This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

39477

Vol. 63, No. 141

Thursday, July 23, 1998

NUCLEAR REGULATORY

COMMISSION

10 CFR Parts 20, 32, 35, 36, and 39

RIN 3150–AF46

Minor Corrections, Clarifying Changes,

and a Minor Policy Change

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission is amending its regulations

to make minor corrections and

clarifying changes to the NRC’s 10 CFR

Part 20, ‘‘Standards for Protection

Against Radiation.’’ The final rule is

also intended to conform other

regulations with the Commission’s 1991

revised radiation protection

requirements. In addition, the final rule

includes a minor policy change that

raises the monitoring criteria for minors

from 0.05 rem (0.5 mSv) to 0.1 rem (1

mSv) in a year and for declared

pregnant women from 0.05 rem (0.5

mSv) to 0.1 rem (1 mSv) during their

pregnancies. The 0.1 rem (1 mSv) in a

year deep dose equivalent monitoring

criterion is consistent with the public

dose limit and represents a quantity

more consistent with the measurement

sensitivity of individual personnel

dosimetry. Licensees are still required to

ensure that the occupational dose limit

of 0.5 rem (5 mSv) in a year is not

exceeded for minors, that the dose limit

of 0.5 rem (5 mSv) to an embryo/fetus

due to occupational exposure of a

declared pregnant woman is not

exceeded during the course of the

pregnancy, and that sufficient effort is

made to ensure that substantial

variations above a uniform monthly

exposure rate for a declared pregnant

woman are avoided. These changes to

the threshold for monitoring exposures

to radiation and radioactive material to

demonstrate compliance with the limits

do not change the occupational dose

limits for minors or declared pregnant

workers.

EFFECTIVE DATE: This regulation

becomes effective on August 24, 1998.

FOR FURTHER INFORMATION CONTACT:

Jayne M. McCausland, Office of Nuclear

Material Safety and Safeguards, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555, telephone (301)

415–6219, e-mail JMM2 @ nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

II. Background

III. Summary of Final Rule

IV. Analysis of Public Comments and Staff

Response

V. Agreement State Compatibility

VI. Environmental Impact: Categorical

Exclusion

VII. Paperwork Reduction Act Statement

VIII. Regulatory Analysis

IX. Backfit Analysis

I. Introduction

On May 21, 1991 (56 FR 23360), a

final rule was published in the Federal

Register that amended 10 CFR Part 20

to update the NRC’s ‘‘Standards for

Protection Against Radiation.’’

Subsequent amendments were

published to (1) change the mandatory

implementation to January 1, 1994, and

make conforming changes to the text to

reflect the new implementation date (57

FR 38588; August 26, 1992), (2) remove

or modify provisions to reflect the new

implementation date for NRC’s revised

‘‘Standards for Protection Against

Radiation’’ (58 FR 67657; December 22,

1993), and (3) restore provisions

inadvertently removed or modified (59

FR 41641; August 15, 1994; and 60 FR

20183; April 25, 1995).

Since then, several inconsistencies

have come to light. The Nuclear

Regulatory Commission (NRC) is

amending its regulations regarding

standards for protection against

radiation to make minor corrections and

clarifying changes that will remove the

inconsistencies and further facilitate

implementation. This final rule also

establishes conforming amendments to

10 CFR Parts 32, 35, 36, and 39. In

addition, a minor policy change raises

the monitoring criteria for minors from

0.05 rem (0.5 mSv) to 0.1 rem (1 mSv)

in a year and for declared pregnant

women from 0.05 rem (0.5 mSv) to 0.1

rem (1 mSv) during their pregnancies.

II. Background

On October 7, 1996, the NRC

published a proposed rule for comment

in the Federal Register (61 FR 52388) to

amend 10 CFR Part 20 of its regulations

to make minor corrections and

clarifying changes regarding standards

for protection against radiation; to

conform other 10 CFR Parts with the

Commission’s revised radiation

protection requirements; and to revise

the deep dose equivalent monitoring

criteria for minors from 0.05 rem (0.5

mSv) to 0.1 rem (1 mSv) in a year and

for declared pregnant women from 0.05

rem (0.5 mSv) to 0.1 rem (1 mSv) during

their pregnancies. The proposed rule

noted that the monitoring criteria would

not raise the dose limit for an embryo/

fetus due to occupational dose to the

declared pregnant woman or the dose

limit for minors. Changing the criteria

for monitoring does not, in any way,

change the dose limits for declared

pregnant women, for the embryo/fetus,

or for minors. The 0.1 rem (1 mSv) in

a year deep dose equivalent monitoring

criterion is consistent with the public

dose limit and represents a quantity

more consistent with the measurement

sensitivity of individual personnel

dosimetry. The current criteria of 0.05

rem (0.5 mSv), if received uniformly in

a year or throughout the gestation

period, would result in an average

monthly dose of less than 0.005 rem

(0.05 mSv). The most routinely utilized

individual monitoring devices cannot

accurately measure doses below 0.01

rem (0.1 mSv), which is greater than the

average monthly dose of 0.005 rem (0.05

mSv).

The public comment period closed on

December 23, 1996. A discussion of the

issues raised by public comment is

covered in Section IV, below.

III. Summary of Final Rule

This final rule makes the following

changes:

(1) In § 20.1003, ‘‘Definitions,’’

clarifying changes and minor

corrections are made to the following:

(a) The definition of ‘‘Declared

pregnant woman’’ is revised to specify

that the written declaration of

pregnancy is to be given to the licensee

rather than the employer, unless the

employer is also the licensee. This is

necessary to ensure that the entity

responsible for work assignments

involving radiation exposure (the
39478 Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 /Rules and Regulations

licensee) is aware of the declaration of

pregnancy to facilitate timely and

appropriate protective action. The

change also specifies that the

declaration, as well as associated dose

restrictions, remains in effect until it is

withdrawn in writing or until the

woman is no longer pregnant. The

determination that a declared pregnant

woman is no longer pregnant should be

based on a discussion between the

declared pregnant woman and the

licensee.

(b) The definitions of ‘‘High radiation

area’’ and ‘‘Very high radiation area’’ are

revised to make it clear that these area

designations exist solely to note

radiation levels from sources external to

an individual who may receive the dose.

(c) The definition of ‘‘Individual

monitoring devices’’ is revised to correct

the misuse of the term

thermoluminescent to describe

thermoluminescence dosimeters.

(d) The term ‘‘Lens dose equivalent

(LDE)’’ replaces ‘‘Eye dose equivalent’’

(EDE) to avoid confusion between the

initialisms for dose to the lens of the eye

and effective dose equivalent (EDE).

This should pose no procedural burden

on licensees because the required NRC

Forms 4 and 5 for records and reports

were revised in August 1995 to reflect

the new terminology, and these or their

equivalent are required to be used by

existing § 20.2104, § 20.2106(c), and

§ 20.2206(b).

(2) In § 20.1101(b), the word

‘‘practicable’’ is changed to ‘‘practical’’

to remove the basis for an incorrect

perception among some licensees that,

by using the word ‘‘practicable’’ in this

section, the NRC is requiring licensees

to use any dose averting technique that

is capable of being used even if the

technique is unproven or impractical.

(3) In §§ 20.1201(a)(2)(i) and (c);

20.1203; 20.2101; 20.2106(a)(1); and

20.2202(a)(1)(ii) and (b)(1)(ii), ‘‘eye dose

equivalent’’ is replaced by ‘‘lens dose

equivalent’’ as described above in the

change to § 20.1003.

(4) In § 20.1206, Planned special

exposures, paragraph (a) is revised to

clarify what was intended by the term

‘‘higher exposure’’ used in the rule

previously. The phrase applies to dose

estimates performed prior to authorizing

the planned special exposure (PSE). The

new wording states that PSE’s are

authorized only in exceptional

situations when alternatives that might

avoid the dose estimated to result from

the PSE are unavailable or impractical.

Improved clarification will avoid

possible misinterpretation of a PSE

criterion.

(5) In § 20.1208(a), (c), (c)(2), and (d),

the phrase ‘‘dose to an embryo/fetus’’ is

changed to read ‘‘dose equivalent to the

embryo/fetus’’ to make it clear that the

dose limit specifically applies to the

dose equivalent, which is the

technically correct term to denote effect

of dose to an organ.

(6) In § 20.1501(a)(2)(i), the phrase

‘‘The extent of radiation levels; * * *’’

is revised to read ‘‘The magnitude and

extent of radiation levels; * * *’’ to

clarify the intended meaning that

surveys should evaluate both the area

covering the dose field as well as the

amount of dose in that area.

(7) In § 20.1501(a)(2)(iii), the phrase

‘‘The potential radiological hazards that

could be present’’ is revised to read

‘‘The potential radiological hazards’’ in

order to remove redundancy.

(8) In § 20.1502, the words ‘‘from

licensed and unlicensed radiation

sources under the control of the

licensee’’ are added after ‘‘exposure to

radiation’’ in paragraph (a) to improve

clarity and to make it clear that, in

determining whether or not monitoring

is required, a licensee need not take into

account sources of radiation not under

its control. It should be noted that,

although the criterion for monitoring

includes only radiation from sources

under the control of the licensee,

occupational dose includes dose from

licensed and unlicensed material,

whether in the possession of the

licensee or other person.

(9) In § 20.1502(a)(2) and (b)(2),

monitoring requirements for minors and

pregnant women are revised. In

addition, for minors the dose limits

referenced in paragraph (a)(2) apply for

an entire year, while for a declared

pregnant woman the dose limit

referenced in paragraph (b)(2) applies

only to the 9-month gestation period.

These paragraphs are separated and

revised accordingly to make this section

consistent with § 20.1208 and

technically correct. The criteria for

monitoring the deep dose equivalent are

changed for minors from 0.05 rem (0.5

mSv) to 0.1 rem (1 mSv) in a year and

for declared pregnant women from 0.05

rem (0.5 mSv) to 0.1 rem (1 mSv) during

their pregnancies. Changing the criteria

for monitoring does not, in any way,

change the dose limits for declared

pregnant women, for the embryo/fetus,

or for minors. This change constitutes a

small licensee burden reduction while

maintaining the current adequate level

of protection of health and safety of

minors and declared pregnant women.

The 0.1 rem (1 mSv) in a year deep dose

equivalent monitoring criterion is

consistent with the public dose limit

and represents a quantity more

consistent with the measurement

sensitivity of individual personnel

dosimetry. This value also is consistent

with the 100 mrem (1 mSv) training

criterion in revised § 19.12 (60 FR

36038; July 13, 1995).

Licensees are still required to ensure

that the occupational dose limits for

minors in § 20.1207 are not exceeded,

that the dose limit of 0.5 rem (5 mSv)

to the embryo/fetus from occupational

dose to the declared pregnant woman is

not exceeded during the course of the

pregnancy, and that sufficient effort is

made to ensure that substantial

variations above a uniform monthly

exposure rate for a declared pregnant

woman are avoided. All of the

occupational dose limits in § 20.1201

continue to be applicable to the

declared pregnant woman as long as the

embryo/fetus dose limit is not exceeded.

Note that the monitoring criteria for lens

dose equivalent and shallow dose

equivalent for skin and extremities

continue to apply to determining the

occupational exposure of declared

pregnant women even though they are

not applicable to the embryo/fetus.

(10) The proposed change to the

posting requirement in § 20.1902(d),

‘‘Posting of Airborne Radioactivity

Area,’’ has not been adopted because the

Commission has determined that the

benefit achieved from replacing signs to

use more precise terminology is

outweighed by the cost to the licensees

to comply with the proposed change.

This issue does not have any health and

safety implications and was proposed

only to make an acceptable term more

precise.

(11) In § 20.1903, a new paragraph is

added to exempt teletherapy rooms in a

hospital from posting requirements as

long as access is controlled by the

licensee to prevent the exposure of

workers, other patients, and members of

the public to radiation. The purpose of

this change is to bring the regulation

into conformity with existing licensing

practices which are intended to avoid

the unwarranted and potentially

unsettling effect that ‘‘GRAVE DANGER,

VERY HIGH RADIATION AREA’’ signs

may have on patients undergoing

medical treatment.

(12) In § 20.1906(d), a revision

requires licensees to notify the NRC

Operations Center instead of an NRC

Regional Office when, upon receiving

and opening packages, radiation levels

exceed regulatory limits. This provides

for consistency by having all prompt

notification requirements direct

licensees to contact a single location. A

conforming change also is made to the

notification requirements in § 20.2202.

(13) In § 20.2101, a revision permits

licensees to add the new SI units to the

old (special) units of dose on records
Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 /Rules and Regulations 39479

1Part 20 was implemented prior to the NRC’s

Statement of Policy on Conversion to the Metric

System (61 FR 31169); therefore, in order to be

consistent with the approach used in Part 20 in its

presentation of dual units, this rule does not follow

the NRC’s metrication policy which supports

presenting the SI units first, followed by the English

(or special) units shown in brackets.

required by this part. Each of the

recorded dose quantities is to be

recorded in the appropriate special unit

and, if so desired, followed by the

appropriate SI unit in parentheses.1 The

term ‘‘eye dose equivalent’’ is replaced

by ‘‘lens dose equivalent’’ as discussed

under the amendment to § 20.1003.

(14) In § 20.2106 (a)(2) and (a)(3), the

references to ‘‘body burden’’ are

removed because this term is obsolete.

Section 20.2106(a)(4) is revised by

adding a reference to § 20.1204(a), that

requires licensees to take measurements

of (1) concentrations of radioactive

materials in air in work areas, or (2)

quantities of radionuclides in the body,

or (3) quantities of radionuclides

excreted from the body, or (4)

combinations of these measurements in

order to determine internal dose when

required by § 20.1502 to monitor

internal dose. This, in effect, uses

recorded concentrations of radioactive

material in air, quantities of radioactive

material determined to be in the body or

excreta, or any combination of these that

would be needed, for assessing the

committed effective dose equivalent

(CEDE). The NRC believes that this

information is necessary to support the

recorded results of the licensee’s

calculation of CEDE. Adding this

reference would not impose any

additional recordkeeping burden on

licensees because they are required to

obtain this information in order to

calculate CEDE under § 20.1204.

(15) A revision to § 20.2202(d) results

in the application of the same incident

reporting requirements to all licensees.

Previously, this section required that all

licensees with an installed Emergency

Notification System make reports to the

NRC Operations Center, but all other

licensees must submit both a telephone

report to the NRC Operations Center and

a telegram, mailgram, or facsimile to the

Regional Office. This change now

requires all licensees to report incidents

by telephone to the NRC Operations

Center to ensure consistency in the

prompt notification requirements

contained elsewhere in this part and

results in a reduction in the information

collection burden.

(16) In § 32.54(a), the reference to

‘‘§ 20.203(a)’’ is corrected to read

‘‘§ 20.1901.’’

(17) The proposed change has not

been adopted in § 35.20 because this

issue is being addressed as part of a

major revision to 10 CFR Part 35.

(18) Safety precautions and survey

requirements for restricted and

unrestricted areas are specified in

§§ 35.315, 35.415, 35.641, and 35.643.

The proposed changes to §§ 35.315(a)(4)

and 35.415(a)(4) have not been adopted

because these issues are being addressed

as part of a major revision to 10 CFR

Part 35. Sections 35.641(a)(2)(i) and

(a)(2)(ii) and 35.643(a) are revised to be

consistent with the dose limits for

occupationally exposed individuals and

members of the public. Also, in

§ 35.643(a)(1), a misreference to

§ 20.1301(c) is corrected to read

§ 20.1301. The 0.5 rem (5 mSv) limit

specified in § 20.1301(c) was never

intended to be required under this

section in Part 35. Rather, it was always

the intent of the NRC to apply the 0.1

rem (1 mSv) limit in § 20.1301(a) to this

section, with a provision for licensees to

request the 0.5 rem (5 mSv) limit

specified in § 20.1301(c).

(19) In § 36.23(g), posting

requirements for a panoramic irradiator

are revised to conform with posting

requirements for high or very high

radiation areas in § 20.1902. The

previous posting requirements in Part

36 required a posting appropriate to a

high radiation area only, which may not

be appropriate for all panoramic

irradiators.

(20) In § 39.33, ‘‘Radiation detection

instruments,’’ a conforming change to

paragraph (a) is made by replacing the

term milliroentgens with the terms

millisieverts (mSv) and millirem (mrem)

to be consistent with revised Part 20

terminology. However, the NRC

recognizes that most licensees may still

use radiation detection instruments that

measure radiation in units of roentgens.

Measurements taken in roentgens may

continue to be recorded in terms of the

roentgen, provided that the

measurements can be readily converted

to rem for records required under 10

CFR Part 20.2101(a).

(21) In § 39.71(b), the reference to

‘‘§ 20.3’’ is corrected to read

‘‘§ 20.1003.’’

Appropriate conforming changes to

regulatory guides such as 8.7, 8.13, 8.34,

8.35, and 8.36 are under consideration

by the Commission.

One matter in the proposed rule was

not adopted. The proposed rule would

have changed the term ‘‘Airborne

radioactivity area’’ to ‘‘Airborne

Radioactive Material Area’’ because it is

more precise language. While the

Commission recognizes that the current

language is somewhat imprecise, it has

determined that the burden imposed on

licensees to revise procedures and

change signs would outweigh any

benefits. In addition, the proposed

change to this term does not constitute

a health and safety improvement. The

proposed conforming changes to

§§ 20.1203 and 20.1902(d) also have not

been adopted.

IV. Analysis of Public Comments and

Staff Response

Four letters of public comment were

received on the proposed rule.

Comments were received from the

Council on Radionuclides and

Radiopharmaceuticals, Inc., the Nuclear

Energy Institute, Commonwealth Edison

Company, and the U.S. Department of

Health and Human Services.

Several suggestions for additional

changes in 10 CFR Part 20 were

submitted and have been referred to the

appropriate program offices for

consideration. Comments specific to the

scope of issues addressed by this

rulemaking and the NRC staff’s response

are as follows:

One commenter observed that

frequent minor changes to the

regulations require licensees to make

numerous changes to written

procedures and training content, thus

constituting a burden. It was observed

by the commenter that the costs of

revising procedures and training

programs in response to a minor

rulemaking such as this can range from

$12,000.00 to $20,000.00 per licensee

site in the nuclear power industry. In

response to this comment, and others,

the proposed change in terminology

from ‘‘Airborne radioactivity area’’ to

‘‘Airborne radioactive material area’’ has

been deleted in this final rule. Although

supported by the comments, it was also

criticized as a change having associated

costs and little benefit. The NRC staff

agrees that the costs outweigh the

benefit and has removed this proposed

change from the final rule. The

regulatory analysis contained in Section

VIII now reflects this adjustment in cost

estimate and concludes that the benefits

of improved clarity and consistency in

NRC regulations remaining in this final

rule will offset any remaining costs.

Similar comments regarding costs and

limited benefit were received regarding

the proposed change to lens dose

equivalent (LDE), and one commenter

suggested that NRC Forms 4 and 5

should be revised to use the new term,

‘‘lens dose equivalent (LDE).’’ The NRC

staff believes any costs incurred by

licensees to implement this change in

terminology would be minimal since the

required NRC Forms 4 and 5 have

already been revised to reflect the new

terminology and have been used by

licensees since August 1995.
39480 Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 /Rules and Regulations

Several suggestions were received

regarding the definition and meaning of

total effective dose equivalent (TEDE)

and effective dose equivalent (EDE).

Revision of 10 CFR Part 20, based on the

recent ICRP–60 publication, was

recommended. These suggestions,

though having merit, go far beyond the

scope of this clarifying rulemaking and

will be held for future consideration.

Several commenters agreed that the

declaration of pregnancy must go to the

licensee, rather than the employer, as

the party responsible for taking timely

protective action. Guidance was

requested on how licensees could

determine the duration of pregnancy

and thus, how long dose restrictions

would remain in effect. The

Commission suggests that licensees

establish an appropriate duration of

restriction based on discussion with the

declared pregnant worker. However, it

is not the Commission’s intent to

require activities which might violate

the individual’s right to privacy.

One commenter suggested that an

important reason for increasing the

monitoring threshold for minors and

declared pregnant women to 100 mrem

(1 mSv) was the difficulty in measuring

50 mrem (0.5 mSv) in a year or during

the gestation period. The NRC agrees

and considered this in the adoption of

the final rule change.

Another commenter observed that the

change in the monitoring threshold for

minors and declared pregnant women

will reduce unnecessary burden on

licensees while maintaining the current

adequate level of protection of health

and safety.

One commenter suggested that

consistency with the public dose limit

of 100 mrem (1 mSv) is not adequate

justification for changing the monitoring

criteria for minors and declared

pregnant women. The NRC did not rely

on consistency with the public dose

limit as sole justification; however, it

lends support to the underlying

scientific basis to revise the criteria.

Since the public dose limit of 100 mrem

(1 mSv) is considered to be an

acceptable level of risk for all members

of the public, and the occupational dose

limit for minors and the dose limit for

the embryo-fetus of declared pregnant

women is 500 mrem (5 mSv),

monitoring for exposures of less than

100 mrem (1 mSv) does not provide an

additional level of protection and is not

necessary to comply with the dose

limits. The final rule requires

monitoring of minors and declared

pregnant women when it is likely that

they would receive over 100 mrem (1

mSv) in 1 year (or during the entire

pregnancy).

V. Agreement State Compatibility

This rulemaking will be a matter of

compatibility between the NRC and the

Agreement States, thereby providing

consistency among State and Federal

safety requirements. Four categories of

compatibility (A through D), as well as

a category identifying rules of Health

and Safety significance (H&S), have

been assigned to portions of this rule.

Category A means the provisions affect

a basic radiation protection standard or

related definitions, signs, labels, or

terms necessary for a common

understanding of radiation protection

that the State should adopt with

(essentially) identical language. The

NRC has assigned a Category A level of

compatibility to the changes to the

definitions Declared pregnant woman,

High radiation area, Lens dose

equivalent (LDE), and Very high

radiation area in § 20.1003. Also

included under the Category A level of

compatibility are the changes to

§§ 20.1201 and 20.1208.

Category B means the provisions

affect a program element with

significant direct transboundary

implications that the State should adopt

with essentially identical language. The

NRC has assigned a Category B level of

compatibility to the changes in § 32.54.

Category C means the provisions

affect a program element, the essential

objectives of which should be adopted

by the State to avoid conflicts,

duplications or gaps. The manner in

which the essential objectives are

addressed need not be the same as NRC

provided the essential objectives are

met. The NRC has assigned a Category

C level of compatibility to the changes

in §§ 20.1003 (Definition of Individual

monitoring devices), 20.2101, 20.2106,

20.2202, 39.33, and 39.71.

Category D means the provisions are

not required for purposes of

compatibility; however, if adopted by

the State, they should be compatible

with NRC. The NRC has assigned a

Category D level of compatibility to the

changes in §§ 20.1101, 20.1206, 20.1501,

20.1502, 20.1903, 20.1906, 35.641,

35.643, and 36.23.

Category H&S means the provisions

are not required for compatibility;

however, they do have particular health

and safety significance. The State

should adopt the essential objectives of

such provisions in order to maintain an

adequate program. The Category H&S

has been assigned to the changes in

§§ 20.1101, 20.1501, 20.1502, 20.1906,

and 36.23.

VI. Environmental Impact: Categorical

Exclusion

The NRC has determined that this

final rule is the type of action described

in the categorical exclusion in 10 CFR

51.22(c)(2). Therefore, neither an

environmental impact statement nor an

environmental assessment has been

prepared for this final rule.

VII. 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 3150–0014, 3150–

0001, 3150–0010, 3150–0158, and 3150–

0130.

Because the rule will reduce existing

information collection requirements by

eliminating written incident reports and

allowing licensees to submit incident

reports by telephone, the public burden

for this information collection is

expected to be reduced by

approximately 250 hours per year over

the entire industry. This reduction

includes the time required for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the information collection.

Send comments on any aspect of this

information collection, including

suggestions for further reducing the

burden, to the Information and Records

Management Branch (T–6F33), 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–

0014), Office of Management and

Budget, Washington, DC 20503.

Public Protection Notification

If a document used to impose an

information collection does not display

a currently valid OMB control number,

the NRC may not conduct or sponsor,

and a person is not required to respond

to, the information collection.

VIII. Regulatory Analysis

This final rule makes minor correcting

and clarifying amendments to the

requirements in 10 CFR Part 20 and

conforms 10 CFR Parts 32, 35, 36, and

39 to 10 CFR Part 20. The final rule

imposes one-time only, minor

additional costs at a maximum of

$12,000 per licensee site in the nuclear

power industry for changing written

procedures and possibly training

associated with correcting and clarifying
Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 /Rules and Regulations 39481

several definitions and minor changes to

requirements addressing standards for

protection against radiation. It is

expected that the cost for other classes

of licensees may be substantially less.

The NRC staff believes that the cost of

revising procedures will be small and is

offset by the benefits of improved clarity

and consistency in the NRC’s

regulations.

The final amendments include a

conforming change in 10 CFR Part 36 to

make the posting requirements for a

panoramic irradiator consistent with

posting requirements in 10 CFR Part 20

for high or very high radiation areas.

Licensees in compliance with the Part

20 posting requirements are also in

compliance with Part 36 posting

requirements; therefore, this is a

conforming change to make the

language in the two sections consistent,

and no impact is expected to result from

this action.

The final amendments also result in a

minor reduction in burden to licensees

by eliminating written incident reports

and allowing licensees to submit

incident reports by telephone. This

change is consistent with the Paperwork

Reduction Act of 1995.

The final requirements also waive

posting requirements in teletherapy

rooms in hospitals to remove the

unsettling effects that the signs may

have on patients. There would be no

decrease in safety because the safety

precautions in 10 CFR Part 35 are

considered adequate to protect

individuals from inadvertent exposure

to radiation, and this change may have

a beneficial effect on patients.

In addition, these final amendments

change the deep dose equivalent

monitoring requirements for minors and

pregnant women from one-tenth of the

applicable limit or 0.05 rem (0.5 mSv)

to 0.1 rem (1 mSv) for the following

reasons:

(1) The value is consistent with the

100 mrem (1 mSv) training criterion in

the recently revised 10 CFR 19.12 (60

FR 36038; July 13, 1995).

(2) The value is consistent with the

0.1 rem (1 mSv) dose limit for members

of the public in 10 CFR 20.1301(a).

There is little benefit to require

monitoring of workers who are expected

to receive less dose than is permitted for

members of the public.

No cost is associated with this rule

change, and there may be some

reduction in burden. However, any

reduction is likely to be small because

many factors impact the decision as to

whether personal dosimeters will be

worn and it is impossible to assess the

extent of this burden reduction.

This discussion constitutes the

regulatory analysis for this final rule.

IX. Backfit Analysis

The NRC has determined that the

backfit rules in §§ 50.109, 72.62, and

76.76 do not apply to this final rule and,

therefore, that a backfit analysis is not

required for this final rule because these

amendments do not involve any

provision that would impose backfits as

defined in §§ 50.109(a)(1), 72.62(a), and

76.76(a).

Small Business Regulatory Enforcement

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,

Office of Management and Budget.

List 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 32

Byproduct material, Criminal

penalties, Labeling, Nuclear materials,

Radiation protection, Reporting and

recordkeeping requirements.

10 CFR Part 35

Byproduct material, Criminal

penalties, Drugs, Health facilities,

Health professions, Medical devices,

Nuclear materials, Occupational safety

and health, Radiation protection,

Reporting and recordkeeping

requirements.

10 CFR Part 36

Byproduct material, Criminal

penalties, Nuclear materials, Oil and gas

exploration—well logging, Reporting

and recordkeeping requirements,

Scientific equipment, Security

measures, Source material, Special

nuclear material.

10 CFR Part 39

Byproduct material, Criminal

penalties, Nuclear materials, Oil and gas

exploration—well logging, Reporting

and recordkeeping requirements,

Scientific equipment, Security

measures, Source material, Special

nuclear material.

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, 32, 35,

36, and 39.

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. In § 20.1003, the definition of Eye

dose equivalent is removed. The

definition of Lens dose equivalent (LDE)

is added in alphabetical order, and the

definitions of Declared pregnant

woman, High radiation area, Individual

monitoring devices, and Very high

radiation area are revised to read as

follows:

§ 20.1003 Definitions.

* * * * *

Declared pregnant woman means a

woman who has voluntarily informed

the licensee, in writing, of her

pregnancy and the estimated date of

conception. The declaration remains in

effect until the declared pregnant

woman withdraws the declaration in

writing or is no longer pregnant.

* * * * *

High radiation area means an area,

accessible to individuals, in which

radiation levels from radiation sources

external to the body could result in an

individual receiving a dose equivalent

in excess of 0.1 rem (1 mSv) in 1 hour

at 30 centimeters from the radiation

source or 30 centimeters from any

surface that the radiation penetrates.

* * * * *

Individual monitoring devices

(individual monitoring equipment)

means devices designed to be worn by

a single individual for the assessment of

dose equivalent such as film badges,

thermoluminescence dosimeters (TLDs),

pocket ionization chambers, and

personal (‘‘lapel’’) air sampling devices.

* * * * *

Lens dose equivalent (LDE) applies to

the external exposure of the lens of the

eye and is taken as the dose equivalent

at a tissue depth of 0.3 centimeter (300

mg/cm2).

* * * * *
39482 Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 /Rules and Regulations

2All of the occupational doses in § 20.1201

continue to be applicable to the declared pregnant

worker as long as the embryo/fetus dose limit is not

exceeded.

Very high radiation area means an

area, accessible to individuals, in which

radiation levels from radiation sources

external to the body could result in an

individual receiving an absorbed dose

in excess of 500 rads (5 grays) in 1 hour

at 1 meter from a radiation source or 1

meter from any surface that the

radiation penetrates.

* * * * *

3. In § 20.1101, paragraph (b) is

revised to read as follows:

§ 20.1101 Radiation protection programs.

* * * * *

(b) The licensee shall use, to the

extent practical, procedures and

engineering controls based upon sound

radiation protection principles to

achieve occupational doses and doses to

members of the public that are as low

as is reasonably achievable (ALARA).

* * * * *

4. In § 20.1201, paragraphs (a)(2)(i)

and (c) are revised to read as follows:

§ 20.1201 Occupational dose limits for

adults.

(a) * * *

(2) * * *

(i) A lens dose equivalent of 15 rems

(0.15 Sv), and

* * * * *

(c) The assigned deep-dose equivalent

and shallow-dose equivalent must be for

the part of the body receiving the

highest exposure. The deep-dose

equivalent, lens dose equivalent, and

shallow-dose equivalent may be

assessed from surveys or other radiation

measurements for the purpose of

demonstrating compliance with the

occupational dose limits, if the

individual monitoring device was not in

the region of highest potential exposure,

or the results of individual monitoring

are unavailable.

* * * * *

5. In § 20.1203, the introductory text

is revised to read as follows:

§ 20.1203 Determination of external dose

from airborne radioactive material.

Licensees shall, when determining the

dose from airborne radioactive material,

include the contribution to the deepdose equivalent, lens dose equivalent,

and shallow-dose equivalent from

external exposure to the radioactive

cloud (see appendix B to part 20,

footnotes 1 and 2).

* * * * *

6. In § 20.1206, paragraph (a) is

revised to read as follows:

§ 20.1206 Planned special exposures.

* * * * *

(a) The licensee authorizes a planned

special exposure only in an exceptional

situation when alternatives that might

avoid the dose estimated to result from

the planned special exposure are

unavailable or impractical.

* * * * *

7. In § 20.1208, the section heading,

paragraph (a), the introductory text of

paragraph (c), and paragraphs (c)(2) and

(d) are revised to read as follows:

§ 20.1208 Dose equivalent to an embryo/

fetus.

(a) The licensee shall ensure that the

dose equivalent to the embryo/fetus

during the entire pregnancy, due to the

occupational exposure of a declared

pregnant woman, does not exceed 0.5

rem (5 mSv). (For recordkeeping

requirements, see § 20.2106.)

* * * * *

(c) The dose equivalent to the

embryo/fetus is the sum of—

* * * * *

(2) The dose equivalent to the

embryo/fetus resulting from

radionuclides in the embryo/fetus and

radionuclides in the declared pregnant

woman.

(d) If the dose equivalent to the

embryo/fetus is found to have exceeded

0.5 rem (5 mSv), or is within 0.05 rem

(0.5 mSv) of this dose, by the time the

woman declares the pregnancy to the

licensee, the licensee shall be deemed to

be in compliance with paragraph (a) of

this section if the additional dose

equivalent to the embryo/fetus does not

exceed 0.05 rem (0.5 mSv) during the

remainder of the pregnancy.

8. In § 20.1501, paragraphs (a)(2)(i)

and (a)(2)(iii) are revised to read as

follows:

§ 20.1501 General.

(a) * * *

(2) * * *

(i) The magnitude and extent of

radiation levels; and

* * * * *

(iii) The potential radiological

hazards.

* * * * *

9. In § 20.1502, paragraph (a)(3) is

redesignated as (a)(4) and new

paragraphs (a)(3) and (b)(3) are added;

and the introductory text of paragraph

(a) and paragraphs (a)(2), (b)(1), and

(b)(2) are revised to read as follows:

§ 20.1502 Conditions requiring individual

monitoring of external and internal

occupational dose.

* * * * *

(a) Each licensee shall monitor

occupational exposure to radiation from

licensed and unlicensed radiation

sources under the control of the licensee

and shall supply and require the use of

individual monitoring devices by—

* * * * *

(2) Minors likely to receive, in 1 year,

from radiation sources external to the

body, a deep dose equivalent in excess

of 0.1 rem (1 mSv), a lens dose

equivalent in excess of 0.15 rem (1.5

mSv), or a shallow dose equivalent to

the skin or to the extremities in excess

of 0.5 rem (5 mSv);

(3) Declared pregnant women likely to

receive during the entire pregnancy,

from radiation sources external to the

body, a deep dose equivalent in excess

of 0.1 rem (1 mSv); 2 and

* * * * *

(b) * * *

(1) Adults likely to receive, in 1 year,

an intake in excess of 10 percent of the

applicable ALI(s) in table 1, Columns 1

and 2, of appendix B to §§ 20.1001–

20.2402;

(2) Minors likely to receive, in 1 year,

a committed effective dose equivalent in

excess of 0.1 rem (1 mSv); and

(3) Declared pregnant women likely to

receive, during the entire pregnancy, a

committed effective dose equivalent in

excess of 0.1 rem (1 mSv).

10. In § 20.1903, a new paragraph (d)

is added to read as follows:

§ 20.1903 Exceptions to posting

requirements.

* * * * *

(d) Rooms in hospitals or clinics that

are used for teletherapy are exempt from

the requirement to post caution signs

under § 20.1902 if—

(1) Access to the room is controlled

pursuant to 10 CFR 35.615; and

(2) Personnel in attendance take

necessary precautions to prevent the

inadvertent exposure of workers, other

patients, and members of the public to

radiation in excess of the limits

established in this part.

11. In § 20.1906, the introductory text

of paragraph (d) is revised to read as

follows:

§ 20.1906 Procedures for receiving and

opening packages.

* * * * *

(d) The licensee shall immediately

notify the final delivery carrier and the

NRC Operations Center (301–816–5100),

by telephone, when—

* * * * *

12. In § 20.2101, paragraph (b) is

redesignated as paragraph (c), paragraph

(c) is redesignated as paragraph (d) and

revised, and a new paragraph (b) is

added to read as follows:
Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 /Rules and Regulations 39483

§ 20.2101 General provisions.

* * * * *

(b) In the records required by this

part, the licensee may record quantities

in SI units in parentheses following

each of the units specified in paragraph

(a) of this section. However, all

quantities must be recorded as stated in

paragraph (a) of this section.

* * * * *

(d) The licensee shall make a clear

distinction among the quantities entered

on the records required by this part (e.g.,

total effective dose equivalent, shallowdose equivalent, lens dose equivalent,

deep-dose equivalent, committed

effective dose equivalent).

13. In § 20.2106, paragraphs (a)(1),

(a)(2), (a)(3), and (a)(4) are revised to

read as follows:

§ 20.2106 Records of individual monitoring

results.

(a) * * *

(1) The deep-dose equivalent to the

whole body, lens dose equivalent,

shallow-dose equivalent to the skin, and

shallow-dose equivalent to the

extremities;

(2) The estimated intake of

radionuclides (see § 20.1202);

(3) The committed effective dose

equivalent assigned to the intake of

radionuclides;

(4) The specific information used to

assess the committed effective dose

equivalent pursuant to § 20.1204(a) and

(c), and when required by § 20.1502;

* * * * *

14. In § 20.2202, paragraphs (a)(1)(ii),

(b)(1)(ii), and (d)(2) are revised to read

as follows:

§ 20.2202 Notification of incidents.

(a) * * *

(1) * * *

(ii) A lens dose equivalent of 75 rems

(0.75 Sv) or more; or

(b) * * *

(1) * * *

(ii) A lens dose equivalent exceeding

15 rems (0.15 Sv); or

(d) * * *

(2) All other licensees shall make the

reports required by paragraphs (a) and

(b) of this section by telephone to the

NRC Operations Center (301) 816–5100.

* * * * *

PART 32—SPECIFIC DOMESTIC

LICENSES TO MANUFACTURE OR

TRANSFER CERTAIN ITEMS

CONTAINING BYPRODUCT MATERIAL

15. The authority citation for Part 32

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).

§ 32.54 [Amended]

16. In § 32.54, paragraph (a) is

amended by revising the reference

to‘‘§ 20.203(a)’’ to read ‘‘§ 20.1901.’’

PART 35—MEDICAL USE OF

BYPRODUCT MATERIAL

17. 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).

18. In § 35.641, paragraphs (a)(2)(i)

and (a)(2)(ii) are revised to read as

follows:

§ 35.641 Radiation surveys for teletherapy

facilities.

(a) * * *

(2) * * *

(i) Radiation dose rates in restricted

areas are not likely to cause any

occupationally exposed individual to

receive a dose in excess of the limits

specified in § 20.1201 of this chapter;

and

(ii) Radiation dose rates in controlled

or unrestricted areas are not likely to

cause any individual member of the

public to receive a dose in excess of the

limits specified in § 20.1301 of this

chapter.

* * * * *

19. In § 35.643, paragraphs (a)

introductory text and (a)(1) are revised

to read as follows:

§ 35.643 Modification of teletherapy unit or

room before beginning a treatment

program.

(a) If the survey required by § 35.641

indicates that any individual member of

the public is likely to receive a dose in

excess of the limits specified in

§ 20.1301 of this chapter, the licensee

shall, before beginning the treatment

program:

(1) Either equip the unit with stops or

add additional radiation shielding to

ensure compliance with § 20.1301 of

this chapter.

* * * * *

PART 36—LICENSES AND RADIATION

SAFETY REQUIREMENTS FOR

IRRADIATORS

20. The authority citation for Part 36

continues to read as follows:

Authority: Secs. 81, 82, 161, 182, 183, 186,

68 Stat. 935, 948, 953, 954, 955, as amended,

sec. 234, 83 Stat. 444, as amended (42 U.S.C.

2111, 2112, 2201, 2232, 2233, 2236, 2282);

secs. 201, as amended, 202, 206, 88 Stat.

1242, as amended, 1244, 1246 (42 U.S.C.

5841, 5842, 5846).

21. In § 36.23, paragraph (g) is revised

to read as follows:

§ 36.23 Access control.

* * * * *

(g) Each entrance to the radiation

room of a panoramic irradiator and each

entrance to the area within the

personnel access barrier of an

underwater irradiator must be posted as

required by 10 CFR 20.1902. Radiation

postings for panoramic irradiators must

comply with the posting requirements

of 10 CFR 20.1902, except that signs

may be removed, covered, or otherwise

made inoperative when the sources are

fully shielded.

* * * * *

PART 39—LICENSES AND RADIATION

SAFETY REQUIREMENTS FOR WELL

LOGGING

22. The authority citation for Part 39

continues to read as follows:

Authority: Secs. 53, 57, 62, 63, 65, 69, 81,

82, 161, 182, 183, 188, 68 Stat. 929, 930, 932,

933, 934, 935, 948, 953, 954, 955, as

amended, sec. 234, 83 Stat. 444, as amended

(42 U.S.C. 2073, 2077, 2092, 2093, 2095,

2099, 2111, 2112, 2201, 2232, 2233, 2236,

2282); secs. 201, as amended, 202, 206, 88

Stat. 1242, as amended, 1244, 1246 (42 U.S.C.

5841, 5842, 5846).

23. In § 39.33, paragraph (a) is revised

to read as follows:

§ 39.33 Radiation detection instruments.

(a) The licensee shall keep a

calibrated and operable radiation survey

instrument capable of detecting beta and

gamma radiation at each field station

and temporary jobsite to make the

radiation surveys required by this part

and by part 20 of this chapter. To satisfy

this requirement, the radiation survey

instrument must be capable of

measuring 0.001 mSv (0.1 mrem) per

hour through at least 0.5 mSv (50 mrem)

per hour.

* * * * *

§ 39.71 [Amended]

24. In § 39.71, paragraph (b) is

amended by revising the reference to

‘‘§ 20.3’’ to read ‘‘§ 20.1003.’’

Dated at Rockville, Maryland, this 9th day

of July 1998.

For the Nuclear Regulatory Commission.

L. Joseph Callan,

Executive Director for Operations.

[FR Doc. 98–19540 Filed 7–22–98; 8:45 am]

BILLING CODE 7590–01–P