Criteria for the Release of Patients Administered Radioactive Material

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