[Federal Register Volume 61, Number 195 (Monday, October 7, 1996)]
[Proposed Rules]
[Pages 52388-52394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25486]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 20, 32, 35, 36, 39
RIN 3150-AF46
Minor Corrections, Clarifying Changes, and a Minor Policy Change
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission is proposing to amend its
regulations to make minor corrections and clarifying changes to the
standards for protection against radiation. The proposed amendments
would also conform other parts with the Commission's revised radiation
protection requirements. In addition, a minor policy change is proposed
that would revise the monitoring criterion 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.
Revising the monitoring criterion would not, in any way, raise the dose
limit for declared pregnant women and minors. Licensees would still be
required to ensure that the dose limit of 0.5 rem (5 mSv) for minors is
not exceeded in a year and that the dose limit of 0.5 rem (5 mSv) for
declared pregnant women is not exceeded during the period of their
pregnancy. The dose limit for the embryo/fetus is unchanged. This
proposed rule is necessary to inform the public of these minor changes
to the NRC's regulations and invite comments.
DATES: Comment period expires December 23, 1996. Comments received
after this date will be considered if it is practical to do so, but the
Commission is able to assure consideration only for comments received
on or before this date.
ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001; Attention: Docketing and Service
Branch.
Deliver comments to: 11555 Rockville Pike, Rockville, Maryland,
between 7:45 am and 4:15 pm Federal workdays.
Copies of the supporting statement submitted to OMB and comments
received may be examined at the NRC Public Document Room at 2120 L
Street NW. (Lower Level), Washington, DC.
For information on submitting comments electronically, see the
discussion under Electronic Access in the Supplementary Information
section.
FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555, telephone (301) 415-6219, e-mail JMM2@nrc.gov.
SUPPLEMENTARY INFORMATION:
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 date 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). This proposed rule would make additional minor corrections and
clarifying changes to the NRC regulation for greater clarity and to
further facilitate implementation. The proposed rule would also make
conforming amendments to 10 CFR Parts 32, 35, 36, and 39. In addition,
a minor policy change is proposed that would revise the monitoring
criterion 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.
This proposed rule would make the following changes:
(1) In Sec. 20.1003, ``Definitions,'' clarifying changes and minor
corrections would be made to the following:
(a) The term ``Airborne radioactivity area'' would be replaced with
``Airborne radioactive material area'' to clarify that radioactivity is
a property of matter and, as such, cannot be airborne. A conforming
change would also be made in Sec. 20.1902(d) to permit licensees the
option of either using the current signs or posting new signs to
reflect this change.
[[Page 52389]]
(b) The definition of ``Declared pregnant woman'' would be revised
to specify that the written declaration of pregnancy would be given to
the licensee. This is necessary to ensure that the licensee responsible
for work assignments involving exposure is aware of the declaration of
pregnancy so that appropriate dose restriction can be imposed. The
change would also specify the duration of the effectiveness of a
woman's declaration.
(c) The term ``Eye dose equivalent'' (EDE) would be replaced with
``Lens dose equivalent'' (LDE) to avoid confusion between the
initialisms for dose to the lens of the eye and effective dose
equivalent (EDE).
(d) The definitions of ``High radiation area'' and ``Very high
radiation area'' would be revised to make it clear that these area
designations are based solely on radiation levels from sources external
to an individual who may receive the dose.
(e) The definition of ``Individual monitoring devices'' would be
revised to correct the terminology for thermoluminescence dosimeters.
(2) In Sec. 20.1101(b), the word ``practicable'' would be 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'' would be replaced by ``lens dose equivalent'' to conform
to the proposed amendment in Sec. 20.1003.
(4) In Sec. 20.1206, Planned special exposures, paragraph (a) would
be revised to clarify the meaning of ``higher exposure.'' The proposed
new wording would state that planned special exposures are authorized
only in exceptional situations when alternatives that might avoid the
dose are unavailable or impractical.
(5) In Sec. 20.1208 (a), (c), (c)(2), and (d), the phrase ``dose to
an embryo/fetus'' would be 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;* * *'' would be revised to read ``The magnitude and extent of
radiation levels;* * *.'' to more clearly reflect the intended meaning.
(7) In Sec. 20.1501(a)(2)(iii), the phrase ``The potential
radiological hazards that could be present'' would be revised to read
``The potential radiological hazards'' to remove the redundancy.
(8) In Sec. 20.1502, the words ``from radiation sources under the
control of the licensee'' would be added after ``exposure to
radiation'' in paragraph (a) to improve clarity and to make it clear
that a licensee is not responsible for sources not under its control.
(9) In Sec. 20.1502 (a)(2) and (b)(2), monitoring requirements are
stated as one-tenth of applicable limits for a year for minors and
pregnant women, even though the dose limits referenced in paragraph
(a)(2) apply for an entire year to minors while the dose limit
referenced in paragraph (b)(2) applies only to the 9-month gestation
period of a declared pregnant woman. These paragraphs would be
separated and revised accordingly to make this section consistent with
Sec. 20.1208 and technically correct. In addition, the criterion for
monitoring minors and declared pregnant women would be 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. This change would constitute a small licensee
burden reduction with no loss in worker health and safety. The
conservative approach currently in use has resulted in the following
problems:
(a) The value is not consistent with the 0.1 rem (1 mSv) dose limit
for members of the public in Sec. 20.1301(a). It is not appropriate to
require monitoring of workers who are expected to receive less dose
than is permitted for members of the public; and
(b) The value is not consistent with the 100-mrem (1 mSv) training
criterion in the recently revised Sec. 19.12 (60 FR 36038; July 13,
1995).
Raising this limit would not, in any way, raise the dose limit for
declared pregnant women and minors. Licensees would still be required
to ensure that the dose limit of 0.5 rem (5 mSv) for minors is not
exceeded in a year and that the dose limit of 0.5 rem (5 mSv) for
declared pregnant women is not exceeded during the period of their
pregnancy.
(10) In Sec. 20.1902(d), a proposed change to the posting
requirement would permit the use of the words ``Airborne Radioactive
Material Area'' in place of the currently required ``Airborne
Radioactivity Area.'' The proposed change would also permit the
continued use of existing stocks of signs with the currently required
``Airborne Radioactivity Area.'' This would conform to the proposed
amendment in Sec. 20.1003.
(11) In Sec. 20.1903, a new paragraph would be added to exempt
teletherapy rooms in a hospital from posting requirements as long as
access is controlled 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 avoid the unwarranted and potentially
unsettling effect that ``GRAVE DANGER, VERY HIGH RADIATION AREA'' signs
may have on patients.
(12) In Sec. 20.1906(d), a revision would require licensees to
notify the NRC Operations Center, instead of an NRC Regional Office,
upon receiving and opening packages when radiation levels exceed
regulatory limits. This would provide for consistency within the prompt
notification requirements contained in Sec. 20.2201. A conforming
change also would be made to the prompt notification requirements in
Sec. 20.2202.
(13) In Sec. 20.2101, a revision would permit licensees to include
both the new SI units and the old (special) units of dose on records
required by this part. Each of the recorded dose quantities would be
recorded in the appropriate special unit and, if so desired, followed
by the appropriate SI unit in parentheses. The term ``eye dose
equivalent'' would be replaced by ``lens dose equivalent'' to conform
to the proposed amendment in Sec. 20.1003.
(14) In Sec. 20.2106 (a)(2) and (a)(3), the references to ``body
burden'' would be removed because this term is obsolete and is not
defined in revised 10 CFR Part 20. Section 20.2106(a)(4) would be
revised by adding a reference to Sec. 20.1204(a), which 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, instead of
``body burden,'' for assessing the committed effective dose equivalent
(CEDE). The NRC believes that this information is clearly necessary to
support the recorded results of the licensee's calculation of CEDE.
Adding this reference would not impose any additional recordkeeping
burden on
[[Page 52390]]
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) would result in the application
of the same incident reporting requirements to all licensees.
Currently, this section requires that power reactor licensees submit
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
would require all licensees to report incidents by telephone to the NRC
Operations Center ensuring consistency in the prompt notification
requirements contained elsewhere in this part and would result in a
reduction in the information collection burden.
(16) In Sec. 32.54(a), the reference to ``Sec. 20.203(a)'' would be
corrected to read ``Sec. 20.1901.''
(17) In Sec. 35.20, ``ALARA program,'' paragraph (c) would be
removed as redundant because the requirements that are to be addressed
in the ALARA program are contained in 10 CFR Part 20, and the training
requirements are addressed in 10 CFR 19.12. Part 35 references both
Parts 19 and 20 as containing requirements for medical licensees.
(18) Safety precautions and survey requirements for restricted and
unrestricted areas are specified in Secs. 35.315, 35.415, 35.641, and
35.643. Sections 35.315(a)(4) and 35.415(a)(4) would be revised to
remove the words ``restricted'' and ``unrestricted'' where they modify
the word ``area.'' Sections 35.641(a)(2)(i) and (a)(2)(ii) and
35.643(a) would be revised to be consistent with definitions of dose to
occupationally exposed individuals and dose to members of the public.
Also, in Sec. 35.643(a)(1), a misreference to Sec. 20.1301(c) would be
corrected to read Sec. 20.1301. The 0.5 rem (5 mSv) limit permitted by
application and NRC approval under 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 the provision for licensees to request the 0.5
rem limit specified in Sec. 20.1301(c).
(19) In Sec. 36.23(g), posting requirements for a panoramic
irradiator would be revised to conform with posting requirements for
high or very high radiation areas in Sec. 20.1902. The posting
requirements in Part 36 currently require a posting appropriate to a
high radiation area only.
(20) In Sec. 39.33, ``Radiation detection instruments,'' a
conforming change to paragraph (a) would be made by replacing the term
``milliroentgens'' with the term ``millirems'' to be consistent with
revised Part 20 terminology. Because the NRC recognizes that most
licensees may still use radiation detection instruments that measure
radiation in units of roentgens, measurements taken in roentgens could
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'' would be
corrected to read ``Sec. 20.1003.''
Electronic Access
Comments on the proposed rule may also be submitted electronically
in either ASCII text or Wordperfect format (version 5.1 or later) by
calling the NRC Electronic Bulletin Board on FedWorld. The bulletin
board may be accessed using a personal computer, a modem, and one of
the commonly available communications software packages, or directly
via Internet.
If using a personal computer and modem, the NRC rulemaking
subsystem on FedWorld can be accessed directly by dialing the toll free
number: 1-800-303-9672. Communication software parameters should be set
as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1).
Use ANSI or VT-100 terminal emulation. The NRC rulemaking systems can
then be accessed by selecting the ``Rules Menu'' option from the ``NRC
Main Menu.'' For further information about options available for NRC at
FedWorld, consult the ``Help/Information Center'' from the ``NRC Main
Menu.'' Users will find the ``FedWorld Online User's Guides''
particularly helpful. Many NRC subsystems and databases also have a
``Help/Information Center'' option that is tailored to the particular
subsystem.
The NRC subsystem on FedWorld can also be accessed by a direct dial
phone number for the main FedWorld BBS: 703-321-3339; Telnet via
Internet: fedworld.gov (192.239.92.3); File Transfer Protocol (FTP) via
Internet: ftp.fedworld.gov (192.239.92.205); and World Wide Web using
the ``Home Page'': www.fedworld.gov (this is the Uniform Resource
Locator (URL)). If you contact FedWorld using Telnet, you will see the
NRC area and menus, including the Rules Menu. Although you will be able
to download documents and leave messages, you will not be able to write
comments or upload files (comments). If you contact FedWorld using FTP,
all files can be accessed and downloaded but uploads are not allowed;
all you will see is a list of files without descriptions (normal Gopher
look). An index file listing all files within a subdirectory, with
descriptions, is available. There is a 15-minute time limit for FTP
access.
Although FedWorld also can be accessed through the World Wide Web,
like FTP that mode only provides access for downloading files and does
not display the NRC Rules Menu.
If using a method other than the NRC's toll free number to contact
FedWorld, the NRC subsystem will be accessed from the main FedWorld
menu by selecting ``F--Regulatory, Government Administration and State
Systems'' or by entering the command ``/go nrc'' at a FedWorld command
line. At the next menu, select ``A--Regulatory Information Mall,'' and
then select ``A--U.S. Nuclear Regulatory Commission'' at the next menu.
If you access NRC from FedWorld's ``Regulatory, Government
Administration'' menu, you may return to FedWorld by selecting the
``Return to FedWorld'' option from the ``NRC Main Menu.'' However, if
you access NRC at FedWorld by using NRC's toll-free number, you will
have full access to all NRC systems, but you will not have access to
the main FedWorld system. For more information on NRC bulletin boards,
call Mr. Arthur Davis, Systems Integration and Development Branch, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone
(301) 415-5780; e-mail AXD3@nrc.gov.
Agreement State Compatibility
This rulemaking will be a matter of compatibility between the NRC
and the Agreement States, thereby providing consistency of State and
Federal safety requirements. The NRC has determined that a Division 2
level of compatibility should be assigned to the changes to
Secs. 20.1003, 20.1101, 20.1201, 20.1206, 20.1208, 20.1501, 20.1502,
20.1902, 20.1903, 20.1906, 20.2101, 20.2106, 20.2202, 32.54, 35.20,
35.315, 35.415, 35.641, 35.643, 36.23, 39.33, and 39.71 because the
requirements in these sections already have been assigned a Division 2
level of compatibility. This rulemaking is primarily of a clarifying
nature so the basis for that assignment should not change.
Environmental Impact: Categorical Exclusion
The NRC has determined that this proposed 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 proposed rule.
[[Page 52391]]
Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). This rule has been submitted to the Office of Management and
Budget for review and approval of the paperwork requirements.
The rule will reduce existing information collection requirements,
and the public burden for this collection of information 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
collection of information. The U.S. Nuclear Regulatory Commission is
seeking public comment on the potential impact of the collection of
information contained in the proposed rule and on the following issues:
1. Is the proposed collection of information necessary for the
proper performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the collection of information be
minimized, including the use of automated collection techniques?
Send comments on any aspect of this proposed collection of
information, including suggestions for 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.
Comments to OMB on the collection of information or on the above
issues should be submitted by (November 6, 1996. Comments received
after this date will be considered if it is practical to do so, but
assurance of consideration cannot be given to comments received after
this date.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
Regulatory Analysis
This proposed 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 proposed rulemaking would not impose
any additional costs on licensees since the rulemaking would be
correcting and clarifying several definitions and current requirements
addressing standards for protection against radiation. No impact is
anticipated to result from any of the proposed correcting or clarifying
amendments. Because the proposed rule would improve clarity and
consistency in the NRC's regulations, it would benefit the licensees.
The proposed amendments should result in a minor reduction in
burden to licensees by eliminating written reports and allowing
licensees to submit incident reports by telephone. This proposed change
is consistent with the Paperwork Reduction Act. The proposed
requirements also would waive posting requirements in teletherapy rooms
in hospitals because of the unsettling effects that the signs 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. This proposed
change would have a beneficial effect on patients.
In addition, these proposed amendments would change the monitoring
requirement 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). Thus, monitoring would not be required at any dose below that
requiring the training of workers.
(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). It is not necessary or
appropriate to require monitoring of workers who are expected to
receive less dose than is permitted for members of the public. There
may be some reduction in burden, but any reduction would be small, and
because of the many factors that impact the decision as to whether
personal dosimeters will be worn, it is impossible to assess this
likely small burden reduction.
This discussion constitutes the regulatory analysis for this
proposed rule.
Backfit Analysis
The NRC has determined that the backfit rule in Sec. 50.109 does
not apply to this proposed rule and, therefore, that a backfit analysis
is not required for this proposed rule because these amendments do not
involve any provision that would impose backfits as defined in
Sec. 50.109(a)(1).
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 material, 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 material, Oil and
gas exploration--well logging, Reporting and recordkeeping
requirements, Scientific equipment, Security measures, Source material,
Special nuclear material.
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,
[[Page 52392]]
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 definitions of Airborne radioactivity area
and Eye dose equivalent are removed. The definitions of Airborne
radioactive material area and Lens dose equivalent are 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.
* * * * *
Airborne radioactive material area means a room, enclosure, or area
in which airborne radioactive materials, composed wholly or partly of
licensed material, exist in concentrations--
(1) In excess of the derived air concentrations (DACs) specified in
Appendix B to Secs. 20.1001-20.2402; or
(2) To such a degree that an individual present in the area without
respiratory protective equipment could exceed, during the hours that an
individual is present in a week, an intake of 0.6 percent of the annual
limit on intake (ALI) or 12 DAC-hours.
* * * * *
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 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).
* * * * *
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 any additional
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 as a result of 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;
* * * * *
(iii) The potential radiological hazards.
* * * * *
9. In Sec. 20.1502, paragraph (a)(3) is redesignated as (a)(4) and
revised 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 radiation sources under the control of the licensee and shall
supply and
[[Page 52393]]
require the use of individual monitoring devices by--
* * * * *
(2) Minors likely to receive, in 1 year, from radiation sources
external to the body, a dose equivalent in excess of 0.1 rem (1 mSv);
(3) Declared pregnant women likely to receive, during the entire
pregnancy from radiation sources external to the body, a dose
equivalent in excess of 0.1 rem (1 mSv); and
(4) Individuals entering a high or very high radiation area.
(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. 20.1902, paragraph (d) is revised to read as follows:
Sec. 20.1902 Posting requirements.
* * * * *
(d) Posting of airborne radioactive material areas. The licensee
shall post each airborne radioactive material area with a conspicuous
sign or signs bearing the radiation symbol and the words ``CAUTION,
AIRBORNE RADIOACTIVITY AREA''; ``DANGER, AIRBORNE RADIOACTIVITY AREA'';
``CAUTION, AIRBORNE RADIOACTIVE MATERIAL AREA''; or ``DANGER, AIRBORNE
RADIOACTIVE MATERIAL AREA.''
* * * * *
11. 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 Sec. 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.
12. 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--
* * * * *
13. In Sec. 20.2101, paragraph (c) is redesignated as paragraph (d)
and revised, paragraph (b) is redesignated as paragraph (c) and
revised, and a new paragraph (b) is added to read as follows:
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.
(c) Notwithstanding the requirements of paragraph (a) of this
section, when recording information on shipment manifests, as required
in Sec. 20.2006(b), information must be recorded in the International
System of Units (SI) or in SI and units as specified 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).
14. 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; and
* * * * *
15. 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
16. 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]
17. In Sec. 32.54, paragraph (a) is amended by removing the
reference ``Sec. 20.203(a)'' and adding ``Sec. 20.1901.''
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
18. 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).
Sec. 35.20 [Amended]
19. In Sec. 35.20, paragraph (c) is removed.
20. In Sec. 35.315, paragraph (a)(4) is revised to read as follows:
Sec. 35.315 Safety precautions.
(a) * * *
(4) Promptly after administration of the dosage, measure the dose
rates in contiguous areas with a radiation measurement survey
instrument to demonstrate compliance with the requirements of part 20
of this chapter, and retain for 3 years a record of each survey that
includes the time and date of the survey, a plan of the area or list of
points surveyed, the measured dose rate at each point surveyed
expressed in millirem per hour, the instrument used to make the survey,
and the initials of the individual who made the survey.
* * * * *
21. In Sec. 35.415, paragraph (a)(4) is revised to read as follows:
Sec. 35.415 Safety precautions.
(a) * * *
(4) Promptly after implanting the material, survey the dose rates
in contiguous areas with a radiation measurement survey instrument to
demonstrate compliance with the
[[Page 52394]]
requirements of part 20 of this chapter, and retain for 3 years a
record of each survey that includes the time and date of the survey, a
plan of the area or list of points surveyed, the measured dose rate at
several of these points expressed in millirem per hour, the instrument
used to make the survey, and the name of the individual who made the
survey.
* * * * *
22. 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 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.
* * * * *
23. 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
24. 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).
25. 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 Sec. 20.1902.
Radiation postings for panoramic irradiators must comply with the
posting requirements of Sec. 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
26. 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).
27. 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 0.1 mrem (0.001 mSv) per hour through at least 50 mrem (0.5
mSv) per hour.
* * * * *
Sec. 39.71 [Amended]
28. In Sec. 39.71, paragraph (b) is amended by removing the
reference to ``Sec. 20.3'' and adding ``Sec. 20.1003.''
Dated at Rockville, Maryland, this 5th day of September 1996.
For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 96-25486 Filed 10-4-96; 8:45 am]
BILLING CODE 7590-01-P
