Criteria for the Release of Individuals Administered Radioactive Material

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20 and 35

RIN 3150-AE41

Criteria for the Release of Individuals Administered Radioactive

Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its

regulations concerning the criteria for the release of patients

administered radioactive material. The new criteria for patient release

are based on the potential dose to other individuals exposed to the

patient. The new criteria are consistent with the recommendations of

the National Council on Radiation Protection and Measurements (NCRP)

and the International Commission on Radiological Protection (ICRP).

This final rule requires the licensee to provide written instructions

to patients on how to maintain the doses to others as low as is

reasonably achievable if the total effective dose equivalent to any

other individual exposed to the released patient is likely to exceed 1

millisievert (0.1 rem). This final rule responds to three petitions for

rulemaking regarding the criteria for release of patients administered

radioactive material.

EFFECTIVE DATE: May 29, 1997.

ADDRESSES: Copies of Regulatory Guide 8.39, ``Release of Patients

Administered Radioactive Materials''; the final regulatory analysis,

NUREG-1492, ``Regulatory Analysis on Criteria for the Release of

Patients Administered Radioactive Material'' (1997); Revision 2 of

NUREG/BR-0058, ``Regulatory Analysis Guidelines of the U.S. Nuclear

Regulatory Commission'' (1996); and the public comments received on the

proposed rule may be examined and copied for a fee in the Commission's

Public Document Room at 2120 L Street NW. (Lower Level), Washington,

DC. Single copies of Regulatory Guide 8.39 may be obtained free of

charge by writing the Office of Administration, Attn: Distribution and

Services Section, USNRC, Washington, DC 20555, or by fax at (301) 415-

2260. Single copies of NUREG-1492 and NUREG/BR-0058 may be purchased at

current rates from the U.S. Government Printing Office, P.O. Box 37082,

Washington, DC 20402-9328 (telephone (202) 512-1800); or from the

National Technical Information Service at 5285 Port Royal Road,

Springfield, VA 22161.

FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear

Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC

20555, telephone (301) 415-6225.

I. Background

Each year in the United States, radioactive pharmaceuticals or

compounds or radioactive implants are administered to approximately 8

to 9 million individuals for the diagnosis or treatment of disease or

for human research. These individuals to whom radioactive materials

have been administered are hereinafter referred to as ``patients.''

These patients can expose others around them to radiation until the

radioactive material has been excreted from their bodies or the

radioactivity has decayed away.

NRC's current patient release criteria in 10 CFR 35.75, ``Release

of patients or human research subjects containing radiopharmaceuticals

or permanent implants,'' are as follows:

``(a) A licensee may not authorize release from confinement for

medical care any patient or human research subject administered a

radiopharmaceutical until either: (1) The measured dose rate from the

patient or human research subject is less than 5 millirems per hour at

a distance of 1 meter; or (2) The activity in the patient or human

research subject is less than 30 millicuries; (b) A licensee may not

authorize release from confinement for medical care of any patient or

human research subject administered a permanent implant until the

measured dose rate from the patient or human research subject is less

than 5 millirems per hour at a distance of 1 meter.''

On May 21, 1991 (56 FR 23360), the NRC published a final rule that

amended 10 CFR part 20, ``Standards for Protection Against Radiation.''

The rule contained limits on the radiation dose for members of the

public in 10 CFR 20.1301. However, when 10 CFR part 20 was issued,

there was no discussion in the supplementary information on whether or

how the provisions of 10 CFR 20.1301 were intended to apply to the

release of patients.

Some licensees were uncertain about what effect the revised 10 CFR

part 20 would have on patient release criteria, and two petitions for

rulemaking were received on the issue. On June 12, 1991 (56 FR 26945),

the NRC published in the Federal Register a notice of receipt of, and

request for comment on, a petition for rulemaking (PRM-20-20) from Dr.

Carol S. Marcus. In addition, Dr. Marcus submitted a letter dated June

12, 1992, further characterizing her position.

[[Page 4121]]

On March 9, 1992 (57 FR 8282), the NRC published a notice of

receipt and request for comment in the Federal Register on another

petition for rulemaking (PRM-35-10) on patient release criteria from

the American College of Nuclear Medicine (ACNM). On May 18, 1992 (57 FR

21043), the NRC published in the Federal Register notice of an

amendment submitted by the ACNM to its original petition (PRM-35-10A).

In addition, a third petition (PRM-35-11) dealing, in part, with

these same issues was submitted by the American Medical Association

(AMA). That petition was noticed in the Federal Register on July 26,

1994 (59 FR 37950). The main point raised in the petition was that the

radiation dose limits in 10 CFR part 20 should not apply to individuals

exposed to the patient and that the dose limit to the individuals

should be 500 millirems per year. The AMA believed that 10 CFR 20.1301

would have an adverse impact on the availability and the cost of

treatment of thyroid disease, which would outweigh the advantages of

reduced radiation exposure to the public. The AMA stated that treatment

of up to 10,000 cancer patients annually for thyroid carcinoma would

require the hospitalization of the patients under the revised

regulation (10 CFR 20.1301), reducing both early release of patients

and the treatment of patients at home.

II. Publication of the Proposed Rule

On June 15, 1994 (59 FR 30724), in response to the first two

petitions, the NRC published a proposed rule on criteria for the

release of patients administered radioactive material. The proposed

rule discussed the public comment letters received on the first two

petitions. Three additional comment letters were received on the third

petition (PRM-35-11). These letters each supported the petition but did

not contain any additional information not covered by the letters on

the first two petitions.

The NRC proposed to amend 10 CFR 20.1301(a)(1) to specifically

state that the dose to individual members of the public from a licensed

operation does not include doses received by individuals exposed to

patients who were released by the licensed operation under the

provisions of 10 CFR 35.75. This was to clarify that the Commission's

policy is that patient release is governed by 10 CFR 35.75, not 10 CFR

20.1301.

The NRC proposed to amend 10 CFR 20.1301(a)(2) to specifically

state that the limit on dose in unrestricted areas does not include

dose contributions from patients administered radioactive material and

released in accordance with 10 CFR 35.75. The purpose was to clarify

that licensees would not be required to control areas (such as waiting

rooms) simply because of the presence of a patient released pursuant to

10 CFR 35.75. If a patient has been released from licensee control

pursuant to 10 CFR 35.75, licensees would not be required to limit the

radiation dose from a patient to members of the public (e.g., visitors

in a waiting room) to 0.02 millisievert (2 millirems) in any 1 hour.

Patient waiting rooms or hospital rooms would need only be controlled

for those patients not meeting the release criteria in 10 CFR part 35.

The NRC proposed to adopt a new 10 CFR 35.75(a) to change the

patient release criteria from 1,110 megabecquerels (30 millicuries) of

activity in a patient or a dose rate of 0.05 millisievert (5 millirems)

per hour at 1 meter from a patient to a total effective dose equivalent

not to exceed 5 millisieverts (0.5 rem) in any 1 year to an individual

from exposure to a released patient. A dose-based limit provides a

single limit that could be used to provide an equivalent level of risks

from all radionuclides. Also, the proposed changes were supported by

the recommendations of the ICRP and the NCRP that an individual could

be allowed to receive an annual dose up to 5 millisieverts (0.5 rem) in

temporary situations when exposure to radiation is not expected to

result in annual doses above 1 millisievert (0.1 rem) for long periods

of time.

The NRC proposed to adopt a new 10 CFR 35.75(b)(1) to require that

the licensee provide released patients with written instructions on how

to maintain doses to other individuals as low as is reasonably

achievable if the total effective dose equivalent to any individual

other than the released patient is likely to exceed 1 millisievert (0.1

rem) in any 1 year. A requirement to give instructions to certain

patients was already contained in 10 CFR 35.315(a)(6) and 35.415(a)(5),

but the proposed requirement would also require instructions for an

additional 50,000 individuals who are administered iodine-131 for the

treatment of hyperthyroidism and another 27,000 individuals who are

breast-feeding and administered various diagnostic and therapeutic

radioactive materials. The purpose of the instructions is to maintain

doses to individuals exposed to patients as low as is reasonably

achievable.

The NRC proposed to adopt a new 10 CFR 35.75(b)(2) to require that

licensees maintain, for 3 years, a record of the released patient and

the calculated total effective dose equivalent to the individual likely

to receive the highest dose if the total effective dose equivalent to

any individual other than the released patient is likely to exceed 1

millisievert (0.1 rem) in a year from a single administration. The

major purpose was to provide a record to allow licensees to assess the

need to limit the dose to individuals exposed to a patient who may

receive more than one administration in a year.

Finally, the NRC proposed to amend its requirements on instructions

in 10 CFR 35.315(a)(6) and 35.415(a)(5). These regulations already

required instructions (not necessarily written) in certain cases, but

the phrase ``if required by Sec. 35.75(b)'' was added to each. The

purpose of this change was to make part 35 consistent as to when

instructions must be given.

In addition, the NRC concurrently issued an associated draft

regulatory guide and supporting draft regulatory analysis for public

comment. The draft regulatory guide, DG-8015, ``Release of Patients

Administered Radioactive Materials,'' proposed guidance on determining

the potential doses to an individual likely to receive the highest dose

from exposure to a patient and established appropriate activities and

dose rates for release of a patient. The draft guide also proposed

guidelines on instructions for patients on how to maintain doses to

other individuals as low as is reasonably achievable and it described

recordkeeping requirements. The draft regulatory analysis, NUREG-1492,

``Regulatory Analysis on Criteria for the Release of Patients

Administered Radioactive Material'' (May 1994), examined the benefits

and impacts of the proposed rule considered by the NRC.

III. Public Comments on the Proposed Rule

A total of 63 comment letters were received on the proposed rule,

the draft regulatory guide, and the draft regulatory analysis. A

majority of the comment letters were from medical practitioners and

medical organizations, but there were also comment letters from private

individuals, public-interest groups, and regulatory agencies in

Agreement States. Overall, the majority of comment letters supported a

dose limit of 5 millisieverts (0.5 rem) for individuals exposed to

patients released with radioactive material. However, about one-fourth

of the comment letters opposed the proposed recordkeeping requirement.

The significant comments are discussed below, arranged by subject.

[[Page 4122]]

Exclusion of Patient Release From Sec. 20.1301(a)

All the commenters except one supported governing patient release

by the regulations in 10 CFR 35.75 and excluding the dose to

individuals exposed to a released patient from 10 CFR 20.1301(a).

Comment. One commenter, representing a public-interest group,

objected to any exposure of a member of the general public who has not

consented freely to the dosage. They said that such exposure would lead

to widespread morbidity and mortality.

Response. In its revision of 10 CFR part 20 (56 FR 23360; May 21,

1991), the NRC determined that, while doses should be maintained as low

as is reasonably achievable, a dose limit of 1 millisievert (0.1 rem),

or a dose limit of 5 millisieverts (0.5 rem) in certain special

circumstances, provides adequate protection. The revised part 20 is

based, in part, upon the recommendations of the International

Commission on Radiological Protection (ICRP) and the recommendations of

the National Council on Radiation Protection and Measurements (NCRP).

The NCRP recommends public dose limits of 1 millisievert (0.1 rem) for

continuous or frequent exposure and 5 millisieverts (0.5 rem) for

infrequent exposure.

The ICRP recommends that the limit for public exposure should be

expressed as an effective dose of 1 millisievert (0.1 rem) in a year,

except that, in special circumstances, the dose could be higher in a

single year provided the average over 5 years does not exceed 1

millisievert (0.1 rem) per year. In ICRP Publication 60, in defining

medical exposure, ICRP stated that medical exposure includes

``exposures (other than occupational) incurred knowingly and willingly

by individuals helping in the support and comfort of patients

undergoing diagnosis or treatment.'' Furthermore, in explaining dose

limits in medical exposure, the ICRP stated in the same publication

that ``the Commission therefore recommends that dose limits should not

be applied to medical exposures.'' Thus, in ICRP's opinion, family

members who are helping in the support and comfort of patients would

not be restricted under the dose limit stated above.

The revision of part 20 incorporated the long-term objective as the

dose limit and included a provision (Sec. 20.1301(c)) to allow for

alternative limits on an occasional basis. Section 20.1301(c) provides

that an annual dose of up to 5 millisieverts (0.5 rem) is acceptable if

there is a need for it and if steps are taken to reduce the dose to as

low as is reasonably achievable. The NRC reaffirms that previous

determination in this rulemaking.

In the case of released patients, it would be unlikely for a single

individual exposed to a patient to receive a dose in a year of over 5

millisieverts (0.5 rem) because large therapeutic doses (greater than

3,700 megabecquerels (100 millicuries)) are usually not administered

more than once to the same patient in a given year.

Comment. One commenter said that the NRC should change the 0.1 rem

dose limit for the public in 10 CFR 20.1301(a)(1) to 0.5 rem for all

licensed activities because a dose limit of 0.5 rem offers adequate

protection and is a dose that has no proven effects.

Response. This issue of the general public dose limit is outside

the scope of this rulemaking. The issue was dealt with when 10 CFR part

20 was recently revised (56 FR 23360; May 21, 1991). That rulemaking

explained the NRC's rationale for adopting the 1-millisievert (0.1-rem)

dose limit in 10 CFR 20.1301(a)(1).

Activity-Based vs. Dose-Based Release Limit

The issue is whether to retain the current patient release limit in

10 CFR 35.75, which is expressed as an activity limit together with an

alternative but approximately equivalent limit on dose rate at 1 meter,

or to express the release limit as a dose to an individual exposed to

the patient. The majority of commenters supported the dose-based limit.

However, some commenters opposed the dose-based approach.

Comment. A number of commenters said that 10 CFR 35.75 should not

be changed and that the 30 millicurie or 5 millirem per hour release

criteria should be retained because they are working well. Some

commenters said that a dose-based release limit as proposed would cause

confusion and potential problems. One commenter said that the Part 20

revision was not intended to alter the status quo for patient release.

Commenters objected to the dose-based release limit because they

thought the dose estimates to the public would be very inaccurate as

these estimates are based on the unreliable method of predicting the

anticipated time and proximity to others. Commenters also said that

dose estimation and the subsequent recordkeeping would be time

consuming and would add to the cost of treatment without a probable

significant decrease in radiation exposure.

Response. The NRC is adopting a dose-based limit rather than an

activity-based limit because the dose-based limit better expresses the

NRC's primary concern for the public's health and safety. A single

activity requirement was not retained because different radionuclides

with the same activity can give very different doses under identical

exposure conditions. Likewise, a single dose rate requirement for all

radionuclides was not retained because different radionuclides with the

same dose rate, at the time of release, can give very different doses

depending upon the half-life of the radionuclide. The total dose

depends on the effective half-life of the radioactive material in the

body of the patient and other factors that vary for different

materials. For these reasons, the NRC is establishing a dose limit

rather than an activity or dose rate limit.

The NRC is establishing a dose limit of 5 millisieverts (0.5 rem)

total effective dose equivalent to an individual from exposure to the

released patient for each patient release. This dose limit is

consistent with the underlying risk basis of the current 10 CFR 35.75

(50 FR 30627; July 26, 1985), the recommendations of the NCRP and the

ICRP, and the provisions in 10 CFR 20.1301(c) pertaining to temporary

situations in which there is justification for a dose limit higher than

1 millisievert (0.1 rem).

The NRC believes that the dose-based release limit can and will

work well because the associated Regulatory Guide 8.39, ``Release of

Patients Administered Radioactive Materials,'' can be used to relate

the dose to the quantity of activity in the patient. The guide provides

conservative estimates of activities for commonly used radionuclides

and their corresponding dose rates with which a patient may be released

in compliance with the dose limits in the final rule. The approach used

in the regulatory guide is based on NCRP Report No. 37, ``Precautions

in the Management of Patients Who Have Received Therapeutic Amounts of

Radionuclides.'' 1 In the case of iodine-131, the most significant

radionuclide, the release quantity based on the standard conservative

assumptions is 1.2 gigabecquerels (33 millicuries), which is

essentially the same as the current release quantity.

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\1\ National Council on Radiation Protection and Measurements

(NCRP), ``Precautions in the Management of Patients Who Have

Received Therapeutic Amounts of Radionuclides,'' NCRP Report No. 37

(October 1, 1970). (Available for sale from the NCRP, 7910 Woodmont

Avenue, Suite 800, Bethesda, MD 20814-3095.)

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NUREG-1492 contains a detailed examination of the benefits and

impacts of the final rule that includes dose

[[Page 4123]]

estimation, recordkeeping, and radiation exposure. Single copies of the

final regulatory analysis and Regulatory Guide 8.39, ``Release of

Patients Administered Radioactive Materials,'' are available as

indicated in the ADDRESSES heading.

Comment. A commenter said that the calculational approach in the

rule would require the physician to ask many personal questions of the

patient.

Response. The commenter is incorrect in believing that the dose-

based approach will generally require personal information from the

patient. The NRC anticipates that nearly all patients will be released

based on default assumptions which do not require any personal

information from the patient. A table of release quantities, based on

standard conservative assumptions, is provided in Regulatory Guide

8.39, ``Release of Patients Administered Radioactive Materials.''

However, the rule does allow the physician to calculate patient-

specific dose estimates to allow early release of a patient not

otherwise subject to release under the default values in Regulatory

Guide 8.39.

Comment. One commenter said that it should continue to be

acceptable to release patients based on the dose rate at 1 meter.

Response. The rule authorizes release of patients based on the dose

to an individual for each patient release. However, release quantities

based on dose rate and conservative assumptions can be calculated. The

table of release quantities in Regulatory Guide 8.39, ``Release of

Patients Administered Radioactive Materials,'' specifies the dose rate

at 1 meter of commonly used radionuclides that allow licensees to

authorize patient release.

Release Quantities

Using a dose-based system based on a dose to the most highly

exposed individual of 5 millisieverts (0.5 rem) would, in some

circumstances, allow release of a patient with more than 1,110

megabecquerels (30 millicuries) of activity. Some commenters were

opposed to allowing releases with higher activities than are now

permitted.

Comment. Several commenters said that the release of patients with

more than 30 millicuries of iodine-131 should not be permitted because

of concerns about the risk of internal exposure. One commenter said

that doses to family members from the patient vomiting were not

adequately considered. The same commenter also said that a study

indicated that in-home contamination by patients dosed with I-131 could

double family members' risk of developing thyroid cancer.

Response. The concern over contamination is not justified by the

radiation doses that are likely to be caused by the removal of

radionuclides from the patient's body by the pathways of exhaled air,

feces, saliva, sweat, urine, and vomit. Measurements from several

studies, as discussed in the supporting regulatory analysis, have shown

that a relatively small proportion of the radioactive material

administered will appear as contamination. Doses to family members

exposed to contamination from living in close contact with released

patients have been measured in several studies and in every case were

less than 10 percent of the 5-millisievert (0.5-rem) total effective

dose equivalent limit and were most often less than 1 percent of the 5-

millisievert (0.5-rem) limit. In addition, the internal doses resulting

from contamination were always less and generally far less than the

external dose, meaning that contamination was the less important source

of radiation exposure. These measurements show that even if the family

members repeatedly touched household items touched by the patient,

contamination does not cause unacceptably high doses. These findings

were true even in the case of a British study where eleven patients

volunteered to disregard special precautions against contamination and

minimizing spousal and family exposure. These measurements are

discussed in NUREG-1492. Also, the NCRP recently addressed the risk of

intake of radionuclides from patients' secretions and excreta in NCRP

Commentary No. 11, ``Dose Limits for Individuals Who Receive Exposure

from Radionuclide Therapy Patients,'' and concluded that, ``* * * a

contamination incident that could lead to a significant intake of

radioactive material is very unlikely.'' 2

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\2\ National Council on Radiation Protection and Measurements,

``Dose Limits for Individuals Who Receive Exposure from Radionuclide

Therapy Patients,'' NCRP Commentary No. 11 (February 28, 1995).

(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800,

Bethesda, MD 20814-3095.)

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In general, the physical reactions (e.g., vomiting) that a patient

may experience from the administration of any radiopharmaceutical are

rare. Vomiting is seldom an important elimination route for

radiopharmaceuticals after the patient has left the medical facility

since orally administered radiopharmaceuticals such as iodine-131 are

rapidly absorbed, within a half hour, by the gastrointestinal system.

Regarding the comment on the doubling of risk of developing thyroid

cancer, there is no scientific consensus by the United Nations

Scientific Committee on the Effects of Atomic Radiation, ICRP, or NCRP

to support the suggested increased risk of thyroid cancer following

ingestion of iodine-131. Based on the information currently available,

the Commission continues to conclude that the benefits outweigh the

potential of small increased risks associated with this rule.

Comment. One commenter noted that hospitals now make great efforts

to control contamination from patients who are now hospitalized because

they contain more than 30 millicuries of iodine-131. This commenter

stated that it would not be possible to maintain the same level of

contamination control at these patients' homes if these patients were

released with more than 30 millicuries of iodine-131.

Response. The NRC agrees that, even though released patients are

given instructions on how to limit the hazard from contamination,

contamination control in a hospital can be more effective than

contamination control out of the hospital. However, the two situations

are not really comparable. In the case of the released patient at home,

therapeutic administrations usually occur no more than once in a year

and probably no more than once in a lifetime; but in the case of a

hospital, large therapeutic administrations are done repeatedly on many

patients. Therefore, areas in hospitals have the potential for

contamination from many patients, and people who frequent the hospital

(e.g., clergy or a hospital orderly) have the potential to be exposed

to contamination from many patients. In addition, the 5-millisievert

(0.5-rem) limit that is applied to household members exposed to a

patient is a special limit that is appropriate for only occasional use

and for use where there is a definite need. This special limit fits the

case of doses received by the household members of a released patient,

but does not fit the case of people who frequent a hospital on a

routine basis. Lastly, in limiting doses, the NRC considers what is

reasonably achievable. The mere fact that a home cannot control

contamination as well as a hospital does not mean that the

contamination control achieved in homes is not adequate. Actual

measurements of doses to household members from contamination, as

discussed in NUREG-1492, show that the doses from contamination are

low, demonstrating that the degree of contamination control that was

achieved is adequate.

[[Page 4124]]

Comment. One commenter said that the proposed rule did not

adequately address the concerns that the Agreement States expressed on

the petitions for rulemaking concerning releasing patients with

quantities of iodine-131 in excess of 30 millicuries.

Response. In commenting on the petitions, a number of States

expressed concerns about releasing patients administered 14.8

gigabecquerels (400 millicuries) of iodine-131, which one of the

petitioners had requested. However, the States that commented were

generally favorable to the proposed rule limiting the dose to the most

exposed individual to 5 millisieverts (0.5 rem), and none of the States

indicated that their concerns were misrepresented. In fact, one

Agreement State commented that it was pleased that the NRC had

considered the comments made by the Agreement States at various

meetings with the NRC. The dose-based limit would generally permit

releases if the dose to another individual would not be likely to

exceed 5 millisieverts (0.5 rem). For example, if a licensee uses the

default table of release quantities provided in the regulatory guide as

the basis for release, a patient administered 1.2 gigabecquerels (33

millicuries) or less of iodine-131 could be immediately released and no

record of release is required. However, if the licensee wishes to

release a patient with an activity that is greater than the value in

the default table, the licensee must do a dose calculation using case-

specific factors to demonstrate compliance with the release criteria.

Furthermore, if the table is used as the basis for release but the

administered activity exceeds the value in the table, the licensee must

hold the patient until the time at which the retained activity is no

greater than the quantity in the table or the dose rate at 1 meter is

no greater than the value in the table. When the administered activity

is greater than the value in the default table, a record of the basis

for the release must be maintained for NRC review during inspection.

Regardless of the method used by the licensee to authorize release, the

dose limit of 5 millisieverts (0.5 rem) in the revised 10 CFR 35.75

applies. By identifying more than one method for calculating the

release of a patient in accordance with 10 CFR 35.75, the NRC provides

greater flexibility for licensees to achieve compliance with the new

requirement while still providing adequate protection of public health

and safety.

Comment. One commenter said that in some cases it should be

permissible to authorize the release of a patient even if the dose to a

family member might exceed 0.5 rem because the release might be

beneficial and acceptable to family members. Another commenter said

that a dose of 0.5 rem to an individual exposed to a patient has so

little hazard that the NRC should not be concerned with it.

Response. The NRC does not believe that individuals exposed to a

patient should, in general, receive doses in excess of 5 millisieverts

(0.5 rem). This is consistent with the recommendations of the ICRP in

ICRP Publication 60, 3 ``1990 Recommendations of the International

Commission on Radiological Protection''; and the recommendations of the

NCRP in NCRP Report No. 116,4 ``Limitation of Exposure to Ionizing

Radiation.'' Each of these recommendations provides a basis for

allowing individuals to receive annual doses up to 5 millisieverts (0.5

rem) under certain circumstances. Both the ICRP and the NCRP recommend

that an individual can receive a dose up to 5 millisieverts (0.5 rem)

in a given year in situations when exposure to radiation is not

expected to result in doses above 1 millisievert (0.1 rem) per year for

a long period of time, as would be the case for doses from released

patients. In NCRP Commentary No. 11, ``Dose Limits for Individuals Who

Receive Exposure from Radionuclide Therapy Patients,'' \2\ the NCRP

recommended a dose limit of 5 millisieverts (0.5 rem) annually for

members of the patient's family. However, on the recommendation of the

treating physician, the NCRP considered it acceptable that members of

the patient's family be permitted to receive doses as high as 50

millisieverts (5 rems). The NRC does not agree that the latter NCRP

recommendation should apply in general. The NRC believes that if the

dose to another individual is likely to exceed 5 millisieverts (0.5

rem), the patient should remain under the control of the licensee.

Licensee control is necessary to provide adequate protection to the

individuals exposed to the patient.

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\3\ International Commission on Radiological Protection (ICRP),

``1990 Recommendations of the International Commission on

Radiological Protection,'' ICRP Publication No. 60 (November 1990).

Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.

\4\ National Council on Radiation Protection and Measurements,

``Limitation of Exposure to Ionizing Radiation,'' NCRP Report No.

116 (March 31, 1993). Available for sale from the NCRP, 7910

Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.

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Recordkeeping

The strongest opposition to the proposed rule was to the proposed

requirement to maintain a record of the released patient and the

calculated total effective dose equivalent to the individual likely to

receive the highest dose if the dose to that person is likely to exceed

1 millisievert (0.1 rem). Under the proposed rule, if a patient had or

might have had one or more administrations within the same year, the

licensee would use the records to determine the dose from the previous

administrations so that the total dose to an individual exposed to a

patient from all administrations would not exceed 5 millisieverts (0.5

rem).

Comment. Many commenters indicated that this requirement would

cause excessive costs in time, effort, and money to track down records

of previous administrations, to perform calculations, and to keep

records of all the work and asked that the requirements to make

calculations and keep records be removed. The commenters believed that

the work would not produce an increased level of safety, that the NRC

greatly underestimated the cost, and that the recordkeeping would be

unnecessary, inappropriate, and impractical. Some commenters said that

multiple administrations that would result in a total effective dose

equivalent greater than 1 millisievert (0.1 rem) are not done to the

same patient routinely. Other commenters said that there have been

decades of experience unencumbered by any paperwork burden at all with

no evidence that a lack of paperwork has resulted in any additional

problems. One commenter said that if 0.5 rem is acceptably safe, why

have the documentation required at the 0.1 rem level.

Another commenter said that it cannot be a licensee's

responsibility to know the details of a radionuclide therapy performed

by another licensee in terms of which members of the public received

the most radiation dose from that other licensee's therapy procedure.

One commenter said that the excessive recordkeeping cost would be a

nonreimbursable cost, and the burden will cause many physicians to stop

offering iodine therapy, which would force patients to travel to large

medical facilities in cities and cause problems with patient access in

sparsely populated areas.

Response. Upon reconsideration, the NRC has decided to delete the

requirement to keep records when the dose to the most highly exposed

individual is likely to exceed 1 millisievert (0.1 rem). The

requirement was proposed so that it would be possible to account for

the dose from multiple administrations in the same year to ensure that

the total dose to an individual exposed to the patient did not exceed 5

millisieverts (0.5 rem).

[[Page 4125]]

The NRC has an advisory committee, the Advisory Committee on the

Medical Uses of Isotopes, or ``ACMUI,'' which advises the NRC on

rulemakings and other initiatives related to the medical use of

byproduct materials. The NRC also has a visiting medical fellows

program that recruits selected physicians or pharmacists to work for

the NRC for a period of 1 to 2 years. Both the ACMUI and the current

Visiting Medical Fellow, Myron Pollycove, M.D., provided advice to the

NRC during the development of this rule. In addition, Barry A. Siegel,

M.D., former Chairman of the ACMUI, reviewed the patient records at his

medical facility for the 1-year period from July 1, 1993, to June 30,

1994 (Mallinckrodt Institute of Radiology, St. Louis, Missouri). Drs.

Siegel and Pollycove concluded that no common nuclear medicine

practice, be it diagnostic, therapeutic, or a combination of the two,

results in multiple large administrations that would be likely to cause

the 5-millisievert (0.5-rem) dose limit to be exceeded because of

multiple administrations in a year.

While the proposed requirement to maintain a record of the dose to

another individual if the dose is likely to exceed 1 millisievert (0.1

rem) has been deleted, a recordkeeping requirement with a reduced

impact has been retained as discussed under the heading, ``Discussion

of Text of Final Rule.''

Comment. Several commenters said that those who pay for health care

will put great pressure on physicians to optimize calculations to

reduce in-patient days and to justify out-patient treatments.

Response. There is no objection to optimizing calculations to

reduce in-patient days as long as the calculations are realistic and

the 5-millisievert (0.5-rem) limit in 10 CFR 35.75 is met. Regulatory

Guide 8.39, ``Release of Patients Administered Radioactive Materials,''

describes examples of calculations that are acceptable to the NRC.

Written Instructions To Patients

In general, there was little objection to providing instructions to

patients on how to minimize the dose to others, but there was

significant opposition to the proposed requirement that the

instructions would have to be written.

Comment. One commenter said that the Statement of Considerations

for the proposed rule was in error in stating that the existing

regulations already required that the instructions to patients be

written.

Response. The commenter is correct. The Statement of Considerations

was in error on that point. The existing regulations do not specify

that instructions have to be in written form.

Comment. A number of commenters said that instructions should not

need to be written and that oral instructions should be permissible.

Some of these commenters said that oral instructions are more effective

and that how the instructions should be given is within the province of

the doctor-patient relationship and that the NRC and its regulations

should not interfere with that relationship. One commenter said that

the physical condition of the patient could lessen the patient's

ability to follow the instructions. Another commenter said that the

standard written instructions require too much time explaining how each

patient varied from the standard instruction sheet. However, one

Agreement State and a major health maintenance organization strongly

supported the requirement that the instructions be written.

Response. The NRC believes that providing written instructions has

a significant value because often patients will not remember all of the

instructions given orally. In addition, written instructions can be

read by other family members or care-givers. The requirement to provide

the instructions in written form was also supported by the ACMUI.

This regulation allows the licensee to determine the form of the

written instructions. The NRC believes that for the majority of

releases requiring written instructions, the written instructions can

be prepared in a generic form. For example, the Society of Nuclear

Medicine has prepared a brief pamphlet, ``Guidelines for Patients

Receiving Radioiodine Treatment,'' which can be given to patients at

nominal cost (less than $1 per patient). However, oral instructions may

also be provided in all cases.

Comment. Several commenters said that dictating to a physician how

and what he or she must tell a patient is not the purview, mandate, or

competence of the NRC and interferes with an essential part of medical

practice, which is communication between physician and patient.

Response. In a policy statement published on February 9, 1979 (44

FR 8242), entitled ``Regulation of the Medical Uses of Radioisotopes;

Statement of General Policy,'' the NRC made three specific statements.

The third statement of the policy is ``The NRC will minimize intrusion

into medical judgments affecting patients and into other areas

traditionally considered to be a part of the practice of medicine.''

The final rule is consistent with this statement because it does not

dictate the choice of medical treatment or diagnosis, does not specify

the details of what the physician must say or must include in the

contents of the written instructions, and is directed at minimizing the

risk to the patient's family who have no doctor-patient relations to

the prescribing or administering personnel. However, Regulatory Guide

8.39, ``Release of Patients Administered Radioactive Materials,''

recommends contents of the written instructions.

Further discussion of the 1979 Medical Policy Statement is

presented under the heading, ``VIII. Consistency with 1979 Medical

Policy Statement.''

Comment. Several commenters asked whether written instructions were

appropriate if the patient was blind, illiterate, or did not read

English. Another commenter said that the instructions should be both

written and oral and should be in the primary language of the patient.

Response. The NRC believes that written instructions are useful and

should be required. If the patient is blind, illiterate, or does not

read English, it is likely that someone else will be able to read the

instructions for the patient. NRC considers it too much of a burden to

require that the instructions be given in the primary language of the

patient, although the regulations do not preclude foreign language

written instructions if the licensee chooses to provide them. In most

situations, it will be possible to find someone who can translate for

the patient if necessary. The requirement that written instructions be

given to the patient does not preclude additional oral instructions.

Comment. Several commenters asked how the NRC would enforce

implementation of the instructions given to the patient. Another

commenter asked how the licensee could verify that the instructions are

followed. Another commenter said that a sizable fraction of patients

may not follow radiation safety instructions to protect spouses and may

be even less careful about protecting total strangers. This commenter

also asked whether it is reasonable to expect that released patients

will alter their behavior and limit their activities for the protection

of others.

Response. The NRC does not intend to enforce patient compliance

with the instructions nor is it the licensee's responsibility. However,

it is the responsibility of licensees to provide instructions to the

patients. Following the instructions is normally the

[[Page 4126]]

responsibility of the patient. However, American medical practice

routinely depends on patients following instructions, such as

instructions on when and how to take medications.

With regard to compliance with the instructions, surveys of

patients and their spouses, as discussed in the supporting regulatory

analysis, indicate that most will attempt to follow the instructions

faithfully, especially with regard to protecting their children,

although some patients and their spouses indicated that they might not

keep physically distant from their spouse for prolonged periods of

time.

Comment. One commenter said that instructions should be given for

all administrations of radioactive material, regardless of the quantity

administered.

Response. The NRC does not agree. In some cases, particularly in

the large number of diagnostic administrations, the potential doses are

so small that the burden of requiring instructions cannot be justified.

Under the final rule, if the dose to any individual exposed to the

patient is not likely to exceed 1 millisievert (0.1 rem), instructions

are not required but the physician could give any instructions that he

or she considers desirable.

Confinement of Patients

Comment. Two commenters said that patients cannot be confined

against their wishes and that the rule provides no penalty for the

patient who leaves confinement in the hospital ``against medical

advice.'' Another commenter said that the rule seems to require that

the licensee have control of the patient's activities after release.

Response. The NRC recognizes that patients cannot be held against

their will. The rule deals with the conditions under which the licensee

may authorize release. The NRC would not penalize a licensee for the

activities of the patient after release or if the patient were to leave

``against medical advice.''

Comment. One commenter asked whether a patient who was releasable

but was still hospitalized for other reasons would still be considered

under the licensee's control.

Response. Once the licensee has authorized the release of the

patient, there is no need to keep the patient under licensee control

for radiation protection purposes if the patient remains hospitalized

for other reasons. However, good health physics practice would be to

continue to make efforts to maintain doses to people at the facility as

low as is reasonably achievable.

Comment. Commenters also asked how a patient can be confined to his

or her house.

Response. These commenters misunderstood the concept of

confinement. As explained in the Statement of Considerations for the

proposed rule (59 FR 30724), the term ``confinement'' no longer applies

to the revision to 10 CFR 35.75. Instead, the text of the rule uses the

phrase ``licensee control'' to more clearly reflect the NRC's intent.

The NRC believes that there is a distinct difference between a

patient being under licensee control in a hospital or other licensee

facility (e.g., a hospice or nursing home) and being at home. In a

hospital or other area or address of use listed on the NRC license, the

licensee has control over access to the patient as well as having

trained personnel and instrumentation available for making radiation

measurements not typically available at the patient's home. In

addition, while under licensee control, a licensee has control over the

dose by limiting the amount of time that individuals are in close

proximity to the patient. A patient who goes home is released from

licensee control.

Comment. One commenter thought that the rule should define the term

``release.''

Response. The term ``release from licensee control,'' when read in

context, refers to radiation protection considerations and is

sufficiently clear that there is no need to define the term.

Miscellaneous Comments on the Rule

Comment. Several commenters said that the rule should not be a

matter of Agreement State compatibility at any level.

Response. The NRC does not agree. The NRC conducts an assessment of

each proposed requirement or rule to determine what level of

compatibility will be assigned to the rule. These case-by-case

assessments are based, for the most part, on protecting public health

and safety. NRC has evaluated the final rule and assigned compatibility

designations ranging from level 1 (full compatibility required) to

level 3 (uniformity not required) as detailed later in this Federal

Register notice.

Comment. Several commenters said that a breast-feeding infant

should not be considered as an individual exposed to the patient for

the purposes of determining whether patient release may be authorized.

These commenters said that consideration of the breast-feeding infant

should be under the jurisdiction of the physician, that the issue is a

medical issue rather than a regulatory issue, and that the NRC should

not interfere in medical issues.

Response. The NRC does not agree. The NRC has a responsibility to

protect the public health and safety, and that responsibility extends

to all individuals exposed to a patient administered licensed

radioactive materials, including breast-feeding children. When the

release is authorized, it is based on the licensee's determination that

the total effective dose equivalent to an individual from the released

patient is not likely to exceed 5 millisieverts (0.5 rem). The dose to

the breast-feeding child from breast-feeding is a criterion for release

but it can be controlled by giving the woman guidance on the

interruption or discontinuation of breast-feeding, as required by the

new 10 CFR 35.75. However, the release could be based on the default

table of release activities in the regulatory guide or a patient-

specific calculation, as required by the new 10 CFR 35.75. The issue of

the dose to the breast-feeding child is discussed in NUREG-1492 and

Regulatory Guide 8.39, ``Release of Patients Administered Radioactive

Materials.''

Comment. One commenter said that the proposed rule did not

accurately represent the position of the Advisory Committee on Medical

Uses of Isotopes.

Response. A review of the transcript for the ACMUI meeting in May

1992 shows that the Federal Register Notice provided an accurate

description of the ACMUI position. The final rule was discussed with

the ACMUI on October 18, 1995, and the ACMUI, in general, supported the

rule. (For ACMUI's comments and NRC's responses, see Section V.

Coordination with the Advisory Committee on Medical Uses of Isotopes.)

Comment. One commenter said that its facility treated many foreign

patients with therapeutic pharmaceuticals. These patients frequently

may leave the hospital and immediately board a plane to return home.

Thus, there is a limit to the amount of control that a licensee has

over the patient.

Response. The NRC recognizes that the licensee has no control over

the patient after the patient has been released. The quantities for

release listed in Table 1 of Regulatory Guide 8.39, ``Release of

Patients Administered Radioactive Materials,'' were calculated using

conservative assumptions (for example, by using the physical half-life

of the radioactive material rather than the more realistic effective

half-life). Thus, the NRC considers it unlikely that the dose to an

individual in real circumstances would approach 5 millisieverts (0.5

rem).

In special situations, such as when a released patient would

immediately board an airplane and would therefore be in close contact

with one or more

[[Page 4127]]

individuals, it may be necessary to base the release on a more

realistic case-specific calculation. Once the patient is released, the

responsibility for following the instructions is entirely the

patient's, not the licensee's.

Comments on the Draft Regulatory Guide

Comments were also requested on Draft Regulatory Guide, DG-8015,

``Release of Patients Administered Radioactive Materials,'' associated

with this rulemaking. Because the guide is associated with the rule,

the comments received on the draft guide are discussed here. Most of

the comments concerned the method and the assumptions used to calculate

the dose to the individual likely to receive the highest dose.

Comment. Several commenters said that the calculational methodology

in the draft guide is too complex and that the assumptions are too

conservative. As an example, several commenters said that the assumed

24-hour nonvoiding assumption used in calculating doses is too

conservative. As evidence that the calculations are too conservative,

several commenters said that the doses measured using dosimeters were

much lower than doses calculated using the models in the draft guide.

Response. The NRC has revised the guide to use a phased approach

for determining when release can be authorized. While the calculations

can sometimes be complex, the results of calculations that use

conservative assumptions are given in a table of release quantities in

Regulatory Guide 8.39, ``Release of Patients Administered Radioactive

Materials.'' Of the 8 to 9 million administrations performed annually,

in all except about 10,000 cases (radioiodine therapy for thyroid

cancer), release can be authorized based on conservative assumptions

and using Table 1 with no calculational effort on the part of the

licensee and no additional recordkeeping beyond what is already

required. For permanent implants, the guide provides dose rates at 1

meter from the patient at which release may be authorized. Thus, for

implants, there would be no calculational effort needed. In addition,

the guide provides information on iodine therapy for thyroid cancer

that can be used for determining release based on retention and

elimination. This additional information in the guide will allow the

licensee to perform the calculation with relatively little effort.

With regard to the comments that the methodology is too

conservative and that measured values are lower than calculated by the

methodology, the methodology in the table giving default release

quantities is intended to be conservative. The NRC believes it is

appropriate and prudent to be conservative when providing generally

applicable release quantities that may be used with little

consideration of the specific details of a particular patient's

release. A review of published information, as described in the

regulatory analysis, NUREG-1492, ``Regulatory Analysis on Criteria for

the Release of Patients Administered Radioactive Material'' (1997),

finds that measured doses are generally well below those predicted by

the methodology used to calculate the table of default release

quantities. Thus, the default release quantities are conservative as

the NRC intended. However, the licensee is given the option of using

case-specific calculations that may be less conservative.

Nevertheless, the NRC agrees that the assumption used in the draft

guide of 24-hour nonvoiding in the thyroid cancer example was overly

conservative. The revised example uses an excretion half-life of 8

hours as recommended by the ICRP in ICRP Publication 53, ``Radiation

Dose to Patients from Radiopharmaceuticals.'' \5\

---------------------------------------------------------------------------

\5\ International Commission on Radiological Protection (ICRP),

``Radiation Dose to Patients from Radiopharmaceuticals,'' ICRP

Publication No. 53 (March 1987). Available for sale from Pergamon

Press, Inc., Elmsford, NY 10523.

---------------------------------------------------------------------------

Comment. One commenter said that the occupancy factor (generally

assumed to be 0.25 at 1 meter) should not be left to the discretion of

the licensee because low occupancy factors could easily be justified by

providing strict safety instructions without any verification that the

instructions will be followed. Another commenter liked the flexibility

provided by being able to adjust the occupancy factor, but wanted to

know if other considerations are allowed and if it is acceptable to use

values lower than 0.125.

Response. Draft Regulatory Guide 8.39 discussed situations in which

it might be permissible to lower the occupancy factor from 0.25 to

0.125, but did not recommend occupancy factors less than 0.125.

Occupancy factors less than 0.125 may be difficult to justify because

it is generally not realistic to assume that the patient can avoid all

contact with others. However, lower values for the occupancy factor are

not prohibited by the regulation, but they must be justified in the

record of the calculation, as the record will be subject to inspection.

Comment. Several commenters said that the iodine-131 retention

fraction of 0.3 used in the draft guide for treatment of thyroid cancer

is too large and that the correct value should be 0.05 or less. Another

commenter said that the biological half-life of extrathyroidal iodine

should be 0.5 day for both the euthyroid and hyperthyroid condition.

One commenter said that the biological half-lives from ICRP Publication

No. 53 should be used for thyroid cancer.

Response. The NRC agrees that the commenters raised valid points.

In Regulatory Guide 8.39, the iodine retention fraction for thyroid

cancer was changed to 0.05. The biological half-life for the

extrathyroidal fraction was changed to 0.33 day. In addition, the

biological half-lives from ICRP Publication No. 53 were used for the

thyroid cancer case.

Comment. One commenter said the table of release quantities in the

draft guide should be expanded to include beta emitters such as

strontium-89 and phosphorous-32. Another commenter said that the table

should be expanded to include chromium-51, selenium-75, yttrium-90,

tin-117m, and iridium-192.

Response. Values for the beta emitters strontium-89 and

phosphorous-32 have been added to the table of release quantities in

Regulatory Guide 8.39. The table of release quantities was also

expanded to add values for chromium-51, selenium-75, yttrium-90, tin-

117m, and iridium-192.

Comment. The table of release quantities in the draft regulatory

guide should be expanded to include accelerator-produced radioactive

materials as an aid to Agreement States.

Response. Several accelerator-produced materials were added to

Regulatory Guide 8.39 as an aid to the States and to medical

facilities. The NRC has no regulatory authority over the release of

patients administered accelerator-produced materials and would not

inspect the release of patients administered accelerator-produced

materials.

Comment. One commenter said that the regulatory guide should have a

table of release quantities based on biological half-life rather than

only the physical half-life.

Response. Regulatory Guide 8.39 now provides more information on

release quantities for iodine-131 based on biological half-lives.

Comment. One commenter said that the factor of 10-6 used in

the draft guide to estimate internal dose is not well supported for

nonoccupational exposures. Another commenter said that the calculation

of dose to individuals exposed to the patient ignores the potential of

radiation dose from the excretion of radioactive material from the

patient, and this could present a

[[Page 4128]]

significant radiological hazard to family members.

Response. It is true that there is not a great deal of information

on the use of the factor in nonoccupational settings, but measurements

(described in NUREG-1492) have been made in which iodine uptake was

measured in people exposed to a patient. These data suggest that the

fractional uptake of the administered activity will be on the order of

10-6. Since iodine is among the most soluble and volatile

radiopharmaceuticals, it can be expected that the transfer to others of

less soluble and less volatile radiopharmaceuticals would be less than

that of iodine.

In addition, the NCRP recently concluded that, for individuals

exposed to radionuclide therapy patients, the risks of external

irradiation and potential contamination are minor from a public health

viewpoint; therefore a significant intake from a contamination incident

is very unlikely.\2\

Comment. A medical organization commented that the draft guide is

not complete and does not provide sufficient comprehensive examples to

assist licensees in complying with the rule.

Response. The NRC has expanded the guide to include information and

further examples on the biological elimination of iodine-131 and on

when guidance on the interruption or discontinuation of breast-feeding

should be given. Expanded examples are now given in Regulatory Guide

8.39, ``Release of Patients Administered Radioactive Materials.'' The

example on thyroid cancer was revised to include more realistic

assumptions, and an additional example on hyperthyroidism was added.

The NRC believes that the examples provided illustrate the techniques

sufficient to perform the whole range of potential calculations.

Comment. One commenter said that the draft regulatory guide did not

provide enough information on when and for how long breast-feeding of

infants should be interrupted.

Response. Regulatory Guide 8.39 has been greatly expanded with

respect to information on the breast-feeding child, including a table

on recommendations for the interruption or discontinuation of breast-

feeding for specific radiopharmaceuticals.

Comment. One commenter said that the sample instructions in the

draft guide concerning implants should include a picture of an implant

seed.

Response. The sample instructions were not expanded to include this

because of graphics limitations, but licensees may add photos if

desired.

Comment. Several commenters asked whether multiple individual

calculations have to be done or if a generally applicable calculation

could be done once and used for many patients.

Response. The NRC believes that there may be some situations for

which a case-specific calculation could be done for a class of

patients. The record for a particular patient's release could then

reference the calculation done for the class of patients. However,

depending on a patient's individual status (e.g., lower occupancy

factor), there may be cases when the calculation will be done for a

specific individual.

Comment. One commenter said that the discussion on radiolabeled

antibodies in the draft guide was wrong because antibodies labeled with

iodine-131 will be deiodinated in the body and the iodine will behave

like other iodine. None of the radiolabeled antibodies now being

developed or planned for the future should have an internal dose hazard

for the general public.

Response. The NRC agrees with this Comment. Statements in

Regulatory Guide 8.39 are now modified.

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

Comment. One commenter said that the value of a person-rem should

be $40 rather than $1,000 as used in the draft regulatory analysis for

the purpose of evaluating the costs and benefits of the rule. The

commenter cited a 1993 Health Physics Society position paper as a

reason that the value should be $40 per person-rem.

Response. The Commission recently adopted a value of $2,000 per

person-rem as explained in Revision 2 of NUREG/BR-0058, ``Regulatory

Analysis Guidelines of the U.S. Nuclear Regulatory Commission (November

1995),'' Section 4.3.3, ``Evaluation of Values and Impacts.'' (Single

copies of NUREG/BR-0058 are available as indicated in the ADDRESSES

heading.) The draft regulatory analysis, which was prepared utilizing

$1,000 per person-rem, employed a simple computational model using the

physical half-life only of radiopharmaceuticals. The regulatory

analysis has been revised to include use of $2,000 per person-rem, as

well as a more realistic dose model based on biological retention and

elimination of the radiopharmaceuticals. The more realistic model with

a value of $2,000 continues to demonstrate the cost-effectiveness of

the dose-based limit. Specifically, the savings in hospital costs under

the earlier release time allowed are estimated at $14 million, whereas

the collective dose of 2,740 person-rem (at a value of $2,000 per

person-rem) corresponds to a cost of about $5 million.

NUREG-1492 contains a detailed discussion of the model and the

benefits and impacts of the dose-based limit. Single copies of the

final regulatory analysis are available as indicated in the ADDRESSES

heading.

Comment. One commenter said that the benefits of the rule were

overestimated because the length of time that a thyroid patient would

have to remain in the hospital was overestimated and the cost of a

hospital room was overestimated, being $450 per day rather than $1,000

per day as assumed in the draft regulatory analysis.

Response. The commenter is correct that the benefits of the rule

were overestimated. The estimates in the draft regulatory analysis of

days of hospitalization required did not include biological elimination

of the radioactive material; only radioactive decay was considered. As

a consequence, the draft regulatory analysis, in some cases,

overestimated the time that patients would need to be retained under

licensee control, and therefore the costs of patient retention were too

high. The final regulatory analysis corrects the estimates.

The NRC believes that the current cost of $1,000 per day for a

hospital room is not an overestimate. Under 10 CFR 35.315(a)(1),

licensees are required to provide a private room with a private

sanitary facility for each patient receiving radiopharmaceutical

therapy and hospitalized for compliance with 10 CFR 35.75. Considering

this NRC requirement and the recent reference cited in the final

regulatory analysis on the cost of hospitalization, $1,000 per day for

a hospital room is a reasonable estimate.

Comment. One commenter said that the description of the measured

doses received by family members was not consistent with the reference

cited.

Response. The commenter is correct. An incorrect reference was

given. The final regulatory analysis provides the correct reference.

IV. Coordination With NRC Agreement States

The NRC staff discussed the status of this rulemaking effort at two

public meetings: The Agreement State Managers Workshop held on July 12-

14, 1994, and at the All Agreement States Meeting held on October 24-

25, 1994. The Agreement States expressed no objections to the approach

in this rule.

[[Page 4129]]

V. Coordination With the Advisory Committee on Medical Uses of

Isotopes

The Advisory Committee on Medical Uses of Isotopes (ACMUI) is an

advisory body established to advise the NRC staff on matters that

involve the administration of radioactive material and radiation from

radioactive material. The NRC staff presented a summary of the comments

on the proposed rule to the ACMUI during a public meeting held in

Rockville, Maryland, on November 17 and 18, 1994.

Drafts of the final rule and regulatory guide were discussed with

ACMUI in Rockville, Maryland, on October 18 and 19, 1995. The ACMUI

supported the approach in this rule but suggested some clarifying

changes. The NRC staff made all but one of the suggested changes. The

ACMUI suggested using the term ``rationale'' instead of

``consequences'' in the requirement under the revised 10 CFR 35.75(b),

to provide ``guidance on the interruption or discontinuation of breast-

feeding, and information on the consequences of failure to follow the

guidance'' for cases where failure to follow the instructions could

result in a dose to the infant exceeding 1 millisievert (0.1 rem).

Since most of the administrations that would be affected by this

requirement are technetium-99m administrations, the ACMUI suggested the

change because there was concern that the consequences of low doses of

radiation cannot always be explained to the patient without causing

unjustified alarm. Also, there was concern that physicians cannot

explain with certainty the effects of low doses of radiation, such as

would be caused by diagnostic administrations of technetium-99m. The

staff did not change the rule in response to the ACMUI comment. The

requirement to provide information on the consequences is included

primarily to protect the breast-feeding infant from therapeutic

administrations of radioiodine, which could cause serious thyroid

damage. Regulatory Guide 8.39 will contain guidance on the types of

information, including expected consequences, to be provided to

patients to meet this requirement. Transcripts of the meetings have

been placed in and are available for examination at the NRC Public

Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

VI. Discussion of Text of Final Rule

This section summarizes the final rule. The NRC is amending 10 CFR

20.1301(a)(1) to state specifically that the dose to individual members

of the public from a licensed operation does not include doses received

by individuals exposed to patients who were released by the licensed

operation under the provisions of 10 CFR 35.75. This is not a

substantive change. It is a clarifying change to make clear that the

Commission's policy is that patient release is governed by 10 CFR

35.75, not 10 CFR 20.1301.

For the sake of consistency and clarity, the same words are used in

Sec. 20.1002, ``Scope''; in Sec. 20.1003, ``Definitions'' (in the

definitions of both public dose and occupational dose); and in

Sec. 20.1301, ``Dose limits for individual members of the public.''

Also for consistency and clarity, the exclusion of dose from background

radiation and from voluntary participation in medical research programs

that are now included in Secs. 20.1002 and 20.1003 are added to

Sec. 20.1301(a). In addition, the definition of ``member of the

public,'' as published in 60 FR 36038 on July 13, 1995, is revised by

removing the footnote which read, ``Except as delineated in other parts

of 10 CFR Chapter 1.'' With the publication of this rule that footnote

is no longer needed.

The NRC is amending 10 CFR 20.1301(a)(2) to state specifically that

the limit on dose in unrestricted areas does not include dose

contributions from individuals administered radioactive material and

released in accordance with 10 CFR 35.75. The purpose of this change is

to clarify that after a patient has been released under 10 CFR 35.75,

licensees are no longer required to control radiation from the patient.

The regulation uses the term ``individual'' to refer to the individual

to whom the radioactive material has been administered rather than

``patient'' to clarify that the regulation refers to anyone receiving a

medical administration.

The NRC is amending 10 CFR 20.1903(b) to use the term ``licensee

control'' rather than ``confinement'' because the latter term no longer

applies to 10 CFR 35.75. The conforming change is necessary since the

term ``licensee control'' more clearly reflects the NRC's intent in 10

CFR 35.75.

The NRC is adopting a new 10 CFR 35.75(a) to change the patient

release criteria from 30 millicuries of activity in a patient or a dose

rate of 5 millirems per hour at 1 meter from a patient to a dose limit

of 5 millisieverts (0.5 rem) total effective dose equivalent to an

individual from exposure to a released patient. (The dose from the

radionuclide involved is taken to be the dose to total decay.) A dose-

based limit provides a single limit that can be used to provide an

equivalent level of protection from risks from all radionuclides. Also,

the changes are supported by the recommendations of the ICRP and NCRP

that an individual can receive an annual dose up to 5 millisieverts

(0.5 rem) in temporary situations where exposure to radiation is not

expected to result in annual doses above 1 millisievert (0.1 rem) for

many years. Usually, the only individuals likely to exceed a dose of 1

millisievert (0.1 rem) will be those who are aware of the patient's

condition such as the primary care-giver, a family member, or any other

individual who spends significant time close to the patient.

This dose-based rule would, in some instances, permit the release

of patients with activities greater than currently allowed. This is

especially true when case-specific factors are evaluated to more

accurately assess the dose to other individuals. The individuals

exposed to the patient could receive higher doses than if the patient

had been hospitalized longer. These higher doses are balanced by

shorter hospital stays and thus lower health care costs. In addition,

shorter hospital stays may provide emotional benefits to patients and

their families. Allowing earlier reunion of families can improve the

patient's state of mind, which in itself may improve the outcome of the

treatment and lead to the delivery of more effective health care.

The release criteria in 10 CFR 35.75(a) could prevent a woman from

being released because of the potential transmission of radioactive

materials in breast milk. The dose to the breast-feeding child is

controlled by giving the woman guidance, as required by 10 CFR

35.75(b), on the interruption or discontinuation of breast-feeding and

information on the consequences of failure to follow the guidance. The

expectation is that the woman would follow the instructions and would

interrupt or discontinue breast-feeding.

Finally, 10 CFR 35.75(a) includes a footnote to inform licensees

that the NRC has made available guidance on rule implementation. The

footnote states that Regulatory Guide 8.39, ``Release of Patients

Administered Radioactive Material,'' contains tables of activities not

likely to cause doses exceeding 5 millisieverts (0.5 rem) and describes

methods for calculating doses to other individuals.

The NRC is adopting a new 10 CFR 35.75(b) to require that the

licensee provide released patients with instructions, including written

instructions, on how to maintain doses to other individuals as low as

is reasonably achievable if the total effective dose equivalent to any

individual other than the released patient is likely to exceed 1

millisievert

[[Page 4130]]

(0.1 rem). This also requires giving instructions to a woman who is

breast-feeding a child if the dose to the child could exceed 1

millisievert (0.1 rem) assuming there were no interruption of breast-

feeding. The instructions must include guidance on discontinuation or

the interruption period for breast-feeding and the consequences of

failing to follow the recommendation. Regulatory Guide 8.39 contains

tables that show temporary interruption periods for various

radiopharmaceuticals or discontinuation. The temporary interruption

periods were calculated based on the determination that the dose to a

child from breast-feeding is unlikely to exceed 1 millisievert (0.1

rem). However, the physician may use discretion in the recommendation,

increasing or decreasing the duration of interruption somewhat

depending on the woman's concerns about radioactivity or interruption

of breast-feeding.

The purpose of describing the consequences is so that women will

understand that breast-feeding after an administration of certain

radionuclides could cause harm (e.g., iodine-131 could harm the child's

thyroid). In other cases, the guidance could simply address avoidance

of any unnecessary radiation exposure to the child from breast-feeding.

A requirement for instructions for certain patients was already

contained in 10 CFR 35.315(a)(6) and 35.415(a)(5), but the modified

requirement for written instructions adds approximately (a) 50,000

patients per year who are administered iodine-131 for the treatment of

hyperthyroidism and (b) 27,000 patients per year, among about 8 million

administered radiopharmaceuticals, who may be breast-feeding to whom

additional written instructions be given. The purpose of the written

instructions is to maintain doses to individuals exposed to patients as

low as is reasonably achievable. The instructions may be either written

only or written plus oral. The NRC believes that written instructions

are necessary so that the patient and the patient's family and friends

will have a document to refer to rather than having to rely solely on

the patient's memory and understanding of the instructions.

The requirement of 10 CFR 35.75(b), requiring a licensee to provide

guidance on discontinuation or the interruption period for breast-

feeding and the consequences of failing to follow the recommendation,

presumes that the licensee will make appropriate inquiry regarding the

breast-feeding status of the patient. For women who are breast-feeding

a child where the dose to the child is likely to exceed 1 millisievert

(0.1 rem), the NRC requires that the patient be provided with specific

instructions, as described in 10 CFR 35.75(b). There is no specific

requirement to maintain a record indicating that breast-feeding status

was determined prior to the release of the patient.

The NRC is adopting a new 10 CFR 35.75(c) to require that the

licensee maintain a record of the basis for authorizing the release for

3 years if the calculation of the total effective dose equivalent to

other individuals uses the retained activity rather than the activity

administered, an occupancy factor less than 0.25 at 1 meter, the

biological or effective half-life of the radionuclide, or shielding of

radiation by the patient's tissue. Thus, records of release are

required when the default assumptions are not used as discussed in

Regulatory Guide 8.39. Measurements made in several studies indicate

that the default assumptions should generally overpredict the dose even

when instructions are not given or are not strictly followed. If a

licensee administers an activity no greater than the value in the

default table of release quantities provided in the regulatory guide as

the basis for release, no record of release is required.

Licensees are already required by 10 CFR 35.53 to retain records of

the measurement of the activity of each dosage of radioactive material

administered to a patient; these records are typically maintained in a

patient dose log. In addition, 10 CFR 35.32 requires licensees to

retain a written directive and a record of each administered radiation

dose or radiopharmaceutical dosage for therapeutic administrations and

diagnostic administrations of iodine-125 or iodine-131 sodium iodide

greater than 30 microcuries. These records can be used in conjunction

with Regulatory Guide 8.39 to demonstrate that patient releases meet

the requirements of 10 CFR 35.75(a) when no record is required by 10

CFR 35.75(c). When the licensee determines that the patient must be

held to allow the reduction of radioactivity and then released, the

licensee will need a record of release time to demonstrate that the

release criteria have been met. A licensee may use any existing record

to establish the release time. If biological elimination of radioiodine

is a basis for release and the licensee uses the information in

Regulatory Guide 8.39, a record of the thyroid uptake may be necessary

as part of the basis for release because it is one of the nonstandard

conservative assumptions listed in 10 CFR 35.75(c). If other case-

specific factors are used as the basis for patient release that are in

addition to, or modify, the standard conservative assumptions, a record

of the basis for the release, including the assumptions used for the

calculations, must also be maintained.

This recordkeeping requirement is a modification of the proposed

rule. The proposed rule would have required that a record be maintained

of the basis for the patient's release, including all calculations

performed, if the total effective dose equivalent to any individual

other than the released patient is likely to exceed 1 millisievert (0.1

rem) in a year from a single administration. Under the proposed rule,

the major purpose of the record was to provide the basis for limiting

the dose to 5 millisieverts (0.5 rem) to individuals exposed to a

patient who may receive more than one administration in a year. Upon

reconsideration, based on public comments and consultation with the

ACMUI, an NRC medical consultant, and the NRC Visiting Medical Fellow,

the NRC has decided to delete this requirement. A review of medical

treatment practices revealed no common practice that would result in

doses exceeding the 5 millisievert (0.5 rem) limit because of multiple

administrations in the same year to the same patient. Without the need

to account for the dose from multiple administrations, maintaining

records for the many tens of thousands of patients released when their

dose to an individual is likely to exceed 1 millisievert (0.1

millisievert) becomes an unnecessary burden. The requirement to retain

these records has therefore been deleted. Each patient release is to be

treated as a separate event, and licensee knowledge of previous

administrations is unnecessary.

The NRC is also adopting a new 10 CFR 35.75(d) to require that the

licensee maintain a record that instructions were provided to a woman

who is breast-feeding a child if the administered activity could result

in a total effective dose equivalent to the breast-feeding child

exceeding 5 millisieverts (0.5 rem) if the woman did not interrupt or

discontinue breast-feeding. Thus, the NRC is requiring records for

certain radiopharmaceutical administrations (e.g., therapeutic

administrations of iodine-131). The activities of radiopharmaceuticals

that require this record are described in Regulatory Guide 8.39.

[[Page 4131]]

Finally, the NRC is deleting its requirements on written

instructions in 10 CFR 35.315(a)(6) and 35.415(a)(5) because those

paragraphs are redundant now that 10 CFR 35.75 has requirements for

instructions. In addition, 10 CFR 35.415(a) and (a)(1) are reworded to

clarify the original intent of the paragraphs, which was to limit the

dose rate at 1 meter from the patient. The ambiguity was introduced

when part 20 was revised and a conforming change was made in 10 CFR

35.415. The conforming change that was made was not fully consistent

with the original intended meaning of 10 CFR 35.415(a) and (a)(1).

VII. Disposition of the Petitions for Rulemaking

The three petitions for rulemaking submitted by Dr. Marcus (PRM-20-

20), the ACNM (PRM-35-10 and PRM-35-10A), and the AMA (PRM-35-11)

requested that the NRC amend the revised 10 CFR part 20 and 10 CFR part

35. These requests and their disposition by this rulemaking are

discussed below.

The requests made by Dr. Marcus and their disposition may be

summarized as follows:

(1) Raise the radiation dose limit in 10 CFR 20.1301(a) for

individuals exposed to radiation from patients receiving

radiopharmaceuticals for diagnosis or therapy from 1 millisievert (0.1

rem) to 5 millisieverts (0.5 rem). The final rule grants this request.

(2) Amend 10 CFR 35.75(a)(2) to retain the 1,110-megabecquerel (30-

millicurie) limit for iodine-131, but provide an activity limit for

other radionuclides consistent with the calculational methodology

employed in the National Council on Radiation Protection and

Measurements (NCRP) Report No. 37, ``Precautions in the Management of

Patients Who Have Received Therapeutic Amounts of Radionuclides.'' \1\

The final rule does not contain activity limits, but Regulatory Guide

8.39 uses a calculational methodology based on NCRP Report No. 37 to

relate the dose to the quantity of activity in the patient. Therefore,

the wish of the petitioner to have an easy method to determine when the

patient may be released is granted in Regulatory Guide 8.39.

(3) Delete 10 CFR 20.1301(d), which requires licensees to comply

with provisions of the Environmental Protection Agency's environmental

regulations in 40 CFR part 190 in addition to complying with the

requirements of 10 CFR part 20. The EPA regulations referenced in 10

CFR 20.1301(d) are contained in 40 CFR part 190, which deals only with

doses and airborne emissions from uranium fuel cycle facilities. Part

190 of Title 40 of the Code of Federal Regulations does not apply to

hospitals or to the release of patients.

Furthermore, 10 CFR 20.1301(d) does not incorporate the EPA's Clean

Air Act standards in 40 CFR part 61 that applies to hospitals. The NRC

is separately pursuing actions with the EPA to minimize the impact of

dual regulation under the Clean Air Act and to take agreed upon actions

that will lead to EPA recision of 40 CFR part 61 for NRC and Agreement

State licensees. Because the reference to EPA regulations in 10 CFR

20.1301(d) has nothing to do with the patient release issue, and

therefore is outside the scope of this rulemaking, the final rule

denies this request.

The requests made by the ACNM and their disposition may be

summarized as follows:

(1) Adopt a dose limit of 5 millisieverts (0.5 rem) for individuals

exposed to patients who have been administered radiopharmaceuticals.

The final rule grants this request.

(2) Permit licensees to authorize release from hospitalization any

patient administered a radiopharmaceutical regardless of the activity

in the patient by defining ``confinement'' to include not only

confinement in a hospital, but also confinement in a private residence.

The final rule denies this request for the reasons described in the

discussion on this issue.

Finally, the requests made by the AMA did not all pertain to the

issue of patient release. The final rule grants the request pertaining

to patient release, i.e., that the radiation dose limits in 10 CFR

20.1301 should not apply to individuals exposed to the patient and that

the dose limit to the individuals should be 5 millisieverts (0.5 rem).

The request to change the term ``hospitalized'' in 10 CFR 35.310(a) and

35.315(a) to the term ``confined'' was denied for the reasons discussed

above. The request not related to the subject of patient release (that

it should be clear in Part 20 that Part 20 does not limit the

intentional exposure of patients to radiation for the purpose of

medical diagnosis or therapy) was addressed in another rulemaking,

``Medical Administration of Radiation and Radioactive Materials,''

which was published as a final rule on September 20, 1995 (60 FR

48623), and became effective on October 20, 1995.

VIII. Consistency With 1979 Medical Policy Statement

On February 9, 1979 (44 FR 8242), the NRC published a Statement of

General Policy on the Regulation of the Medical Uses of Radioisotopes.

The first statement of the policy reads ``The NRC will continue to

regulate the medical uses of radioisotopes as necessary to provide for

the radiation safety of workers and the general public.'' The rule is

consistent with this statement because its purpose is to provide for

the safety of individual members of the public exposed to patients

administered radioactive materials.

The second statement of the policy is ``The NRC will regulate the

radiation safety of patients where justified by the risk to patients

and where voluntary standards, or compliance with these standards, are

inadequate.'' This statement is not relevant to the rule because the

rule does not affect the safety of patients themselves. The rule

instead affects the safety of individuals exposed to patients.

The third statement of the policy reads ``The NRC will minimize

intrusion into medical judgments affecting patients and into other

areas traditionally considered to be a part of the practice of

medicine.'' The rule is consistent with this statement because it

places no requirements on the administration of radioactive materials

to patients and because the release of patients administered

radioactive materials has long been considered a matter of regulatory

concern to protect members of the public rather than solely a matter of

medical judgment.

Thus, the final rule is considered to be consistent with the 1979

Medical Policy Statement.

IX. Issue of Compatibility for Agreement States

The NRC considers the definitions contained in Sec. 20.1003 and the

text in Sec. 20.1301(a) that are modified by this rulemaking are

Division 1 levels of compatibility. The definitions and text in these

sections must be the same for all NRC and Agreement State licensees so

that national consistency can be maintained.

Section 20.1002, ``Scope,'' is a Division 3 level of compatibility

because this section by nature is not a regulatory requirement and many

States are prohibited by their administrative procedures act from

including such sections in their rules. The scope section is a general

statement of scope of the rule and does not contain specific

requirements that are not presented in other sections of part 20. Rules

at the Division 3 level would be appropriate for Agreement States to

adopt, but they do not require any degree of uniformity between NRC and

State rules.

Additionally, Secs. 35.75(a) and (b) are a Division 2 level of

compatibility because the patient release criteria

[[Page 4132]]

required by the rule are the minimum requirements necessary to ensure

adequate protection of the public health and safety. The Agreement

States will be allowed to establish requirements that are more

stringent than the NRC's requirements, but not less stringent. The

recordkeeping requirements in Secs. 35.75(c) and (d) are a Division 3

level of compatibility because uniformity in recordkeeping is not

considered essential for this rule.

X. Small Business Regulatory Enforcement Fairness Act

In accordance with the Small Business Regulatory Enforcement

Fairness Act of 1996, the NRC has determined that this action is not a

major rule and has verified this determination with the Office of

Information and Regulatory Affairs of OMB.

XI. Finding of No Significant Environmental Impact: Availability

The NRC has determined under the National Environmental Policy Act

of 1969, as amended, and the Commission's regulations in subpart A of

10 CFR part 51, that the amendments are not a major Federal action

significantly affecting the quality of the human environment, and

therefore an environmental impact statement is not required. The final

amendments clarify the pertinent regulatory language to reflect

explicitly the relationship between 10 CFR part 20 and part 35 with

respect to release of patients, and the amendments revise the release

criteria for patients receiving radioactive material for medical use

from an activity-based standard to a dose basis. It is expected that

there will be relatively little change in radiation dose to the public

or to the environment as a result of the revised regulation.

The final environmental assessment and finding of no significant

impact on which this determination is based is available for inspection

at the NRC Public Document Room, 2120 L Street NW. (Lower Level),

Washington, DC. Single copies of the environmental assessment and the

finding of no significant impact are available as indicated in the FOR

FURTHER INFORMATION CONTACT heading.

XII. Paperwork Reduction Act Statement

This final rule amends information collection requirements that are

subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et

seq.). These requirements were approved by the Office of Management and

Budget, approval number 3150-0010.

The public reporting burden for this collection of information is

estimated to average 13 hours per licensee per year, including the time

for reviewing instructions, searching existing data sources, gathering

and maintaining the data needed, and completing and reviewing the

collection of information. Send comments on any aspect of this

collection of information, including suggestions for reducing the

burden, to the Information and Records Management Branch (T-6 F33),

U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by

Internet electronic mail at [email protected]; and to the Desk Officer,

Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010),

Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to

respond to, a collection of information unless it displays a currently

valid OMB control number.

XIII. Regulatory Analysis

The NRC has prepared a final regulatory analysis (NUREG-1492) on

this regulation. The analysis examines the benefits and impacts

considered by the NRC. The NRC has received public comments regarding

the draft regulatory analysis and has addressed the comments (see

Comments on the Draft Regulatory Analysis in Section III. Public

Comments on the Proposed Rule). The final regulatory analysis is

available for inspection at the NRC Public Document Room at 2120 L

Street NW. (Lower Level), Washington, DC. Single copies are available

as indicated in the ADDRESSES heading.

XIV. Regulatory Flexibility Certification

As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.

605(b), the NRC certifies that this rule will not have a significant

economic impact on a substantial number of small entities. This rule

affects medical use of byproduct material licensees. The impact of the

final rule will not be significant because the final rule basically

represents a continuation of current practice.

XV. Backfit Analysis

The NRC has determined that the backfit rule, 10 CFR 50.109, does

not apply to this rule, and therefore, that a backfit analysis is not

required for this rule, because these amendments do not involve any

provisions that impose backfits as defined in 10 CFR 50.109(a)(1).

Lists of Subjects

10 CFR Part 20

Byproduct material, Criminal penalties, Licensed material, Nuclear

materials, Nuclear power plants and reactors, Occupational safety and

health, Packaging and containers, Radiation protection, Reporting and

recordkeeping requirements, Special nuclear material, Source material,

Waste treatment and disposal.

10 CFR Part 35

Byproduct material, Criminal penalties, Drugs, Health facilities,

Health professions, Incorporation by reference, Medical devices,

Nuclear materials, Occupational safety and health, Radiation

protection, Reporting and recordkeeping requirements.

For the reasons set out in the preamble and under the authority of

the Atomic Energy Act of 1954, as amended; the Energy Reorganization

Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting

the following amendments to 10 CFR parts 20 and 35.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

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

Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68

Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701,

106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133,

2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88

Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

2. Section 20.1002 is revised to read as follows:

Sec. 20.1002 Scope.

The regulations in this part apply to persons licensed by the

Commission to receive, possess, use, transfer, or dispose of byproduct,

source, or special nuclear material or to operate a production or

utilization facility under parts 30 through 35, 39, 40, 50, 60, 61, 70,

or 72 of this chapter. The limits in this part do not apply to doses

due to background radiation, to exposure of patients to radiation for

the purpose of medical diagnosis or therapy, to exposure from

individuals administered radioactive material and released in

accordance with Sec. 35.75, or to exposure from voluntary participation

in medical research programs.

3. In Sec. 20.1003, the footnote to the definition of member of the

public is removed and the definitions of occupational dose and public

dose are revised to read as follows:

[[Page 4133]]

Sec. 20.1003 Definitions.

* * * * *

Occupational dose means the dose received by an individual in the

course of employment in which the individual's assigned duties involve

exposure to radiation or to radioactive material from licensed and

unlicensed sources of radiation, whether in the possession of the

licensee or other person. Occupational dose does not include dose

received from background radiation, from any medical administration the

individual has received, from exposure to individuals administered

radioactive material and released in accordance with Sec. 35.75, from

voluntary participation in medical research programs, or as a member of

the public.

* * * * *

Public dose means the dose received by a member of the public from

exposure to radiation or radioactive material released by a licensee,

or to any other source of radiation under the control of a licensee.

Public dose does not include occupational dose or doses received from

background radiation, from any medical administration the individual

has received, from exposure to individuals administered radioactive

material and released in accordance with Sec. 35.75, or from voluntary

participation in medical research programs.

* * * * *

4. In Sec. 20.1301, paragraph (a) is revised to read as follows:

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

(a) Each licensee shall conduct operations so that--

(1) The total effective dose equivalent to individual members of

the public from the licensed operation does not exceed 0.1 rem (1

millisievert) in a year, exclusive of the dose contributions from

background radiation, from any medical administration the individual

has received, from exposure to individuals administered radioactive

material and released in accordance with Sec. 35.75, from voluntary

participation in medical research programs, and from the licensee's

disposal of radioactive material into sanitary sewerage in accordance

with Sec. 20.2003, and

(2) The dose in any unrestricted area from external sources,

exclusive of the dose contributions from patients administered

radioactive material and released in accordance with Sec. 35.75, does

not exceed 0.002 rem (0.02 millisievert) in any one hour.

* * * * *

5. In Sec. 20.1903, paragraph (b) is revised to read as follows:

Sec. 20.1903 Exceptions to posting requirements.

* * * * *

(b) Rooms or other areas in hospitals that are occupied by patients

are not required to be posted with caution signs pursuant to

Sec. 20.1902 provided that the patient could be released from licensee

control pursuant to Sec. 35.75 of this chapter.

* * * * *

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

6. The authority citation for part 35 continues to read as follows:

Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,

as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.

1242, as amended (42 U.S.C. 5841).

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

Sec. 35.8 Information collection requirements: OMB approval.

* * * * *

(b) The approved information collection requirements contained in

this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.20, 35.21,

35.22, 35.23, 35.29, 35.13, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60,

35.61, 35.70, 35.75, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315,

35.404, 35.406, 35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632,

35.634, 35.636, 35.641, 35.643, 35.645, 35.647, 35.980 and 35.981.

* * * * *

8. Section 35.75 is revised to read as follows:

Sec. 35.75 Release of individuals containing radiopharmaceuticals or

permanent implants.

(a) The licensee may authorize the release from its control of any

individual who has been administered radiopharmaceuticals or permanent

implants containing radioactive material if the total effective dose

equivalent to any other individual from exposure to the released

individual is not likely to exceed 5 millisieverts (0.5 rem).\1\

---------------------------------------------------------------------------

\1\ Regulatory Guide 8.39, ``Release of Patients Administered

Radioactive Materials,'' describes methods for calculating doses to

other individuals and contains tables of activities not likely to

cause doses exceeding 5 millisieverts (0.5 rem).

---------------------------------------------------------------------------

(b) The licensee shall provide the released individual with

instructions, including written instructions, on actions recommended to

maintain doses to other individuals as low as is reasonably achievable

if the total effective dose equivalent to any other individual is

likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-

feeding infant or child could exceed 1 millisievert (0.1 rem) assuming

there were no interruption of breast-feeding, the instructions shall

also include:

(1) Guidance on the interruption or discontinuation of breast-

feeding and

(2) Information on the consequences of failure to follow the

guidance.

(c) The licensee shall maintain a record of the basis for

authorizing the release of an individual, for 3 years after the date of

release, if the total effective dose equivalent is calculated by:

(1) Using the retained activity rather than the activity

administered,

(2) Using an occupancy factor less than 0.25 at 1 meter,

(3) Using the biological or effective half-life, or

(4) Considering the shielding by tissue.

(d) The licensee shall maintain a record, for 3 years after the

date of release, that instructions were provided to a breast-feeding

woman if the radiation dose to the infant or child from continued

breast-feeding could result in a total effective dose equivalent

exceeding 5 millisieverts (0.5 rem).

Sec. 35.315 [Amended]

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

Sec. 35.315 Safety precautions.

(a) * * *

(6) [Reserved]

* * * * *

10. In Sec. 35.415, the introductory text to paragraph (a) and

paragraph (a)(1) are revised and paragraph (a)(5) is removed.

Sec. 35.415 Safety precautions.

(a) For each patient or human research subject receiving implant

therapy and not released from licensee control pursuant to Sec. 35.75

of this part, a licensee shall:

(1) Not quarter the patient or the human research subject in the

same room as an individual who is not receiving radiation therapy.

* * * * *

Dated at Rockville, Md., this 23rd day of January, 1997.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 97-2166 Filed 1-28-97; 8:45 am]

BILLING CODE 7590-01-P