Standards for Protection Against Radiation; Clarification

Federal RegisterApr 25, 1995

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NUCLEAR REGULATORY COMMISSION

10 CFR Part 20

RIN 3150-AA38

Standards for Protection Against Radiation; Clarification

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule; clarification.

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SUMMARY: A final rule was published in the Federal Register on December

22, 1993 (58 FR 67657) that made a number [[Page 20184]] of conforming

amendments to the NRC's standards for protection against radiation.

References to the former 10 CFR Part 20 were removed from the revised

Part 20, and, in that process, certain requirements not intended to be

removed were inadvertently deleted. This final rule reinstates those

requirements to retain records generated under the previously existing

provisions of Part 20 which were intended to remain in effect.

EFFECTIVE DATE: April 25, 1995.

FOR FURTHER INFORMATION CONTACT: Mary L. Thomas or Jayne M. McCausland,

Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory

Commission, Washington, DC 20555-0001, telephone (301) 415-6230 or 415-

6219, email [email protected] or [email protected]

SUPPLEMENTARY INFORMATION: On May 21, 1991 (56 FR 23360), the Nuclear

Regulatory Commission (NRC) published its revised standards for

protection against radiation (10 CFR 20.1001-20.2401 and the associated

appendices). The revised standards for protection against radiation

incorporated scientific information and reflected changes in the basic

philosophy of radiation protection that had occurred since the

promulgation of the original regulations. The revisions conformed the

Commission's regulations to the ``Presidential Radiation Protection

Guidance to Federal Agencies for Occupational Exposure'' and to

recommendations of national and international radiation protection

organizations. The revised standards for protection against radiation

became effective on June 20, 1991. However, NRC licensees were

permitted to defer the mandatory implementation of these regulations

until January 1, 1994.

On December 22, 1993 (58 FR 67657), the NRC published a final rule,

effective on January 1, 1994, that removed or modified a number of

provisions to reflect the effective date for NRC's revised standards

for radiation protection. It has been determined that several

requirements, scheduled for removal or modification by the December 22,

1993 rulemaking, should not have been removed or modified because they

have continuing effect beyond the January 1, 1994, effective date for

10 CFR Part 20. Accordingly, the current action restores those

requirements that were incorrectly modified or removed by the December

22, 1993, rulemaking.

Specifically, this action is necessary to clarify the Commission's

intent in 10 CFR Part 20 to require that licensees continue to retain

the following records until the Commission terminates the pertinent

license:

(1) Records of surveys which were required by the formerly

applicable Sec. 20.401(c)(2) (i), (ii), and (iii), such as records of

the results of surveys to determine the external radiation dose in the

absence of personnel monitoring data to ensure compliance with NRC

regulations concerning the concentrations of radioactive materials in

air (formerly applicable 10 CFR Part 20 Appendix B), and records of the

results of surveys used to evaluate the release of radioactive

effluents to the environment;

(2) Records used in the preparation of NRC Form 4, such as records

of the individual's occupational exposure from former employers which

were required by the formerly applicable Sec. 20.102(c)(2);

(3) Waste shipment manifests and documentation of acknowledgement

of receipt which were required by the formerly applicable

Secs. 20.311(d)(7), (e)(5), (f)(8), and (g)(2);

(4) Records of radiation monitoring which were required by the

formerly applicable Sec. 20.401(c)(1);

(5) Records of disposal into sanitary sewers, by land burial, and

other approved disposals which were required by the formerly applicable

Sec. 20.401(c)(3).

2. In addition, this action is necessary to correct the reference

to ``appendices A, B, C, D, or F to Secs. 20.1001-20.2401'' to read

``appendices B, C, D, or F to part 20'' in Sec. 20.1201 (d) and (e),

Sec. 20.1204(c)(3), (e)(i), and (h)(2), Sec. 20.1302 (b)(2)(i) and (c),

Sec. 20.1502(b)(1), Sec. 20.1703 (b)(1), (b)(2), and (d), Sec. 20.1704,

Sec. 20.1902(e), Sec. 20.1905 (a) and (b), Sec. 20.1906(d),

Sec. 20.2003 (a)(2) and (a)(3)(i), Sec. 20.2006 (a), (b), (c), and (d),

Sec. 20.2201 (a)(i), (a)(ii), and (b)(2)(ii), Sec. 20.2203(d), and

Sec. 20.2204.

3. To be consistent with the ALARA definition found in

Sec. 20.1003, the word ``practicable'' is changed to read ``practical''

in Secs. 20.1701, 20.1702, 20.1906(c), and Appendix F to Part 20.

4. Finally, in Appendix C to 10 CFR Part 20, Quantities of licensed

material requiring labeling, the quantity for Carbon-14 is corrected to

read ``100'' rather than ``1000.'' This change corrects a typographical

error.

These amendments are corrective in nature, restore provisions

inadvertently deleted in prior amendments, and correct reference and

typographical errors found in the aforementioned sections of the

revised 10 CFR part 20 (December 22, 1993; 58 FR 67657). Because the

opportunity for public comment was previously provided for the changes

which formed the basis for the December 22, 1993, amendments (May 21,

1991; 56 FR 23360 and August 26, 1992; 57 FR 38588), and because the

proposed changes are minor corrective amendments, the NRC has

determined that good cause exists to dispense with the notice and

comment provisions of the Administrative Procedures Act (APA) pursuant

to 5 U.S.C. 553(b)(B). For the same reasons, the NRC has determined

that good cause exists to waive the 30-day deferred effective date

provisions of the APA (5 U.S.C. 553(d)).

Enforcement

During the interim period from January 1, 1994 to the present,

there has been no explicit requirement that licensees retain the five

categories of records addressed in this rule that were required under

the old Part 20. Therefore, a violation will not be cited in any case

in which a licensee discarded the records during this period. In the

case of a licensee that retained any of the five categories of records

but discards those records after the effective date of this rulemaking,

a violation may be cited in accordance with the NRC Enforcement Policy.

Environmental Impact: Categorical Exclusion

The NRC has determined that this rule is the type of action

described in categorical exclusion 51.22(c)(2). Therefore, neither an

environmental impact statement nor an environmental assessment has been

prepared for this final rule.

Paperwork Reduction Act Statement

This final rule does not contain a new or amended information

collection requirement subject to the Paperwork Reduction Act of 1980

(44 U.S.C. 3501 et seq.). Existing requirements were approved by the

Office of Management and Budget, approval number 3150-0014.

Regulatory Analysis

This final rule is administrative in that it reinstates provisions

inadvertently removed from the text of an existing regulation and

corrects errors found in the revised 10 CFR Part 20. These amendments

will not have a significant impact. Therefore, the NRC has not prepared

a separate regulatory analysis for this final rule. The final

regulatory analysis for the May 21, 1991, final rule examined the costs

and benefits of the alternatives considered by the Commission in

developing the revised standards for protection against radiation and

is available for inspection [[Page 20185]] in the NRC Public Document

Room, 2120 L Street NW (Lower Level), Washington, DC 20037.

Backfit Analysis

The NRC has determined that the backfit rule, 10 CFR 50.109, does

not apply to this final rule and, therefore, that a backfit analysis is

not required for this final rule because these amendments do not

involve any provision that would impose backfits as defined in 10 CFR

50.109(a)(1).

List of Subjects in 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.

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 Part 20.

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 (2 U.S.C.

2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as

amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.

5841, 5842, 5846).

Sec. 20.1201 [Amended]

2. In Sec. 20.1201, paragraphs (d) and (e) are amended by

correcting the reference to ``Appendix B to Secs. 20.1001-20.2401'' to

read ``Appendix B to Part 20.''

Sec. 20.1203 [Amended]

3. Section 20.1203 is amended by correcting the reference to

``Appendix B to Secs. 20.1001-20.2401'' to read ``Appendix B to Part

20.''

Sec. 20.1204 [Amended]

4. In Sec. 20.1204, paragraphs (c)(3), (e)(1), and (h)(2) are

amended by correcting the reference to ``Appendix B to Secs. 20.1001-

20.2401'' to read ``Appendix B to Part 20.''

Sec. 20.1302 [Amended]

5. In Sec. 20.1302, paragraphs (b)(2)(i) and (c) are amended by

correcting the reference to ``Appendix B to Secs. 20.1001-20.2401'' to

read ``Appendix B to Part 20.''

Sec. 20.1502 [Amended]

6. In Sec. 20.1502, paragraph (b)(1) is amended by correcting the

reference to ``Appendix B to Secs. 20.1001-20.2401'' to read ``Appendix

B to Part 20.''

Sec. 20.1701 [Amended]

7. Section 20.1701 is amended by deleting the word ``practicable''

and replacing it with the word ``practical.''

Sec. 20.1702 [Amended]

8. Section 20.1702 is amended by deleting the word ``practicable''

and replacing it with the word ``practical.''

9. In Sec. 20.1703, paragraph (b)(1), the introductory text of

paragraph (b)(2), and paragraph (d) are revised to read as follows:

Sec. 20.1703 Use of individual respiratory protection equipment.

* * * * *

(b) * * *

(1) The licensee selects respiratory protection equipment that

provides a protection factor (see Appendix A, Part 20) greater than the

multiple by which peak concentrations of airborne radioactive materials

in the working area are expected to exceed the values specified in

Appendix B to Part 20, Table 1, column 3. If the selection of a

respiratory protection device with a protection factor greater than the

multiple defined in the preceding sentence is inconsistent with the

goal specified in Sec. 20.1702 of keeping the total effective dose

equivalent ALARA, the licensee may select respiratory protection

equipment with a lower protection factor only if such a selection would

result in keeping the total effective dose equivalent ALARA. The

concentration of radioactive material in the air that is inhaled when

respirators are worn may be initially estimated by dividing the average

concentration in air, during each period of uninterrupted use, by the

protection factor. If the exposure is later found to be greater than

estimated, the corrected value must be used; if the exposure is later

found to be less than estimated, the corrected value may be used.

(2) The licensee shall obtain authorization from the Commission

before assigning respiratory protection factors in excess of those

specified in Appendix A to Part 20. The Commission may authorize a

licensee to use higher protection factors on receipt of an application

that--

* * * * *

(d) The licensee shall notify, in writing, the Regional

Administrator of the appropriate NRC Regional Office listed in Appendix

D to Part 20 at least 30 days before the date that respiratory

protection equipment is first used under the provisions of either

Sec. 20.1703 (a) or (b).

Sec. 20.1704 [Amended]

10. The introductory paragraph of Sec. 20.1704 is amended by

correcting the reference to ``Appendix A to Secs. 20.1001-20.2401'' to

read ``Appendix A to Part 20.''

Sec. 20.1902 [Amended]

11. In Sec. 20.1902, paragraph (e) is amended by correcting the

reference to ``Appendix C to Secs. 20.1001-20.2401'' to read ``Appendix

C to Part 20.''

Sec. 20.1905 [Amended]

12. In Sec. 20.1905, paragraph (a) is amended by correcting the

reference to ``Appendix C to Secs. 20.1001-20.2401'' to read ``Appendix

C to Part 20'' and paragraph (b) is amended by correcting the reference

to ``Appendix B to Secs. 20.1001-20.2401'' to read ``Appendix B to Part

20.''

Sec. 20.1906 [Amended]

13. In Sec. 20.1906, paragraph (c) is amended by deleting the word

``practicable'' and replacing it with the word ``practical,'' and the

introductory text of paragraph (d) is amended by correcting the

reference to ``Appendix D to Secs. 20.1001-20.2401'' to read ``Appendix

D to Part 20.''

Sec. 20.2003 [Amended]

14. In Sec. 20.2003, paragraphs (a)(2) and (a)(3)(i) are amended by

correcting the reference to ``Appendix B to Secs. 20.1001-20.2401'' to

read ``Appendix B to Part 20.''

Sec. 20.2006 [Amended]

15. In Sec. 20.2006, paragraphs (a), (b), (c), and (d) are amended

by correcting the reference to ``Appendix F to Secs. 20.1001-20.2401''

to read ``Appendix F to Part 20.''

16. In Sec. 20.2103, paragraphs (b)(1), (b)(2), (b)(3), and (b)(4)

are revised to read as follows:

Sec. 20.2103 Records of surveys.

* * * * *

(b) * * *

(1) Records of the results of surveys to determine the dose from

external sources and used, in the absence of or in combination with

individual monitoring data, in the assessment of individual dose

equivalents. This includes those records of results of surveys to

determine the dose from external sources and used, in the absence of or

in combination with individual monitoring data, in the assessment of

individual dose equivalents required under the [[Page 20186]] standards

for protection against radiation in effect prior to January 1, 1994;

and

(2) Records of the results of measurements and calculations used to

determine individual intakes of radioactive material and used in the

assessment of internal dose. This includes those records of the results

of measurements and calculations used to determine individual intakes

of radioactive material and used in the assessment of internal dose

required under the standards for protection against radiation in effect

prior to January 1, 1994; and

(3) Records showing the results of air sampling, surveys, and

bioassays required pursuant to Sec. 20.1703(a)(3) (i) and (ii). This

includes those records showing the results of air sampling, surveys,

and bioassays required under the standards for protection against

radiation in effect prior to January 1, 1994; and

(4) Records of the results of measurements and calculations used to

evaluate the release of radioactive effluents to the environment. This

includes those records of the results of measurements and calculations

used to evaluate the release of radioactive effluents to the

environment required under the standards for protection against

radiation in effect prior to January 1, 1994.

17. In Sec. 20.2104, paragraph (f) is revised to read as follows:

Sec. 20.2104 Determination of prior occupational dose.

* * * * *

(f) The licensee shall retain the records on NRC Form 4 or

equivalent until the Commission terminates each pertinent license

requiring this record. The licensee shall retain records used in

preparing NRC Form 4 for 3 years after the record is made. This

includes records required under the standards for protection against

radiation in effect prior to January 1, 1994.

18. In Sec. 20.2106, paragraph (f) is revised to read as follows:

Sec. 20.2106 Records of individual monitoring results.

* * * * *

(f) The licensee shall retain the required form or record until the

Commission terminates each pertinent license requiring this record.

This includes records required under the standards for protection

against radiation in effect prior to January 1, 1994.

19. In Sec. 20.2108, paragraph (b) is revised to read as follows:

Sec. 20.2108 Records of waste disposal.

* * * * *

(b) The licensee shall retain the records required by paragraph (a)

of this section until the Commission terminates each pertinent license

requiring this record. This includes records required under the

standards for protection against radiation in effect prior to January

1, 1994.

Sec. 20.2201 [Amended]

20. In Sec. 20.2201, paragraphs (a)(1) (i) and (ii), are amended by

correcting the reference to ``Appendix C to Secs. 20.1001-20.2401'' to

read ``Appendix C to Part 20,'' and paragraph (b)(2)(ii) is amended by

correcting the reference to ``Appendix D to Secs. 20.1001-20.2401'' to

read ``Appendix D to Part 20.''

Sec. 20.2203 [Amended]

21. In Sec. 20.2203, paragraph (d) is amended by correcting the

reference to ``Appendix D to Secs. 20.1001-20.2401'' to read ``Appendix

D to Part 20.''

Sec. 20.2204 [Amended]

22. Section 20.2204 is amended by correcting the reference to

``Appendix D to Secs. 20.1001-20.2401'' to read ``Appendix D to Part

20.''

23. In Appendix C, the quantity for Carbon-14 is revised to read as

follows:

Appendix C to Part 20--Quantities of Licensed Material Requiring

Labeling

* * * * *

Appendix C to Part 20--Quantities of Licensed Material Requiring

Labeling

------------------------------------------------------------------------

Quantity

Radionuclide (Ci)

------------------------------------------------------------------------

Carbon-14................................................ 100

------------------------------------------------------------------------

* * * * *

Appendix F to part 20 [Amended]

24. In Appendix F, paragraph I, Manifest is amended by deleting the

word ``practicable'' and replacing it with the word ``practical,'' and

paragraphs III(A)(7), (B)(5), (C)(8), and (D)(2) are revised to read as

follows:

III. Control and Tracking

(A) * * *

(7) Retain a copy of the manifest and documentation of

acknowledgement of receipt as the record of transfer of licensed

material as required by parts 30, 40, and 70 of this chapter. This

includes those manifests and documents required under the standards for

protection against radiation in effect prior to January 1, 1994; and

* * * * *

(B) * * *

(5) Retain a copy of the manifest and documentation of

acknowledgement of receipt as the record of transfer of licensed

material as required by parts 30, 40, and 70 of this chapter, and

retain information from generator manifest until the license is

terminated. This includes those manifests and documents of

acknowledgement of receipt required under the standards for protection

against radiation in effect prior to January 1, 1994; and

* * * * *

(C) * * *

(8) Retain copies of original manifests and new manifests and

documentation of acknowledgement of receipt as the record of transfer

of licensed material as required by parts 30, 40, and 70 of this

chapter. This includes those manifests and documents of acknowledgement

of receipt required under the standards for protection against

radiation in effect prior to January 1, 1994; and

* * * * *

(D) * * *

(2) Maintain copies of all completed manifests or equivalent

documentation until the license is terminated. This includes those

manifests or equivalent documents required under the standards for

protection against radiation in effect prior to January 1, 1994; and

* * * * *

Dated at Rockville, Maryland, this 11th day of April 1995.

For the Nuclear Regulatory Commission.

James L. Milhoan,

Acting Executive Director for Operations.

[FR Doc. 95-10123 Filed 4-24-95; 8:45 am]

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