Minor Corrections, Clarifying Changes, and a Minor Policy Change

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 JMM[email protected].

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 AXD[email protected].

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