the treatment of thyroid remnants and metastases. factor is 0.25 at 1 meter.
$_olution:
In this example, we will account for the elimination of iodine-131 from the body by using the biological half-lives appropriate for thyroid cancer to calculate the dose. it is generally recognized that, after surgical removal of the thyroid, the uptake of iodine-131 by the thyroidal remnants and metastases does not exceed 5 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: 10 DINE-131 PARAMETERS FOR THYR 010 CANCER EXAMPLE 8.0 days Physical half-life of iodine-131. T, ............... Extrathyroidal fraction, fi.....................0.95' 0.33 day' Biological half-life of extrathyroidal fraction, T , , . . . . . 0.3 day Ef fective half-life of extrathyroidal fraction, 7,,, 3 Thyroidal fraction, f, ........,,.............0.05' 80 days' Biological half-life of thyroidal fraction, T,, .......... 7.3 days Ef fective half-life of thyroidal fraction. T,,,, , . . . . . . . . .
.......... 2.2 R cm*/ mci h Specific gamma ray constant, f .. . .. ...
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.
DRAFT: October 13, 1995 B-3
-. .- .~ .-. . . . . - -. -- -
i A licensee m y take into account the effective half life of the l radioactive material to demonstrate compliance with the dose limits to members of the public stated in 10 CFR 35.75. The effe'tive half-life is defined as: T.,, - (Equation B-2)
- 1. + 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: 34.6f0,T.,E D(t) - (Equation B-3) (r)* with the factors defined as above. T ,, is the effective half-life, for radiciodine, 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 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 T' 1 ,,, . (Equation B-4) 3 T,3 + T,
"' ' (Equation B-5)
T,,,, - T,, + T , Where T,, biological half-life for extrathyroidal iodide, T., biological half-life of iodide following uptake by the thyroid, T, - physical half-life of iodine-131. I DRAFT: October 13, 1995 B-2 i
j APPENDIX B l PROCEDURES FOR CALCULATING DOSES BASED ON CASE-SPECIF in certain situations, a licensee may release a patient with an activity I higher than the values listed in Table 1 for a specific radionuclide. Licensees may calculate the potential doses to individuals exposed to patients receiving treatment with radioactive material on a case-by-case basis to l account for certain factors specific to an individual. l According to 10 CFR 35.75(b), a record must be kept for 3 years of the basis for the release of the patient if the release of the patient is based on other than standard conservative assumptions, for example, a licensee may use assumptions other than the standard conservative ones, i.e., (1) biological elimination rather than just the physical half-life of the radionuclide, (2) an occupancy factor less than 0.25 at one meter, or (3) the attenuation of radiation by body tissue of the released individual. The following equation is generally used to calculate doses: , 34.6rQ,T,E (Equation B-1) 0(t) = (r)' Where 0(t) = dose to total decay, 34.6 = conversion factor of 24 hrs / day times the total integration of decay (1.44), f= exposure rate constant, Q, = initial activity at the start of the time interval. 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 1
ORAFT: October 13, 1995 B-1
- - . . .. .- . - . _ , . . _~_m ,. - .
1 Where E, = the energy of the gamma ray or x-ray 1 in Hev.
- I f, = the probability of decay of gamma rays or x-rays with energy E, i
per disintegration. Values for E, and f, were taken from: Bernard Shleten, lhe Health Physics and Rtdioloaical Health j i
$ ndbook, Revised Edition Scinta, Inc., 1992, pages 294-334. for Rd-186, Re-188, and Sn-ll7m the values for E, and f, were taken
- Laurie M. Unger and D. K. Trubey, " Specific Gamma-Ray Dose
- from
' Constants for Nuclides important to Dosimetry and Radiological 1 Assessment,' ORNL/RSIC-45/R1, 1982.
- p. , , = the linear energy absorption coefficient in air of photons of energy _ E , taken from Radiological 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 to-NUREG-1492.
- R. Nath A.S. Neigoont, and J. A. Heli, " Dosimetry on Transverse Axes of '"I and "'Ir interstitiel 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 gamma 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 gamma rays within the implant capsule itself.
- Not. applicable (NA) because release quantities based on beta emission rather than gamma emission.
DRAFT: October 13, 1995 A-2
I l l APPENDIX A Table A-1. Half-Lives and Exposure Rate Constants of Radionuclides Used in Medicine Half- Exposure Hal f- Exposure Radio- Life Rate Constant' Radio- Life Rate nuclide (days)' Constant' nuclide (days)' (R.ca'/mC1.h) (R en'/ mci.h) 0.150 Pd-103 16.97 0.86* Ag-ll! 7.45 (implants) 2.36 Re-186 3.777 0.168 Au-198 2.696-Cr-51 27.704 0.177 Re-188 0.7075 _ 0.337 1.10 Sc-47 3.351 0.626 Cu-64 0.5292 0.753 So-75 119.8 2.60 Ga-67 3.261 1.61 Sm-153 1.9458 0.425 1-123 0.55 1.42 Sn-ll7m 13.61 -1.48 1-125 60.14 Sr-89 50.5 NA' l-125 60.14 1.11' (implants) 2.20 Tc-99m 0.2508 0.756 1-131 8.040 3.15 T1-201 3.044 0.447 In-lll 2.83 0.1329 NA' 1r-192 74.02 4.69, Y-90 NA' Yb-169 32.01 1.83 P-32 14.?9
' Keith F. Eckerman, Anthony B. Wolbarst, and Allan C, 8. Rich 3rdson, [_ederal Guidance Reoort No,11. Limitina Values of Rad {gnuclide intake and Air .
Concentration and Dose Conversion factors for Inhalation. Submersion. and jnjestion, Report # EPA-520/1-88-020, Office of Radiation Programs, U. S. Environmental Protection Agency, Washington, DC, 1988.
- The exposure rate f actor 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:
# ' =
* ' C" --- )
r . (1.332 = 10" mci hr -) E 4E, ( p gm cm" mci hr -) Air (100 cm)' 9* '" erg ) ( 87.6 erg)(1.6 i 10.. MeV DRAFT: October 13, 1995 A-1
Except in those cases in which a licenste uses an acceptable alternative method for complying with 10 CFR 35.75, the methods described in this guide will be used in the evaluation of a licensee's compliance with 10 CFR 35,75, j4 ORAFT: October 13. 1995
- 3. 3rf,o, Lpg.
3.1 Records _af E g yg There is nc rered d eeping requirement for immediate release of patients based or Tat,le 1. However, if the release of the patient is based on factors other tMa W ' standard tenservative assumptions on which Table 1 is based, 10 CFR 35.?b(c) rF.t. ires that the-licensee mair.tain, for 3 years, a record of
-the basis for the rslease.- for example, when the licca...ee releases a patient with an activity that is greater than the value in the default table, a record-of the basis for the relene must t'e maintained for NRC review during inspection.
Records should include (1) the patient's name (2) the radioactive material (3) the administered activity (4) the date and tir s of a administration, (5) .:e date and time-of the. patient's release .(6) the case-specific factors that were 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. The record for a particular patient's release could reference the calculation done for the class of patients. 3.2 Records of Instructions A record that instructions were provided is required by 10 CfR 35.75(d)
-if a woman is breast-feeding and failure to interrupt breast-feeding could result in a dae to the beast-feeding child in excess of 5 millisteverts (0.5 rem)
D. IMPLEMENTATION The purpose of this section is to provide information about the NRC statf's plans for using this regulatory guide. DRAFT: October 13, 1995 -13
Tc-99m WBC's 3 15 24 hr for 30 mci 12 hr for 12 mci da-67 citrate 0.04 0.2 Complete cessation Cr-51 EDTA 1.6 8 NA In-ll! WBC's 0.3 1.5 6 hr for 0.5 mci T1-201 1 5 Complete cessatioil for 3 mci 48 hr for 1.5 mci
- NA, meaning "not applicable " is used if the administered activity requiring instructions exceeds the maximum activity normally administered.
DRAFT: October 13, 1995 12
P e The length of time precautions should be in effect. 1 The Society of Nuclear Medicine published a pamphlet in 1987 that provides information for patients receiving treatment with radiciodine.' ; This pamphlet was prepared jointly by the Society of Nuclear Medicine 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 develop their own instructions, addressing the items discussed above as appropriate. Sample instructions for patients who have received permanent implants are given in. Appendix C. 1 2.3- Additional Instructions for Release of Women Who Could be Breast-feedina after Release If the patient ~to be released is a woman who could be breast-feeding after release. Table 2 provides information and instructions on the , interruption of breast-feeding for the radiopharmaceuticals commonly used in medicai diagnosis and treatment. In order to use this table it will be necessary to determine the breast-feeding status of women patients receiving 4 some administrations. The purpose of describing the consequences is so that women will : understand that breast-feeding after an administration of certain radionuclides could cause harm (e.g., iodine-131 could harm the child's-thyroid). In other cases, the guidance could simply address avoidance of any
- unnecessary radiation exposure to the child from breast-feeding, t
.4
?
8 " Guidelines for Patients Receiving Radiciodine Treatment," Society of j: Nuclear Medicine, 1987. This pamphlet may be obtained from the Society of ; ' Nuclear Medicine, 136 Madison Avenue, New York, NY 10016-6760. 1 DRAFT: October 13, 1995 10 r-. , -, .me,,- , , - . __*.<.+..-.~+,..,,.w,-.#mm
, . , - . . , 2 -y ,,,,.,%.yn,-y--y.vy- --,w . wy,,, ,, -,-~y3,, +-m -p o
- 2. INSTRUCTIONS 2.1 Activities Reautrina Instructions If the total effective dose equivalent to an individual exposed to a patient is likely to exceed 1 mil 11 sievert (0.1 rem), 10 CFR 35.75(b) requires ,
that the released patient be given instructions, including written l
-instructions, on how to maintain doses to other individuals as low as reasonably achievable.
Licensees may use the 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 Table 2 to determine when additional instructions on the interruption of breast-feeding must be given to the patient to meet the requirements in 10 CFR 35.75(b).-
.2.2 Content of Instructions
'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. The instructions should include, as appropriate e Maintaining distance from other persons, including separate sleeping arrangements, o Minimizing time in public places (e.g., public transportation, grocery stores, shopping centers, theaters, restaurants, 7. rid sporting events),
e Precautions to reduce the spread of radioactive contamination, and DRAFT: October 13, 1995 9
Y-90 100 4 NA 20 0.8 NA l 10 0.4 2 2 0.07 0.4 Yb-169 l l 9 DRAFT: October 13, 1995 8
i Table 1. Activities and Dose Rates for Authorizing Patient Release and Giving Instructions' Column 1 Column 2 Column 3 Column 4 l - Dose Rate At Activity At Or 1 meter At Requiring Requiring Below Which or Below Instruct'ons If Instructions Patients May Which Activity Is If Dose Rates Be Released Patients May Greater Than at 1 meter Is Be Released Greater Than Radio-nuclide (mC1) (GBq) (ares /hr) (sci) (Gbe) (pres /hr)
- Ag-111 50G 20 8 100 4 2 I
Au-198 90 3 20 20 0.7 4 Cr-51 100 4 2 20 0.8 0.4 I Cu-64 200 9 30 40 2 5 l Ca-67 200 9 20 40 2 4 l-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 l In-lll 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 impl ant s l Re-186 900 30 10 , 200 7 2 Re-188 600 20 20 100 4 4 St-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 l Sn-117m 30 1 4 6 0.2 0.8 Sr-89 100 4 NA 20 0.8 NA Tc-99m 700 30 50 100 6 10 11-201 400 10 20 80 2 4 l
' Values rounded to one significant figure, except in a few instancas where it was considered appropriate to use two significant figures. The 4 details of the calculations are shown in NUREG-1492, Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material.
DRAFT: October 13, 1995 7 I_ -
i Appendix B contains procedures for performing case-specific dose calculations, and it describes how various factors may be considered in the < calculations. l 1.4 Soecia)_[onsideration for Breas_t Feedina Women The release quantities in Table 1 do not include consideration of the dose to a breast-feeding infant from ingestion of radiopharmaceuticals If the patient is a breast-feeding woman contained in a woman's breast milk. it may be necessary to give instructions as described in Secti... C.2.3 as a condition for release because the activities in Table 1 could cause a dose exceeding 5 millisteverts (0.5 rem) to the breast-feeding infant if there were no interruption of breast-feeding. DRAFT: October 13, 1995 6
C. REGULATORY POSITION
- 1. RELEASE CRITERIA 1.1 Activities for Release of Patients Licensees may demonstrato compliance with the dose limit in 10 CFR 35.75(a) for release of patients from licensee control if the activity administered is no greater than the activity in Column 1 of Table 1. In this case, no record of the release is required. If the activity administered exceeds the activity in Column ! of Table 1, the ifcensee may hold the patient until the activity in the patient's body is no greater than Column 1 of lable 1 and then authorize release. In this case a record is required by 10 CCR 35.75(c) because the release is based on an activity less than the activity administered.
1.2 Dose Rates for Release of Patients Licensees may also demonstrate compliance with the dose limit in 10 CFR 35.75(a) for release of patients from licensee control if the dose rate at 1 meter (from the patient centerline) is no greater than the value in Column 2 of Table I for that radionuclide. If the release is based on the dose rate at 1 meter, a record of the measured dose rate is required by
-10 CFR 35.75(c) because the measurement includes shielding by tissue.
1.3 Releases Based on Case-Specific Factors Licensees may calculate the maximum likely dose to an individual exposed ' to the patient on a case-by-case basis to account for factors specific to a patient, in such cases, licensees may be able to release 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 material and other factors l ' that may be levant to the particular case. ORAFT: October 13, 1995 5 l
- 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 cf the dose to total decay (0.25 in Equation 2) at a distance of 100 centimeters. Selection of 25 percent of the dose to total
[ decay for estimating the dose is based on measurements indicating that the dose calculated using the factor is conservative in most ' normal situations.
- For radionuclides with half-lives no greater than 1 day, the factor of 0.25 used in Equation 2 is replaced with a factor of 1.0 to give Equation 3. The factor of 0.25 cay not be valid when relatively long-term averaging of behavior cannot be assumed.
Thus, for radionuclides with a half-life greater than 1 day:
* (Equation 2) 0(w) -
(100 cm)' for radionuclides with a half-life no greater than 1 day: 34.6FQ,T, (Equation 3) D(m) - -- (100 cm)' Equations 2 and 3 calculate the dose from external exposure to gamma radiation. The equations do not explicitly include dose from internal intake by housenold members and members of the public because the dose from intake by other individuals is expected to be small for most radiopharmaceuticals (less than a few percent) relative to the gamma dose (see section 3.2 of Appendix B). Further, the equations above do not apply to the dose to breast-feeding children who continue to breast-feed. Breast-feeding must be considered separately as described below. DRAFT: October 13, 1995 4
NCRP Report No. 37 uses the following equation to calculate the eaposure until time t at a distance r_from the patient:
'34. 6 T Q,T, (1-e "*") (Equation 1)
D(t)'= r' TWhere 0(t).- accumulated exposure at time t, in roer,tgens, 34.6 = conversion factor of 24 hrs / day times the total integration of decay (1.44), f= specific' gamma ray constant for a point source, R/ mci h at I cm, Q, = initial activity of the point source in millicuries, at the time of the release, T, = physical half-life in days, r- distance from the point' source to the point of interest in centimeters, t = -exposure time in days. This guide uses the NCRP equation-(Equation 1) in the following manner to calculate the activities at which patients may be released, e The dose to an individual likely to receive the highest dose from exposure to the_ patient is taken to be the dose to total decay.
- Therefore, (1-e'"'") is set equal to 1.
e it is assumed that I roentgen is equal to 1 rem, o The doses are calculated using the physical half-life of. the radionuclides given in Appendix A and do not account for the > biological half-life of the radionuclide.
;e The gamma. ray constants and half-lives for radionuclides typically used in nuclear medicine and brachytherapy procedures are given in
' Appendix A-to this guide.
DRAFT: October 13, 1995 3
actions recommended to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem)." Section 35.75(c) requires that the licensee maintain "a record of the basis for authorizing the release of a individual for 3 years after the date of release, if the tchi effective dose equivalent is calculated (1) using an activity less than the activity administered, (2) using an occupancy factor less than 9.25 at I meter, (3) using the biological or effective half-life, or (4) considaring the shielding by tissue." Section 35.75(d) requires that the licensee maintain a record "that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisteverts (0.5 rem)." bereafter in this guide the individual to whom the radioactive material has been administered will be called the patient. This guide provides guidance on determining when a licensee may authorize the release of a patient and when instructions must be given and records kept. The 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 10 CFR 35.75. The information collections contained in this roulatory guide are covered by the requirements in 10 CFR 35.75, wnich have been approved by the Office of Management and Budget, Approval No. 3150-0010. B. DISCUSSION 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 M:nagement of Patients Who Have Received Therapeutic Amounts of Radionuclides."'
' 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 20814-3095.)
DRAFT: October 13, 1995 2
NOTE TO COMMISSION This guide is a working draft rather than a final draft. It does not have Office concurrence, 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 relatively minor. There should be no difficulty in publishing the final guide before the final rule is effective. REGULATORY GUIDE 8.39 (Draft was issued as DG-8015) RELEASE OF PATIENTS ADMINISTERED RADI0 ACTIVE MATERIALS A. INTRODUCTION Section 35.75, " Release of individuals containing radiopharmaceuticals or permanent implants," of 10 CFR Part 35, " Medical Use of Byproduct Material," permits licensees to " authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem)." In addition, 10 CFR 35.75(b) requires that the licensee " provide the released individual with instructions, including written instructions, on 4 DRAFT: October 13, 1995
ATTACHMENT 2 DRAFT REGULATORY GUIDE 8,39 J l
- 10. In 5 35.415, the introdu: tory text to paragraph (a) and paragraph (a)(1) are revised and paragraph (a)(5) is removed.
L 35.415 Safety precautions. (a) For each patient receiving implant therapy and not released from licensee control pursuant to i 35.75 of this part, a licensee shall: (1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy. Dated at Rockville, Maryland, this day of 1996. For the Nuclear Regulatory Commission. John C. Hoyle, Secretary of the Commission. 60 Attachment I
r maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent- to any other individual-is likely to exceed - __
-1 millisievert'(0.1 rem), if the dose to a breast-feeding infant or child
- could exceed 1 millisievert (0.1 rem) assuming there were no interruption of
' breast-feeding. the> instructions shall also include (1): guidance on the interruption or discontinuation of breast-feeding and (2) information on the
- consequences of failure to follow the guidance.
(c) The licensee. thall maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated (1) using 'the retained activity rather _than the activity administered, (2) using an occupancy factor less than 0.25 at 1 meter,-(3). using-the biological or effective half-life, or
-(4) considering the shielding by tissue.
(d) The licensee shall maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continu3d breast-feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0,5 rem). 5 35.315 [Aa. ended] In 5 35.315, paragraph (a)(6) is removed and reserved. ! 9.
! 35.315 Safety precautions.
(a) (6) [ Reserved] 59 Attachment =1 I l
,. . . . . . . . . A
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).
- 7. In Section 35.8, paragraph (b);is revised to read as follows:
1.35.8 Infornation collection requirements:' OMB approval. (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 35.647.
- 8. Section 35.75 is revised to read as follows:
535.75 Release of individuals containing radiopharmaceuticals or permanent implants. (a) The licensee may authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposur.e 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 instruct' ions, on' actions recommended to
' Regulatory Guide 8.39, " Release of Patients Administered Radioactive - Materials," describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 millisteverts (0.5 rem).
58 Attachment 1
! (a) Each licensee shall conduct operations so that-- The total ef fective dose equivalent to individual members of the l (1) public from the licensed operation does not exceed 0.1 rem (1 millisievert) in a year, exclusive of the dose contributions fron. background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance i 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 6 20.2003, and The dose in any unrestricted area from external sources, exclusive (2) of the dose contributions from patients udministered radioactive material and released in accordance with i 35.75, does not exceed 0.002 rem (0.02 millisievert) in any one hour. *
- 5. In i 20.1903, paragraph (b) is revised to read as follows:
5 20.1903 Exceptions to posting requirements. Rooms or other areas in hospitals that are occupied by patients are (b) 20.1902 provided not required to be posted with caution signs pursuant to i that the patient could be released from licensee control pursuant to i 35.75 of this chapter. PART 35--MEDICAL USE OF BYPRODUCT MATERI AL
- 6. The authority citation for part 35 continues to read as follows:
57 Attachment 1 1 l
I
- 3. In 5 20.1003, the footnote to the definition of member of the public is removed and the definitions of occupational dose and pubife dose are-revised to read as follows:
i20.1003 Definitions. { 4 1 Occupational dose means the dose received by an individual in the_ course : -! of empicyment in which the individual's assigned duties _ involve exposure.to l radiation or to radioactive material from licensed and unlicensed sources of I radiation, whether in the possession of the licensee or other' person.. Occupational: dose does not include dose received from background radiation, I from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with
- _5 35.75, from voluntary participation in medical research programs, or as a member of the public.
Pubife dose maans the dose received-by a member of the public-from exposure to radiation or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee.- Public dose does not include occupational dose or doses received from background radiation. from any medical administration the individual has received, from exposure to individuals administered radioactive material-and released in accordance with 5 35.75, or from voluntary participation in medical research - programs.
- 4. In i 20.1301, paragraph-(a) is revised to read as.follows:
i20.1301 Dose limits for individual members of the public. 56 Attachment I
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. 552 and 553; the NRC is adopting the following amendments to 10 CFR parts 20 and 35. - PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
- 1. The authority citation for part 20 continues 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, sec. 1701, 106 Stat. 2951,_ 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended. 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
- 2. Secticn 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 limits-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, to exposure from individuals administered radioactive material and-released in accordance with 5 35.75, or to exposure from voluntary participation in medical research programs.
55 Attachment 1
_ Xill. 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 number of small entities. This rule affects medical use of byproduct material licensees. The impact of the final rule will not be significant because the final rule basically represents a continuation of , -, current practice. XIV .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 f.ot involve any provisions that impose backfits as defined in 10 CFR 50.109(a)(1). Lists of Subjects-in 10 CFR part 20 , l Byproduct material Licensed material. Nuclear materials, Nuclear power plants and' reactors, Occupational safety and l....th, Packaging and containers.
-Penalty, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal.
Lists of Subjects in 10 CFR part 35 Byproduct material,-Criminal penalty, Drugs, Health facilities, Heal _th professions, incorporation by reference, Medical devices, Nuclear materials,_ Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements. 54 Attachment I
XI. Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the P, 3rwork Reduction Act of 1995 (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 13 hours per licensee per year, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspect of this collection of information, including suggestions for reducing the burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJSl@NRC. GOV; and to the Desk l j Officer, Office of Information and Regulatory Affairs, NE08-10202, (3150-0010), Office of Ma'.agement and Budget, Washington, DC 20503. Xil. 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 NRC has received public comments regarding the draf t regulatory analysis and has addressed the comments (see Comments on the Draft Regulatory Analysis in 111. Public Comments on the Proposed Rule). 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 in the ADDRESSES heading. 53 Attachment 1
requirements that are more stringent than the NRC's requirements, but not less stringent. The recordkeeping requirements in il 35.75(c) and (d) are a Division 3 level of compatibility because uniformity in recordkeeping is not considered essential for this rule. X. Finding of No Significant Environmental Impact: Availability The NRC has determined under the National Environmental Policy Act of l 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 significantly affecting the quality of the human environment, and therefore an 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 the amendments 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 impact are available as indicated in the FOR FURTilER INFORMATION CONTACT heading. 52 Attachment 1
~ .- . _ _
3 The third statement of the policy reads "The NRC will minimize intrusion into medical judgments 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 administration of radioactive materials to patients and because the release of patients administered radioactive materials has long been considered a matter of regulatory concern to protect members of the public rather than solely a matter of medical judgment. Thus, the final rule is considered to be consistent with the 1979 Medical Policy Statement. IX. Issue of Compatibility for Agreement States The NRC considers the definitions contained in i 20.1003 and the text in i 20.1301(a) that are modified by this rulemaking are Division I levels of compatibility. The definitions and text in these sections must be the same for all NRC and Agreement State licensees so that national consistency can be maintained. Section 20.1002, " Scope," is a Division 3 level of compatibility because this section by nature is not a regulatory requirement and many States are prohibited by their administrative procedures act from including such sections in their rules. The scope section is a general statement of scope of the rule and does not contain specific requirements that are not presented in other sections of Part 20. Rules at the Division 3 level would be appropriate for Agreement States to adopt, but they do not require any degree of uniformity between NRC and State rules. Additionally, il 35.75(a) and (b) are a Division 2 level of compatibility because the patient relea u 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 51 Attachment 1
Finally, the requests made'by the AMA did not all pertain to the issue
- of patient release._ The final rule grants the request pertaining to patient.
release, i.e., that-the radiation dose limits in 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. The request to change the term
" hospitalized" in 10 CFR 35.310(a) and 35.315(a) to the term " confined" was
[ denied-for the reasons discussed above. The request not related to the subject of patient release (that it should be clear in Part 20 that Part 20 l does not limit the intentional exposure of patients to radiation for the purpose _of medical diagnosis or therapy) was addressed in another rulemaking,
" Medical Administration of Radiation and Radioactive Materials," which was-published as a final rule on September 20, 1995 (60 FR 48623), and became-effective on October 20, 1995.
Vill. Consistency with 1979 Medical Policy Statement On February 9, 1979 (44 FR 8242), the NRC published a Statement of General Policy on the Regulation of the Medical Uses of Radioisotopes. The ; first statement of the policy reads "The NRC will continue to regulate the medical uses of radioisotopes 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 admiristered radioactive materials. The second statement of the policy is "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 rdevant to the rule because the rule does not affect i the safety of patients themselves, The rule instead affects the safety of
-individuals exposed to patients.
50 Attachment _1 a
s I based on NCRP_ Report _No. 37 to relate the dose to the quantity of activity in the patient. -Therefore, the wish of-the petitioner to'have an easy method-to determine when the patient may be released i' Jranted in Regulatory )- Guide 8.39. l (3) Delete 10 CFR 20.1301(d), which requires licensees to comply with provisions of the Environmental Protection Agency's environmental regulations in 40 CFR part 190 in addition to_ complying with the requirements of 10 CFR part 20. The EPA regulations referenced in 10 CFR 20.1301(d) are contained in 40 CFR part 190, which deals only with doses and airborne emissions from uranium fuel cycle facilities. Part 190 of Title 40 of the { Code of Federal Regulations does not apply to hospitals or to the release of patients. I Furthermore, 10 CFR 20.1301(d) does not incorporate the EPA's Clean Air Act standards in 40 CFR part 61 that applies to hospitals. The NRC is separately pursuing actions with the EPA to minimize the impact of-dual regulation under the Clean Air Act and to take agreed upon actions that will lead to EPA recision of 40 CFR part 61 for NRC and Agreement State licensees. I Because the reference to EPA regulations in 10 CFR 20.1301(d) has nothing to do with the patient release issue, and therefore is outside the scope of this
- rulemaking. the final rule denies this request.
The requests made by the ACNM and their disposition may be summarized as follows: (1) Adopt a dose limit of 5 millisieverts-(0.5 rem) 'for individuals The exposed to patients who have been administered radiopharmaceuticals. final rule grants this request. (2) Permit licensees to authorize release from hospitalization any patient administ'ered a radiopharmaceutical regardless of the activity in the patient by defining-" confinement" to include not only confinement in a
- hospital, but also confinement in a private residence. The final rule denies this request for the reasons described in the discussion on this issue.
49 Attachment 1 N
,.c
radiopharmaceuticals that require this record are described -in Regulatory
.-f ' -- Guide 8.39.
/ -Finally, the NRC is deleting its requirements on written instructions in l . 10 CFR 35.315(a)(6) and 35.415(a)(5) because those paragraphs are redundant j . now that 10 CFR 35.75'has requirements for instructions.
In addition, ! l - 10 CFR-35.415(a) and a(1) are reworded _to clarify the original intent of the i paragraphs, which was to limit the dose rate'at-1 meter from the patient. The
' ambiguity was introduced when Part 20 was revised and a conforming change was made in 10 CFR-35.415. The conforming change that was made was not fully consistent with the original intended meaning of 10 CFR 35.415(a) and (a)(1).
Vll. -Disposition of the Petitions for Rulemaking The three petitions.for rulemaking submitted by Dr. Marcus (PRM-20-20), the ACNM (PRM-35-10 and PRM-35-10A), and the AMA (PRM-35-ll) requested.that-the NRC. amend the revised 10 CFR part 20 and.10 CFR part 35. -These requests and their disposition by this rulemaking are discussed below. The requests made by Dr. Marcus and their disposition may be summarized as follows: (1) Raise the annual radiation dose limit in 10 CFR 20.1301(a) for individuals exposed to radiation from patients receiving radiopharmaceuticals , for diagnosis _or therapy from 1 millisievert (0.1 rem) to 5 millisieverts
- (0.5 rem). The final rule grants this request.
(2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel (30-millicurie)_ limit for iodine-131, but provide an activity limit-for other
- radionuclides consistent with the calculational methodology employed in-the National Council on_ Radiation Protection and Measurements (NCRP) Report q No. 37, " Precautions in the_ Management of Patients Who Have Received 4 Therapeutic Amounts of Radionuclides."' The final rule does not contain.
activity limits, but Regulatory Guide 8.39 uses a calculational methodology 48 Attachment 1
basis for the release, including the assumptions used for the calculations, must also be maintained. This recordkeeping requirement is a modification of 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 individual other than the released patient is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration. Under the proposed rule, the major purpose of the record was to provide the basis for limiting 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 doses exceeding the 5 millisievert (0.5 rem) limit because of multiple administrations in the same year to the same patient. Without the need to account for the dose from multiple administrations, maintaining records for the many tens of thousands of patients released when their dose to an individual is likely to exceed 1 millisievert (0.1 millisievert) becomes an unnecessary burden. The requirement to retain these records has therefore been deleted. Each patient release is to be treated as a separate event, and licensee knowledge of previous administrations is unnecessary. The NRC is also adopting a new 10 CFR 35.75(d) to require that the licensee maintain a record that instructions were provided to a breast-feeding woman if the administered activity could result in a total effective dose equivalent to the breast-feeding child exceeding 5 millisieverts (0.5 rem) if the mother did not interrupt or discontinue breast-feeding. Thus, the NRC is requiring records for certain radiopharmaceutical administrations (e.g., therapeutic administrations of iodine-131). The activities of 47 Attachment 1 i l
the retained activity rather than the activity administered. an occupancy factor less than 0.25 at I meter, the biological or effective half-life of the radionuclide, or shieldf.ng of radiation by the patient's tissue. Thus, records of release are required when the default assumptions are not used as discussed in Regulatory Guide 8.39. Measurements made in several studies indicate that the default assumptions should generally overpredict the dose even when instructions are not given or are not strictly followed. If a i licensee administers an activity no greater than the value in the default table of release quantities provided in the regulatory guide as the basis for release, no record of release is ra' ired, licensees are already required by 10 CFR 35.53 to retain records of the measurement of the activity of each dosage of radioactive material administered to a patient; these records are typically maintained in a patient dose log. In addition,10 CFR 35.32 requires licensees to retain a written directive and a record of each administered radiation dose or radiopharmaceutical-dosage for therapeutic administrations and diagnostic administrations of iodine-125 or iodine-131 sodium iodide greater than 30 microcuries. These records can be used in conjunction with Regulatory Guide 8.39 to demonstrate that patient releases meet the requirements of 10 CFR 35.75(a) when no record is required by 10 CFR 35.75(c). When the licensee determines that the patient must be held to allow the reduction of radioactivity and then released, the licensee will reed a record of release time to demonstrate that the release criteria have been met. A licensee may use any existing record to establish the release time, if biological elimination of radiciodine is a basis for release and the licensee uses the information in Regulatory Guide 8.39, a record of the thyroid uptake may be necessary as part of the basis for release because it is one of the nonstar.dard conservative assumptions listed in 10 CFR 35.75(c). If other case-specific factors are used as the basis for patient release that are in addition to, or modify, the standard conservative assumptions, a record of the 46 Attachment I s i
5 i a The purpose of describing the consequences is sn that women will
. understand _that breast-feeding after an administration of certain radionuclides could cause harm (e.g.,-iodine-131 could harm the child's thyroid). In other cases, the guidance could simply address avoidance-of any
-unnecessary-radiation exposure to the child from breast-feeding.-
A requirement for instructions for certain patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the modified requirement for-written instructions adds approximately (a) 50,000 patients per year who are administered iodine-131 for the treatment of hyperthyroidism and (b) 27,000 patients per year, among about 8 million administered radiopharmaceuticals, who may be breast-feeding to whom additional written instructions be given. The purpose of the written instructions is to maintain doses to tindividuals exposed to patients as low as is reasonably achievable. The instructions may be either written only or written plus oral. 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 requirement of 10 CFR 35.75(b),_ requiring a licensee to provide guidance on discontinuation or the interruption period for breast-feeding and . the consequences of-failing to follow the recommendation, presumes that the licensee will make appropriate inquiry.regarding the breast-feeding status of the patient. For breast-feeding women where the dose to the child is likely 1 to exceed 1 millisievert (0.1 rem), the NRC requires that the patient be provided with specific instructions, as described in 10 CFR 35.75(b). There is no specific requirement to maintain a record ~ indicating that breast-feeding status was determined prior tolthe release of the patient. ,
~
The NRC-is adopting a new-10 CFR 35.75(c) to require that the licensee maintain a record of the basis for authorizing the release for_3 years if the ' calculation of the total effective dose equivalent to other individuals uses 45 Attachment 1
< l
_ - _ _ _ _ -- 1
~ .= __ . . - - . ~- .. . - - . - - - . - - - ~ --
l d The release criteria in 10 CFR 35.75(a) could prevent a woman from being
' released because of-the potential transmission of radioactive materials in breast milk. The dose to the breast-feeding child is controlled by giving the ..
woman guidance, as required by 10 CFR 35.75(b), on the interruption or . ' discontinuation of breast-feeding and information on the consequences of failure to follow' the guidance.- The expectation is that the woman would ! follow the instructions and would interrupt or discontinue breast-feeding. Finally, 10 CFR 35.75(a) includes a footnote to inform licensees that , the NRC has made available guidance on rule implementation. The footnote states that Regulatory Guide 8.39, " Release of Patients Administered Radioactive Material," contains tables of activities not likely to cause doses exceeding 5 millisieve'rts (0.5 rem) and describes methods for calculating doses to other individuals. 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 is reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millisievert (0.1 rem). This also requires giving instructions to breast-feeding women if the dose to the. child could exceed 1 millistevert (0.1 rem) assuming there were no interruption of breast-fceding. 'The instructions must include guidance-on discontinuation or the interruption period for breast-feeding and the consequences of failing to follow the recommendation. Regulatory Guide 8.39 contains tables that show temporary interruption periods for various radiopharmaceuticals or discontinuation; The temporary interruption periods were calculated based on
. the determination that the dose to a child- from breast-feeding is unlikely to exceed l millisievert (0.1 rem). However, the physician may use discretion in the recommendation, increasing or decreasing the duration of interruption somewhat depending on the woman's concerns about radioactivity or_ interruption a of breast-feeding.
44 Attachment I t
( The NRC is amending 10 CFR 20.1903(b) to use the term " licensee control" 8 rather than " confinement" because the latter term no longer applies to 10 CFR 35.75. The conforming change is necessary since the term:' licensee control" more clearly reflects the NRC's intent in 10 CFR 35.75.
-The NRC is' adopting a new 10 CFR 35.75(a) to change the patient release criteria from 30 mill _icuries 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 millisteverts (0.5 rem) total effective dose equivalent to an individual l 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 receive an annual dose up to 5 millisteverts (0.5 rem) in temporary situations where exposure to radiation is not expected to result in annual doses above 1 millislevert (0.1 rem) for many years. Usually, the only individuals likely to exceed a dose of 1 millistevert (0.1 rem) will be those who are aware of the patient's condition such as the primary care-giver, a family member, or any other individual who spends significant time close to the patient.
.This dose-based rule would, in some instances, permit the release of patients with activities greater than currently allowed. This_is especially true when case-specific factors are evaluated to more accurately. assess the J
dose to other individuals. The individuals exposed to the patient could These a receive higher doses than if the patient had been hospitalized longer. higher doses are balanced by shorter hospital stays and thus lower health care costs. -In' addition, shorter hospital stays may provide emotional benefits to patients and their families. Allowing 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. 43 Attachment 1
VI. Discussion of Text of Final Rule This section summarizes the final rule. The NRC is amending 10 CFR 20.1301(a)(1) to state specifically that the dose to individual members of the public from a licensed ope ation 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 cicrity, the same words are used in i 20.1002, " Scope"; in i 20.1003, " Definitions" (in the defiaitions of both nublic dose and occupational dose); and in i 20.1301, " Dose limits for individual members of the public." Also for consistenc,v 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). In addition, the definition of " member of the public," as published in 60 FR 36038 on July 13, 1995, is revised by removing the footnote which read, "Except as delineated in other parts of 10 CFR Chapter 1." With the publication of this rule that footnote is no longer needed. , The NRC is amending 10 CFR 20.1301(a)(2) to state specifically that the limit on dose in unrestricted areas does not include dose contributions from individuals administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that after a patient has been released under 10 CFR 35.75, licensees are no longer required to control radiation from the patient. The regulation uses the term " individual" to refer to the individual to whom the radioactive material has been administered rather than " patient" to clarify that the regulation refers to anyone receiving a medical administration. 42 Attachment I
administration'of radioactive material and radiation from radioactive materi al .. The NRC staff presented a summary of the comments on the proposed rule to the ACMUI during a public meeting held in Rockville, Maryland, on
- -November 17 and 18 -1994.--
Drafts of the final rule and regulatory guide were discussed with ACMU) in Rockville, Maryland, on October 18 and 19,1995. The ACMUI supported the approach in this rule but suggested some clarifying changes. The NRC staff made all but-one of the suggested changes. The ACM01 suggested using the term
" rationale" instead of " consequences" in the requirement under the revised 35.75(b),cto provide " guidance on the interruption or discontinuation of breast-feeding, and information on the consequences of failure to-follow the '
guidance" for cases where failure to follow the instructions could result in a dose to the infant exceeding 1 millistevert (0.1 rem). Since most of the administrations that would be affected by this requirement are technetium-99m administrations, the ACMUI suggested the change because there was concern that the consequences of low doses of radiation cannot always- be explained to the patient without causing unjustified alarm. Also, there was concern that physicians cannot explain with certainty the effects of low doses of. radiation, such as would be caused by diagnostic administrations of technetium-99m. The staff did not change the rule in response to the ACMul comment. The re_uirement q to provide information on the consequences is-included primarily to protect the breast-feeding. infant from therapeutic
-administrations of radioiodine, which could cause serious thyroid damage.
Regulatory Guide 8.39 will contain guidance on the types of information, including expected conseqcances, to be provided to patients to meet this requirement. Transcripts'of the meetings have been placed in and are available for examination at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. 41 Attachment 1
radioactive material; only radioactive decay was considered. As a consequence.--the draft regulatory analysis, in some cases, overestimated the time that patients would need to be retained under licensee control, and therefore the costs of patient rotention were too high. The final regulatory analysis corrects the estimates. The NRC believes that the current cost of 31,000 per day for a hospital room is not an overestimate. Under 10 CFp,35.315(a)(1), licensees are required to provide a private room with a private sanitary facility for each patient receiving radiepharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75. Considering this NRC requirement and the recent reference j'. cited in the final regulatory analysis on the cost 'of hospitalization,-$1,000 per day for a hospital room is a reasonable estimate. Comment. One commenter said that the description of the measured doses received by family members was not consistent with the reference cited, Response. The commenter is correct. An incorrect reference was given. The final regulatory analysis provides the correct reference. IV. Coordination with NRC Agreement States , The NRC staff discussed the status of this rulemaking effort at two public meetings: the Agreement State Managers Workshop held on July 12-14, .; 1994, and at the All Agreement States Meeting held on October 24-25, 1994. The Agreement States expressed ne objections to the approach in this rule. V. Coordination with the Advisory Committee on Medical Uses of Isotopes The Advisory Committee on Medical. Uses of isotopes (ACMUI) is an advisory body established to advise the NRC staff on matters that involve the 40 Attachment 1
i Response. The Comission.recently adopted a value of $2,000 per _ person-rem as explained in Revision 2 of. NUREG/BR-0058, ' Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission (November 1995),"
- Section 4.3.3, " Evaluation of Values and Impacts." (Single copies of NUREG/BR-0058 are available as indicated in the ADDRESSES heading.) The draft regulatory analysis, which was prepared utilizing $1,000 per person-rem, l
employed a simple compdtational model using the physical half-life only of radiopharmaceuticals.- The regulatory analysis has been revised to include use of $2,000 per person-rem, as' well as a more realistic dose model based on biological retention and elimination of the radiopharmaceuticals. The more realistic model with a value of $2,000 continues to demonstrate the cost-effectiveness of the dose-based limit. Specifically, the savings in hospital costs under the earlier release time allowed are estimated at
$14 million, whereas the collective dose of 2,740 person-rem (at-a value of
$2,000 per_ person-eem) corresponds to a cost of about $5 million.
NUREG-1492 centains a detailed discussion of the model and the benefits and impacts of the dose-based limit. Single copies of the final regulatory
, analysis are available as indicated in the ADDRESSES heading.
Comment.- One commenter said that 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 ho:,pital room was overestimated, being $450 per day rather than $1,000 per day as assumed in the draft regulatory analysis. Response. The commenter is correct that the benefits of th'e rule were overestimated. The estimates in the draft regulatory analysis of days of hospitalization required did not include biological elimination of the 4 39 Attachment'1
I o Response._-The NRC believes that there may be some situations for which .- I a case-specific calculation could be done for a class of patients. The= record for a particular patient's release could then reference the calculation done for_ the class of patients. However, depending on a patient's individual-status (e.g., lower occupancy factor), there may be cases when the calculation will be done for a specific individual. . s Comment. One commenter said that the discussion on radiolabeled antibodies in the draft guide was wrong because antibodies labeled with iodine-131 will be deiedinated 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 are now modified. COMMENTS ON THE DRAFT REGULATORY ANALYSIS (DRAFT NUREG-1492) Consent. One commenter said that the.value of a person-rem should be
$40 rather than $1,000 as used in the draf t regulatory analysis for the
-purpose of evaluating the costs and benefits of the rule. The commenter cited a 1993 Health Physics Society position paper as a reason that the value should ;
be $40 per person-rem. 38 Attachment 1
guidance on the. interruption'or. discontinuation of breast-feeding should be lgiven. Expanded examples are 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 uample on hyperthyroidism was added. The NRC believes that the examples provided' illustrate the techniques sufficient to perform the whole range of potential calculations. Comment. One comenter said that the draft regulatory guide did not-provide enough information on when and for how long breast-feeding of infants should be interrupted. Response. Regulatory Guide 8.39 has been greatly expanded with-respect to information on the breast-feeding child, including a table on recomendations for the interruption or discontinuation of breast-feeding for specific radiopharmaceuticals. ' Comment. One comenter 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
.because of graphics limitations, but licensees may add photos if desired.
Comment. Several comenters asked whether multiple -individual calculations have-to be done or if a generally applicable calculation could be done once and-used for many patients.
?7 Attachment 1
Comocnt. One commenter said that the f actor of 10~' used in th.' draf t guide to estimate 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 af 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 upta6 #as measured in people exposed to a patient. These data suggest that .ie fractirnal uptake of the administered activity will be on the order of 10. Since iodine is among the most soluble and volatile radiopharmaceuticals, l', csn be expected that the transfer to others of less soluble and less volat!1e racicpharmaceuticals would be less than that of iodine, in addition, the NCRP recently concluded that, for individuals exposed te radionuclide therapy patients, the risks of external irrachtion and potential contamination are minor from a public health viewpoint: cherefore a significant intake from a contamination incident is very unlikely ' Comment . A medical organization coamented that the draft guide is not complete and does not provide sufficient comprehensive exampler to assist licensees in complying with the rule. Response. The NRC has expanded the guide to include information and further examples on the biological elimination of iodine-131 and on when 36 Attachment 1
and phosphorous-32. Another commenter said that the table should be expanded to include chromium-51, selenium-75, ytterbium-90, tin-ll7m. 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. The table of release quantities was also expanded to add values for chromium-51, selenium-75, ytterbium-90, tin-ll7m, and iridium-192. Comment. The table of release quantities in the draf t regulatory guide l should be expanded to include accelerator-produced radioactive materials as an aid to Agreement States. Response. Several accelerator-produced materials were added to The Regulatory Guide 8.39 as an aid to the States and to medical f acilities. NRC has no regulatory authority over the release of patients administered accelerator-produced materials and would not inspect the release of patients adtinistered accelerator-produced materials. Connent. 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 now provides more information on release quantities for iodine-131 based on biological half-lives. 35 Attachment 1
Response. Draft Regulatory Guide 8.39 discussed situations in which it might be permissible to lower the occupancy factor from 0.25 to 0.125, but did not recommend occupancy factors less than 0.125. Occupancy factors less than 0.125 may be difficult to justify because it is generally not realistic to assume that the patient can avoid all contact with others. However, lower values for the occupancy factor are not prohibited by the regulation, but they must be justified in the record of the calculation, as the record will be subject to inspection. 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 biological half-lives from ICRP Publication No. 53 should be used for thyroid Cancer. In Response. The NRC agrees that the commenters raised valid points. Regulatory Guide 8.39, the lodine retention fraction for thyroid cancer was changed to 0.05. The biological half-life for the extrathyroidal fraction was changed to 0.33 day. In addition, the biological half-lives from ICRP Publication No. 51. were osed for the thyroid cancer case. Connat. One carnunter said the table of release quantities in the draft guide should bc expanded to include beta emitters such as strontium-89 34 Attachment I b
be used with little consideration of the specific details of a particular patient's release. A review of published information, as described in the regulatory analysis, NUREG-1492, ' Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material" (1996), finds that measured doses are generally 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 given the option of using case-specific calculations that may be less conservative. Nevertheless, the NRC agrees that the assumption used in the draft guide of 24-hour nonvoiding in the thyroid cancer example was overly conservative. The revised example uses an excretion half-life of 8 hours as recommended by the ICRP in ICRP Publication 53, " Radiation Dose to Patients from Radiopharmaceutic al s . "' Comment. One commenter said that the occupancy factor (generally assumed to be 0.25 at I meter) should not be left to the discretion of the licensee because low occupancy 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 adjust the occupancy f actor, but wanted to know if other considerations are allowed and if it is acceptable to use values lower than 0.125.
' 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, 33 Attachment 1
assumption used in calculating doses is too conservative. As evidence that the calculations are too conservative, several commenters said that the doses measured using dosimeters were much lower than doses calculated using the models in the draft guide. Response. The NRC has revised the guide to use a phased approach for determining when release can be authorized. While the calculations can sometimes be complex, the results of calculations that use conservative assumptions are given in a table of release quantities in Regulatory Guide 8.39, ' Release'of Patients Administered Radioactive Materials
- Of the 8 to 9 million administrations performed annually, in all except about 10,000 cases (radiolodine therapy for thyroid cancer), release can be authorized based on conservative assumptions and using Table I with no calculational effort on the part of the licensee and no additional recordkeeping beyond what-is already required. - for permanent implants, the guide provides dose rates at 1 meter from the patient at which release may be authorized. Thus, for implants, there would be no calculational effort needed, in addition, the guide provides information on iodine therapy for thyroid cancer that can be used for determining release based on retention and elimination. This additional information in the guide will allow the licensee to perform the calculation with relatively little effort.
With regard to the comments that the methodology is too conservative and 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 release quantities that may 32 Attachment 1
1 l 1 l Response. The NRC recognizes that the licensee has no control over the patient after the patient has been released. The quantities for release l l listed in Table 1 of Regulatory Guide 8.39, " Release of Patients Administered l Radioactive Materials," were calculated using conservative assumptions (for example, by using the physical half-life of the radioactive material rather than the more realistic effective half-life). Thus, the NRC considers it unlikely that the dose to an individual in real circumstances would approach 5 millisieverts (0.5 rem). In special situations, such as when a released patient would tranediately board an airplane and would therefore be in close contact with one or more individuals, it may be necessary to base the release on a more realistic case-specific calculation. Once the patient is released, the responsibility for following the instructions is entirely the patient's, not the licensee's. COMMENTS ON THE DRAFT REGULATORY GUIDE Comments were also requested on Draft Regulatory Guide, DG-8015
" Release of Patients Administered Radioactive Materials," associated with this rulemaking. Because the guide is associated with the rule, the comments received on the draft guide are discussed here. Most of the comments concerned the method and the assumptions used to calculate the dose to the individual likely to receive the highest dose.
Comment. Several commenters said that the calculational methodology in the draft guide is too complex and that the assumptions are too conservative. As an example, several commenters said that the assumed 24-hour nonvoiding 31 Attachment 1
based on the licensee's determination that the total effective dose equivalent to aa individual from the released patient is not likely to exceed 5 millisieverts (0.5 rem). The dose to the bre'.st-feeding child from breast-feeding is a criterion for release but it can be controlled by giving the woman guidance on the interruption or discontinuation of breast-feeding, as required by the new 10 CFR 35.75. However, the release could be based on the def ault table of release activities in the regulatory guide or a patient-specific calculation, as required by the new 10 CFR 35.75. The issue l of the dose to the breast-feeding child is discussed in NUREG-1492 and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." Coment . One commenter said that the proposed rule did not accurately 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 ACMU! position. The final rule was discussed with the ACMul on October 18. 1995, and the ACMul, in general, supported the rule. (for ACMul's comments and NRC's responses, see V. Coordination with the ACMul,) Comment. One commenter said that its facility treated many foreign patients with therapeutic pharmaceuticals. These patients frequently may leave the hospital and immediately board a plane to return home. Thus, there is a limit to the amount of control that a licensee has over the patient. l 30 Attachment 1
Response. The term " release from licensee control." when read in context, refers to radiation protection considerations and is sufficiently clear that there is no need to define the term. MISCELLANEOUS COMMENTS ON THE RULE Consent. Several commenters said that the rule should not be a matter of Agreement State compatibility at any level. Response. The NRC does not agree. The NRC conducts an assessment of each proposed requirement or rule to determine what level of compatibility will be assigned to the rule. These case-by-case assessments are based, for the most part, on protecting public health and safety. NRC has_ evaluated the final rule and assigned compatibility designations ranging from level 1 (full compatibility required) to level 3 (uniformity not required) as detailed later in this federal Register notice. Comment. Several commenters said that a breast-feeding infant should - not be considered as an individual _ expossd to the patient for the purposes of determining whether patient release may be authorized. These commenters said that consideration of the breast-feeding 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--the public health and safety, and that responsibility extends to all individuals exposed to a patient administered licensed radioactive materials, including breast-feeding children. When the release is authorized, it is 29 Attachment 1
However, 9000 health physics practice would be to continue to make efforts to maintain doses to people at the facility as low as is reasonably achievable. Cossent. Commenters also asked how a patient can be corfined to his or her house. l Response. These commenters misunderstood the concept 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 text of the rule uses the phrase " licensee control" to more clearly reflect the NRC's intent. The NRC believes that there is a distinct difference between a patient being under licensee control in a hospital or other licensee facility (e.g., a hospice or nursing home) and being at home. In a hospital or other area or address of use listed on the NRC license, the Itcensee 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 under 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. Comment. One commenter thought that the rule should define the term I
" release."
28 Attachment 1
th'at 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 f I to exceed 1 millistevert (0.1 rem), instructions are not required but the l physician could give any instructions that he or she considers desirable.. i I i CONFINEMENT Of PATIENTS , Consent. Two commenters said that patients cannot be confined against ; their wishes and that the rule provides no penalty for the patient who leaves c.onfinement 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. i
#esponse. The NRC recognizes that patients cannot be held against their ,
will. The rule deals with the conditions under which the licensee may l 1 authorize release. The NRC would not penalize a licensee for the activities of.the patient after release or if the patient were to leave "against medical i advice." . Comment, One commenter asked whether a patient who was releasable but was still hospitalized for other reasons would still be considered under the licensee's control. Response. 0nce the itcensee has authorized the release of the patient, E there is no need to keep the patient under licensee control for radiation I '- protection purposes if the patient remains hospitalized for other reasons. ; i 27 Attachment 1 l i.
- u. _ . . . . . _ . ,.._._.u _ . . , _ _ . _ . . , _ _., _ ,- _ _ __ ._ -....._ _ ,_ _ _ ._ _.-
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 ever 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. However, it is the l responsibility of licensees to provide instructions to the patients, following the instructions is normally the responsibility of the patient. However, American medical practice routinely depends on patients following instructions, such as instructions on when and how to take medications. With regard to compliance with the instructions, surveys of patients and their spouses, as discussed in the supporting regulatory analysis, indicate that most will attempt to follow the instructions faithfully, especially with regard to protecting their children, although some patients and their spouses indicated that they might not keep physically distant from their spouse for prolonged periods of time. Comment. One commenter said that instructions should be given for all administrations of radioactive material, regardless of the quantity administered. Response. The NRC does not agree. In some cases, particularly in the large number of diagnostic administrations, the potential doses are so small 26 Attachment 1
1 include in the contents of the written instructions, and is directed at minimizing the risk to the patient's family who have no doctor-patient relations to the prescribing or administering personnel. However, Regulatory Guide 8.39, ' Release of Patients Administered Radioactive Materials," recommends contents of the written instructions. Further discussion of the 1979 Medical Policy Statement is presented under the heading, " Vill. Consistency with 1979 Medical Policy Statement." 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 patient, although the 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 additional oral instructions.
Consent. Several commenters-asked how the NRC would enforce implementation of the instructions given to the patient. Another commenter 25 Attachment 1
#esponse. 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 or care givers. 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 instructions. The NRC believes that for the majority of releases requir%g written instructions, the written instructions can be prepared in a generic form. For example.-the Society of Nuclear Medicine has prepared a brief pamphlet, " Guidelines for Patients Receiving Radiciodine Treatment," which can be 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 is "The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine." The final rule is consistent with this statement because it does not dictate the choice of medical treatment or diagnosis, does not specify the details of what the physician must say or must-24 Attachment 1
i WR111LN INSTRUCTIONS 10 PAllENTS l l in general, thare was little objection to providing instructions to patients on how to minimize the dose to others, but there was significant opposition to the propostd requirement that the instructions would have to be 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 connenter is correct. The Statement of Considerations was ir. errer on that point. The existing regulations do not specify that instructions have to be in written form. Comeent. A number of commenters said that instructions should not need Some of these to be written and that oral instructions should be permissible. comnienters said that oral instructions are more effective and that how 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. One commenter said that the physical condition of the patient could lessen the patient's ability to follow the instructions. Another consenter 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 maintenance organization strongly supported the requirement that the instructions be written. 23 Attachment I
pharmacists to work for the NRC for a period of 1 to 2 years. Both the ACMut and the current Visiting Medical Fellow, Myron Pollycove, M.D. provided advice to the NRC during the development of this rule. In addition, Barry A. Siegel, M.D., Chairman of the ACMul, 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 of the two, results in multiple large administeattons that would be likely to cause the 5-millistevert (0.5-rem) dose limit to Oe 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 millistevert (0.1 rem) has been deleted, a recordkeeping requirement with a reduced impact has been retained as discussed under the heading, " Discussion of Text of final Rule." Comment. Several commenters said that those who pay for health care will put great pressure on physicians to optimize calculations to reduce in-patient days and to justify out-patient treatments. Response. There is no objection to optimizing calculations to reduce in-patient days as long as the calculations are realistic and the 5-miliistevert (0.5-rem) limit in 10 CFR 35.75 is met. Regulatory Guide 8.39,
" Release of Patients Administered Radioactive Materials " describes examples of calculations that are acceptable to the NRC.
4 22 Attachment 1
effective dose equivalent greater than 1 millisievert (0.1 rem) are not done to the same patient routinely. Other commenters said that there have been 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 documentation required at the 0.1 rem level. Another commenter said that it cannot be a licensee's responsibility to know the detatis of a radionuclide therapy performed by another licensee in terms of which members of the public received the most radiation dose from 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, which would 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 millistevert (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 ensure that the total dose to an individual exposed to the patient did not exceed 5 millisieverts (0.5 rem). The NRC has an advisory committee, the Advisory Comittee on the Medical Uses of Isotopes, or "ACMul," which advises the NRC on rulemakings and other initiatives related to the medical use of byproduct materials. The NRC also has a visiting medical fellows program that recruits selected physicians or 21 Attachment I f;
1he NRC does not agree that the latter NCRP recommendation should apply in l general. The NRC believes that if the dose to another individual is likely to exceed 5 millisieverts (0.E rem), the patient should reaatn under the control l of the licensee. Licensee control is necessary to provid: adequate protection l to the individuals exposed to the patient. RECO'tDKEEPING The strongest opposition to the prop 3 sed rule was to the proposed l 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, the licensee would use the records to determine the dose from the previous administrations so that the total dose to an individual exposed to a patiert from all administrations would not exceed 5 millisieverts (0.5 rem). Comeent. 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 mske calculations and keep records be removed. The commenters believed that the work would not produce an increased level of safety, that the NRC greatly underestimated the cost, and that the recordkeeping would be unnecessary, inappropriate, and impractical. Son'a commenters said that multiple administrations that would result in a total 20 Attachment 1 w
individual exposed to a patient has 50 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 millisteverts (0.5 rem). This is consistent with the recommendations of the ICRP in ICRP Pubitcation 60,* '1990 Recomendations of the International Commission on Radiological Protection"; and the recommendations of the NCRP in NCRP Report No.116,* " Limitation of Exposure to lonizing Radiation." Each of these recommendations provides a basis for allowing individuals to receive annual doses up to 5 millisteverts (0.5 rem) under certain circumstances. Both the ICRP and the NCRP recommend that an individual can receive a dose up to 5 niillisieverts (0.5 rem) in a given year in situations when exposure to radiation is not expected to result in doses above 1 mil 11 sievert (0.1 rem) per year for a long period of time, as would be the case for doses from released patients, in NCRP Commentary No. 11, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients "' the NCRP recommended a dose limit of 5 millisieverts (0.5 rem) annually for members of the patient's family. However, on the recommendation of the treating
. physician, the NCRP considered it acceptable that members of the patient's family be permitted to receive doses as high as 50 millisieverts (5 rems).
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.
' National Council on Radiation Protection and Measurements, " Limitation of Exposure to lonizing Radiation," NCRP Report No, 116 (March 31, 1993).
Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda. 7 20814-3095. 19 Attachment 1
5 millisteverts (0.5 rem). For example, if a licensee uses the default table of release quantities provided in the regulatory guide as the basis for release, a patient administered 1,221 megabecquerels (33 millicuries) or less of iodine-131 could be immediatcly released and no record of release is required. However, if the licensee wishes to release a patient with an activity that is greater than the value in the default table, the licensee must do a dose calculation using case-specific factors to demonstrate compliance with the release criteria. Furthermore, if the table is used as the basis for release but the administered activity exceeds the value in the table, the licensee must hold the patient until the time at which the retained activity is no greater than the quantity _in the table or the dote rate at 1 meter is no greater than the value in the table. When the administered activity is greater than the value in the default table, a record of the basis for the release must be maintained for NRC review during inspection. Regardless of the method used by the licensee to authorize release, the dose limit of 5 millisteverts (0.5 rem) in the revised 10 CFR 35.75 applies. By-identifying more than one method for calculating the release of a patient in accordance with 10 CFR 35.75, the NRC provides greater flexibility for .itcensees to achieve compilance with the new requirement while still providing adequate protection of public health and safety. Consent. One commenter said that in some cases it should be permissible to authori.t the release of a patient even if the dose to a family member might exceed 0.5 rem because the release might be beneficial and acceptable:to family members. Another commenter said that a dose of 0.5 rem to an 18 Attachment-1
l i (0.5-rem) limit that is applied to household members exposed to a patient is a special limit that is appropriate for only occasional use and for use where there is a definite need. This special limit fits the case of .toses received i by the household members of a released patient, but does not fit the case of people who frequent a hospital on a routine basis. Lastly, in limiting doses, the NRC considers what is reasonably achievable. The mere fact that a home cannot control contamination as well as e hospital does not mean that the contamination control achieved in homes is not adequate. Actual measurements of doses to household members from contamination, as discussed in NUREG-1492, show that the doses from contamination are low, demonstrating that-the degree of contamination control that was achieved is adequate. Consent. One commenter said that the proposed rule did not adequately address the concerns that the Agreement States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries. Response. -In commenting on the petitions, a number of States expressed concerns about releasing patients administered 14.8 gigabecquerels (400 millicuries) of iodine-131, which one of the petitioners had requested. However, the States that commented were generally favorable to the proposed rule limiting the dose to the most exposed individual to 5 millisieverts (0.5 rem), and none of the States indicated that their concerns 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. The dose-based limit would generally permit releases if the dose to another-individual would not be likely to exceed 17 Attachment 1
Regarding the comment on the doubling of risk of developing thyroid cancer, there is no scientific consensus by the United Nations Scientific Committee on the Effects of Atomic Radiation, ILRP, or NCRP to support the suggested increased risk of thyroid cancer following ingestion of iodine-131. Based on the information currently available, the Commission continues to conclude that the benefits outweigh the potential of small increased risks associated with this rule. Comocnt. One commenter noted that hospitals now make great efforts to control contamination from patients who are now hospitalized because they contain more than 30 millic~ies of iodine-131. This commenter stated that it would not be possible to maintain the same level of contamination control at these patients' hores if these patients were released with more than 30 millicuries of iodine-131. Rcsponse. Tne NRC agrees that, even though released patients are given ins'. ructions en how to limit the hazard from contamination, contamination cuntrol in a hospital can be more effective than contamination control out of In the the hospital. However, the two situations are not really comparab!e. case of the released patient
- iome, therapeutic administrations almost never occur more than once in 1 year and only rarely occur more than once in a lifetime; but in the case of a hospital, large therapeutic administrations are done repeatedly on many patients. Therefore, areas in hospitals have the potential for contamination from many patients, and people who frequent the hospital (e.g., clergy or a hospital orderly) have the potential to be exposed to contaminat ion from many patients. In addition, the S-milli:ievert 16 Attachmcat 1
l i released patients'have been measured in several studies and in every case were less than 10 percent of the 5-millistevert (0.5-rem) total effective dose equivalent limit and were most often less than 1 percent of the 5-millistevert In addition, the internal doses resulting from contamination (0.5-rem) limit. were always less and generally far less than the external dose, meaning that These contamination was the less important source of radiation exposure. measurements show that even if the family members repeatedly touched household
-items touched by the patient, contamination does not cause unacceptably high doses. These findings were true even in the case of a British study =where eleven patients volunteered to disregard special precautions against These measurements - contamination and minimizing spousal and family exposure.
are discussed in NUREG-1492. Also the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No.11. " Dose Limits f or Individuals Who Receive Exposure from Radionuclide Therapy Patients," and concluded that, "... a contamination incident that could lead to a significant intake of radioactive material is very-unlikely."' In general, the physical reactions (e.g., vomiting) that a patient may experience from the administration of any radiopharmaceutical are rare. Vomiting is seldom an important elimination route for radiopharmaceuticals af ter the patient has lef t the medical f acility since orally administered radiopharmaceuticals such as iodine-131 are rapidly absorbed, within a half hour, by the gastrointestinal system.
' National Council on Radiation Protection and Measurements, " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Commentary No. 11 (February 28,1995). (Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
15 Attachment 1 y
i 3 specifies the dose rate at I meter of commonly used radionuclides that allow ; licensees to authorize patient release. i RELEASE QUANTITIES Using 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 release of a patient with more than 1,110 megabecquerels (30 millicuries) of-activity. Some commenters were opposed to allowing releases with higher activities than are now permitted. Consent. Several commenters said that the release of 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 I The same members'from the patient vomiting were not adequately considered. commenter'also said that a study indicated that in-home contamination by patients dosed with 1-131 could double family members' risk of developing thyroid cancer.
+
Response. The concern over contamination is not justified by the radiation doses that- are likely to be caused by the removal of radionuclides from the patient's body by the pathways of exhaled air, feces, saliva, sweat. urine, and vomit. Measurements- from several studies, as discussed in the i supporting regulatory analysis, have shown that a relatively small proportion t Doses of the radioactive material administered will appear as contamination. to f amily members exposed to contamination from living in close contact with 14 Attachment I a
NOREG-1492 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 analysis and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials " are available as indicated in the ADDRESSES heading. Consent. A commenter said that the calculational approach in the rule would require the physician to ask many personal questions of the patient. Response. The commenter is incorrect in believing that the dose-based approach will generally require personal information from the patient. Tne NRC anticipates-that nearly all patients will be released based on default assumptions which do not require any personal information from the patient. A table of release quantities, based on standard conservative assumptions, is provided in Regulatory Guide 8.39 " Release of Patients Administered Radioactive Materials." However, the rule does allow the physician to calculate patient-specific dose estimates to allow early release of_ a patient not otherwise subject to release under the def ault values in Regulatory Guide 8.39. ' Personal information may be necessary for such patient-specific Cases. Consent. One commenter said that it should continue to be acceptable to release patients based on the dose rate at I meter. Response. The rule authorizes release of patients based on the dose in a year. However, release quantities based on dose rate and conservative assumptions can be calculated. The table of releaseiquantities in Regulatory Guide 8.39. " Release of Patients Administered Radioactive Materials," 13 Attachment 1
i radioactive material in the body of the patient and other factors that vary for different materials. For these reasons, the NRC is establishing a dnse limit rather than an activity or dose rate limit. The NRC is establishing a dose limit of 5 millisteverts (0.5 rem) total effective dose equivalent to an individual from exposure to the released patient for each patient release. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35.75 (50 FR 30627' July 26, 1985), the recommendations of the NCRP and the ICRP, and the provisions in 10 CFR 20.130)(c) pertaining to temporary situations in which there is justification for a dose limit higher than 1 millistevert (0.1 rem). The NRC believes that the dose-based release limit can and will work well because the associated Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," 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 guide is based on NCRP Report No. 37, " Precautions in the M wagement of Patients Who Have Received Therapeutic Amounts of Radionuclides."' In the case of iodine-131, the most significant radionuclide, the release quantity based on the standard conservative assumptions is 1,221 megabecquerels (33 millicuries), which is essentially the same as the current release quantity. l
' National Council on Radiation Protection and Measurements (NCRP),
" Precautions in the Management of Patients Who Hwe 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 20814-3095.)
12 Attachment 1 l t
,= _ - . . -
The majority of commenters supported the dose-based limit, tiowever, 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 millirem per hour releare criteria should be retained because-they are working well. Some comenters said that a dose-based release limit as proposed would cause confusion and potential problems. One commer.ter said that tne 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 these estimates are based on the unreliable method of predicting the anticipated time and proximity to others. Commenters also said that dose estimation and the subsequent recordkeeping would be time consuming and would add to the cost of treatment without a probable significant decrease in radiation exposure. l Response. The NRC is adopting a dose-based limit rather than an activity-based I;mit because the dose-based limit better expresses the NRC's primary concern for the public's health and safety. A single activity requirement was not retained because different radionuclides with the same activity can give very different doses under identical exposure conditions. Likewise, a single dose rate requirement for all radionuclides was not retained because different radionuclides with the same dose rate, at the time of release, can give very different doses depending upon the half-life of the radionuclide. The total dose depends on the effective half-life of the l_ l i 11 Attachment 1
~ _ _ . _ . , _ . . . _ _ . . _ . . - _
1 l l l -. steps are taken to reduce the dose to as low as is reasonably achievabic. The NRC reaffirms that previous determination in this rulemaking. - In the case of released patients, it would be unlikely for a single individual exposed to a patient to receive a dose in a year of over 1 mil 11 sievert (0.1 rem) because large therapeutic doses (greater than 3,700 megabecquerels (100 militcuries)) are rarely administered more than once to the same patient in a given year. 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 rem offers adequate protection and is a dose that has no proven effects. 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 , recently revised (56 FR 23360; May 21, 1991). That rulemaking explained the NRC's rationale for adopting the 1-mil 11 sievert (0.1-rem) dose limit in 10 CFR 20.1301(a)(1). ACTIVITY-BASED VS. DOSE-BASED RELEASE LIMIT The issue is whether to retain the current patient release limit in 10 CFR 35.75, which is expressed as'an~sctivity limit together with an alternative but approximately equivalent limit on dose rate at I meter, or to express the release limit as a dose to an individual exposed to the patient. < 10 Attachment 1- ; 2
i f i ; 1 - low as-is reasonably achievable, a dose limit of 1 millistevert (0.1 rem), or
- +
a dose limit of 5 millisleverts (0.5 rem) in certain special circumstances, [- provides adequate protection. The revised Part 20 is based, in part, upon the I 4 recommendations of the International Commission on Radiological Protection , (ICRP) and the recommendations of the National Council on Radiation Protectio f r and Measurements (NCRP). The NCRP recommends public dose -limits of 1 mi111 sievert (0.1 rem) for continuous or frequent exposure and 5 millisieverts (0.5 rem) for infrequent exposure. ~ The ICRP reenmmends'that the limit for public exposure should be
- expressed as an effective dose of 1 mil 11 sievert (0.1 rem) in a year, except f
that, in special circumstances, the dose could be higher in a single year provided the average over 5 years does not exceed 1 millistevert (0.1 rem) per l year. In ICRP Publication 60, in defining medical exposure, ICRP stated that medical exposure includes " exposures (other than occupational) incurred i knowingly and willing1/ by individuals helping in the support and comfort of patients undergoing diagnosit >r treatment." furthermore, in explaining dose limits in medical exposure, the ICRP stated in' the same publication that "the Commission therefore recommends that dose limits should not be applied to ; 4 medical exposures." Thus, in ICRP's opinion, family members who are helping in the support and comfort of patients would not !a restricted under the dose limit stated above. The revision of Part 20-incorporated the long-term objective as the dose i limit and included a provision ($ 20.1301(c)) to allow for a'ternative limits on an occasional basis. Section 20.1301(c) provides that an annual dcse of up to-5 millisieverts (0.5 rem) is acceptable if there is a need for it aid if 9- Attachment 1
, . - ~ - y.r,-
i
..,_,,,,,c ~
,y ,r,- , .n,.m __-,.cm-_ um...,- U,.y,.w3.- .._.~c,,, ., or-, - _ -.- -
,-m.- - ., . %.M,',-
111. Public Comments on the Proposed Rule A total of 63 comment letters were received on the proposed rule, the draf t regulatory guide, and the draft regulatory analysis. A majority of the [ comment letters were front medical practitioners and medical organizations, but there were also comment letters from private individuals, public-interest groups, and regulatory agencies in Agreement States. Overall, the majority of comment letters supported a dose limit of 5 millisleverts (0.5 rem) for individuals exposed to patients released with radioactive material. However, about one-fourth of the comment letters opposed the proposed recordkeeping h requirement. The significant comments are discussed below, arranged by subject. EXCLUSION OF PATIENT RELEASE FROM i 20.1301(a) All the commenters except one supported governing patient release by the regulations 4 tr JR 35.75 and excluding the dose to individuals exposed to a - released patient fron 10 CFR 20.1301(a). Comment. One commenter, representing a public-interest group, objected to any exposure of a member of the general public who has not consented freely to the dosage. They said that such exposure would lead to widespread morbidity and mortality. Response. In its revision of 10 CFR part 20 (56 FR 23360; May 21, 1991), the NRC determined that, while doses should be maintained as 8 Attachment 1
- calculated total effective dose equivalent to the irdividual 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 millistevert (0.1 rem) in a' year from a single administration. The major purpose was to provide a e
record to allow licensees to assess the need to limit the dose to individuals exposed to a patient'who may receive more than one administration 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 phrase "if required by 5 35.75(b)" was added-to each. The purpose of this change was to make Part 35 consistent-as to when instructions must be given. In addition, the NRC concurrenvly issued an associated draft regulatory guide and supporting draft regulatory analysis for public comment. -The draft regulatory guide, DG-8015 " Release of Patients Administered Radioactive Materials," proposed 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 uatient. The draft guide also proposed guidelines on instructions for patients on how to maintain doses to other individuals as low as is reasonably achievable and it described recordkeeping requirements.- The draft regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Haterial" (May 1994), examined the benefits and impacts of'the proposed rule considered by the NRC. 7 Attachment 1 <
-The NRC proposed to adopt a new 10 CFR 35.75(a)-to change the patient-release criteria from 1,110 megabecquerels (30 millicuries) of activity in a patient or a dose rate'of 0.05 millisievert (5 millirems) per hour at I meter from a_ patient to a total effective dose equivalent not to exceed 5 millisieverts (0.5 rem) in any 1 year to an individual from exposure to a released patient. A dose-based limit provides a single limit that could be used to provide an equivalent level of risks from all radionuclides, Also, .the proposed changes were supported by the recommendations of the ICRP and the NCRP that an individual could be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations when exposurc to radiation.
is not expected to result in annual doses above 1 millisievert (0.1 rem) for long periods of time. The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that the licensee provide released patients with written instructions on how to-maintain doses to other individuals as low as is reasorably 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 l_ year. A-t requirement to give instructions to certain patients was already contained in
-10 CFR 35.315(a)(6) and 35.415(a)(5), but the proposed requirement would also require' instructions for an additional 50,000 individuals who are administered -iodine-131 for_ the treatment of hyperthyroidism and another 27,000 individuals who are breast-feeding and administered various diagnostic and therapeutic . radioactive materials. The purpose of the . instructions is to maintain doses to individuals exposed'to patients as low as is reasonably achievable.
The NRC proposed to aCopt a new 10 CFR 35.75(b)(2) to requi_re that licensees maintain, fo' 3 years, a record of the released patient and the 6 Attachment 1 i
On June 15, 1994 (59 FR 30724), in response to the first two petitions, the NRC published a proposed rule on criteria for_the release of patients administered radioactive material. . 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-il). 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 would not be required to control areas (such as waiting rooms) simply because of the y 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, licenseu would not be required to limit the radiation dose from a patient _to members.of the i public (e.g., visitors in a waiting roum) to 0.02 millisievert (2 millirems) in any I houri Patient waiting rom:, or hospital rooms would need only be
~ controlled for those patients not meeting the release criteria in 10 CFR-part-_35, 5 Attachment 1
1 i
-comment on,'a petition for rulemakina (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 regtest 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 j petition (PRM-35-10A), in addition, a third petition (PRM-35-ll) 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 raised in the petition was that the radiation dose limits in 10 CFR part 20 should not apply to individuals exposed to the patient and that The AMA the cose limit to the individuals should be 500 millirems per year. 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 (10 CFR 20.1301), reducing both et.rly release of pattents and the treatment of
- patients at home.
- 11. Publicatior, of'the Proposed Rule 4 Attachment 1
\
hereinafter referred to as " patients," These patients can expose others
- around them to radiation until- the radioactive material has been excreted fro their bodies or_the radioactivity 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 I 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 the' measured dose rate'from the patient or human research subject is less than i '5 millirems per hour at a distance of 1 meter."
On May 21, 1991 (56 FR'23360), the NRC published a final rule that The -l amended 10 CFR part 20, " Standards for Protection Against Radiation." f 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 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. Some licensees were uncertain about what effect the revised 10 CFR part 20 would have on patient release criteria,- and 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 l 3 Attachment 1 ll w .,. - f e v , -,, -e. - - .- --%, .-
t 2
. ADDRESSES: Copies. of Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials"; the final regulatory analysis..NUREG-1492, " Regulatory i
Analysis on Criteria for the Release of Patients Administered Radioactive Material" (1996); Revision 2 of NUREG/BR-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission" (1996); and the public comments f received on the proposed rule may be examined and copied for a fee in the Commission's Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC.- Single copies of Regulatory Guide 8.39 may be obtained free of charge by writing the Office of Administration, Attn: Distribution and Services Section, USNRC,-Washington, DC 20555, or by fax at (301) 415-2260. Single copies of NUREG-1492 and NUREG/BR-0058 may be purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328 (telephone (202) 512-1800); or from the National Technical Information Service at 5285 Port Royal Road, Springfield, VA 22161. FOR 'FURTHER :lNFORMATION CONTACT: Stewart Schneider or Stephen A. McGuire, Of fice of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6225. I. Background Each year in the United States, radioactive pharmaceuticals or compounds or radioactive implants are administered to approximately 8 to 9 million individuals for the diagnosis or treatment of disease or for human research. These individuals to whom radioactive materials have been administered are 2 - _ _ _ - - _ - _ _ - . .~ _ . _ . _ .
. -- .- .. . - - . . - - -. - ~ .-_ - . . ... ._ - . - - . . . . . . . -
1 [7590-01-P) ; NUCLEAR REGULATORY COMMISSION i 10 CfR Parts 20'and 35 4 RIN 3150-AE41 Criteria for the Release of Individuals ' Administered Radioactive Material ; 4 AGENCY: Nuclear Regulatory Commission.- 1-i ACTION: Final rule.- i T i
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 the potentia ^
5 dose to othat individuals' exposed to the patient.._The new criteria are ,
- consistent with the recommendations 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 1 provide written instructions to patients on how to maintain the doses to i others as low as is reasonably achievable if the total-effective dose ' equivalent to any other individual exposed to the released patient is likely to exceed 1 millistevert (0.1 rem). This final rule responds to three b petitions for rulemaking regarding the criteria for release of patients administered radioactive material. 5 # L EFFECTIVE DATE: (120 days following publication in the Federal i j; Register). ) i r
ATTACHMENT 1 FErlFDf.L REGI!?ER NOTICE
7 The Commissioners
- 3. Notes:
- a. The final rule will become effective 120 days after publication in the Federal Reaister,
- b. A final regulatory guide will be published, for use, before the ,
final rule becomes effective (Attachment 2).
- c. A final regulatory analysis will be available in the Public Document Room (Attachment 3),
- d. A final environmental assessment and a finding of no significant impact have been prepared (Attachment 4),
- e. 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,
- f. The appropriate Congressional Committees will be informed (Attachment 5);
9 A public announcement will be issued (Attachment 6).
- h. The rule contains information collection requirements that are Upon subject to review by the Office of Management and Budget.
Commission approval, the OMB supporting statement (Attachment 7) will be submitted to OMB for approval.
- i. Copies of the Federal Reaister notice of final rulemaking and the associated regulatory guide will be distributed to all NRC medical licensees and each Agreement State. The notice will be sent to other interested parties upon request.
I James M. Taylor Executive Director for Operations Attachments: As Stated (7)
lhe Commissioners 6 Second,-the ACNUI suggested using the phrase "the retained activity rather j than the activity administered" instead of "an activity other than the activity administered" in the requirement under 10 CFR 35.75(c), to maintain a record of the basis for authorizing the release-of an individual, if the total effective dose equivalent is calculated. The ACMul was concerned that the meaning was not clear, and in addition, the requirement was already implicit in the remainder of the recordkeeping requirements in 10 CFR 35.75(c). The staff changed the rule in response to the ACMul coment. This information would be needed for cases where a patient would be held for some time period prior to release. Such cases would not be covered in the default rele;se l table that appears in the-regulatory guide, in this case, a record is needed to confirm that the licensee has released the individual in accordance with the limit in Part 35. Regulatory Guide 8.39 will provide guidance on-cases where such records will be needed for release.
-Third, the ACMUI suggested that the term " discontinuation" should be used in p conjunction with " interruption" in the requirement to provide "guida_nce on the interruption of breast-feeding" if failure to follow the instructions could result in a dose to the infant exceeding 1 millisievert (0.1 rem). The ACMUI suggested the change because they said that there is a. distinct difference between the two terms. The staff changed the rule in response to the ACMul comment. As stated in the Federal Register notice, "the instructions must include guidance on the interruption period for breast-feeding." Table 2 in the guide gives interruption periods for various radiopharmaceuticals which can be temporary (48 hours or less) in some cases, or discontinuation (no resumption) when_necessary.
Finally, the ACMUI recommended that the Commission proceed with the rule as promptly-as possible. 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 have a significant economic impact on a substantial number of small entities; such certification will satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
S The Commissioners The regulatory guide will contain interruption periods that keep the dose from breast-feeding to less than 1 millisievert (0.1 rem). The purpose of describing the consequences is so that women will understand that breast-feeding after an administration of certain radionuclides could cause harm (e.g., iodine-131 could harm the child's thyroid). In other cases, the guidance could simply address avoidance of any The unnecessary radiation exposure to the child from breast-feeding. regulatory analysis indicates the basis fnr selecting the option of enhancing communications and instructions to breasting-feeding women.
- 6. The amendments make it clear that the limit on dose in unrestricted areas presented in 10 CFR 20.1301(a)(2) 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 licensees are not responsible for doses outside ofThetheir restricted areas from radiation sources not under their control.
comments supported this position. The final amendments represent a partial granting of the regulatory relief requested by the petitioners. The request to delete 10 CFR 20.1301(d) was denied because the reference to the Environmental protection Agency's regulations in 10 CFR 20.1301(d) has nothing to do with the patient release issue. Also, the request to permit licensees to authorize release from hospitalization any patient administered a radiopharmaceutical regardless of the activity in the patient by defining " confinement" to include not only confinement in a hospital, but also confinement in a private residence, was denied. The staff considers it inadvisable to use a patient's home for the purpose of confinement when the activity in the patient is expected to result in a dose exceeding 5 millisteverts (0.5 rem) to another individual. At its last meeting, held on October 18 and 19, 1995, the ACMUI passed several motions suggesting changes to three aspects of the rule. First, the ACMul suggested using the term " rationale" instead of
" consequences" in the requirement, under 10 CFR 35.75(b), to provide " guidance on the interruption of breast feeding, and information on the consequences of failure to follow the guidance" for cases where f ailure to follow the instructions could result in a dose to the infant exceeding 1 millisievert Since most of the administrations that would be affected by this (0.1 rem).
requirement are technetium-99m administrations, the ACMUI suggested the change , because there was concern that the consequences of low doses of radiation l cannot always be explained to the patient without causing unjustified alarm. Also, there was concern that physicians cannot explain with certainty the effects of low doses of radiation, such as would be caused by diagnostic The staff did not change the rule in administrations of technetium-99m. response to the ACMUI comment because the requirement to provide information on the consequences is included primarily to protect the breast-feeding infans l from therapeutic administrations of radiciodine, which could cause serious l thyroid damage. Regulatory Guide 8.39 will contain guidance on the types of j information, including expected consequences, to be provided to patients to meet this requirement. l
The Commissioners 4 Overall, a substantial majority of all comments supported an explicit dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material in their bodies. In addition, ACHUI and the Agreement States supported the criterion based on a dose limit. A few commenters who thought that the present criteria were working well and were adequate opposed allowing the release of patients with quantities of radioactive material greater than that permitted under the current regulations.
- 4. The proposed rule would have required 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. This requirement was proposed so that records would be available to calculate the dose if a patient received multiple administrations in a year.
This proposed recordkeeping requirement met a great deal of opposition. Commenters were especially concerned about having to retrieve records of previous administrations, sometimes from another medical facility. Upon reconsideration, it was decided to delete this requirement because a review of nuclear medicine procedures indicated that there was nu significant likelihood of exceeding a 5-millisievert (0.5-rem) annual dose because of multiple administrations. In place of the deleted recordkeeping requirement, the final rule contains requirements to maintain: (1) a record for the basis of the release for a limited number of certain radiopharmaceutical administrations (e.g., therapeutic administrations of iodine-131) and (2) a record that instructions were provided to a breast-feeding woman if the administered activity could result in a total effective dose equivalent to the breast-feeding child exceeding 5 millisieverts The (0.5 rem) if the woman did not interrupt breast-feeding. requirements (in 10 CFR 35.75(c) and (d)) would affect about 20,000 of the 8 to 9 million administrations done annually.
- 5. The amendments require that the patient be given instructions, including written instructions, on how to maintain doses to others as low as is reasonably achievable if the dose to an individual is likely to exceed 1 millistevert (0.1 rem). In general, most commenters agreed with this requirement, although a few did not think that instructions should necessarily havr. to be written.
The proposed rule had a requirement to provide instructions which would include guidance on breast-feeding children, 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 final rule requires that guidance regarding interruption of breast-feeding and consequences be provided if the released individual may be breast-feeding an infant or child and the total effective dose equivalent is likely to exceed 1 millisievert '0.1 rem).
E, i 3 The Commissioners -t
- 1. The major changes to the final rulemaking are: (1)'significant :
expansion-of the discussion on breast-feeding in the Statement of Considerations and the regulatory analysis and (2) explicit use of the , term " breast-feeding" in the final rule text to make it clear that breast-feeding women are a class of patients requiring additi The subject of breast-feeding.was mentioned in the Statement of ' Considerations to the proposed rule but not in the proposed rule text.
.The amendments make it clear that patient release is gcVerned by.
- 2. ;
10 CFR 35.75 rather thra by 10 CFR 20.1301(a). There was very broad agreement with this p- ion in the comment letters, with ACMUI, and with the Agreement States. ' 3.- 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 of 5 millisieverts (0.5 rem), excluding background or any occupational exposure, to an individual exposed to the patient.
I Specifying the release criterion in terms of radiation dose requires that the NRC provide an acceptable method that relates the quantity of radioactivity administered to that dose. That relationship will be: included in a regulatory guide. A working draft of that guide is , attached (Attachment 2); the staff is still reviewing the guide, but l will publish it in final form before the final rule becomes effective. The-guide presents-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 staff anticipa es that nearly all patients will be released based on the default table of activities. 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 patient's 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 or. allowed with use of the-default table. The authorization to release a patient.is based on the licensee's determination that'the total effective dose equivalent to an individual from the released patient is not likely to exceed 5 millisieverts The dose to the breast-feeding child from breast-feeding is . (0.5necessarily'a not rem). criterion for release since it can be controlled by giving the woman guidance on the interruption of breast-feeding, as required by the amendments (see No. 5). J
The Commissioners 2 NRC's current patient release criteria are contained in 10 CFR 35.75, " Release of patients or human research_ subjects containing radiopharmaceuticals or permanent - impl ants. " That section states: "(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 I 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 the measured dose rate from the _p atient or the human research subject is less than 5 millirems per hour at a distance of 1 meter," Some licensees were uncertain about the effect that the revised 10 CFR Part 20 would have on patient release criteria, and 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 governs patient release. Information Notice No. 94-09 was issued on February 3, 1994, to inform licensees of this position in accordance with a Staff Requirements ~ Memorandum (SRM) dated January 28, 1994. The longer term resolution was to address this issue through rulemaking, and a proposed rule was published for comment on June 15, 1994 (59 FR 30724). The proposed rule was transmitted to the Commission in SECY-94-054 and responses to questions raised by the Office of the inspector Generhi are contained in SECY-94-054A, DISCUSSION: The final rule (Attachment 1) takes into consideration the recommendations of 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 63 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 October 18 and 19,. 1995. The following summarizes the main features of the amendments:
- One commenter raised an issue about contacts allegedly relating to this rulemaking between one of the petitioners and the Office of the Chairman. The staff notes that the final rule is based on the public record associated with the rulemaking and that the NRC decision maker with whom contact was made is no longer with the Commission. The staff has not included any further comment with respect to this issue in the final rulemaking package.
l fA8: The Commissioners FROM: James M. Taylor Executive Director for Operations
SUBJECT:
FINAL AMENDMENTS TO 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 Reatster. BACKGROUND': On May 21,19'11 (56 FR 23360), the NRC published a final rule that sended 10 CFR Part f.0, " 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.
' The subject paper was submitted to the Commission on November 30, 1995 (SECY-95-286). Subsequently, the staff requested withdrawal of the paper to revise the regulatory analysis (RA) to conform with the new RA guidelines. In a Staff Requirements Memorandum dated December 21, 1995, the Commission granted the request. The staff revised the RA (a sumary of major changes is attached to the RA) and made conforming changes to the Federal Register Notice (FRN) and the Environmental Assessment (EA). These revisions did not affect the content of this staff paper except in items 1 and 5 of the DISCUSSION in which the staff mentioned the expanded discussions of breast-feeding women in the RA.
CONTACTS: Stewart Schneider, RES 415-6225 Stephen A. McGuire, RES 415-6204
l CONTENTS
. .... ... ... . . . iii !
AHSTRACT . .
... .... .. . .... . ., is ACKNOWLEDGENIENTS ,, . .
, . .. . .. I 1 STATEhtENT OF Tile PRDilLEht s
2 OlHECTIVES OF Tile RULEhtAKING . . . . . .
. ... .. .. . 2 3 ALTERNATIVES . .
. . . . . 2 4 CONSEQUENCES .. .... ., . ........
.... ... .... . ..... 2 4.1 Current Uses of Radiopharmaceuticals ..... ..... .. .
.... . 3 4.1,1 Diagnostic Administrations . . . . . . .. ..,
3 4.1.1.1 Estimates of the Number of Diagnostic Procedures Performed . .., . . 4 4.1.1.2 Age and Sex Distribution of Patients . .. . ,
.. ... . , 6 4.1.2 Therapeutic Administrations .
. . . ... ... . . 6 4.1.2.1 Radiopharmaceuticals Used in Therapy . ,
9 4.1.2.2 Radioacthe Staterials Used in Permanent implants (firachpherapy)
.. , .. 10 4.1.23 Summary of Therapeutic Administrations . , ,
4.2 Assessment of Doses to individuals Exposed to Patients Administered Radioactive 10 hfaterials . . .. . . . 10 4.2.1 Niethodology for Calculating External Gamma Dose , , . . II 4.2.1.1 Occupancy Factor . . 13 4.2.1.2 Esposure Rate Constant , 13 4.2.13 liiological Retention and Elimination .. . 14 4.2.1.4 Tissue Shiciding for Permanent implants .
.. . 14 4.2.2 Assessment of internal Exposure . ....
. .. ... .. 14 4.2.2.1 Internal Exposure Pathwap
. . 15 4.2.2.2 Nicasurements of Internal Exposure , .
Ib 4.23 Estimate of Ntaximum 1.ikely Doses to Individuals Exposed to Patients
., 16 4.23.1 Diagnostic Procedures .
, . Ib 4.2.3.2 Therapeutie Procedures
.. . . , in 4.2.4 Assessment of Doses to Breast. Feeding infants ..
19 4.2.4.1 Internal Dose , , 19 4.2.4.2 External Dose . 19 4.2.43 Special Considerations for lodine-131 Sodium lodide 20 4.2.4.4 Summary of Doses to Breast. Feeding infants NUREG 1492 v
ABSTRACT The evaluation demonstrates that diagnostic The Nuclear Regulatory Commission (NRC) has procedures are unaffected by the choice of received three petitions to amend its regulations alternative. Only some therapeutic in 10 CFR Parts 20 and 35 as they apply to doses recched by members of the public exposed to adminhtrations of radioactive material could be affected by the choice of alternative. The patients released from a hospital after they hase evaluation indicates that Alternative I would cause been administered radioactive material. While the a large increase in the national health care cost three petitions are not identical, they all request from retaining patients in a hospitallonger and that the NRC establish a dose limit of 5 millisieverts would cause significant personal and psychological (0.5 rem) per year for indhiduak exposed to costs to patients and their families. The choice of patients who have been administered radioactive Alternatives 2 or 3 would affe:t only thyroid materials. This Regulatory Analysis evaluates cancer patients and some hyperthyroid patients three alternatives. Alternative ! is for the NRC treated with iodine 131 For those patients, to amend its patient release criteria in 10 CFR 35.75 Alternative 3 would result in less hospitalization to use the more stringent dose limit of I millisievert than Alternative 2. Alternative 3 has a potential (0.1 rem) per year in 10 CFR 20.1301(a) for its decrease in national health care cost of patient release criteria. Alternathe 2 is for the $13,700px) per year but would increase the NRC to continue using the existing patient release criteria in 10 CFR 35.75 of 1,110 megabecquerek potential collectise dose from released therapy patients by about 2,740 person-rem per year, (30 millicuries) of activity or a dose rate at mainly to family members. Alternative 3 would I meter from the patient of 0.05 millisievert also hase personal and psychological benefits for (5 millirems) per hour. Ahe native 3 is for the NRC to amend the patient release criteria in the patients and their families. 10 CFR 35 75 to specify a dose limit of 5 millisieverts (0.5 rem) for patient release. iii NURE(i-1492 _)
'" ""~--- ----,,... __,_,_ _ " 'N----.--.--.._ , s 9 I I -
- . _ _ .. .._.. _ _ _ _ _ . _ - _ . . _ _ _ _ _ . _ _ _ . _ _ . _ _ - . . . _____m-- _ _ _ _ _ . _ _
i I 1 Attachment 2
' - 535.8 Information collection requirements: 02 approval _
(b) The approved information collection requirements contained in this part appear 4- in SS 35.12. 35.13, 35.14, 35.21, 35.22, 35.23, 35.29. 35.31, 35.50. 35.51, 35.52, 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, 35.647, 35.980, and 35.981.
- J
T Attachment 1 PAPERWORK REDUCTION ACT STATEMENT This final rule (or final policy statement) amends information collection ' requirements that are subject to the Paperwork Reduction Act of 1980 (44 O.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 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records- Management Branch (T 6 F33), U.S. Nuclear Regulatory Commission. Washington. DC 20555 0001, and to the Desk Officer, Office of Information and Regulatory Affairs. NE0810202, (3150 0010). Office of Management and Budget, Washington, DC 20503.
I l 6p ai r.
*$j % UNITED STATES f'iAY\
*' f NUCLEAR REGULATORY COMMISSION WASHINGTON, D C 20%b 0001 June 8, 1995
'.) '%- .. ' . . . / HEMORANDUM TO: Michael T. Lesar, Chief Rules Review Section Rules Review and Directives Branch Division of Freedom of Information and Publications Services Off e of A&iinistr in FRON: a . .
, f Info ti and Records Management Branch Offic of Information Resources Managanent REQUEST FOR COMMENT AND CONCURRENCE ON THE FINAL RULE,10 CF
SUBJECT:
CRITERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERE MATERIALS . In response to your subject memorandum, the Information and Records Manageme (IRMB) provides the following: The Paperwork Reduction Act Statement (PRAS) is correct. X Change the PRAS to-Attachment 1. Cb The "Information Collection Requirements: OMB Approval" section is correct. O section to X Change Attachment 2,the "Information Collection Requirements:gysgApprova X Do not publish the " Federal Register Notice" until further notice. The " Federal Register Notice" can be published. Enclosed is a copy of the IRMB memorandum to the program of fice addressing our concerns. A copy of the IRMB memorandum to the program affice addressing our c be forwarded at a later date. X An IRMB memorandum to the program office is not required. Attachments: As stated cc: S. McGuire.-RES J. Glenn, RES ./ 0 0 O $lE O + % 3 y
+
v
. p s r,,4 e
.u_ UNITED STATES '
. [- .:
. NUCLEAR REGULATORY. COMMISSION
.'! i
" ~I y.
.! wasmwotow. o e acma.3 z.
-i s, e _
** - June 0 iom i
MEMORANDUM T0: David L. Morrison,'Ofrector Office of N9 clear Regulatory Research f FRON: James Lieberman, Director Office of Enforcement-4Qk r
~'
SUBJECT:
OfflCE REVIEW AND CONCURRENCE ON A FINA ' TNE RELEASE Of INDIVIDUALS ADMINISTERED RADIO i MATERIALS The Office of Enforcement has no objection to the subject draft final rule. Attached are three pages with miscellaneous edits that you may-wish to corsider.
Enclosure:
As stated:
Suggested Changes - Final Rule On Patient Release Criteria
- .l. Page 24, Miscellaneous comments on the Rule We suggest the response to the first statement be revised as follows
Response: The NRC does not agree. F.P.C ::r. ducts an assessment of each proposed requirement or rule to determine what level of compatibility will be assigned to the rule. These case-by-case assessments are based, for the most part, on protecting public health and safety.
- 2. Page, 34, IV. Coordination with NRC Agreement States We suggest the paragraph be revised as follows:
The staff discu: sed the status of this rulemaking effort at two public meetings; the Agreement State Managers Workshop held on July 12-14, 1994 and at the All Agreement States Meeting held on October 24-25, 1994. The Agreement States _ expressed no objections to the approach in this rule. 3, Page 39, Vill. Issues of Compatibility for Agreement States 10 CFR 20.1002 Scope. Office of State Programs Internal Procedure B.7 entitled,
" Criteria for Compatibility Determinations", states that
" Scope" in 10 CFR Part 20 is a Division 111 item of compatibility. Therefore, the wording regarding 20.1002
" scope" should be designated as:a Olvision 111 matter of compatibility rather than Division 11. ' Division 111 rules would be appropriate for Agreement States to adopt, but do not require any degree of uniformity between NRC and. State rules.
4 p' "' cw ,
;/j s- 8 3 *.
UNITED STATES j jc NUCLEAR REGULATORY COMMISSION wasHMCTON. O C. N1
's, p# Nay 3, 1995 MEMORANDUM T0: Bill M. Morris, Director Division of Regulatory Applications, RES Richard L. Bangart, Director -
FROM: Office of State Programs [( h b (Lt. L7
SUBJECT:
TECHNICAL REVIEW: DRAFT FINAL RULE - CRITERIA FOR THE RELEASE OF PATI QTS ADMINISTERED RADIOACTIVE MATERIALS-This is in response to your April 12, 1995 memora.idum on the subject document. We have reviewed the draft final rule as it applies to the Agreement States through compatibility requirements. Attached are several suggested changes relating to staff's interaction with the Agreement States. . We nave no objection to proceeding with this rulemaking effoit. If you have any questions, please contact me or Lloyd Bolling of my staff.
Attachment:
As stated
,d 0'
i 1
8 I
+ * *
/ g>R #f Cgo l 3 .
. 't '
UNITED STATES 3 E g E NUCLEAR REGUL.ATORY COMMISSION cc: Morris 1 n snisorow,o.c. - , Glenn 5 / Schneider
..,,, June 12, 1995 McGuire file dm MEMORANDUM T0: . David L. Morrison, Director Office of Nuclear Regulatory Research FROM:
K1cnaro L. Bangart, Director Office of State Programs Il tth { g A,f
SUBJECT:
0FFICE REVIEW AND CONCURRENCE: ORAFT FINAL RULE - FOR THE RELEASE OF INDIVIOVALS ADMINISTERED RADI0 ACT MATERIALS This is in response to your May 01, 1995 memorandum on the subject document. We have reviewed the draft final rule as it applies to the Agreement States through compatibility requirements. In a meeting between Lloyd Bolling of my staff
-in 10 and CFRSte6; Part art Schneider, RES on Wednesday June 7, 1995, the scope section 20,1002 Agreement States. was revised to a Division III' item of compatibility for Based on this revision and our previous comments (see attached memorandum dated May 3, 1995), we concur in the rule.
Attachment:
As stated
~
cf, gQ l(C I9 $ - jf,
From: Shelly L. Shortt (SIS) To:' SAM 2, SXS4 Date: Thursday, June 8,1995 11:21 am
Subject:
FINAL AMEND TO 10 CFR PARTS 20 AND 35 Stewart Schneider, RES Stephen McGuire, RES As requested by DMorrison's memorandum of May 31,1995, OC 'has reviewed th Draft Final Rule on the Criteria for the Release of Individuals Administe Materials. By this e mail I am providing you with office concurrence, Please contact me on 415 6032 if you have any questions.
'Thanks. ,
' Shelly Short CC: eahl s
s
]
David L. Morrison To assist you in preparing the list of documents centrally re place the designator "AE41" in the upper right-hand corner of each document concerning the rule that you forward to the Nuclear Documents System. If you have any questions concerning Rules this matter, Reviewplease Section,have a member Division of of you staff contact Michael T. Lesar, 415-7163, Freedom of Information and Publications Services.
Attachment:
As stated h f
ypa ct os%?*, UNITED ST'iES ye 3 ; NUCLEAR REGULATORY COMMISSION l
, e nimuotow. o c. neem
%,e....j' June 5, 1995 MEMORANDUM 10: David L. Morrison, Director Office of Nuclear Regylatory Research Sh (.L I. ? -
p'DavidL.Meyer,ChieT'.ne, - FROM: Rules Review and Directives Branch Division of Freedom of Information and Publications Services Office of Administration
SUBJECT:
OFFICE CONCURRENCE ON A FINt.L RULE PACKAGE REGARDING REGARDING CRITERIA FOR 1HE RELEASE OF INDIVIOUALS ADMINISTERED RADIOACTIVE MATERIAL The Office of Administration concurs, subject to the comments provided, on the inal rule package regarding the criteria for the release of individuait We have attached a marked copy of the Jministered radioactive material. package that presents additional editorial comments. The Statement of Considerations for the final rule must contain a clear statement that indicates the final disposition of the petitions for rulemaking If the that the rule addresses (PRMs 20-20, 35-10 and 10A, and 35-11). , statement in the proposed rule remains valid, the final rule should indicate that these petitions are partially granted, specify the aspects of the petitions that have been granted, indicate that the remaining portions of the petitions are denied, and state that the final rule completes action on the petitions. We have adjusted the amendatory instruction for the authority citation to Part &j ' . 20 and provided the currently effective text of that authority citatien. When these documents are forwarded for signature and publication, please have - a member of your staff include a 3.5-inch diskette that contains a copy ofThethe , , , document in Wordperfect 5.0 or 5.1 as part of the transmittal packages. diskettes will be forwarded to the Office of the Federal Register and the G + 54. ,, , . , Government Printing Office for their use in typesetting the documents.
']? w Please note that the information collection requirements contained in the final rule must be approved by the Office of Management and Budget before the final rule may be submitted for signature and publication. Please contact the Information and Records Management Branch, Office of Information Resources Management, concerning the paperwork management aspects of this rulemaking action.
t= b
l UNif f 0 SToif 5 v
/p*$8c'% NUCLE AR REGULATORY COMMISSION
'
- W A$HING10N D C . a%- 0001
) ,,
o ? June 15, 1995 S, ,,,,,/ i Of fICE Of f Mt i Gi Nt RAL COUN56 L , MlMORANDUM 10: David L. Morrison, Director Office of Nuclear Regulatory Research 7 FROM: Stuart A. Treby p[/ / Associate General Counsel for Rulemaking and fuel Cycle SUBJECl: DRATT FINAL RULE - PATIENT RELEASE CRIT [RIA We have reviewed the final version of the draft final rule addressing The revisions have release of individuals administered radioactive materia's. satisfactorily addressed our earlier comments and we have no legal objection to this rulemaking package. CONTACT: Bradley W. Jones, OGC 415-16?8 l
%
- M e a 3 /p,
p "%y
*l* f*, OHITED STAiLS j NUCLEAR REGULATORY COMMISSION f,, ,e wasniwotow, o c roa!wroi
)
June 13, 1995 S,e'..../
/
NEMORANDUM 10: David L. Norrison, Director Office of Nuclear Regulatory Research TRON: Carl J. Paperiello, Director ' I Office of Nuclear Material Safety and Safeguards l
SUBJECT:
Off!CE REVIEW AND CONCURRENCE: DRAFT FINAL RULE - CRITERIA FOR THE RELEASE Of IN0lVIDUALS ADMINISTERED RADI0 ACTIVE NATERIALS This Office has reviewed the rulemaking package for ' final Amendments to 10 CFR Parts 20 and 35 on Criteria for the Release of Individuals Administered Radioactive Naterial' and we concur. As you requested in your memorandum dated Nay 31, 1995, we are not providing comments or concurrence on the draft Regulatory Guide at this time.
Contact:
Patricia K. Holahan, HMSS (301) 415-7847 c1
i 1 l 5 The Commissioners i
- b. A final regulatory analysis will be available in the Public 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 entitle,s'and the recsons for it as required by the Regulatory Fle,xibility Act;
- e. Therulecontainsinformatio$collectionrequirementsthatare subject to review by OMB./ Upon Commission approval, the OMB supporting statement (Attachment 7) will be submitted to OMB for approval. f'
- f. The appropriate Congressional Committees will be informed (Attachment 5); ,.
' (
- g. A public announdement will be issued (Attachment 6); and
- h. Copies of thd federal Register Notice of final rulemaking and the associated ' regulatory guide will be distributed to all Commission medical licentres and each Agreement State. The notice will be sent to other interested parties upon request.
/
James M. Taylor Executive Director for Operations Attachm nts: As Stated (7) RECORD N01E: A draf t of the final rule was sent to OlG for
,/ information on May 31, 1995.
0:SPdd8 ADMelW Offc DRA R .
'dDRA 0:0RA:n K 0:N S CPaperiello RBangart WOI tu %, W Name: SSch elder SMc ire P etp/n BMorri (,$/95 Date: (/ 95 6 / /95 jp/ / /95 t/f(/95 f//y/95 (,/j)/95 P 0:0E d' Di E00 Offc: 0:IRM OC$ffithOGCb'O PScroggins MMalsch JLieberman 0Morri ontJMTaylor Name: GCranford Date: 6/f/95 (; /i /95 /,/ 6 /95 / /fvy95 / /95 g( / hd 7 /95 d%Wd g pf flCIM. RECORD COPY
l l The Commissioners 1 J
- d. A final environmental assessment and a finding of on' significant impact have been prepared (Attachment 4).
- e. 1he Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on smail enutie> and the reasons for it as required by the Regulatory flexibility Act.
- f. The ep:>ropriate Congressional Committees will be informed (Attac1 ment 5);
9 A public announcement will be issued (Attachment 6).
- h. The rule contains information collection requirements that are subject to review by the Office of Management and Budget. Upon '
Commission approval, the OMB supporting statement (Attachment 7) will be submitted to OMB for approval. 14 Copies of the federal Reaister notice of final rulemaking and the associated regulatory guide will be distributed to all NRC medical
. licensees and each Agreement State. The notice will be sent to other interested parties upon request.
Original Signed By Hugh L. Thompson, Jr. for James M. Taylor Executive Director for Operations Attachments: As Stated (7) RECORD NOTE: A draft of the final rule was sent to 01G for information on May 31. 1995.
- see previous concurrence Offe: RPHEB:0RA RPHEB:0RA RPHEB:DRA 0:0RA:RES 0:NMSS 0:SP ADM Name: SSchneider SMcGuire JGlenn BMorris CPaperiello RBangart WO11u Date: 6/08/95* 6/08/95* 6/09/95* 6/14/95* 6/13/95* 6/13/95* 6/05/95*
Offc: 0:lRM OC OGC 0:0E 0:RES E00 ' Name: GCranford PScroggins HMalsch JLieberman 0Morrison JMiaylor Date: 6/07/95* 6/08/95* 6/08/95* 6/06/95* 6/14/95* H /h /95 OfflCIAL RECORD COPY RES FILE NO.3A-3
7 the Commissioners
- 3. tjgigi:
- a. The final rule will become effective 120 days after publication in the f.tdr al_Reaister,
- b. A final regulatory guide will be published, for use, before the final rule becomes effective (Attachment 2),
- c. A final regulatory analysis will be available in the Public Document R-v J'tachment 3).
- d. A final env w : # Ai assessment and a finding of no significant impact have becn pospared (Attachment 4),
- c. 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.
- f. The appropriate Crngressional Committees will be informed (Attachment 5);
9 A public announcement will be issued (Attachment 6), h, The rule contains information collection requirements that are subject to review by the Office of Management and Budget. Upon Commission approval, the OMB supporting statement (Attachment 7) will be submitted to OMB for approval,
- i. Copies of the [t.deral Reaister notice of final rulemaking and the associated regulatory guide will be distributed to all NRC 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) RECORD N01f: A draf t of the final rule was sent to OlG for information on May 31, 1995. *seepreviouscope.' Offc: il RA RP
- QRA PHEB:DRA .fm M 0:DRA:RQ)\ Cpa 'rieJV D:Sp ADM W0liu BMorrist RBangart Name: h Gn der St1 i ce c., Glenn 3pu/Sc 6/13/95* 6/05/95*
Date: 3/11/96 3/ 1/96 )3/11/9 gw3/ll/96 D:0E D:RES E00 Offt: D:lRM OC JMlaylor Name: r.cranford PScroggins STrehy / JLeiberman DMorri Mn 6/08/95* 3/11/96 6/06/95* 3/11/96 / /96 Date: 6/07/95* RES FILE NO. 3A-3 OfflCIAL RECORD COPY 1
b 1ECY PAPER DISTRlBMIj M Rev 07/11/95 POLICY MEETING SECY . RULEMAKING __L. AFFIRMATION ADJUDICATORY NOTATION Reviewed By NEGATIVE CONSENT NOTE: Classified - (1) to each Connission office. 0GC (2), INFORMATION SECY (3), & Central Files (1) CLAS$1FICAT!0N CHAIRMAN JACKSON (3) (2 for INF0) ,___ EXECUTIVEDIRECTORFOROPERATIONS(3) 3 COMIS$10NER ROGERS (3) " NTY EXECUf!VE DIRECTORS (2) n COMIS$10NER (3) 4 ( ) (2)* COMISSIONER b. d . I (3) , 1) COMIS$10NER (3) IRM(3)(4)* SECY (10-14) (80 ForMtg) AE00 (5) __. OGC (17) (7 For ADJ) NRR(12) 0FFICEOFCAA(1/4) NMS$(5) b O!G (3) RES (12) b PA (2) OE (1) IP (5) O! (2) . CA(2) SP (3) ' ACRS(20) OP (2) ACNW(10) SBCR (1) ASLBP (4) DOCUMENT CONTROL DESK (1) I FILES CENTER (1) REGIONAL OFFICES: (C&RBRANCH,SECY) J hg7 ; RI-KingofPrussia(2) Q@ R!! - Atlanta (2)
) @ k (N {
RI!! - Chicago (2) I' RIV - Dallas (2) TOTAL NUMBER OF COPIES
*If Rulemaking RETURN ORIGINAL T0:
4.
Table 1. Reporting Requirements No. of Procedures Requiring Written Instructions Hours Per Total Burden Per Year Procedure Hours Section 35.75(b) 62,000' 10,333 exceeding 0.1 rem 1/6 breast-feeding mothers 27,000' 1/6 4.500 Recordkeeping Requirements No. of Procedures Requiring Records Hours Per Total Burden Per Year Licensee Hours Section 10,000' 2/15 1.333 35.75(c) 2/15 960 35.75(d) 7.200' Total burden = 17,126 hours or 13 hours per licensee (17,126 + 1,350) at a cost of $2.277,758 (5133 x 17,126). l l l i
'50,000 todine administrations for thyroid ablation ^ 10,000 iodine administrations for thyroid cancer + 2,000 iodine permanent implants - 62,000.
l
'8,000,000 administrations x 0.5 fraction of the administrations potentially requiring instructions x 0.135 fraction of females of child bearing age (from Table 4.3 of NUREG-1492) x 0.05 breast-feeding 27,000.
' Iodine treatment for thyroid cancer patients.
1 l '(60,000 iodine + 1,000,000 technetium-99m pertechnetate) x 0.135 fraction of females of child bearing age x 0.05 breast feeding 7,200. l 1 ' 5 Attachment 7
L i
.in additien, the estimated burden on the Agreement States to review records is estimated to be 1 hour per Agreement State licensee per year,- or 900 hours for all Agreement State licensees. At a cost of 5133 per hour, the annual cost to Agreement States is 5119,700 annually.
- 12. Estimate of Burden The total burden to provide instructions and maintain release records is estimated to be about 13 hours per licensee annually, or a total of approximately 17,126 hours annually for all 1,350 NRC and Agreement State medical use of byproduct material' licensees. See attached-table for details.
-13. Reasons for Chance in Burden The amendment adds recordkeeping and reporting requirements to 10 CFR 35.75 to j protect individuals likely to be exposed to patients administered -l radiopharmaceuticals or permanent implants,'for demonstrating compliance with :
I the annual limit for individuals due to the release of patients administered radioactive material. The final rule reflects a burden decrease from that of the proposed rule from 19 to 13 hours per licensee. The proposed rule required records for releases if the total effective dose equivalent to any , individual other than the released patient exceeded 0.1 rem. The final rule requires records only for exceptions to standard assumptions and when instructions were provided to a breast-feeding woman if the dose to the child from continued breast-feeding could result in a total offective dose equivalent exceeding 5 millisieverts (0.5 rem).
- 14. Publication for Statistical Use There is no application to statistics in the information collected. There is no publication of this information.
B. 00LtECT10NS OF INFORMATION EMPLOYlNG STATISTICAL METHODS Not applicable. 4 Attachment 7
- 4. Effort to identify Duplication and Use Similar Information l There is no similar information available to the NRC. The Information Requirements Control Automated System (IRCAS) was searched for duplication, and none was found.
- 5. Effort to Reduce Small Business Burden The NRC believes that there is no way to reduce the burden on small businesses by less frequent or less complete records while maintaining the required level of safety.
- 6. Consequences of less frecuent 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.
- 7. Circumstances Which Justif_Y Variation from OMB Guidelines There are no variations from OMB guidelines.
- 8. Consultation Outside the Agency 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 ACMut in November 1994, May 1995, and October 1995. The Agreement States and the ACMUI were generally supportive of the approach in the rule.
- 9. Confidentia.lity of Information No information normally considered confidential is requested.
- 10. Justification of Sensitive Information No sensitive information is requested under these regulations.
- 11. Estimated Annual Cost to the Federal Government The estimated burden on the NRC to review records is estimated to be 1 hour per NRC licensee per year, or 450 hours for all NRC licensees. At a cost of $133 per hour, the annual cost to NRC is $59,850 ant.ually. This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Part 171.
3 Attachment 7
exceed 1 millistevert (0.1 rem). In those cases where the released individual may be a breast-feeding woman, paragraph (b) also requires the instructions to include guidance on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance. 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 number in case the patient has any questions. Instructions shoulci include, as appropriate: (1) maintaining distance from other individuals, including slee)ing arrangements and the need to minimize use of public transportation; (2) tie interruption period for breast-feeding and the consequences to the breast-feeding child upon failure to follow the guidance, if applicable; (3) minimizing time in public places (such as grocery stores, shopping centers, restaurants, and sporting events); l the length of time precautions should be taken. Written (4) hygiene;are instructions andnee (5)ded to provide a reference available after the >attent's l release, if questions regarding patient care arise, and to reduce t1e 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 generally given to patients. Paragraph (c) of this section requires licensees to maintain, for 3 years, a record of the basis for the release 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 dose to determine that the method is adequate to show that the requirements in paragraph (a) were met. Paragraph (d) of this section requires licensees to maintain, for 3 years, a record that instructions were provided to a breast-feeding woman if the administered activity could result in a total effective dose equivalent to the breast-feeding infant exceeding 5 millisteverts (0.5 rem) if the woman did not interrupt or discontinue breast-feeding. The records are necessary so inat the NRC inspector can verify that instructions were given to the breast-feeding woman to inform her of the need to interrupt or discontinue breast-feeding.
- 2. Agency use of Information 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 Technolooy No responses are submitted to NRC. NRC encourages licensees to utilize any technology which would reduce the burde 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. 2 Attachment 7
OMB SUPPOR11NG STATEMENT FOR 10 CFR PART 35, i Criteria for the Release of Individuals -I Administered Radioactive Material" (3150-0010) l f t Description of Information Collection This clearanco package covers the recordkeeping and reporting requirements of , amendments to 10 CFR Part 35, " Medical Use of Byproduct Material," l 35.75,
}
" Release of individuals containing radiopharmaceuticals or permanent l
implants." The existing i 35.75 contains no information collection ! requirements. The revision to i 35.75 incorporates the information collection [
- required below.
1 The information collection requirements in the proposed rule were submitted to ' OMB and approved under OMB control number 3150-0010. The entire collection is - being resubmitted at the final rule stage because of some major changes in the ! informattor. collections. t A. JUSilFICATION The amenument to 6 35.75 revises the criteria for authorizing the release of individuals administered radioactive material under 10 CFR Part 35 to permit a maximum annual dose of 5 millisteverts (0.5 rem) to an individual member of l the public, requires written instruction on how to maintain doses to others as l low as is reasonably achievable if the dose to an-individual exposed to a - released patient is likely to exceed 1 millisievert (0.1 rem). In those cases ! where the released individual may be a breast-feeding woman, the instructions must also include guidance on the interruption or discontinuation of [ breast-feeding and information on the consequences of failure to follow the ' guidance. The amendment also establishes recordkeeping requirements when the release is authorized using other than standard assumptions or when instructions were provided to a breast-feeding woman because the dose to the- , child from continued breast-feeding could result in a total effective dose ! equivalent exceeding 5 millisieverts (0.5 rem).
- 1. Need for tne Collection of Information The information collection requirements of the amendments to 10 CFR Part 35 are identified below.:
i 35.75' Release of individuals containino radiopharmaceuticals or permanent t implants. j} 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 achievablo if the total effective dose ,
equivalent to any individual other than the released patient is likely to ; Attachment 7 . I e 9
+-w--,. ,-w , e-m,- ,-,-m, s. - . ~ , - ,e',--.,-,,,-g, ,,._w., .w w r ** w q r-- w'eg e w e e wa
- t ee -vsm e's- r-
- e --e --w-s-r-+-=e-~-g-- -
- Comments and questions can be directed by mail to the OMB reviewer:
Peter francis Office of information and Regulatory Affairs (3150-0010) N[00-10202 l Office of Management and Budget I Washington, DC 20503 l ! Connents may also be communicated by telephone at (202) 395-3084. The NRC Clearance Officer is Brenda Jo. Shelton, (301) 415-7230. Dated at Rockville, Maryland, this day of , 1996. For the Nuclear Regulatory Commission. Gerald f. Cranford Designated Senior Official for Information Resources Management. 4 Attachment 7
i written instructions on how to maintain doses to other individuals as low as is reasonably achievable if the dose to an individual exposed to the patient is likely to exceed . 0.1 rem. In those cases where the released individual may be a breast-feeding woman, the instructions must also , include guidance on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance. The amendment also requires the licensee to maintain a record of the basis for the release if the release is authorized using other than standard assumptions or that instructions were provided to a breast-feeding woman if the dose to the child from continued breast-feeding could result in a total effective dose equivalent exceeding 0.5 rem. 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 reasonably achjevable. Copies of the submittal may be inspected or obtained for a fee from the NRC l Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. l l 3 Attachment 7 l
- . _ _- - . . - . , .- . _ _ . . . - _ . - . - . . . . . . . - . ~ . - _ . - - _
l
- 4. How often is the collection required: On occasion; when the release of a patient is based on other than standard 1
i assumptions or requires interruption or discontinuation of breast-feeding to meet the 5-millisievert (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: 17,126 hours (includes NRC and Agreement State licensees).
- 8. The average annual burden per respondent: 13 hours.
- 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 2 Attachment 7
t t (7590-01) NUCLEAR REGULATORY COMMIS$10N Documents Containing Reporting or Recordkeeping Requirements; Office of Management and Budget (OMB) Review 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).
Type of submission, new, revised, or extension: Revision. 1.
- 2. The title of the information collection: Final amendments to 10 CFR 35.75, " Criteria for the Release of Individuals Administered Radioactive Material."
- 3. The form number if applicable: Not applicable.
1 Attachment 7
- . - - -.--,r , . . - , - - , -
ATTACHMENT 7 l FEDERAL REGISTER NOTICE AND SUPPORTING STATEMENT FOR OMB REVIEW
i Release of patients containing radioactivity is instead governed by the more explicit requirements of revised medical use regulations, 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 axceed 100 millirems, the licensee must provide the patient with written instructions on how to maintain doses to other individuals as low as reasonably achievable, if the released individual may be breast-feeding an infant or child, the instructions must also include guidance on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the < guidance. The revisions partially grant three petitions for rulemaking on criteria , On for release of patients who have been administered radioactive material. 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 I Dr. Carol S. Marcus, the American College of Nuclear Medicine and the American Medical Association. A proposed rule on this subject was published in the federal Register on June 15, 1994. The final rule reflects public comments received. (120 days after - The rule will be effective __). publication of a federal Register notice on van r 2 Attachment 6
HRC REVISES REGULA110NS ON RELEASE l l OF PAllEN15 ADMINISTERED BYPRODUCI MATERIAL 1 lhe Nuclear Regulatory Commission 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 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 authorize the release of patients if the estimated dose, to the individual likely to receive the highest dose from exposure to the patient, would be greater than 500 millirems. (Typical natural background radiation in the United States is 300 millirems per year.) The new criteria are consistent with recommendations of the International Commission on Radiological Protection and the National Council on Radiation Protection and Measurements. Under current NRC medical use regulations, licensees are not permitted to authorize the release of patients to whom nuclear material has been administered until either (1) the measured dose rate 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. The final rule amends the general radiation protection regulations in 10 CFR Part 20 to exclude doses to individuals exposed to released patients. 1 Attachment 6
i ATTACHMENT 6 DRAFT PUBLIC ANNOUNCEMENT
I DRAF1 CONGRfSS10NAL Ll11[R l
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a public announcement and a final amendment to 10 CFR Parts 20 and 35 dealing with criteria for the release of patients administered radioactive materials. Roughly P to 9 million medical diagnostic and therapeutic administrations of radioat.ive 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 amendmerts 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 makes it clear that the release of patients administered . radioactive materials continues to be regulated by the requirements in NRC's Part 35, " Medical Use of Byproduct Material." While the comments of the medical community on the proposed rule were 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 Attachment 5
,a_. .. +_a ,4-- __ . 1._m,64,mwm -__w-wa_a_d. _w.h -, _ _W_ l_u_%J _~u_C,A-e__ aamm. Jee meu. -- me,a - _ - -.. ..ha_._ A_uwam,_wa. ,.euas.Aw-__,.4_JLA. A, A&
ATTACHMENT 5 DRAFT CONGRESSIONAL LETTER 1 I 1 l i f 1 l l I l ( 1 l l
-,me + ,, e- , a-- -
--e--o a .- m,
M. Rosenstein, Ph.D., food and Drug Administration, Center for Devices and Radiology Health, Rockville, MD J. St.Germain, Radiation Safety Officer, Memorial Sloan Kettering, New York City, NY l B.A. Siegel, M.D. (Chairman, NRC Advisory Committee on Medical Use of isotopes), Director, Division of Nuclear Medicine Hallinckrodt Institute of Radiology Washington University Medical Center, St. Louis, M0 M.G. Stabin, Ph.D., CHP, Radiation Internal Dose Information Center Oak Ridge Institute for Science and Education Oak Ridge, TN D. Steidley, Ph.D., CHP, Medical Health Physicist. Department of Oncology, St. Barnabas Medical Center, Livingston, NJ J. Stubbs, Ph.D., Radiation Internal Dose Information Center, Oak Ridge institute for Science and Education, Oak Ridge, TN K. Suphanpharian, Ph.D., President, Best industries, Springfield, VA R E. Toohey, Ph.D., Director, Radiation Internal Dose Information Center Oak Ridge institute for Science and Education, Oak Ridge, TN 9
l
- 10/18/95 Rockville, MD Advisory Committee on the Medical uses of 10/19/95 Isotopes (ACMul) l l
Much of the statistical nnd 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 l individuals are acknowledged for their cooperation and contributioit of technical information and data: R. Atcher, Ph.D., Radiation and Cellular Oncology Department University of Chicago, Chicago, il K. Behling, S. Cohen and Associates, McLean, VA U. H. Behling, S. Cohen and Associates, McLean, VA D. flynn, M.D. (NRC Advisory Committee on Medical Use of Isotopes). Massachusetts General Hospital. Doston, MA D. Goldin, S. Cohen and Associates, McLean, VA W.R. Hendee, Ph.D., Dean of Research, Medical College of Wisconsin, Milwaukee, WI P. Holahan, Ph.D., U.S. Nuclear Regulatory Commission, Washington, DC-C. Jacobs, President, lheragenics 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, Ph.D., Professor of Yale University, School of Medicine, and past President of the American Association of Physicists in Medicine, New Haven, CT M.P. Nunno, Ph.D., CHP, Cooper Hospital, University Medical Center, Camden, NJ P. Paras, Ph.D., Food and Drug Administration, Center for Devices and Radiology Health, Rockville, MD M. Pollycove, M.D., Visiting Medical fellow, U.S. Nuclear Regulatory Commission, Washington, DC G.E. Powers, Ph.D., Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission Washington, DC 8
V. FINDING Of NO SIGNif! CANT IMPACT The Commission has determined under the National Environmental Policy l 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 significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required. The amendments establish new criteria for patient release that are based on the potential radiation dose to other ,dividuals exposed to the patient, furthermore, the amendments require the licensee to provide written instructions to patients on how to maintain the doses to others as low as is reasonai:1y achievable. It is expected that there will be no significant impact to the environment. VI. LIST Of AGENCIES 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 meeting. Public Meetinas Held Date location Groups Represented 07/15/92 Atlanta, GA Agreement States: AL, AR, AZ, CA, 00, FL, GA, IL, KS, KY, LA, MD, NC, ND, NE, NH, 07/16/92 NV, NY, OR, SC TX, UT, WA, and NY City 10/24/92 Tempe, AZ Agreement States: AL, AR, AZ, CA, 00, FL, GA, IA, IL, KY, LA, MD, MS, NC, ND, NE, 10/25/92 NH, NV, OR, RI SC, TN, TX, UT, WA, and 10/26/92 10/27/92 NY City 10/24/94 Portland, ME Agreement $tates: AL, AR, IL, KS, LA, NH, NV, NY, PA, R1, TX, UT, WA, and NY City 10/25/94 Rockville, M3 Advisory Committee on the Medical Uses of 10/22/92 10/23/92 Isotopes (ACMUI) Bethesda, MD Advisory Committee on the Medical Uses of 05/03/93 05/04/93 Isotopes (ACMUI) Reston, VA Advisory Committee on the Medical Uses of 11/01/93 Isotopes (ACMUI) Rockville, MD Advisory Committee on the Medical Uses of 11/18/94 Isotopes (ACMUI) 05/12/95 Rockville, MD Advisory Committee on the Medical Uses of isotopes (ACMUI) 7
- . - - - - .- - --- . - - - - ~.._ . . -
Included within this range of options was the option to enhance communication ; between the licensee and woman regarding instructions to interrupt or discontir,ue breast-feeding before the woman is released from the hospital, ; which is the option adopted in this rulemaking. As discussed in the l Regulatory Analysis, the other options were dismissed as ineffective orthe impractical due to a variety of "easons: hospital was dismissed due to psychological impacts to the woman and breast-feeding infants, impacts on the practice of medicine, and health care costs
- l the option of maintaining status quo was dismissed due to lack of assuranceTherefore, th '
that instructions will be provided to a breast-feeding woman. option to enhance communication is selected as the preferred option. To enhance communications and reduce the probability of a mother breast-feeding af ter administration of large quantities of iodine-131, amended 10 CTR 35,75(b) will require licensees to provide guidance on the interruption or discontinuation of breast-feeding and information on the rationale for following the guidance. Comp 1tance with the regulation provides NRC with confidence that the licensee will give the instructions to breast-feeding womete and it is expected that almost all women wi'l follow instructions to interrupt or discontinue breast-feeding to protect their children from The NRC is not aware of any instances where potentially harmful effects. instructions were given to the woman but she igno breast-feeding a child. The decision to require instructions as shown in column 5 of Table B.5 of the Regulatory Analysis (NUREG-1492) is based on both the external and internal dose to the nursing infant. It can be seen from column 4 that for some radiopharmaceuticals the external dose from breast-feeding can be significant part of the total dose. column 6 is selected to reduce thethe However, maximum actual doses dose that would to a newborn be inf ant than 1 millislevert (0.1 rem). received by most inf ants for the recommended interruption perit,ds shown should be a small fraction of 1 millisievert (0.1 rem) (1) thedue maximum to the conservatism measured analysis. The conservative factors are based on: level of activity in breast milk, (2) the longest biological half-life, and (3) the lowest body weight (i.e., the newborn). It is expected that there will be no effect from breast-feeding on collective dose due to therapeutic administrations, although there may be a small effect from more infants having an opportunity to have However, contact with a instructions woman sent home from hospital (i.e., cancer patients). providing guidance, such as to maintain distance from other perso aid in minimizing this effect. iodine-131 sodium iodide, it is currently normal practice to recommend interruption of breast-feeding. Thus, this rule is expected to have little or In sum, the no effect on collective dose due to diagnostic administrations. environmental impact is not considered significant. l 6
,-->-- ,e,-,7- -m -w,, ,-c =m .r- . ,m-- -r -
----5
iodine-131 sodium iodide for thyroid cancer (see Tables 4.10 and 4.11 of NUREG-1492); whereas, 1 person-sievert (100 person-rem) is associated with exposure to released patients (about 1.000) administered more than 1,110 megabecquerels-(30 millicuries) of iodine-131 sodium for thyroid ablation (see Tables 4.10 and 4.11 of NUREG-1492). Based on the assumption that each patient could expose about seven family members and friends (including the primary care-provider) the increase in dose to an affected individual in a year is about 0.00037 sievert (37 millirem) for thyroid cancer and about 0.00014 sievert (14 millirem) for thyroid ablation. The increase in risk to the affected individual could vary from zero-(if a dose threshold exists) to 1.8x10 per year (if the linear no threshold hypotheses is valid and a risk f actor of about 5x10" per person-rem is used). When compared with the incidence of cancer of 0.20 from natural causes, the potential cancer risk ' for a family member or other person who has close contact with a thyroid cancer or-thyroid ablation patient is small. Thus, the environmental impact is not considered significant. Breast-feedina Infant 1here are_ specific issues associated with the administration of iodine-131 sodium iodide in that following both diagnostic and therapeutic administrations, the dose to-a breast-feeding child could exceed 5 millisteverts (0.5 rem) if there was no interruption of breast-feeding. In particular, if the woman does not cease breast-feeding after administration of millicurie quantities of iodine-131 sodium iodide, the internal dose to the breast-feeding infant could be large enough to cause the infant's thyroid to be severely damaged resulting in hypothyroidism. If. hypothyroidism were undlagnosed in very young children, severe mental retardation may occur. However, if the patient was'provided instructions to discontinue breast-feeding, as well as being advised of the consequences of not following the instructions, the NRC believes that the probability of a woman failing to cease breast-feeding after being administered iodine-131 sodium-iodide is small. For example, in 1990 an administered dosage of 185 megabecquerels (5 millicuries) of iodine-131 sodium iodide to a patient resulted in her breast-fed infant receiving an unintended radiation dose of 300 grays-(30,000 rads)-to the infant's thyroid gland. This dose would result'in ablation of the infant's thyroid. This situation was recognized in 2 days which allowed prompt action to be taken thereby reducing potential consequences such as mental retardation. The NRC is aware of two other cases that occurred during
-1991 and 1995.- In each of these cases, there was a breakdown in-communications, rather than lack of intent to prevent breast-feeding.
Although instructions to keep doses to household members and the public as low as is reasonably achievable are currently required for radiopharmaceutical_ therapy in 10 CFR 15.315(a)(6), there is no requirement specific to the dose from breast-feeding. In some cases,-instructions to= interrupt or discontinue breart-feeding may not be effectively communicated. To deal with this issue, the NRC considered a range of options which varied
.from maintaining the status quo to the extreme option of a woman remaining in the hospital for a period of time af ter administration of millicurie -
quantities of-1-131 sodium iodide to ensure her milk production has stopped, 5
$412,000,000 per year, mostly because of increased national health care costs, in view of this, Alternative 1 may be dismissed.
- 3. Alternative 3 relative to Alternative 2 has a net value of about
$9,000,000 per year, mostly due to lower health care costs. Also, Alternative 3 has psychological benefits to patients and their f amilics.
Thus, Alternative 3 is 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 oa 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 other radionuclides and too 1:w for others.
- 5. A dose-based rule no longer restricts patient release to a specific 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 j
occasional cases 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 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. Allowing 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.
IV. ENVIRONMENTAL IMPACTS OF THE PROPOSED ACTION AND THE ALTERNAllVE Family Members or Other Persons For the purpose of evaluating the environmental impact of the proposed action, the proposed action (Alternative 3) is compared to the impact of the The existing patient release criteria, the status quo (Alternative 2). impacts can be seen in Table 1 above. The estimated change in the collective dose when comparing Alternative 3 to Alternative 2 is an increase of about 27 person-sievert (2,700 person-rem). Most of the increase, about 26 person-sievert (2,600 person-rem), is received by the primary care-providers and family members exposed to released patients (about 10,000) administered 4 l
b o Alternative 2: < l.110 megabecouerels (30 millicuries) or
< 0,05 millisievert (5 millirems)/hr at 1 meter In this alternative, the existing patient release criteria in
[ 10 CFR 35.75 are evaluated as the controlling requirements for determining when a patient may be released. e Alternative 3: 5 millisieverts (0.5 rem) total effective dose ' eautvilent) in this alternative, a dose limit of 5 millisieverts (0.5 rein) for determining when a patient may be released is evaluated. The alternatives were evaluated in the regulatory analysis done for the \ rulemaking (Regulatory Analysis on Criteria for the Release of Patients 3 Administered Radioactive Materials, Final Report, Stewart Schneider and Stephen A. McGuire, NRC report NUREG-1492, 1996). The regulatory analysis found that there would be no need to retain patients because of any diagnostic procedure under any of the alternatives. Only about 62,000 therapeutic procedures per y 7.r. mostly using iodine-131, would be potentially affe" ed. The costs of the alternatives for the affected therapeutic procedures are presented in Table ), For details of how the results were calculated, the regulatory analysis should be consulted. Table 1 Annual Attributes of Alternatives 1,2, and 3 Cost Estimates Hospitchiation Value of Records & Collective Hospital cost lost time in*tructions Psychological Dose Rotentbn 4 4 s cost Alternative (person-tem) (days) (millions) (millions) (millions) (relative) K 1 18,100 427,000 427 25 62 0 High 2 29,840 16.000 16 0.96 0 Moderate 3 32,5B(, 0 0 0 2,3 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 uore 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 3
7 y
y. h f
=information on whether or how;the provisions of 10 CFR 20.1301 were intended
'to apply'to'the release of pat.ients.
Because some licensees were uncertain about what d 'er the revised
-10 CFR Part 20 would have on patient release criteria, tt = . petitions were received on the issue. On June 12, 1991 (56 FR 26945), the NAC 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 (0.1 rem) to 5 millisteverts (0.5 rem) from patients administered radioactive materials. In addition, Dr. Marcus submitted a letter dated June 12, 1992, further characterizing her positica. On M ech 9, 1932 (57 FR 8282? the NRC nublished a notice .of receipt and request for comment in the Federu eteoister for a similar petition for rulemaking (PRM-35-10) from the American College of Nuclear Medicine (ACNM). On ty 18,1992 (57 FR 21043), the NRC published in the Federal Reaister notice o' an amendment submitted by the ACNM to its original petition (PRM-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 Reaister a petition from the American Medical Association 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. Three comment letters, each supporting the petition, were received on the third petition (PRM-35-ll), but these letters did not contain any additional information not covered by-the letters on the first two .titions. 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 licensad 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. , I 111. ALTERNATIVES CONSIDERED To evaluate the issues raised byLthe 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: ( Aiternative 1: 1 millisiever t (0.1 remi-total effective dose touivalent in this alternative, the I'millisievert (0.1 rem) per year dose limit in 10 CFP 20.1301(a) is evaluated as t5e controlling criterion for. determining when a patient may be released from the licensee's control.
?
ENVIRONMENTAL ASSESSMENT t AND FINDING OF NO SIGNIFICANT IMPACT ON AMENDMENTS OF 10 CFR PARTS 20 AND 35 ON , j
" CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTEREO RADI0 ACTIVE MATERIAL" Stewart Schneider and Steohen A. McGuire Office of Nuclear Regulatory Research V. S. Nuclear Regulatory Commirsion April 1996 I. THE PROPOSED ACTION The Nuclear Regulatory Commission (NRC) is amending its regula' ions in 10 CFR Parts 20 and 35 concerning criteria for the release of patients administered radioactive material. The amendments permit licensees to authorize the release from licensee control of patients administered radiopharmaceuticals or permanent implants only if the. dose to total decay to c
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 or Human 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 authorize release from confinement for medical care of any patient ;r human research subject administered a permanent implant until the measured dose rate from the patient or the human research subject 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 1 4 a
ATTACHMENT 4 ENVIRONMENTAL ASSESSMENT
ST95 Stabin, ht.,1995, ' internal Dosimetry WE44 Weiner, R.E. and R.P. Spencer, in Pediatric Nuclear hiedicinelin "QuantiGcation of Gallium 47 Citrate Pediatric Nuclear hiedicine; ed, in Breast hiilk.' Clin. Nud. hted. S. Treves; Springer Verlag, NY. 18:763. 1 076 Tobin, R.E. and P.tl. Schneider, W EtW) Weaser, J.C, htL Kamm, R.L. i- 1976 " Uptake ofGa in the tactating Dobson.1960
- Excretion of lirrast and its Persistence in hiill: Radiciodine in lluman htilk," J ANIA l Case Report,' J. Nucl. hied. 17:1055. 173:872.
VA71 Vagenakis, A.G., C.ht. Abreau, LE. WY73 Wyburn, J.R.,1973, *lluman Elteast Ilraverman,1971 " Duration of N1 ilk Excretion of Radionuclides Radioacthity in the htilk of a Following Administration of Nursing hiother rollowing *Tc Radiopharmaceuticals," J. Nucl. l hied.14:115. t Aministration/ J. Nucl. hted.12:188. I i B.27 NUREG-1492 4
Mountford P.J. and AJ, Coakley, 0G83 Ogunleye, O.T.,1983,
- Assessment M OM9a 1989,"A Resiew of the Secretion of of Radiation Dose to infants from Breast Milk Following the Radioactivity in lluman Breast Milk:
Data, Quantitative Analysis and Administration of ***Tc Pertechnetate to Nursing Mothers? Recommendations? Nucl. Med. Ilealth Physics 45:149. Commun.10:15. Pl79 Pittard 111, W.ll., K. Bill, B.D. MOS9b Mountford, PJ, and AJ. Coakley, Fletcher,1979, Excretmn of 1989," Secretion of Radioacthity in Technetmm m lluman milk,, J. Breast Milk Following Administration Pediatrics 94h05, of "'I Ilippuran? Br. J. Radiol. 62:388. Robinson, P.S., P, Ilarker, A. RO94 Campbell, P. lienson,1. Surveyor, MO87 Mountford, PJ. and AJ, Coakley, P.R. Young,1994, " lodine 131 in 1987
- Breast Milk Radioacthity Breast Milk Following Therapy for Folkming injection of *Tc- Thyroid Carcinoma 7 J. Nucl. Med.
~
Pertechnetate and *Tc- 35:1797. Glucoheptonatel Nucl. Med. l Commun. 8:839 RO90 Rose, M.R., M.C. Prescott, KJ. lierman,1990. " Excretion of M OM5a Mountford, PJ, and AJ. Coakley, lodine 12311 hippuran, 1985," Excretion of Radioacthity in Technetium 99m Red Blood Celh, Breast Milk After an Indium leukocyte and Technetium 99m Scan / J. Nucl. Med. 26:1096. Macroaggregrated Albumin into Breast Milk? J. Nucl. Med. 31:978. M OM5h Mountford, PJ,, AJ. Coakley, F.M. RU94 Rubow, S., J. Klopper,11, Itall, i1985 " Excretion of Wasserman, B. Baard, M. van Radioactivity in Breast Milk Niekerk,1994 'The Excretion of Following injection of Tc.99m ( Radiopharmaecuticals in Breast DTPA7 Nuc. Med. Commun. 6:341. ! Milk: Additional Data and [ Dosimetry? Eur. J. Nucl. Med. 21:144. MOS4 Mountford, PJ., F.M. Itall, C.P. Wells, AJ, Coakley,1984, 'llreast- RU91 Rubow, S., J. Klopper, P. Scholu, Milk Radioactiuty After a Tc 99m g99 Excretion of Gallium-67 in DTPA Aerosol /Tc 99m MAA Lung Iluman Breast Milk and its Study? J. Nucl. Med. 25:1108. Inadvertent ingestion by a 9-Montb Old Child? Eur J. Nucl. Med.18:529 MU89 Murphy, P ll., C.W. Beasley, W.ll. Moore, and M.G. Stabin,1989, RU88 Rubow, S. and J. Klopper,1988,
' Thallium-201 in lluman Milk: -Excretion of Radioiodine in lluman Observations and Radiological Milk Following a Therapeutic Dose Consequesnces/ Ilealth Physics of I 131," Eur. J. Nucl. Med.14:632.
56:539 RU78 Rumble, W,F., R.L. Aamodt, A.E. Jones, R. llenkin,1978,' Accidental NU52 Nurnberger, C.E. and A. Lipscomb, 1952," Transmission of Radioiodine Ingestion of Tc-99m in Breast Milk (l"') to infants Through liuman by a 10-Week Old Child? J. Nucl. Maternal Milk l J AMA 150:1398. Med.19:913. NUREG-1492 B.26 1 _j
H.3 REFERENCES llE80 liedrick, R.ll., R.N. Di Simone, AllM5 Ahlgren, L., S. Ivarsson, L Johansson, S. Mattsson,11. Nosslin, R.L. Keen,1986, " Radiation 1985, " Excretion of Radionuclides in Dosimetry from Breast Milk i lluman Breast Mill After the Excretion of Radioiodine and Administration of Radiopharma. Pertechnetate? J. Nucl. Med. 27:1569 ceuticals? J. Nucl. Med. 26:1085. BE73 Berke, R.A., E.C. Iloops, J.C. IIE79 Ileaton, B.,1979,"The Build Up of Kerciakes, E.L. Saenger,1973, Technetium in Breast Milk
" Radiation Dose to Breast-Feeding Following the Administration of Child Aft - Mother has "*Te-MAA "Tc aO, Labelled Macroaggregated Lung Scan? J. Nucl. Med.14:51. Albumin," Br, J. Radiol. 52:149 BU86 Butt, D. and K. Siar,1086, JO95 Johnston, R.E., S.K. Mukherji, J.R.
" Indium-lli Radioactivity in Breast Milk? Brit. J Radiol,59:80. Perry, M.G. Stabin,1995, " Radiation Dose from Breast Feeding Following Administration of TI 2017 in press.
CR87 Cristy, M. and K. Eckerman,1987,
" Specific Absorbed Fractions of l
Energy at Various Ages from KE94 Kettle, A.G., MJ, O'Doherty, P.J. Internal Photons Sources? Blower,1994, " Secretion of [*ll l ORNL/TM 83SI VI V7, Oak Ridge lodide in Breast Milk Followine ~ l l National Laboratory, Oak Ridge. TN. Administration of [*ll mera-I iodobenzylguanidine? Eur. J. Nucl. ! CR85 Cranage, R. and M. Palmer,1985, Med. 21:lSt.
" Breast Milk Radioactisity Alter
*'"Tc-MAA Lung Studics? Eur. J.
LA71 Lars n, S.M. and G.L Schall,1971 Nucl. Med.11:257. " Gallium b7 Concentration in iluman Breast Milk? (letter to the DY88 Dydek, GJ. and P.W. Blue,1988, editor) JAMA 218(2):257.
"lluman Breast Milk Excretion of todine-131 Following Diagnostic and Therapeutic Administration to a MASI Mattsson, S., L. Johansson, B.
Lactating Patient with Grases' Nosslin, L Ahlgren,1981," Excretion Disease? J. Nucl. Med. 29:407. of Radionuclider in lluman Breast Milk Following Administration of GRS3 Greener, A.W., PJ. Conte, K.D. *l fibrinogen,"Tc" MAA and Steidley,1983 " Update in Gallium 67 SCR-EDTA," In Third International Radiopharmaceutical Dosimetry Concentration in lluman Breast Milk l J. Nucl. Med. Technol.11:171. Svrnnosiung eds. E.E. Watson A.T. Schlafke-Stetson, J.L. Coffey, RJ. Hesselwood, S.R., J.R. Thornback, Cloutier; 1111S Publication FDA SI-IIE88 J.M. Brameld,1988, " Indium Il1 in 8166, U.S. Dept. of Health and Breast Milk Following Administration lluman Services, Food and Drug of Indium Ill Labeled Leukocytes? Administration, Rockville, MD. J. Nucl. Med. 29:1301. pp 102-110. B.25 NUREG 1492 1
Table 11,5 Potential Doses to lircast Feeding infants from Radiopharmacculicals Admini Woman if Nu interruption of lircast Feeding and Recommendations on Interruption lircast-Feeding (Continued) Internal Ibe to External Dme to infant if No Infant if No Masimum Interruption of Rnommendation Administered laterruption of on Interruption of Breast Ferding 3 Breast Feeding' Instructions Radio- Actiilt)' (mrem) Required?' Breast-Feedina' -_ (mci) 6f Bq) Imrem) pharmaceutical no None 30 10 (370) 0.2 2 Te-99m M AG3 Interruption for 10 >cs 5 (185) 20-800 about 24 hours Tc-99m
%%te Blood reus yes Complete cessanon 300-10,000 NA*
Ga 67 Citrate 5 (185) no None
< 0.01 2 Cr-51 EDTA 0.05 (1.85) yes interruption for 20-100 60 In til 0.5 (18.5) about 24 hours __ %hte Blood Cells Complete cessauon N A* 3es 3 (111) 100-200 4201 Chlande
- 1. Maximum aetmty normally admtmatered.
- 2. Doses were taleulated unmg the matimum adnumsteredifa tiviues doses toshown one > ear- in column adnumstered, the doses would be pnsporuonally smauer, ne doses i were calculated for newborn n ants;d old infants would be less than half the doses shown. If a dme range a .hown, the range h i sTable B.2. All measurement vanabihty as mdiented by different measurements of soceentrauons i m isbreast mdk as s ow l dose, values have been rounded to one sigmficant figure. The external dose, typteally small relative to the n considered separatley under column J.
( Doses
- 3. Dose to the infant from external radiauon only dunng breast feedmg t ue of 0.2 assummg meter, All no interru w cre cateulated uung an occupancy factor of 0.16 and an etteetne distance from source to receptor iss values have been rounded to one sigmticant figure.
l f the
- 4. The decision on whether instrueuons are required by 10 CFR 3535 is dbased on the sum of the m mternal dose range for the newborn mfant plus the esternal dose anuming no mierrupuon of bre The
- 5. De durauon of mterrupuan u selected to reduce the maumum dow todneretmn a newborn m the mfant to les actual doses that would be recened by most mfants would be far below 0.1 rem. The physician bout may use recommendauon. increasmg or decreasing the durauon of interrupuon somewhat depending on radioactmty or interruption of breast feedmg.
- 6. Not applicable (N A) because complete cessanon of breast-feeding ts assumed.
8.24 NU REG-1492
Table 11.5 Potential Doses lo Itreast Feeding infants from Radiopharmaceuticals Administered to a Woman if No Interruption of lircast Feeding and Recommendations on Interruption of lircast Feeding Internal Dose to External Dose to Wilmum infant if No Infant if No Interrupthm of Interruption of Recommendathm Administered Breast-Feeding8 Bres t-Ferding' Instructions on Interrupthm of R ad k>- Activit3' Breast-Feeding' pharmaceutical (mCl) (hlBq) (mrem) (mrem) Required?' _ 130 (5,550) very large F A' yen Complete cewauon l 131 Nal is necessary to avoid thyroid ablanon in the infant 60 5 no None j 1123 Nat 0.4 (14.8) 4-30 30 no None 1123 OlH 2 (74) 300 100 yes interruptwn for l 123 mlBG 10 (370) about 24 hours 0.2 10 no None 1125 OlH 0.01 (0.37) 0.3 (11,1) 3-20 70 no None 1-131 OlH 0.3-6 50 no None Te-99m DTPA 20 (740) 4-300 10 3es interrupuon for Te-99m 51AA 4 (148) about 12 hours 30 (1,110) 20 800 80 yes Interrupuon for Te-99m 04 about 24 hours t Pertechnetate) 4 20 20 no None Te-99m DISIDA B (300) 25 50 no None Te-99m 20 (740) Gluecheptonate 20-50 20 no None Te 99m H ant 8 (300) 30 (1,110) 1-10 80 no None Tc-99m N1181 45 50 no None Tc-99m htDP 20 (740) 5-20 50 no None Te 99m PYP 20 (740) 0.3 100 50 yes interruption tor Te 99m RBC 20 (740) in Vivo Labehng about o hours 1-2 50 no None Te-99m RBC 20 (740) in Vitro Labehng Te 99m 0100 30 yes interrupuon for 12 (444) Sulfur Colloid about 6 hourn Te 99m DTPA 0.02-0.3 3 no None 1(37) Aerosol B.23 NU REG-1492 e l ____J
Table llA Total Acthity Ingested and laternal Radiation Doses Recched from the intake of Radiopharmaceuticals in lircast Stilk Under Different interruption Schedules tContinued) Total Aceity Ntin hise Equisalent Administered Interruption I" I"""I Activity Time _ Radio- (%) Newboen I Vr-Old __ Concentration (hr) (mci) pharmaceutical (mci) 4.08E -01 1.84E + 02 1.04E + 02 mmimum 3 1.22E -02 TI-201 Chlonde 3 8.26E + 01 9.72E-03 3.24E-01 1.46E + 02 12 2.50E-01 1.12E + 02 6.36E 4 01 24 7.49E -03 1.64 E-01 7.38E + 01 4.18E + 0! 48 4.92E -03 8.17E -02 3.68E + 01 3.08E + 01 96 2.45E -03 5.86E -02 2.64E + 01 1.50E + 0! 120 1.76E-03 1.36E + 01 7. 74 E + 00 168 9.10E -04 3.03E-02 3.04E -03 1.37E + 00 7.74 E -01 336 9.llE -05 3.04 E -05 1.37E -03 7.76E -03 672 9.13E- 07 7.91E -Ol 3.55E + 02 2.01 E + 02 maxnt: mum 3 2.37E 02 7.08E -01 3.18E + 02 1.80E + 02 12 2.12E-02 6.2 t E-01 2.79 E + 02 1.58E + 02 24 1.86E -02 5.04E -01 2.26E + 02 1.28E + 02 48 1.51 E -02 3.88E -01 1.74E + 02 9.86E + 0! 96 1.16E -02 3.56E -01 1.60E + 02 9.10E + 0i 120 1.07E -02 3.14E -01 1.41 E + 02 8.00E + 01 168 9.41E -03 2.24E - 01 1.01 E + 02 5.70E + 0 i 336 6.71 E -03 1.18E -01 5.30E + 01 3.00E + 0 ! 672 3.53E-03 B.22 NUREG-1492 5 l
Table llA Total Acthity Ingested and Internal Radiation Doses Recched from the intake of Radiopharinaceuticals in lircast Milk Under Different Interruption Schedules (Continued) otal Act ty tise Nw Quisalent Administered Interruption . Time
'""' I"""*I l
Radk>- Actisity pharmaceutical (mci) Concentratkm (hr) (mci) (%) Newborn I Yr-Old I mimmum 3 1.26E-02 1.05 E -01 9.33E + 00 4.57E + 00 Tc-99m 12 12 3.74E -03 3.11E -02 2.76E + 00 1.35E + 00 sulfur Colloid 24 7.38E-04 6.15 E -03 5.46E-01 2.68E + 01 48 2.88E -05 2.40E -04 2.13 E - -02 1.0$ E -02 96 4.40E-08 3.67E-07 3.26E -05 1.60E -05 120 1.72E -09 1.43 E-08 1.27E -06 6.23E -07 168 2.62E - 12 2.19 E - I l 1.94 E -09 9.51 E - 10 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.0(,E + 00 0.00E + 00 0.00E + 00 0.00E + 00 maxmimum 3 1.76E -01 1.47E + 00 1.30E + 02 6.38L + 01 12 8.30E -02 6.92 E -01 6.14E + 0! 3.01E + 01 l 24 3.05E-02 2.54 E -01 2.26E + 0 ! 1. l l E + 0 L 48 4.11 E -03 3.42 E -02 3.04E + 00 1.49E + 00 96 7.47 E-05 6.22E-04 5.53E -02 2.71 E -02 120 1.01 E - 05 8.39 E -05 7.45 E - 03 3.65 E -03 168 1.83 E- 07 1.53 E -06 1.35 E -04 6.64 E -05 336 1.48 E - 13 1.23E - 12 1.09E - 10 5.36E - 11 672 0.00E + 00 0 00E +00 0.00E + O2 0.00E + 00 Te-99m 30 mmimum 3 4.78 E -02 1.59E -01 1.95 E + 0! 9.02E + 00
%1ute Blood Cdis' 12 5.10E-03 1,70E - 02 2.08 ti + 00 9.63 E -01 e
24 2.58 E -04 8.61 E -04 1.0$ E -01 4.88 E -02 f 1.25 E -04 48 6.63 E -07 2.2 t E -06 2.70E -04 96 4.36E - 12 1.45 E - 11 1.77E -09 8.23 E H 0 120 1. l l E - 14 3 69E - 14 4.50E - 12 2.09E - 12 108 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 masmimum 3 2.03 E + 00 6.76E + 00 8.25E +02 3.83E +02 12 6.54 E -01 2.18E + 00 2.66E + 02 1.23E + 02 24 1.44E -01 4.81 E -01 5 88E+01 2.73 E + 01 48 7.05 E-03 2.35E -02 2.87E + 00 1.33 E + 00 96 1.68E -05 5.61 E -05 6.84E - 03 3.17 E -03 120 8.21E -07 2.74 E -06 3.34E -04 1.55 E -04 168 1,96E -09 6.53 E -09 7.97E -07 3.69 E -07 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E +00
- The done estamates for Te 99m labeled white blood eclls are actually the dose estimate
- for Te-99m pertechnetate, as it wa.e anumed that astmty released m breast mdk from this product would be in the form of pertechnetate.
B.21 NUREG-1492
Table 11.4 Total Artisity ingested and Internal Radiation Doses Recched from the intake of Radiopharmaceuticals in Breast Milk Under Different Interruption Schedules (Continued) Total Actisit) Effntise the Equisalent Administered Interruption I" '"#"U Actisity Time Radio- Newtwrn 1.Yr Old (mci) Conceration (hr) (mci) ('7r) pharmaceutical 1,76E -02 1.10E + 00 4.83 E -01 20 nurumum 3 3.53E -03 Tc-99m RBC 7.92E -03 4.93E -01 2.17E -01 12 1.58E -03 in Vitro Labehng 1.70E-01 7.47E -02 24 5.46E -04 2.73E -03 3.24E -04 2 01E-02 8.86E -03 48 6.47E -05 4.55 E -06 2.83 E -04 f .25 E -04 96 9.10E -07 539E -07 3.35E-05 1.48 E -05 120 1.08E -07 7.58 E -09 4.71 E -07 2.08E -07 168 1.52E-09 2.48E- 15 1.54E- 13 6.78 E - 14 336 4.95E - 16 0,00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 6,06E -03 3.03 E -02 1.88E + 00 830E -01 masnuinum 3 1.52 E-02 9.42 E -01 4.15 E - 01 12 3.03E -03 6.01E -03 3.74 E -01 1.65 E -01 24 1.20E -03 9.48E -04 5.89E -02 2.59E -02 48 1.90E-04 2.35E -05 1.46E -03 6.44 E -04 96 4.70E -06 3.71 E -06 2.30E -04 1.01 E -04 120 7.41 E -07 9.20E -08 5.72 E -06 2.52 E - 06 168 1.84 E -08 2.22E - 13 1.38 E - I l 6.07E - 12 336 4.43 E - 14 0.00E + 00 0.00E + 00 0.00E + 00 u72 0.00E + 00 4.75E -03 2.88 E -01 1.30E -01 nurumum 3 9.49 E -04 Tc 99m RBC 20 5.19 E -02 12 3.79 E -04 1.90E -03 1.15E -01 in Vivo Labehng 3.39E -02 1.53 E -02 24 1.12E -04 5.58 E -04 4.84E-05 2.94E -03 1.32E - 03 48 9.67E -06 3.63 E -07 2.20E -05 9.94 E -06 96 7.26E -08 3.15 E -08 1.91 E -06 8.62E - 07 120 6.29 E -09 2.36E - 10 1.43E 48 6.47E -09 168 4.73 E - I l 2.2SE - 18 1.39E - 16 6.25 E - 17 336 4.57E - 19 0.00E + G 0.00E +00 0.00E + 00 672 0.00E +00 2.19E + 00 133E + 02 5.99E + 01 monumum 3 4.38E -01 8.93E - 01 5.4 5E + 01 2.46E + 01 12 1.80E -01 7,50E + 00 5.48E-02 2.7 4E -01 1.66E + 01 24 2.54 E -02 1.54E + 00 6.96E-01 48 5.09 E -03 1.33 E -02 6.01 E -03 96 4.39 E -05 2.20E -04 2.04E - 05 1.24E -03 5.59E -04 120 4.08E -06 1.76E -07 1.07E -05 4.82 E -06 168 3.52 E - 08 4.45E - 13 2.01E- 13 336 1.47 E - 15 733E-15 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 B.20 NUREG 1492
Table H.4 Total Acthity Ingested and internal Hadiallon Dmes Recebed from the intake of Radiopharmaceuticals in Breast Milk Under DitTerent Interruption Schedules (Continued)
"I*I ^'N' " ' '"
I Adminhtert4 Interruption I" I*"O Radio- Actitity Time Concentration (hr) (mCl) (%) Newtern I-Yr-Old pharmaceutical (mci) 4.78E-02 1.59 E - 01 1.95E 4 01 9.02E + 00 Tc.99m O, 30 muumum 3 12 5.10E -03 1.70E -02 2.08E + 00 9.63 E -01 (Penechnetate) 24 2.58E -04 8.61 E -04 1.05E-01 4.8SE-02 48 6.63 E -07 2.21 E -06 2.70E -04 1.25 E -04 96 4.36E - 12 1.45E - 11 1.77E -09 8.23 E - 10 120 1.llE - 14 3.69E - 14 4.50E -12 2.09E - 12 168 0.00E + 00 0.00E + 00 0.00E 4 00 0.00E + 00 336 0.00E + Jo 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 2.03E + 00 6.76E + 00 8.25E + 02 3.83 E + 02 masnumum 3 12 6.54 E -01 2.18E + 00 2.66E + 02 l .23 E + 02 24 1.44 E -01 4.81 E -01 5.88E + 01 2.73E + 01 48 7.05 E -03 2.35 E -02 2.87E + 00 1.33E + 00 96 1.662 - 05 5.61 E -05 6.84 E - 03 3.17E -03 120 8.21 E -07 2.74E -06 3.34E -04 1.55 E -04 168 1.96E -09 6.53 E -04 7.97E -07 3.69 E -07 336 0.00E + 00 0.00E + 00 0,00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.wJE + 00 0.00E +00 muumum 3 1.73E -02 8.66E -02 4.8 t E + 00 2.05 E + 00 Te 99m PYP 20 12 2.92 E -G3 1.46E -02 8.10E -01 3.46E - 01 24 2.72E -04 1.36E -03 7.55E-02 3.22E-02 48 2.30E -06 1.18 E -05 6.54 E -04 2.79 E -04 96 1,77E - 10 8.87E - 10 4.92 E -08 2.10E -08 120 1.54E - 12 7.70E - 12 4.27E - 10 1.82E - 10 168 8.0$ E - 17 4.02 E - 16 2.23 E - 14 9.53 E - 15 336 0.00E + 00 0.00E + 00 0 00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 3 8.73 E -02 4.37 E -01 2.42E + 01 1.03 E + 0 ! masnumum 12 3.40 E -02 1.74 E -01 9.68 E + 00 4.13E + 00 24 1.03 E -02 5.14E -02 2.85E + 00 1.22E + 00 48 8.90E -04 4.45 E -03 2.47E -O n 1.05 E -01 96 6.68 E -06 3.34E -05 1.85 E -03 7.91E -04 120 5.79E -07 2.90E -06 1.61E -04 6.86E -05 lb8 4.35 E -09 2.17E -08 1.2 t E -06 5.15 E -07 336 4.20E - 17 2,10E -lb 1.17E - 14 4.97 E - 15 072 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 B.19 NUREGl492
Table H.4 Total Arthity Ingested and Internal Radiation Doses Recei ed from the Intake of Radiopharmaceuticals in lircast Milk Under DitTerent Interruption Schedules (Continuedi
' ' b " ' '"'
""'^*"'D Adminhtered Interruptism I * *I I"
Radio- Actisity Time (hr) (mci) (M Newhorn I Vr-Old pharmaceutical (mCl) Concentration 20 nummum 3 8.94E -03 4.47E-02 3.64E + 00 1.39 E + 00 Tc-99m MDP 2.34E -01 12 1.51E -03 7.53E -03 6.13 E -01 24 1.40E -04 7.02 E -04 5.71 E -02 2.18E -02 48 1.22E-06 6.09 E -06 4.95 E -04 1.89 E -04 96 9.16E - 11 4.58 E - 10 3.73E-08 1.42 E -08 120 7.94E - 13 3.97E - 12 3.23E -10 1.23E- 10 4.15E - 17 2.08E- 16 1.69 E- 14 6.45 E -- 15 168 336 0,00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 3 1.20E -02 5.98E -02 4.87E + 00 1.86E + 00 mumimum 12 3.53E-03 1.76E-02 1.44E + 00 5.48 E -01 6.92 E -04 3.46E -03 2.82 E -01 1.08 E -01 24 48 2.67E-05 1.33 E -04 1.09E -02 4.14 E - 03 96 3.96E -08 1.98E -07 1.61 E-05 6.15 E -06 120 1.52 E -09 7.62E -09 6.20E - 07 2.37E -07 168 2.26E- 12 1.13E -I l 9.20E - 10 3.51E - 10 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 3 2.23 E -03 7.44 E -03 1.16E + 00 5.37E -On Tc-99m MIBl 30 mmimum 12 5.59E -04 1.86E -03 2.90E -01 1.34E-01 24 8.83 E -05 2.9 4 E -04 4.57E-02 2.12 E -02 48 2.20E -06 7.34 E -06 1.14 E -03 5.30E -04 46 1.37E -09 4.56E -09 7.09 E -07 3.29 E - 07 3.41 E - I l 1.14 E - 10 1.77E - 08 8.21 E -04 120 168 2.12 E - 14 7.08E - 14 1,10E - I l 5.l lE - 12 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 3 1.97E -02 6.56 E -02 1.02E + 01 4.73E + 00 mumimum 7.76E -03 2.59 E -02 4.02E + 00 1.87E + 00 12 7.47 E -03 1.16E + 00 5,39 E - 01 24 2.24E -03 48 1.87 E -04 6.24E -04 9.70E -02 4.51 E -02 96 1.31E -06 4.36E -06 6.77E -04 3.14E -04 120 1.09 E -07 3.64E -07 5.66E -05 2.63E - 05 168 7.62 E - 10 2.54 E -09 3.95 E -07 1.83 E -07 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 NUREG-1492 B.18
Table BA Total Arthit) Ingested and internal Radiation Doses Recched from the Intake of Radiopharmaceuticals in lircast Milk Under Different Interruption Schedules (Continued) Administered Interruption Total Ac% Nu h huhalent I"A I"'"*I R adk>- Actitity Time pharmaceutical (mci) Concentrathm (hr) (mci) (%) Neutmrn 1.Yr-Old Tc-99m M AA 4 nunimum 3 6.66E -03 1.66E -01 4.19E + 00 1.70E + 00 12 7.l l E-04 1.78 E -02 4.47E -01 1.81 E -01 24 3.60E-05 9.00E --04 2.26E-02 9.19 E -03 48 9.23 E -08 2.31 E -06 5.BI E-05 2.36E - 05 96 6.07E- 13 1.52 E - 11 3.82E - 10 1.55 E - 10 120 1.54 E - 15 3.85 E - 14 9.69 E - 13 3.93 E - 13 168 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E 4 00 0.00E 4 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 munumun' 3 4.78E-01 1.19E + 01 3.01E + 02 1.22E + 02 12 1.47E -01 3.68E + 01 9.27E + 01 3.76E + 01 l 7.84E + 00 24 3.07E-02 7.68E -01 1.93E + 01 48 1.33E -03 3.33 E-02 8.38E -01 3.40E -01 96 2.51E-06 6.28';-05 1.58E -03 6.41 E -04 120 1.09 E -07 2.73 E -06 6.86E -05 2.78 E -05 168 2.06E - 10 5.14 E -09 1.29E-07 5.2SE-08 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 l Tc-99m M AG3 10 mmimum 3 1.29E -03 1.29E -02 1.52E-01 6.66E -02 12 1.74 E -04 1.74 E -03 2.07E -n2 9 NE-03 24 1.22E -05 1.22 E -04 1.44 E -03 6.30E -04 48 5.92E -08 5.92 E -07 7.00E -06 3.06E -06 96 1.40E - 12 1.40E - 11 1.66E - 10 7.25 E - 11 120 6.80E - 15 6.80E - 14 8.05E - 13 3.52E - 13 168 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 munumum 3 2.39E -02 2.39 E -01 2.83E + 00 1.24E + 00 12 6.88 E - 03 6.8% E -02 8.15 E -01 3.56E-01 24 1.31 E -03 1.3 t E - 02 1.55E-01 6.77E -02 48 4.72E-05 4?72E -04 5.58E -03 2.44E-03 96 6.14E -08 6.14 E -07 7.27E -06 3.18E -06 120 2.22 E -09 2.22E-08 2.62 E-07 1.15 E -07 168 2.89E - 12 2.89 E - 11 3.42 E - 10 1.50E - 10 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E +00 672 0.00E + 00 0.00E + 00 0.00E +00 0.00E + 00 B.17 NUREG-1492
\
Table 11.4 Total Acthity ingested and Internal Radiation Doses Meteised from the lutake of Radiopharmaceuticals in lircast Milk Under Different interruption Rhedules (Continued) Total ActMty - Nthe be fauWent Adminhtered Interruption (mnml Time insM Radk>- Activity I Yr4)ld (hr) (mCO M) Scutwrn pharmaceutical (mCl) Concentrathm 7.41 E -02 2.30E + 00 5.38E + 00 20 nurumum 3 1.48E - 02 Tc-99m 4.08 E -01 9.52 E -01 12 2.63E -03 1.31 E -02 Glucoheptanate 9.48E - 02 24 2.61E - 04 1.31 E -03 4.06E -02 1.29E -05 4.02 E -04 9.38 E - 04 48 2.59E- 06 2,53E- 10 1.27E -09 3.94E -08 9.19 E -08 96 2.5 t E - 12 1.25E-Il 3.90E - 10 9.100 - 10 , 120 l 1.llE - 15 3.44 E - 14 8.03E - 14 168 2.21E - 16 0.00E + 00 0.00E + 00 0.00E + 00 l 336 0.00E +00 0.00E +00 0.00E + 00 0.00E + 00 l 672 0.00E + 00 1.51E -01 4.70E + 00 1.10E + 0 i masmimum 3 3.02E-02 6.37 E -03 3.19E -02 9.90E - 01 2.31 E + 00 12 7.99E -04 3,09E -03 1.24E -01 2.90E -01 24 48 1.250 - 05 b.27 E -05 1.95 E -03 4.55E-03 96 3.10E -09 1,55 E -08 4,815 - 07 1.12E-06 4.87E - I l 2.43E - 10 7.5bE -09 1.76E - OS 120 1.19 E - 14 5,97E - 14 1.86E - 12 4.33E - 12 168 0.00E + 00 0.00E 4 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E 4 00 0.00E + 00 672 0.00E + 00 4.50E -01 2.00E + 01 8.13E + 00 Tc 99m HAM 8 nummum 3 3.60E -02 5.64 E -02 2.50E + 00 1.02 E + 00 12 4.51 E - 01 3.54E -03 1.57E -01 6.3sE -02 24 2.83E -04 1.11 E -06 1.39 E -05 6.17E -04 2.51 E -04 48 2.14E - 10 9.5 2E -09 3.87 E -09 96 1.72 E - 11 6.730 - 14 8.42 E - 13 3.74E - I l 1.52E - i l 120 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 168 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 8.95 E -02 1.12E + 00 4.97E + 0! 2.02E + 01 masmimum 3 4.59 E -01 2.04E + 0! 8.29E + 00 12 3.67E -02 1,40E -01 6.21E + 00 2.53E + 00 24 1.12 E -02 48 1.04E - 03 1.30E -02 5.77E-01 2.35 E -01 96 8.98E - 06 1.12E -04 4.98E -03 2.03E -03 8.35E-07 1.04E -05 4.63E - 04 1.BB E -04 120 7.21E -09 9.01E -08 4.00E -06 1.63 E -06 16P. 3.00E - lo 3.75E- 15 1.66E - 13 6.7bE - 14 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 072 NUREG 1492 B.16 1
Table 11.4 Total Acthity Ingested and Internal Radiation Doses Receised from the intake of Radiopharmaceuticals in lircast Milk Under DitTerent interruption khedules (Continued)
"'#' ' I '"#"'
Administered Interruptkin Activity Time I "#' I""'"'I Radke- _ _ . pharmaceutical (mCl) Concentration (hr) (mCl) (%) Newborn I.Yr-Old Tc-99m DTPA 20 nunimum 3 2.57E -03 129E -02 3.23 E -01 1.43 E - 01 12 3.49 E -04 1.74E 03 4.39E -02 1.94 E -02 24 2.43E -05 1.22 E - 04 3.06E -03 1.35 E - 03 48 1.18 E -07 5.92E -07 1.49 E -05 6.57E - 06 96 2.80E - 12 1.40E - I l 3.52 E - 10 1.55 E - 10 120 1.36E - 14 6.80E - 14 1.71 E - 12 7.55 E - 13 168 0.00E 4 00 0.00E + 00 0.00E + 00 0.00E + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.008' + 00 0.00E + 00 0.00E + 00 0.00E + 00 munumum 3 4.780 - 02 2.39 E - 01 6.02E + 00 2.65E + 00 12 1.38E -02 6.88E-02 1.73E + 00 7.640 - 01 l 1.45 E - 01 I 24 2.61 E -03 1.31 E-02 3.29E -01 48 9.e3E -05 4.72E -04 1.19 E -02 5.24E -03 l 6.14E -07 1.53E -05 6.82 E -06 46 1.23 E -07 120 4.43E -04 2.22E -08 5.58E -07 2.46E - 07 l 168 5.77E - 12 2.89E - 11 7.26E - 10 3.23 E - 10 l 336 0.00E + 00 0.000 + 00 0.00E + 00 0.000 + 00 l 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 l l 6.09 E - 03 Te-99m DTPA 1 mimmum 3 5.14 E -05 5.14 E -03 1.43 E -02 Aero*ol 12 6.98E - 06 6.98 E -04 1.94 E -03 8.26E -04 24 4.87E -07 4.87E -05 1.35 E - 04 5.76E -05 48 2.3 7E -09 2.37E -07 6.57E - 07 2.80E -07 96 5.60E - 14 5.60E - 12 1.55 E - 11 6.63 E - 12 120 2.72 E - 16 2.72 E - 14 7.55 E - 14 3.22E - 14 168 0.00E + 00 0.00E + 00 0.00E + 00 0 00E + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 mumimum 3 4.93E - 04 0.93 E -02 2.76E -01 1.18 E -01 12 2.86E -04 2.86E -03 7.43E-02 3.38E - 02 24 5.43 E -05 5.43E - 03 1.51E -02 6.43 E -03 48 1.96E -06 1.06E - 04 5.44 E -04 2.32 E - 04 96 2.55 E -09 2.55E -07 7.08E --07 3.02E -07 120 9.2 t E -I l 9.21 E -09 2.56E -08 1.09 E -08 168 1.20E - 13 1.20E - I l 3.33E - Il 1.42 E -I l 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 t 11.1 5 NU REG-1492
Table 11.4 Total Acthily Ingested and internal Radiation Doses Recched from the intate of Radiopharmaceuticals in fireau Milk l'nder Dilierent Interruption Schedules (Continued) a Act y th he huhukut Interruption '**' Administered Time I"" Radkr Activit) (%) Newimrn I Yr4)ld (mCl) Concentration (hr) (mCl) pharmaceutical 1.24E -01 2.04E + 01 8.04E + 00 0.5 mimmum J 6.21 E -04 in-ll! 1.15E -01 1.90E + 01 7.47E + 00 12 5.77E-04 Wlute Blood Cells 1.72E + 01 6.77E + 00 24 5.23 E --04 1.050 - 01 1.42E + 01 5.57E 4 00 48 4.30E - 04 R .60E -02 5.82E -02 9.58E + 00 3.77E + 00 96 2.91 E -04 4.78E - 02 7.88E 4 00 3.10E + 00 120 2.39 E -04 3.23 E -02 5.32E + 00 2.09E + 00 f 168 162E -04
- 4. 61 E -05 8.22E-03 1.35 E + 00 5.32E -01 336 5.31 E -04 8.75 E -02 3.44 E - 02 672 2.66E -06 6.19 E -01 1.02E + 02 4.01 E + 01 matmtmum 3 3.10E-03 5.92 E -01 9.7$E + 01 3.83E +01 12 2.96E -03 5.58E -01 9.10E + 01 3.6t E + 0i 24 2.79E-03 4.95 E -01 8.16E + 01 3.21E + 01 48 2.48E -03 96 1.95 E - 03 3.91 E -01 6.43E + 01 2.53E + 01 1.73 E -03 3.47E-01 5.71E + 01 2.25E + 01 120 2.74E -01 4.50E + 0! 1.77E +01 168 1.37E - 03 5.95 E -04 1.19 E -01 1.96E + 01 7.71E 4 00 336 1.46E + 00
/
672 1.13 E -04 2.26E -02 3.72E + 00 7.05E -02 4.80E +00 2.30E + 00 8 nummum 3 5.64 E -03 Tc 99m DISIDA 9.12 E -01 436E -01 12 1.07E -03 1.34E -02 1.17E -04 1.46E -03 9.95E -02 4.7eE -02 24 1.39 E - 06 1.74E -05 1.18E -03 5.67E - 04 48 1.97E - 10 2.47E -09 1.68E -07 8.03E -Os 46 2.94E - 11 2.00E -09 9.57E - 10 120 2.35E - 12 4.02E - 15 2.73E - 13 1.31 E - 13 168 3.21 E - 16 0.00E + 00 0.00E + 00 0.00E + 00 0.00E +00 336 0.00E + 00 0,00E + 00 672 0.00E + 00 0.00E + 00 2.82E - 01 1.92E + 01 9. l ?E + 00 masnumum i
. 2.25E -02 1.42 E- 01 9.66E + 00 4.62 E + 00 12 1.13E -02 5,69E-02 3.87E + 00 1.85E + 00 24 4.55E -03 48 7.32E -04 9.15E -03 6.23 E -01 2.98E -01 2.36E -04 1.bl E -02 7.70E - 03 96 1.89E -05 3.04E -06 3.80E-05 2.59 E-03 1.24E -03 120 7.86E -0S 9.83E -07 6.69 E -05 3.20E -05 168 2.73E- 12 1.86E - 10 8.89 E - 11 336 2.18E - 13 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 NUREG 1492 B.14
~ -
Table 15.4 Total Acthity ingested and Internal Radiation Doses Hecched from the intake of Radiopharmaceutkah in lircast Milk Under Different interruption Mhedules (Continuedi otal Ac N t) Wth N @ stent Administered Interruption (mreml in m ted Rad u>- Actiilty Time pharmaceutical (mci) Concentratkm (hr) (mCl) (%l New twrn l Yr-Old mmimum 3 2.62E -03 8.73 E -01 2.91 E + 00 1.16E + 00 1131 OiH 0.3 12 1.49E -04 4.96E - 02 1.65 E -01 6.61 E -02 24 3.26E - % l .09 E - 03 3.61E - 03 1.45E -03 48 1.56E -09 5.19E - 07 1.73 E - 06 6.91 E - 07 96 3.480 -16 1.16E - 13 3.86E - 13 1.54E - 13 120 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 168 0.00E + 00 0.00E + 00 0.00E + 00 0.000 + 00 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.000 + 00 0.00E + 00 matmsmum 3 1.50E -02 4.99E + 00 1.66E + 0! 6.65E 4 00 12 5.13E -03 1.71 E + 00 5.69 E - 00 2.29E + 00 l 5.45 E -01 24 1.23E -03 4.09 E - 01 1.36E -00 48 7.0$ E -05 2.35 E -02 7.82E -02 3.13 E- 02 i ' 96 2.32 E -07 7.73 E -05 2.58E -04 1.03 E - 04 120 1.33 E -08 4.44 E -06 1.48 E -05 5.9 t E - 06 168 4.38E - I l 1.46E - 08 4.86E -08 1/.5 E -08 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 1131 Soshum lodide 150 mimmum 3 1.06E + 00 7.07E -01 2.08 E + 07* 1.53 E + 0D 12 4.52 E -01 3.01 E --01 8.86E + 06* 6.5204 06* (Nal) 24 1.45 E -01 9.66E -02 2.84E + 06* 2.00E + 06* 48 1.49E -02 9.94 E -03 2.92E + 05* 2.15 E + 05 * , 96 1.5 B E - 04 1.05E-04 3.10E + 03* 2.28E + 03
- 120 1.62 E -05 1.08 E -05 3.18E + 02
- 2.330 , 02*
168 1.71E-07 1.14E -07 3.35E + 00* 2.47E + 00* 336 1.92 E - 14 1.28E - 14 3.76E -07
- 2.77E -07*
672 0.00E + 00 0.00E + 00 0.00E + 00* 0.00E + 00* matmimum" 3 7.50E + 01 5.00E + 01 1.47E + 09' l .0$ E + 09' 12 7.50E + 01 5.00E + 01 1.47E + 09' l .08E + 09* 24 7.50E + 01 5.00E + 01 1.47E + 09* 1,0&E + 0e 48 7.50E + 01 5.00E +01 1.47E + 0e 1.38E + 09* 96 7.50E + 01 5.0dE + 01 1.47E + 00* 1.08E + 00* 120 7,50E + 01 5.00E + 01 1.47E + 09' l .0SE + 09* 168 7.06E + 01 5.00E + 01 1.47E + 09' l .08E + 09' 336 1.88E + 01 1.25 E + 01 3.69E + 08* 2.71 F + 08* 672 7.68 E -01 ' .12 E -01 1.51E + 07* 1.l lF + 07 *
- Dow to the mfant thyroid, mrad.
" The salues under Total Actmty ingested and Etfecuve Dose Equnalent for interrupuun times 3 to 168 hours how no change with ume because the total traction of adnumstered activity etereted in the breast milk exceeded the upper hmat (or cap) of 0.50 (see B.1 CALCULATION AL METilODI.
H.13 NU REG.1492
Table 11.4 Total Acthity Ingested and internal Radiation Dose [Recened from the intake of Radiopharmaceuticals in lircust Milk Under DitTerent Interruption Schedules (Continuedi
"' 'I Administered Interruption "*I I"8 Radio- Actiilt) Time Concentration (hr) (mCl) (%) Newimrn 14r-Old pharmaceutical (mci) 3 1.03 E -02 2.58E + 00 6. l l E + 0' 4.20E + 01 1123 Nal 0.4 mimmum 12 3.53E -03 8.830 - 01 2.00E + 01 1.44E + 0!
24 8.45 E -04 2.l l E-01 5.00E + 00 3.44E + 00 48 4.84E -05 1.21E-02 2.87E 01 1.97 E -01 96 1.59E -07 3.98E-05 9.42E-04 6.48 E -04 120 9.12E -09 2.28E -06 5.40E -05 3.71 E -05 168 3.00E - Il 7.49 E - 09 1.77E -07 1.22E - 07 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 0.00E +00 0.00E + 00 672 2.70E + 00 6.40E + 01 4.40E 4 01 matm.imum 3 1.08E - 02 3.70E -03 9.25E - 01 2.19E + 01 1.5 t E + 01 12 24 8.8bE -04 2.22E-01 5.25 E + 00 3.blE+00 48 5.08 E -05 1.27E -02 3.01 E -01 2.07 E - 01 46 1.67E -07 4.17E-05 9.8 S E -04 6.79 E -04 120 9.56E -09 2 J9E -06 5.66E - 05 3.89 E -05 168 3.14E -11 7.55E - 09 1.86E -07 1.28E - 07 336 0 00E '00 0.000 + 00 0.00E +00 0.000 + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 2.52E -04 2.52E +00 2.24E -01 9.04 E -02 1-125 0111 0.01 mimmum 3 12 6.84E - 05 6.84 E -01 6.07E -02 2.45E-02 24 1.20E -05 1.20E -01 1.07E-02 4 31E-03 48 3.72 E -07 3.72 E -03 330E -04 1.33 E -04 46 3.55 E - 10 3.55E-06 3.15 E -07 1.27 E -07 120 1.10E - I l 1.10E -07 4 75E-09 3.04 E - 09 1.03E - 14 1,050 -10 9.32E - 12 3.77E - 12 168 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 3 2.52E -04 2.52 E + 00 2.24E -01 9.04 E - 02 mumimum 12 6.84E-05 6.84E -01 6.07 E - 02 2.54E-02 24 1.20E -05 1,20E -01 1.07E -02 4J t E -03 48 3.72 E -07 3.72E -03 3 JOE -04 l .33 E -04 96 3.55E- 10 3.55E-06 3,15E-07 1.27 E - 07 120 1.10E - I l 1.10E -07 9.75 E -09 3.94E -09 168 1.05 E - 14 1.05 E - 10 9320-12 3.77E - 12 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 0{ NUREG-1492 B.12
Table h..l Total A(thil) ingested and Internal Radiation Doses Recelled from the intake of Radiopharmateuticals in Breast Milk Under DitTerent Interruption Schedules (Continued) Total Actish hthe the Equitaient Administered laterruption Actiitty Time I " ** I'"""'I Raden-pharmaceutical (aiCl) Concentrat'um (hr) (mCl) (%) Newlx>rn 14r-Old 1123 m!BG 10 nurumum 3 5.41E -02 5.41 E -01 3.20E + 02 2.20E 4 02 12 3.13E -02 3.13 E -01 1.86E + 02 1.28E 4 02 24 1.51E -02 1.5 t E -01 8.96E + 0! 6.16E + 01 48 3.53E -03 3.53 E-02 2.09E + 0! 1.44 E -01 96 1.92 E -04 1.92 E -03 1.14E + 00 7.82E -01 120 4.48 E -05 4.48 E -04 2.65 E -01 1.820 - 01 168 2.44E -06 2.44E-05 1.44E -02 9.92 E - 03 336 9.15 E -I l 9.15 E- 10 5.42E -07 3.73 E -07 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 mannumum 3 5.41 E - 02 5.41 E -01 3.20E + 02 2.20E + 02 12 3.13E-02 3.13 E -01 1.86E + 02 1.28E + 02 24 1.51 E -02 1.51 E -01 8.96E + 01 6.16E + 01 l 48 3.53E -03 3.53E -02 2.09E + 01 1.44E -01 l 96 1.92 E -04 1.92E -03 1.14 E + 00 7.8 E -01 120 4.48E-05 4.48 E -04 2.65 E -01 1,82E -01 163 2.44 E -06 2.44 E -05 1.44 E -02 9.92 E -03 l ! 336 9.15 E - 11 9.15 E - 10 5.42E -07 3.73 E -07 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 l-123 Olli 2 nurumum 3 1.63 E -02 8.13 E - 01 3.85 E + 00 1.62 E + 00 l ! 12 2.76E - 03 1.38E -01 6.54E -01 2.76E - 01 24 2.60E -04 1.30E -02 6. l bE -02 2.60E -02 48 2.31 E - 06 1. l S E -04 5.47 E -04 2.31 E -04 96 1.82E - 10 9.08E -09 4.30E - 08 1.82E -08 ' 120 1.61 E - 12 8.06E - 11 3.82 E - 10 1.b l E - 10 168 8.'9E - 17 4.40E - 15 2.03E - 14 8.78 E - 15 336 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 mumimum 3 1.240 - 01 6.18E + 00 2.93E + 0! 1.24E + 01 12 4.18 E -02 2.00E + 00 9.91E + 00 4.18E + 00 24 9.86E 4.93 E -01 2.33E + 00 9.85 E -01 48 5.48 E -04 2.74E-02 1,30E -01 5.47E -02 06 1.69E -% 8.45E-05 4.00E -04 1.69E -04 120 9.38 E -08 4.69E -06 2.22E -05 0.37 E - 06 168 2.89E - 10 1.45 E -08 6.85 E -08 2.89 E -OS 336 0.00E + 00 0.00E +00 0.00E + 00 0.00E + 00 672 0.00E + 00 0.00E + 00 0.00E + 00 0.00E + 00 i H.li NURE(i-1492 i
Table IL4 Total Acthity ingested and internal Radiation Doses Recched from ihr intake of Radiopharmaceuticals in lircast Milk Under Different Interruption Schedules _ Effectise Dme Equisalent Total Actitity Adm.men
. tered In'erruption Ingoted (mrem)
Rad,un- Activity Time (%) New tx>rn 1 Vr-Old (mci) Concentration (hr) (mCl) pharmaceutical 1.54E-02 8.85 E -04 3.71E-04 0.05 mammum 3 7.71 E -06 Cr 51 EDTA 6.27E -03 3.60E -04 1.51 E -04 12 3.14E -06 1.89 E -03 1.08E -04 4.54E - 05 24 9.44E-07 48 8.55E-08 1.7 t E-04 9.81 E -Oo 4.llE-06 1.40E-06 8.06E-08 3.380 -08 96 7.02E - 10 1.27E -07 7.30E -09 3.06E -09 120 6.37E -I l 1.05 E -09 6,00E - 11 2.51E - 1 i 168 5.23E- 13 3.12E- 17 1.79 E - 18 7.50E - 19 336 1.56E-20 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 6.75E -02 3.87E -03 1.62E -03 masnumum 3 3.37E-05 2.74E-02 1.57E -03 6.60E -04 12 1.37E -05 8.26E -03 4.74 E -04 f .99 E -04 24 4.13 E -06 7.48 E -04 4.29 E -05 1.80E -05 48 3.74 E -07 6.15E -06 3.53 E -07 1.48 E -07 96 3.07E-09 5.57E -07 3.19E -08 I .34 E -08 120 2.79E - 10 4.58E -09 2.62E - 10 1.10E - 10 168 2.29E- 12 1.36E - 16 7.82E - 18 3.28 E - t 8 336 6.82E ~20 0.00E + 00 0.00E + 00 0.00E + 00 672 0.00E + 00 8.17E -01 2.72E + 02 1.04E + 02 5 mirumum 3 4.09E -02 Ga-67 Citrate 5.52E -01 1.84E + 02 7.05E + 01 12 2.76E -02 1.09 E + 02 4. ! R E + 0! 24 1.64E-02 3.28E -01 3.84E + 0! l .47E + 01 48 5.77E -03 1.15 E -01 4.76E + 00 1.82E + 00 96 7.14E-04 1.43E -02 1.67 E + 00 6.42 E - 01 120 2.51 E -04 5.03E-03 6.23 E -04 2.07E -01 7.95 E -02 168 3. l l E -05 2,08E -08 4.17E -07 1.39 E -04 5.32 E -05 336 6.17 E- 1 I 2.37C - 1 I 672 9.27E - 15 1.85E - 13 3.98E + 01 1.33E + 04 5.0SE+03 m.nmimum 3 1.99 E + 00 3.62E + 01 1.20E + 04 4.62E +03 12 1.81 E + 00 1.06E + 04 4.00E + 03 24 1.59E +00 3.18E + 01 8.2 t E + 03 3.15E + 03 48 1.2.3 E + 00 2.47E + 01 1.48E + 0! 4.93E + 03 1.89E + 03 96 7.40E-01 1.15E + 01 3.82 E + 03 1.46E + 03 120 5.73E -01 6.8BE + 00 2.29E 4 03 8.78E + 02 6 168 3.44E -01 1 l!E + 00 3.83E + 02 1.47E + 02 336 5.76E -02 3.23E-02 1.07E + 01 4.12E + 00 672 1.61E -03 B. It) NUREGl492
Table 11.3 liiological and Phpical Parametern Used to Calculate the Total Artht) Ingested and Internal Ibdiation Doses Recched from the intake of Radiopharnuccuticals in lircast .\ link (Contiuned) liiological llalf life Escretion Fraction"' for Escretion ' Administered Acthity lamest liighest Shortest lamgest Radiopharmaceutical (mCl) as a, T,, (br) T,3 thr) 0.05 3.2E 'l 1.4E-6 7 7 Cr 51 EDTA Tc-Wm Sulfur Colloid 12 2.8E-6 2.6E-5 35 (8.3) Tc-99m White Blood Cells 30 6.7E-6 1.7E-4 5.2 66 i 43 l TI 201 Chloride 3 1.7E 6 2.2E 6 13 9.5E-7 1.9E-7 43 (362) l 1
"' " Lowest" and "thshest" in this table refer to the lowest and highest concentranon obsened at peak for a given
! radiopharmaceutical by any author (see Table B.2 for references), nese are combined with the shortest and I longest biological half-hves for that radiopharmaceutical reported by any author. A given concentration and half-hfe combined to produce a supposedly best case or uont case scenano did not necessardy mme from the same study.
- For some radiopharmaeucaeals, T., and'or T., may be negauve (i.e., salues show n in parentheses) because these were the unusual cases reported in the hierature in which the the effectne half-hfe uas greater than the radionuchde's phy sieal half-hfe ti.e., effeetne half hfe > T, indicates wnunued aetnity accumulanon).
In these cases, the effectne half-hfe was used to perform the analysis. B.9 NUREG 1492
Table B3 Biological and Ph 3sical Parameters Used to Calculate the Total Actht) Ingested und Internal Radiation Doses Recched from the intake of Radiopharmaceuticals in Itreast hlill Biological llatf Life Escretion fraction"' for Escretion* Administered Arthity Lowest liighest Shortrst lamgest n, T,, (br) T,3 thr) Radiopharmaceutical tmCl) ni 0,05 1.4E 6 7 7 Cr 51 EDTA 3.2E 7 8.0E-6 1.0E 4 20 390 Ga 67 Citrate 5 7.2E-6 85 85 1 123 mlB G 10 7.2E-6 2.9E-5 1.5E-4 4.8 10.2 l-123 Olli 2 6.5E-5 10.4 10.4 1-123 Sodiua lodide (Nal) 0.4 6.2E5 7.lE 5 4.8 4.8 1-125 0 111 0.01 7 lE 5 43E5 1.2E-4 2.2 '0 l 131 0111 03 6.7E 4 7.6 117 1 131 Sodium lodide (Nal) 150 1.4E 5 0.5 2.4tt 7 73E 7 (85) (140) In ll! White Bhiod Cells i 8 2.4E 6 4.6E-6 10 (9.1) ! Tc Wm DISIDA 6.5E 6 6.5 30 Tc-Wm DTPA 20 5.0E-7 2.0E 7 2.7E-6 6.5 30 Tc-Wm DTPA Acrosol 1 2.6E-6 4.9E-6 9 12 Tc Wm Glucoheptonate 20 8 1.8E 5 23E 5 6 (7) Tc-Wm liAh! 3.lE-4 5.2 45 Tc Wm h1AA 4 7.0E-6 6.5E 6 6.5 30 Tc Wm h1AG3 10 5.0E 7 1.6E 6 8.4 34 Tc-Wm hlDP 20 1.6E-6 30 2.2E 7 1.4E 6 18 (6.7) Tc Wm hilBI 1.7E-4 5.2 66 Tc-99m O. (Pertechnetatc) 30 6.7E 6 3.lE 6 9.2E-6 8.4 (6.8) Tc 99m PYP 20 Tc Wm RBC In Vitre 1.abeling 20 33E 7 5.0E 7 (7.8) (9) Tc-99m RBC - In Vivo Labeling 20 1.UE-7 4.5E-5 (6.8) (7) NUREG-1492 B.8
Table it.2 Escretion l'ractions and liiological llatf Lhes for Radiopharmaceuticals Eureted in Breast Milk (Continued) liiological llatf Life Measured for Escretion l'ractions' Escretion T (hr) Reference Radiopharmaceutical 6.0E 365 1.0E-265 (7.7)tt ROM) Tc-Wm RilC - (6.8)tt RO'Al in Vivo labeling 4.5E 5 (8)
- 1.0E 7 ( ~ 4) (7)1 r Alis5 Tc-Wm Sulphur Colloid 1.6E 3fl - 1.5E-265 35-(8.3)tt RU94 Tc-Wm White Blood Cells Treated as Tc-99m pertechnetate, as fraction of free Tc 99m is highly variable.
TI 201 Chloride 2.2E-6 43 MU89 (2 com-1.9E 7 (362)tt partment model) 1.7E-6 13 JO95 (2 com-9.5E-7 164 partment model) Xc 133 Gas insignificant Dose to the breast feeding infant.
- Peak fraction per mdidater of nutk. All salues corrected to the time of acuvity aJnurustration. The number in parenthesis is the ume (hr) at which this maumum was observed. If data trom more than one pauent are reported, data are prewnted as a range.
" Pooled data from 4 pauents.
t Panent aJnutted for study of enlarged thyroid. t Conservatne value chosen due to anecdotal report (n-1)(see addendum of MO84). I Data in Table 1 of RU91 recalculated due to pouable errors in denved values for the percent excreted in mdk. In Total fraeuon exereted - milk concentrauons not gnen.
++ Effectne half-hfe > T, mdientes conunued metnity accumulanon.
- Speciauon tests indicated that the aetnity excreted was most likely in the form of Nat, a.1 mlBG.
B.7 NUREG 1492 I
. _J
Table 11.2 Escretion Fractions and liiological llalf thes for Radiopharmaceuticals Escreted in lircast Milk (Continued) liiological llatf life Measured for Escretion Fractions
- Escretion Reference Radiopharmaceutical a T. (br) 15 MOS4$
Tc3Nm DTPA 7.2E-7 (2.2) 15 Mos5 6.0E 7 (2.8) 6.5-30 RU94 5.0E-466 2.4E 356 9.6 Al{S5
-5.0E-7 ( ~3)
TcdNm DTPA Acrosel Fraction of administered acrosol assumed to reach bhedstream (0.406) treated as Tc 99m C,TPA. 9.0 RU94 Tc-99m Glucoheptonate 1.4E 3sl 2.6E-6 12 MOS7 6.0-(7.0)tt RU94 Tc>Nm l(AM 8.NE-3&& - 1.lE 2il 20 MOS4 Tc-99m MAA I.4E-4 (2.2) 5.2 45 MASI 7.lE-6 (5) - 3.lE 4 (7) 53 ilE73 2.4E-5 (4) 1.4E-4 (3,5) 12 " CR85
- 12 IfE79 7.0E-6 (6) 4.0E-3fl 12E-2ii 7 3-18 All85 Treated as Tc-99m DTPA (renal agent for wh'ch data exist).
TcdNm MAG 3
- 1.6E-6 (- 4) S.4 34 Alix5 Tes Nm MDP/ilDP 23 RU914 TcJNm MlBI 1.4E-6 (33) 18-(6.7)t t RU94 1.0E 446 - 3.0E 446 RU78 Te>Nm 0, (Pertechnetate) - 6.7E 6 (8.5) 9 66 WY73 2.6E-5 (10) 6.4E-5 (2) 20 VA71 1.4E 4 (22)
Pl79
- 1.3E-5 (3)
OG83t 7.19E-3 (2.4) - 1.7E 2 (2) 6.9 All85
- 5.0E 4 ( - 5) 6 MO87 1.7E-4 (8.2) 5.2 IIE86 1.4E-4 ( -3) 8.4-(6.8)t t RU94 Tc>Nm PYP 1.5E 356 - 4.4E-3fl (7.8 9.0)tt RU94 Tc-99m RBC - 2.0E-416 - 3.0E-446 in Vitro Labeling B .6 NUREG-1492
Table B.2 Escretion l'ractions and liiological llalf 1.ises for Radiopharmaceuticals Escreted in Breast Milk liiological llalf Life Measured for Escretion Fractions
- Escretion Radiopharmaceutical a T. (hri Reference Cr-51 EDTA 1.5E-466 - 6.5E-466 5.0-7.0 All85 Ga-67 Citrate 9.5E 5 (72) 216 TO76 2.7E-5 (38) - 3.7E-5 (58) 82 385 RU94 5.6E-5 (%) LA71 1.0E-4 (88) GR83 43E 5 (48) WE94 3.16E-219 - 9.9E 266 20-390 RU94 1123 mlBG* 7.2E 6 (8) 85 KE94 I 123 0111 6.0E-f 4.8 M OM9b 1.2E 0261 3.5E 255 8.1 10.2 ROR) 1.5E-4 (4) 83 R O90 1123 Sodiun Imlide (Nal) 2.6E 2f 6 10.4 IIE86 6.5E-5 10.4 IIE86 1 125 OlF1 2.4E 26s 4.8 Ai!85 l 131 0111 1.8E 214 - 4.9E-2sl 2.2-6.0 All85 l 131 Sodiun lodide (Nal) 1.4E 5 (24) 4.0E-5 (d) - 0.9 NU52 h.7E-4 (6) WE60 6.hE-4 12 DY88 (2 comp 1.hE-5 526 model) 3.0E 2 (18) ~ 9.4 RUS8
- 5.0E-4 13 RO94 (diag.)
1I RO94 (ther. 235 2 comp model) 23E-Inn 117 RU94 2.5E ist - 4.6E Ifd 7.6-12 MOS9a In ll! White Bhmd Cells 33E-7 (13) (853)tt MOS5 73E-7 (16) (140)tt llE88 2.4E 7 (20) BU86 Tc-99m DISIDA 1.0E-3%i - 2.8E 365 10-(9.1)tt RU94 B.5 NUREG-1492
.......i ' - . ... .
Table B.1 EITecthe Dose Equhalents to Newborns and One Year Olds from infant's intake of Radiopharmaceuticals EITecthe Dose Equhalent'" (rem /mCD Newborn One Year Old Radiopharmaceutical 0.11 0.(M Cr 51 EDTA 6.7 2.6 Ga-67 Citrate 5.9 4.1 1 123 mlBG* 0.24 0.10 1 123 0111 4.1 5.9 1123 Sodium imlide (Nal) 0.89 0.36 1 125 0 111 1.1 0.44 1 131 0111 20,00P 14,(D Y 1 131 Sodium lodide (Nal) 33 13 in ll! White Blood Celk 0.85 0.41 Tc 99m DISIDA 0.13 0.056 Tc-Wm DTPA 0.28 0.12 Tc-99m DTPA Aerosol 0.16 0.36 Tc 99m Glucoheptonate 0.50 0.23 Tc.90m IIANI 0.61 0.26 Tc-Wm NtAA 0.12 0.052 Tc 99m NIAG3 0.41 0.10 Tc-Wm N1DP 0.52 0.24 Tc Wm NilB1 0.41 0.19 Tc-Wm 0, (Pertechnetate) 0.28 0.12 Tc-90m PYP 0.31 0.14 Tc-Wm RBC - In Vitro L.abeling 030 0.14 Tc-99m RBC - In Vho Labeling 0.74 0.36 Tc-Wm Sulfur Colloid 0.41 0.19 Tc 99m White Blood Cells'* 15 8.5 TI-201 Chloride
"' Effecuve done equivalent to the infant per urut aeuvity adnunisterted intravenously to the mfant (except in the case of Tc-99m DTPA Aerosol).
"' Specificauon tenta indicated that the acuuty was most hkely m the form of Nat, nr3 mIBG.
Done to the infant's thyroid per umt activity adnumstered intravenously (or orally) to the mfant (radJmCO.
'*' The values shown are actually the dose esumates for Tc 99m pertechnetate, as it was assumed that acuvity releawd m breast nulk from this product would be in the form of pertwhnetate.
NUREG 1492 B.4
tclereme. Most prpers rep >rted an cffative cals s.tc the total attisit) irigested and the half life for escretion of radiopharmaceuticah in internal adiation dmes tached from the intaic breast mill and these salues were mmerted to of tadiopharmaceutiuh in breast milk for biologint half lives. Sneral values c' the ncwborns and one year olds. reporud effective half life for curetum werc larger than the physital half. life of the radionudide (c g., T,,
- 9 hours for ,l.2.2 Radiation Dow Estimatts Tuhnelium49m RIICS (RUv4)) indicating mntinued accumulation in the breast milk of the radiopharmaceutical over time. Thesc salues are .
denoted in the table in parrnthesrs. Several Table il4 lists the dose estimates for the 25 l ablications reported cumulative escretion radioharmaceuticah analped, for both the I tractions (<1enoted by the symbol ll) and these newborn and the one year old, for both bnt and l i values were used to estimate the concentrations of wor 61 can scenarios and for all interruption the radiopharmaceuticalin breast mi!L as uhedules. Note, that in the case of iodinc.131 ]' dextbed alm: (see $cction 11.1 CAln'IA'I10NAL sodium .dide the infant throid do3n,instcad of Ml!TilOD-). When data for a single subject effective dme equhalents, were shown, due to the were reported, the report:d/ derived value of high doses predicted. Table 11.5 shows the nerttion fraction per milliliter of breast milk was summary of recommendatiorn for the considctn' to be " highest *, for that publication, radmpharmaceutkals mnsidered in this analpis and no "lownt" value was listed. In some cases, showing the masimum administered actiutin the breast milk peak concentration was estimated auumed, the internal dose to the infant if no from graphical information in an artide; these interruption of breast feeding is auumed, whethcr estimates are shown with a
- symbol. or not instructions are required, the niernal dose from radiation during titrat. fccding assurning inson ct al. (RO94) rep irted a concentration interruption, and the remmmendation on curetion half life fe; a diagnostic dose of interruption of breast. feeding (whish inc.,
. nc 13 sodium bdide and also artwirted that adjustnient for tiic esternal dose during breast-the same patient nhibited biphasic curetion of feeding) the iodine 131 administered in a therapeutic stub.
Murphy et al. (MUM 9) reported that thallium 201 None of the analpes for the iodine mmpounds chloride ethibited bipha.k dearance. All other induded any mnsiderations for free iodide in the radiopharmaceuticals seemed to follow monophasic product, and none of the other analyses induded dearance patterns occpt for two (ase studies considerations for powible radhucthe contaminanh imotving iodine 131 sod,um iodide This or breakthrough produch. Thne additional radiopharmaceutical was noncthelew modeled components of the dose are usually scry small. In with a monophasic dearance pattern for the addition,the awignment of numerical salues to purswes of thh study. these quantities ( the fraction of tree iodide, percent acthit) of mntaminants, cie.) would be Table 113 this the biological and phrical arbitrary, as these values sary considerably parameters used by the mmputer program to between products and nen with time. 11 3 NURI:01492
(Wwa). 1hh h probabl> a consersatne upper uptake of ingested radmpharmaceuticals from the limit in most caset in those (ases in whnh a infant gastrointestinal ((ii) tratt, thus it was htcrature tricicmc gne only the cumulatne auumed that im percent of the ingested aethis) hclion of acthity curettd in the bicut milk our was quitkly and complcitly r.bsorbed from the the coarke of the study, the Iraction ol injected infarlt's Ul tratt. aethity cwrcted per milhhter of milk at diffctri.t tirors wm not mailable (although a dcarante Radiation doses for newborns (3 4 kg) and one. half-hfe may have been reported). A single salue
) ear olds (9.N kg), bued on the inathematical of turnulative eurction could not be used in thh phantoms of Cthty and Etterman (CR87) hase analph, as u 'mt likely represented the been ratimated for the radiopharmaceuticah tumuh.li e fraction excreted auuming no comidered in thh analpis and compiled in a mterruption of b, cast Iceding, and thercfore wuld neferente on pediatric radiation dosimetry in not be uwd diret-tly to infer the cumulathe nudcar medicine (NT95). These dme estimates fraction under different interruption uhedulet generally apply to intravenous adminhtration of To estimate the tumula..te frution under these pharmaceutia.h. The dose estimates are diffuent interruption schedules, it was nettuary cspecued as effettive dose equivalents (EDU) per to calculate the time depender.t behavior of the unit ingested activity; a summary of the values drarance. The, a breast milk concentration at used are given in Teble 11.1, (Some dmc early times we estimated whith would result in a estimates, bued on more recent O odch were cumulathe escretion equal to the salue reported supplied by the Radiation internal Dose auuming no mictruption of breast. feeding, the Information Center. Oak Ridge, TN.) Typical clearance half. life reported by the authors, and salues of acthity admin 8 tered to the woman per udng the nurung ahedule and wiume auumed in procedure were taken from sarious sources to thh analpit 1hh derhed early concentration un estimate the totalinternal dose to the infant from then used in the computer program with the a typical procedure. There are certainly cnes, mmt notably for ther.p utic adminhtratiom of dearance half life thosen to estimate the cumulathe fraction ingested under different iodine 131 i.mhum iodide, in which the cifcethe interruption whcdulet dose equhalent should not be used for dechion making and the indhidual organ absorbed doses should be considered.
1he mmputer program estimated the intale and 11,2 IESULTS subsequent dose to newborns and one > ear-olds for bon the best and worst case scenarim. for no imerruption (first feeding 3 hours af ter administration to the womanh and for the sarious 16 d 3 of the radio @mmutiuh mterrupuon whedules deunbed abme. odmmly used in nudcar medidne procedures
"'" "E 'd "E * *"# "
An upper limit of 0.50 was plated on the total fraction of administered acthity whith muhl be ewreted mer all time in the breast mill, it we 11.2.1 Illokinetic Data for Excretioti pouible for unreathlic salues (e g., fractions of Radiopharmacueticals in greater than 1.0) to be calculated by merely permitting inc mmputer program to sum the lircast Milk e product of the f. action of actnity per milliliter arid 125 milliliter per feeding for a large number of feedmgs. Thus, it was thought that an upper limit The data obtained from the literature esiew are of 0.50 should be placed on this value, whish summarized in Table IL2. The biolinctic data for cath radiopharmaceutical cureted in breast milk represents eurelion through the breast mili are given in Table il 2 as the curetion fraction, pathway competing equally with all other per unit volume of breast milk, the biological curetion pathwap available. This value is aho hall.hfe for ewrction, time of peal cornentration compatible wit h the highest fraction reported for (when data were repo4cd as concentration rather total cwretion of any radiopharmaceutical, namel) than cumulathe excretion fraction), and the a fraction of 0.33 for iodine-131 smhum iodide IL2 NUREG I492
APPENDIX H PARAMETERS AND CALCULATIONS FOR DETERMINING INSTRUCTIONS TO HREAST-FEEDING WOMEN-aanntration was assumed to ouur ai 3 houn H.I CALCULATIONAL P" *d*i"I'"i"" h mi8 h' h* b"" *"'e METilOD conservative to extrapolate this back from the time at whkh the concentration was observed to 3 hours pmt adminhtration, but in many cum, only one value was reported and a biological The breast milk concentration as a funtthm of half life was not available. Il concentrations were time C(r),(i.e., the acthity per milliliter of breast reported at times le.s than 3 hours, the highest milk) was calculated from the equation, concentration reported was used without I correction for biological removal, and assumed to l C(r) = A a exp(-f A + 1,)(r-3)), (11.1) occur at 3 hours post administeation. A computer program was written which used where A = the activity adminhtered to the Equation 11.1 describing breast milk wncentration woman, es a function of time represented by cath scenario to estimate the Iraction of the acthily administered a = madmum fractionof adminhtered to the woman whkh would be excreted in the acthity (per milliliter of breast inilk), breast milk and ingested by the infant. The program assumed that the infant would resume h biological decay constant, feeding at 3 hours post administration and would then nurse ever) 3 hours thereafter (i.e.,8 feedings A, = physical decay constant, per day), consuming 125 milliliters of milk per feeding (thh represen.$ a Aily aserage r = time at whkh brsast. feeding occurs. consumption of 1,um) inilliliters). Thus, the program takulated the breast milk concentration A comprehenshe search of the medicalliterature (in units of fraction of administered activity per was performed in early IW5. from the data milbliter of mill) at 3 hour intervals based on the excretion functions obsened, multiplied by gathered from the literra.re, the highest concentration (or highest fraction) o, of a 125 millihtens to estimate the total fraction radiopharmaceuticalin the breast milk post ingested at that feeding, and added up a total administration to the women and the longest fractional absorption user all feedings (summations Sialogical half life Tu (not neecuarily from the were carried out to 50 effective half.thes). The same study) were chosen to represent the worst program aho calculated cumulative ingestion for case scenario, and the lowest concentration (or awumed interruption periods of 12 hours (0.5 day) lowest traction) o, arid shortest biological half.l;fe 24 hours (1 day),48 hours (2 days), % hours T., were chosen to represent the best case scenaria. (4 dap),120 hours (5 dap), IM hours (7 dap), llreast milk concentrations reputed in the 336 hours (14 days), and ta2 hours (2x dap). for inerature were first corrected for radioactive cumple,if the interruption time was 24 hours decay to the time of adminhtration (unless the the first calculation would hase been for r = 24, artiste explicitly stated that such a correction had followed by 27 hours. 30 hours, and so on. There already been made), Then, thh madmum is no information in the literature describing
'information in this appendix was prosided by R.E. Toohey, hl G. Stabin, and i Stubbs Radiation internal Dose Information Center (RIDIC), Oak Ridge institute for Science and Education, Oak Ridge, TN.
11.1 NUREG.IN2
- 5 s 3t o + 2 '&
,13O .tp
,s W
+
m W { 3 e 5 L-N f -
"z _
bY 7= 4,. =* 5e l o.g-t _ - s. - - 43 AeA $,3 3* S 0 o W. R o ; 'd y 3 a
]d
=
C am
- o. , t.
w .h,
- n h
dE ft b. 6 t g 4 g d
'l g 6 4 g c. C- $ 9 7'; e !
j i 7; -
- 7. -
Ol r g s.-
,r g -
n & 6- . m e g ~i y u
=
e6e - m
- 3 *Z
- e4 e s z
g < T lG (. M 1* -n-unnn - o
- -- ..nnn--
o, o, eoieo o o oiii. n-o o o o o o, o o, 84 f.*1
,y g
t' g ooooooo iiiii i s W 5 g
$ h .o.
s WmWWWW
;P3CH~n f WfmWWWWWWWWWW"fW To?%;2Hsy3R? u3 s !$7s ,- $g a 8y -e-n--. , ,,nn- ---o-- .. .- -
IT
, u
-!Ej = $"
5 ia - t a s a s s, a s, a a s, s, u, a, s s s s. e, a s, s, a. ab we a, 13 mmmmmmm _m m a43
- c y- i ii i o
4 memmmmmmmmmW 2
- E
.; UE3EM~M 4 l o $ % $ 2 4 s 'e* 5 E $~n 202 5 3 i e.
- , nnn---.- e-n- -
*3 *: 9g
- l a ". - e - e. - - .
d E, s, $, s s, s, s E 8, 8 "o 8, 5 s s E, 8 $, E E, $ sa )g .,* 'e rEe . , eamywawww'dr4461ns w.auwas - a t' mmwomwa n i. ]gnps,; f,7 5 n g.-" A r e. ;. u. .. z*E .- . u et
% - - ..- e s t~s . a - ,2 - _
E D b 2 a s s s s s s s s, s, s s s a s. s,ssssss ts w .a w w w w w m w w w w .u w w I 2 {h1 - g g ,g36 e
= Wn;.51 . .
a 24w w% P4 PMP = 80sIjkss EPe%2T sI S
- u. t: ww a
{ ggs m t
= ,$d",3 4
$jg~ 4 or, --mm er-- -mm w
<v --.merm L -Ib0
% e- c
; ^
e, E~ MEO c -~ N S e" w,C 7 eT E U ~
- n%3,-,s
- g. -{.fcyr. .,e <-
se e- ,
> s l
=,3 a
3c ocooooo g-eseo6oo ss -- zaoo88 o eooooooooooeooo eaE[s.sC$- -g.4 r
*g 3-i g e c
, . . ~,ss a ia 3g .l s.1nuns ,
r eg:JGR* m a n ;: 21 J 2I ua nr e n y PEE 24:s ; ; s sCsns o - o - e4 m 3 0
*) y "sn4ps&E8- no oooeooeooooeooq ;x,*g y _st. e -gooooeoo % I# 0 i s e-3= 42 12 i
s s= v u wt. s
-a 4
L g . n
- sm m
3 3 7 4
+
_I . e - rio Nt'RI E IN2
s 8t o
+
ypg, s t. @. 5 + + W W p j #- " h h g + a1 E 4 -
^
3 8 5 f 6,{ - - + -
+
g, 4 W A W e O @ M
]g O
- h N
p g D
- m e h C O o +
Q w
@f w
+ 4
{ h 8 " E, " 7,
- 1 ~
A 3u I r r it N
$h g:
W W I
~
w $ vb A 94 k 555U5 8 8 8 UUU,58 5 18 ,k' t, 1 l 1 i i + 6 4 1 1 I e i WWWWW W W WW I $ Q, J #s 8n,--o 3 7. 3 F ; * * . W W <- kIA,E. n 8 8 m
- a - n -
h
,t ggggg g g ; ;;;gg g 3 [ , , 4 , , ,
y a 13 , , , , , , , h u $
- $,, N $-
N N I., Y kN.84$ erF
, se e 4 4 $
s E ed g E -. 4 $ h 6 j E E 5 sss,ss s; s;s 5"qss* gy I -l i e2 i i 3 al e,3or e u , 1 oe4 88 1 Y E
#' it Y vf 94 e & 9 mW *, ,
}
U . 5 5 I i .ls- j - U, E, E E. E 3 , E s E8,2EE
, s e a m m
= aWWww w
* = E2002 t
- 2 t. uuq*w688 & F. e.
[, W}wE e
.$ , e-~me <
t
-s -m t
a L L L d kh ~3 e
- "l7 a nnns:
me c - z F eeAsu oco-- 3 yC coo-- O CCO CC 3 OCoOC T. c e r. u 5 i s.1 e, , - -
$Ib EE553 $. sE$5 e p, ! $.
') .6. o.6
, s3v 3=
b b $ 3 1o e 3 O
$0 k o
E E R r $ o C $ e 3 6 c i& l
- + . s t
d _9 bbllbb*IMl.'
I 8 _. f 0 -
! O *
-
- re c -
E eQ, % t , -
?
E h "**ierM e m 2 9 e 5 2 f 4
- R t m a (
i 2 0
) 0 +
g - y E 5 _ ) d n O QsG 5
)
E 6 2 0 e 5 e y ( 2_ 8 2 _ u d a O n wc 6 _ i e = 4 t aD e 0 n R l r 1 _ o a ) n 0 am + _ s g t E . C( i e to ,s c a
+ F 9 tT Qf F E y 5 o 6 -
s t e t no a t y 5 a. 2 - a ua u. 6 - - R Qr e r 2 0 - e s e s r w 0 0 % + e a5 ) c
- O( E D le0 Q,C i
O( E 9 e 5 9 e s R ( m 5 6 a t l e e R 3 1 22 4 4 4 3 1 0 d n c n 1 3 2 2 1 2 1 1 2 1 0000000000 0 0 0000o00000 2 1 a h a ---------- E
+
EEEEE0EEEE 7 E 5 GI EEEEEEEEEE c h$ 0 6$ t s e : e s 4 0 5 ? 3 01 1 3 76 2 e t 2 3 6t M 9. l 6 6 1
- 4. % M 4 it a
/mta 4. x; 8 4 4 85 2 2 g 1 3 1 7 5 e , 3 1 R 53 . t
- 3 1 8 3 it n e R a r 2 e 1 2 1 1 s5 s4 2 4 0 u
Q m r Z 4 3 3 2 3 2 21 2 0 1 0 0 00 O -0O - -000 - - - p r e t 0000000000 EEE0E E w a E s e EEEEEEEEEE M EEE040 S 2 6
%8 3031 37 t> 5 1 7 5 2
i c GM R I 2 0 S 3 6I 6i 68,f. 47 4 4 85 6 9. 2 f 2 i 4 4 i3 1 7 8 63 1 6 4 e t 93 1 8 3 22 R a 53 I t h
. h 9 S7 9 a 0000@900O00 7 7 7 7 t t s ne a t -
6 5 900O0O0 00 7 n7 e67 6 t
- - - - T(
a
- - - - - - - - 00 n /i a
mta EEEEEEEEE.E i. T EEEEEEEEEE 2
- t t
s ( 4 4 0 t n n Wr g e 1 9 t 4 7 M2 4 W32 175 a 5 0. M 7 1657 n 4 4 o ct n 1 t
> 47 89 9 2 B 1
a 5 9 21 4 - 5 4 2 8 4 t C Mia i t n 3 29 621 5 2 1 e e t a - d E
- m. 1 1 3 3 1 C
e 1 1 4 1 1 R mne 1 1 2 1 1 1 3 3 1001 e 0000 0 00 - - -000 t a e r e o=h)m 00000000 -
- - R ta EE0ELEEEEE 00 0% 5 00 00 $
R c E r
/ EE1 5 5 0 EE1 000 stEEE 05 0 e 7 1 6 4 J10 0. 0 R. r u
2 6 - 01 2 5 e7 70 r
m p .n
- R a r u 1 2 222 1 6 1 Q r 3 3 4 3 4 1 4 1 3 2 4 1 4 0 00000 0 0 e P r e h e t 0090000000000 s E 0EEEEE E
- a. G -M EEEEEEEEEEEEE 0 00M7 260 65 5 1 1 8 03 4 5 60.6032 7 62 2 2 6 9 9 9 5 4 4 3 1 s / i 2 5 2 e R 2 1 6 i7 1 2 3 R
- s et t 1 1 3 3 33 3 3 33 3 3 si 'o E i nAC p p f L m s o 8 9 3 E 4 4 3 7 8 9 1 E s y) 8 88 97 9 9 3 2 3 8 57 9 13 61 5 0 1
- 28E -02 1.28E -01 1.73E - 02 8.56E - 07 .
- McV/cm/ RICi-hr gg3q, (, tem,,rl Energy Ceefficient at i e,. g c;) gyg,3 llatf-l.ife (fraction /
- Espmsre Rate Constant (Totat):
- OsE-03 4 OSE -02 0.9551 2.72E - 07 0 67589 3 80E - 03 i33E-03 1.33E -02
- Dosimetry on Transverse Axes of '2'I and '"Ir Interstitial Ilrachytherapy Sources,* Medical Physics, Volume 17, Number 6, November / December 1990. The exposure rate constant given is a measured value averaged for several r.ource modeh and takes into account the attenuation of gamma rays within the implant capsule itself.
- value (i.e., with respect to an apparent source acti ity) and tales into account the attenuation of gamma rays within the implant capsule itself.
- Keith F. Eckerman, Anthony 11. Wolbarst, and Allan C. II. Richardson, Federal Guidance Rpri No.11.
- strontium 89 Therapy for the Pain Presten A.V. Wegst, N.L hlartin, 1987,"Itcatment of hietastatic lione of Osseous hietastases" J Nucl.
- Clinical Sur ey of Practice in the United States in 1981/ Special Report, Resp (mse and Tosicity following Radiohigy 150.547.
- Monitoring of Courtenay Luck, R. Rampling, AJ. !
- Antibody.
- Release Pleural and Pericardial Eflusions/
- Guided Brachpherapy for Oncol. 3:1573. Treatment of Confined Prostate Cancer / Urology 40(1):27.
- lodine 125 Interstitial irradiation rpm Riva. P., S. Lauari, M. Agostini, G.
- Dosimetry of Palladium 103 Nucl. Med.11i01.14:223. lirachytherapy Sources for Perma-nent implants / Endoeurietherap)
- Continuous Cultures of Fused Celh Secreting Antibody of Predefined
- Clinical and . MO92 Mobiuddin, M, F, Rosato, D.
- lodine 125 Implants sersus Adsanced llodgkin's Disease? J. Euernal Eleam Therapy for Stage-Clin. Oncol 3:1296. A2,11 and C Prostate Cancer / Int.
- Radiation Expertence Data (RED), D E. Johnwn, bl.A. Iloileau, Eds.,
- Age-Iinkler, NJ., A.I. Kawis, hl.G. dependent Doses to hiembers of the flH9 htuto, K. Weado(L. S S. Tumch, Public from Intake of Radionuclides:
- Radiation Esposure to the Family 1983,
- Diagnostic Imaging Procedure Volume in the U.S.7 Radiology of Radioactive Patients / J. Nucl.
- Combined interstitial and Lapctricre, P. l.cung, M. Lurnley, External Irradiation for Prostatic 1992,
- Patterns of Recurren(c of Cancer / Prog. Clin. liiol. Res, Malignant Astrornoma following 243H:141.
- Evaluation of Radioactive Phys. 23(2):321, Phosphorus in the Palliation of Metastatic lione Lesions from litM lilake, G.M., M A. Zivaninic, R.M.
- 3. Alternathe 3 relative to Alternathe 2 has a adrninistered to a patierit, it snay be possible nel salue of about 59,tn),(KR) per year, mostly to ghe all of the attivit) in a single due to hw cr health care costs. adminhtration. This would redute the l j
- 4. Ilasing the patient release critcria iri hospitali/ation to meet the curtrnt l requirements, which may lead to a more l
- 5. A dose based rule no longer restricts patient release to a specilie acthity, and therefore would permit the release of patients with No impediments to implementation of the activities that are greater than currently recommended alternative base been identified.
- Costs Associated llospitalitation Lost Time, Value Records and Instructions Nel lienefit 5 5 Dose Aseritd 5 (millione (millions) tmillions)
- 2. Alternathe 1 is considerably more espensive recommendations of the NCRP in NCRP Report No,116," Limitation of Exposure to lonizing to the public compared to Alternathe 2 (the Radiation? Each of these provide a basis for status quo) or Alternative 3. Even neglecting allowing indhiduah to receive annual doses up to the psychological costs, which have not been espressed in dollar terms, the adJitional cost 5 millisieverts (0.5 rem) under certain of Alternative i relative to Alternative 2 h circumstances. Both ICRP and NCRP about $412000,00) per year, mostly due to recommend that an indhidual be allowed to receive a dose up to 5 millisieserts (0.5 rcm) in a increased national health care costs. In view of this Alternative I may be dismissed.
- such as disruption of normal routines, social and services that base been bought for final use isolation, and enhanced financial strain are clearly during a sear. From the GNP of about elements of psyhological costs that are directly
- Matimum setnity admminiered This analpii esiumes that 95 percent of the retients are t)risel'y administered 1.110 mill.iirverte t30 milhcuneet and that percent are aJminimiered the n.4timum acnity.
- Maumum othvity admituntered.11ue an jlysis annu,we that 98 percent of the ratwnie are typically admemetered 1.ll0 nuthueverts t.s0 nulhcuneu and that 2 percent are admimstervJ the maumum quantity.
- The number of breast feeding women was determined as follows 60,000 patients The dose to the breast feeding infant can be administered millicuric quantities of iodine 131 sodium iodide s 0.135 child bearing a6e x 0.05 controlled by giving the woman lastructions, as breast feeding - 405 patients administered required by the revised 10 CFR 35.75, to discoctinue or to interrupt breast feeding as millicuries of imline who could be breast feeding, 20 NUREG 1492
- 0. fin 0.40 3.48 (0.34S) 0,70 0.30 2.70 (0 270)
- Actigity per Esamination"* Gamma Dosed' Esamination Type (Radiopharmaceuticall (Mity) (mCip (mM) (rem s lirain 740 (20) 0.13 (0.013)
- T, T:, = effective half-life of the thyroidal component in dap (based on the Under the final rule a licensee could authorite on the biological half life 7,: of the release on a :ase by-case basis based on the thyroidal component),
- Based on permnal communwatens. F. A lbfuer, March 1993 and M. Pollysove. January IN
- Based on personal commurucahons. F. A. Menier and K L.. Miller, March 199L
- who spends significant time close to the patient.
- 2. among the cancer sites for which permanent emitters, these pathwap will generally be implants are currently employed, prostate insignificant in relation to the doses that can cancer represents the overwhelming majority; result from exposure to the direct gamma radiation from the patient, with the exception of
- 3. among the 132,000 annual new cases of intake from the milk in breast-feeding infants.
- Numbers tot in parenthesis indwate number of esamm4nora t 1.000
- Alternative 3 5 millisieserts (0.5 rem) total effective dose cauivalent)
- o. Alternative 1: 1 millisiesert (0 I reml total effective dose equivalent Radiopharmaceuticah can be defined as " drugs" that are radioactive. Although radiopharrna-This alternative evaluates a dose limit of ceuticals, diagnostic or therapeutic, may be I millisievert (0.1 rem) to an indhidual classified as drugs,it should be noted that exposed to a patient as the limiting factor for determining when a patient may be released radiopharmaceuticals are not given for the purpose to exert any pharmacological action.