ML20149K793

Concurs W/Proposed Amends to 10CFR20,32,35,36 & 39, Minor Corrections & Clarifying Changes in Response to 960212 Request

ML20149K793
Person / Time
Issue date:	03/07/1996
From:	Jordan E NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:	Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20149C780	List: ML20149E517 ML20149E738 ML20149E813 ML20149F728 ML20149F764 ML20149K210 ML20149K254 ML20149K713 ML20149K731 ML20149K739 ML20149K745 ML20149K753 ML20149K763 ML20149K772 ML20149K781 ML20149K786 ML20149K790 ML20149K793 ML20149K797 ML20149K801 ML20149L465 ML20149L471 ML20149L587 ML20149L609 ML20149L695
References
FRN-61FR52388, RULE-PR-20, RULE-PR-32, RULE-PR-35, RULE-PR-36, RULE-PR-39 AF46-1-023, AF46-1-23, NUDOCS 9707300161
Download: ML20149K793 (29)

Text

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 he"*

%y # March 7, 1996 1

MEMORANDUM T0: David L. No rison, Director '

e of  : lear Re ulatory Research FROM: r6a2[ irNr r Analysis and Evaluation Office  !

of Ope tional Data l

SUBJECT:

OFFICE REVIEW AND CONCURRENCE: PROPOSED AMENDMENTS TO 10 CFR PARTS 20, 32, 35, 36, AND 39, " MINOR CORRECTIONS AND CLARIFYING CHANGES" In response to your request dated February 12, 1996, AE00 has reviewed the proposed rulemaking package. We concur in the publication of these rule revisions.

AE00 staff identified several comments which we suggest you consider prior to publishing the rule:

. Pages 4, Item (1) (a):

Suggestion - Although the term " Airborne Radioactivity area" would be deleted and replaced with " Airborne radioactive material area," it will be appropriate to require of licensee to eventually replace old signs with th's new ones.

. Page 6, Item (4):

Suggestion - Rewrite the whole paragraph to read: In 6 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 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.

. Page 6, Item (8), line 8:

Instead of using 50 mr and 100 mr, use .05 rem (.5 mSv) and .1 rem (1 mSv), respectively, to be consistent with the regulations. Refer to pages 19, 21, and 22.

. Page 7, Item (10) (also refer to Page 23, Item 9. (d)):

"In 9 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 and members of the public to radiation or radioactive materials. The purpose of this change is to avoid the unwarranted and potentially unsettling effect that ' GRAVE DANGER, VERY HIGH RADIATION AREA' signs may have on patients."

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e, l D. Morrison Comment: Although the above fear may be true, it may be a good idea to require posting a sign, in addition to access control, as soon as the room is occupied.

l e Page 11, Paragraph 2, line 13:

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e Page 15, Paragraph 2:

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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20,32,35,36,39 RIN 3150-AF46 Minor Corrections, Clarifying Changes, and One Minor Policy Change AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission is proposing to amend its regulations to make

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minor corrections and clarifying changes to the NRC's , standards for aprotection against n radiatio The proposed amendments would also conform other 10 CFR parts with the Commission's revised y

radiation protection requirements. In addition, a minor policy change is proposed that would revise js#f Wy' the monitoring criterion for minors and declared pregnant women from 50 millirem to 100 millireng.

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This proposed rule is necessary to inform the public of thes[ minor changes to the NRC's 4

wt i~it'e coma <.at regulationg l

EFFECTIVE DATE: Comment period expires (75 days following publication in the Federal Register).

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.

4 SUPPLEMENTARY INFORMATION:

On May 21,1991 (56 FR 23300), a final rule was published in the Federal Register that amended 10 CFR Part 20 to update the NRC'syandards forgrotection againstpdiation.

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 modif provisions to reflect the new hjo&Laf implementation date for NRC's revised standards fogradiation protection (58 FR 67657; December

? S 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 tho'NRC regulatio or greater clarity and to further facilitate r-

. 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 dqilt p'fp monitoring criterion for minors and declared pregnant women from 50 millirem to 100 miirireng This proposed rule would make the following changes:

(1) In i 20.1003, " Definitions," clarifying changes and minor corrections would be made to the following:

(a) The term " Airborne radioactivity area" would be replaced with "Airbome radioactive

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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 i 20.1902(d) to permit licensees the option of either posting new signs to reflect this change or w 1 urrent signs.

(b) The definition of " Declared pregnant woman" would be revised to specify that the written declaration of pregnancy may be given to the licensee or to her employer if her employer is the licensee. This is necessary to ensure that the licensee responsible for work assignments S

involving exposure is aware of the declaration of pregnancy so that appropriate dose restrictiorgcan 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 kjhth:m equivalent" (LDE) to avoid confusion between the acronyma 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 So!c revised to make it clear that these area designations are based radiation levels on&

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 i 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 i 20.1201(a)(2)(i), " eye dose equivalent" would be replaced by " lens dose equivalent" to conform to the proposed amendment in i 20.1003.

(4) in i 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

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exposures are authorized only in exceptional situations when alternatives that might avoid the dose, f6 are unavailable or impractical. MIo i 7

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(5) In i 20.1208(a), (c), (c)(2), and (d), the phrase " dose to an embryo / fetus" would be ,

1 changed to read " dose equivalent to the embryo / fetus" to make it clear that the dose limit l specifically applies to the dose equivalent, which technicall is the correct term. 1 j

(6) In i 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.

l (7) In i 20.1501(a)(2)(iii), the phrase "The ptential radiological hazards that could be A

rwe 4Le rehrt29 present." would be revised to read "The potential radiological hazards." t mprove clarity.

l 1

(8) In i 20.1502, the words "from radiation sources under the control of the licensee" 1

would be added after " exposure to radiation" in paragraph (a) to improve clarity and to make it clear 1

1 that a licensee is not responsible for sources not under its control. l l

(9) In i 20.1502(a)(2) and (b)(2), monitoring requirements are stated as one-tenth of l l

applicable limits for a year for minors and pregnant women, (eNew rc d even though the dose limits. dest:rlhetin paragraph (a)(2) apply for an entire year to minors while i tchcraed the dose limitgin paragraph (b)(2) applies only to the 9-month gestation period of a declared l pregnant woman. These paragraphs would be separated and revised accordingly to make this i 1 g<x t;$ 2 p.)2-0 8 i

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, ' section 4not n technically correct. In addition, the criterion for monitoring minors and declared pregnant women would be changed from 50 millirems in a year (or 9 months) to 100 l Itcewe millirems. This change would constitute a small 4burden reduction with no loss in worker health and l l

safety. The 100-millirem value for monitoring was selected for the following reasons: i l

(a) The value is consistent with the 100-millirem training criterion in the recently revised i 19.12 (60 FR 36038 July 13,1995). Thus, monitoring would not be required at doses that are (c.r4IcYa n hi Y i et below the dose #'that-the-Nf1G-bet worker shardd+[e traing;O (b) The value is consistent with the 100-millirem dose limit for members of the public in i

i 20.1301(a). It is not necessety=ef appropriate to require monitoring of workers who are are l l

expected to receive less dose than is permitted for members of the public; and cr Ue&n 1 (c) It is difficult to establish compliance with the monitoring requirepent of 50 millirems l l

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i equipment. It is not logical to req 9vimonitonag-et hveh net capable +f-bew)g' measured by existing personnel monitoring equipment.

(10) in i 20.1902(d), a proposed change to the posting requirement would permit the use of two'new signs as well as current signs. This would conform to the proposed amendment that would substitute the term " Airborne radioactive material area" for the term "Altbornehadioactivity i

area" in i 20.1003.

(11) in i 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 and members of the public to radiationkradioardly alet The purpose of this kkiyth Cry /,enki& ^ < &U wk[ era Mce u i y pe d ite r t d a f change is to avoid the unwarranted and potenti lly unsettling effect that " GRAVE DANGER, VERY HIGH RADIATION AREA" signs may have on patients.

(12) In i 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 .

1 levels exceed regulatory limits. This would provide for consistency within the prompt notification i

requirementspe ontained in i 20.2201. A conforming change also would be made to the prompt notification requirements in i 20.2202.

1 (13) In i 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 i 20.1003.

(14) In i 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 i 20.1204(a), which requires licensees to take measurements of (1) concentrations of

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radioactive materials in air in work areas, or (2) quantities of radionuclides in the body, or (3) quantities of radionuclides excret from the body, or (4) combinations of these measurements in od rs h m Ythe ? N$

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order to determine internal dose This, in effect, usesjecords of-measurementrWf concentrations in clhe>rwAM N be 2 air, quantities of radioactive materialyn the bodydereta, or any combination of these that would d

d be needed, instead of " body burden," for calculating g

$L dose equivalent (CEDE).

committed effective wn j{$ a $$e hhwM j

ft A, uM,J We believe that this information is clearly necessary to support the.licen[cordegcalculationsr Yo ld

'o.) of CEDE. Adding this reference does not impose any additional recordkeeping burden on licensees p.F , rt ' iP- )g ,

g because they are required to obtain this information in order to calculate CEDE under i 20.1204. /

7(0 Y t f Q(ri' 0' (15) A revision to i rmt/{A Ne */V A co7k afle cort hilYrif 20.2202(d) woulgpeini;i oii iicenseurto-submit-incidoni iope.ia, wi-

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defep NRC Operations Centerg. Currently, this section requires that power reactor licensees submit reports to the NRC perations Center, but all other licensees must suB5iit'botika

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telephor e report to the NRC Operations Center and a telegram, mailgram, or facsimile to the /

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Regional Office. This change vi6uld ensu[gonsistency in the prompt notnicati6n requirements contained elsewhere in this part and would result in a reduction in the information collection burden.

(16) In i 32.54(a), the reference to "i 20.203(a)" would be corrected to read "i 20.1901."

(17) In i 35.20, "ALARA program," paragraph (c) would be removed because the requirements that are to be addressed in the ALARA program are,udunu% the ALARA j

requirements containedjn 10 CFR Part 20 and the training requirements addressed in 10 CFR An(e&JwT A 19.1g (18) Safety precautions and survey requirements for restricted and unrestricted areas are specified in il 35.315, 35.415, 35.641, and 35.643. Sections 35.315(a) 35 415 gg would be revised to remove the references 40 restricted and unrestricted ffem-the.mngarea.

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 i 35.643(a)(1), a misreference to i 20.1301(c) would be corrected to read i 20.1301(a). The 500-mrem limit permitted by application and NRC approval under i 20.1301(c) was never intended

/

. . _ . . _ _ _ _ _ _ . _ . _ _ _ _ _ . . . _ . . ~ - . _ .-._ .-_.-

i to be allowed under this section in Part 35. Rather, it was always the intent of the NRC to apply the 100 mrom limit in i 20.1301(a) to this section.

(19) in i 36.23(g), posting requirements for a panoramic irradiator would be revised to W

conform with posting requirements appsepnetettrhigh or very high radiation areas in i 20.1902, I mn The posting requirements in Part 36 currently require a posting appropriate to a high radiation areg (20) in i 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 A&

with revised Part 20 terminology. BecausegNRC recognizes that most licensees may still use Yodtd)bw radiation detection instruments that measu iesetMt7tn units of roentgens, measurements taken in roentgens could continue to be recorded in terms of 6t: - l roentgen, provided that the measurements can onverted to rem for records required under 10 CFR Part 20.2101(a).

Electronic Access Comments on the proposed rule may also be submitted electronically in either ASCll text or Wordperfect format (version 5.1 or later) by calling the NRC Electronic Bulletin Board on FedWorld.

I The bulletin board may be accessed using a personal computer, a modem, and one of the commonly available comrnunications software packages, or directly via Internet.

1 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 1

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l particular subsystem. l The NRC subsystem on FedWorld can also be accessed by a direct dial phone number for l

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. i 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 1

(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 FedWorlu by selecting the " Return to FedWorld" option from the "NRC Main Menu." However, if you access NRC at FedWorf f 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.

Environmental Impact: Categorical Exclusion

l The NRC has determined that this proposed rule is the type of action described in fkG categorical exclusion in 10 CFR 5122(c)(2). Therefore, neither an environmental impact statement ar an environmental assessment has been prepared for this proposed rule.

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 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> 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 potentialimpact 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? l

2. Is the estimate of burden accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information to be l collected?  !

1

4. How can the burden of the collection of information be minimized, including the use j l

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),

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U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1@NRC. GOV; 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 (insert date 30 days after publication in the Federal Reaister). 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 ef ,7

~ ~7 collection of informati unless it displays a currently valid OMB control number.

'7 -

Regulatory Analysis l

l This proposed rule makes minor correcting and clarifying amendments to the requirements in 1 l

10 CFR Part 20 and conforms 10 CFR Parts 32,35,36, and 39 to 10 CFR Part 20. The proposed vA-rulemaking would not impose any additional costs glicensees since the rulemaking would be correcting and clarifying several definitions and current requirements in the standards for protection 1

against radiation. No impact is anticipated to result from any of the proposed correcting or l l

clarifying amendments. Because the proposed rule would improve clarity and consistency in the NRC's regulations, it would benefitJh consees.

/

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. The j 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 j safety because the safety precautions in 10 CFR Part 35 are considered adequate to protect c>M % f f(-Z I fe(It it e (64 .C **.5SK ' Ye Y h*3 '** ' ' 'IWkb l'E** I' jhn qc es /Adk/efenganmrde ~

p.~ pas .fes a s. r % ,c, e c.ekT&*!YW'*""^k) er & < wfiu ~zogang .

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inadvertent exposure to the radiatio . 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 limits (50 millirem) to 100 millirem for the following reasons:

(1) The value is consistent with the 100-millirem training criterion in the recently revised

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, 10 CFR 19.12 (60 FR 36038; July 13,1995). Thus, monitoring would not be required at doses gO)Y D/11 A144 ~9 771JE n<f a2*M"y sig wcck.y ' g that are below the doses that he NRC believes workers should be trained.

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• (2) The value is consistent with the 100-millirem dose limit for members of the public in

& 0'f-10 CFR 20.1301(a). It is not necessary or appropriate to require monitoringJyworkers who p expected to receive less dose than is permitted for members of the public.

(3) Current personnel monitoring equipment and bioassay techniques are not capable of reliable measurements at 50 millirems per year.

This change may be a small burden reduction in that the change may reduce the monitoring that would be done. On the other hand, the need for monitoring is generally based on job function rather than on precisely projected doses. As a consequence, there may not be significantly less worker monitoring because of this change.

This discussion constitutes the regulatory analysis for this proposed rule.

Backfit Analysis The NRC has determined that the backfit rule in i 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 i 50.109(a)(1). l List of Subjects 10 CFR Part 20

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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 7.0 - STANDARDS FOR PROTECTION AGAINST RADIATION

1. The authority citation for Part 20 continues to read as follows:

A 1

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 i 20.1003, the definitions of Airborne radioactivity area and Eve dose eauivalent are removed. The definitions of A_irborne radioactive material area and Lens dose eouivalent are added in alphabetical order, and the definitions of Declared oreanant woman. Hioh rao:ation area, Individual monitorino devices. and Ygrv hiah radiation area are revised to read as follows:

1 20.1003 Definitions.

Airborne radioactive material uga 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 il 20.1001-20.2402; or C

(2) To such a degree that an individual present in the area without respiratory protective d WC equipment could exceed, during theMthat an individual is present in a week, an intake of 0.6

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percent of the annual limit on intake (All) or 12 DAC-hours. Yb" Declared oreanant woman means a woman who has voluntarily informed the licenseeg

.smployertf-her-omploynt ic-the4icen writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman gives birth or withdraws the declaration in writing. Idw e3 //ccw 1 c <

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Hioh radiation area means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in t.n individual receiving a dose equivalent in B

v excess of 0.1 rem (1 mSv) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> a JO centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates.

Individual monitorino devices (individual monitoring equipment) means devices designed to I be worn by a sin 0l e 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 eauivalent applies to the external exposure of the lens of the eye and is taken as .

l the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

Very hiah 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 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 1 meter from a radiation source or 1 meter from any surface that the radiation penetrates.

3. In i 20.1101, paragraph (b) is revised to read as follows:

i 20.1101 Radiation protection programs.

(b) The licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiction protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

/dI

4, in i 20.1201, paragraph (a)(2)(i) is revised to read as follows:

1 20.1201 Occupational dose limits for adults (s)

(2)

(i) A lens dose equivalent of 15 rems (0.15 Sv), and

5. In i 20.1206, paragraph (a) is revised to read as follows:

1 20.1206 Planned special exposures.

. . . . . pC, (a) The licensee authorizes a planned special exposure only in an exceptional situation

'd -(

c '. /,

when alternatives that might avoid the additional dose estimated to result from the planned special f 7

exposure are unavailable or impractical. .

6. In i 20.1208, paragraph (a), the introductory text of paragraph (c), and paragraphs (c)(2) and (d) are revised to read as follows:

i 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 s a result of ccupational exposure of a declared pregnant womary oes not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see i 20.2106.)

E5 (c) The dose equivalent to the embryo / fetus.shall-be-takerres the sum of--

7 (2) rawthW The dose equivalent to the embryo / fetus from radionuclides in the embryo / fetus and 4

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 rom (0.5 mSv) of this dose, by the time the woman declares the pregnancy gf

^A/ to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section 1

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/, if the additional dose to the embryo / fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.

7. In i 20.1501, paragraphs (a)(2)(i) and (a)(2)(iii) are revised to read as follows: )

i I 20.1501 General.

(a)

(2)

(i) The magnitude and extent of radiation levels; and (iii)The potential radiological hazards.

8. In i 20.1502, paragraph (a)(3) is redesignated as (a)(4) and new paragraphs (a)(3) and (b)(3) are added; and the introductory te hf paragraph (a) and paragrapha)(2), (b)(1), and g (b)(2) are revised to read as follows:

i 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

(a) Each licensee shall monitor occupational exposure to radiation from radiation sources 19

. . . - . - . - _ - - _ = . . _ . ..-. -.. . --. .- . _ _ --

s V

i under the control of the licensee and shall supply and require the use of individual monitoring i devices by -

l 1 e . . . .

(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a dose equivalent in excess of 0.1 rem; i

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(3) Declared pregnant women likely to receive, during the entire pregnancy, 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 All(s) in table 1, Columns 1 and 2, of Appendix B to il 20.1001 20.2402; and (2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem; 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).

?

9. In i 20.1902, paragraph (d) is revised to read as follows:

I 20.1902 Posting requirements.

(d) Postina 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 Alfl0CL6U6 words " CAUTION, AIRBORNE RADIOACTIVITY AREA"; " DANGER, RADIOACTIVITY AREA";

. 6

" CAUTION, AIRBORNE RADIOACTIVE MATERIAL AREA"; or " DANGER, AIRBORNE RADIOACTIVE MATERIAL AREA."

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10. In i 20.1903, a new paragraph (d) is added to read as follows:

l 20.1903 Exceptions to posting requirements.

'4 (d) Rooms in hospitals or clinics that are used for teletherapy are exempt from the I y requirement to post caution signs under i 20.1902 if -

/ (1) Access to the room is controlled; and (2) Personnel in attendance take necessary precautions to prevent the exposure of pm - - - -

workers and members of the public to radiationg, n radioactive materia 3"l[ ex

{

established in this part. bb b #

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C hhh W a$e M n " g ok T}s QsVs W%wAhse f kol9b2- Ve .

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0frYppr#T1.;In i 20.1906, the introductory text of p e raph #

l l 20.1906 Procedures for receiving and opening packages. [

(d) Tha licensee shall immediately notify the final delivery carrier and the NRC Operations Center (301816-5100), by telephone, when--

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12. In i 20.2101, paragraph (b) is redesignated as paragraph (c) and revised, and a new paragraph (b) is added to read as follows:

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I 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) 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).

i

13. In i 20.2106, paragraphs (a)(2), (a)(3), and (a)(4) are revised to read as follows:

i 20.2106 Records of individual monitoring results.

(a)

(2) The estimated intake of radionuclides (see i 20.1202); and (3) The committed effective dose equivalent assigned to the intake of radionuclides; and ~

%c (4) The specific information used to calculate the committed effective dose equivalent ) ",

g p suant to il 20.1204(a) and (c); and g*

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14. In i 20.2202, paragraph (d)(2) is revised to read as follows:

.I 20.2202 Notification of incidents.

(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).

I 32.54 (Amended]

1

16. In i 32.54, paragraph (a) is amended by revising the reference to

'l 20.203(a)" to read "i 20.1901."

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k 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).

I 35.20 (Amended).

18. In i 35.20, paragraph (c) is removed.

b

19. In i 35.315, paragraph (a)(4) is revised to read as follows:

i 35.315 Safety precautions.

(a) l (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 i requirements of Part 20 of this chapter, and retain for 3 years a record of each survey that includes

/jeJ dw the time and date of the survey, aorpiangf thesurveyed, q points list of area the

% measured dose (L e 4in millirem per hour, the instrum /

rate =t rn.Jpoint swgsed expr t used to make the survey, and '

the initials of the individual who made the survey. g- [

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20. In i 35.415, paragraph (a)(4) is revised to read as follows:  ;

I i

i i 35.415 Safety precautions.

fj# (a) j( (4) Promptly after implanting the material, measure the dose rates in contiguous areas oi with a radiation measurement i trument to demonstrate compliance with the requirements V

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 su,rveyed, the measured ~dose rate at several f

points expressed in millirem per hour, the instrument used to make the survey, and the name of the t individual who made the survey,

21. In i 35.641, paragraphs (a)(2)(i) and (a)(2)(ii) are revised to read as follows:

s i 35.641 Radiation surveys for teletherapy facilities.

(a)

(2)

(i) Radiation dose rates in restricted areas are not likely to cause any occupationally exposed individua o receive a dose in excess of the limits specified in i 20.1201 of this chapter; and We IU /e e .fsf /,'%[ f /

%,)

(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 i 20.1301 of this chapter.

22. In i 35.643, paragraphs (a) and (a)(1) are revised to read as follows:

, i 35.643 Modification of teletherapy unit or room before beginning a treatment program.

(a) If the survey required by i 35.641 indicates t al men of the public

@] ? 1 is likely to receive a dose in excess of the limits spec' d in i 20.1301 of this chapter [before '

beginning the treatment prografhe licensee shah

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(1) Either equip the unit with stops or add additional radiation shielding to ensure compliance with i 20.130{Th) f this chapter.

7, PART 36 -- LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

23. 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, 1 </

g-f,

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. 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202,206,88 Stat.1242, as t

i amended, 1244,1246 (42 U.S.C. 5841, 5842, 5846).

24. In i 36.23, paragraph (g) is revised to read as follows:

l I 36.23 Access control.

(g) Each entrance to the radiation room of a panoramic irradiator and each entrance to i be_pafee(  !

the area within the personnel access barrier of an underwater irradiator must.h.e e .;vu i

tappropriate-to- '4h ,i very hylcrediatiewervsf

. i W R&d i as i 20.1902. Radiation postings for panoramic irradiators c) must comply with the posting requirements cen:;d ed: i 20.1902, except that signs may be i removed, covered, or otherwise made inoperative when the sources are fully shielded.

I l

PART 39 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING i

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25. 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).

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26. In i 39.33, paragraph (a) is revised to read as follows:

139.33 Radiat instruments, l

(a) The licensee shall keep a calibrated and operable radiati m r}strument 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 millirem per hour through at least 50 millirems per hour.

4 Dated at Rockville, Maryland, this day of 1996.

For the Nuclear Regulatory Commission.

James M. Taylor, Executive Director for Operations.

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26. In i 39.33, paragraph (a) has been revised to read as follows:

139.33 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 measurino 0.1 millirem per hour through at least 50 millirems per hour.

Dated at Rockville, Maryland, this day of 1996. l For the Nuclear Regulatory Commission.

l James M. Taylor, Executive Director for Operations.

Distribution: [O:\MCCAUSLA\NEWFRN20.JMM) l JEGlenn/RPHEB rf File Center RECORD NOTE: A DRAFT COPY OF THE PROPOSED AMENDMENTS WAS SENT TO OlG FOR INFORMATION ON: .

• see previous concurrences Office: RPH5B:DRA RPHEB:DRA RPHEB:DRA D:DRA:RES RRDB:ADM Name: McCausland Roecklein JGlenn BMorrisDMeyer l Date: 10/11/95* 10/11/95* 10/12/95* 2/9/95* / /95 Dist: Yes/No Yes/No Yes/No Yes/No Yes/No Office: D:NMSS D:NRR OGC D:OE D:OSP Name: CPaperiello WRussell WOlmstead JLieberman RBangart Date: / /95 / /95 / /95 / /95 / /95 Dist: Yes/No Yes/No Yes/No Yes/No Yes/No Office: D:AEOD D:lRM D:RES EDO Name: EJordan GCranford DMorrison JTaylor Date: / /95 / /95 / /95 / /95 Dist: Yes/No Yes/No Yes/No Yes/No OFFICIAL RECORD COPY FILE CODE NO