[Federal Register Volume 63, Number 141 (Thursday, July 23, 1998)]
[Rules and Regulations]
[Pages 39477-39483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19540]



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

[[Page 39477]]


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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