[Federal Register Volume 59, Number 114 (Wednesday, June 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14544]
[[Page Unknown]]
[Federal Register: June 15, 1994]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20 and 35
RIN 3150-AE41
Criteria for the Release of Patients Administered Radioactive
Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations concerning the criteria for the release of patients
administered radioactive material. The new criteria for patient release
would be dose-based rather than activity-based and would be consistent
with the recommendations of the International Commission on
Radiological Protection (ICRP). The proposed rule would require the
licensee to maintain a record for 3 years if the quantity of
radioactive material is likely to result in an annual total effective
dose equivalent to an individual exposed to the patient that exceeds 1
millisievert (0.1 rem) from a single administration. The proposed rule
responds to two petitions for rulemaking regarding the criteria for
release of patients administered radioactive material.
DATES: The comment period expires August 29, 1994. Comments received
after this date will be considered if it is practicable to do so, but
the Commission is able to assure consideration only for comments
received on or before this date.
ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555. Attn: Docketing and Service Branch.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland
between 7:45 a.m. and 4:15 p.m. Federal workdays.
Examine comments received, the environmental assessment and finding
of no significant impact, and the regulatory analysis at: The NRC
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Obtain single copies of the environmental assessment and finding of
no significant impact and the regulatory analysis (NUREG-1492) from:
Jayne McCausland, Office of Nuclear Regulatory Research, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, telephone: (301) 415-6219.
Obtain single copies of the draft regulatory guide, ``Release of
Patients Administered Radioactive Material,'' which is related to this
rulemaking, by writing to: Distribution and Mail Services Section,
Office of Administration, U. S. Nuclear Regulatory Commission,
Washington, DC 20555.
FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555, telephone (301) 415-6225.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Petitions for Rulemaking
III. Public Comments Received on the Petitions
IV. Coordination with NRC Agreement States
V. Coordination with the Advisory Committee on Medical Uses of
Isotopes
VI. Issues and Their Resolution
VII. Summary of the Proposed Changes
VIII. Consistency with 1979 Medical Policy Statement
IX. Issue of Compatibility for Agreement States
X. Finding of No Significant Environmental Impact: Availability
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfit Analysis
I. Background
Each year in the United States, radioactive pharmaceuticals or
radioactive implants are administered to approximately 8 to 9 million
patients for the diagnosis or treatment of disease (hereinafter this
group will be referred to as patient(s)). These patients can expose
others around them to radiation until the radioactive material has been
excreted from their bodies or has decayed away. As discussed below,
most of these exposures would be much less than 1 millisievert (0.1
rem) total effective dose equivalent per year.
NRC's current patient release criteria in 10 CFR 35.75, ``Release
of patients containing radiopharmaceuticals or permanent implants,''
are as follows: ``(a) A licensee may not authorize release from
confinement for medical care any patient administered a
radiopharmaceutical until either: (1) The measured dose rate from the
patient is less than 5 millirems per hour at a distance of one meter;
or (2) The activity in the patient is less than 30 millicuries; (b) A
licensee may not authorize release from confinement for medical care of
any patient administered a permanent implant until the measured dose
rate is less than 5 millirems per hour at a distance of one meter.''
On May 21, 1991 (56 FR 23360), the NRC published a final rule that
amended 10 CFR part 20, ``Standards for Protection Against Radiation.''
The rule contained 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, thereby creating the need to address this issue.
To determine the potential number of patients that could be
affected by this issue, the NRC performed a screening analysis to
determine how many patients administered radioactive materials could
cause the exposure of an individual to a dose exceeding 1 millisievert
(0.1 rem) total effective dose equivalent in a year if there were no
restrictions on patient release. The screening analysis indicated that
none of the diagnostic administrations were likely to result in a dose
to an individual exposed to the patient exceeding 1 millisievert (0.1
rem), except for a few diagnostic procedures using iodine-131. The
therapeutic administrations that the screening analysis indicated
needed consideration were: (1) The treatment of hyperthyroidism with
iodine-131 (50,000 per year); (2) the treatment of thyroid cancer with
iodine-131 (10,000 per year); and (3) the treatment of a variety of
cancers (e.g., prostate cancer) with the permanent implantation of
iodine-125 seeds (2,000 per year). Other radionuclides may also warrant
consideration. For example, doses to individuals exposed to a patient
administered ytterbium-169 and gold-198 for therapy might result in
radiation exposures exceeding 1 millisievert (0.1 rem) to individuals
exposed to the patient. However, these radionuclides are seldom used.
In addition, procedures involving radiolabeled antibodies might result
in doses exceeding 1 millisievert (0.1 rem), although no such
procedures using byproduct material are yet approved for routine use.
(For further information see the regulatory analysis for the proposed
rule. Single copies of the draft regulatory analysis are available as
indicated in the ADDRESSES heading.)
II. Petitions for Rulemaking
Because some licensees were uncertain about what effect the revised
10 CFR part 20 would have on patient release criteria, two petitions
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. Dr. Marcus requested that the NRC amend the revised 10
CFR part 20 and 10 CFR part 35 to--
(1) Raise the annual radiation dose limit in 10 CFR 20.1301(a) for
individuals exposed to radiation from patients receiving
radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1
rem) to 5 millisieverts (0.5 rem).
(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
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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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(3) Delete 10 CFR 20.1301(d) which requires licensees to comply
with provisions of Environmental Protection Agency's environmental
regulations in 40 CFR part 190 in addition to complying with the
requirements of 10 CFR part 20.
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, the ACNM submitted two letters dated September 24, 1991,
and October 8, 1991, on the issues in their petition. The ACNM
requested (considering the contents of all four letters) that the NRC
revise 10 CFR part 35 to--
(1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals
exposed to patients who have been administered radiopharmaceuticals.
(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.
Because the petitions submitted by Dr. Marcus and the ACNM both
address the patient release criteria set forth in 10 CFR 35.75, the NRC
has decided to resolve both petitions with this single rulemaking. The
proposed actions, if adopted in final form, would constitute the
partial granting of these petitions as set forth in this notice. All
other portions of petitions PRM-20-20 and PRM-35-10 would be denied.
III. Public Comments Received on the Petitions
There were 140 comment letters received on PRM-20-20 and 88 comment
letters on PRM-35-10 and PRM-35-10A. Commenters represented hospitals
and clinics, professional associations, citizens' groups, Agreement
States and Government agencies, State radiation advisory boards,
universities, consulting firms, public utilities, a utility
association, and a labor union. The majority of the commenters were
physicians who expressed concerns primarily related to the cost of
hospitalization. Other commenters included health and medical
physicists, pharmacists, nuclear medicine technicians, professors, and
one former nuclear medicine patient. Overall, the majority of all
comments supported a dose limit of 5 millisieverts (0.5 rem) for
individuals exposed to patients released with radioactive material.
IV. Coordination with NRC Agreement States
The NRC conducted a public workshop with representatives of the
Agreement States on July 15 and 16, 1992, to discuss a variety of
medical issues, including the proposals for amending 10 CFR parts 20
and 35. The workshop was held in Atlanta, Georgia. Twenty-one of the
Agreement States were represented, as well as a representative from the
City of New York. The major recommendations on the rule provided by the
representatives may be summarized as follows:
(1) Revise 10 CFR part 20 to exclude doses to individuals exposed
to patients released under 10 CFR 35.75.
(2) In 10 CFR 35.75, retain the dose rate limit of 0.05
millisievert (5 millirems) per hour at a distance of 1 meter and add a
dose limit of 5 millisieverts (0.5 rem) in 1 year for individuals
exposed to patients.
(3) Retain the current 1,110-megabecquerel (30-millicurie) activity
limit for iodine-131 but provide activity limits for other
radionuclides based on the recommendations of NCRP Report No. 37,
``Precautions in the Management of Patients Who Have Received
Therapeutic Amounts of Radionuclides.''
(4) Do not define ``confinement'' in 10 CFR part 35 because the
present wording gives regulatory agencies the prerogative to confine
patients by means other than hospitalization.
(5) Require that written instructions on how to maintain doses to
other individuals as low as reasonably achievable be given to the
released patient and any individual likely to spend significant time in
close proximity with the patient.
The NRC staff presented a status report on the requirements of the
proposed rule to the Agreement States at another public meeting in
October 1993, in Tempe, Arizona. The Agreement States were generally
supportive of the approach in this proposed rule. Transcripts of both
meetings have been placed in and are available for examination at the
NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington,
DC.
In addition, in July 1993, the NRC requested the Agreement States
to provide comments on a previous version of the proposed rule. Of
those responding, 14 Agreement States were generally supportive of the
approach in this proposed rule, one was in opposition, and one was
uncertain of its support without further study. The Agreement State
that opposed the annual dose limit of 5 millisieverts (0.5 rem) (total
effective dose equivalent) believed that instructions on how to
maintain doses as low as reasonably achievable to household members and
other individuals would not be followed, radioactive contamination
would be a problem, and permanent implants could dislodge.
V. Coordination With the Advisory Committee on Medical Uses of Isotopes
The NRC staff presented their suggestions for a proposed rule to
the Advisory Committee on Medical Uses of Isotopes (ACMUI) during a
public meeting held in Rockville, Maryland, on October 22 and 23, 1992.
The ACMUI is an advisory body established to advise the NRC staff on
matters that involve the administration of radioactive material and
radiation from radioactive material. The major ACMUI recommendations on
the proposed rule were to--
(1) Add a dose limit of 5 millisieverts (0.5 rem) in 1 year for
individuals exposed to a patient released with radionuclides.
(2) Retain both the 1,110-megabecquerel (30-millicurie) activity
limit and the maximum dose rate of 0.05 millisieverts (5 millirems) per
hour for patient release in 10 CFR 35.75 because they are a simple
means to show compliance without assumptions or calculations.
(3) Develop a regulatory guide that includes a set of standardized
calculations with factors (e.g., occupancy factor) for licensees to
determine compliance with patient release criteria on an individual
basis. Provide tables of acceptable release activities that are
radionuclide specific, based on exposure at 1 meter for routine patient
releases, with built-in safety factors to avoid doses to individuals
near the 5-millisievert (0.5-rem) limit.
(4) Require that written instructions on how to maintain doses to
other individuals as low as reasonably achievable be provided to the
patient upon release from confinement.
The NRC staff presented status reports on the requirements of the
proposed rule to the ACMUI at two other public meetings in May 1993, in
Bethesda, Maryland, and in November 1993, in Reston, Virginia. The
ACMUI was generally supportive of the approach in this proposed rule.
Transcripts of all 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. Issues and Their Resolution
There are seven issues that arise in responding to the two
petitions. These issues and their resolution are discussed below.
Issue 1: Should the limits in 10 CFR 35.75 or in 20.1301(a) govern
patient release? The petitioners requested an annual dose limit of 5
millisieverts (0.5 rem) for individuals exposed to radiation from a
released patient.
Supporting Comments
The majority of commenters favored a dose limit of 5 millisieverts
(0.5 rem) per year for individuals exposed to released patients rather
than the 1 millisievert (0.1 rem) in 10 CFR 20.1301(a). The
representatives from Agreement States who attended the public meeting
held in Atlanta, Georgia, on July 15 and 16, 1992, and the ACMUI public
workshop held in October 1992 in Rockville, Maryland, also favored the
5-millisievert (0.5-rem) limit. Some commenters stated that a dose
limit of 5 millisieverts (0.5 rem) per year for individuals exposed to
a patient is in line with the recommendations of the ICRP and the NCRP.
Some commenters believed that the 5-millisievert (0.5-rem) limit is
beneficial to both the patient and the family because patients are able
to return home earlier than would be permitted if a 1-millisievert
(0.1-rem) limit were used. One commenter believed that the case could
be made that no limit should be applied to the patient's family, just
maintain doses as low as reasonably achievable, because there is a
benefit to the family from the patient's being home. A physician
commented that many patients come from homes in which no member of the
family is under the age of 30, and therefore, contended that there was
less risk from radiation exposure. Other comments in favor included:
(1) Hospitalization can be a distressing experience for many cancer
patients; (2) patients can develop hospital acquired infections if kept
in the hospital too long; and (3) confining patients in a hospital
until the release criteria are met increases the dose to hospital
personnel and other patients.
Controlling the cost of medical care was one of the most cited
reasons in favor of the 5-millisievert (0.5-rem) limit. Concern was
expressed that the costs to all parties involved (i.e., patients,
hospitals, insurance companies, etc.) would dramatically rise if a 1-
millisievert (0.1-rem) limit were used. Commenters said a 1-
millisievert (0.1-rem) limit would require longer periods of
hospitalization, that many outpatients would become inpatients, and
that this would be extremely expensive.
Comments from nuclear power utilities supported the 5-millisievert
(0.5-rem) limit requested by PRM-20-20. These commenters stated further
that if the limit for annual dose to the public exposed to patients
were 5 millisieverts (0.5 rem), then the dose limit should be 5
millisieverts (0.5 rem) for all exposures to the public, including
those from nuclear power plants, because no demonstrable health effects
have been observed at chronic exposure levels of 5 millisieverts (0.5
rem).
Opposing Comments
A citizens' group commented that any amount of radiation, no matter
how small, carries a risk to the recipient. Thus, decisions that affect
the public health should be made strictly on the basis of health, not
economic considerations. A second citizens' group expressed similar
concerns.
A few commenters stated that the licensee already has the requested
relief because the Commission has made provision in 10 CFR 20.1301(c)
for approval of a licensee's request to increase the annual dose limit
to 5 millisieverts (0.5 rem) for individuals exposed to a patient.
Response
The NRC has determined that patient release should be governed by
10 CFR 35.75, not 10 CFR 20.1301(a). 10 CFR 35.75 of the NRC's
regulations adopted in 1986 (51 FR 36932; October 16, 1986) prohibits
an NRC licensee from authorizing patient release until the measured
dose rate from the patient is less than 0.05 millisievert (5 millirems)
per hour at 1 meter or the activity in the patient is less than 1,110
megabecquerels (30 millicuries). 10 CFR 20.1301(a) of the revised
standards for protection against radiation, adopted in 1991 (56 FR
23360; May 21, 1991), requires a licensee to limit the radiation dose
of any individual member of the public from licensed activities to less
than 0.1 rem (1 millisievert) (total effective dose equivalent) in a
year.
The NRC's view that 10 CFR 35.75 governs patient release represents
a reasonable interpretation of the Commission's regulations on this
subject. As a general rule, requirements in 10 CFR part 35 are ``in
addition to,'' rather than ``in substitution for,'' compliance with
other NRC requirements including 10 CFR part 20. However, in this case,
the dose limit of 10 CFR 20.1301(a), if it were interpreted to apply to
patient release, could require a license to continue confinement of a
patient whose release would be permitted under 10 CFR 35.75. The NRC
will not adopt this interpretation because that would make 10 CFR 35.75
essentially meaningless.
When the NRC proposed 10 CFR 35.75 (50 FR 30627; July 25, 1985), it
said, ``The Commission believes that either limit (i.e., 30 millicuries
of activity or the 6 milliroentgen per hour exposure rate at 1 meter)
provides an adequate measure of safety for the general public and that
further reductions in public exposure are not reasonably achievable
considering the cost and potential for detrimental effect from an
unnecessarily long hospital confinement.'' Further, when it approved 10
CFR 35.75 in final form, the NRC again said, ``The NRC believes that a
30-millicurie release limit provides an adequate measure of public
health and safety.'' See 51 FR 36932. The NRC's conclusion was based on
an independent NRC public health and safety judgement that is specific
to patient release. This conclusion was neither tied to nor designed to
implement the more general considerations in the 10 CFR part 20 dose
limits that had already been proposed when the conclusion of adequacy
was reached.
The NRC maintains that the public health and safety judgement
specific to patient release in 10 CFR part 35 should prevail over the
more general 10 CFR part 20. The criterion in the proposed 10 CFR part
35, 5 millisieverts (0.5 rem) total effective dose equivalent per year,
excluding background or any occupational exposure, is consistent with:
The Commission's provision in 10 CFR 20.1301(c) for authorizing a
licensee to operate up to this limit for limited periods of time; the
recommendations of the International Commission on Radiological
Protection (ICRP) in ICRP Publication 60,2 ``1990 Recommendations
of the International Commission on Radiological Protection;'' and the
recommendations of the National Council on Radiation Protection and
Measurements (NCRP) in NCRP Report No. 116,3 ``Limitation of
Exposure to Ionizing Radiation.'' Each of these provides a basis for
allowing individuals to receive annual doses up to 5 millisieverts (0.5
rem) under certain circumstances. Both the ICRP and NCRP recommend that
an individual be allowed to receive a dose up to 5 millisieverts (0.5
rem) in a given year in situations where exposure to radiation is not
expected to result in doses above 1 millisievert (0.1 rem) per year for
long periods of time, as would be the case for doses from released
patients. The recommendations of the ICRP and NCRP are based on their
findings that annual exposures in excess of 1 millisievert (0.1 rem) to
a small group of people, provided that they do not occur often to the
same group, need not be regarded as especially hazardous. Therapeutic
treatments with radioactive materials are limited to a relatively small
proportion of the population and are not often repeated for the same
patient.
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\2\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.
\3\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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Although the NRC adopted 10 CFR 20.1301(a) after 10 CFR 35.75, it
did not intend to supersede 10 CFR 35.75. There is no indication in the
associated statements of consideration or response to comments that NRC
intended to supersede 10 CFR 35.75 criteria when 10 CFR part 20 was
amended. Because the NRC finalized 10 CFR 35.75 after proposing
revisions to 10 CFR part 20 in 1986, the NRC's silence should indicate
that it did not intend the revised standards for protection against
radiation to supersede either 10 CFR 35.75 or the NRC's underlying
adequacy judgement.
As reflected in the above discussion, the NRC's finding of adequacy
with respect to patient release criteria does not apply to or set a
precedent for the operations of nuclear power plants. The basis for the
limit for patient release is justified by the considerations that
specifically apply to patient release.
To codify the policy regarding the issue of the applicability of 10
CFR 20.1301 to patient release, the NRC is proposing to amend 10 CFR
20.1301(a)(1) to explicitly exclude doses to individuals exposed to
released patients. In addition, 10 CFR 20.1301(a)(2) would be amended
by adding the words ``exclusive of the dose contributions from patients
administered radioactive material and released in accordance with
Sec. 35.75'' to make it clear 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.
Issue 2: Should the patient release criteria in 10 CFR 35.75 be
expressed as a dose-based limit instead of being expressed in terms of
activity retained in the patient and dose rate at 1 meter from the
patient?
Supporting Comments
While the choice of a dose-based vs. an activity-based limit was
not presented as an issue in the petitions, many commenters supported a
dose-based limit of 5 millisieverts (0.5 rem), although those same
commenters also generally supported retaining an activity limit.
Some commenters and the ACNM discussed the inadequacy of the
current activity-based limit in 10 CFR part 35 to deal with new
techniques such as the use of radiolabeled antibodies.
Supporting Comments
PRM-20-20 requested that patients given 1,110 megabecquerels (30
millicuries) of iodine-131, or more, be hospitalized and released in
accordance with the guidelines of NCRP Report No. 37, and that the
maximum activity that a patient can be released with for a specific
nuclide be consistent with the calculations methodology of NCRP Report
No. 37. Many commenters and representatives from the Agreement States
that attended the public workshop held in Atlanta, Georgia, on July 15
and 16, 1992, also agreed with this reqiuest.
Opposing Comments
No comments opposing the methodology in NCRP Report No. 37 were
received.
Response
The NRC agrees that the calculational methodology of NCRP Report
No. 37 can be used to calculate external doses from patients. Although
NCRP Report No. 37 is dated, it still contains an appropriate method to
calculate the integrated dose at 1 meter from a patient following
administration of certain radionuclides. This methodology is modified
in the draft regulatory guide to calculate activities to meet the 5-
millisievert (0.5-rem) (total effective dose equivalent) limit.
Opposing Comments
Several commenters, as well as representatives from the Agreement
States and the ACMUI, noted that the 1,110-megabecquerel (30-
millicurie) activity limit is a simple method to demonstrate compliance
with NRC regulations and should be retained.
PRM-20-20 requested that the NRC specify an activity for each
specific radionuclide consistent with the calculational methodology of
NCRP Report No. 37, ``Precautions in the Management of Patients Who
Have Received Therapeutic Amounts of Radionuclides.''
Response
The NRC's primary concern is the public's health and safety. Doses
are a measure of degree of protection, whereas activity of different
radionuclides is not related in any consistent way to the level of
protection. For this reason, the NRC proposes to establish a dose limit
as the only patient release criterion in 10 CFR 35.75. The proposed
dose limit is 5 millisieverts (0.5 rem) total effective dose equivalent
in a year. This dose limit is consistent with the underlying risk basis
of the current 10 CFR 35.75 (50 FR 30627), the recommendations of the
ICRP, and the provisions in 10 CFR 20.1301(c), pertaining to temporary
situations in which there is requisite justification for a dose limit
higher than 1 millisievert (0.1 rem).
Unlike the current 10 CFR 35.75, the proposed 10 CFR 35.75 does not
specify an activity or dose rate for authorizing patient release. The
1,110-megabecquerel (30-millicurie) requirement was not retained
because the doses from a released patient are different for different
radionuclides that have the same activity. Likewise, a release
criterion based on dose rate from the patient is not a uniform
indicator of dose because the total dose depends on the effective half-
life of the radioactive material in the body of the patient and other
factors, which will differ for different materials.
In most cases, the dose received by an individual exposed to the
patient will be from external exposure. However, in the case of a
breast-feeding mother, the infant could be exposed following ingestion
of breast milk. In this case, the 5-millisievert (0.5-rem) limit
applies to the infant as the individual likely to receive the highest
exposure.
To help licensees easily determine if they may authorize the
release of a patient, a draft regulatory guide, published concurrently
with this proposed rule, contains a table that specifies the activity
of commonly used radionuclides with which a patient can be released in
compliance with the proposed dose limit. The table in the draft guide
provides a simple method to demonstrate compliance that assumes no
biological elimination of the radioactive material. For example, in the
case of iodine-131, the value specified is 1,200 megabecquerels (33
millicuries). The draft regulatory guide also offers guidance for the
licensee who chooses to calculate activities at which patient release
may be authorized based upon case specific information. Single copies
of the draft regulatory guide are available as indicated in the
ADDRESSES heading.
The 0.05 millisievert (5 millirems) per hour at 1 meter dose rate
limit was not retained in the regulation because, in essence,
consideration of the dose rate is included in calculating the activity
for each of the radionuclides specified in the draft regulatory guide.
In addition, the draft regulatory guide now relates the dose rate with
the release criteria in the proposed 10 CFR 35.75.
Newer techniques, such as the therapeutic use of radiolabeled
antibodies, involve the administration of perhaps as much as several
gigabecquerels (hundreds of millicuries). These newer techniques
require that a patient remain under the control of the licensee for a
much longer period of time before the current release criteria can be
met. By changing the basis for the release of patients in the proposed
rule to an annual dose limit, the activity or resulting dose rate are
no longer the only limiting factors upon which a patient release is
based. Under the proposed rule, the dose would be the determining
criteria, irrespective of the amount of radioactive material
administered or the potential pathways of exposure of individuals as a
result of contact with the patient. This is particularly important for
proper control of some types of materials, such as strong beta
emitters, which do not pose a large external dose hazard. In these
cases, dose through inhalation or ingestion of contamination could be
significant pathways and must be accounted for in a calculation for
compliance. To demonstrate compliance with the proposed rule in this
situation, the optional calculational method described in the draft
regulatory guide could be used, potentially resulting in an earlier
patient release than would otherwise have been allowed, while still
providing the specified level of protection.
Issue 3. Should the calculational methodology in NCRP Report No.
37, ``Precautions in the Management of Patients Who Have Received
Therapeutic Amounts of Radionuclides,'' be an acceptable means to
demonstrate compliance with the proposed rule?
Issue 4. Should, as the ACNM requested, the word ``confinement'' be
defined to include confinement in a private residence?
Supporting Comments
The ACNM petitions stated that 10 CFR 35.75 seems to mandate
hospitalization as the only place of confinement for patients receiving
radiopharmaceutical therapy for compliance with 10 CFR 35.75. The ACNM
petitions also stated that 10 CFR 35.75 overlooks the merits of a
necessary option, temporary home confinement, for outpatient
radiopharmaceutical therapy at levels exceeding 1,110 megabecquerels
(30 millicuries). This petition further stated that patients containing
quantities up to 14,800 megabecquerels (400 millicuries) of iodine-131
could be confined in a private residence, as justified by published
scientific papers that contend that home confinement of such patients
would not adversely affect public health and safety.
Another commenter supported home confinement because it would
greatly improve patient comfort while reducing medical expenditures by
a considerable amount, and that this can be accomplished without any
significant risk to the public. Some commenters believed that patients
confined at home with as much as 14,800 megabecquerels (400
millicuries) of iodine-131 would not create a safety hazard to the
public if simple precautions were followed.
Several commenters believed that they had been told by the NRC that
the use of the term confinement in 10 CFR 35.75 provided for a
nonhospital option.
A couple of commenters suggested that if a patient is medically
capable of self-care, informed and cooperative, release in amounts
greater than 1,110 megabecquerels (30 millicuries) is sensible.
Opposing Comments
The Conference of Radiation Control Program Directors (CRCPD)
commented that confinement should not be defined in 10 CFR part 35
because the present wording already provides the option to confine
patients by means other than hospitalization.
An Agreement State representative remarked that it is not realistic
to believe that a person will go home and lock themselves in a room for
two to three days with limited contact with family and friends. Another
Agreement State representative maintained it is difficult to control
actions of an ambulatory patient and difficult to ensure that the
patient has remained in confinement. This commenter also noted that the
ACNM definition does not address transportation to a confined area in a
private residence that would prohibit a patient from using public
transportation.
A former radiopharmaceutical therapy patient opposed the changing
of the existing requirements. He said that cutting hospital costs by
releasing highly radioactive patients may afford short-term economic
benefits for health care providers but it carries serious health and
safety risks to the family and the public. He also indicated that some
people would have a difficult time following the extensive advice that
is given as to the precautions to be taken on returning home.
Some commenters expressed the belief that release from a hospital
with activities as high as 14,800 megabecquerels (400 millicuries) of
iodine-131 is dangerous to public health and safety.
Response
The NRC has decided that the term ``confinement'' should be deleted
from the proposed revision to 10 CFR 35.75. Instead, the proposed rule
language now uses the phrase ``licensee control.'' The NRC believes
that the phrase ``licensee control'' more clearly reflects the NRC's
intent.
The phrase ``licensee control'' refers to the ability of the
licensee to demonstrate that it can control doses to other individuals
from the patient, as well as the spread of radioactive material. The
licensee maintains control both from the location of patients and by
the actions the licensee takes to control doses. Although licensee
control does not necessarily restrict a patient to a hospital, the
location of the patient must be listed as a place of use on the license
or a license amendment must be issued pursuant to 10 CFR 35.13(e).
Additional choices would be available (e.g., hospices or nursing homes)
as long as the licensee can demonstrate that it can control doses to
other individuals as well as the spread of radioactive material.
The NRC believes that there is a distinct difference between a
patient being ``confined'' in a hospital and ``confined'' in a home. In
hospital confinement, 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. Therefore, as a
general practice, the NRC does not want licensees to use a patient's
home for the purpose of confining the patient.
Issue 5. Should 10 CFR 20.1301(d) require compliance with
Environmental Protection Agency (EPA) regulations? PRM-20-20 stated
that compliance with the EPA's Clean Air Act air effluent standards
would cost medical facilities $100,000,000 per year, which would be
added to national health care costs.
Supporting Comments
Most comments from physicians and medical associations expressed
concern over redundant NRC and EPA regulations contained in 40 CFR 61
resulting from the EPA's limitation on air effluent from NRC-licensed
facilities.
Opposing Comments
No opposing comments were received.
Response
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. 40 CFR part 190 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 apply to hospitals. The NRC is separately pursuing actions with
the EPA to minimize the impact of dual regulation under the Clean Air
Act.
Because the reference to EPA regulations in 10 CFR 20.1301(d) has
nothing to do with the patient release issue and has no impact on the
petitioner, the NRC will not grant this request of the petitioner.
Issue 6. Should the regulations require that patients, upon
release, receive written instructions on how to maintain doses to other
individuals as low as reasonably achievable?
Supporting Comments
PRM-20-20 recommended education of the patient and the care
provider. Some commenters supported written instructions for the
patient upon release. Representatives from the Agreement States who
attended the public workshop held in Atlanta, Georgia, on July 15 and
16, 1992, and the ACMUI public workshop held in October 1992 in
Rockville, Maryland, also agreed with this concept.
Opposing Comments
A physician stated that instructions regarding patient activities
significantly increase apprehension needlessly.
Response
The NRC agrees that written instructions on how to maintain doses
as low as reasonably achievable to people exposed to released patients
should be provided. These written instructions would specify what
actions should or should not be taken by the released patients and by
the individuals potentially exposed. In fact, written instructions are
already required under 10 CFR 35.315(a)(6) and 35.415(a)(5). Under the
proposed 10 CFR 35.75(b), when the total effective dose equivalent to
any individual other than the released patient is likely to exceed 1
millisievert (0.1 rem) from a single administration, the licensee would
be required to provide written instructions to the patient on how to
maintain doses as low as reasonably achievable to household members and
other individuals. 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.
Written instructions provide an available reference after the
patient's release, if questions regarding patient care arise. Written
instructions reduce the chance of misunderstanding the licensee's
instructions as verbal instructions may not be properly conveyed to
persons not present at the time of release. The NRC also believes that
providing written instructions will help relieve apprehensions of the
patient, primary care-giver, and family.
The draft regulatory guide published concurrently with this
proposed rule includes recommended contents of the written
instructions. The instructions should be specific to the type of
treatment given, such as radioiodine for hyperthyroidism or thyroid
carcinoma, or permanent implants; and may include additional
information regarding individual situations. The instructions should
include a contact and phone number in case the patient has any
questions. Written instructions should include, as appropriate: (1)
maintaining distance from individuals, including sleeping arrangements
and the need to avoid public transportation; (2) the need to stop
breast-feeding if appropriate; (3) avoidance of public places (such as
grocery stores, shopping centers, theaters, restaurants, and sporting
events); (4) hygiene; and (5) the length of time precautions should be
taken. Not all of these precautions are necessary for every patient;
therefore, patients should be given specific instructions that are
applicable to their situation.
Issue 7. Should records of patients released containing radioactive
materials be required?
Although the issue of records did not arise in the petitions or the
comments on the petitions, proposed 10 CFR 35.75(b) would require the
licensee to maintain a record of the basis for the patient's release
and the calculations performed to determine the total effective dose
equivalent if an individual is likely to receive a dose in excess of 1
millisievert (0.1 rem) in a year from a single administration. It is
anticipated that this requirement will be met by either a notation,
such as a reference to the Regulatory Guide, or calculation(s) to be
retained in the patient's file. This record would provide a basis for
assuring that the maximum dose to an individual exposed to the patient
is below 5 millisieverts (0.5 rem) for any single administration. This
record also provides the basis for ensuring that doses from multiple
administrations greater than 1 millisievert (0.1 rem) each do not total
more than 5 millisieverts (0.5 rem) in any year.
The 1-millisievert (0.1-rem) threshold for recordkeeping is based
on the public dose limit of 1 millisievert (0.1 rem) specified in 10
CFR part 20. This threshold would not result in an undue recordkeeping
burden for the majority of diagnostic administrations because these
administrations are well below 1-millisievert (0.1-rem). Based on the
regulatory analysis, the majority of administrations requiring records
involve iodine-131 therapeutic administrations and a few diagnostic
procedures using iodine-131. Recordkeeping would affect less than one
percent of all administrations. (For further information, see the
regulatory analysis for the proposed rule. Single copies of the draft
regulatory analysis are available as indicated in the ADDRESSES
heading.)
The proposed record retention period of 3 years is consistent with
similar recordkeeping requirements in 10 CFR parts 20 and 35.
VII. Summary of the Proposed Changes
This section summarizes the regulation changes that are being
proposed. The NRC proposes 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 is not a
substantive change but clarifies the NRC policy that patient release is
governed by 10 CFR 35.75, not 10 CFR 20.1301, as discussed above under
Issue 1.
The NRC proposes 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 of this change is
to clarify that licensees are not required to control areas, such as a
waiting room, simply because of the presence of a patient released
pursuant to 10 CFR 35.75. If a patient is not required to be confined
pursuant to 10 CFR 35.75, licensees are not required to limit the
radiation dose to members of the public (e.g., visitor in a waiting
room) from a patient to 0.02 millisievert (2 millirems) in any one
hour. Patient waiting rooms or hospital rooms need only be controlled
for those patients not meeting the release criteria in 10 CFR 35.75.
The NRC proposes to adopt 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) in any one year, excluding
background or any occupational exposure, to an individual from exposure
to a released patient. The reasons for this change were discussed above
under Issue 2. In brief, a dose-based limit provides a single limit
that can be used to provide an equivalent level of risks from all
radionuclides. Also, the proposed changes are supported by the
recommendations of the ICRP and NCRP that an individual can be allowed
to receive an annual dose up to 5 millisieverts (0.5 rem) in temporary
situations where exposure to radiation is not expected to result in
doses above 1 millisievert (0.1 rem) for long periods of time.
Doses among individuals who may come in contact with a released
patient are highly variable and reflect the crucial, but difficult to
define, parameters of time, distance, and shielding. Although all
members of society have the potential for exposure to a released
patient, based on time and distance considerations, it is reasonable to
conclude that for the overwhelming majority of released patients, the
maximally exposed individual is likely to be one who is aware of the
patient's condition such as the primary care-giver, a family member, or
any other individual who spends significant time close to the patient.
The NRC proposes 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 as low as reasonably achievable doses to other individuals
if the total effective dose equivalent to any individual other than the
released patient is likely to exceed 1 millisievert (0.1 rem) in any
one year. A requirement for written instructions for certain patients
was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5). The
proposed requirement would add approximately 50,000 patients per year
who are administered iodine-131 for the treatment of hyperthyroidism.
The purpose of the written instructions is to maintain as low as
reasonably achievable doses to individuals exposed to patients, as
discussed in more detail under Issue 6.
The NRC proposes to revise 10 CFR 35.75(b)(2) to require that
licensees maintain a record of the basis for the patient's release for
three years. These records must include the calculations performed to
determine the total effective dose equivalent of 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. It is
anticipated that this requirement will be met by either a notation,
such as a reference to the applicable regulatory guide or
calculation(s) to be retained in the patient's file. The major purpose
of the change is to provide the basis for controlling the dose to
individuals exposed to a patient who may receive more than one
administration in a year, as discussed above under Issue 7.
Finally, the NRC proposes to amend its requirements on written
instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations
already required written instructions in certain cases, but the phrase
``if required by Sec. 35.75(b)'' was added. The purpose of this change
was to ensure internal consistency within 10 CFR part 35 on when
written instructions must be provided.
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 this policy states that, ``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
proposed rule is consistent with this statement because its purpose is
to provide for the safety of individuals exposed to patients who are
administered radioactive materials.
The second statement of the policy states that, ``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
proposed rule because the proposed rule does not affect the safety of
patients themselves but affects the safety of individuals exposed to
patients.
The third statement of the policy states that, ``The NRC will
minimize intrusion into medical judgements affecting patients and into
other areas traditionally considered to be a part of the practice of
medicine.'' The proposed 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 rather than solely a matter of medical judgement.
Thus, the proposed rule is considered to be consistent with the
1979 medical policy statement.
IX. Issue of Compatibility for Agreement States
The NRC believes that the proposed modifications to 10 CFR
20.1301(a) and 10 CFR 35.75 should be Division 1 and 2 items of
compatibility, respectively, because the patient release criteria
required by the rule are the minimum requirements necessary to ensure
adequate protection of public health and safety. However,
representatives of the Agreement States who attended the public
workshop held in Atlanta, Georgia, on July 15 and 16, 1992, have
recommended that the proposed changes to 10 CFR part 35 should not be a
matter of compatibility (i.e., Division 3) for the Agreement States. In
addition, two Agreement States in their written comments on the draft
rule reviewed in July 1993 addressed the issue of patient release under
10 CFR part 35 as a Division 3 matter. Under Division 2 status, the
Agreement States must address the changes and may adopt more stringent
requirements, but may not adopt less stringent provisions.
X. 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 proposed amendments, if adopted, would not be
a major Federal action significantly affecting the quality of the human
environment and therefore, an environmental impact statement is not
required. The proposed amendment would clarify the pertinent regulatory
language to reflect explicitly the relationship between 10 CFR part 20
and part 35 with respect to release of patients, and revise the release
criteria for patients receiving radioactive material for medical use
from an activity-based standard to a dose basis. Because the risk basis
of the current regulation remains unchanged, it is expected that there
would be no significant change in radiation dose to the public as a
result of the revised regulation.
The draft 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 draft environmental assessment and
the finding of no significant impact are available as indicated in the
FOR FURTHER INFORMATION CONTACT heading.
XI. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et
seq.). This rule has been submitted to the Office of Management and
Budget for review and approval of the information collection
requirements.
The public reporting burden for this collection of information is
estimated to average 0.42 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to the Information and Records
Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; and to the Desk Officer, Office of
Information and Regulatory Affairs, NEOB-3019 (3150-0010), Office of
Management and Budget, Washington, DC 20503.
XII. Regulatory Analysis
The NRC has prepared a regulatory analysis (NUREG-1492) for the
proposed amendment. The analysis examines the benefits and impacts
considered by the NRC. The regulatory analysis is available for
inspection at the NRC Public Document Room at 2120 L Street NW. (Lower
Level), Washington, DC. Single copies are available as indicated under
the FOR FURTHER INFORMATION CONTACT heading.
XIII. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the NRC certifies that, if adopted, this proposed rule would
not have a significant economic impact on a substantial number of small
entities. As a result of the revised regulation, the impact would not
be significant because the revised regulation basically represents a
continuation of current practice.
The NRC is seeking public comment on the initial regulatory
flexibility certification. The NRC is particularly seeking comment from
small entities as defined under the NRC's size standards published on
November 6, 1991 (56 FR 56672), as to how the regulations will affect
them and how the regulations may be tiered or otherwise modified to
impose less stringent requirements on small entities while still
adequately protecting the public health and safety. Any small entity
subject to this regulation who determines that, because of its size, it
is likely to bear a disproportionate adverse economic impact should
offer comments that specifically discuss the following items:
(a) The licensee's size and how the proposed regulation would
result in a significant economic burden or whether the resources
necessary to implement this amendment could be more effectively used in
other ways to optimize public health and safety, as compared to the
economic burden on a larger licensee;
(b) How the proposed regulation could be modified to take into
account the licensee's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulation were modified as suggested by the
licensee;
(d) How the proposed regulation, as modified, could more closely
equalize the impact of NRC regulations or create more equal access to
the benefits of Federal programs as opposed to providing special
advantages to any individual or group; and
(e) How the proposed regulation, as modified, would still
adequately protect the public health and safety.
The comments should be sent to the Secretary of the Commission,
U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN:
Docketing and Service Branch. Hand deliver comments to 11555 Rockville
Pike, Rockville, Maryland, between 7:45 a.m. and 4:15 p.m. Federal
workdays.
XIV. Backfit Analysis
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this proposed rule and, therefore, that a backfit analysis
is not required for this proposed rule, because these amendments do not
involve any provisions which would impose backfits as defined in 10 CFR
50.109(a)(1).
XV. List of Subjects
10 CFR part 20
Byproduct material, Licensed material, Nuclear materials, Nuclear
power plants and reactors, Occupational safety and health, Packaging
and containers, Penalty, Radiation protection, Reporting and recording
requirements, Special nuclear material, Source material, Waste
treatment and disposal.
10 CFR part 35
Byproduct material, Criminal penalty, Drugs, Health facilities,
Health professions, Incorporation by reference, Medical devices,
Nuclear materials, Occupational safety and health, Penalty, Radiation
protection, Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to
adopt the following amendments to 10 CFR parts 20 and 35.
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
1. The authority citation for part 20 is revised to read as
follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C.
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (U.S.C.
5841, 5842, 5846).
2. 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 mSv)
in a year, exclusive of the dose contributions from the licensee's
disposal of radioactive material into sanitary sewerage in accordance
with Sec. 20.2003 and from patients administered radioactive material
and released in accordance with Sec. 35.75, 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 mSv) in any one hour.
* * * * *
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
3. 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).
4. 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. 35.12, 35.13, 35.14, 35.21, 35.22, 35.23,
35.27, 35.29, 35.13, 35.50, 35.51, 35.53, 35.59, 35.60, 35.61, 35.70,
35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406,
35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636,
35.641, 35.643, 35.645, and 35.647.
* * * * *
5. Section 35.75 is revised to read as follows:
Sec. 35.75 Release of patients containing radiopharmaceuticals or
permanent implants.
(a) A licensee may authorize release from licensee control any
patient administered radiopharmaceuticals or permanent implants
containing radioactive material if the total effective dose equivalent
to an individual from exposure to the released patient is not likely to
exceed 5 millisieverts (0.5 rem) in any one year.
(b) 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, upon release the licensee
shall:
(1) Provide the patient with written instructions on how to
maintain doses to other individuals as low as reasonably achievable;
and
(2) Maintain, for three years, a record of the released patient and
the calculated total effective dose equivalent to the individual likely
to receive the highest dose.
6. In Sec. 35.315, paragraph (a)(6) is revised to read as follows:
Sec. 35.315 Safety precautions.
(a) * * *
(6) Provide the patient with radiation safety guidance, if required
by Sec. 35.75(b), that will help to keep radiation dose to household
members and the public as low as reasonably achievable before
authorizing release of the patient.
* * * * *
7. In Sec. 35.415, paragraph (a)(5) is revised to read as follows:
Sec. 35.415 Safety precautions.
(a) * * *
(5) Provide the patient with radiation safety guidance, if required
by Sec. 35.75(b), that will help to keep radiation dose to household
members and the public as low as reasonably achievable before releasing
the patient if the patient was administered a permanent implant.
* * * * *
Dated at Rockville, MD, this 9th day of June, 1994.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 94-14544 Filed 6-14-94; 8:45 am]
BILLING CODE 7590-01-P
