[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