[Federal Register Volume 62, Number 19 (Wednesday, January 29, 1997)]
[Rules and Regulations]
[Pages 4120-4133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2166]


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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.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations concerning the criteria for the release of patients 
administered radioactive material. The new criteria for patient release 
are based on the potential dose to other individuals exposed to the 
patient. The new criteria are consistent with the recommendations of 
the National Council on Radiation Protection and Measurements (NCRP) 
and the International Commission on Radiological Protection (ICRP). 
This final rule requires the licensee to provide written instructions 
to patients on how to maintain the doses to others as low as is 
reasonably achievable if the total effective dose equivalent to any 
other individual exposed to the released patient is likely to exceed 1 
millisievert (0.1 rem). This final rule responds to three petitions for 
rulemaking regarding the criteria for release of patients administered 
radioactive material.

EFFECTIVE DATE: May 29, 1997.

ADDRESSES: Copies of Regulatory Guide 8.39, ``Release of Patients 
Administered Radioactive Materials''; the final regulatory analysis, 
NUREG-1492, ``Regulatory Analysis on Criteria for the Release of 
Patients Administered Radioactive Material'' (1997); Revision 2 of 
NUREG/BR-0058, ``Regulatory Analysis Guidelines of the U.S. Nuclear 
Regulatory Commission'' (1996); and the public comments received on the 
proposed rule may be examined and copied for a fee in the Commission's 
Public Document Room at 2120 L Street NW. (Lower Level), Washington, 
DC. Single copies of Regulatory Guide 8.39 may be obtained free of 
charge by writing the Office of Administration, Attn: Distribution and 
Services Section, USNRC, Washington, DC 20555, or by fax at (301) 415-
2260. Single copies of NUREG-1492 and NUREG/BR-0058 may be purchased at 
current rates from the U.S. Government Printing Office, P.O. Box 37082, 
Washington, DC 20402-9328 (telephone (202) 512-1800); or from the 
National Technical Information Service at 5285 Port Royal Road, 
Springfield, VA 22161.

FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear 
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 
20555, telephone (301) 415-6225.

I. Background

    Each year in the United States, radioactive pharmaceuticals or 
compounds or radioactive implants are administered to approximately 8 
to 9 million individuals for the diagnosis or treatment of disease or 
for human research. These individuals to whom radioactive materials 
have been administered are hereinafter referred to as ``patients.'' 
These patients can expose others around them to radiation until the 
radioactive material has been excreted from their bodies or the 
radioactivity has decayed away.
    NRC's current patient release criteria in 10 CFR 35.75, ``Release 
of patients or human research subjects containing radiopharmaceuticals 
or permanent implants,'' are as follows:
    ``(a) A licensee may not authorize release from confinement for 
medical care any patient or human research subject administered a 
radiopharmaceutical until either: (1) The measured dose rate from the 
patient or human research subject is less than 5 millirems per hour at 
a distance of 1 meter; or (2) The activity in the patient or human 
research subject is less than 30 millicuries; (b) A licensee may not 
authorize release from confinement for medical care of any patient or 
human research subject administered a permanent implant until the 
measured dose rate from the patient or human research subject is less 
than 5 millirems per hour at a distance of 1 meter.''
    On May 21, 1991 (56 FR 23360), the NRC published a final rule that 
amended 10 CFR part 20, ``Standards for Protection Against Radiation.'' 
The rule contained limits on the radiation dose for members of the 
public in 10 CFR 20.1301. However, when 10 CFR part 20 was issued, 
there was no discussion in the supplementary information on whether or 
how the provisions of 10 CFR 20.1301 were intended to apply to the 
release of patients.
    Some licensees were uncertain about what effect the revised 10 CFR 
part 20 would have on patient release criteria, and two petitions for 
rulemaking were received on the issue. On June 12, 1991 (56 FR 26945), 
the NRC published in the Federal Register a notice of receipt of, and 
request for comment on, a petition for rulemaking (PRM-20-20) from Dr. 
Carol S. Marcus. In addition, Dr. Marcus submitted a letter dated June 
12, 1992, further characterizing her position.

[[Page 4121]]

    On March 9, 1992 (57 FR 8282), the NRC published a notice of 
receipt and request for comment in the Federal Register on another 
petition for rulemaking (PRM-35-10) on patient release criteria from 
the American College of Nuclear Medicine (ACNM). On May 18, 1992 (57 FR 
21043), the NRC published in the Federal Register notice of an 
amendment submitted by the ACNM to its original petition (PRM-35-10A).
    In addition, a third petition (PRM-35-11) dealing, in part, with 
these same issues was submitted by the American Medical Association 
(AMA). That petition was noticed in the Federal Register on July 26, 
1994 (59 FR 37950). The main point raised in the petition was that the 
radiation dose limits in 10 CFR part 20 should not apply to individuals 
exposed to the patient and that the dose limit to the individuals 
should be 500 millirems per year. The AMA believed that 10 CFR 20.1301 
would have an adverse impact on the availability and the cost of 
treatment of thyroid disease, which would outweigh the advantages of 
reduced radiation exposure to the public. The AMA stated that treatment 
of up to 10,000 cancer patients annually for thyroid carcinoma would 
require the hospitalization of the patients under the revised 
regulation (10 CFR 20.1301), reducing both early release of patients 
and the treatment of patients at home.

II. Publication of the Proposed Rule

    On June 15, 1994 (59 FR 30724), in response to the first two 
petitions, the NRC published a proposed rule on criteria for the 
release of patients administered radioactive material. The proposed 
rule discussed the public comment letters received on the first two 
petitions. Three additional comment letters were received on the third 
petition (PRM-35-11). These letters each supported the petition but did 
not contain any additional information not covered by the letters on 
the first two petitions.
    The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically 
state that the dose to individual members of the public from a licensed 
operation does not include doses received by individuals exposed to 
patients who were released by the licensed operation under the 
provisions of 10 CFR 35.75. This was to clarify that the Commission's 
policy is that patient release is governed by 10 CFR 35.75, not 10 CFR 
20.1301.
    The NRC proposed to amend 10 CFR 20.1301(a)(2) to specifically 
state that the limit on dose in unrestricted areas does not include 
dose contributions from patients administered radioactive material and 
released in accordance with 10 CFR 35.75. The purpose was to clarify 
that licensees would not be required to control areas (such as waiting 
rooms) 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 would not be required to limit the 
radiation dose from a patient to members of the public (e.g., visitors 
in a waiting room) to 0.02 millisievert (2 millirems) in any 1 hour. 
Patient waiting rooms or hospital rooms would need only be controlled 
for those patients not meeting the release criteria in 10 CFR part 35.
    The NRC proposed to adopt a new 10 CFR 35.75(a) to change the 
patient release criteria from 1,110 megabecquerels (30 millicuries) of 
activity in a patient or a dose rate of 0.05 millisievert (5 millirems) 
per hour at 1 meter from a patient to a total effective dose equivalent 
not to exceed 5 millisieverts (0.5 rem) in any 1 year to an individual 
from exposure to a released patient. A dose-based limit provides a 
single limit that could be used to provide an equivalent level of risks 
from all radionuclides. Also, the proposed changes were supported by 
the recommendations of the ICRP and the NCRP that an individual could 
be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in 
temporary situations when exposure to radiation is not expected to 
result in annual doses above 1 millisievert (0.1 rem) for long periods 
of time.
    The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that 
the licensee provide released patients with written instructions on how 
to maintain doses to other individuals as low as is reasonably 
achievable if the total effective dose equivalent to any individual 
other than the released patient is likely to exceed 1 millisievert (0.1 
rem) in any 1 year. A requirement to give instructions to certain 
patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), 
but the proposed requirement would also require instructions for an 
additional 50,000 individuals who are administered iodine-131 for the 
treatment of hyperthyroidism and another 27,000 individuals who are 
breast-feeding and administered various diagnostic and therapeutic 
radioactive materials. The purpose of the instructions is to maintain 
doses to individuals exposed to patients as low as is reasonably 
achievable.
    The NRC proposed to adopt a new 10 CFR 35.75(b)(2) to require that 
licensees maintain, for 3 years, a record of the released patient and 
the calculated total effective dose equivalent to the individual likely 
to receive the highest dose if the total effective dose equivalent to 
any individual other than the released patient is likely to exceed 1 
millisievert (0.1 rem) in a year from a single administration. The 
major purpose was to provide a record to allow licensees to assess the 
need to limit the dose to individuals exposed to a patient who may 
receive more than one administration in a year.
    Finally, the NRC proposed to amend its requirements on instructions 
in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already 
required instructions (not necessarily written) in certain cases, but 
the phrase ``if required by Sec. 35.75(b)'' was added to each. The 
purpose of this change was to make part 35 consistent as to when 
instructions must be given.
    In addition, the NRC concurrently issued an associated draft 
regulatory guide and supporting draft regulatory analysis for public 
comment. The draft regulatory guide, DG-8015, ``Release of Patients 
Administered Radioactive Materials,'' proposed guidance on determining 
the potential doses to an individual likely to receive the highest dose 
from exposure to a patient and established appropriate activities and 
dose rates for release of a patient. The draft guide also proposed 
guidelines on instructions for patients on how to maintain doses to 
other individuals as low as is reasonably achievable and it described 
recordkeeping requirements. The draft regulatory analysis, NUREG-1492, 
``Regulatory Analysis on Criteria for the Release of Patients 
Administered Radioactive Material'' (May 1994), examined the benefits 
and impacts of the proposed rule considered by the NRC.

III. Public Comments on the Proposed Rule

    A total of 63 comment letters were received on the proposed rule, 
the draft regulatory guide, and the draft regulatory analysis. A 
majority of the comment letters were from medical practitioners and 
medical organizations, but there were also comment letters from private 
individuals, public-interest groups, and regulatory agencies in 
Agreement States. Overall, the majority of comment letters supported a 
dose limit of 5 millisieverts (0.5 rem) for individuals exposed to 
patients released with radioactive material. However, about one-fourth 
of the comment letters opposed the proposed recordkeeping requirement. 
The significant comments are discussed below, arranged by subject.

[[Page 4122]]

Exclusion of Patient Release From Sec. 20.1301(a)

    All the commenters except one supported governing patient release 
by the regulations in 10 CFR 35.75 and excluding the dose to 
individuals exposed to a released patient from 10 CFR 20.1301(a).
    Comment. One commenter, representing a public-interest group, 
objected to any exposure of a member of the general public who has not 
consented freely to the dosage. They said that such exposure would lead 
to widespread morbidity and mortality.
    Response. In its revision of 10 CFR part 20 (56 FR 23360; May 21, 
1991), the NRC determined that, while doses should be maintained as low 
as is reasonably achievable, a dose limit of 1 millisievert (0.1 rem), 
or a dose limit of 5 millisieverts (0.5 rem) in certain special 
circumstances, provides adequate protection. The revised part 20 is 
based, in part, upon the recommendations of the International 
Commission on Radiological Protection (ICRP) and the recommendations of 
the National Council on Radiation Protection and Measurements (NCRP). 
The NCRP recommends public dose limits of 1 millisievert (0.1 rem) for 
continuous or frequent exposure and 5 millisieverts (0.5 rem) for 
infrequent exposure.
    The ICRP recommends that the limit for public exposure should be 
expressed as an effective dose of 1 millisievert (0.1 rem) in a year, 
except that, in special circumstances, the dose could be higher in a 
single year provided the average over 5 years does not exceed 1 
millisievert (0.1 rem) per year. In ICRP Publication 60, in defining 
medical exposure, ICRP stated that medical exposure includes 
``exposures (other than occupational) incurred knowingly and willingly 
by individuals helping in the support and comfort of patients 
undergoing diagnosis or treatment.'' Furthermore, in explaining dose 
limits in medical exposure, the ICRP stated in the same publication 
that ``the Commission therefore recommends that dose limits should not 
be applied to medical exposures.'' Thus, in ICRP's opinion, family 
members who are helping in the support and comfort of patients would 
not be restricted under the dose limit stated above.
    The revision of part 20 incorporated the long-term objective as the 
dose limit and included a provision (Sec. 20.1301(c)) to allow for 
alternative limits on an occasional basis. Section 20.1301(c) provides 
that an annual dose of up to 5 millisieverts (0.5 rem) is acceptable if 
there is a need for it and if steps are taken to reduce the dose to as 
low as is reasonably achievable. The NRC reaffirms that previous 
determination in this rulemaking.
    In the case of released patients, it would be unlikely for a single 
individual exposed to a patient to receive a dose in a year of over 5 
millisieverts (0.5 rem) because large therapeutic doses (greater than 
3,700 megabecquerels (100 millicuries)) are usually not administered 
more than once to the same patient in a given year.
    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 general public dose limit is outside 
the scope of this rulemaking. The issue was dealt with when 10 CFR part 
20 was recently revised (56 FR 23360; May 21, 1991). That rulemaking 
explained the NRC's rationale for adopting the 1-millisievert (0.1-rem) 
dose limit in 10 CFR 20.1301(a)(1).

Activity-Based vs. Dose-Based Release Limit

    The issue is whether to retain the current patient release limit in 
10 CFR 35.75, which is expressed as an activity limit together with an 
alternative but approximately equivalent limit on dose rate at 1 meter, 
or to express the release limit as a dose to an individual exposed to 
the patient. The majority of commenters supported the dose-based limit. 
However, some commenters opposed the dose-based approach.
    Comment. A number of commenters said that 10 CFR 35.75 should not 
be changed and that the 30 millicurie or 5 millirem per hour release 
criteria should be retained because they are working well. Some 
commenters said that a dose-based release limit as proposed would cause 
confusion and potential problems. One commenter said that the Part 20 
revision was not intended to alter the status quo for patient release. 
Commenters objected to the dose-based release limit because they 
thought the dose estimates to the public would be very inaccurate as 
these estimates are based on the unreliable method of predicting the 
anticipated time and proximity to others. Commenters also said that 
dose estimation and the subsequent recordkeeping would be time 
consuming and would add to the cost of treatment without a probable 
significant decrease in radiation exposure.
    Response. The NRC is adopting a dose-based limit rather than an 
activity-based limit because the dose-based limit better expresses the 
NRC's primary concern for the public's health and safety. A single 
activity requirement was not retained because different radionuclides 
with the same activity can give very different doses under identical 
exposure conditions. Likewise, a single dose rate requirement for all 
radionuclides was not retained because different radionuclides with the 
same dose rate, at the time of release, can give very different doses 
depending upon the half-life of the radionuclide. The total dose 
depends on the effective half-life of the radioactive material in the 
body of the patient and other factors that vary for different 
materials. For these reasons, the NRC is establishing a dose limit 
rather than an activity or dose rate limit.
    The NRC is establishing a dose limit of 5 millisieverts (0.5 rem) 
total effective dose equivalent to an individual from exposure to the 
released patient for each patient release. This dose limit is 
consistent with the underlying risk basis of the current 10 CFR 35.75 
(50 FR 30627; July 26, 1985), the recommendations of the NCRP and the 
ICRP, and the provisions in 10 CFR 20.1301(c) pertaining to temporary 
situations in which there is justification for a dose limit higher than 
1 millisievert (0.1 rem).
    The NRC believes that the dose-based release limit can and will 
work well because the associated Regulatory Guide 8.39, ``Release of 
Patients Administered Radioactive Materials,'' can be used to relate 
the dose to the quantity of activity in the patient. The guide provides 
conservative estimates of activities for commonly used radionuclides 
and their corresponding dose rates with which a patient may be released 
in compliance with the dose limits in the final rule. The approach used 
in the regulatory guide is based on NCRP Report No. 37, ``Precautions 
in the Management of Patients Who Have Received Therapeutic Amounts of 
Radionuclides.'' 1 In the case of iodine-131, the most significant 
radionuclide, the release quantity based on the standard conservative 
assumptions is 1.2 gigabecquerels (33 millicuries), which is 
essentially the same as the current release quantity.
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    \1\ 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.)
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    NUREG-1492 contains a detailed examination of the benefits and 
impacts of the final rule that includes dose

[[Page 4123]]

estimation, recordkeeping, and radiation exposure. Single copies of the 
final regulatory analysis and Regulatory Guide 8.39, ``Release of 
Patients Administered Radioactive Materials,'' are available as 
indicated in the ADDRESSES heading.
    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 be released 
based on default assumptions which do not require any personal 
information from the patient. A table of release quantities, based on 
standard conservative assumptions, is provided in Regulatory Guide 
8.39, ``Release of Patients Administered Radioactive Materials.'' 
However, the rule does allow the physician to calculate patient-
specific dose estimates to allow early release of a patient not 
otherwise subject to release under the default values in Regulatory 
Guide 8.39.
    Comment. One commenter said that it should continue to be 
acceptable to release patients based on the dose rate at 1 meter.
    Response. The rule authorizes release of patients based on the dose 
to an individual for each patient release. However, release quantities 
based on dose rate and conservative assumptions can be calculated. The 
table of release quantities in Regulatory Guide 8.39, ``Release of 
Patients Administered Radioactive Materials,'' specifies the dose rate 
at 1 meter of commonly used radionuclides that allow licensees to 
authorize patient release.

Release Quantities

    Using a dose-based system based on a dose to the most highly 
exposed individual of 5 millisieverts (0.5 rem) would, in some 
circumstances, allow release of a patient with more than 1,110 
megabecquerels (30 millicuries) of activity. Some commenters were 
opposed to allowing releases with higher activities than are now 
permitted.
    Comment. Several commenters said that the release of patients with 
more than 30 millicuries of iodine-131 should not be permitted because 
of concerns about the risk of internal exposure. One commenter said 
that doses to family members from the patient vomiting were not 
adequately considered. The same commenter also said that a study 
indicated that in-home contamination by patients dosed with I-131 could 
double family members' risk of developing thyroid cancer.
    Response. The concern over contamination is not justified by the 
radiation doses that are likely to be caused by the removal of 
radionuclides from the patient's body by the pathways of exhaled air, 
feces, saliva, sweat, urine, and vomit. Measurements from several 
studies, as discussed in the supporting regulatory analysis, have shown 
that a relatively small proportion of the radioactive material 
administered will appear as contamination. Doses to family members 
exposed to contamination from living in close contact with released 
patients have been measured in several studies and in every case were 
less than 10 percent of the 5-millisievert (0.5-rem) total effective 
dose equivalent limit and were most often less than 1 percent of the 5-
millisievert (0.5-rem) limit. In addition, the internal doses resulting 
from contamination were always less and generally far less than the 
external dose, meaning that contamination was the less important source 
of radiation exposure. These measurements show that even if the family 
members repeatedly touched household items touched by the patient, 
contamination does not cause unacceptably high doses. These findings 
were true even in the case of a British study where eleven patients 
volunteered to disregard special precautions against contamination and 
minimizing spousal and family exposure. These measurements are 
discussed in NUREG-1492. Also, the NCRP recently addressed the risk of 
intake of radionuclides from patients' secretions and excreta in NCRP 
Commentary No. 11, ``Dose Limits for Individuals Who Receive Exposure 
from Radionuclide Therapy Patients,'' and concluded that, ``* * * a 
contamination incident that could lead to a significant intake of 
radioactive material is very unlikely.'' 2
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    \2\ National Council on Radiation Protection and Measurements, 
``Dose Limits for Individuals Who Receive Exposure from Radionuclide 
Therapy Patients,'' NCRP Commentary No. 11 (February 28, 1995). 
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, 
Bethesda, MD 20814-3095.)
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    In general, the physical reactions (e.g., vomiting) that a patient 
may experience from the administration of any radiopharmaceutical are 
rare. Vomiting is seldom an important elimination route for 
radiopharmaceuticals after the patient has left the medical facility 
since orally administered radiopharmaceuticals such as iodine-131 are 
rapidly absorbed, within a half hour, by the gastrointestinal system.
    Regarding the comment on the doubling of risk of developing thyroid 
cancer, there is no scientific consensus by the United Nations 
Scientific Committee on the Effects of Atomic Radiation, ICRP, or NCRP 
to support the suggested increased risk of thyroid cancer following 
ingestion of iodine-131. Based on the information currently available, 
the Commission continues to conclude that the benefits outweigh the 
potential of small increased risks associated with this rule.
    Comment. One commenter noted that hospitals now make great efforts 
to control contamination from patients who are now hospitalized because 
they contain more than 30 millicuries of iodine-131. This commenter 
stated that it would not be possible to maintain the same level of 
contamination control at these patients' homes if these patients were 
released with more than 30 millicuries of iodine-131.
    Response. The NRC agrees that, even though released patients are 
given instructions on how to limit the hazard from contamination, 
contamination control in a hospital can be more effective than 
contamination control out of the hospital. However, the two situations 
are not really comparable. In the case of the released patient at home, 
therapeutic administrations usually occur no more than once in a year 
and probably no more than once in a lifetime; but in the case of a 
hospital, large therapeutic administrations are done repeatedly on many 
patients. Therefore, areas in hospitals have the potential for 
contamination from many patients, and people who frequent the hospital 
(e.g., clergy or a hospital orderly) have the potential to be exposed 
to contamination from many patients. In addition, the 5-millisievert 
(0.5-rem) limit that is applied to household members exposed to a 
patient is a special limit that is appropriate for only occasional use 
and for use where there is a definite need. This special limit fits the 
case of doses received by the household members of a released patient, 
but does not fit the case of people who frequent a hospital on a 
routine basis. Lastly, in limiting doses, the NRC considers what is 
reasonably achievable. The mere fact that a home cannot control 
contamination as well as a hospital does not mean that the 
contamination control achieved in homes is not adequate. Actual 
measurements of doses to household members from contamination, as 
discussed in NUREG-1492, show that the doses from contamination are 
low, demonstrating that the degree of contamination control that was 
achieved is adequate.

[[Page 4124]]

    Comment. One commenter said that the proposed rule did not 
adequately address the concerns that the Agreement States expressed on 
the petitions for rulemaking concerning releasing patients with 
quantities of iodine-131 in excess of 30 millicuries.
    Response. In commenting on the petitions, a number of States 
expressed concerns about releasing patients administered 14.8 
gigabecquerels (400 millicuries) of iodine-131, which one of the 
petitioners had requested. However, the States that commented were 
generally favorable to the proposed rule limiting the dose to the most 
exposed individual to 5 millisieverts (0.5 rem), and none of the States 
indicated that their concerns were misrepresented. In fact, one 
Agreement State commented that it was pleased that the NRC had 
considered the comments made by the Agreement States at various 
meetings with the NRC. The dose-based limit would generally permit 
releases if the dose to another individual would not be likely to 
exceed 5 millisieverts (0.5 rem). For example, if a licensee uses the 
default table of release quantities provided in the regulatory guide as 
the basis for release, a patient administered 1.2 gigabecquerels (33 
millicuries) or less of iodine-131 could be immediately released and no 
record of release is required. However, if the licensee wishes to 
release a patient with an activity that is greater than the value in 
the default table, the licensee must do a dose calculation using case-
specific factors to demonstrate compliance with the release criteria. 
Furthermore, if the table is used as the basis for release but the 
administered activity exceeds the value in the table, the licensee must 
hold the patient until the time at which the retained activity is no 
greater than the quantity in the table or the dose rate at 1 meter is 
no greater than the value in the table. When the administered activity 
is greater than the value in the default table, a record of the basis 
for the release must be maintained for NRC review during inspection. 
Regardless of the method used by the licensee to authorize release, the 
dose limit of 5 millisieverts (0.5 rem) in the revised 10 CFR 35.75 
applies. By identifying more than one method for calculating the 
release of a patient in accordance with 10 CFR 35.75, the NRC provides 
greater flexibility for licensees to achieve compliance with the new 
requirement while still providing adequate protection of public health 
and safety.
    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 the release might be 
beneficial and acceptable to family members. Another commenter said 
that a dose of 0.5 rem to an individual exposed to a patient has so 
little hazard that the NRC should not be concerned with it.
    Response. The NRC does not believe that individuals exposed to a 
patient should, in general, receive doses in excess of 5 millisieverts 
(0.5 rem). This is consistent with the recommendations of the ICRP in 
ICRP Publication 60, 3 ``1990 Recommendations of the International 
Commission on Radiological Protection''; and the recommendations of the 
NCRP in NCRP Report No. 116,4 ``Limitation of Exposure to Ionizing 
Radiation.'' Each of these recommendations provides a basis for 
allowing individuals to receive annual doses up to 5 millisieverts (0.5 
rem) under certain circumstances. Both the ICRP and the NCRP recommend 
that an individual can receive a dose up to 5 millisieverts (0.5 rem) 
in a given year in situations when exposure to radiation is not 
expected to result in doses above 1 millisievert (0.1 rem) per year for 
a long period of time, as would be the case for doses from released 
patients. In NCRP Commentary No. 11, ``Dose Limits for Individuals Who 
Receive Exposure from Radionuclide Therapy Patients,'' \2\ the NCRP 
recommended a dose limit of 5 millisieverts (0.5 rem) annually for 
members of the patient's family. However, on the recommendation of the 
treating physician, the NCRP considered it acceptable that members of 
the patient's family be permitted to receive doses as high as 50 
millisieverts (5 rems). The NRC does not agree that the latter NCRP 
recommendation should apply in general. The NRC believes that if the 
dose to another individual is likely to exceed 5 millisieverts (0.5 
rem), the patient should remain under the control of the licensee. 
Licensee control is necessary to provide adequate protection to the 
individuals exposed to the patient.
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    \3\ International Commission on Radiological Protection (ICRP), 
``1990 Recommendations of the International Commission on 
Radiological Protection,'' ICRP Publication No. 60 (November 1990). 
Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.
    \4\ National Council on Radiation Protection and Measurements, 
``Limitation of Exposure to Ionizing Radiation,'' NCRP Report No. 
116 (March 31, 1993). Available for sale from the NCRP, 7910 
Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.
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Recordkeeping

    The strongest opposition to the proposed rule was to the proposed 
requirement to maintain a record of the released patient and the 
calculated total effective dose equivalent to the individual likely to 
receive the highest dose if the dose to that person is likely to exceed 
1 millisievert (0.1 rem). Under the proposed rule, if a patient had or 
might have had one or more administrations within the same year, the 
licensee would use the records to determine the dose from the previous 
administrations so that the total dose to an individual exposed to a 
patient from all administrations would not exceed 5 millisieverts (0.5 
rem).
    Comment. Many commenters indicated that this requirement would 
cause excessive costs in time, effort, and money to track down records 
of previous administrations, to perform calculations, and to keep 
records of all the work and asked that the requirements to make 
calculations and keep records be removed. The commenters believed that 
the work would not produce an increased level of safety, that the NRC 
greatly underestimated the cost, and that the recordkeeping would be 
unnecessary, inappropriate, and impractical. Some commenters said that 
multiple administrations that would result in a total effective dose 
equivalent greater than 1 millisievert (0.1 rem) are not done to the 
same patient routinely. Other commenters said that there have been 
decades of experience unencumbered by any paperwork burden at all with 
no evidence that a lack of paperwork has resulted in any additional 
problems. One commenter said that if 0.5 rem is acceptably safe, why 
have the documentation required at the 0.1 rem level.
    Another commenter said that it cannot be a licensee's 
responsibility to know the details of a radionuclide therapy performed 
by another licensee in terms of which members of the public received 
the most radiation dose from that other licensee's therapy procedure.
    One commenter said that the excessive recordkeeping cost would be a 
nonreimbursable cost, and the burden will cause many physicians to stop 
offering iodine therapy, which would force patients to travel to large 
medical facilities in cities and cause problems with patient access in 
sparsely populated areas.
    Response. Upon reconsideration, the NRC has decided to delete the 
requirement to keep records when the dose to the most highly exposed 
individual is likely to exceed 1 millisievert (0.1 rem). The 
requirement was proposed so that it would be possible to account for 
the dose from multiple administrations in the same year to ensure that 
the total dose to an individual exposed to the patient did not exceed 5 
millisieverts (0.5 rem).

[[Page 4125]]

    The NRC has an advisory committee, the Advisory Committee on the 
Medical Uses of Isotopes, or ``ACMUI,'' which advises the NRC on 
rulemakings and other initiatives related to the medical use of 
byproduct materials. The NRC also has a visiting medical fellows 
program that recruits selected physicians or pharmacists to work for 
the NRC for a period of 1 to 2 years. Both the ACMUI and the current 
Visiting Medical Fellow, Myron Pollycove, M.D., provided advice to the 
NRC during the development of this rule. In addition, Barry A. Siegel, 
M.D., former Chairman of the ACMUI, reviewed the patient records at his 
medical facility for the 1-year period from July 1, 1993, to June 30, 
1994 (Mallinckrodt Institute of Radiology, St. Louis, Missouri). Drs. 
Siegel and Pollycove concluded that no common nuclear medicine 
practice, be it diagnostic, therapeutic, or a combination of the two, 
results in multiple large administrations that would be likely to cause 
the 5-millisievert (0.5-rem) dose limit to be exceeded because of 
multiple administrations in a year.
    While the proposed requirement to maintain a record of the dose to 
another individual if the dose is likely to exceed 1 millisievert (0.1 
rem) has been deleted, a recordkeeping requirement with a reduced 
impact has been retained as discussed under the heading, ``Discussion 
of Text of Final Rule.''
    Comment. Several commenters said that those who pay for health care 
will put great pressure on physicians to optimize calculations to 
reduce in-patient days and to justify out-patient treatments.
    Response. There is no objection to optimizing calculations to 
reduce in-patient days as long as the calculations are realistic and 
the 5-millisievert (0.5-rem) limit in 10 CFR 35.75 is met. Regulatory 
Guide 8.39, ``Release of Patients Administered Radioactive Materials,'' 
describes examples of calculations that are acceptable to the NRC.

Written Instructions To Patients

    In general, there was little objection to providing instructions to 
patients on how to minimize the dose to others, but there was 
significant opposition to the proposed requirement that the 
instructions would have to be written.
    Comment. One commenter said that the Statement of Considerations 
for the proposed rule was in error in stating that the existing 
regulations already required that the instructions to patients be 
written.
    Response. The commenter is correct. The Statement of Considerations 
was in error on that point. The existing regulations do not specify 
that instructions have to be in written form.
    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. One commenter said that 
the physical condition of the patient could lessen the patient's 
ability to follow the instructions. 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 strongly 
supported the requirement that the instructions be written.
    Response. The NRC believes that providing written instructions has 
a significant value because often patients will not remember all of the 
instructions given orally. In addition, written instructions can be 
read by other family members or care-givers. The requirement to provide 
the instructions in written form was also supported by the ACMUI.
    This regulation allows the licensee to determine the form of the 
written instructions. The NRC believes that for the majority of 
releases 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 Radioiodine Treatment,'' which can be given to patients at 
nominal cost (less than $1 per patient). However, oral instructions may 
also be provided in all cases.
    Comment. Several commenters said that dictating to a physician how 
and what he or she must tell a patient is not the purview, mandate, or 
competence of the NRC and interferes with an essential part of medical 
practice, which is communication between physician and patient.
    Response. In a policy statement published on February 9, 1979 (44 
FR 8242), entitled ``Regulation of the Medical Uses of Radioisotopes; 
Statement of General Policy,'' the NRC made three specific statements. 
The third statement of the policy is ``The NRC will minimize intrusion 
into medical judgments affecting patients and into other areas 
traditionally considered to be a part of the practice of medicine.'' 
The final rule is consistent with this statement because it does not 
dictate the choice of medical treatment or diagnosis, does not specify 
the details of what the physician must say or must include in the 
contents of the written instructions, and is directed at minimizing the 
risk to the patient's family who have no doctor-patient relations to 
the prescribing or administering personnel. However, Regulatory Guide 
8.39, ``Release of Patients Administered Radioactive Materials,'' 
recommends contents of the written instructions.
    Further discussion of the 1979 Medical Policy Statement is 
presented under the heading, ``VIII. Consistency with 1979 Medical 
Policy Statement.''
    Comment. Several commenters asked whether written instructions were 
appropriate if the patient was blind, illiterate, or did not read 
English. Another commenter said that the instructions should be both 
written and oral and should be in the primary language of the patient.
    Response. The NRC believes that written instructions are useful and 
should be required. If the patient is blind, illiterate, or does not 
read English, it is likely that someone else will be able to read the 
instructions for the patient. NRC considers it too much of a burden to 
require that the instructions be given in the primary language of the 
patient, although the regulations do not preclude foreign language 
written instructions if the licensee chooses to provide them. In most 
situations, it will be possible to find someone who can translate for 
the patient if necessary. The requirement that written instructions be 
given to the patient does not preclude additional oral instructions.
    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 total strangers. This commenter 
also asked whether it is reasonable to expect that released patients 
will alter their behavior and limit their activities for the protection 
of others.
    Response. The NRC does not intend to enforce patient compliance 
with the instructions nor is it the licensee's responsibility. However, 
it is the responsibility of licensees to provide instructions to the 
patients. Following the instructions is normally the

[[Page 4126]]

responsibility of the patient. However, American medical practice 
routinely depends on patients following instructions, such as 
instructions on when and how to take medications.
    With regard to compliance with the instructions, surveys of 
patients and their spouses, as discussed in the supporting regulatory 
analysis, indicate that most will attempt to follow the instructions 
faithfully, especially with regard to protecting their children, 
although some patients and their spouses indicated that they might not 
keep physically distant from their spouse for prolonged periods of 
time.
    Comment. One commenter said that instructions should be given for 
all administrations of radioactive material, regardless of the quantity 
administered.
    Response. The NRC does not agree. In some cases, particularly in 
the large number of diagnostic administrations, the potential doses are 
so small 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

    Comment. Two commenters said that patients cannot be confined 
against their wishes and that the rule provides no penalty for the 
patient who leaves confinement in the hospital ``against medical 
advice.'' Another commenter said that the rule seems to require that 
the licensee have control of the patient's activities after release.
    Response. The NRC recognizes that patients cannot be held against 
their will. The rule deals with the conditions under which the licensee 
may authorize release. The NRC would not penalize a licensee for the 
activities of the patient after release or if the patient were to leave 
``against medical advice.''
    Comment. One commenter asked whether a patient who was releasable 
but was still hospitalized for other reasons would still be considered 
under the licensee's control.
    Response. Once the licensee has authorized the release of the 
patient, there is no need to keep the patient under licensee control 
for radiation protection purposes if the patient remains hospitalized 
for other reasons. However, good health physics practice would be to 
continue to make efforts to maintain doses to people at the facility as 
low as is reasonably achievable.
    Comment. 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 ``confinement'' no longer applies 
to the revision to 10 CFR 35.75. Instead, the text of the rule uses the 
phrase ``licensee control'' to more clearly reflect the NRC's intent.
    The NRC believes that there is a distinct difference between a 
patient being under licensee control in a hospital or other licensee 
facility (e.g., a hospice or nursing home) and being at home. In a 
hospital or other area or address of use listed on the NRC license, the 
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 patient. A patient who goes home is released from 
licensee control.
    Comment. One commenter thought that the rule should define the term 
``release.''
    Response. The term ``release from licensee control,'' when read in 
context, refers to radiation protection considerations and is 
sufficiently clear that there is no need to define the term.

Miscellaneous Comments on the Rule

    Comment. Several commenters said that the rule should not be a 
matter of Agreement State compatibility at any level.
    Response. The NRC does not agree. The NRC conducts an assessment of 
each proposed requirement or rule to determine what level of 
compatibility will be assigned to the rule. These case-by-case 
assessments are based, for the most part, on protecting public health 
and safety. NRC has evaluated the final rule and assigned compatibility 
designations ranging from level 1 (full compatibility required) to 
level 3 (uniformity not required) as detailed later in this Federal 
Register notice.
    Comment. Several commenters said that a breast-feeding infant 
should not be considered as an individual exposed to the patient for 
the purposes of determining whether patient release may be authorized. 
These commenters said that consideration of the breast-feeding infant 
should be under the jurisdiction of the physician, that the issue is a 
medical issue rather than a regulatory issue, and that the NRC should 
not interfere in medical issues.
    Response. The NRC does not agree. The NRC has a responsibility to 
protect the public health and safety, and that responsibility extends 
to all individuals exposed to a patient administered licensed 
radioactive materials, including breast-feeding children. When the 
release is authorized, it is based on the licensee's determination that 
the total effective dose equivalent to an individual from the released 
patient is not likely to exceed 5 millisieverts (0.5 rem). The dose to 
the breast-feeding child from breast-feeding is a criterion for release 
but it can be controlled by giving the woman guidance on the 
interruption or discontinuation of breast-feeding, as required by the 
new 10 CFR 35.75. However, the release could be based on the default 
table of release activities in the regulatory guide or a patient-
specific calculation, as required by the new 10 CFR 35.75. The issue of 
the dose to the breast-feeding child is discussed in NUREG-1492 and 
Regulatory Guide 8.39, ``Release of Patients Administered Radioactive 
Materials.''
    Comment. One commenter said that the proposed rule did not 
accurately represent the position of the Advisory Committee on Medical 
Uses of Isotopes.
    Response. A review of the transcript for the ACMUI meeting in May 
1992 shows that the Federal Register Notice provided an accurate 
description of the ACMUI position. The final rule was discussed with 
the ACMUI on October 18, 1995, and the ACMUI, in general, supported the 
rule. (For ACMUI's comments and NRC's responses, see Section V. 
Coordination with the Advisory Committee on Medical Uses of Isotopes.)
    Comment. One commenter said that its facility treated many foreign 
patients with therapeutic pharmaceuticals. These patients frequently 
may leave the hospital and immediately board a plane to return home. 
Thus, there is a limit to the amount of control that a licensee has 
over the patient.
    Response. The NRC recognizes that the licensee has no control over 
the patient after the patient has been released. The quantities for 
release listed in Table 1 of Regulatory Guide 8.39, ``Release of 
Patients Administered Radioactive Materials,'' were calculated using 
conservative assumptions (for example, by using the physical half-life 
of the radioactive material rather than the more realistic effective 
half-life). Thus, the NRC considers it unlikely that the dose to an 
individual in real circumstances would approach 5 millisieverts (0.5 
rem).
    In special situations, such as when a released patient would 
immediately board an airplane and would therefore be in close contact 
with one or more

[[Page 4127]]

individuals, it may be necessary to base the release on a more 
realistic case-specific calculation. Once the patient is released, the 
responsibility for following the instructions is entirely the 
patient's, not the licensee's.

Comments on the Draft Regulatory Guide

    Comments were also requested on Draft Regulatory Guide, DG-8015, 
``Release of Patients Administered Radioactive Materials,'' associated 
with this rulemaking. Because the guide is associated with the rule, 
the comments received on the draft guide are discussed here. Most of 
the comments concerned the method and the assumptions used to calculate 
the dose to the individual likely to receive the highest dose.
    Comment. Several commenters said that the calculational methodology 
in the draft guide is too complex and that the assumptions are too 
conservative. As an example, several commenters said that the assumed 
24-hour nonvoiding assumption used in calculating doses is too 
conservative. As evidence that the calculations are too conservative, 
several commenters said that the doses measured using dosimeters were 
much lower than doses calculated using the models in the draft guide.
    Response. The NRC has revised the guide to use a phased approach 
for determining when release can be authorized. While the calculations 
can sometimes be complex, the results of calculations that use 
conservative assumptions are given in a table of release quantities in 
Regulatory Guide 8.39, ``Release of Patients Administered Radioactive 
Materials.'' Of the 8 to 9 million administrations performed annually, 
in all except about 10,000 cases (radioiodine therapy for thyroid 
cancer), release can be authorized based on conservative assumptions 
and using Table 1 with no calculational effort on the part of the 
licensee and no additional recordkeeping beyond what is already 
required. For permanent implants, the guide provides dose rates at 1 
meter from the patient at which release may be authorized. Thus, for 
implants, there would be no calculational effort needed. In addition, 
the guide provides information on iodine therapy for thyroid cancer 
that can be used for determining release based on retention and 
elimination. This additional information in the guide will allow the 
licensee to perform the calculation with relatively little effort.
    With regard to the comments that the methodology is too 
conservative and that measured values are lower than calculated by the 
methodology, the methodology in the table giving default release 
quantities is intended to be conservative. The NRC believes it is 
appropriate and prudent to be conservative when providing generally 
applicable release quantities that may be used with little 
consideration of the specific details of a particular patient's 
release. A review of published information, as described in the 
regulatory analysis, NUREG-1492, ``Regulatory Analysis on Criteria for 
the Release of Patients Administered Radioactive Material'' (1997), 
finds that measured doses are generally well below those predicted by 
the methodology used to calculate the table of default release 
quantities. Thus, the default release quantities are conservative as 
the NRC intended. However, the licensee is given the option of using 
case-specific calculations that may be less conservative.
    Nevertheless, the NRC agrees that the assumption used in the draft 
guide of 24-hour nonvoiding in the thyroid cancer example was overly 
conservative. The revised example uses an excretion half-life of 8 
hours as recommended by the ICRP in ICRP Publication 53, ``Radiation 
Dose to Patients from Radiopharmaceuticals.'' \5\
---------------------------------------------------------------------------

    \5\ International Commission on Radiological Protection (ICRP), 
``Radiation Dose to Patients from Radiopharmaceuticals,'' ICRP 
Publication No. 53 (March 1987). Available for sale from Pergamon 
Press, Inc., Elmsford, NY 10523.
---------------------------------------------------------------------------

    Comment. One commenter said that the occupancy factor (generally 
assumed to be 0.25 at 1 meter) should not be left to the discretion of 
the licensee because low occupancy factors could easily be justified by 
providing strict safety instructions without any verification that the 
instructions will be followed. Another commenter liked the flexibility 
provided by being able to adjust the occupancy factor, but wanted to 
know if other considerations are allowed and if it is acceptable to use 
values lower than 0.125.
    Response. Draft Regulatory Guide 8.39 discussed situations in which 
it might be permissible to lower the occupancy factor from 0.25 to 
0.125, but did not recommend occupancy factors less than 0.125. 
Occupancy factors less than 0.125 may be difficult to justify because 
it is generally not realistic to assume that the patient can avoid all 
contact with others. However, lower values for the occupancy factor are 
not prohibited by the regulation, but they must be justified in the 
record of the calculation, as the record will be subject to inspection.
    Comment. Several commenters said that the iodine-131 retention 
fraction of 0.3 used in the draft guide for treatment of thyroid cancer 
is too large and that the correct value should be 0.05 or less. Another 
commenter said that the biological half-life of extrathyroidal iodine 
should be 0.5 day for both the euthyroid and hyperthyroid condition. 
One commenter said that the biological half-lives from ICRP Publication 
No. 53 should be used for thyroid cancer.
    Response. The NRC agrees that the commenters raised valid points. 
In Regulatory Guide 8.39, the iodine retention fraction for thyroid 
cancer was changed to 0.05. The biological half-life for the 
extrathyroidal fraction was changed to 0.33 day. In addition, the 
biological half-lives from ICRP Publication No. 53 were used for the 
thyroid cancer case.
    Comment. One commenter said the table of release quantities in the 
draft guide should be expanded to include beta emitters such as 
strontium-89 and phosphorous-32. Another commenter said that the table 
should be expanded to include chromium-51, selenium-75, yttrium-90, 
tin-117m, and iridium-192.
    Response. Values for the beta emitters strontium-89 and 
phosphorous-32 have been added to the table of release quantities in 
Regulatory Guide 8.39. The table of release quantities was also 
expanded to add values for chromium-51, selenium-75, yttrium-90, tin-
117m, and iridium-192.
    Comment. The table of release 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 
Regulatory Guide 8.39 as an aid to the States and to medical 
facilities. The NRC has no regulatory authority over the release of 
patients administered accelerator-produced materials and would not 
inspect the release of patients administered accelerator-produced 
materials.
    Comment. One commenter said that the regulatory guide should have a 
table of release quantities based on biological half-life rather than 
only the physical half-life.
    Response. Regulatory Guide 8.39 now provides more information on 
release quantities for iodine-131 based on biological half-lives.
    Comment. One commenter said that the factor of 10-6 used in 
the draft guide to estimate internal dose is not well supported for 
nonoccupational exposures. Another commenter said that the calculation 
of dose to individuals exposed to the patient ignores the potential of 
radiation dose from the excretion of radioactive material from the 
patient, and this could present a

[[Page 4128]]

significant radiological hazard to family members.
    Response. It is true that there is not a great deal of information 
on the use of the factor in nonoccupational settings, but measurements 
(described in NUREG-1492) have been made in which iodine uptake was 
measured in people exposed to a patient. These data suggest that the 
fractional uptake of the administered activity will be on the order of 
10-6. Since iodine is among the most soluble and volatile 
radiopharmaceuticals, it can be expected that the transfer to others of 
less soluble and less volatile radiopharmaceuticals would be less than 
that of iodine.
    In addition, the NCRP recently concluded that, for individuals 
exposed to radionuclide therapy patients, the risks of external 
irradiation and potential contamination are minor from a public health 
viewpoint; therefore a significant intake from a contamination incident 
is very unlikely.\2\
    Comment. A medical organization commented that the draft guide is 
not complete and does not provide sufficient comprehensive examples to 
assist licensees in complying with the rule.
    Response. The NRC has expanded the guide to include information and 
further examples on the biological elimination of iodine-131 and on 
when guidance on the interruption or discontinuation of breast-feeding 
should be given. Expanded examples are now given in Regulatory Guide 
8.39, ``Release of Patients Administered Radioactive Materials.'' The 
example on thyroid cancer was revised to include more realistic 
assumptions, and an additional example on hyperthyroidism was added. 
The NRC believes that the examples provided illustrate the techniques 
sufficient to perform the whole range of potential calculations.
    Comment. One commenter said that the draft regulatory guide did not 
provide enough information on when and for how long breast-feeding of 
infants should be interrupted.
    Response. Regulatory Guide 8.39 has been greatly expanded with 
respect to information on the breast-feeding child, including a table 
on recommendations for the interruption or discontinuation of breast-
feeding for specific radiopharmaceuticals.
    Comment. One commenter said that the sample instructions in the 
draft guide concerning implants should include a picture of an implant 
seed.
    Response. The sample instructions were not expanded to include this 
because of graphics limitations, but licensees may add photos if 
desired.
    Comment. Several commenters asked whether multiple individual 
calculations have to be done or if a generally applicable calculation 
could be done once and used for many patients.
    Response. The NRC believes that there may be some situations for 
which a case-specific calculation could be done for a class of 
patients. The record for a particular patient's release could then 
reference the calculation done for the class of patients. However, 
depending on a patient's individual status (e.g., lower occupancy 
factor), there may be cases when the calculation will be done for a 
specific individual.
    Comment. One commenter said that the discussion on radiolabeled 
antibodies in the draft guide was wrong because antibodies labeled with 
iodine-131 will be deiodinated in the body and the iodine will behave 
like other iodine. None of the radiolabeled antibodies now being 
developed or planned for the future should have an internal dose hazard 
for the general public.
    Response. The NRC agrees with this Comment. Statements in 
Regulatory Guide 8.39 are now modified.

Comments on the Draft Regulatory Analysis (Draft NUREG-1492)

    Comment. One commenter said that the value of a person-rem should 
be $40 rather than $1,000 as used in the draft regulatory analysis for 
the purpose of evaluating the costs and benefits of the rule. The 
commenter cited a 1993 Health Physics Society position paper as a 
reason that the value should be $40 per person-rem.
    Response. The Commission recently adopted a value of $2,000 per 
person-rem as explained in Revision 2 of NUREG/BR-0058, ``Regulatory 
Analysis Guidelines of the U.S. Nuclear Regulatory Commission (November 
1995),'' Section 4.3.3, ``Evaluation of Values and Impacts.'' (Single 
copies of NUREG/BR-0058 are available as indicated in the ADDRESSES 
heading.) The draft regulatory analysis, which was prepared utilizing 
$1,000 per person-rem, employed a simple computational model using the 
physical half-life only of radiopharmaceuticals. The regulatory 
analysis has been revised to include use of $2,000 per person-rem, as 
well as a more realistic dose model based on biological retention and 
elimination of the radiopharmaceuticals. The more realistic model with 
a value of $2,000 continues to demonstrate the cost-effectiveness of 
the dose-based limit. Specifically, the savings in hospital costs under 
the earlier release time allowed are estimated at $14 million, whereas 
the collective dose of 2,740 person-rem (at a value of $2,000 per 
person-rem) corresponds to a cost of about $5 million.
    NUREG-1492 contains a detailed discussion of the model and the 
benefits and impacts of the dose-based limit. Single copies of the 
final regulatory analysis are available as indicated in the ADDRESSES 
heading.
    Comment. One commenter said that the benefits of the rule were 
overestimated because the length of time that a thyroid patient would 
have to remain in the hospital was overestimated and the cost of a 
hospital room was overestimated, being $450 per day rather than $1,000 
per day as assumed in the draft regulatory analysis.
    Response. The commenter is correct that the benefits of the rule 
were overestimated. The estimates in the draft regulatory analysis of 
days of hospitalization required did not include biological elimination 
of the radioactive material; only radioactive decay was considered. As 
a consequence, the draft regulatory analysis, in some cases, 
overestimated the time that patients would need to be retained under 
licensee control, and therefore the costs of patient 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), 
licensees are required to provide a private room with a private 
sanitary facility for each patient receiving radiopharmaceutical 
therapy and hospitalized for compliance with 10 CFR 35.75. Considering 
this NRC requirement and the recent reference cited in the final 
regulatory analysis on the cost of hospitalization, $1,000 per day for 
a hospital room is a reasonable estimate.
    Comment. One commenter said that the description of the measured 
doses received by family members was not consistent with the reference 
cited.
    Response. The commenter is correct. An incorrect reference was 
given. The final regulatory analysis provides the correct reference.

IV. Coordination With NRC Agreement States

    The NRC staff discussed the status of this rulemaking effort at two 
public meetings: The Agreement State Managers Workshop held on July 12-
14, 1994, and at the All Agreement States Meeting held on October 24-
25, 1994. The Agreement States expressed no objections to the approach 
in this rule.

[[Page 4129]]

V. Coordination With the Advisory Committee on Medical Uses of 
Isotopes

    The Advisory Committee on Medical Uses of Isotopes (ACMUI) is an 
advisory body established to advise the NRC staff on matters that 
involve the administration of radioactive material and radiation from 
radioactive material. The NRC staff presented a summary of the comments 
on the proposed rule to the ACMUI during a public meeting held in 
Rockville, Maryland, on November 17 and 18, 1994.
    Drafts of the final rule and regulatory guide were discussed with 
ACMUI in Rockville, Maryland, on October 18 and 19, 1995. The ACMUI 
supported the approach in this rule but suggested some clarifying 
changes. The NRC staff made all but one of the suggested changes. The 
ACMUI suggested using the term ``rationale'' instead of 
``consequences'' in the requirement under the revised 10 CFR 35.75(b), 
to provide ``guidance on the interruption or discontinuation of breast-
feeding, and information on the consequences of failure to follow the 
guidance'' for cases where failure to follow the instructions could 
result in a dose to the infant exceeding 1 millisievert (0.1 rem). 
Since most of the administrations that would be affected by this 
requirement are technetium-99m administrations, the ACMUI suggested the 
change because there was concern that the consequences of low doses of 
radiation cannot always be explained to the patient without causing 
unjustified alarm. Also, there was concern that physicians cannot 
explain with certainty the effects of low doses of radiation, such as 
would be caused by diagnostic administrations of technetium-99m. The 
staff did not change the rule in response to the ACMUI comment. The 
requirement to provide information on the consequences is included 
primarily to protect the breast-feeding infant from therapeutic 
administrations of radioiodine, which could cause serious thyroid 
damage. Regulatory Guide 8.39 will contain guidance on the types of 
information, including expected consequences, to be provided to 
patients to meet this requirement. Transcripts of the meetings have 
been placed in and are available for examination at the NRC Public 
Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

VI. Discussion of Text of Final Rule

    This section summarizes the final rule. The NRC is amending 10 CFR 
20.1301(a)(1) to state specifically that the dose to individual members 
of the public from a licensed operation does not include doses received 
by individuals exposed to patients who were released by the licensed 
operation under the provisions of 10 CFR 35.75. This is not a 
substantive change. It is a clarifying change to make clear that the 
Commission's policy is that patient release is governed by 10 CFR 
35.75, not 10 CFR 20.1301.
    For the sake of consistency and clarity, the same words are used in 
Sec. 20.1002, ``Scope''; in Sec. 20.1003, ``Definitions'' (in the 
definitions of both public dose and occupational dose); and in 
Sec. 20.1301, ``Dose limits for individual members of the public.'' 
Also for consistency and clarity, the exclusion of dose from background 
radiation and from voluntary participation in medical research programs 
that are now included in Secs. 20.1002 and 20.1003 are added to 
Sec. 20.1301(a). In addition, the definition of ``member of the 
public,'' as published in 60 FR 36038 on July 13, 1995, is revised by 
removing the footnote which read, ``Except as delineated in other parts 
of 10 CFR Chapter 1.'' With the publication of this rule that footnote 
is no longer needed.
    The NRC is amending 10 CFR 20.1301(a)(2) to state specifically that 
the limit on dose in unrestricted areas does not include dose 
contributions from individuals administered radioactive material and 
released in accordance with 10 CFR 35.75. The purpose of this change is 
to clarify that after a patient has been released under 10 CFR 35.75, 
licensees are no longer required to control radiation from the patient. 
The regulation uses the term ``individual'' to refer to the individual 
to whom the radioactive material has been administered rather than 
``patient'' to clarify that the regulation refers to anyone receiving a 
medical administration.
    The NRC is amending 10 CFR 20.1903(b) to use the term ``licensee 
control'' rather than ``confinement'' because the latter term no longer 
applies to 10 CFR 35.75. The conforming change is necessary since the 
term ``licensee control'' more clearly reflects the NRC's intent in 10 
CFR 35.75.
    The NRC is adopting a new 10 CFR 35.75(a) to change the patient 
release criteria from 30 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 protection from risks from all radionuclides. Also, 
the changes are supported by the recommendations of the ICRP and NCRP 
that an individual can receive an annual dose up to 5 millisieverts 
(0.5 rem) in temporary situations where exposure to radiation is not 
expected to result in annual doses above 1 millisievert (0.1 rem) for 
many years. Usually, the only individuals likely to exceed a dose of 1 
millisievert (0.1 rem) will be those who are aware of the patient's 
condition such as the primary care-giver, a family member, or any other 
individual who spends significant time close to the patient.
    This dose-based rule would, in some instances, permit the release 
of patients with activities greater than currently allowed. This is 
especially true when case-specific factors are evaluated to more 
accurately assess the dose to other individuals. The individuals 
exposed to the patient could receive higher doses than if the patient 
had been hospitalized longer. These higher doses are balanced by 
shorter hospital stays and thus lower health care costs. In addition, 
shorter hospital stays may provide emotional benefits to patients and 
their families. Allowing earlier reunion of families can improve the 
patient's state of mind, which in itself may improve the outcome of the 
treatment and lead to the delivery of more effective health care.
    The release criteria in 10 CFR 35.75(a) could prevent a woman from 
being released because of the potential transmission of radioactive 
materials in breast milk. The dose to the breast-feeding child is 
controlled by giving the woman guidance, as required by 10 CFR 
35.75(b), on the interruption or discontinuation of breast-feeding and 
information on the consequences of failure to follow the guidance. The 
expectation is that the woman would follow the instructions and would 
interrupt or discontinue breast-feeding.
    Finally, 10 CFR 35.75(a) includes a footnote to inform licensees 
that the NRC has made available guidance on rule implementation. The 
footnote states that Regulatory Guide 8.39, ``Release of Patients 
Administered Radioactive Material,'' contains tables of activities not 
likely to cause doses exceeding 5 millisieverts (0.5 rem) and describes 
methods for calculating doses to other individuals.
    The NRC is adopting a new 10 CFR 35.75(b) to require that the 
licensee provide released patients with instructions, including written 
instructions, on how to maintain doses to other individuals as low as 
is reasonably achievable if the total effective dose equivalent to any 
individual other than the released patient is likely to exceed 1 
millisievert

[[Page 4130]]

(0.1 rem). This also requires giving instructions to a woman who is 
breast-feeding a child if the dose to the child could exceed 1 
millisievert (0.1 rem) assuming there were no interruption of breast-
feeding. The instructions must include guidance on discontinuation or 
the interruption period for breast-feeding and the consequences of 
failing to follow the recommendation. Regulatory Guide 8.39 contains 
tables that show temporary interruption periods for various 
radiopharmaceuticals or discontinuation. The temporary interruption 
periods were calculated based on the determination that the dose to a 
child from breast-feeding is unlikely to exceed 1 millisievert (0.1 
rem). However, the physician may use discretion in the recommendation, 
increasing or decreasing the duration of interruption somewhat 
depending on the woman's concerns about radioactivity or interruption 
of breast-feeding.
    The purpose of describing the consequences is so that women will 
understand that breast-feeding after an administration of certain 
radionuclides could cause harm (e.g., iodine-131 could harm the child's 
thyroid). In other cases, the guidance could simply address avoidance 
of any unnecessary radiation exposure to the child from breast-feeding.
    A requirement for instructions for certain patients was already 
contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the modified 
requirement for written instructions adds approximately (a) 50,000 
patients per year who are administered iodine-131 for the treatment of 
hyperthyroidism and (b) 27,000 patients per year, among about 8 million 
administered radiopharmaceuticals, who may be breast-feeding to whom 
additional written instructions be given. The purpose of the written 
instructions is to maintain doses to individuals exposed to patients as 
low as is reasonably achievable. The instructions may be either written 
only or written plus oral. The NRC believes that written instructions 
are necessary so that the patient and the patient's family and friends 
will have a document to refer to rather than having to rely solely on 
the patient's memory and understanding of the instructions.
    The requirement of 10 CFR 35.75(b), requiring a licensee to provide 
guidance on discontinuation or the interruption period for breast-
feeding and the consequences of failing to follow the recommendation, 
presumes that the licensee will make appropriate inquiry regarding the 
breast-feeding status of the patient. For women who are breast-feeding 
a child where the dose to the child is likely to exceed 1 millisievert 
(0.1 rem), the NRC requires that the patient be provided with specific 
instructions, as described in 10 CFR 35.75(b). There is no specific 
requirement to maintain a record indicating that breast-feeding status 
was determined prior to the release of the patient.
    The NRC is adopting a new 10 CFR 35.75(c) to require that the 
licensee maintain a record of the basis for authorizing the release for 
3 years if the calculation of the total effective dose equivalent to 
other individuals uses the retained activity rather than the activity 
administered, an occupancy factor less than 0.25 at 1 meter, the 
biological or effective half-life of the radionuclide, or shielding of 
radiation by the patient's tissue. Thus, records of release are 
required when the default assumptions are not used as discussed in 
Regulatory Guide 8.39. Measurements made in several studies indicate 
that the default assumptions should generally overpredict the dose even 
when instructions are not given or are not strictly followed. If a 
licensee administers an activity no greater than the value in the 
default table of release quantities provided in the regulatory guide as 
the basis for release, no record of release is required.
    Licensees are already required by 10 CFR 35.53 to retain records of 
the measurement of the activity of each dosage of radioactive material 
administered to a patient; these records are typically maintained in a 
patient dose log. In addition, 10 CFR 35.32 requires licensees to 
retain a written directive and a record of each administered radiation 
dose or radiopharmaceutical dosage for therapeutic administrations and 
diagnostic administrations of iodine-125 or iodine-131 sodium iodide 
greater than 30 microcuries. These records can be used in conjunction 
with Regulatory Guide 8.39 to demonstrate that patient releases meet 
the requirements of 10 CFR 35.75(a) when no record is required by 10 
CFR 35.75(c). When the licensee determines that the patient must be 
held to allow the reduction of radioactivity and then released, the 
licensee will need a record of release time to demonstrate that the 
release criteria have been met. A licensee may use any existing record 
to establish the release time. If biological elimination of radioiodine 
is a basis for release and the licensee uses the information in 
Regulatory Guide 8.39, a record of the thyroid uptake may be necessary 
as part of the basis for release because it is one of the nonstandard 
conservative assumptions listed in 10 CFR 35.75(c). If other case-
specific factors are used as the basis for patient release that are in 
addition to, or modify, the standard conservative assumptions, a record 
of the basis for the release, including the assumptions used for the 
calculations, must also be maintained.
    This recordkeeping requirement is a modification of the proposed 
rule. The proposed rule would have required that a record be maintained 
of the basis for the patient's release, including all calculations 
performed, if the total effective dose equivalent to any individual 
other than the released patient is likely to exceed 1 millisievert (0.1 
rem) in a year from a single administration. Under the proposed rule, 
the major purpose of the record was to provide the basis for limiting 
the dose to 5 millisieverts (0.5 rem) to individuals exposed to a 
patient who may receive more than one administration in a year. Upon 
reconsideration, based on public comments and consultation with the 
ACMUI, an NRC medical consultant, and the NRC Visiting Medical Fellow, 
the NRC has decided to delete this requirement. A review of medical 
treatment practices revealed no common practice that would result in 
doses exceeding the 5 millisievert (0.5 rem) limit because of multiple 
administrations in the same year to the same patient. Without the need 
to account for the dose from multiple administrations, maintaining 
records for the many tens of thousands of patients released when their 
dose to an individual is likely to exceed 1 millisievert (0.1 
millisievert) becomes an unnecessary burden. The requirement to retain 
these records has therefore been deleted. Each patient release is to be 
treated as a separate event, and licensee knowledge of previous 
administrations is unnecessary.
    The NRC is also adopting a new 10 CFR 35.75(d) to require that the 
licensee maintain a record that instructions were provided to a woman 
who is breast-feeding a child if the administered activity could result 
in a total effective dose equivalent to the breast-feeding child 
exceeding 5 millisieverts (0.5 rem) if the woman did not interrupt or 
discontinue breast-feeding. Thus, the NRC is requiring records for 
certain radiopharmaceutical administrations (e.g., therapeutic 
administrations of iodine-131). The activities of radiopharmaceuticals 
that require this record are described in Regulatory Guide 8.39.

[[Page 4131]]

    Finally, the NRC is deleting its requirements on written 
instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5) because those 
paragraphs are redundant now that 10 CFR 35.75 has requirements for 
instructions. In addition, 10 CFR 35.415(a) and (a)(1) are reworded to 
clarify the original intent of the paragraphs, which was to limit the 
dose rate at 1 meter from the patient. The ambiguity was introduced 
when part 20 was revised and a conforming change was made in 10 CFR 
35.415. The conforming change that was made was not fully consistent 
with the original intended meaning of 10 CFR 35.415(a) and (a)(1).

VII. Disposition of the Petitions for Rulemaking

    The three petitions for rulemaking submitted by Dr. Marcus (PRM-20-
20), the ACNM (PRM-35-10 and PRM-35-10A), and the AMA (PRM-35-11) 
requested that the NRC amend the revised 10 CFR part 20 and 10 CFR part 
35. These requests and their disposition by this rulemaking are 
discussed below.
    The requests made by Dr. Marcus and their disposition may be 
summarized as follows:
    (1) Raise the radiation dose limit in 10 CFR 20.1301(a) for 
individuals exposed to radiation from patients receiving 
radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1 
rem) to 5 millisieverts (0.5 rem). The final rule grants this request.
    (2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel (30-
millicurie) limit for iodine-131, but provide an activity limit for 
other radionuclides consistent with the calculational methodology 
employed in the National Council on Radiation Protection and 
Measurements (NCRP) Report No. 37, ``Precautions in the Management of 
Patients Who Have Received Therapeutic Amounts of Radionuclides.'' \1\ 
The final rule does not contain activity limits, but Regulatory Guide 
8.39 uses a calculational methodology based on NCRP Report No. 37 to 
relate the dose to the quantity of activity in the patient. Therefore, 
the wish of the petitioner to have an easy method to determine when the 
patient may be released is granted in Regulatory Guide 8.39.
    (3) Delete 10 CFR 20.1301(d), which requires licensees to comply 
with provisions of the Environmental Protection Agency's environmental 
regulations in 40 CFR part 190 in addition to complying with the 
requirements of 10 CFR part 20. The EPA regulations referenced in 10 
CFR 20.1301(d) are contained in 40 CFR part 190, which deals only with 
doses and airborne emissions from uranium fuel cycle facilities. Part 
190 of Title 40 of the Code of Federal Regulations does not apply to 
hospitals or to the release of patients.
    Furthermore, 10 CFR 20.1301(d) does not incorporate the EPA's Clean 
Air Act standards in 40 CFR part 61 that applies to hospitals. The NRC 
is separately pursuing actions with the EPA to minimize the impact of 
dual regulation under the Clean Air Act and to take agreed upon actions 
that will lead to EPA recision of 40 CFR part 61 for NRC and Agreement 
State licensees. Because the reference to EPA regulations in 10 CFR 
20.1301(d) has nothing to do with the patient release issue, and 
therefore is outside the scope of this rulemaking, the final rule 
denies this request.
    The requests made by the ACNM and their disposition may be 
summarized as follows:
    (1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals 
exposed to patients who have been administered radiopharmaceuticals. 
The final rule grants this request.
    (2) Permit licensees to authorize release from hospitalization any 
patient administered a radiopharmaceutical regardless of the activity 
in the patient by defining ``confinement'' to include not only 
confinement in a hospital, but also confinement in a private residence. 
The final rule denies this request for the reasons described in the 
discussion on this issue.
    Finally, the requests made by the AMA did not all pertain to the 
issue of patient release. The final rule grants the request pertaining 
to patient release, i.e., that the radiation dose limits in 10 CFR 
20.1301 should not apply to individuals exposed to the patient and that 
the dose limit to the individuals should be 5 millisieverts (0.5 rem). 
The request to change the term ``hospitalized'' in 10 CFR 35.310(a) and 
35.315(a) to the term ``confined'' was denied for the reasons discussed 
above. The request not related to the subject of patient release (that 
it should be clear in Part 20 that Part 20 does not limit the 
intentional exposure of patients to radiation for the purpose of 
medical diagnosis or therapy) was addressed in another rulemaking, 
``Medical Administration of Radiation and Radioactive Materials,'' 
which was published as a final rule on September 20, 1995 (60 FR 
48623), and became effective on October 20, 1995.

VIII. Consistency With 1979 Medical Policy Statement

    On February 9, 1979 (44 FR 8242), the NRC published a Statement of 
General Policy on the Regulation of the Medical Uses of Radioisotopes. 
The first statement of the policy reads ``The NRC will continue to 
regulate the medical uses of radioisotopes as necessary to provide for 
the radiation safety of workers and the general public.'' The rule is 
consistent with this statement because its purpose is to provide for 
the safety of individual members of the public exposed to patients 
administered radioactive materials.
    The second statement of the policy is ``The NRC will regulate the 
radiation safety of patients where justified by the risk to patients 
and where voluntary standards, or compliance with these standards, are 
inadequate.'' This statement is not 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 reads ``The NRC will minimize 
intrusion into medical judgments affecting patients and into other 
areas traditionally considered to be a part of the practice of 
medicine.'' The rule is consistent with this statement because it 
places no requirements on the administration of radioactive materials 
to patients and because the release of patients administered 
radioactive materials has long been considered a matter of regulatory 
concern to protect members of the public rather than solely a matter of 
medical judgment.
    Thus, the final rule is considered to be consistent with the 1979 
Medical Policy Statement.

IX. Issue of Compatibility for Agreement States

    The NRC considers the definitions contained in Sec. 20.1003 and the 
text in Sec. 20.1301(a) that are modified by this rulemaking are 
Division 1 levels of compatibility. The definitions and text in these 
sections must be the same for all NRC and Agreement State licensees so 
that national consistency can be maintained.
    Section 20.1002, ``Scope,'' is a Division 3 level of compatibility 
because this section by nature is not a regulatory requirement and many 
States are prohibited by their administrative procedures act from 
including such sections in their rules. The scope section is a general 
statement of scope of the rule and does not contain specific 
requirements that are not presented in other sections of part 20. Rules 
at the Division 3 level would be appropriate for Agreement States to 
adopt, but they do not require any degree of uniformity between NRC and 
State rules.
    Additionally, Secs. 35.75(a) and (b) are a Division 2 level of 
compatibility because the patient release criteria

[[Page 4132]]

required by the rule are the minimum requirements necessary to ensure 
adequate protection of the public health and safety. The Agreement 
States will be allowed to establish requirements that are more 
stringent than the NRC's requirements, but not less stringent. The 
recordkeeping requirements in Secs. 35.75(c) and (d) are a Division 3 
level of compatibility because uniformity in recordkeeping is not 
considered essential for this rule.

X. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

XI. 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 a major Federal action 
significantly affecting the quality of the human environment, and 
therefore an environmental impact statement is not required. The final 
amendments clarify the pertinent regulatory language to reflect 
explicitly the relationship between 10 CFR part 20 and part 35 with 
respect to release of patients, and the amendments revise the release 
criteria for patients receiving radioactive material for medical use 
from an activity-based standard to a dose basis. It is expected that 
there will be relatively little change in radiation dose to the public 
or to the environment as a result of the revised regulation.
    The final environmental assessment and finding of no significant 
impact on which this determination is based is available for inspection 
at the NRC Public Document Room, 2120 L Street NW. (Lower Level), 
Washington, DC. Single copies of the environmental assessment and the 
finding of no significant impact are available as indicated in the FOR 
FURTHER INFORMATION CONTACT heading.

XII. Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). These requirements were approved by the Office of Management and 
Budget, approval number 3150-0010.
    The public reporting burden for this collection of information is 
estimated to average 13 hours per licensee per year, including the time 
for reviewing instructions, searching existing data sources, gathering 
and maintaining the data needed, and completing and reviewing the 
collection of information. Send comments on any aspect of this 
collection of information, including suggestions for reducing the 
burden, to the Information and Records Management Branch (T-6 F33), 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by 
Internet electronic mail at [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010), 
Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

XIII. Regulatory Analysis

    The NRC has prepared a final regulatory analysis (NUREG-1492) on 
this regulation. The analysis examines the benefits and impacts 
considered by the NRC. The NRC has received public comments regarding 
the draft regulatory analysis and has addressed the comments (see 
Comments on the Draft Regulatory Analysis in Section III. Public 
Comments on the Proposed Rule). The final regulatory analysis is 
available for inspection at the NRC Public Document Room at 2120 L 
Street NW. (Lower Level), Washington, DC. Single copies are available 
as indicated in the ADDRESSES heading.

XIV. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the NRC certifies that this rule will not have a significant 
economic impact on a substantial number of small entities. This rule 
affects medical use of byproduct material licensees. The impact of the 
final rule will not be significant because the final rule basically 
represents a continuation of current practice.

XV. Backfit Analysis

    The NRC has determined that the backfit rule, 10 CFR 50.109, does 
not apply to this rule, and therefore, that a backfit analysis is not 
required for this rule, because these amendments do not involve any 
provisions that impose backfits as defined in 10 CFR 50.109(a)(1).

Lists of Subjects

10 CFR Part 20

    Byproduct material, Criminal penalties, Licensed material, Nuclear 
materials, Nuclear power plants and reactors, Occupational safety and 
health, Packaging and containers, Radiation protection, Reporting and 
recordkeeping requirements, Special nuclear material, Source material, 
Waste treatment and disposal.

10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Incorporation by reference, Medical devices, 
Nuclear materials, Occupational safety and health, Radiation 
protection, Reporting and recordkeeping requirements.
    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting 
the following amendments to 10 CFR parts 20 and 35.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

    1. The authority citation for part 20 continues to read as follows:

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 
2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 
Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

    2. Section 20.1002 is revised to read as follows:


Sec. 20.1002  Scope.

    The regulations in this part apply to persons licensed by the 
Commission to receive, possess, use, transfer, or dispose of byproduct, 
source, or special nuclear material or to operate a production or 
utilization facility under parts 30 through 35, 39, 40, 50, 60, 61, 70, 
or 72 of this chapter. The limits in this part do not apply to doses 
due to background radiation, to exposure of patients to radiation for 
the purpose of medical diagnosis or therapy, to exposure from 
individuals administered radioactive material and released in 
accordance with Sec. 35.75, or to exposure from voluntary participation 
in medical research programs.
    3. In Sec. 20.1003, the footnote to the definition of member of the 
public is removed and the definitions of occupational dose and public 
dose are revised to read as follows:

[[Page 4133]]

Sec. 20.1003  Definitions.

* * * * *
    Occupational dose means the dose received by an individual in the 
course of employment in which the individual's assigned duties involve 
exposure to radiation or 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, from any medical administration the 
individual has received, from exposure to individuals administered 
radioactive material and released in accordance with Sec. 35.75, from 
voluntary participation in medical research programs, or as a member of 
the public.
* * * * *
    Public dose means the dose received by a member of the public from 
exposure to radiation or radioactive material released by a licensee, 
or to any other source of radiation under the control of a licensee. 
Public dose does not include occupational dose or doses received from 
background radiation, from any medical administration the individual 
has received, from exposure to individuals administered radioactive 
material and released in accordance with Sec. 35.75, or from voluntary 
participation in medical research programs.
* * * * *
    4. In Sec. 20.1301, paragraph (a) is revised to read as follows:


Sec. 20.1301  Dose limits for individual members of the public.

    (a) Each licensee shall conduct operations so that--
    (1) The total effective dose equivalent to individual members of 
the public from the licensed operation does not exceed 0.1 rem (1 
millisievert) in a year, exclusive of the dose contributions from 
background radiation, from any medical administration the individual 
has received, from exposure to individuals administered radioactive 
material and released in accordance with Sec. 35.75, from voluntary 
participation in medical research programs, and from the licensee's 
disposal of radioactive material into sanitary sewerage in accordance 
with Sec. 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 Sec. 35.75, does 
not exceed 0.002 rem (0.02 millisievert) in any one hour.
* * * * *
    5. In Sec. 20.1903, paragraph (b) is revised to read as follows:


Sec. 20.1903  Exceptions to posting requirements.

* * * * *
    (b) Rooms or other areas in hospitals that are occupied by patients 
are not required to be posted with caution signs pursuant to 
Sec. 20.1902 provided that the patient could be released from licensee 
control pursuant to Sec. 35.75 of this chapter.
* * * * *

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

    6. 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).

    7. In Sec. 35.8, paragraph (b) is revised to read as follows:


Sec. 35.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.20, 35.21, 
35.22, 35.23, 35.29, 35.13, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60, 
35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 
35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 
35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980 and 35.981.
* * * * *
    8. Section 35.75 is revised to read as follows:


Sec. 35.75  Release of individuals containing radiopharmaceuticals or 
permanent implants.

    (a) The licensee may authorize the release from its control of any 
individual who has been administered radiopharmaceuticals or permanent 
implants containing radioactive material if the total effective dose 
equivalent to any other individual from exposure to the released 
individual is not likely to exceed 5 millisieverts (0.5 rem).\1\
---------------------------------------------------------------------------

    \1\ Regulatory Guide 8.39, ``Release of Patients Administered 
Radioactive Materials,'' describes methods for calculating doses to 
other individuals and contains tables of activities not likely to 
cause doses exceeding 5 millisieverts (0.5 rem).
---------------------------------------------------------------------------

    (b) The licensee shall provide the released individual with 
instructions, including written instructions, on actions recommended to 
maintain doses to other individuals as low as is reasonably achievable 
if the total effective dose equivalent to any other individual is 
likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-
feeding infant or child could exceed 1 millisievert (0.1 rem) assuming 
there were no interruption of breast-feeding, the instructions shall 
also include:
    (1) Guidance on the interruption or discontinuation of breast-
feeding and
    (2) Information on the consequences of failure to follow the 
guidance.
    (c) The licensee shall maintain a record of the basis for 
authorizing the release of an individual, for 3 years after the date of 
release, if the total effective dose equivalent is calculated by:
    (1) Using the retained activity rather than the activity 
administered,
    (2) Using an occupancy factor less than 0.25 at 1 meter,
    (3) Using the biological or effective half-life, or
    (4) Considering the shielding by tissue.
    (d) The licensee shall maintain a record, for 3 years after the 
date of release, that instructions were provided to a breast-feeding 
woman if the radiation dose to the infant or child from continued 
breast-feeding could result in a total effective dose equivalent 
exceeding 5 millisieverts (0.5 rem).


Sec. 35.315  [Amended]

    9. In Sec. 35.315, paragraph (a)(6) is removed and reserved.


Sec. 35.315  Safety precautions.

    (a) * * *
    (6) [Reserved]
* * * * *
    10. In Sec. 35.415, the introductory text to paragraph (a) and 
paragraph (a)(1) are revised and paragraph (a)(5) is removed.

Sec. 35.415  Safety precautions.

    (a) For each patient or human research subject receiving implant 
therapy and not released from licensee control pursuant to Sec. 35.75 
of this part, a licensee shall:
    (1) Not quarter the patient or the human research subject in the 
same room as an individual who is not receiving radiation therapy.
* * * * *
    Dated at Rockville, Md., this 23rd day of January, 1997.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-2166 Filed 1-28-97; 8:45 am]
BILLING CODE 7590-01-P