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April 12, 1995 MEMORANDUM 10: Donald A. Cool, Director Division of Industrial Medical, and Nuclear Safety, NMSS Stuart A. Treby, Assistant General Counsel for Rulemaking and fuel Cycle, OGC Richard L. Bangart, Director, OSP FROM: 18111M. Morris, Director Division of Regulatory Applications, RES
SUBJECT:
TECHNICAL REVIEW REQUEST: DRAFT FINAL RULE - CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADI0 ACTIVE MATERIALS Your assistance is requested in reviewing the attached document and providing me with your comments and recommendations. I am still considering whether the requirement to provide written instructions is justified from a cost-benefit perspective and may drop this from the office concurrence version of this rule. . Please provide your recommendation on this matter and the rationale for that recommendation.
The following is a summary of this request.
1.
Title:
Final Rule on Criteria for the Release of Patients Administered Radioactive Materials 2.- RES Task leaders: Stewart Schneider, 415-6225, and Stephen A. McGuire, 415-6204
- 3. Coanit ant Individuals:
NMSS - Patricia Holahan, Cathy Haney OGC - Bradley Jones SP --Lloyd Bolling
- 4. Reauested Action: Review, comment, and make recommendations.
- 5. Reauested completion Date: 2 weeks from the date of this memo.
- 6. Backaround: A working group was formed to develop the draft final rule.
The members of the working group are: Stephen McGuire, Stewart Schneider, Sam Jones, Cathy Haney, Patricia Holahan, and Bradley Jones.
The attached draft reflects the work done by the working group.
The attachment includes the draft final FRN and guide. However, the guide does rat include the complete table with information of the breast feeding infant because that information is still being developed by 4081y99970807 20 62FR4120 PDR GrlONS~Oc%. . dLb-
D. A. Cool, et al ORISE. HMSS committed to deliver that information to RES by April 7.
RES will send a revised guide that contains the completed table and supplemental discussion to the reviewers one week after HMSS provides the basic information, in addition, the final regulatory analysis and the Commission Paaer will be sent with the office concurrence package.
This version of t1e FRN and guide may be sent to the Agreement States for their review.
Attachment Draft Final FRN and Draft Active Guide t'
DISTRIBUTION:
RPHEB R/F LRiani (all with a copy of the enclosures)
SJones .
Stewart Schneider PHolahan, NMSS CHaney, NMSS BJones, OGC SMcGuire Lloyd Bolling, SP
- See previous concurrences Offe: RPHEB:DRA* RPHEB:DRA* RPHEB:DRA* D:DRA$}4"
- Name: SSchneider SMcGuire- JGlenn BMorris cu t Date: 03/23/95 03/23/95 03/28/95 h. ,/i; /95 0FFICIAL RECORD COPY , ,
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EED_ERALBEGISTEll NOTICI Critena_ tor thelelease_of Individ_uah Administetell RadioactixeMaterial
NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20 and 35 RIN 3150-AE41 Criteria for the Release of Individuals Administered Radioactive Material AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the criteria for the release of patients administered radioactive material. The new criteria for patient release are based on potential dose to other individuals exposed to the patient, including nursing infants, and replace criteria based on activity in the patient. The new criteria are consistent with the recommendations of the International Commission on Radiological Protection (ICRP). This final rule requires the licensee to provide written instructions to patients on how to maintain the doses to others as low as reasonably achievable if the total effective dose equivalent to any other individual exposed to the released patient is likely to exceed 1 ml111 sievert (0.1 rem). In addition, this final rule requires the licensee to maintain a record for 3 years if the total effective dose equivalent to the individual likely to receive the highest dose from exposure to the patient is based on factors other than the physical half-life of the radioactive material and an occupancy factor of 0.25 at 1 meter. This final rule responds to three DRAFT: April 7, 1995 1 Enc 1csure 1
e petitions for rulemaking regarding the criteria for release of patients administered radioactive material.
EFFECTIVE DATE: (90 days following publication in the Federal Register).
ADDRESSES: Copies of the public record, including the final regulatory guide, the final regulatory analysis and any public comments received on the proposed rule, may be examined and copied for a fee in the Commissions's Public Document Room at 2120 L Street, NW. (Lower Level), Washington DC.
FOR FURTHER INFORMATION CONTACT: Stewart Schneider or Stephen A. McGuire, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission.
Washington, DC 20555, telephone (301) 415-6225.
SUPPLEMENTARY INFORMATION:
Table of Contents I. Background
- 11. Publication of the Proposed Rule
!!!. Public Comments IV. . Coordination with NRC Agreement States V. . Coordination with the Advisory Committee on Medical Uses of Isotopes VI. Discussion of Final Rule Text VII. Consistency with 1979 Medical Policy Statement Vill. Issue of Compatibility for Agreement States IX. Finding of No Significant Environmental Impact: Availability DRAFT: April 7, 1995 2 Enclosure 1
X. Paperwork Reduction Act Statement XI. Regulatory Analysis Xil. Regulatory Flexibility Certification X111. Backfit Analysis XIV. Listofsubjects XV. Text of Final Regulations
- 1. Background Each year in the United States, radioactive pharmaceuticals or radioactive implants are administered to approximately 8 to 9 million patients for the diagnosis or treatment of disease. These patients can expose others around them to radiation until the radioactive material has been excreted from their bodies or has decayed away.
NRC's current patient release criteria in 10 CfR 35.75, " Release of patients containing radiopharmaceuticals or permanent implants," are as follows: "(a) A licensee may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either:
(1) The measured dose rate from the patient is less than 5 millirems per hour at a distance of one meter; or (2) The activity in the patient is less than 30 millicuries; (b) A licensee may not authorize release from confinement for medical care of any patient administered a permanent implant until the measured dose rate is less than 5 millirems per hour at a distance of one meter,"
On May 21,1991 (56 FR 23360), the NRC published a final rule that amended 10 CFR part 20, " Standards for Protection Against Radiation." The DRAFT: April-7, 1995 3 Enclosure 1
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 discussion in the supplementary information on whether or how the provisions of 10 CFR 20.1301 were intended to apply to the release of patients.
Because some licensees were uncertain about what effect the revised 10 CFR part 20 would have on patient release criteria, two petitions for rulemaking were received on the issue. On June 12, 1991 (56 FR 26945), the NRC published in the Federal Register a notice of receipt af, and request for comment on, a petition for rulemaking (PRM-20-20) from Dr. Carol S. Marcus.
On March 9,1992 (57 FR 8282), the NRC published a notice of receipt and request for comment in the Federal Register on another petition for rulemaking (PRM-35-10) on patient release criteria from the American Lollege of Nuclear Medicine (ACNM). On May 18, 1992 (57 FR 21043), the NRC published in the Federal Register notice of an amendment submitted by the ACNM to its original petition (PRM-35-10A).
In addition, a third petition (PRM-35-11) dealing, in part, with these same issues was submitted by the American Medical Association. That petition was noticed in the Faderal Register on July 26, 1994 (59 FR 37950). The main point of the petition was 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 per year. The AMA believed that 10 CFR 20.1301 would have an adverse impact on the availability and the cost of treatment of thyroid disease, which would outweigh the advantages of reduced radiation exposure to the public. The AMA stated that treatment of up to 10,000 cancer patients annually for thyroid carcinoma would require the DRAFT: ~ April 7, 1995 4 Enclosure 1 i .. . . . . . . . . . . . . . . . . . . . . .
. . . . i
hospitalization of the patients under the revised regulation (10 CFR 20.1301),
reducing both early release of patients and the treatment of patients at home.
- 11. Publication of the Proposed Rule 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 petitions.
The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically state that the dose to individual members of the public from a licensed operation does not include doses received by individuals exposed to patients who were released by the licensed operation under the provisions of 10 CFR 35.75. This was to clarify that the Commission's policy is that patient release is governed by 10 CFR 35.75. not 10 CFR 20.1301.
The NRC proposed'to amend 10 CFR 20.1301(a)(2) to specifically state that the limit on dose in unrestricted areas does not include dose contributions 'from patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose was to clarify that licensees are not required to control areas, such as a waiting room, simply because of the presence of a patient released pursuant to 10 CFR 35.75. If a patient has been released from licensee control, pursuant to 10 CFR 35.75, licensees are not required to limit the radiation dose to members of the public DRAFT: April 7, 1995 5 Enclosure 1
(e.g., visitor in a waiting room) frcm a patient to 0.02 mi111 sievert (2 millirems) in any one hour. Patient waiting rooms or hospital rooms need only be controlled for thnse patients not meeting the release criteria in 10 CFR 35.75.
The NRC proposed to adopt a new 10 CFR 35.75(a) to change the patient release criteria from 1,110 megabecquerels (30 mil 11 curies) of activity in a patient or a dose rate of 0.05 millistevert (5 millirems) per hour at 1 meter from a patient to a total effective dose equivalent not to exceed 5 millisteverts (0.5 rem) in any one year to an individual from exposure to a released patient. A dose-based limit provides a single limit that can be used to provide an equivalent level of risks from all radionuclides. Also, the proposed changes are supported by the recommendations of the ICRP and the National Council on Radiation Protectinn and Measurements (NCRP) that an individual can be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where exposure to radiation is not expected to result in doses above 1 mil 11 sievert (0.1 rem) for long periods of time.
The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that the licensee provide released patients with written instructions on how to maintain doses to other individuals as low as reasonably achievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 mil 11 sievert (0.1 rem) in any one year. A requirement to give instructions to certain patients was already contained in 10 CFR 3b.315(a)(6) and 35.415(a)(5), but the proposed requirement would add per year approximately 50,000 individuals who are administered iodine-131 for the treatment of hyperthyroidism and another 70,000 individuals who are breast-feeding and administered various diagnostic and therapeutic radioactive DRAFT: April 7, 1995 6 Enclosure 1
5
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, matorials. The purpose of the instructions is to maintain doses to individuals exposed to patients as low as reasonably achievable.
The NRC proposed to adopt a new 10 CFR 35.75(b)(2) to require that licensees maintain, for three years, a record of the released patient and the i calculated total effective dose equivalent to the individual likely to receive the highest dose if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 mil 11 sievert (0.1 rem) 4 in a year from a single administration. The major purpose was to provide the i basis for controlling the dose to individuals' exposed to a patient who may
, receive more than one administration in a year.
I finally, the NRC proposed to amend its requirements on instructions in 0 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 i required by i 35.75(b)" was added to each. The purpose of this change was to assure internal consistency within part 35 on when instructions must be given. .;
2 In addition, the NRC issued concurrently for public comment an associated draft regulatory guide and supporting draft regulatory analysis.
The draft regulatory guide, DG-8015,:" Release of Patients Administered
. Radioactive Materials " provided guidance on determining the potential doses l to an individual likely to receive the highest dose-from exposure to a patient
- and established appropriate activities and dose rates for release of a patient. The guide also provided guidelines on instructions for patients on how to maintain doses to other individuals as low as reasonably achievable and described _recordkeeping requirements. The draf t regulatory analysis, NUREG-1492, " Regulatory Analysis on Criteria for the Release of Patients DRAFT
- April 7, 1995 7 Enclosure 1 P
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Administered Radioactive Material," exandned the benefits and impacts of the oraposed rule considered by the NRC.
111. Public Comments on the Proposed Rule A total of 62 comment letters were received on the proposed rule, the draft regulatory guide, and the draft regulatory analysis. A majority of the comment letters were from medical practitioners and medica's organizations, but there were also comment letters from regulatory agencies in Agreement States, private individuals, and public-interest groups. Overall, the majority of all comment letters supported a dose limit of 5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material. However, about one-fourth of all commenter lettere opposed the proposed method of implementation. The significant comments are discussed below, arranged by subject.
EXCLUSION OF PATIENT RELEASE FROM 20.1301(a)
All of the commenters except one supported governing patient release by the regulations in 10 CFR 35.75 and excluding the dose to individuals exposed to a released patient from 10 CFR 20.1301(a).
Comment: One commenter, 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.
DRAFT: April-7, 1995 8 Enclosure 1
_ _ _ _ _ _ J
Response: In its previous rulemailng on 10 CTR part 20 (56 FR 23360; May 21, 1991), the NRC determined that, while doses should be maintained as low as reasonably achievable, a dose limit of 1 millisievert (0.1 rem), or a dose limit of 3 millisieverts (0.5 rem) in certain special circumstances, provides adequate protection. The NRC reaffirms that determination in this rulemaking.
Comment: One commenter said that the NRC should change the 0.1 rem dose limit for the public in 10 CFR 20.1301(a)(1) to 0.5 rem for all licensed activities because a dose limit of 0.5 rem offers adequate protection and is a dose that has;no proven effects.
Response: This issue of the get eral public dose limit is outside the scope of this rulemaking. The issue was dealt with when 10 CFR part 20 was recently amended (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.II01(a)(1).
ACTIVITY-BASED VS DOSE-BASED RELEASE LIMIT s
The issue is whether the patient release limit in 10 CFR 35.75 should be expressed as an activity limit together with an equivalent limit on dose-rate at 1 meter or whether it should be exprested as a limit on dose to an individual exposed to the patient. The majority of commenters supported the dose-based limit. However, some commenters opposed the dose-based approach.
DRAFT: April 7, 1995 9 Enclosure 1
Comment: A number of commenters said that 10 CFR 35.75 should not be changed and that the 30 millicurie and 5 millirems per hour release criteria should be retained because they are working well. Some commenters said that a dose-based release limit as proposed will cause confusion and potential problems. One commenter said that th part 20 revision was not intended to alter the status quo for patient release. Commenters objected to the dose-based release limit because they thought the dose estimates to the public would be very inaccurate as they are based on the unreliable method of predicting the anticipated time and proximity to others. Commenters also said that dose estimation and the subsequent recordkeeping would be time consuming and would add to the cnst of treatment with probably no significant decrease in radiation exposure.
Response: The NRC is adopting a dose-based limit rather than an activity-based limit because the NRC's primary concern is the public's health and safety. A single activity requirement was not retained because the doses from a released patient are different for different radionuclides that have the same activity. Also, a single dose rate requirement for all radionuclides was not retained because one value is not a uniform indicator of the total dose which depends on the effective half-life of the radioactive material in the body of the patient and other factors which will vary for different-materials. For these reasons, the NRC is establishing for each patient release a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual from exposure to a released patient. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35,75 (50 FR 30627), the recommendations of the ICRP, and the provisions in DRAFT: April 7, 1995 10 Enclosure 1
- _ _ _ _ _ _ _ . ._ N
10 CfR 20.1301(c), pertaining to tempor4 y situations in which there is requisite justification for a dose limit higher than 1 mil 11 sievert (0.1 rem).
The NRC believes that the dose-based release limit can and will work well because the associated regulatory quide 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 Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."'
The supporting regulatory analysis contains a thorough examination of the benefits and impacts of the final rule thtt includes dose estimation, recordkeeping end radiation exposure. The regulatory analysis shows that the final rule is cost effective, resulting in lower national health care costs.
Single copies of the final regulatory analysis and final regulatory guide are available as indicated in the ADDRESSES heading.
Comment: 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. The NRC anticipates that nearly all patients will remain under licensee control or
' 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: April 7, 1995 11 Enclosure 1
+ t I
be released based on the activity values of commonly used radionuclides l provided in the table of release quantities in the regulatory guide associated with the rule. The table of release quantities approach, based on standard conservative assumptions, does not require any personal information from the patient. Personal information would only be necessary for certain patient-specific cases.
Coment: One commenter said that it should continue to be acceptable to release patients based on the dose rate at 1 meter.
Response: The rule permits release of patients based on the dose rate at I meter. The table of release quantities in the associated final regulatory guide specifies the dose rate at 1 meter of commonly used radionuclides that allow licensees to authorize patient release.
i RELEASE QUANTITIES Going to a dosa-based system based on a dose to the most highly exposed individual of 5 millisieverts (0.5 rem) would, in some circumstances, allow patient release with more than 1,110 megabecquerels (30 millicuries) of activity. Some commenters were opposed to allowing release with higher activities than now permitted.
Coment: Several commenters said that the release of patients with more than 30 millicuries of iodine-131 should not be permitted. Some commenters were concerned about the risk of :nternal exposure. One commenter said that DRAFT: April 7, 1995 12 Enclosure 1
[
doses to family members due to patient mmiting were not adequately considered.
Response: As stated above, the NRC bases its measure of adequate protection on the dose received. In the case of patient release, the NRC has established a dose not to exceed 0.5 rem (5 millisieverts) to the individual likely to receive the highest dose as providing an adequate level of protection. The question to be asked is, what quantities of radioactive materials correspond to that dose? Those quantities are tabulated in the Regulatory Guide associated with this rulemaking. For the case of iodine-131, the quantity for the general case has been established to be 33 mil 11 curies.
However, in certain specific cases, it is possible to show that patients can be released with quantities of iodine-131 exceeding 33 millicuries and the doses to other individuals exposed to the patient are not likely to exceed 0.5 rem (5 millisieverts), in those situations the NRC will permit the release of patients containing more that 33 millicuries of iodine-131 because a adequate level of protection still exists.
Doses to individuals exposed to the patient from pathways other than direct external exposure (e.g., internal exposure due to intake of radionuclides from vomited matter, sweat, etc.) were considered and were found to be relatively low compared to direct external exposure, with the exception of intake from the milk in breast-feeding infants. These considerations are discussed in the supporting regulatory analysis.
Comment: One commenter said that the Federal Register Notice for the proposed tule-did not adequately represent the concerns that the Agreement DRAFT: April 7, 1995 13 Enclosure 1
States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries.
Response: In commenting on the petitions, the States did express concerns about releasing patients administered relatively large quantities of iodine-131. However, the Agreement States were generally favorable to the approach that was contained in the proposed rule, and none of the States that commented on the proposed rule said that the concerns of the Agreement States were misrepresented, in fact, one Agreement State commented that it was pleased that the NRC had considered the comments made by the Agreement States at various meetings with the NRC.
Comment: One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member might exceed 0.5 rem because it might be beneficial and acceptable to family members in some cases. Another commenter said that a dose of 0.5 rem to an individual exposed to a patient has so little hazard that the NRC should not be concerned with it.
Response: The NRC does not believe that individuals exposed to a patient should, in general, receive doses in excess of 5 millisieverts (0.5 rem). This is consistent with the recommendations of the ICRP in ICRP Publication 60,* "1990 Recommendations of the International Commission on
' International Commission on Radiological Protection (ICRP), "1990 Recommendations of the International Commission on Radiological Protection,"
ICRP Publication No. 60 (November 1990). Available for sale from Pergamom Press, Inc., Elmsford, NY 10523.
DRAFT: April 7, 1995 14 Enclosure 1 i
l Radiologiu.1 Protection;" and the reconaandationr. of the National Council on Radiation Protection and Measurements (NCRP) in NCRP Report No.116,'
" Limitation of Exposure to lonizing Radiation." Each of these provides a basis for allowing individuals to receive annual doses up to 5 millisieverts (0.5 rem) under certain circumstances. Both the ICRP and the NCRP recommend that an individual be allowed to receive a dose up to 5 millisieverts (0.5 rem) in a given year in situations where expoture 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 d(ses from released patients. The NRC believes that if the dose to another individual is likely to exceed 5 millisteverts (0.5 rem), the patier' should remain under the control of the licensee. Licensee control is necessary to provide adequate protection to the individuals exposed to the patient.
RECORDKEEPING FOR ADMINISTRATIONS AB0VE 1 MILLISIEVERT (0.1 REM)
The strongest opposition to the proposed rule was to the proposed new requiremen' to maintain a record of the released patient and the calculated total effective dose equivalent to the inMvidual likeb to receive the
- highest dose if the dose to that person is likely to exceed 1 mil 11 sievert (0.1 rem). Under the proposed rule, if a patient had or might have had one or more administratior.s within the same year, it would be necessary fur the licensee to use the records to determine the dose from the previous
' National Council on Radiation Protection and Measurements, " Limitation of Exposure to lonizing Radiation," NCRP Report No. 116 (March 31, 1993).
Available for sale form the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.
DRAFT: April 7, 1995 15 Enclosure 1
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administr;tions so that the total dose to an individual exposed to a patient 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 make calculations and keep records be removed. The commenters believed that the work would not ,iroduce an increased level of safety and that the NRC greatly underestimated the cost, and that therefore the recordkeeping would be unnecessary, inappropriate and impractical. Some commenters said that multiple administrations that would result in a tctal effective dose equivalent greater than 1 mil 11 sievert (0.1 rem) are not done to the same patient routinely. Other commenters said that there are decades of experience unencumbered by any paperwork burden at all with no evidence that a lack of paperwork has resulted in any additional problems. One commenter said that if 0.5 rem is acceptably safe, why have the 0.1 rem level with all the documentation required.
Another commenier said that it cannot be the licensee's responsibility to know the details of a radionuclide therapy performed by another licensee in terms of which members of the public receive the most radiation dose.due to that other licensee's therapy procedure.
One m enter said that the excessive recordkeeping cost would be a nonreimbursable cost and the burden will cause many physicians to stop offering iodine therapy and force patients to travel to large medical facilities in cities and cause problems with patient access in sparsely populated areas.
DRAFT: April 7, 1995 16 Enclosure 1
]
Response: Upon reconsideration, the NRC has decideu to delete the requirement to keep records when the dose to the most highly exposed individual is likely to exceed 1 mil 11 sievert (0.1 rem) based on standard conservative assun'ptions. The requirement was proposed so that it would be possible to account for the dose from multiple administrations in the same year, to assure that the total dose to an individual exposed to the patient did not exceed 5 millisieverts (0.5 rem).
The NRC has an advisory committee (the Advisory Committee on the Medical Uses of Isotopes or "ACMul"), which since its establishment many years ago, has advised 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 allows selected physicians or pharmacists to work for NRC for a period of 1 to 2 years. Both the ACMUI and the 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, 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 thereof, results in exceeding the 5-mil 11 sievert (0.5-rem) doss limit because of multiple administrations in the same year.
Although there is no recordkeeping requirement for patient releases based on standard conservative assumpticns, a record is required if the optional calculational method described in the associated regulatory guide is used to release the patient.. This record provides a basis for assuring that DRAFT: April 7, 1995 17 Enclosure 1
a ,
the maximum dose to an individual exposed to the patient, as determined by the
-licensee, is below 5 millisieverts (0.5 rem).
Consent: - Several commenters said that those who pay for health care will put great pressure on physicians to optimize calculations to reduce inpatient days and to justify out-patient treatments.
Response: There is no objection to optimizing calculations to reduce impatient days as-long as the calculations are realistic and the
- 5-mil 11 sievert (0.5-rem) limit in 10 CFR 35.75 is met. _The regulatory guide associated with this rule describes calculations that are acceptable to the NRC.
WRITTEN INSTRUCTIONS TO PATIENTS In general, there was little objection to providing . instructions ta patients on how to minimize the dose-to others, but there was significant opposition to the proposed _ requirement that the instructions would have to be wricten.
' 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 pctients be written.
DRAFT: April--7;1995 18 Enclosure 1
l Response: The commenter is corred. The Statement of Considerations was in error on that point. The existing regulations did not specify that instructions have to be in written fore.
Comment: A number of commenters said that instructions should not need to be written and that oral instructions should be permissible. Some of these commenters said that oral instructions are more effective and that how the instructions should be given is within the province of the doctor-patient relationship and that the NRC and its regulations should not interfere with that relationship. Another commenter said that the standard written instructions require too much time explaining how each patient varied from the standard instruction sheet. _However, one Agreement State and a major health maintenance organization stiongly supported the requirement that the instructions be written.
W sponse: The NRC believes that providing written instructions has a significant value because often patients will not remember all of the instructions given orally, in addition, written instructions can be read by other family members. The NRC believes that for the majority of releases requiring 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). In those situations where the release is based on the optional calculational method described in the associated regulatory guide, modifications to the DRAFT: April 7, 1995 19 Enclosure 1
written instructions may be needed. Honver, oral instructions can also be i
provided in-all cases.
1 Comment: Several commenters said that dictating to a physician how and what he or sh6 4.Jst 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, lhe third statement of the policy states that, "The NRC will minimize intrusion into medical judgements affecting patients and into other areas traditionally considered to be a part of the practice of rc.edicine." The final rule is consistent with this statement because it does not specify the details of what the physician must say verbally or include in the contents of the written instructions. However, the regulatory guide associated with this rule includes recommended contents of the written instructions. Single copies of the regulatory guide are available as indicated in the ADDRESSES heading.
The 1979 Medical Policy Statement is presented in its entirety with a full discussion of the consistency of the final rule 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.
DRAFT: April 7, 1995 20 Enclosure 1
Another commenter said that the instructions should be both written and oral I
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 i English, it is likely that someone else will be able to read the instructions i
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. In most situations, it will be possible to find someone who can translate for the patient if necessary. The requirement that written instructions be given to the patient does not preclude oral instructions.
Comment: Several commenters asked how the NRC would enforce implementation of the instructions given to the patient. Another commenter asked how the licensee could verify that the instructions are followed.
Another commenter said that a sizable fraction of patients may not follow radiation safety instructions to protect spouses and may be even less careful about protecting tot al strangers. This commenter also asked whether it it reasonable te 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 the implementation of instructions nor is it the licensee's responsibility. Following of the
. instructions is voluntary for the patient.
DRAFT: April 7, 1995 21 Enclosure 1
f Coment: One commenter said that instructions should be given for all administratic% of radioactive material regardless of the quantity administered.
Response: The NRC does not agree, in some cases, particularly the large number of diagnostic administrations, the potential doses are so small that the burden of requiring instructions cannot be justified. Under the final rule, if the dose to any individual exposed to the patient is not likely to exceed 1 millisievert (0.1 rem) instructions are not required but the physician could give any instructions that he or she considers desirable.
CONFINEMENT OF PATIENTS Coment: Two commenters said that patients cannot be confined against their wishes and that the rule provides no penalty for the patient who leaves confinement in the hospital "against medical advice." Another commenter said that the rule seems to require that the licensee have control of the patient's activities after release.
Response: The NRC recognizes that patients cannot be held against their will. The rule deals with the conditions under which the licensee may authorize release. The NRC would not penalize a licensee if the patient were to leave "against medical advice." However, there is the possibility that such an event places the licensee, patient, or both, in violation of a state or local regulation.
DRAFT: April 7, 1995 22 Enclosure 1 l- . _ _ _ _ _ - - -
k Coment: One commenter asked if a patient that was releasable b., vas still hospitalized for other reasons would still be considered under the licensee's control.
e Response: Once the licensee has authorized the release of the patient, there is no need te keep the patient under licensee control if the patient remains hospitalized for other reasons. However, good health physics practice would be to continue to make efforts to maintain doses to people at
\ r the facility as low as reasonably achievable.
Coment: Commenters also asked how a patient can be confined to his or her house.
\
Response: These commenters misunderstood the concept of confinement.
As explained in the Statement of Considerations for the proposed rule (59 FR 30724), the term "c of i e t" no longer applies to the revision to li: D R 35.75. Instead. the rule language uses the phrase " licensee control" whi;n the NRC believes more clearly reflects the NRC's intent.
The NRC believes that there is a distinct difference between a patient being under licensee control i" a hospital or other licensed facility (e.g., hospices or nursing homes) and being at home. In a hospital or other NRC licensed facility, the licensee has control over access to the patient as well as having trained personnel and instrumentation available for making radiation measurements not typically available at the patient's home. In addition, while under licensee control, a licensee has control over the dose by limiting the amount of time that individuals are in close proximity to the DRAFT: April 7, 1995 23 Enclosure 1
!*1 .
1 patient.- A patient _who'goes home is released from licensee control, not confined.;
Comment: One commenter thbught'that the rule-should define-the' term
' release."
Response: The_NRC- thinks the rule is sufficiently clear- and does not Esee the need:toLdefine the term.-
MISCELLANEOUS COMMENTS ON THE RULE
~remvent: .Several commenters said-that the rule should not be a matter of)qre ser. State t.ompatibility at any level, q
--j Response: The NRC!does not_ agree. It is general.NRC policy-that regulations that:are necessary to protect health and safety shoul'd be. matters -
of compatibil.ity. ,
Comment: 1Several commenters said that the nursing infant should not be considered as an individual exposed to.the patient forithe purposes of determining if patient release may be authorized. These commenters said=that
-consideration:of the: nursing: infant should be under the jurisdiction of the !
Lphysician, that the issue isia medical issue rather a regulatory issue,~ and
^ thatithe NRC should-not interfere in_. medical issues. 1 DRAFT: April:1711995- 24- Enclosure 1 s
..__-__..__..__u---
Response: The NRC does not agree. The NRC has a responsibility to protect public health and safety and that responsibility extends to all individuals exposed to a patient administered licensed radioactive materials, including the nursing infant.
Comment: One commenter said that the Federal Register Notice on 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 ACMUI position.
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 exists a limit as to the amount of control that a licensee has over the patient.
Response: The NRC recognizes that the licensee has no control over the patient after the patient has been released. The quantities listed in the Regulatory Guide associated with this rulemaking for normal release were calculated using conservative assumptions (for example, by using the physical halflife of the radioactive material ratha. than the more realistic biological hal fli fe) . Thus, the NRC considers it very enlikely that the actual dose to any real person in real circumstances wou16 ever exceed 0.5 rem DRAFT: April 7, 1995 25 Enclosure 1
d (5 millisieverts). If the release is based on a more realistic case-specific calculation, it is necessary to consider and evaluate special situations, such as when a released patient would immediately board an airplane flight and would therefore be in close contact with another individual. In those situations, it may occasionally be necessary to obtain the patient's agreement to follow instructions as a condition for authorizing the release of the patient. But 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 the draft regulatory guide associated with this rulemaking. Because the guide is so closely 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 dose to the individual likely to receive the highest dose.
Comment: Several commenters said that the calculational methodology in the draft regulatory guide is too complex and that the assumptions are too conservative. As an example, several commenters said that the assumed 24-hour non-voiding assumption used in calculating doses is too conservative. As 4
evidence that the calculations are too conservative, several commenters said that the doses measured using dosimeters were muca iower than doses calculated using the models in the guide.
DRAFT: April 7, 1995 26 Enclosure 1
Response: The NRC does not agree alth these comments. With regard to the comment that the calculations are too complex, it will rarely be necessary 4 to do a calculation.- Almost all releases can be done using the table of release quantities in the associated final regulatory guide. If a case-specific calculation is appropriate, it is possible to do a generic calculation that would represent a condition such as treatment for thyroid cancer for all patients. This calculation could be done once and placed on file. A separate calculation would not have to be done for each patient.
With regard to the comments that the methodology is too conservative and 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 3
be used with little consideration of the specific details of a specific patient's release. A review of published information in the regulatory analysis (NUREG-1492) finds that the measured doses were below those predicted by the methodologj used to calculate-the table of default release quantities, but were not "much below" as the commenters claimed. The licensee is also given the option to do case-specific calculations that may be less conservative. The' assumption used in the guide of 24-hour non-voiding is generally conservative, but may not be in every case. In any case, it is appropriate that the calculation be done conservatively because the 0.5 rem dose that may be received by another individual is at the outer limit of acceptability. The 0.5-rem dose exceeds the 0.1-rem dose generally used as a limit, and it is acceptable only under special circumstances such as the case of patient release.
DRAFT: April 10, 1995 27 Enclosure 1
Comment: -One commenter said that the exposure factor (generally assumed to be.0.25 at-1 meter) should not be left to the discretion of th? licensee .
because low exposure factors could easily be justified by providing strict safety instructions without any verification that the instructions will be followed. Another commenter liked the flexibility provided by being able to adjust the exposure factor, but wanted to be know if other considerations are allowed and if it is acceptable to use values lower than 0.125.
Response: The exposure factor is not left entirely to the digression of the licensee, in general, the NRC does not believe that the exposure factors should be less than 0.125 because it is not possible to avoid someone being exposed to the patient at all times. This view is expressed in the associated regulatory guide. Lower values for the exposure factor are not specifically prohibited by the regulation, but must be justified in the record of the calculation, as the record will be subject to inspection.
Comment: Several commenters said that the iodine-131 retention fraction of 0.3 used in the guide for treatment of thyroid cancer is too large and_ that the ccrrect value should be 0.05 or less. Another commenter said that the biological half-life of extrathyroidal iodine should be 0.5 day for both the euthyroid and hyperthyroid condition. One commenter said that the values from ICRP Publication No. 53 should be used instead. (The value used in the draft regulatory guide for the euthyroid condition was 0.21 day.)
Response: The example in the guide has been revised, and an explanation of the basis for the factors chosen has been added.
DRAFT: April 7, 1995 28 Enclosure 1
Coment: One commenter said the table of release quantities in the draft regulatory guide should be expanded to include beta emitters such as strontium-89 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 the final regulatery guide. The table of release quantities was also expanded to add values for chromium-51, selenium-75, ytterbium-90, tin-ll7m, and iridium-192.
Coment: The table of releases quantities in the draft regulatory guide should be expanded to include accelerator-produced radioactive materials as an aid to Agreement States.
Response: Several accelerator-produced materials were added to the guide.
Comment: One commenter said that the draft regulatory guide should have a table of release quantities based on biological half-life rather than only the physical half-life.
Response: The NRC did not accept this suggestion. In general, it is sufficient to use the physical half-life to make the decision to authorize the release of patients. In those instances when a case-specific calculation is DRAFT: April 7, 1995 29 Enclosure 1 i
i
_c -
appropriate,Jit Ican be done by- the licensee using biological half-lives that
- are appropriate for the' specific treatment.
Consent: One:commenter said that the factor of 10 used in the draft r' egulatory guide to estimate internal dose ~ is not well; supported for-nonoccupation'al t exposures. Another commenter.said that the calculation of dose to individuals exposed to the patient ignores the potential of radiation dose from the excretion of radioactive material from the patient and this could present a significant radiological hazard to family members.
Response: It-is true that there i.s-_not a great deal of information on
- the'use of the factor in nonoccupational settings, but there are two studies-referenced in NUREG-1492 in which iodine uptake was measured in people exposed to-a. patient,':That data support the factor of-10. Since iodine is quite soluble and volatile it can be expected that its transfer to others would be higher than_ that of _less soluble and volatile materials. Thus, the NRC considers use of the factor appropriate on a general basis.
Comment:-_A medical organization commented that the~ guide is not comp 1'ete and does not provide sufficient comprehensive examples to assist:
Llicensees-in> complying with the rule ,
j Response: The NRC believes that the four examples ~provided illustrate
- the techniques sufficient. to ' perform' the whole range of potential calculations.-
DRAFT: ; April.7,l1995' 30 Enclosure 1 i
j
Comment: One commenter saiJ that the draft regulatory guide did not provide enoujh information on when and for how long nursing of infants should be stopped.
Re!,ponse: The final regulatory guide has been greatly expanded with respecc to information on the breast-feeding infant, including a table of relsase quantities requiring interruption of breast-feeding and the time for which breast-feeding should be stopped.
Comment: One commenter said that the sample instructions in the regulatory guide concerning implants should include a picture of an implant seed.
Response: The sample instructions in the final regulatory guide Appendix were not expanded to include this due to graphics limitations, but licensees may add photos if desired.
Comment: Several commenters asked whether multiple individual calculations have to be specifically done or if a generally-applicable calculation could be done once and used for many patients.
Response: The NRC would expect that if a case-specific calculation were done by a licensee, it would be done for a class of patients rather than done individually for each patient.
DRAFT: April 7, 1995 11 Enclosure 1 l
l
Conraent: One commenter said that the discussion on radiolabeled antibodies in the draft regulatory guide was wrong because iodine-131-labeled antibodies will be deiodinated in the body and the iodine will behave like other iodine. None of the radiolabeled antibodies now being developed or planned for the future should have an internal dose hazard for the general public..
Response: The NRC agrees with this comment. Statements in the final regulatory guide were appropriately modified.
COMMENTS ON THE REGULATORY ANALYSIS (NUREG-1492)
Comment: One commenter said that the value of a person-rem should be
$40 rather than $1,000 as used in the regulatory analysis for the purpose of evaluating the costs and benefits of the rule. The commenter cited a Health Physics Society position paper.
Response: The NRC does not believe that the value of $40 per person-rem recommended by the Health Physics Society is appropriate because it places too low a value on a day of human life lost. The NRC continues to believe that for the purposes of this evaluation a value of $1,000 per person-rem is appropriate.
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 hospital room was DRAFT: April 7, 1995 32 Enclosure 1
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 the rule were overestimated. The estimates of days of hospitalization required did not include biological elimination of the radioactive material. Only radioactive decay was considered. As a consequence, the estimates of the periods of time that patients would need to be retained under licensee control were too long, and therefore the costs of patient retention were too high. The final regulatory analysis corrects the estimates.
The NRC believes that the current cost of $1,000 per day for a hospital room is not an overestimate. Under 10 CFR 35,315(a)(1), for each patient receiving radiopharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75, licensees are required to provide a private room with a private sanitary facility. Considering this NRC requirement and the recent reference cited in the final regulatory analysis on the cost of hospitalization, $1,000 per day for a hospital room is a reasonable estimate.
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.
DRAFT: April 7, 1995 33 Enclosure 1
IV. Coordination with NRC Agreement States The NRr conducted a public workshop with representatives of the Agreement States on October 24 and 25, 1994, to discuss public comments on the proposed amendments _of 10 CFR parts 20 and 35. The workshop was held in
- Portland, Maine. the Agreement States had no objection to the approach in this rule.
V. Coordination with the Advisory Committee on Medical Uses of Isotopes The NRC staff presented a summary of the comments on the proposed rule to the Advisory Committee on Medical Uses of Isotopes (ACMUI) during a public ,
meeting held in Rockville, Maryland, on November 17 and 18, 1994. The ACMUI is an advisory body established to advise the NRC staff on matters that involve the administration of radioactive material and radiation from radioactive material. The ACMUI was generally supportive of the approach in this rule. . Transcripts of the meetings have been placed in and are available for examination at the NRC Public Document Room, 2120 L St. NW. (Lower Level),
-Washington; DC.
VI. Discussion of Final Rule Text i
This section summarizes the final rule. The NRC is amending 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 DRAFT: April 7, 1995 34 Enclosure 1
- _ _ - \
I under the provisions of 10 CFR 35,75. This is not a substantive change, it is a clarifying change to make clear that the Commission's policy is that
, patient release is governed by 10 CFR 35.75, not 10 CFR 20.1301.
For the sake of consistency and clarity, the same words are used in i 5 20.1002, " Scope," in i 20.1003, " Definitions," (in the definitions of both
- public dose and occupational dose), and in i 20.1301, " Dose limits for
- j. individual members of the public." Also for consistency and clarity, the exclusion of dose from background radiation and from voluntary participation in medical research programs that are now included in in 20.1002 and 20.1003 are added to 5 20.1301(a).
4 The NRC is amending 10 CFR 20.1301(a)(2) to specifically state that the limit en dose in unrestricted areas does not include dose contributions from
- patients administered radioactive material and released in accordance with 10 CFR 35.75. The purpose of this change is to clarify that after a patient ,
has been released under 10 CFR 35.75, licensees are no longer required to control radiation -from the patient.
4 The NRC is adopting a new 10 CFR 35.75(a) to change the patient release
- criteria from 30 millicuries of activity in a patient or;a dose rate of 5 millirems per hour at 1 meter from a patient to a dose limit of 5 millisieverts (0.5 rem) total effective dose equivalent to an individual 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 risks from all
. radionuclides. Also, the changes are supported by the recommendations of the ICRP and NCRP that an individual can be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary situations where exposure to DRAFT: April 7, 1995 35 Enclosure 1 o
radiation is not expected to result in annual doses above 1 millisievert (0.1 rem) for many years.
Doses among individuals who nay come in contact with a released patient are highly variable and reflect the crucial, but difficult to define, parameters of time, distance and shielding. Although all members of society have the potential for exposure to a released patient, based on time and distance considerations, it is reasonable to conclude that for the overwhelming majority of released patients he maximally exposed individual is likely to be one who is 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.
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 tn other individuals as low as reasonably uchievable if the total effective dose equivalent to any individual other than the released patient is likely to exceed 1 millistevert (0.1 rem). 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 adds approximately 50,000-patients per year who are administered iodine-131 for the l treatment of-hyperthyroidism and another 70,000 patients who are breast-feeding. The purpose of the written instructions is to maintain doses ,
to individuals exposed to patients as low as reasonably achievable. The instructions may be either written plus oral or written only. The NRC believes that written instructions are necessary so that the patient and the patient's family and friends will have a document to refer to rather than DRAFT: April 7, 1995 36 Enclosure 1
L
?
having to rely solely on the patient's memory and understanding of the instructions.
The NRC is adopting a new 10 CFR 35.75(c) to require that tne licensee maintain, for three years, a record of the released patient and the calculated total effective dose equivalent to ancther individual likely to receive the highest dose if the patient release is based on biological elimination rather than just the physical half-life of the radionuclide or if the licensee uses an occupancy factor other than 0.25 at one meter. This is a modification to the proposed rule. The proposed rule required that a record be maintained of the basis .or .the patient's release, including all calculations performed, if the total effective dose equivalent to any other individual other than the released patient is likely to exceed 1 mil 11 sievert (0.1 rem) in a year from a
' single. administration.
Under the proposed rule, the major purpose of the record was to provide l the basis for controlling the dose to 5 millisieverts (0.5 rem) to individuals exposed to a patient who may receive more than one administration in a year.
Upon reconsideration based on public comments and consultation with the ACMUI, the ACMUI Chairman, and the NRC Visiting Medical Fellow, the NRC has decided to delete this requirement. A review of medical treatment practices revealed no routine practice that would result in exceeding the 5-millisievert (0.5-rem) limit because of multiple administrations in the same year. Without ,
the need to account for the dose from multiple administrations, maintaining records for the tens-of-thousands of patient releases where the dose to an individual is likely to exceed l' millisievert (0.1 millisievert) becomes an unnecessary burden, and therefore has been deleted. Each patient release is to be treated as a separate event upon which licensee knowledge of previous DRAFT: April 7, 1995 37 Enclosure 1
administrations is unnecessary. However, a record is still required if the optional calculational method described in the associated regulatory guide is used to release the patient.
Finally. the NRC is amer. ding its requirements on written instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already required written instructions in certain cases, but the phrase "if required by 5 35.75(b)" was added to each. The purpose of this change is to assure internal consistency within part 35 on when instructions must be given.
Vll. Consistency.with 1979 Medical Policy Statement On February 9,1979, the NRC published a Statement of General Policy on the Regulation of the Medical Uses of Radioisotopes (44 FR 8242). The first I
statement of the policy states, "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 administered radioactive materials.
The second statement of the policy states, "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate."
4 This statement is not relevant to the rule because the rule does not affect the safety of patients themselves. The rule instead affects the safety of ,
individuals exposed to patients.
The third statement of the policy states, "The NRC will minimize intrusion into medical- judgements affecting patients and into other areas ORAFT: April 7, 1995 38 Enclosure 1
i traditionally considered to be a part of the practice of medicine." The rule is consistent with this sie.tement because it places no requirenents on the administration of radioactive materials to patients and because the release of patients administered radioactise materials has long been considered a matter of regulatory concern rather than solely a m6tter of medical judgement.
Thus, the final rule is considered to be totally consistent with the 1979 medical policy statement.
Vill. Issue of Compatibility for Agreement States The NRC believes that the definitions contained in i 20.1003 and text in il 20.1002 and 20.1301(a) that are modified by this rulemaking are Division 1 levels of compatibility. These definitions and sections must be the same for all NRC and Agreement State licensees so that national _ consistency can be maintained.
Additionally, il 35.75, 35.315(a)(6), and 35.415(a)(5) are Division 2 levels of compatibility because.the patient release criteria required by the rule are the minimum requirements necessary to ensure adequate protection of the public health and safety. The Agreement States will be allowed to establish requirements that are more stringent thta the NRC's requirements, but not less stringent.
DRAFT: April 7, 1995 39 Enclosure 1
__j
IX. Finding of No Significant-Environmental Impact: Availability
-The NRC has^ determined under the National Environmental Policy Act of 1969, as amended,:and the Commission's regulations in Subpart A of 10 CFR part 51, that the amendments are not be a major Federal action significantly-affecting the quality of the human environment, and therefore an environmental-impact statement is not required. The final amendments clarify t.he pertinent regulatory language to reflect explicitly the relationship between 10 CFR part 20 and part 35 with respect to release of patients, and revise the release criteria for patients receiving radioactive material for medical use from an activity-based standard to a dose basis. Since the risk basis of the current regulation remains unchanged, it is expected that there will be no significant 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 c 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 FURTHER INFORMATION CONTACT heading.
DRAFT: April 7, 1995 40 Enclosure 1 l
f
X. Paperwork Reduction Act Statement lhis final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44.U.S.C. 3501 et seq.).
These requirements were approved by the Office of Management and Budget, approval number 3150-0010.-
The public reporting burden for this collection of information is estimated to average 0.42 hours4.861111e-4 days <br />0.0117 hours <br />6.944444e-5 weeks <br />1.5981e-5 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. '
XI. Regulatory Analysis The NRC has prepared a final- regulatory analysis (NUREG-1492) on this regulation. The analysis examines the benefits and impacts considered by the !
NRC. The final regulatory analysis is available for inspection at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC.
Single copies are available as indicated-under the FOR FURTHER INFORMATION CONTACT heading.
XII. 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' l on a substantial number of small entities. - This rule affects medical use of byproduct material licensees. As a result of the final rule, the impact will DRAtT: April 7, 1995 41 Enclosure 1 l
- , . I
not be significant becanse the final rt.'a basically represents a continuation of currer,t practice, Xill, 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, beca'use these amendments do not involve any provisions which impose
.backfits as defined in 10 CFR 50.109(a)(1).
XIV. List of Subjects 10 CFR part 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recording requirements, Special nuclear material, Source material, Waste treatinent and disposal.
10 CFR part 35 Byproduct material, Criminal penalty, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
DRAFT: April 7, 1995 42 Enclosure 1
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553; the NRC is adopting the following amendments to 10 CFR parts 20 ar.d 35.
XV. Text of Final Regulations PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
- 1. The authority citation for part 20 is revised to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as-amended, 202, 206, 88 Stat. I 1242, as amended, 1244, 1246 (U.S.C. 5841, 5842, 5846). Section 20.408 also issued under secs. 135, 141, Pub. L.97-425. 96 Stat. 2232, 2241 (42 U.S.C.
10155,10161).
- 2. Section 20,1002 is revised to read as follows:
1 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 DRAFT: April 7, 1995 43 Enclosure 1
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 to patients administered radioactive material and released in accordance with;5 35,75, or to voluntary participation in medical research programs.
- 3. In i 20.1003, the definitions of occupationa7 dose and public dose are revised to read as follows: !
i 20.1003 Definitions.
Occupational dose means the dose received by an individual in a restricted area or in the course of employment in which the individual's assigned duties involve exposure to radiation and to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include dose received from background radiation, as a patient from medical practices, from exporure to! patients 1administeredfradioictIve material. and. released in7accordance?with 5?,15.75, from voluntary participation in medical research programs, or as a member of the general public.
Public dose means the dose received by a member of the public from exposure to radiation and to radioactive material released by a licensee, or to another source of radiation either within a licensee's controlled area- or in unrestricted areas. Public dose does not include occupational dose or DRAFT: April 7, 1995 44 Enclosure 1
doses received from background radiation, as a patient from medical practices, from;sxposure-to patients administered radioactive material and released in accordance with-l 35.75' or from voluntary participation in medical research programs.
- 4. In 5 20.1301, paragraph (a) is revised to read as follows:
6 20.1301 Dose limits for individual members of the public. *
(a) Each licensee shall conduct operations so that--
(1) The total effective dose equivalent to individual members of the public from the licensed operation does not e:<ceed 0,1 rem (1 mSv) in a year, exclusive of the dose contributions from background radiation, from exposure of patients;to radiation for the:purposefof medical diagnosis or. therapy, from exposure to patients administered' radioactive ' material- and released in acco'r dancef with l'35.75, from voluntary participation in: medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 5 20.2003, and (2) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with 5 35.75, does not exceed 0.002 rem (0.02 mSv) in any one hour.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL DRAFT: April 7, 1995 45 Enclosure 1
- 5. The authority citation for part 35 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
- 6. In Section 35.8, paragraph (b) is revised to read as follows:
5 35.8 Information 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.
- 7. Section 35.75 is revised to read as follows:
1 35.75 Release of individuals containing radiopharmaceuticals or permanent implants.
(a) A licensee may authorize release from licensee control any individual administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other DRAFT: April 7, 1995 46 Enclosure 1
_ _ - - - - - - - - - . - I
individual (including a breast-feeding infant) from exposure to the released
^
individual is-not likely to exceed 5 millisieverts (0.5 rem).
(b) If. the total effective dose equivalent to any individual other than the released individual is likely to exceed 1 millisievert (0.1 rem) in a year from a- single administration, upon release the licensee shall provida the released individual with instructions, including written instructions, on how to maintain doses to other individuals at low as reasonably ach.evable.
(c) If the release of the individual is based on biological elimination rather than just the physical half-life of the radionuclide or an occupancy factor other than 0.25 at one meter, or includes consideration of the attenuation of radiation by body tissue, the licensee shall maintain, for three years, a record of the released in61vidual and the calculated total effective dose equivalent to another individual likely to receive the highest ,
l dose.
- 8. In Section 35.315, paragraph (a)(6) is revised to read as follows:
5.35.315 Safety precautions.
(a)
(6) Provide the patient or human research subject with radiation safety guidance, if required by 5 35.75(b), that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient or human research subject.
P DRAFT: April 7, 1995 47 Enclosure 1
- 9. In Section 35.415, paragraph (a)(5) is revised to read as follows:
5.35.415 Safety precautions.
(a)
(5) . Provide-the patient or human research subject with radiation safety guidance,- if required by i 35.75(b), that will help to keep radiation dose to
. household members and the public as low as reasonably achievable before releasing the individual if the individual was administered a permaner,.
implant.
Dated at Rockville, Maryland, this day of , 1995.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Co:tinission.
DRAFT: April 7, 1995 48 Enclosure 1
+
REGULATORY GUIDE X.XX (Draft was issued as DG-8015)
RELEASE OF PATIENTS ADMINISTERED RADIDACTIVE MAIERIALS 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 release from licensee control any individual administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual (including a breast-feeding infant) from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem)."
In addition, Section 35.75 requires that if "the total effective dose equivalent to any individual other than the released individual is likely to exceed 1 millisievert (0.1 rem) in a year from a single administration, upon release the licensee shall provide the released individual with instructions, including written instructions, on how to maintain doses to other individuals as low as reasonably achievable."
Section 35.75 also requires that if "the release of the individual is
= based on biological elimination rather than just the physical half-life of the radionuclide, or an occupancy factor other than 0.25 at one meter, or includes
. DRAFT: March 24, 1995 1
_ _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ i
i 1 .
j ..
consideration of the attenuation of radiation by body tissue, the licensee shall maintain, for three years, a record of the released individual and the calculated total effective dose equivalent to another individual likely to receive the-highest dose."
This guide is being developed to provide guidance on determining the potential doses to an individual likely to receive the highest dose from exposure to the patient, to establish appropriate activities and dose rates for release, to provide guidance on instructions for patients on how to maintain doses to other individuals as low as reasonably achievable, and to describe recordkeeping requirements.
The information collections contained in this regulatory guide are covered by the requirements in 10 CFR 35.75, which have been approved by the Office of Management and Budget, Approval No. 3150-XXXX.
B. DISCUSSION This guide lists activities for commonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dore limits in Section 35.75.
The activities were calculated by using, as a starting point, the method discussed in National Council on Radiation Protection and Measurements (NCRP)
Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides "
NCRP Report No. 37 uses the following equation to calculate the exposure until time t at a distance r from the patient:
34.6rQ,T, (l-e' """')
D(t) = (Equation 1) r' Where D(t) - accumulated exposure at time t, in roentgens, F- specific gamma ray constant for a point source, R/ mci h 2
National Council on Radiation Protection and Measurements, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," Report No. 37, 1970.
DRAFT: March 24, 1995 2 l
l at I cm, 0, - initial activity of the point source in millicuries, at the time of the release, 1, - 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 ths NCRP equation (Equation 1) in the following manner to calculate the activities at which patients may be relcared.
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 d '"""') is set equal to 1.
e 11 is assumed that I roentgen is equal to I rem.
e The doses are calculated using the physical half-life of the radionuclides as listed in Appendix A and do not account for the biological half-life of the radionuclide, e The gamma ray constants and half-lives for typical radionuclides used in ;uclear medicine and brachytherapy procedures are given in Appendix A.
- For radionuclides with half-lives greater than 1 day, it is assumed that the individual likely to receive the highest dose from exposure to the patient would receive a dose of 25 percent of the 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 maximal likely exposure is a judgement based on time-distance combinations believed to occur when instructions to spend as little time as possible near the patient are given.
DRAFT: March 24, 1995 3 i
e for radionucl.Jes with half-lives less than 1 day, the factor 1.0 is used in Equation 3 because the assumption that W time that individual! will spend near the patient will be limited is not valid when most of the dose is delivered in a relat1vely short time.
Thus, for radionuclides with a half-life grt ater than 1 day:
34.6rQ,T, (0.25)
D(m) = (Equation 2; (100 cm)'
For radionuclides with a half-life less than 1 day;
- 34. 6rQ,T, D(m) = *
(Equation 3)
(100 cm)*
Equations 2 and 3 calculate the dose from external exposure to gamma radiation. The equations do not account for internal intake by household members and members of the public because the dose from intake by other individuals is normally expected to be small (less than a few percent) relative to the gamma dose (see Appendix u, Section 3.2). Further, the equations above do not apply to the relet.se of breast-feeding mothers if they continue to breast-feed. There could be a significant exposure to a breast-fed child.
C. REGULATORY POSITION
- 1. ACTIVITY LEVELS 1.1 Activities for Release of Patients (Who Are Not Breast-Feeding Women)
Licensees may demonstrate compliance with the dose limit in Section 35.75 for release of patients (who are not breast-feeding women) from licensee control if the amount of the specific radionuclide in the patient's body at the time of release is less than the value in Column 1 of Table 1 or if the dose rate at 1 meter (from the patient centerline) is less than the value in Column 2 of Table 1 for that radionuclide.
DRAFT: March 24, 1995 4 i
l The radionuclides currently cstd in medical diagnosis and treatment deliver the majority of their dose through an external dose pathway (e.g., radiation from the patient's body that exposes someone standing nearby). If a radionuclide is, for example, a beta emitter, other pathways of exposure may need to be considered. The values in lable 1 do not take these other pathways into account, and licensees should refer to Regulatory Position 1.4 for further information.
1.2 Activities for Release of Women Who Will be Breast-Feedina af ter Release If radioactive materials are to be administered to a mother who is currently breast-feeding, several alternatives are available. First, the licensee may determine that the quantity and type of radionuclido administered is not likely to result in a dose to a breast-fed infant exceeding 5 millisieverts (0.5 rem); this is unlikely to be the case for most administrations of radioiodine. A second alternative is for the mother to stop breast-feeding the infant for a predetermined period of time. A third alternative is to postpone the administration until the mother has stopped breast-feeding. References on the transfer of drugs and other chemicals into human milk and the cessation of breast-feeding after administration of radiopharmaceuticals to mothers can be used by licensues to determine whether it is necessary to stop breast-feeding.*
' L.K. Wagner, Editor, Radiation Bioeffects and Management Test and Syllabus, American College of Radiology, 1991.
- American Academy of Pediatrics, Committee on Drugs, " Transfer of Drugs and Other Chemicals into Human Milk," Pediatries, Volume 84, Number 5,1989.
- United States Pharmacopeial Drug Information, " Drug information for the Health Care Professional," Volume 1, 15th Edition, 1995.
DRAFT: March 24, 1995 5
\.. . . . . . . . .
Table 1 Activities and Dose Rates for Authorizing Patient Release and Giving Instructions Column l' Column 2' Column 3' Column 4' Activity Below Dose Rate at Activities Dose Rates Which Patients 1 meter at Requiring at 1 meter May Be Released Which Instructions Requiring Patients May Instructions Be Released Radio-nuclide mci GBq mrem /hr mci GBq mrem /hr summmmmmmmmme- - ummmmmmma summmmmmmmmmmmmes summmmmmmm ammmmmmma Ag-ll! _390!JO 14 14 8 J' 77 2.9 2 Au-198 93 3 / I.'l 21 19 0.69 4 Co-64 230 8.4 28 45 1.7 5 Ga-67 1-123 1-125 8.7 0.32 1 1.7 0.06 0.2 (implant) 1-131 33 / 1.2 7 6.5 0.24 1 In-ll! __
Pd-103 40 1.5 3 7.9 0.29 0.7 Re-185 780 29 16 160 5.8 3 Re-188 700 29 21 _160 5.9 , 4 St-47 300 11 17 60 2.2 3 Sn-153 660 25 30 130 4.9 6 Tc-99m 960 36 '58 190 7.1 11 T1-201 Yb-169 7.6 0.28 g 2 1.5 0.06 0.4
' Values have been rounded to two significant figures.
Most values have been rounded to the nearest whole number.
DRAFT: March 24, 1995 6
( p t,* *V * (,,'.
f Th.o.hq. ' f_
,p i rih n P "
j Table 2 04 '" ' " 4" #
rnite .'
Instructions for Breast-Feeding Women * -
y -
Cr wwrJ . .sW Radiopharmaceutical l' MoEmW #'os$6 D Mil 5n'g"tr/ Instructions " " " P "
mci / ri, irrJ ' "" "'),'2,"
t b
l-131, all therapeutic 5 - 150 / Mothe/ may no longer .nu administrations
/
/ breast-feed the child.
' No interruption of Xe-133 breast feeding 4, necessary.
(f
^
//
~
300' l1 h-cs. !o\.
- Table to be completed based on ORISE provided information, 1 Ai mar, cd;gM g n u rn o lf g c, a rn c , s i e , ,J ,
4 Y .lw m ,;fo m , ( T).a -f o o , yu ot1 lu; 14g he.d & dac r (6w)
- -/ I % ,. A c c , 3. . -, 4 c, m q,v ,';Ir9 4rdevet.ar r ,s lu t , a 0- 3% -
m o v, w- ~ se k e ,,{ . y l,, < Q ,, ,, ,
3 g , y,,x c a r,,B i ,,0 p
b~ du.s(r OI id(
- T 'b < ^- E#
l l1 t. 3v sa is 3efe( i*d *M 4
- e b s % u . ..'o ,
, p1lb.i) W 0,1 gm , 0..'
,n u i pf u w
^is t ec 5
<, o j,v' y
i v
,, . .h ,:-
(s/y m& o',I d
- o',n 3% f, . q)..
.-j t' ( riU^
- I d #}' C '
"#w"vid'"
7{,gRfhr[wGXhhC- X ,J(, - ), w red,ed bg s
20 6)*
K (o kr DRAFT: March 24, 1995 7 I 'A na rte
1.3 Activities _Requirinq Instructions Licensees may use thc values in Column 3 or Column 4 of Table 1 to determine when instructions should be given to patients. Column 3 provides activites 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 I meter, based on the activities in Column 3.
1.4 Calculations Based on Case-Spec'MlJdars 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 that may be relevant to the particular case.
Appendix B provides procedures for performing casa-specific dose calculations, and it describes how various factors may be considered in the calculations.
- 2. INSTRUCTIONS FOR PATIENTS TO BE RELEASED If the total effective dose equivalent to an individual exposed to a patient is likely to exceed 1 millisievert (0.1 rem), Section 35.75(b) requires that the released patient be given instructions on how to maintain doses to other individuals as low as reasonably achievable.
The instructions should be specific to the type of treatment given, such as permanent implants or radiciodine for hyperthyroidism or thyroid carcinoma, or they may include additional information for individual situations. The instructions should include a contact and phone number in case the patient has any questions. Instructions should include, as appropriate, the need for e Maintaining distance from individuals, including sleeping arrangements and avoiding public transportation, o Stopping breast-feeding if appropriate, DRAFT: March 24, 1995 8 l
e Avoiding public places (e.g., grocery stores, shopping centers, theaters, restaurants, and sporting events),
o Maintaining good hygiene, and e The length of time precautions should be taken.
Not all of these precautions are necessary for every patient; patients '
should be given specific instructions that are applicable to their particular situation.
The Society of Nuclear Medicine published a pamphlet in 1987 that provides information for patients receiving treatment with
- m w dine.'
o This pamphlet was prepared jointly by the Society of N. i.e Medicine and the NRC.
The NRC considers the instructions in this pamphies -
se acceptable instructicns for patients, provided specific informat,on is given to patients regarding any case-specific factors. However, licensees may develop their own instructions, addressing the items discussed in the above paragraph as appropriate.
Sample instructions for patients who have received permanent implants are given in Appendix C.
- 3. !LECORDS There is no recordkeeping requirement for patient releases based on Table 1. However, if the release of the patient is based on biological elimination rather than just the physical half-life of the radionuclide or an occupancy factor other than 0.25 at one meter, or includes consideration of the attenuation of radiation by body tissue Section 35.75(c) requires that the licensee maintain, for three years, a record of the released patient and the calculated total effective dose equivalent to another individual likely to receive the highest dose.
Records should include (1) the patient's name, (2) the radioactive material, (3) the administered activity, (4) the date and time of administration, (5) the date and time of release, (6) the case specific factors that were used in calculating the dose to the individual, and (7) the
' " Guidelines for Patients Receiving Radiciodine Treatment," Society of Nuclear Medicine, 1987. This pamphlet may be obtained from the Society of Nuclear Medicine, 136 Madison Avenue, New York, NY 10016-6760.
DRAFT: March 24, 1995 9 J
estimated dose to an individual exposed to the patient, in those instances for which a case-specific calculation applies to more than one patient release, the calculation need not be performed again.
D. IMptEMtNTATION The purpose of this section is to provide information about the NRC staff's plans for using this regulatory guide.
Except in those cases in which a licensee uses an acceptable alternative method for complying with 10 CFR i 35.75, the method described in this guide will be used in the evaluation of a licensee's compliance with Section 35.75.
( =
DRAFT: March 24, 1995 10
I APPENDIX A Table A-1. Half-Lives and Exposure Rate Constants of Commonly Administered Radionuclides Hal f- Exposure Hal f- Exposure Radio- Life Rate Constant Radio- Life Rate Constant nuclide (days)' (R cm'/ mci h) nuclide (days)' (R cm'/ mci h)
Ag-lll 7.45 0.2' O.)I Re-186 3.777 0.2' Au-198 2.69b 2.3' LN Re-183 0.7075 0,26' Cu-64 0.529 1.2' s. Sc-47 3.341 .56' ta-67 3.261 Sm-153 1.04 0.447' l-123 0.55 Sr-89 50.6 NA' l-125 60,1 Tc-99m 0.250 0.607' (implants) 1.11' T1-201 3.05 1-131 8.040 2.2' Yb-169 32.02 2.38' In-lll 2.807 _
Pd-103 16.97 0.86' '
' Table of Radioactive isotopes, Edgardo Browne and Richard B. Firestone, John b Wiley & Sons, New York, 1986.
- The exposure rate factor includes gamma rays and x rays with an energy above 11.3 kev. The 11.3 kev cutoff is the one used in NCRP Report No, 41,
" Specification of Gamma-Ray Brachytherapy Sources," 1974. The exposure rate was calculated from the following equation:
p mR em: = 1. 33 2 x 10" dis 1 mci hr E f,xE,MeVx mcihr 4 x (100 cm) a f(I' V a . , cm " g mR .s era p g cm -3 87.6 erg Me\'
f('
where: E, - the energy of the gamma ray or x ray i in Mev, f, = the number of gamma rays or x rays with energy E, per disintegration. Values for E, and f, were taken from
- 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.
DRAFT: March 24, 1995 11
i pa the density of air at standard temperature and pressure, taken to be 0.0012929 g/cm'.
( ' R. Nath, A.S. Meigoon , and J. A. Meli,
- Dosimetry on Transverse Axes of '"1 d
and '"Ir Interstitial Brachytherapy Sources," Medical Ph_ysics, Volume 17, Number 6, November / December 1992. The exposure rate constant given is a measured value takes into account the attenuation of gamma rays within the implant capsule itself.
- Ravinder Nath. Yale University School of Medicine, letter to Dr. V. Hans Bohling 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.
- D.E. Barber, J.W. Baum, anJ C.B. Meinhold, " Radiation Safety Issues Related to Radiolabeled Antibodies," NUREG/CR-4444 (BNL-NUREG-52275), NRC, March 1991.
- Calculated by Radiation Internal Dose Information Center, Oak Ridge Associated Universities,-Oak Ridge, Tennessee.
- Not applicable (NA), 0.91 MeV gamma (0.009%, with Y-89m).
' H.E. Johns and J.R. Cunningham, The Physics of Radiolony, Third Edition, Charles C. Thomas Publisher, 1978.
- 5. Schneider et al., " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material," NUREG-1492 (Final report), NRC, 1995.
DRAFT: March 24, 1995 12
APFENDIX B PROCEDURES FOR CALCVLATING DO5ES BASED ON CASE-SPECIFIC FACTORS There may be situations in which a licensee may release a patient with an activity higher than the values listed in Table 1 for a specific radionuclido. Licensees may calculate potential doses to individuals exposed to patients receiving treatment with radioactive material on a case-by-case basis to account for certain factors specific to an individual. Such factors include (1) the effective half-life of the radioactive material, (2) exposure factors, and (3) other factors that may be relevant to the particular case.
Section 35.75 requires that a record of the release of the patient and the evaluation of the dose to an individual likely to receive the highest dose from a patient be maintained if the release of the patient is based on biological elimination rather than just the physical half-life of the radionuclide or an occupancy factor other than 0.25 at one meter, or includes consideration of the attenuation of radiation by body tissue The following equation may be used to calculate doses based on case-specific factors:
34.6rQoi,E D(t) = (Equation B-1)
(r)*
Where D(t) = dose.to total decay, F= specific gamma-ray constant, Q, - initial activity at the start of the time interval, 4 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 DRAFT: March 24, 1995 13 i
A licensee may take into account the effective half-life of the
]
radioactive material to demonstrate compliance with the dose limits to members of the public stated in Section 35.75. The effective half-life is defined as:
T, x T, T,,, = -(Equation B-2)
T, + T, I Where T, - biological half-life of the radionuclide, T, = physical half-life of the radionuclide.
Using the effective half-life, Equation 0-1 becomes:
34.6rQoT,,E D(t) = (Equation B-3) with the factors defined as above and 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, and F,, respectively) can be calculated with the following equations:
T .,, -
i (Equation B-4)
T , + T, T ,, , , = (Equation B-5)
T., + T, Where T,, = biological half-life for extrathyroidal iodide, T , = biological half-life of iodide following uptake by the thyroid, T, - phyr.ical half-life of iodine-131.
DRAFT: March 24, 1995- 14
Example: Calculate the maximum likely dose to an individual exposed to a patient who has been administered 100 mil 11 curies (3,700 megabecquerels) of iodine-131 for the treatment of thyroid cancer. The occupancy factor is 0,25 at one meter.
Solution: In this example, we will account for elimination of iodine-131 from the body by using the biological half-lives appropriate for thyroid cancer to calculate the dose. It will be necessary to consider the different biological half-lives for thyroidal and extrathyroidal iodine. The following assumptions are made in this example:
Physical _ half-life of lodine-131, T, , ............. 8.0 days Extrathyroidal fraction, f 3 . . . . , , . . . . . , . . . . . . . . . . 0.9 Biological half-life of extrathyroidal fraction, i n ,,..... 0.33 day Effective half-life of extrathyroidal fraction, T ,,, 3
. . . . . . . 0.3 day Thyroidal fraction, F, . . . . . . . . . . . . . . . . . . . . . . . . 0.1 Biological half-life of thyroidal fraction, T,, . . . . . . . . . . 80 days Effective half-life of thyroidal fraction, T,,,, . . . . . . . . . . 7.3 days Spec i fi c gamma ray con s t an t , F . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. 2 R cm'/mC i h The total dose comprises the doses from the extrathyroidal and thyroidal fractions. The equation is:
- 4.6 r F Qo T ,,, (0. 25) (1-e'"'"""'*")
3 3 D(t) = ,
+ (Equation B-6) 3 4. 6 i f,0,T,,,, ( 0. 2 5 ) ( 1-e*"""")
(100 cm)'
Substituting the values from above, the dose to total decay is 34.6(2.2R.cm'/ mci h)(0,9)(100 mci)(0.3d)(0.25)
(100 cm)'
34.6(2.2R cm'/ mci h)(0,1)(100 mci)(7.3d)(0.25)
(100 cm)*
DRAFT: March 24, 1995 15
O 0(w) - 0.051 + 0.139 D(m) = 0.19 rem (1.9 mSv)
Therefore, thyroid cancer patients administered 100 millicuries (3,700 megabecquerols) of iodine-131 or less would not have to remain under licensee control and could be released under Section 35.75, assuming that there is documentation of the validity of the foregoing assumptions in the individual patient's case and that the patient is given instructions, in the example above, the thyroidal fraction, F, 1, 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.
- 2. EXp0SURE FACTOR The distance and the time that other individuals will spend in the proximity of the patient may occasionally be taken into account when determining the dose to an individual. If the patient is living alone, will have few if any visits by family or friends, will not be returning to work immediately, and will be generally isolated from other people, the exposure factor can be decreased by a factor of two (for example, from the general value of 0.25 to 0.125). This would allow an individual to be 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 will have to be increased to account for the increased exposure of the individual caring for the patient.
If this option is used in calculating the dose, the licensee should state in the record why a lower exposure factor was justified.
Example; Calculate the maximum likely dose to an individual exposed to a patient who has received 10 mil 11 curies (370 megabecquerels) of iodine-131.
-The patient lives alone and will not be working.
ORAFT: March 24, 1995 16
O-
[ -Solution: The dose -is calculated using Equation B-1:
- 34. 6rQ,T,E D(t) =
(r)'
Since the patient lives alone and will not be returning to work. and therefore will not be around the public, the exposure factor can be reduced to 0.125:
D(t) = (34.6) (2.22R cm*/ mci hr) (10 mci)(8.05d)(0.125)
(100 cm)'
D= 0.077 rem (0.77 mSv)
'Since the dose is less than 1 mil 11 sievert (0.1 rem), the patient may be released and instructions to the patient.are not required. Because the administered activity would indicate instructions and a record to be maintained based on the values in Table 1, it is recommended that a record of
-the calculation be maintained to ensure compliance with the dose limits in Section 35.75.
Examples -Calculate the maximum likely dose to an individual-exposed to a patient who has received 10 millicuries (370 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 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:
0 < (34.6) (2.2R cm'/ mci hr) (10 mC1)(8.05d)(0,5)-
(100 cm)'
D= 0.304 rem (3.04 mov)
[ DRAFT: March'24, 1995 17
I i
Sincc the dose exceeds 1 millisie.*ert (0.1 rem), tl.e licensee must !
provide the patient with written instructions, and a record of the released !
patient is required.
l
- 3. OTHER FACTORS 3.1 Attenuation of the Radiation in the Body Licensees may take into account attenuation of the radt tion by the patient. The fraction of the dose that results after attenuation by the body may be calculated using the following equation:
0- Doe "" (Equation B-8)
+
Where D dose after attenuation, j D, = dose before attenuation.
linear attenuation coefficient of tissue, x thickness of tissue covering the implant.
Also, the dose before attenuation is, from Equation 2 in the guide:
34.6rQ,T, (0.25)
D, - (Equation B-9)
(100 cm)'
Substituting Equation B-9 for D, in Equation B-8, the dose after attenuation becomes 34.6rQoT, (0.25)(e'"')
D - (Equation B-10)
(100 cm)*
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:
r 1.11 R<m*/ mci hr, T, - 60.2 days,
= 0.387/cm (Ref. B-1),-
DRAFT: March 24, 1995 18 l
l
. = - -- , . .- . . . . . _
W 5 liVLs - 9 cm (assume 5 Half Value Layei s, !
1 Italf 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 Rtm'/ mci h for iodine 425 already accounts for the reduction in exposure rate from attenuation by the source capsule.
Based on empirical assessment involving patients with implants, tissue shielding for iodine-125 is likely to exceed 5 or more half-value layers (Reference B-1). r Solution: The dose is calculated using Equation B-10:
0- 34.6(1. llR cm*/ mci hr)(60 mci)(60.2d)(0.25)(e"* "'"*"' "')
(100 cm)'
D- 107 rem (1.065 mSv)
Therefore, a patient who has received a permanent implant of 60 mil 11 curies (2,220 megabecquerels) of iodine-125 may still be authorized for release. The licensee must provide the patient with instructions and maintain a record that documents the validity of the foregoing assumptions in the individual patient's case.
3.2 Internal Dose Internal dose may be a consideration with certain radiopharmaceuticals now being developed, such as radiolabeled antibodies, or those that are developed in the future. Many of the radionuclides used in radiolabeled antibodies are predominantly beta or alpha emitters, which emit few gammas.
One way of evaluating the internal dose is to compare the internal dose with the annual limit on intake (All) value in 10 CFR Part 20. A rule of thumb is to assume that the individual likely to receive the highest dose from exposure to the patient will receive an internal dose of 1-millionth of the activity that is in the patient. This rule of thumb was developed in Reference B-2 for cases of worker intakes during normal workplace onerations, worker intakes from accidental exposures, and public intakes from accidental DRAFT: March 24, 1995 19
o airborne releases from a facility, but it does not specifically apply for cases of intake by an individual exposed to a patient. However, two studies (Refs. B-3 and B-4) reg'.rding the intakes of individuals exposed to patients administered iodine-131 indicated that internal doses are negligible compared to external doses and that intakes were of the magnitude of one 1-millionth of the quantity in the patient. for additional discussion on the subject, see Reference B-1.
Thus, a rough estimate of the effective dose equivalent can be calculated from the following equation:
"*S 0, = .
(Equation B-ll)
All Where D, = the internal effective dose equivalent to the individual exposed to the patient in rems, Q = the activity in the patient at time of release in microcuries.
All the occupational inhalation annual limit on intake from Appendix B of Part 20, 5 rems = the dose from an intake of one All, 10 = the assumed fractional intake, for example, assume that 30 mil 11 curies (30,000 microcuries) iodine-131 was administered to a patient, if 1-millionth of the administered activity is taken in by another individual, the activity would be 0.03 microcuries. The stochastic All for iodine-131, 200 microcuries, corresponds to an effective dose equivalent of 50 millisieverts (5 rems). Thus, the individual would receive a dose of about 75 microsieverts (0.75 millirem). In this case, the internal dose would be considerably less than 1 percent of the assumed 5 millisieverts (0.5 rem) external gamma dose. Internal doses may be ignored in the calculations if they are likely to be less than 10 percent of the external dose since they would be significantly less than the uncertainty in the external dose.
DRAFT: March 24, 1995 20 V
O o
REFERENCE 5 FOR APPENDIX B B-1. S. Schneider et al., " Regulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material," NVREG-1492 (Final report).
NRC, 1995.*
B-2. A. Brodsky, 'Resuspension Factors and Probabilities of Intake of Material in Process (Or 'Is 10 a Magic Number in Health Physics?'),"
llealth Physics, Volume 39, Number 6, 1980.
B-3. R.C.T. Buchanan and J.M. Brindle, "Radiciodine 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 Environnent by Patients Treated with lodine-131," American Journal of Public Health, Volume 68, Number 3. 1978.
- Requests for single copies of drafts should be made in writing to the U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
Distribution and Mail Services Section. Requests for drafts will be filled as long as supplies last._ Copies of drafts are also available for inspection and copying for a fee from the NRC Public Document Room at 2120 L Street NW, (Lower 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:- March-24, 1995 21
s o
APP [NDiX C SAMPLE INSTRUC110NS FOR PAllENTS RECEIVING PERMANENT IMPLANTS A small radioactive source has been placed (implanted) inside your body. The source is actually many small metallic pellets or seeds, which are about 1/3 to 1/4 of an inch long, similar in size and shape to a grain of rice. To minimize exposure to radiation to others from the source inside your body and to yourself if the source f alls out or comes out, yuu should do the following:
o $tay at a distance of feet from for days / weeks.
e Minimize time with children and pregnant women for days / weeks.
- Do not hold or cuddle children for days / weeks.
e Avoid public transportation for days / weeks.
e Examine any bandages or linens that come into contact with the implant site for any pellets or seeds that may have come out of the implant site.
- 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 container that you an close with a lid.
- Place the container with the seed / pellet in a location away from people, e Notify , at 1 phone number) for further instructions as soon as possible, if you have any questions, contact the following individual (s):
Name __ Phone number Beeper number Name Phone number Beeper number DRAFT: March 24, 1995 B-1 j