4120 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

We have determined that Louisiana

meets the standards for Class Free

status. The interim rule was necessary

to relieve certain restrictions on the

interstate movement of cattle from

Louisiana.

EFFECTIVE DATE: The interim rule was

effective on October 31, 1996.

FOR FURTHER INFORMATION CONTACT: Dr.

Michael J. Gilsdorf, Senior Staff

Veterinarian, Brucellosis Eradication

Staff, VS, APHIS, USDA, Suite 3B08,

4700 River Road Unit 36, Riverdale, MD

20737–1236; (301) 734–7708.

SUPPLEMENTARY INFORMATION:

Background

In an interim rule effective and

published in the Federal Register on

October 31, 1996 (61 FR 56116–56118,

Docket No. 96–043–1), we amended the

brucellosis regulations in 9 CFR part 78

by removing Louisiana from the list of

Class A States in § 78.41(b) and adding

it to the list of Class Free States in

§ 78.41(a).

Comments on the interim rule were

required to be received on or before

December 30, 1996. We did not receive

any comments. The facts presented in

the interim rule still provide a basis for

the rule.

This action also affirms the

information contained in the interim

rule concerning Executive Order 12866

and the Regulatory Flexibility Act,

Executive Orders 12372 and 12988, and

the Paperwork Reduction Act.

Further, for this action, the Office of

Management and Budget has waived the

review process required by Executive

Order 12866.

List of Subjects in 9 CFR Part 78

Animal diseases, Bison, Cattle, Hogs,

Quarantine, Reporting and

recordkeeping requirements,

Transportation.

PART 78—BRUCELLOSIS

Accordingly, we are adopting as a

final rule, without change, the interim

rule that amended 9 CFR 78 and that

was published at 61 FR 56116–56118 on

October 31, 1996.

Authority: 21 U.S.C. 111–114a-1, 114g,

115, 117, 120, 121, 123–126, 134b, and 134f;

7 CFR 2.22, 2.80, and 371.2(d).

Done in Washington, DC, this 23rd day of

January 1997.

Terry L. Medley,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–2198 Filed 1–28–97; 8:45 am]

BILLING CODE 3410–34–P

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.

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.
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 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 § 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.
4122 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

1National 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.)

Exclusion of Patient Release From

§ 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 (§ 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 activitybased 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 iodine131, 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.

NUREG–1492 contains a detailed

examination of the benefits and impacts

of the final rule that includes dose
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4123

2National 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.)

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

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 iodine131 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 iodine131. 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.
4124 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

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.

4National 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.

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.

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).
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 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 inpatient days and to justify out-patient

treatments.

Response. There is no objection to

optimizing calculations to reduce inpatient 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
4126 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

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 caseby-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 breastfeeding 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
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4127

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.

individuals, it may be necessary to base

the release on a more realistic casespecific 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

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 chromium51, 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 acceleratorproduced 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
4128 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

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 iodine131 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 personrem 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 personrem, 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 costeffectiveness 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.
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 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

§ 20.1002, ‘‘Scope’’; in § 20.1003,

‘‘Definitions’’ (in the definitions of both

public dose and occupational dose); and

in § 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 §§ 20.1002 and 20.1003 are

added to § 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 breastfeeding 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
4130 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

(0.1 rem). This also requires giving

instructions to a woman who is breastfeeding 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 breastfeeding 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 breastfeeding.

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 breastfeeding.

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 breastfeeding 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 breastfeeding 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.
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 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 § 20.1003 and the text in

§ 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, §§ 35.75(a) and (b) are a

Division 2 level of compatibility

because the patient release criteria
4132 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations

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

§§ 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

BJS1@NRC.GOV; 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:

§ 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 § 35.75, or to exposure

from voluntary participation in medical

research programs.

3. In § 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:
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations 4133

1Regulatory 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).

§ 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 § 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 § 35.75, or from voluntary

participation in medical research

programs.

* * * * *

4. In § 20.1301, paragraph (a) is

revised to read as follows:

§ 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 § 35.75,

from voluntary participation in medical

research programs, and from the

licensee’s disposal of radioactive

material into sanitary sewerage in

accordance with § 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 § 35.75,

does not exceed 0.002 rem (0.02

millisievert) in any one hour.

* * * * *

5. In § 20.1903, paragraph (b) is

revised to read as follows:

§ 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 § 20.1902 provided that the

patient could be released from licensee

control pursuant to § 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 § 35.8, paragraph (b) is revised to

read as follows:

§ 35.8 Information collection

requirements: OMB approval.

* * * * *

(b) The approved information

collection requirements contained in

this part appear in §§ 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:

§ 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

(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 breastfeeding, 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).

§ 35.315 [Amended]

9. In § 35.315, paragraph (a)(6) is

removed and reserved.

§ 35.315 Safety precautions.

(a) * * *

(6) [Reserved]

* * * * *

10. In § 35.415, the introductory text

to paragraph (a) and paragraph (a)(1) are

revised and paragraph (a)(5) is removed.

§ 35.415 Safety precautions.

(a) For each patient or human

research subject receiving implant

therapy and not released from licensee

control pursuant to § 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