ML20149K753

Forwards Comments & Changes on Proposed Rulemaking for 10CFR2,20,32 & 36,further Clarifications

ML20149K753
Person / Time
Issue date:	01/03/1995
From:	Bradley Jones NRC
To:	Mccausland J NRC
Shared Package
ML20149C780	List: ML20149E517 ML20149E738 ML20149E813 ML20149F728 ML20149F764 ML20149K210 ML20149K254 ML20149K713 ML20149K731 ML20149K739 ML20149K745 ML20149K753 ML20149K763 ML20149K772 ML20149K781 ML20149K786 ML20149K790 ML20149K793 ML20149K797 ML20149K801 ML20149L465 ML20149L471 ML20149L587 ML20149L609 ML20149L695
References
FRN-61FR52388, RULE-PR-20, RULE-PR-32, RULE-PR-35, RULE-PR-36, RULE-PR-39 AF46-1-014, AF46-1-14, NUDOCS 9707300131
Download: ML20149K753 (24)

Text

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From: Bradley W. Jones (BWJ)

To: WN1:HMS3:HMS1:TW10:TW9:JMM2 Date: Tuesday, January 3, 1995 4:27 pm

Subject:

10 CFR 2,20,32,36-further clarifications I have reviewed the proposed rulemaking and have comments included in the attached line-in, line-out version. To explain the changes please note the following.

1 I believe after 21/2 years, it is risky at best to be relying on previous notice l and comment processes to justify issuing this rule in final form. However, the  ;

APA exempts interpretive rules from notice and comment requirements, as well as  ;

the 30 day effective date delay. Case law has indicated that " interpretive" I rules include those that " simply clarify or explain exisitng... regulations". I have, therefore, made some changes to justify our issuing this rule in final form based on the " interpretive" exception to the notice and comment requirements.

Since we are making clarifying changes to the " declared pregnant woman" ,

definition, I am also suggesting a clarification related to the length of time l' the delaration is effective. This is one area where there is room for differing interpretations which may cause employers to be in some doubt as to when a delaration is over. Suggested language is included in the attached file.

l Please call me if you have any questions.

Flies: G:\BWJ\ CLARIFY.P20 l l

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97o7300131 970711 61 52388 PDR 6

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, NUCLEAR REGULATORY COMISSION 10 CFR PARTS 2, 20, 32, A"3 36

~

RIN 3150-AA38 i

j Standards for Protection Against Radiation; Further clarification )

l 1

j AGENCY: Nuclear Regulatory Commission. i j ACTION: Final rule; further clarification.

SUMARY: On May'21, 1991, a final rule was published in the Federal l Register (56 FR 23300) that amended 10 CFR Part 20 to include the NRC's 4

I revised standards for protection against radiation.

Subsequent amendments were published to (1) change the mandatory implementation date to January 1, j l

l 1994, and make conforming changes to the text to reflect the new l

l implementation date (57 FR 38588), (2) remove or modify provisions to reflect

j. the new implementation date for NRC's revised standards for radiation l protection (58 FR 67657), and (3) restore provisions inadvertently removed or i

modified by action described in (2), above. This document intends to make 4

further minor corrections and clarifying changes to the NRC's standards for

$ protection against radiation. l @ jj)$ N @ ]jjif)} E @ j $fj M Qji

~ . v . . - -

l IEEEEfM1XfiHDMEEE@DuM j EFFECTIVE DATE: (Date of publication in the Federal Register).  ;

i l FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear

. Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC

, 20555, telephone (301) 415-6219.

l i

a i

i i

SUPPLEMENTARY INFORMATION:

This final rule makes minor corrections and clarifying changes to 10 CFR Parts 2, 20, 32, and 36 as follows:

(1) In Appendix C to Part 2, i 20.1101(d) and (e),

i 20.1204(c)(3)(e)(1) and (h)(2), i 20.1302(b)(2)(1) and (c), i 20.1501(b)(1), i 20.1703(b)(1), (b)(2), and (d), i 20.1704, i 20.1902(e), i 20.1905(a) and (b), i 20.1906(d), i 20.2003(a)(2) and (a)(3)(1), t 20.2006(a), (b), (c), and (d), i 20.2201(a)(i), (a)(ii), and (b)(2)(ii), i 20.2203(d), and i 20.2204, line 4, the reference to "I 20.2401" is corrected to read "i 20.2402."

(2) In 10 CFR 20.1003, " Definitions," clarifying changes and minor corrections are made to the following:

(a) The term " Airborne radioactivity area" is deleted and is replaced with " Airborne radioactive materials area" to cla. ify that radioactivity is a property of matter and, as such, cannot be airborne. Al so, the potential for external dose from submersion in a cloud of airborne radioactive material is added.

(b) The definition of " Declared pregnant woman" is revised to clarify that the responsible party is the licensee, who is not always the empioyer @j@[aj{$7M@d((@@@[{ff@$6jE ~[@ME@i]la ]

MEDH2 (c) The definition of " Derived air concentration (DAC)" is revised to include those cases when dose is external from submersion.

(d) The term " Eye dose equivalent" is deleted and replaced with

" Lens dose equivalent" to avoid confusion between dose to the lens of the eye and effective dose equivalent.

J (e) The definitions of "High radiation area" and "Very high radiation area" are revised to make clear that the area designations are based on external dose levels.

(f) The definition of " Individual monitoring devices" is revised to clarify the purpose of personal air sampling devices and to correct terminology for thermoluminescense dosimeters.

(g) A definition for " Submersion dose" is added.

(3) In 120.1101(b), the word " practicable" is changed to " practical" to be consistent with the definition of ALARA (As low As Is Reasonably Achievable). This change also removes 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 dose reduction techniques that are unproven and impractical. l (4) In i 20.1206, fourth line, the word " higher" is changed to read

" additional" for clarity.

(5) In i 20.1208(a), (c), (c)(2), and (d), the phrase " dose to an embryo / fetus" is changed to read " embryo / fetus dose equivalent" because the dose limit applies to the embryo / fetus dose equivalent. See Regulatory Guide 8.36 for details.

(6) In i 20.1208(a)(2)(i), the phrase "The extent of radiation levels;..." is revised to read "The magnitude and extent of radiation levels;...." to improve clarity.

(7) In i 20.1208(a)(2)(iii), the phrase "The potential radiological hazards...." is revised to read "The current and potential radiological hazards...." to improve clarity.

..__.___._m.;

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. l

(8) In i 20.1502, the words "from sources under control of the j licensee" are added after " exposure to radiation" in paragraph (a), second j line, to improve clarity and to be consistent with the requirements.

I i

i (9) In i 20.1502(a)(2) and (b)(2), minors and pregnant women j are discussed together even though the dose limits described in (a)(2) apply i h for an' entire year to minors while in (b)(2) the dose limits apply to the 9-month gestation period for declared pregnant women. These paragraphs are

! separated and revised accordingly to make this section more precise and 4

technically correct.

l -(10) In il 20.1701, 20.1702, 20.1906(c), and Appendix F to Part 20, l

l the word " practicable" is changed to read " practical" in order to be <

consistent with the ALARA definition found in i 20.1003.

l (11) In i 20.1703(b)(1), the second. sentence is revised to correct i

wording that refers to a protection factor (which has no units) that is i i greater than a peak concentration (which has units of activity per unit i I volume). The revised wording is consistent with the intended meaning of this l

sentence, l

j (12) In i 20.2101, a revision is made to permit licensees to include i

4 both the new SI units and the old units of quantities on records required by this part; however, the special unit will be first and the quantitative i

designation will be for the special unit. This is consistent with the NRC decision as to how new SI units are currently addressed.

4 d

i

_ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ . _ _ . . , - _ _ . _ _ __ _. ____m 1

I (13) In i 20.2106(a)(2) and (a)(3), the references to " body burdens"

)

are deleted because this term is not defined in revised 10 CFR Part 20 and, as j such, is inconsistent with the new concepts therein.

(14) The typography for the footnotes in Appendix A to 10 CFR Part 20 t

is revised to eliminate the confusion caused by abrupt format changes. Also, '

! footnote e. in this appendix is revised to correct a mathematical error that 1

1 i occurred in calculating the maximum effective protection factor when i

{ approximately one-third of the intake occurs through the skin.

i i

) (15) In Appendix C to 10 CFR Part 20, Quantities of licensed material l requiring labeling, the quantity for Carbon-14 is corrected to read "100"

l

rather than "1000." This change corrects a typographical error.  !

j l

, (16) In 10 CFR 32.54(a), the reference to "I 20.203(a)" is corrected i )

i to read "i 20.1901."

l (17) In 10 CFR 36.23(g), posting requirements for a panoramic j l

irradiator area are revised to conform with 10 CFR 20.1902 posting '

requirements appropriate to very high radiation areas. The posting ,

requirements under Part 20 take precedence and require the change to Part 36, which currently requires a posting appropriate to a high radiation area. The Part 20 posting requirements have been approved by OM8 No. 3150-0014.

These amendments are either corrective in nature or contain conforming changes.  ::::::: th: :pportunity for public :::::nt w:: previ ::ly pr vided for pri:r :::nf ::t: th:t form the b::: for thi: rule:: king (M:y 21, 1991; 55 FR 233f? nd 8. ;;;t 25,1992; 57 FR 305S0), the NRC h:: d:termin:d th:t ;;;d

ext:t: te di:p:n:: with th: ::tice :nd ::::::t provi:ica: Of the ed ini:tr:tiv: Pr:::dur: Act (APA) pur:::nt t 5 U.S.C. 553(b)(3)(B). [hjy EMIMfi3MRisHWi1EERIBUE!IiffiMME!5HliffsiMMIM

1

@l{@J{Qifl[jffj$1@)). For the same reasons, the NRC has determined that goed c=:: ext:t: tc n4ve the 30-day deferred effective date provisions of the APA

! Ed3EMEDIWfi1EIsilfMRsly;ggssamygig i

Environmental Impact: Categorical Exclusion l

The NRC has determined that this rule is the type of action described. in l categorical exclusion 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

l 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 numbers 3150-0136, -0014, and -0001.

I Regulatory Analysis This final rule is administrative in that it is corrective in nature and i

makes conforming changes and clarifications to existing regulations. These amendments will not have a significant impact. Therefore, the NRC has not prepared a separate regulatory analysis for this final rule. The final i regulatory analysis for the May 21, 1991, final Part 20 rule examined the costs and benefits of the alternatives considered by the Commission in developing the revised standards for protection against radiation and is

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

l available for inspection in the NRC Public Document Room, 2120 L Street,. NW.

-(Lower Level), Washington, DC.

i 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  !

4 provision that would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects 10 CFR Part 2 i Administrative practice and procedures, Antitrust, Byproduct material, Classified information, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalties, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal. i 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear i materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal.

10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

10 CFR Part 36 Byproduct material, Criminal penalties, Nuclear material, Oil and gas t '1 oration - well logging, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Source material, Special nuclear l

material.

PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS l

1. The authority citation for Part 2 continues to read as follows:

AUTHORITY: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C.  !

l 2201, 2231); sec. 191, as amended, Pub. L.87-615, 76 Stat. 409 (42 U.S.C.

2241); sec. 201, 88 Stat. 1242, as amended 42 (U.S.C. 5841); 5 U.S.C. 552.

I Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L.97-425, 96 Stat. 2213, as amended (42 U.S.C. 10134(f); sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 Stat. 1248 (42 U.S.C. 5871). Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 U.S.C. 2132, 2133, 2134,2135,2233,2239). Section 2.105 also issued under Pub. L.97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued under secs.

161b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 U.S.C. 2236, 2282); sec. 206, 88 Stat. 1246 (42 U.S.C. 5846). Sections 2.600-2.606 also issued under sec. 102, Pub. L.91-190, 83 Stat. 853, as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also issued under 5 U.S.C. 554.

Sections 2.754, 2.760, 2.770, 2.780 also issued under 5 U.S.C. 557. Section

j 2.764 and Table 1A of Appendix C also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 U.S.C. 2133) and 5 U.S.C. 552.

Sections 2.800 and 2,808 also issued under 5 U.S.C.553. Section 2.809 also j issued under 5 U.S.C. 553 and sec. 29, Pub. L.85-256, 71 Stat. 579, as

. l j amended (42 U.S.C. 2039). Subpart K also issued under sec.189, 68 Stat. 955 1

! (42 U.S.C. 2239); sec. 134, Pub. L.97-425, 96 Stat. 2230 (42 U.S.C. 10154).

Subpart L also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Appendix A also issued under sec. 6, Pub. L.91-560, 84 Stat. 1473 (42 U.S.C. 2135). i

[

Appendix B also issued under sec.10, Pub. L.99-240, 99 Stat.1842 (42 U.S.C. l 2021b et seq.).

1 l l l

Appendix C to Part 2 [ Amended]

2. The subject center header for Supplement IV to Appendix C to part 2 is amended by revising the reference to "Il 20.1001-20.2401" to read "li 20.1001-20.2402." l l

PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION  :

3. 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 (42 U.S.C. 2073, 2093, 2095, i

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).

4. In 10 CFR 20.1003, remove the definitions Airborne radioactivity ArtA and Eve dose eauivalent. The definitions Airborne radioactive material

i ESA, Lens dose eauivalent, and Submersion dose are added, and the definitions of Annual limit on intake, Declared oreanant woman, Derived air concentration

~

(DAC), Hiah radiation area, Individual monitorina devices, and Very hiah

radiation area are revised in alphabetical order to read as follows

1 20.1003 Definitions.  !

j * * * *

• Airborne radioactive materials area means a room, enclosure, or area in i

which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations --

(1) In excess of the derived air concentrations (DAC's) specified in

! appendix B to il 20.1001-20.2402, or i

i e

1 l (2) To such a degree that an individual present in the area without i 4  !

l respiratory protective equipment, could exceed, during the hours an individual l is present in a week, an intake (or an external exposure of 30 mR for the case i

i of submersion dose) of 0.6 percent of the annual limit on intake (ALI) or 12 I DAC-hours.

i Annual limit on intake (ALI) means the derived limit for the amount of

! radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed

) effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent

, of 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake

. by ingestion and by inhalation of selected radionuclides are given in Table 1, Columns 1 and 2, of appendix B to il 20.1001-20.2402.)

{

i

Declared oreanant woman means a woman who has voluntarily informed the 2

4 licensee,-hcr =.L y* , in writing, of her pregnancy and the estimated date of conception f@]QJgj{i6is@f6ffaMiif))R[yff{Gh[$syji liSIMIN3kiEINEINININS5NNNN!INNINI$IllINI255I55Ek5$1Ei$

3B E N D M Ii E M I B IEVE M I6? E iV @ E WIII#s W MZH M 6Mir# # @

IEE5ssiMiGlWIisIDEMMEMMEMHW1111)i%EtiliGEd'cTINI@

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aWisisM1HfiEffliE3s11Ei0iBifHMINIEME!iEI#i!EES Derived air concentration (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> under conditions of light work (inhalation rate 1.2 cubic metcrs of air per hour), results in an intake of one ALI or, in the case of i

submersion in a cloud of radioactive material, presence in the atmosphere for 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> per year will produce a dose equivalent of 5 rems from external a

exposure. DAC values are given in Table 1, Column 3, of appendix B to il 20.1001-20.2402.

i Hiah radiation area means an area, accessible to individuals, in which radiation levels from external sources could result in an individual receiving e

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 from any surface that the radiation penetrates.

Individual monitorina devices (individual monitoring equipment) means j devices designed to be worn by a single individual for the assessment of dose

4 1

4 equivalent such as film badges, thermoluminescense dosimeters (TLDs), pocket 4

ionization chambers, or devices designed to be worn by a single individual for l the assessment of committed effective dose equivalent, such as personal 1

(" lapel") air sampling devices.

j Lens dose eauivalent 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/ct') .

l * *

• _

! Submersion dose is the dose received from external sources resulting l

from being submerged in a cloud of radioactive material.

i

• * * *

• 1 Very hiah radiation area means an area, accessible to individuals, in which radiation levels from external sources could result in an individual j 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 from any surface that the radiation penetrates.

l * * * *

• J l

1 i 20.1101 [ Amended]

1

5. In i 20.1101, paragraph (b) is arended by deleting the word 3

" practicable" and replacing it with the word ' practical."

4 I 20.1201 [ Amended)

! 6. In i 20.1201, paragraphs (d) and (e) are amended by revising the reference to "El 20.1001-20.2401" to read "il 20.1001-20.2402."

J 1

1

9 20.1203 [ Amended]

7. Section 20.1203 is amended by revising the reference to "l! 1 20.1001-20.2401" to read "El 20.1001-20.2402." l

)

j i 20.1204 [ Amended]

8. In i 20.1204, paragraphs (c)(3), (e)(1), and (h)(2) are amended by revising the reference to "El 20.1001-20.2401" to read "il 20.1001-20.2402."

9. In i 20.1206, paragraph (a) is revised to read as follows: l 9 20.1206 Planned special exposures.

j * * * *

• i (a) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the additional exposure are unavailable or impractical.

10. In i 20.1208, paragraphs (a), (c), and (d) are revised to read as follows:

E 20.1208 Dose to an embryo / fetus.

(a) The licensee shall ensure that the embryo / fetus dose equivalent during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv). (For recordkeeping requirements, see i 20.2106.)

(b)

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

i ,

(c) The embryo / fetus dose equivalent shall be taken as the sum of--

(1)

(2)

(d) If the embryo / fetus dose equivalent 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 1

, woman dechres the pregnancy to the licensee, the licensee shall be deemed to be in compliance with paragraph (a) of this section if the additional dose to the embryo / fetus does not exceed 0.05 rem (0.5 mSv) during the re minder of the pregnancy.

! 120.1302 [ Amended]

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

! revising the reference to "il 20.1001-20.2401" to read "El 20.1001-20.2402."

s

12. In i 20.1501, paragraphs (a)(2)(i) and (a)(2)(iii) are revised to f

l read as follows:

i

!  ! 20.1501 General.

l (a) i  :

(2) f (i) The magnitude and extent of radiation levels; and i * * * *

• 1 1

(iii)The current and potential radiological hazards that could be present.

) * * * *

• l

13. In i 20.1502, the introductory text of paragraph (a), and j paragraphs (a)(2), (b)(1), and (b)(2) are revised as follows

;

] ]

1

i 5 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

(a) Each licensee shall monitor occupational exposure to radiation from l sources under control of the licensee and shall supply and require the use of '

individual monitoring devices by --

(1)

(2) Minors likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the limit in 520.1207, and i'

(b) 1 (1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to  ;

il 20.1001-20.2402.

(2) Declared pregnant women likely to receive, during the entire l

pregnancy, from external sources, a dose in excess of 10% of the applicable l l

limit in i 20.1208. l i 20.1701 [ Amended]

14. Section 20.1701 is amended by deleting the word " practicable" and replacing it with the word " practical."

l 20.1702 [ Amended]  ;

l

15. Section 20.1702 is amended by deleting the word " practicable" and ,

replacing it with the word " practical."

I

d a

16. In i 20,1703, paragraph (b)(1), the introductory text of f paragraph (b)(2), and paragraph (d) are revised to read as follows

l 5 20.1703 Use of individual respiratory protection equipment.

i (b)'

(1) The licensee selects respiratory protection equipment that provides 1

! a protection factor (see appendix A to il 20.1001-20.2402) 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 1 il 20.1001-20.2402, 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 i 20.1702 of keeping the total effective dose equivalent ALARA, the licensee may 1

select respiratory protection equipment with a lower protection factor only if i 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 il 20.1001-20.2402. The Commission may authorize a licensee to use higher protection factors on receipt of an application that --

.i (d) The licensee shall notify the Regional Administrator, in writing, j of the appropriate NRC Regional Office listed in appendix D to il 20.1001-20.2402 at least 30 days before the date that respiratory protection equipment

is first used under the provisions of either i 20.1703(a) or (b).

1

, i 20.1704 [ Amended]

l l 17. 'In i 20.1704, the introductory paragraph is amended by revising

\

the reference to "il 20.1001-20.2401" to read "il 20.1001-20.2402."

9 20.1902 [ Amended]

18. In i 20.1902, paragraph (e) is amended by revising the reference to "Il 20.1001-20.2401" to read "il 20.1001-20.2402."

1 20.1905 [ Amended]

19. In i 20.1905, paragraphs (a) and (b) are amended by revising the reference to "il 20.1001-20.2401" to read "ll 20.1001-20.2402."

i 20.1906 [ Amended]

20. In i 20.1906, paragraph (c) is amended by deleting the word

" practicable" and replacing it with the word " practical."

21. In i 20.1906, paragraph (d) is amended by revising the reference to " E l 20.1001-20.2401" to read "El 20.1001-20.2402."

6 20.2003 [ Amended]

22. In i 20.2003, paragraphs (a)(2) and (a)(3)(1) are amended by revising the reference to "El 20.1001-20.2401" to read "il 20.1001-20.2402."

i 20.2006'[ Amended]

23. In i 20.2006, paragraphs (a), (b), (c), and (d) are amended by revising the reference to "il 20.1001-20.2401" to read "il 20.1001-20.2402."

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

l 4

5 20.2101 General provisions.

(b) The licensee may indicate in parenthesis the SI Units, but the l quantitative reporting must be done as stated in paragraph (a) of this section.

(c) The licensee shall make a clear distinction among the quantities entered on the records required by this part (e.g., total effective dose equivalent, shallow-dose equivalent, lens dose equivalent, deep-dose equivalent, committed effective dose equivalent).

25. In i 20.2106, paragraphs (a)(2) and (a)(3) are revised to read as I l

follows:

1 20.2106 Records of individual monitoring results.

(a)

(1)

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

radionuclides; and

]

i 20.2201 [ Amended]

26. In i 20.2201, paragraphs (a)(i), (a)(ii), and (b)(2)(ii) are amended by revising the reference to "El 20.1001-20.2401" to read "El 20.1001-20.2402."

i 20.2203 [ Amended]

27. In i 20.2203, paragraph (d) is amended by revising the reference to "il 20.1001-20.2401" to read "il 20.1001-20.2402."

' i 20.2204 [ Amended]

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28. Section 20.2204 is amended by revising the reference to

l "il 20.1001-20.2401" to read "Il 20.1001-20.2402." l

29. In Appendix A to Part 20, footnotes d. through 1. are revised to 4 read as follows:

Appendix A to Part 20 - Protection Factors for Respirators Footnotes i

d.l. The protection factor is a measure of the degree of protection afforded by a respirator, defined as the ratio of the concentration of airborne radioactive material outside the respiratory protective equipment to l that inside the equipment (usually inside the facepiece) under conditions of use. It is applied to the ambient airborne concentration to estimate the l concentrations inhaled by the wearer according to the following formula:

Ambient airborne Concentration - concentration inhaled Protection factor

2. The protection factors apply:

4 (a) Only for individuals trained in using respirators and wearing

$ properly fitted respirators that are used and maintained under supervision in

, a well-planned respiratory protective program.

j (b) For air-purifying respirators only when high efficiency particulate filters (above 99.97% removal efficiency by thermally generated 0.3 pm dioctyl phthalate (D0P) test or equivalent) are used in atmospheres not I deficient in oxygen and not containing radioactive gas or vapor respiratory j hazards, i

(c) No adjustment is to be made for the use of sorbents against

radioactive material in the form of gases or vapors.

4

(d) For atmosphere-supplying respirators only when supplied with adequate respirable air. Respirable air shall be provided of the quality and quantity required in accordance with NIOSH/MSHA certification (described in 30 CFR part 11). Oxygen and air shall not be used in the same apparatus.

e. Excluding radioactive contaminants that present an absorption or submersion hazard. For tritium oxide, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of less than 3 is appropriate when atmosphere-supplying respirators are used to protect against tritiutn oxide. If the protection factor for a device is 5, the effective protection factor for tritium is about 2.1; for devices with protection factors of 10, the effective factor for tritium oxide is about 2.5;  :

and for devices with protection factors of 100 or more, the effective factor for tritium oxide is about 2.94. Air-purifying respirators are not suitable ,

for protection against tritium oxide. See also footnote i. concerning  !

supplied-air suits.

f. Canisters and cartridges shall not be used beyond service-life .

limitations.

g. Under-chin type only. This type of respirator is not satisfactory  ;

for use where it might be possible (e.g., i' sn accident or emergency were to occur) for the ambient airborne concentrations to reach instantaneous values greater than 10 times the pertinent values in table 1, column 3 of appendix B to il 20.1001-20.2402 of this part. This type of respirator is not suitable for protection against plutonium or other high-toxicity materials. The mask is to be tested for fit prior to use, each time it is donned.

h.1. Equipment shall be operated in a manner that ensures that proper air flow-rates are maintained. A protection factor of no more than 1000 may be utilized for tested-and-certified supplied-air hoods when a minimum air

i i

flow of 6 cubic feet (0.17 cubic meters) per minute is maintained and calibrated air-line pressure gauges or flow measuring devices are used. A protection factor of up to 2000 may be used for tested and certified hoods only when the air flow is maintained at the manufacturer's recommended maximum rate for the equipment, this rate is greater than 6 cubic feet (0.17 cubic meters) per minute, and calibrated air-line pressure gauges or flow measuring devices are used.

I 2. The design of the supplied-air hood or helmet (with a minimum flow of 6 cfm (0.17 m' per minute) of air) may determine its overall efficiency and the protection it provides. For example, some hoods aspirate contaminated air into the breathing zone when the wearer works with hands-over-head. This aspiration may be overcome if a short cape-like extension to the hood is worn under a coat or overalls. Other limitations specified by the approval agency shall be considered before using a hood in certain types of atmospheres (see footnote 1).

i. Appropriate protection factors shall be determined, taking into  ;

account the design of the suit and its permeability to the contaminant under conditions of use. There shall be a standby rescue person equipped with a respirator or other apparatus appropriate for the potential haards and communications equipment whenever supplied-air suits are used.

j. No approval schedules are currently available for this equipment.

Equipment is to be evaluated by testing or on the basis of reliable test information.

k. This type of respirator may provide greater protection and be used as an emergency device in unknown concentrations for protection against j inhalation hazards. External radiation hazards and other limitations to i

4 l

i permitted exposure, such as skin absorption, must be taken into account in l

j such circumstances.

i' 1. Quantitative fit testing shall be performed on each individual, i

i and no more than 0.02% leakage is allowed with this type of apparatus, j Derceptible outward leakage of gas from this or any positive pressure self-l coritained breathing apparatus is unacceptable because service life will be j reduced substantially. Special training in the use of this type of apparatus

shall be provided to the wearer.

30. In Appendix C, the quantity for Carbon-14 is revised as follows:

j_ Appendix C to Part 20 Carbon-14 100 l Appendix F to Part 20 (Amended]

31. In Appendix F, paragraph I. Manifest is amended by deleting the j word " practicable" and replacing it with the word " practical."

)

i

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR i

TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL l 32. The authority citation for Part 32 continues to read as follows:

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

I 32.54 [ Amended]

33. In i 32.54, paragraph (a) is amended by revising the reference to "i 20.203(a)" to read "i 20.1901."

PART 36 -- LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS

34. The authority citation for part 36 continues to read as follows:

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

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

35. In 6 36.23, paragraph (g) is revised to read as follows:

6 36.23 Access control.

1 l

' (g) Each entrance to the radiation room of a panoramic irradiator and f each entrance to the area within the personnel access barrier of an underwater 4 irradiator must have a sign bearing the radiation symbol and the words,

" Caution (or danger) radioactive material." Panoramic irradiators must also l

have a sign stating "Very High Radiation Area," but the sign may be removed,  :

covered, or otherwise made inoperative when the sources are fully shielded.

Dated at Rockville, Maryland, this day of 1994.

For the Nuclear Regulatory Commission.

James M. Taylor Executive Director for Operations l

l l

W_._