Minor Corrections, Clarifying Changes, and a Minor Policy Change

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.

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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 Sec. 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

[[Page 39478]]

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 Sec. 20.2104, Sec. 20.2106(c), and Sec. 20.2206(b).

(2) In Sec. 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 Secs. 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 Sec. 20.1003.

(4) In Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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

Sec. 19.12 (60 FR 36038; July 13, 1995).

Licensees are still required to ensure that the occupational dose

limits for minors in Sec. 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 Sec. 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

Sec. 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 Sec. 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 Sec. 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

Sec. 20.2202.

(13) In Sec. 20.2101, a revision permits licensees to add the new

SI units to the old (special) units of dose on records

[[Page 39479]]

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 Sec. 20.1003.

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\1\ Part 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.

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(14) In Sec. 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 Sec. 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 Sec. 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 Sec. 20.1204.

(15) A revision to Sec. 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 Sec. 32.54(a), the reference to ``Sec. 20.203(a)'' is

corrected to read ``Sec. 20.1901.''

(17) The proposed change has not been adopted in Sec. 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 Secs. 35.315, 35.415, 35.641, and

35.643. The proposed changes to Secs. 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 Sec. 35.643(a)(1), a misreference to Sec. 20.1301(c)

is corrected to read Sec. 20.1301. The 0.5 rem (5 mSv) limit specified

in Sec. 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 Sec. 20.1301(a) to this section, with a

provision for licensees to request the 0.5 rem (5 mSv) limit specified

in Sec. 20.1301(c).

(19) In Sec. 36.23(g), posting requirements for a panoramic

irradiator are revised to conform with posting requirements for high or

very high radiation areas in Sec. 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 Sec. 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 Sec. 39.71(b), the reference to ``Sec. 20.3'' is corrected

to read ``Sec. 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 Secs. 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.

[[Page 39480]]

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 Sec. 20.1003. Also included

under the Category A level of compatibility are the changes to

Secs. 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 Sec. 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 Secs. 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 Secs. 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 Secs. 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

[email protected]; 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

[[Page 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 Secs. 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 Secs. 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 Sec. 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:

Sec. 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).

* * * * *

[[Page 39482]]

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 Sec. 20.1101, paragraph (b) is revised to read as follows:

Sec. 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 Sec. 20.1201, paragraphs (a)(2)(i) and (c) are revised to

read as follows:

Sec. 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 Sec. 20.1203, the introductory text is revised to read as

follows:

Sec. 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 deep-dose

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 Sec. 20.1206, paragraph (a) is revised to read as follows:

Sec. 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 Sec. 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:

Sec. 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 Sec. 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 Sec. 20.1501, paragraphs (a)(2)(i) and (a)(2)(iii) are

revised to read as follows:

Sec. 20.1501 General.

(a) * * *

(2) * * *

(i) The magnitude and extent of radiation levels; and

* * * * *

(iii) The potential radiological hazards.

* * * * *

9. In Sec. 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:

Sec. 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

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

\2\ All of the occupational doses in Sec. 20.1201 continue to be

applicable to the declared pregnant worker as long as the embryo/

fetus dose limit is not exceeded.

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

* * * * *

(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 Secs. 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 Sec. 20.1903, a new paragraph (d) is added to read as

follows:

Sec. 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 Sec. 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 Sec. 20.1906, the introductory text of paragraph (d) is

revised to read as follows:

Sec. 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 Sec. 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:

[[Page 39483]]

Sec. 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, shallow-dose equivalent, lens dose

equivalent, deep-dose equivalent, committed effective dose equivalent).

13. In Sec. 20.2106, paragraphs (a)(1), (a)(2), (a)(3), and (a)(4)

are revised to read as follows:

Sec. 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 Sec. 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 Sec. 20.1204(a) and (c), and when required

by Sec. 20.1502;

* * * * *

14. In Sec. 20.2202, paragraphs (a)(1)(ii), (b)(1)(ii), and (d)(2)

are revised to read as follows:

Sec. 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).

Sec. 32.54 [Amended]

16. In Sec. 32.54, paragraph (a) is amended by revising the

reference to``Sec. 20.203(a)'' to read ``Sec. 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 Sec. 35.641, paragraphs (a)(2)(i) and (a)(2)(ii) are revised

to read as follows:

Sec. 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 Sec. 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 Sec. 20.1301 of this chapter.

* * * * *

19. In Sec. 35.643, paragraphs (a) introductory text and (a)(1) are

revised to read as follows:

Sec. 35.643 Modification of teletherapy unit or room before beginning

a treatment program.

(a) If the survey required by Sec. 35.641 indicates that any

individual member of the public is likely to receive a dose in excess

of the limits specified in Sec. 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 Sec. 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 Sec. 36.23, paragraph (g) is revised to read as follows:

Sec. 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 Sec. 39.33, paragraph (a) is revised to read as follows:

Sec. 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.

* * * * *

Sec. 39.71 [Amended]

24. In Sec. 39.71, paragraph (b) is amended by revising the

reference to ``Sec. 20.3'' to read ``Sec. 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