[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