ML23151A582

PR-020,032,035,036,039 - 61FR52388 - Minor Corrections, Clarifying Changes, and a Minor Policy Change

ML23151A582
Person / Time
Issue date:	10/07/1996
From:	Taylor J NRC/EDO
To:
References
PR-020, PR-032, PR-035, PR-036, PR-039, 61FR52388
Download: ML23151A582 (1)

Text

DOCUMENT DATE:

TITLE:

CASE

REFERENCE:

KEYWORD:

ADAMS Template: SECY-067 10/07/1996 PR-020, 032, 035, 036, 039 - 61 FR52388 - MINOR CORRECTIONS, CLARIFYING CHANGES, AND A MINOR POLICY CHANGE PR-020,032,035,036,039 61FR52388 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNS! Review Complete

STATUS OF RULEMAKING PROPOSED RULE:

PR-020, 032, 035, 036, 039 OPEN ITEM (Y/N) N RULE NAME:

MINOR CORRECTIONS, CLARIFYING CHANGES, AND A MINOR POLICY CHANGE PROPOSED RULE FED REG CITE:

61FR52388 PROPOSED RULE PUBLICATION DATE:

10/07/96 ORIGINAL DATE FOR COMMENTS: 12/23/96 NUMBER OF COMMENTS:

EXTENSION DATE:

I I

4 FINAL RULE FED. REG. CITE: 63FR39477 FINAL RULE PUBLICATION DATE: 07/23/98 NOTES ON: CORRECTIONS AND/OR CHANGES TO PART 20 & OTHER PARTS W/REVISED RADI STATUS ATION PROTECTION REQUIREMENTS. PR & FR /S/'D BY EDO.

EFFECTIVE DA OF RULE: TE OF FR EXTENDED TO 10/26/98 (63FR45393, 8/27/98). FILE IN 16G4.

HISTORY OF THE RULE PART AFFECTED: PR-020, 032, 035, 036, 039 RULE TITLE:

MINOR CORRECTIONS, CLARIFYING CHANGES, AND A MINOR POLICY CHANGE PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER:

SRM DATE:

I I

SIGNED BY SECRETARY:

09/05/96 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER:

SRM DATE:

I I

SIGNED BY SECRETARY:

07/27/98 STAFF CONTACTS ON THE RULE CONTACTl: JAYNE M. MCCAUSLAND CONTACT2:

MAIL STOP: T-9C24 MAIL STOP:

PHONE: 415-6219 PHONE:

DOCKET NO. PR-020, 032, 035, 036, 039 (61FR52388)

In the Matter of MINOR CORRECTIONS, CLARIFYING CHANGES, AND A MINOR POLICY CHANGE DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 10/03/96 09/05/96 FEDERAL REGISTER NOTICE - PROPOSED RULE 12/23/96 12/18/96 COMMENT OF COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS (LEONARD R. SMITH, VICE CHAIRMAN) (

1) 12/23/96 12/23/96 COMMENT OF NUCLEAR ENERGY INSTITUTE (RALPH ANDERSEN) (

2) 12/26/96 12/17/96 COMMENT OF COMMONWEALTH EDISON (JOHN C. BRONS, VICE PRESIDENT) (

3) 12/26/96 12/23/96 COMMENT OF NAT. INSTITUTE FOR OCCUPATIONAL SAFETY & HEALTH (DR. PAUL A. SCHULTE) (

4) 07/27/98 07/09/98 FEDERAL REGISTER NOTICE - FINAL RULE 09/ 17/98 08/20/98 FEDERAL REGISTER NOTICE - FINAL RULE; EXTENSION OF EFFECTIVE DATE

AGENCY:

ACTION:

c2.o1 3f ital.

(,/F/J.5~3t!~)

DOCKETED USNRC

.98 SEP 17 P 4 :36 OFr-l RLL.

NUCLEAR R~M-iiA TORY COMMISSION 10 CFR Parts 20, 32, 35, 36, and 39 RIN 3150 -AF46 Minor Corrections, Clarifying Changes, and a Minor Policy Change; Extension of Effective Date Nuclear Regulatory Commission.

Final rule; extension of effective date.

[7590-01-P]

SUMMARY

This document extends the effective date of a final rule that appeared in the Federal Register on July 23, 1998 (63 FR 39477), that makes minor corrections and clarifying changes to 10 CFR Part 20 and conforms other regulations with the Commission's 1991 revised radiation protection requirements. In addition, the final rule includes a minor policy change that raises the monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (.5 mSv) to 0.1 rem (1 mSv) during their pregnancies.

~

d2.l1 /99 5>

EFFECTIVE DA TE: This document is effective on ( date of filir 19 will. ti ie Office of the Fetlml Register).

P~. rm r/~1,f q8' a:t f,3F~ 1/ 5"3~3

FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6219.

SUPPLEMENTARY INFORMATION: The Nuclear Regulatory Commission (NRC) issued a final rule on July 23, 1998 {63 FR 39477) that presented minor corrections, clarifying changes, and a minor policy change to 10 CFR Parts 20, 32, 35, 36, and 39. The effective date noted in that rule was August 24, 1998. A request was made by industry to delay the effective date to allow sufficient time for modification of procedures to comply with the new requirements. In response to this request, NRC is extending the effective date of the final rule to October 26, 1998.

Dated at Rockville, Maryland, this 20 J,c day of ~

998.

For the Nuclear Regulatory Commission.

p Callan,

-==

D;ector for Operations.

2

r.:n*Qcit TED USNRC "98 JUL 27 A 9 :32 NUCLEAR REGULA TORY COMMISSION 10 CFR Parts 20, 32, 35, 36, sitfi' *ifa LJ*_ -

RIN 3150-AF46 ADJUD1 Minor Corrections, Clarifying Changes, and a Minor Policy Change AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

[7590-01-P]

SUMMARY

The Nuclear Regulatory Commission is amending its regulations to make minor corrections and clarifying changes to the NRC's 10 CFR Part 20, "Standards for Protection Against Radiation." The final rule is also intended to conform other regulations with the Commission's 1991 revised radiation protection requirements. In addition, the final rule includes a minor policy change that raises the monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring criterion is consistent with the public dose limit and represents a quantity more consistent with the measurement sensitivity of individual personnel dosimetry.

Licensees are still required to ensure that the occupational dose limit of 0.5 rem (5 mSv) in a year is not exceeded for minors, that the dose limit of 0.5 rem (5 mSv) to an embryo/fetus due to occupational exposure of a declared pregnant woman is not exceeded during the course of the pregnancy, and that sufficient effort is made to ensure that substantial variations above a uniform monthly exposure rate for a declared pregnant woman are avoided. These changes to

the threshold for monitoring exposures to radiation and radioactive material to demonstrate

• compliance with the limits do not change the occupational dose limits for minors or declared pregnant workers.

EFFECTIVE DATE; This regulation becomes effective on (30 days following publication in the Federal Register).

t:J-},_ '-/ f q~

FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone {301) 415-6219, e-mail JMM2 @ nrc.gov.

SUPPLEMENTARY INFORMATION:

I.

Introduction.

II.

Background.

Ill.

Summary of Final Rule.

IV.

Analysis of Public Comments and Staff Response.

V.

Agreement State Compatibility.

VI.

Environmental Impact: Categorical Exclusion.

VII.

Paperwork Reduction Act Statement.

VIII.

Regulatory Analysis.

IX.

Backfrt Analysis.

I. Introduction On May 21, 1991 (56 FR 23360), a final rule was published in the Federal Register that amended 10 CFR Part 20 to update the NRC's "Standards for Protection Against Radiation."

Subsequent amendments were published to (1) change the mandatory implementation to January 1, 1994, and make conforming changes to the text to reflect the new implementation date (57 FR 38588; August 26, 1992), (2) remove or modify provisions to reflect the new implementation date for NRC's revised "Standards for Protection Against Radiation" (58 FR 67657; December 22, 1993), and (3) restore provisions inadvertently removed or modified (59 FR 41641; August 15, 1994; and 60 FR 20183; April 25, 1995).

Since then, several inconsistencies have come to light. The Nuclear Regulatory Commission (NRC) is amending its regulations regarding standards for protection against radiation to make minor corrections and clarifying changes that will remove the inconsistencies and further facilitate implementation. This final rule also establishes conforming amendmef'!tS to 10 CFR Parts 32, 35, 36, and 39. In addition, a minor policy change raises the monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared 4I pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies.

II. Background On October 7, 1996, the NRC published a proposed rule for comment in the Federal Register (61 FR 52388) to amend 10 CFR Part 20 of its regulations to make minor corrections and clarifying changes regarding standards for protection against radiation; to conform other 10 CFR Parts with the Commission's revised radiation protection requirements; and to revise the 3

deep dose equivalent monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. The proposed rule noted that the monitoring criteria would not raise the dose limit for an embryo/fetus due to occupational dose to the declared pregnant woman or the dose limit for minors. Changing the criteria for monitoring does not, in any way, change the dose limits for declared pregnant women, for the embryo/fetus, or for minors. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring criterion is consistent with the public dose limit and represents a quantity more consistent with the measurement sensitivity of individual personnel dosimetry. The current criteria of 0.05 rem (0.5 mSv), if received uniformly in a year or througliout the gestation period, would result in an average monthly dose of less than 0.005 rem (0.05 mSv). The most routinely utilized individual monitoring devices cannot accurately measure doses below 0.01 rem (0.1 mSv), which is greater than the average monthly dose of 0.005 rem (0.05 mSv).

The public comment period closed on December 23, 1996. A discussion of the issues raised by public comment is covered in Section IV, below.

Ill. Summary of Final Rule This final rule makes the following changes:

(1)

In§ 20.1003, "Definitions," clarifying changes and minor corrections are made to the following:

(a)

The definition of "Declared pregnant woman" is revised to specify that the written declaration of pregnancy is to be given to the licensee rather than the employer, unless the employer is also the licensee. This is necessary to ensure that the entity responsible for work 4

assignments involving radiation exposure (the licensee) is aware of the declaration of pregnancy to facilitate timely and appropriate protective action. The change also specifies that the declaration, as well as associated dose restrictions, remains in effect until it is withdrawn in writing or until the woman is no longer pregnant. The determination that a declared pregnant woman is no longer pregnant should be based on a discussion between the declared pregnant woman and the licensee.

(b)

The definitions of "High radiation area" and 'Very high radiation area" are revised to make it clear that these area designations exist solely to note radiation levels from sources external to an individual who may receive the dose.

(c)

The definition of "Individual monitoring devices" is revised to correct the misuse of the term thermoluminescent to describe thermoluminescence dosimeters.

(d)

The term "Lens dose equivalent (LOE)" replaces "Eye dose equivalent" (EDE) to avoid confusion between the initialisms for dose to the lens of the eye and effective dose equiv~lent (EDE). This should pose no procedural burden on licensees because the required NRC Forms 4 and 5 for records and reports were revised in August 1995 to reflect the new terminology, and these or their equivalent are required to be used by existing § 20.2104,

§ 20.2106(c), and§ 20.2206(b).

r I

(2)

In § 20.1101 (b), the word "practicable"* is changed to "practical" to remove the basis for an incorrect perception among some licensees that, by using the word "practicable" in this section, the NRC is re.quiring licensees to use any dose averting technique that is capable of being used even if the technique is unproven or impractical.

(3)

In§§ 20.1201 (a)(2)(i) and (c); 20.1203; 20.2101; 20.2106(a)(1); and 20.2202(a)(1 )(ii) and (b)(1 )(ii), "eye dose equivalent" is replaced by "lens dose equivalent" as described above in the change to § 20.1003.

5

(4)

In§ 20.1206, Planned special exposures, paragraph (a) is revised to clarify what was intended by the term "higher exposure" used in the rule previously. The phrase applies to dose estimates performed prior to authorizing the planned special exposure (PSE). The new wording states that PSE's are authorized only in exceptional situations when alternatives that might avoid the dose estimated to result from the PSE are unavailable or impractical. Improved clarification will avoid possible misinterpretation of a PSE criterion.

(5)

In§ 20.1208(a), (c), (c)(2), and (d), the phrase "dose to an embryo/fetus" is changed to read '.'dose equivalent to the embryo/fetus" to make it clear that the dose limit specifically applies to the dose equivalent, which is the technically correct term to denote effect of dose to an organ.

(6)

In § 20.1501 (a)(2)(i), the phrase "The extent of radiation levels;""'*" is revised to read The magnitude and extent of radiation levels;*-* to clarify the intended meaning that surveys should evaluate both the area covering the dose field as well as the amount of dose in that area.

(7)

In § 20.1501 (a)(2)(iii), the phrase "The potential radiological hazards that could be present'.' is revised to read The potential radiological hazards" in order to remove 9

redundancy.

(8)

• In§ 20.1502, the words from licensed and unlicensed radiation sources under the control of the licensee" are added after "exposure to radiation" in paragraph (a) to improve clarity and to make it clear that, in determining whether or not monitoring is_required, a licensee need not take into account sources of radiation not under its control. It should be noted that, although the criterion for monitoring includes only radiation from sources under the control of the licensee, occupational dose includes dose from licensed and unlicensed material, whether in the possession of the licensee or other person.

6

(9)

In § 20.1502(a)(2) and (b)(2), monitoring requirements for minors and pregnant women are revised. In addition, for minors the dose limits referenced in paragraph (a)(2) apply for an entire year, while for a declared pregnant woman the dose limit referenced in paragraph (b)(2) applies only to the 9-month gestation period. These paragraphs are separated and revised accordingly to make this section consistent with § 20.1208 and technically correct. The criteria for monitoring the deep dose equivalent are changed for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. Changing the criteria for monitoring does not, in any way, change the dose limits for declared pregnant women, for the embryo/fetus, or for minors. This change constitutes a small licensee burden reduction while maintaining the current adequate level of protection of health and safety of minors and declared pregnant women. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring criterion is consistent with the public dose lin:,it and represents a quantity more consistent with the measurement sensitivity of individual personnel dosimetry. This value also is consistent with the 100 mrem (1 mSv) training criterion in revised § 19.12 (60 FR 36038; July 13, 1995).

Licensees are still required to ensure that the occupational dose limits for minors in

§ 20.1207 are not exceeded, that the dose limit of 0.5 rem (5 mSv) to the embryo/fetus from occupational dose to the declared pregnant woman is not exceeded during the course of the pregnancy, and that sufficient effort is made to ensure that substantial variations above a uniform monthly exposure rate for a declared pregnant woman are avoided. All of the occupational dose limits in § 20.1201 continue to be applicable to the declared pregnant woman as long as the embryo/fetus dose limit is not exceeded. Note that the monitoring criteria for lens dose equivalent and shallow dose equivalent for skin and extremities continue to apply to 7

determining the occupational exposure of declared pregnant women even though they are not applicable to the embryo/fetus.

(10) The proposed change to the posting requirement In § 20.1902(d), "Posting of Airborne Radioactivity Area," has not been adopted because the Commission has determined that the benefit achieved from replacing signs to use more precise terminology is outweighed by the cost to the licensees to comply with the proposed change. This issue does not have any health and safety implications and was proposed only to make an acceptable term more precise.

(11) In § 20.1903, a new paragraph is added to exempt teletherapy rooms in a hospi~al from posting requirements as long as access is controlled by the licensee to prevent the exposure of workers, other patients, and members of the public to radiation. The purpose of this change is to bring the regulation into conformity with existing licensing practices which are intended to avoid the unwarranted and potentially unsettling effect that "GRAVE DANGER,

. VERY HIGH RADIATION AREA" signs may have on patients undergoing medical treatment.

(12)

In § 20.1906(d), a revision requires licensees to notify the NRC Operations Center instead of an NRC Regional Office when, upon receiving and opening packages, radiation levels exceed regulatory limits. This provides for consistency by having all prompt notification requirements direct licensees to contact a single location. A conforming change also is made to the notification requirements in § 20.2202.

(13)

In § 20.2101, a revision permits licensees to add the new SI units to the old (special) units of dose on records required by this part. Each of the recorded dose quantities is to be recorded in the appropriate special unit and, if so desired, followed by the appropriate SI 8

unit in parentheses1. The term "eye dose equivalent is replaced by "lens dose equivalent" as discussed under the amendment to § 20.1003.

(14)

In§ 20.2106(a)(2) and (a)(3), the references to "body burden" are removed because this term is obsolete. Section 20.2106(a)(4) is revised by adding a reference to

§ 20.1204(a), that requires licensees to take measurements of (1) concentrations of radioactive materials in air in work areas, or (2) quantities of radionuclides in the body, or (3) quantities of radionuclides excreted from the body, or (4) combinations of these measurements in order to determine internal dose when required by § 20.1502 to monitor internal dose. This, in effect, uses recorded concentrations of radioactive material in air, quantities of radioactive material determined to be in the body or excreta, or any combination of these that would be needed, for assessing the committed effective dose equivalent (CEDE). The NRC believes that this information is necessary to suppott the recorded results of the licensee's calculation of CEDE.

Adding this reference would not impose any additional recordkeeping burden on licensees because they are required to obtain this information in order to calculate CEDE under § 20.1204.

(15)

A revision to § 20.2202(d) results in the application of the same incident reporting requirements to all licensees. Previously, this section required that all licensees with an installed Emergency Notification System make reports to the NRC Operations Center, but all other licensees must submit both a telephone report to the NRC Operations Center and a telegram, mailgram, or facsimile to the Regional Office. This change now requires all licensees to report incidents by telephone to the NRC Operations Center to ensure consistency in the prompt 1 Part 20 was implemented prior to the NRC's Statement of Policy on Conversion to the Metric System (61 FR 31169); therefore, in order to be consistent with the approach used in Part 20 in its presentation of dual units, this rule does not follow the NRC's metrication policy which supports presenting the SI units first, followed by the English (or special) units shown in brackets.

9

notification requirements contained elsewhere in this part and results in a reduction in the information collection burden.

(16)

In § 32.54(a), the reference to"§ 20.203(a)" is corrected to.read"§ 20.1901."

(17)

The proposed change has not been adopted in § 35.20 because this issue is being addressed as part of a major revision to 10 CFR Part 35.

(18)

Safety precautions and survey requirements for restricted and unrestricted areas are specified in§§ 35.315, 35.415, 35.641, and 35.643. The proposed changes to

§§ 35.315(a)(4) and 35.415(a)(4) have not been adopted because these issues are being addressed as part of a major revision to 10 CFR Part 35. Sections 35.641 (a)(2)(i) and (a)(2)(ii) and 35.643(a) are revised to be consistent with the dose limits for occupationally exposed individuals and members of the public. Also, in§ 35.643(a)(1), a misreference to§ 20.1301(c) is corrected to read § 20.1301. The 0.5 rem (5 mSv) limit specified in § 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 § 20.1301 (a) to this section, with a provision for licensees to request the 0.5 rem (5 mSv) limit specified in § 20.1301 (c).

(19)

In § 36.23(9), posting requirements for a panoramic irradiator are revised to conform with posting requirements for high or very high radiation areas in § 20.1902. The previous posting requirements in Part 36 required a posting appropriate to a high radiation area only, which may not be appropriate for all panoramic irradiators.

(20)

In§ 39.33, "Radiation detection instruments," a conforming change to paragraph

\\

(a) is made by replacing the term milliroentgens with the terms millisieverts (mSv) and 'millirem (mrem) to be consistent with revised Part 20 terminology. However, the NRC recognizes that most licensees may still use radiation detection instruments that measure radiation in units of roentgens. Measurements taken in roentgens may continue to be recorded in terms of the 10

roentgen, provided that the measurements can be readily converted to rem for records required under 10 CFR Part 20.2101 (a).

(21)

In § 39.71 (b), the reference to"§ 20.3" is corrected to read"§ 20.1003."

Appropriate conforming changes to regulatory guides such as 8.7, 8.13, 8.34, 8.35, and 8.36 are under consideration by the Commission.

One matter in the proposed rule was not adopted. The proposed rule would have changed the term "Airborne radioactivity area" to aAirbome Radioactive Material Area" because it is more precise language. While the Commission recognizes that the current language is somewhat imprecise, it has determined that the burden imposed on licensees to revise procedures and change signs would outweigh any benefits. In addition, the proposed change to this term does not constitute a health and safety improvement. The proposed conforming changes to §§ 20.1203 and 20.1902(d) also have not been adopted.

IV. Analysis of Public Comments and Staff Response Four letters of public comment were received on the proposed rule. Comments were received from the Council on Radionuclides and Radiopharmaceuticals, Inc., the Nuclear Energy Institute, Commonwealth Edison Company, and the U.S. Department of Health and Human Services.

Several suggestions for additional changes in 10 CFR Part 20 were submitted and have been referred to the appropriate program offices for consideration. Comments specific to the scope of issues addressed by this rulemaking and the NRC staffs response are as follows:

One commenter observed that frequent minor changes to the regulations require licensees to make numerous changes to written procedures and training content, thus 11

constituting a burden. It was observed by the commenter that the costs of revising procedures and training programs in response to a minor rulemaking such as this can range from

$12,000.00 to $20,000.00 per licensee site in the nuclear power industry. In response to this comment, and others, the proposed change in terminology from aAirbome radioactivity area* to "Airborne radioactive material area" has been deleted in this final rule. Although supported by the comments, it was also criticized as a change having associated costs and little benefit. The NRC staff agrees that the costs outweigh the benefit and has removed this proposed change from the final rule. The regulatory analysis contained in Section VIII now reflects this adjustment in cost estimate and concludes that the benefits of improved clarity and consistency in NRC regulations remaining in this final rule will offset any remaining costs.

Similar comments regarding costs and limited benefit were received regarding the proposed change to lens dose equivalent (LOE), and one commenter suggested. that NRC Form~ 4 and 5 should be revised to use the new tern,, "lens dose equivalent (LOE)." The NRC staff believes any costs incurred by licensees to implement this change in terminology would be minimal since the required NRC Forms 4 and 5 have already been revised to reflect the new terminology and have been used by licensees since August 1995.

Several suggestions were received regarding the definition and meaning of total effective dose equivalent (TEDE) and effective dose equivalent (EDE). Revision of 10 CFR Part 20, based on the recent ICRP-60 publication, was recommended. These suggestions, though having merit, go far beyond the scope of this clarifying rulemaking and will be held for future consideration.

Several commenters agreed that the declaration of pregnancy must go to the licensee, rather than the employer, as the party responsible for taking timely protective action. Guidance was requested on how licensees could determine the duration of pregnancy and thus, how long 12

dose restrictions would remain in effect. The Commission suggests that licensees establish an appropriate duration of restriction based on discussion with the declared pregnant worker.

However, it is not the Commission's intent to require activities which might violate the individual's right to privacy.

One commenter suggested that an important reason for increasing the monitoring threshold for minors and declared pregnant women to 100 mrem (1 mSv} was the difficulty in measuring 50 mrem (0.5 mSv) in a year or during the gestation period. The NRG agrees and considered this in the adoption of the final rule change.

Another commenter observed that the change in the monitoring threshold for minors and declared pregnant women will reduce unnecessary burden on licensees while maintaining the current adequate level of protection of health and safety.

One commenter suggested that consistency with the public dose limit of 100 mrem (1 mSv) is not adequate justification for changing the monitoring criteria for minors and declared pregnant women. The NRG did not rely on consistency with the public dose limit as sole justification; however, it lends support to the underlying scientific basis to revise the criteria.

Since the public dose limit of 100 mrem (1 mSv) is considered to be an acceptable level of risk for all members of the public, and the occupational dose limit for minors and the dose limit for the embryo-fetus of declared pregnant women is soo* mrem (5 mSv), monitoring for exposures of less than 100"mrem (1 mSv) does not provide an additional level of protection and is not necessary to comply with the dose limits. The final rule requires monitoring of minors and declared pregnant women when it is likely that they would receive over 100 mrem (1 mSv) in 1 year (or during the entire pregnancy).

13

V. Agreement State Compatibility This rulemaking will be a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among State and Federal safety requirements. Four categories of compatibility (A through D), as well as a category identifying rules of Health and Safety significance (H&S), have been assigned to portions of this rule. Category A means the provisions affect a basic radiation protection standard or related definitions, signs, labels, or terms necessary for a common understanding of radiation protection that the State should adopt with (essentially) identical language. The NRC has assigned a Category A level of compatibility to the changes to the definitions Declared pregnant woman, High radiation area, Lens dose equivalent (LOE), and Very high radiation area in§ 20.1003. Also included under the Category A level of compatibility are the changes to§§ 20.1201 and 20.1208.

Category B means the' provisions affect a program element with significant direct transboundary implications that the State should adopt with essentially identical language. The NRC has assigned a Category B level of compatibility to the changes in§ 32.54..

Category C means the provisions affect a program element, the essential objectives of which should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are addressed need not be the same as NRC provided the essential objectives are met. The NRC has assigned a Category C level of compatibility to the changes in§§ 20.1003 (Definition of Individual monitoring devices), 20.2101, 20.2106, 20.2202, 39.33, and 39.71.

Category D means the provisions are not required for purposes of compatibility; however, if adopted by the State, they should be compatible with NRC. The NRC has assigned 14

a Category D level of compatibility to the changes in §§ 20.1101, 20.1206, 20.1501, 20.1502, 20.1903, 20.1906, 35.641, 35.643, and 36.23.

.('

Category H&S means the provisions are not required for compatibility; however, they do have particular health and safety significance. The State should adopt the essential objectives of such provisions in order to maintain an adequate program. The Category H&S has been assigned to the changes in §§ 20.1101, 20.1501, 20.1502, 20.1906, and 36.23.

VI. Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in the categorical exclusion in 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

VII. Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget, approval number 3150-0014, 3150-0001, 3150-0010, 3150-0158, and 3150-0130.

Because the rule will reduce existing information collection requirements by eliminating written incident reports and allowing licensees to submit incident reports by telephone, the public burden for this information collection is expected to be reduced by approximately 250 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 15

completing and reviewing the information collection. Send comments on any aspect of this information collection, including suggestions for further reducing the burden, to the Information and Records Management Branch (T-6F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at 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.

Public Protection Notification If a document used to impose an information collection does not djsplay a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

VIII. Regulatory Analysis This final rule makes minor correcting and clarifying amendments to the requirements in 10 CFR Part 20 and conforms 10 CFR Parts 32, 35, 36, and 39 to 10 CFR Part 20. The final rule imposes one-time only, minor additional costs at a maximum of $12,000 per licensee site in the nuclear power industry for changing written procedures and possibly training associated with correcting and clarifying several definitions and minor changes to requirements addressing standards for protection against radiation. It is expected that the cost for other classes of licensees may be substantially less. The NRC staff believes that the cost of revising procedures will be small and is offset by the benefits of improved clarity and consistency in the NRC's regulations.

16

The final amendments include a conforming change in 10 CFR Part 36 to make the posting requirements for a panoramic irradiator consistent with posting requirements in 10 CFR Part 20 for high or very high radiation areas. Licensees in compliance with the Part 20 posting requirements are also in compliance with Part 36 posting requirements; therefore, this is a -

conforming change to make the language in the two sections consistent, and no impact is expected to result from this action..

The final amendments also result in a minor reduction in burden to licensees by eliminating written incident reports and allowing licensees to submit incident reports by telephone. This change is consistent with the Paperwork Reduction Act of 1995.

The final requirements also waive posting requirements in teletherapy rooms in hospitals to remove the unsettling effects that the signs may have on patients. There would be no decrease in safety because the safety precautions in 10 8FR Part 35 are considered adequate to protect individuals from inadvertent exposure to radiation, and this change may have a beneficial effect on patients.

In addition, these final amendments change the deep dose equivalent monitoring requirements for minors and pregnant women from one-tenth of the applicable limit or 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) for the following reasons:

(1)

The value is consistent with the 100 mi-em (1 mSv) training criterion in the recently revised 10 CFR 19.12 (60 FR 36038; July 13, 1995).

(2)

The value is consistent with the 0.1 rem (1 mSv) dose limit for members of the public in 10 CFR 20.1301 (a). There is little benefit to require monitoring of workers who are expected to receive less dose than is permitted for members of the public.

No cost is associated with this rule change, and there may be some reduction in burden.

However, any reduction is likely to be small because many factors impact the decision as to 17

whether personal dosimeters will be worn and it is impossible to assess the extent of this burden reduction.

This discussion constitutes the regulatory analysis for this final rule.

IX. Backfit Analysis The NRG has determined that the backfrt rules in §§ 50.109, 72.62, and 76. 76 do not apply to this final rule and, therefore, that a backfrt analysis is not required for this final rule because these amendments do not involve any provision that would impose backfits as defined in §§ 50.109(a)(1 ), 72.62(a), and 76. 76(a).

Small Business Regulatory Enforcement Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRG has determined that this action is not a "major rule" and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

List of Subjects 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal.

18

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.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR Parts 20, 32, 35, 36, and

39.

19

PART 20-STANDARDS FOR PROTECTION AGAINST RADIATION

1.

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

AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930,933,935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093,2095, 2111,2133,2134,2201,2232,2236,2297n, secs. 201, asamended,202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

2.

In § 20.1003, the definition of Eye dose equivalent is removed. The definition of Lens dose equivalent (LDE) is added in alphabetical order, and the definitions of Declared pregnant woman. High radiation area. Individual monitoring devices. and Very high radiation filfil! are revised to read as follows:

§ 20.1003 Definitions.

Declared pregnant woman means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

High radiation area means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 mSv) in 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates.

20

Individual monitoring devjces (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 (LOE) applies to tlie 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/cm).

Very high radjatjon 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 § 20.1101, paragraph (b) is revised to read as follows:

§ 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).

21

4.

In§ 20.1201, paragraphs (a)(2)(i) and (c) are revised to read as follows:

§ 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§ 20.1203, the introductory text is revised to read as follows:

§ 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).

22

6.

In§ 20.1206, paragraph (a) is revised to read as follows:

§ 20.1206 Planned special exposures.

(a)

The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical.

7.

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

§ 20.1208 Dose equivalent to an embryo/fetus.

(a)

The licensee shall ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see§ 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) 23

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

§ 20.1501 General.

(a)

(2)

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

9.

In§ 20.1502, paragraph (a)(3) is redesignated as (a)(4) and new paragraphs (a)(3) and (b)(3) are added; and the introductory text of paragraph (a) and paragraphs (a)(2},

(b)(1), and (b}(2) are revised to read as follows:

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

(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by -

24

(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem ( 1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);

(3} Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and (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 §§ 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§ 20.1903, a new paragraph (d) is added to read as follows:

§ 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§ 20.1902 if -

2AII of the occupational dose limits in§ 20.1201 continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded.

25

(1)

Access to the room is controlled pursuant to§ 35.615; and (2)

Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this part.

11. In § 20.1906, the introductory text of paragraph (d) is revised to read as follows:

§ 20.1906 Procedures for receiving and opening packages.

(d)

The licensee shall immediately notify the final delivery carrier and the NRC Operations Center (301-816-5100), by telephone, when-

12.

In§ 20.2101, paragraph (b) is redesignated as paragraph {c), paragraph (c) is redesignated as paragraph (d) and revised, and a new paragraph (b) is added to read as follows:

§ 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 § 20.2006(b), information must be recorded in 26

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).

13.

In§ 20.2106, paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) are revised to read as follows:

§ 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§ 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§ 2*0.1204(a) and (c), and when required by§ 20.1502;

14. In§ 20.2202, paragraphs (a)(1)(ii), (b)(1)(ii), and (d)(2) are revised to read as follows:

§ 20.2202 Notification of incidents.

(a) 27

(1)

(ii)

(b)

(1)

(ii)

(d)

A lens dose equivalent of 75 rems (0.75 Sv) or more; or A lens dose equivalent exceeding 15 rems (0.15 Sv); or (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).

§ 32.54 [Amended]

16.

In§ 32.54, par~graph (a) is amended by revising the reference to

"§ 20.203(a)" to read "§ 20.1901."

28

PART 35-MEDICAL USE OF BYPRODUCT MATERIAL

17.

The authority citation for Part 35 continues to read as follows:

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935,948,953,954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

18.

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

§ 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 § 20.1201 of this chapter; and (ii)

Radiation dose rates in controlled or unrestricted areas are not likely to cause any individual member of the public to receive a dose in excess of the limits specified in § 20.1301 of this chapter.

19.

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

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

29

(a)

If the survey required by § 35.?41 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in § 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 § 20.1301 of this chapter.

PART 36 -- LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

20.

The authority citation for Part 36 continues to read as follows:

AUTHORITY: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.

5841, 5842, 5846).

21.

In § 36.23, paragraph (g) is revised to read as follows:

§ 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 § 20.1902. Radiation postings for panoramic irradiators must comply with the 30

a posting requirements of§ 20.1902, except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

PART 39 - LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING

22.

The authority citation for Part 39 continues to read as follows:

AUTHORITY: Secs. 53, 57, 62, 63, 65, 69, 81, 82, 161, 182, 183, 188, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2112, 2201, 2232, 2233, 2236, 2282);

secs. 201, as amended, 202,206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

23.

In § 39.33, paragraph (a) is revised to read as follows:

§ 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 surve~ instrument must be capable of measuring 0.001 mSv (0.1 mrem) per hour through at least 0.5 mSv (50 mrem) per hour.

31

§ 39. 71 [Amended]

24.

In § 39. 71, paragraph (b) is amended by revising the reference to "§ 20.3" to read

"§ 20.1003."

fJ:.

Dated at Rockville, Maryland, this 1-:iay of~

1998.

For the Nuclear Regulatory Commission.

L. Joseph Ca a,

Executive Dire or for Operations.

32

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institute for Occupational Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

• 96 OF 26 P 4 :O 0 Attention: Docketing and Service Branch

Dear Sir/Madam:

Safety and Health Robert A. Taft Laboratories 4676 Columbia Parkway Cincinnati OH 45226-1998 December 23, 1996

~90KET NUMBER

• *10POSED RULE Pl Jo

( {p/ FJe.5;J.3gg The National Institute for Occupational Safety and Health (NIOSH) has reviewed the Nuclear Regulatory Commission (NRC) proposed rule, Minor Corrections, Clarifying Changes, and a Minor Policy Change [61 FR 52388] published on October 7, 1996. NIOSH has the following comments on the proposed rule:

NIOSH agrees that the proposed change in the monitoring requirements from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) for pregnant women and minors does not raise the dose limit (0.5 rem[5mSv]) for these workers and thus should not result in an increased risk from exposure.

However, the basis provided for this change is not appropriate since it compares the monitoring criteria, which is currently set at one-tenth of the applicable dose limit for minors and declared pregnant women, with the public dose limit. Paragraph (9)(a) of the preamble indicates that the change in the monitoring criterion is being made because the current value is not consistent with the 0.1 rem (1 mSv) dose limit for members of the public, and "it is not appropriate to require monitoring of workers who are expected to receive less dose than is permitted for members of the public." Thus, the NRC is comparing the dose limit for the public, a predetermined annual limit, with the monitoring criterion for workers (minors and declared pregnant women), a trigger value that is currently one-tenth of the applicable dose limit and predicated on a likelihood of exposure. This justification for the proposed change in the monitoring criterion for workers does not provide a logical basis for making the change.

NIOSH also recommends that the NRC consider requiring the licensee to assign a dosimeter to the declared pregnant woman that would be worn during the entire gestation period to measure the total dose to the embryo/fetus during gestation. This dosimeter would be in addition to any dosimeter required for routine monitoring and would assure that the dose to the embryo/fetus not exceed the regulatory limit.

JAN O 7 1997_

~cknowtedged by card

• II I II Ill II 111111......

aL

U.S. NUCLEAR REGUlATORY COMW6$ION DOCKETING I SERVICE SEC1DI OFFICE OF THE SECRETAfW Of THE COMMISSION OocumentSlatisllel Postmalt oa-, _ / ;;.p 3 Lt fe Coples Reoeived. ________ _

Ad~ICopiesReproduced ___ J _____ _

Special Dtsb1ootlon,~,:----------

t1t &µ/a '"'J, '£IDS ?1:> fl I

Page 2 - Secretary, U.S. Nuclear Regulatory Commission These comments are intended to clarify the intent of the proposed rule changes; we hope they are helpful in the development of the final rule. If I can be of further assistance, please contact me at 513/533-8303.

Sincerely yours,

1. £~~.A rv& Paul A. ~li.D.

v

( Director Education and Information Division

Commonwealth Edison Company 1400 Opus Place Downers Grove, IL 60515-5701 December 1 7, 1996

• 96 DEC 26 P,~ : 1 2 ComEd OFF! [,_, :'

Secretary DOCK E. 1: :,

DOCKET NUMBER

. ~.

PROPOSED RULE PR ~

-d.cJ..

U.S. Nuclear Regulatory Commission

' *

• f Washington, D.C. 20555-0001 Attention:

Subject:

Docketing and Service Branch Commonwealth Edison Company (ComEd) Comments Pertaining to USNRC Proposed Rulemaking for 10 CFR Parts 20, 32, 35, 36, 39, "Minor Corrections, Clarifying Changes, and a Minor Policy Change" The Commonwealth Edison Company (ComEd) supports the proposed rule and does not anticipate any significant impact on its licensed operations.

ComEd provides the following comments with respect to the proposed rule definition section 10 CFR 20.1003:

Definition of the "declared pregnant woman" - A statement has been added to require a declaration to remain "in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant." Although these added words clarify an existing issue, they will also create a new question as to how the licensee may determine that a woman is no longer pregnant if she never withdraws her declaration. Specifically, from a compliance perspective, does a licensee need to verify with a woman that she is no longer pregnant? It would be helpful if the Statements of Consideration for the final rule discuss that, in lieu of receiving a written declaration withdrawal or verification with the worker, that it would be appropriate to allow a declared pregnant woman's status to expire after a reasonable period of time, e.g., ten months.

Definition of"airborne radioactivity area"- ComEd believes that it is no longer necessary to reference Appendix B to "20.1001-20.2402." There is currently only one Appendix B to Part 20 and it may be referenced as such. A similar reference to "20.1001 - 20.2402" occurs in 10 CFR 20.1502 (b) (1) of the proposed rule.

t JAN O 7 1997

-4cknowtedged by card,.. -

I I

W a..,

A Unicom Company

0.$ r,*;.-1.,u:AR REGULATORY COMMISSIOrf DOCKETING & SERVICE SECTU.

OFFICE OF THE SECRETAfW OF THE COMMISSION Document Slatistlcl Postmark Date _

I :J.(! 9 /ei '2 Copies Received, __ -:/ ____

Add'I Copies Reproduced.......,-,13 ____ _

Special Dlstributlon~~------

/11 e C,au 5/Bbd1 R (/lS1 PD &

NRC Docketing and Service Branch December 17, 1996 Also, ComEd requests the following changes that are not addressed in the proposed revision for clarification:

With the proposal to transition from a terminology of "airborne radioactivity" to "airborne radioactive material," it is suggested that the Note for 10 CFR 20.1203 also be changed for consistency. Specifically, the first words in the note should be changed from "Airborne radioactivity measurements... " to "Measurements for airborne radioactive material... "

The definition of"Total Effective Dose Equivalent" (TEDE) should be modified.

TEDE is defined by 10 CFR 20.1003 as "the sum of deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures)." It is recommended that "Effective Dose Equivalent (EDE)" be added as a second meaning for TEDE. The term "Effective Dose Equivalent" or EDE is utilized extensively within the scientific community, e.g., by the National Council on Radiation Protection and Measurements, and is also used by other government agencies, such as the Environmental Protection Agency. This clarifying change would alleviate confusion as to the technical relationship between TEDE and EDE and would also provide greater support for the application of calculational techniques being developed within the nuclear industry for estimating EDE caused by external radiation sources.

ComEd appreciates the opportunity to comment on this proposed rule. Please direct any questions pertaining to these comments to Denise Saccomando, Senior Licensing Administrator at 630-663-7283.

Sincerely,

~~

John C. Brons Vice President Nuclear Support cc:

G. Dick, Generic Issues Project Manager-NRR A.B. Beach, Regional Administrator-RIii Office ofNuclear Safety-IONS 2

E :o 960EC23 Pf-14: 19

oqu.E. TEO Jr:::

V

\\ (~

NUCLEAR ENE RG Y INSTIT UTE

'96 Q[r; 2J p J :S ]Ralph Andersen, CHP SENIOR PROJECT MANAGER.

PLANT SUPPORT 0

December 23, 1996 Mr. John C. Hoyle Secretary DOCKET NUMBER

, ~

PROPOSED RULE PR ;) ~

,-..a a(

U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

( & / Ff 5 'J-3 g<Z_j

SUBJECT:

Proposed Rule: Minor Corrections, Clarifying Changes, and a Minor Policy Change to 10 CFR Parts 20, 32, 35, 36, 39 (61 Fed. Reg. 52388 -- October 7, 1996)

This letter provides comments by the Nuclear Energy Institute (NEI)* on behalf of the nuclear energy industry in response to the subject notice. The industry appreciates the opportunity to provide input on this proposed rule.

NEI believes that many of the proposed changes support the intent of the rulemaking to "achieve greater clarity and to further facilitate implementation" of NRC radiation protection regulations. The proposed minor change in policy regarding monitoring of occupational dose to minors and declared pregnant women will improve consistency with definitions and requirements regarding dose to members of the public. This change will also help to reduce unnecessary and unjustified burden on licensees, while maintaining the current adequate level of protection of health and safety of minors and declared pregnant women. We strongly urge the NRC to retain this proposed change in the final rule.

Revising Part 20 to specify that written declaration of pregnancy would be given by the worker to the licensee will help facilitate the taking of timely and appropriate protective actions by the licensee. Clarifying the duration of applicability of monitoring requirements for declared pregnant women as the 9-month gestation period reflects common sense and may result in minor burden reduction for some licensees. In conjunction with issuing the final rule, we suggest that the NRC provide supplementary information clarifying that, for compliance purposes,

• NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including regulatory aspects of generic operational and technical issues.

NEI members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

JA Acknowledged by card.... ~~.. ?

... ~:! -. -*

1776 I STREET NW SU'TE 400 WASHINGTON DC 20006-370B PHONE 202 739 8000 FAX 202 785 4019

U.S. NUCLEAR REGULATORY COMMISSION OOCKETING & SERVICE SECTm OFFICE OF THE SECRETAR\\'

Of THE COMMISSK)N DoQlnent Slatistlel Po~ Dae Ji-and defi*v1red 12/-u/q(.

I Coples AeceiWd. ____

l -~---

Ad~t Copies Reproduced ___

.3 ___ _

s~ otslrlbutlon. _ ____

/1/etal{.s(and ' 12/f)S, PD((..

I

Mr. John C. Hoyle December 23, 1996 Page 2 determining that a declared pregnant "is no longer pregnant" is a matter of judgment on the part of the licensee using reasonable assumptions and available information.

NEI supports the intent of the NRC to minimize implementation burden on licensees by recognizing use in the rule of either "airborne radioactivity area" or "airborne radioactive material area." We believe similar reduction in implementation burden can be achieved by applying this approach to some of the other proposed rule changes. We recommend modifications to the proposed changes to definitions in Part 20 to be issued in the final rule as "airborne radioactive material area (or airborne radioactivity area) means... " and "lens dose equivalent (or eye dose equivalent) applies to.... " This will provide necessary flexibility to licensees to implement these minimal changes in terminology in a time and manner commensurate with the significance to their specific program and circumstances.

NEI recommends that Section 20.1003, "Definitions," be revised to clarify that the total effective dose equivalent is based upon and analogous to the effective dose equivalent. This change will enhance the effectiveness of the final rule because it helps accomplish the purpose of the original revision to Part 20 (56 Fed. Reg. 23360

-- May 21, 1991): "to put into practice recommendations from [International Commission on Radiological Protection - ICRP] Publication 26" and "to implement the 1987 Presidential guidance on occupational radiation exposure." The ICRP recommendations and Presidential guidance are based on the concept of the effective dose equivalent. We suggest wording as follows: "Total effective dose equivalent (TEDE) means the sum of the effective dose equivalent or deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

The suggested wording (above) will improve the internal consistency and practicality of the rule. Footnote 2 to the Section 20.1003 definition of Weighting Factor provides that the "use of other weighting factors for external exposure will be approved on a case-by-case basis.... " It is not clear that such NRC-approved weighting factors could be implemented by licensees under the current wording in Part 20 defining total effective dose equivalent. Therefore, a change to Part 20, as suggested above, is necessary to clarify and facilitate implementation of the rule, the stated goals of the proposed rulemaking.

The regulatory analysis accompanying the proposed rule states, "[t]he proposed rulemaking would not impose any additional costs on licensees.... " We do not agree. Several Part 50 licensees have reviewed costs to make changes to procedures, training, software, etc., that would be required to implement the rule.

The preliminary estimates of implementation costs developed from these reviews range from $12,000 to $20,000 per reactor site. Sound regulatory policy dictates

Mr. John C. Hoyle December 23, 1996 Page 3 that NRC more carefully consider and justify the resource burden of the proposed rule. However, it is our assessment that overall, the rule changes will generally be of sufficient benefit to licensees to justify the costs. We, therefore, support promulgation of the proposed rule, taking our comments into account.

If you have questions concerning the enclosed comments, please contact me at (202) 739-8111.

Sincerely, ~~,r-Ralph Andersen RLA/tnb

Henry H. Kramer, Ph.D., FACNP Executive Direccor December 18, 1996 OF,r oo*:Kc.

• 0

{

Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 DOCKET NUMBERp PROPOSED RULE c20 ~tJ. al

( ~I F~ 5:2.38~)

Attention:

Reference:

Docketing and Service Branch Proposed Rule: Minor Corrections, Clarifying Changes, and a Minor Policy Change.

Federal Register, October 7, 1996. Page 52388 These comments are submitted on behalf of the Council on Radionuclides and -

Radiopharmaceuticals (CORAR). CORAR members include the major manufacturers and distributors of radiopharmaceuticals, radioactive sources and research radionuclides used in the U.S. for therapeutic and diagnostic medical applications and for industrial, environmental and biomedical research and quality control. CORAR members are U.S.

NRC or Agreement State licensees and are therefore affected by this proposed rule.

CORAR has attached detailed, comments on this proposed rule and has the following general comments.

CORAR supports these proposed changes, but recommends that there are additional changes needed to improve consistency and clarity and remove redundancy from current and proposed regulations. Examples of further needed changes are:

a.

Elimination of dual EPA and NRC regulation of air emissions and mixed waste.

b.

Inclusion of 33P in _ 10 CFR 30 Schedule B and 10 CFR 20 Appendix C, etc., to achieve compatibility with Agreement States.

c.

Correction of technical error in 10 CFR 20 Appendix B where tritium gas is assumed to behave similar to tritium labeled water in the environment.

d.

Provision of separate inhalation classifications in 10 CFR 20 Appendix B for tritium gas and certain 14C labelled compounds.

.JAN O 7 1991'

Acmowlectged by cara........ -

U.S. NUCLEAR REGULATORY COMMISSION DOCKETING & SERVICE SECTot OFFICE OF THE SECRETAIW OF THE COMMISSION Document Slatisttcs Postmark Date J;i/~o / 9 t.

Copies Reoeived. __

~-----

M.j'I Copies Reproduced __,3--. __ _

Special Dlstributlon,~-=-----~---

Afe, fau.,slaod1 'PID~, PI>@

e.

Removal of unnecessarily restrictive notification requirements in or proposed for 10 CFR 30, including notifications of the misuse of trivial quantities of radioactive material, contaminated areas secured for decay and trivial levels of contamination on an individual requiring treatment at a medical facility.

While CORAR encourages the NRC to make improvements to the regulations we are also concerned that frequent minor changes to regulations are often counterproductive. The main objection is that these changes cause many licensees to make changes in their radiation protection programs which consumes resources with little or no benefit. Furthermore, these changes are more burdensome to those licensees that have made the extra effort to include NRC requirements in detailed written operating procedures and policies. By making frequent minor regulatory changes the NRC inadvertently penalizes the more conscientious licensees.

We note that many of the currently proposed changes were recommended to the NRC when the NRC proposed to revise 10 CFR 20 in its entirety. There is evidently a need for the NRC to more closely consider recommended comments when major revisions to the regulations are intended. Perhaps also the comment period has not been long enough to obtain full participation from the regulated community.

Licensees find regulatory changes more immediately burdensome when the regulations are prescriptive. Most of the proposed changes involve unnecessarily detailed prescriptive requirements. If the NRC intends to continue to promulgate prescriptive regulatory requirements there is a need for extra care to ensure that the requirements are clear and consistent. A preferred means to avoid regulatory instability is to minimize prescriptive requirements.

NRC has recently invited comments on NRC responsiveness to the public. This current proposed rule is a good example of CORAR's concern that reasonable comments are often not acted on expeditiously.

NRC has recently invited comments on its Strategic Assessment and Rebaselining Initiative. This proposed rule is an example of why the NRC should consider the root cause of the technical errors, inconsistencies and redundancy in the regulations and address these causes in the new initiative.

We appreciate the opportunity to comment and would be glad to provide further information or clarification.

Enclosure:

CORAR Comments 2

Sincerely yours,

/:~l/l~

Leonard R. Smith, CORAR-Vice Chairman

r' CORAR COMMENTS ON PROPOSED NRC RULE: MINOR CORRECTIONS, CLARIFYING CHANGES, AND A MINOR POLICY CHANGE

1.

Page 52392, column 1, paragraph 3.

2.

"Airborne radioactive material area... "

While CORAR agrees that the new terminology is grammatically correct, NRC should recognize that this change will cause many licensees to change their written policies and procedures. This is an example of how over prescriptive regulations can consume resources without any safety benefit.

Page 52392, column 1, paragraph 6.

"Declared pregnant woman... "

CORAR agrees that the declared pregnant women should be required to inform the licensee rather than the employer and that the declaration should remain in effect until the women is no longer pregnant or wishes to nullify the declaration.

However NRC should recognize that this change will require many licensees to change their written policies and procedures and to retrain radiation workers and their supervisors in the new requirements. This is an example of how a prescriptive regulation, without thinking the process through, can consume resources without any safety benefit.

3.

Page 52392, column 1, paragraph 9.

"Lens dose equivalent... "

a.

CORAR appreciates that changing the terminology from Eye dose equivalent to Lens dose equivalent will avoid confusing the initials for this quantity (LDE) with EDE, meaning Effective Dose Equivalent. However it should be recognized that the term Effective Dose Equivalent is obsolete and was replaced in 1990 by the ICRP by the term Effective Dose. The NRC should explain why it has decided to not adopt the current ICRP definitions and continues to use the 1979 ICRP definitions.

b.

This new definition will require licensees to change their written policies and procedures and to change forms used to document personnel exposure.

Does the NRC intend to make changes to NRC forms 4 and 5? The NRC should explain how historic records are to be treated and for how long can licensees use the current terminology.

1

4.

t

c.

Again this is an example of how a prescriptive regulation can consume resources without any safety benefit.

Page 52392, column 3, paragraph 10.

Page 52393, column 1, paragraphs 1, 2, 3, 6 and 7.

1120.1502 Conditions requiring individual monitoring of external and internal occupational dose."

a.

CORAR agrees that individual monitoring should be required for minors and declared pregnant women when internal or external occupational exposure can be expected to exceed 100 mrem in one year or during the pregnancy, respectively. This proposed requirement is compatible with public dose limits and the training criterion in 10 CFR 19.12.

b.

CORAR believes that the NRC should state another reason for requiring monitoring when occupational dose to minors and declared pregnant women can exceed 100 mrem. Doses below 100 mrem are often difficult to distinguish from fluctuations in background radiation. It is therefore often difficult for licensees to demonstrate compliance with the current requirement for providing monitoring when occupational doses can exceed 50 mrem. It should be easier for licensees to demonstrate compliance with the proposed 100 mrem requirement.

C.

However, CORAR is concerned that licensees will require to change written policies and procedures. This is another example of how changes in prescriptive regulatory requirements can consume resources without any safety benefit. NRC should investigate its method for developing regulations with the purpose of providing regulations that do not need frequent adjustments after implementation.

5.

Page 52393, column 1, paragraph 10.

11

( d) Posting of airborne radioactive material areas 11 This paragraph implies that both "Airborne Radioactivity" and "Airborne Radioactive Material" are to be permitted in the regulations. However in the supporting text, the intent appears to be to replace "Airborne Radioactivity" with Airborne Radioactive Material" but to permit the continued use of existing postings for an unspecified time. It would be useful for licensees if the intent of the regulatory proposal was clarified. CORAR recommends that licensees should be permitted to use existing stocks of signs.

2

I *

6.

Page 52389, column 1, paragraph 13.

"Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs.... "

CORAR agrees that teletherapy rooms should be exempt from posting signs that could be frightening to patients and agrees that the proposed alternative access control measures are sufficient.

7.

Page 52393, column 2, paragraph 1.

"The licensee shall immediately notify... the NRC Operations Center... "

Again this change will require licensees to change written policies, procedures and call-lists. Manufacturers frequently will inform NRC regional offices when packages of radioactive materials are delayed in transit or are faced with other issues that are not required to be reported. It would be useful if the NRC would clarify whether issues that are not required to be reported should continue to be communicated to regional offices or to the Operations Center.

3

~[cY oocKET NuMaeRPR

-~0 12 d..t1--!;,-

T PROPOSED R~LE

~ / yj oort~~0-01-P]

C 6 I F /'-, 5 J...

NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20, 32, 35, 36, 39 RIN 3150-AF46

'96 OCT - 3 p 4 : 1 2 Minor Corrections, Clarifying Changes, and a Minor Policy Change AGENCY:

Nuclear Regul~tory Connission.

ACTION:

Proposed rule.

SUMMARY

The Nuclear Regulatory Convnission is proposing to amend its regulations to make minor corrections and clarifying changes to the NRC,s 10 CFR Part 20, "Standards for Protection Against Radiation." The proposed amendments would also conform other 10 CFR 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.

~,~1u EFFECTIVE DATE:

Conment period expires (75 days following publication in the Federal Register).

Co0111ents received after this date will be considered if it is practical to do so, but the Co11111ission is able to assure consideration only for comments received on or before this date.

ADDRESSES:

Mail written comments to: Secretary, U.S. Nu~lear 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 0MB 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 co11111ents 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 Co11111ission, 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 2

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 m.~v) 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§ 20.1003, "Definitions," clarifying changes and minor corrections would be made to the following:

(a)

The term nAirborne 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§ 20.1902(d} to permit licensees the option of either using the current signs or posting new -~gns to reflect this change.

(b)

The definition of "Declared pregnant womanr 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 3

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" (LOE) 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§ 20.llOl(b}, the word "practicable" would be changed to Mpractical" 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§§ 20.120l(a}(2}(i} and (c}; 20.1203; 20.2101; 20.2106(a}(l};

and 20.2202(a}(l}(ii} and (b}(l}(ii), "eye dose equivalent" would be replaced by "lens dose equivalent" to conform to the proposed amendment in§ 20.1003.

(4)

In§ 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§ 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" 4

to make it clear that the dose limit specifically applies *to the dose equivalent, which 1s the technically correct term to denote effect of dose to an organ.

(6)

In§ 20.150l(a)(2)(1), 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§ 20.1501(a)(2)(1ii), 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§ 20.1502, the words "from radiation sources under the control of the licensee" would be added after "exposure to radiation" in pa-:graph (a) to improve clarity and to make it clear that a licensee is not responsible for sources not under its control.

(9)

In§ 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§ 20.1208 and technically correct.

In addition, the criterion for monitoring m~nors 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:

5

(a)

The value is not consistent with the 0.1 rem (1 mSv) dose limit for members of the public in§ 20.130l(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§ 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§ 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§ 20.1003.

(11)

In§ 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§ 20.1906(d), a revision would require licensees to notify the NRC Operations Center, instead of an NRC Regional Office, upon receiving and 6

opening packages when radiation levels exceed regulatory limits. This would provide for consistency within the prompt notification requirements contained in§ 20.2201. A conforming change also would be made to the prompt notification requirements in§ 20.2202.

(13)

In§ 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§ 20.1003.

(14)

In§ 20.2106(aJ(2} and (a)(3), the refe~ences 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§ 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§ 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 convnitted 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 7

burden on licensees because they are required to obtain this information in order to calculate CEDE under§ 20.1204.

(15)

A revision to§ 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

§ 32.54(a), the reference to"§ 20.203(a}" would be corrected to read"§ 20.1901."

(17)

In § 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§§ 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§ 35.643(a)(l), a misreference to

§ 20.130l(c) would be corrected to read§ 20.1301.

The 0.5 rem (5 mSv) limit 8

permitted by application and NRC approval under§ 20.130l(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

§ 20.l30l(a) to this section, with the provision for licensees to request the 0.5 rem limit specified in§ 20.130l(c).

(19)

In§ 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§ 20.1902.

The posting requirements in Part 36 currently require a posting appropriate to a high radiation area only.

(20}

In§ 39.33, "Radiation detection instruments," a conforming change to paragraph (a),would be made by replacing the term 11milliroentgens with the term 11millirems" 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, p,rovided that the measurements can be readily converted to rem for records required 9

under 10 CFR Part 20.210l(a).

. (21}

In§ 39.7l{b), the reference to"§ 20.3 11 would be corrected to read"§ 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 9

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 fbr 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 colllTlents or upload files (convnents).

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 RF - Regulatory, Government Administration and State Systems" or by entering the command ft/go nrc 11 at a FedWorld co11111and line. At the next menu, select "A - Regulatory Information Mall," and then select "A - U.S. Nuclear Regulatory Commission 11 at the next menu.

If you access NRC from FedWorld's "Regulatory, Government Administration 11 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 Co11111ission, Washington, DC 20555-0001, telephone (301) 415-5780; e-mail AXD3@nrc.gov.

Agreement State Compatibility This rulemaking will be a matte1 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§§ 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, 11

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.

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 instructi.ons, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

The U.S. Nuclear Regulatory Cotm1ission is seeking public convnent on the potential impact of the collection of information contained in the proposed rule and on the following issues:

12

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 connnents 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 Corrmission, Wasti*rngton, DC 20555-0001, or by Internet electronic mail at BJSl@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 0MB on the collection of information or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Corrments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to connnents 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 0MB control number.

13

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).

14

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 (I mSv) dose limit for members of the public in 10 CFR 20.130l{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 dosimeter~ 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§ 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§ 50.l09(a)(l).

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.

15

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, 16

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§ 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:

§ 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§§ 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.

17

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 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> 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/cm 2).

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

18

3.

In§ 20.1101, paragraph (b) is revised to read as follows:

§ 20.1101 Radiation protection programs.

(b)

The licensee shall use, to the extent practical, procedure~ 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§ 20.1201, paragraphs {a)(2)(i) and (c) are revised to read as follows:

§ 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 Jhallow-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.

19

5.

In§ 20.1203, the introductory text is revised to read as follows:

§ 20.1203 Determination of external dose from airborne radioactive material.

Licensees shall, when determining the dose from airborne radioactive material, include the contributiorr 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§ 20.1206, paragraph (a} is revised to read as follows:

§ 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 unavaitable or impractical.

7.

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

§ 20.1208 Dose equivalent to an embryo/fetus.

(a)

The licensee shall ensure that the dose eq~ivalent to the embryo/fetus during the entire pregnancy as a result of the occupational 20

exposure of a declared pregnant woman does not exceed 0.5 rem (5 mSv).

(For recordkeeping requirements, see§ 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 ~11all 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§ 20.1501, paragraphs (a){2)(i) and (a)(2)(iii) are revised to read as follows:

§ 20.1501 General.

(a)

(2)

(i) The magnitude and extent of radiation levels; and

{iii)The potential radiological hazards.

21

9.

In§ 20.1502, paragraph {a){3) is redesignated as (a)(4) and new paragraphs (a)(3) and (b)(3) are added; and the introductory text of paragraph (a) and paragraphs (a}(2), (b)(l), and (b)(2) are revised to read as follows:

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

(a)

Each licensee shall monitor occupational exposure to radiation from radtation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by --

(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a 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 I year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of Appendix B to

§§ 20.1001-20.2402; and (2)

Minors likely to receive, in I year, a co111J1itted 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).

22

10.

In§ 20.1902, paragraph (d} is revised to read as follows:

§ 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 11

or "DANGER, AIRBORNE RADIOACTIVE MATERIAL AREA.

11

11.

In§ 20.1903, a new paragraph {d) is added to read as follows:

§ 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§ 20.1902 if --

(1)

Access to the room is controlled pursuant to§ 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 estublished in this part.

12.

In§ 20.1906, the introductory text of paragraph (d) is revised to read as follows:

23

§ 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§ 20.2101, paragraph (b) is redesignated as paragraph (c),

paragraph (c) is redesignated as paragraph {d) and revised, and a new paragraph (b) is added to read as follows:

§ 20.2101 General provisions.

(b}

In the records required by this part, the licensee may record J

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§ 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).

24

14.

In§ 20.2106, paragraphs (a)(l}, (a)(2}, (a}{3), and (a)(4) are revised to read as follows:

§ 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; and (2)

The estimated intake of radionuclides (see§ 20.1202); and (3)

The committed effective dose equivalent assigned to the intake of radionuclides; and (4}

The specific information used to assess the committed effective dose equivalent pursuant to§ 20.1204(a) and (c}, and when required by

§ 20.1502; and

15.

In§ 20.2202, paragraphs (a}(l}(ii}, (b)(l)(ii), and (d)(2) are revised to read as follows:

§ 20.2202 Notification of incidents.

(a)

(1)

( i i)

A lens dose equivalent of 75 rems (0.75 Sv) or more; or (b)

{l) 25

(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 follow~:

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).

§ 32.54 [Amended]

17.

In § 32. 54, paragraph { a) is amended by revising the reference to

"§ 20.203(a)" to read"§ 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}.

26

§ 35.20 [Amended].

19.

In§ 35.20, paragraph (c) is removed.

20.

In§ 35.315, paragraph (a)(4) is revised to read as follows:

§ 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§ 35.415, paragraph {a)(4) is revised to read as follows:

§ 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 requirements of Part 20 of this chapter, and retain for 27

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

§ 35.641 Radiation surveys for teletherapy facilities.

1

( a)

(2)

(i)

Radiation dose rates in restricted areas are not likely to cause any occupationally exposed individual to receive a dose i.n excess of the limits specified jn § 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§ 20.1301 of this chapter.

23.

In§ 35.643, paragraphs (a) and (a)(l) are revised to read as follows:

28

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

(a)

If the survey required by§ 35.641 indicates that any individual member of the public is likely to receive a dose in excess of the limits specified in§ 20.1301 of this chapter, the licensee shall, before beginning the treatment program:

(I)

Either eauip the unit with stops or add additional radiation shielding to ensure compliance with§ 20.1301 of this chapter.

PART 36 -- LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRAD1HTORS

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.

9 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

25.

In§ 36.23, paragraph (g) is revised to read as follows:

§ 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§ 20.1902.

Radiation postings for panoramic irradiators must comply with the posting requirements of§ 20.1902, 29

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 s~at.

1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

27.

In§ 39.33, paragraph (a) is revised to read as follows:

§ 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.

30

§ 39.71 [Amended]

28.

In§ 39.71, paragraph (b) is amended by revising the reference to

"§ 20.3" to read"§ 20.1003."

Dated at Rockville, Maryland, this D~~ay of ~

1996.

For the Nuclear Regulatory Commission.

r Operations.

31