[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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Rules and Regulations
Federal Register
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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