ML20154S314

Requests That When Proposed Regulation Amends to Louisiana Admin Code,Title 33,Part Xv, Radiation Protection, Dtd 980820,are Adopted & Published as Final Regulations,Copy Be Provided to NRC for Review

ML20154S314
Person / Time
Issue date:	10/15/1998
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Shaw S LOUISIANA, STATE OF
Shared Package
ML20154S317	List: ML20154S314 ML20154S365
References
NUDOCS 9810270372
Download: ML20154S314 (14)

Text

_ _ _ _ _ _ _ _

y ACT 151998' 7

Dr. Stan Shaw, Assistant Administrator -

Radiation Protection Division Office of Air Quality & Radiation Protection.

. Department of Environmental Quality 7220 Bluebonnet Road P.O. Box 82135

. Baton Rouge, LA 70884-2135

Dear Dr. Shaw:

)

As requested, we have reviewed the proposed regulation amendments to the Louisiana Administrative Code, Title 33, Part XV, Radiation Protection dated August 20,1998. The :

i regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,32, and 34 through 36. - We also discussed our review of the regulations with Michael Defley on October 5,1998.-

As a result of our review we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure,

. a finding that a State regulation meets the compatibility and health and safety categories of the

. equivalent NRC regulation may only be made based on a review of the final State regulation.

However, we have determined that if your proposed regulations were adopted without

. significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.

We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027,"Reauest to Hiahliaht Chanaes to Aareement State

, Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format,if possible.

[

t if you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or

~ Thomas O'Brien of my staff at (301) 415-2308.

Sincerely, OrlGinalSigned By:

PAULH.LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs g

Distribution:

DIR RF (8S224) 1DCD'(SP08)L

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PDR (YES()

Uv SDroggitis JHMyers, ASPO p~ 3 9 '""~"

f NQM n = e9 CHackney, RSLO MMdh*Mh k

Louisiana File

• SEE PREVIOUS CONCURREN

' DOCUMENT NAME: G:\\LAREGLTR.WPD

, Ts receive e copt of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N". No copy OFFICE OSP l

OSP:DD l

OGC l

OSP:@ ( /

l NAME TJO'Brien:od:nb PHLohaus FXCameron RLBang&t~ e DATE 10/05/98

• 10/06/98

• 10/09/98

• 10/K/98 9810270372 991015 OSP FILE CODE: SP-AG-121 :,

PDR STPRO ESOLA PDR

-/

Dr. Stan Shaw, Assistant Administrator Radiation Protection Division

)

Office of Air Quality & Radiation Protection Department of Environmental Quality 7220 Bluebonnet Road P.O. Box 82135 Baton Rouge, LA 70884-2135

Dear Dr. Shaw:

As requested, we have reviewed the proposed regulation amendments to the Louisiana Administrative Code, Title 33, Part XV, Radiation Protection dated August 20,1998. The regulations were reviewed by comparison to the equivale'nt NRC regulations in 10 CFR Parts 19,20,30,32, and 34 through 36. We also discussed dur review of the regulations with Michael Defley on October 5,1998..

/

As a rr;sult of our review we have no comments. Plea lse note that we have limited our review to regulations req 2 ired for compatibility and/or health' and safety. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation.

However, we have determined that if your proposed regulations were adopted without significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.

We request that when the proposed regulatior/s are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027,"Recuest to Hiabliaht Chanaes to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one copy 'n a computer readable format, if possible.

l If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations hsed in the review, please contact me or Thomas O'Brien of my staff M (301) 415-2308.

Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs Distribution:

DlR RF (8S224)

DCD (SP08)

SDroggitis PDR (YES()

JHMyers, ASPO f

CHackney, RSLO Louisiana File 3{p

• SEE PREVIOUS CONCURRENCE.

DOCUMENT NAME: G:\\LAREGLTR.WPD To r sv.. con, of ini. ooeum.,vi, indie. in in. box: c - cos< without a kniini/onciosur. e. Copy with attachment / enclosure *N - No copy l OFFICE OSP l

OSP:DD

'OGC "l OSP:D l

l lNAME TJO'Brien:gd:nb PHLohaus FXCameron RLBangart lDATE 10/05/98

• 10/06/98 *l 10/A /98 10/ /98

(

(

OSP FILE CODE: SP-AG-12

.\\

l 1

William H. Spell, Administrator

Radiation Protection Division -

Office of Air Quality & Radiation Protection Department of Environmental Quality 7220 Bluebonnet Road, P.O. Box 82135 i

Baton Rouge, LA 70884-2135' Dear Mr. Spell As requested, we have reviewed the proposAd regulation amendmen to the Louisiana Administrative Code, Title 33, Part XV, Radiation Protection dated pgust 20,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in.10 CFR Parts 19,20,30,32, and 34 through 36. We also discussed our revied of the regulations with 9

Michael Defley on October 5,1998.'

l As a result of our review we 'have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure,

a finding that a State regulation meets the compatibili/and health and safety categories of the L

_ equivalent NRC regulation may only be made base 40n a review of the final State regulation.

However, we have determined that if your proposed regulations were adopted without i

significant change, they would meet the compati lity and health and safety categones established in OSP Internal Procedure B.7.

]

We request that when the proposed regulaWons are adopted and published as final regulations,

)

a copy of the "as published" regulations be provided to us for review. As requested in our All

- Agreement States Letter SP-96-027,"Rdauest to Hiahliaht Chanaes to Aareement State Reaulations Submitted to NRC for Cornoatibility Review" (March 1,1996), please highlight the

- final changes and send one copy in computer readable format, if possible.

If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC e'gulations used in the review, please contact me or J

Thomas O'Brien of my staff at (301) 415-2308.

/

Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs Distnbution:

- DIR RF (8S224)

DCD (SP08)

SDroggitis PDR (YES()

TJHMyers, ASPO '

CHackney, RSLO Louisiana File DOCUMENT NAME: G:\\LAREGLTR.WPD

- Tm receive o cop t of this docu,nont, Indicate in the bon 0*= by without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy 4

OFFICE OSP-1-

O(P)I M l

OGC l

OSP:D l

l NAME TJO'Brien:gd PHLoSats' '

FXCameron RLBangart DATE 10/5I/98 10/U/98

' 10/ /98,

10/ /98 OSP FILE CODE: SP-AG-12

M*:0 y

UNITED STATES

r j

NUCLEAR REGULATORY COMMISSION g

WASHINGTON, D.C. 30686 0001 b % g *#

October 15, 1998 i

Dr. Stan Shaw, Assistant Administrator Radiation Protection Division Office of Air Quality & Radiation Protection Department of Environmental Quality 7220 Bluebonnet Road P.O. Box 82135 Baton Rouge, LA 70884 2135

Dear Dr. Shaw:

As requested, we have reviewed the proposed regulation amendments to the Louisiana Administrative Code, Tit's 33, Pad XV, Radiation Protection dated August 20,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 19,20,30,32, and 34 through 36. We also discussed our review of the regulations with Michael Defley on October 5,1998.

As a result of our review we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation.

However, we have determined that if your proposed regulations were adopted without significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B 7.

We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027,"Reauest to Hiahlicht Chances to Aareement State Reaulations Submitted to NRC for Comcatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.

If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or Thomas O'Brien of my staff at (301) 415-2308.

erely, s

.4h Paul H. Lohaus, Deputy Director Office of State Programs t

'/,

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EXECUTIVE TASK MANAGEMENT SYSTEM ll l

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TASK # - 8S224

--- -- - - 55,, DATE- 0 8 /18 /9 8 MAIL CTRL. - 1998

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TASK STARTED - 08/18/98 TASK DUE - 10/10/98 TASK COMPLETED -

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IA8b DESCRIPTION - LTR. FROM WILLIAM SPELL REQUESTING REVIEW OF LA REGS.

REQUESTING OFF. - LA REQUESTER - SPELL WITS -

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f NE020 Abstract, Page 1 4-ERC 10 CFR FED AMENDMENT ABSTRACT SECTION SECTION REG.

Chapter 4, 10 CFR 20 60 FR.

Switched all low-level waste shipping manifests'to NRC forms, allowing for App. D App.~G

15649, electronic media. This required total rewrite of the Appendix. Added 60 FR authority and historical notes as required by Regulation Development.

7MLS 9102

%35.961 h9 FR Added qualification in dermition of" Radiological Physicist" to comply with i 61767,,

new certification allowance for teletherapy physicists (i772).

) 59 FR (65243 5102

%30.4 59 FR Added defimtion of" Principal Activities," for use in amendments to section N

36026 i332.

H102 535.2 59 FR Deleted defm' ition of" Visiting Authorized User," added definition of

61767,

" Authorized Nuclear Pharmacist," and amended definitions of" Authorized

{,L 59 FR.

User," " Medical Use," " Misadministration," " Pharmacist," " Recordable 65243 Event," and " Written Directive."

6102 620,1003 60 FR Amended def'mitions of" Occupational Dose," and "Public Dose."

36038, Subsequently reamended in accordance with 60 FR 48623 and 62 FR 4120.

60 FR Cp

48623, 62 FR 4120

'l102

1. 20.1003 N/A Inserted definitions for " Controlled Area," and amended definitions of

" Restricted Area,""High Radiation Area,"" Radiation Area,"" Survey,", and V

0"

" Working Level (WL)," to conform to NRC requirements stipulated in their 1995 review of our 10 CFR 20 equivalent.

6102 535.2p 60 FR Amended the definition of" Misadministration" by removing the term

/

48623

" patient" and substituting the term " individual."

'5304

~ @30.2 62 FR Create.d a new section named s304.C.5, and inserted 10 CFR 30.21," Capsules V

63634 Containing Carbon-14 Urea for "In Vivo" Diagnostic Use in Humans."

f325 lgl5,f 60 FR Clarified decommissioning funding requirements.

38235 6326 6.13 58 FK Added new subsection regarding specific licenses for irradiators, in 0 (s 7715 accordance with SSRCR Part O, derived from 10 CFR 36 (see Chapter 17).

1

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NE020 Abstract, Page 2 ERC 10 CFR -

FED AMENDMENT ABSTRACT -

SECTION.

SECTION REG.

f$328 532.72

~ 59 FR _

Amended !328.J. for licensing of radioactive drugs, adding nuclear pharmacy

61767, provisions.

59 FR bb 652436 0 FR 332 5 5328-

-#32.73,

9 FR Deleted 6328.K;" Licensing the Manufacture and Distribution of Generators 67, or Reagent Kits for Preparation of Radiopharmaceuticals Containing d b l/ 59 Radioactive Material."

(6524 5328-s32.21 bR

' Inserted 10 CFR 32.21," License Requirements for the Manufacture and

~

63634>

Distribution of Capsules Containing Carbon-14 Urea for "In Vivo" Diagnostic o lA--

Use in Humans," into @328.K, which had lieen deleted in accordance with 59 FR 61767.

r 5332; Added new paragraphs and amended others to include Timeliness in X

30.36

36026, Decommissioning and Decommissioning Funding requirements.

J' 2

9402

1. 20.1002 60 FR Amended the " Scope" section'of the General Provisions of the Standards for

48623, Protection Against Radiation to include the new concept of" medical 62 FR administration," and to clarify the meaning of" sources of radiation." Added

-4120 provision regarding exposure to released patients.

-5414-620.2104 60 FR Removed the phrase, " who may enter the licensee's or registrant's restricted 36038 area," from description ofindividuals for whom a licensee must determine a prior occupational dose.

_l421,

$20.1301 -

60 FR Added a phrase to exclude background, medical administration, and research

48623, dose contributions, and exposure to released patients from public TEDE.

k 62 FR 4120 16445 620.1 0 -

N/A-Added stipulation that unauthorized use of materials in controlled areas, as 1

well as in unrestricted areas, needs to be prevented. As per 10 CFR 20 review.

6452 620.1903 62 FR Cnanged language in room posting exemption to clarify patient release from LD 4120 licensee control.

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NE020 Abstract, Page 3 l

E ERC

'10 CFR FED AMENDMENT ABSTRACT SECTION' SECTION REG.

-6465

$20.2006 -

60 FR Added clarifying phrase to description of waste transfers. NRC has many

15649, changes to this section regarding grandfathering of applicable appendices, but bp-60 FR ~

none apply now that the due date for this reg has passed.

25983

$470-

{20.2101

~ 60 FR Required that all low-level waste shipment manifests be in SI units.

15649, DC-60 FR 25983

-6550.

's3.20-60 FR Added a sentence in $550.A.1 and a new section,9550.A.3.k; that relax the o

28323 unreasonably rigid ANSI test requirements on cameras.

5701-

.635.7-59 FR Added sentence to end of f701, " Purpose and Scope."

61767, gM 59 FR 65243

-6702 f 35.11 59 FR Amended 5702.A, and added s702.C and D, with nuclear pharmacy

l35.15 61767,-

provisions and broad scope exemptions.

.f]

59 FR -

65243 5703-

@35.13 59 FR Revised the " License Amendments" section to include nuclear pharmacy and f35.6 61767,-

broad scope provisions, and provisions for research on human subjects.

(jW 59 FR 65243

-5704 535.14 59 FR Revised " Notifications" section of Chap 7 to comply with NRC changes.

61767,.

'h 59 FR -

65243

5707:

Q35.22 -

59 FR

Amended section on Radiation Safety Committee, mostly to include nuclear

61767, pharmacy provisions.

L

. C 59 FR i

65243 6709:

f35.25

' 59 FR Amended " Supervision" section, adding Nuclear pharmacy provisions.

61767, hk 59 FR

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65243

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NE020 Abstract, Page 4 I

ERC 10 CFR FED AMENDMENT ABSTRACT SECTION SECTION REG.

N710 935.27 59 FR Removed entire section regarding " Visiting Authorized User."

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61767,

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59 FR 65243 f712 635.33 60 FR Amended the section by removing the. term " patient" and substituting the

48623, word " individual," and clarified language by deleting one sentence and 59 FR inserting another in 5712.A.2. 60 FR changes supersede 59 FR changes.

h

61767, 59 FR 65243 f713

' 35.49 59 FR Amended to explicitly include sealed sources and devices.

61767, j

(/

59 FR.

65243 5715 635.52 59 FR Changed the Section title and added Subsection F., covering provisions

61767, regarding instruments to measure dosages of alpha-or beta-emitting (j k 59 FR radionuclides.

65243 6715' Q35.50 59 FR Amended 1st paragraph to make clear that measurement had to be performed

61767, before administration, and to include human research subject provision. Other QL 59 FR parts of this section are already in compliance.

65243 4

6717 635.53 59 FR '

Added new section C and relettered section, to include measurement of alpha-

/

61767, and beta-emitters.

O Vd 59 FR 65243 6720

. f 35.60 59 FR Amended to include human research subjects.

61767, h%

59 FR 65243

'%721 635.60 59 FR.

Amended to include human research subjects,

'pv

61767, L

59 FR 65243 r

NE020 Abstract, Page 5 l

I.

L ERC' 10 CFR-FED LAMENDMENT ABSTRACT SECr10N -

SECTION REG.

l 6725.:

.535.75 59 FR, Amended to. include human research subjects: entirely superseded by changes

61767,

-in 62 FR 4120, which is a total rewrite of the section, including breast-feeding -

59 FR requirements.

i o[V

65243, 62 FR l

4120

'5729-

'535.100-59 FR '

Ins ~erted nuclear pharmacy provisions.

I

61767,

!(jlt-59 FR 65243 l731 635.200 59 FR '

Inserted nuclear pharmacy provisions.

61767,

.dk 59 FR 65243' 6735-635.300.-

59 FR '

Inserted nuclear pharmacy provisions.

61767,.

(A 59 FR 65243

-6736-635.310 59 FR Amended to include human research subjects.

61767,

(;W 59 FR '

65243

'l737.

-935.315.

59 FR '

Amended to include human research subjects. Paragraph A.6, regarding

61767, patient release requirements, is removed.

59 FR b

65243, 62 FR 4120 5742:

-635.410 59 FR;

- Amended to include human research subjects.

1

61767, J ()P 59 FR '

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65243 i

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NE020 Abstract, Page 6 p

ERC 10 CFR FED AMENDMENT ABSTRACT SECTION -

SECTION

' REG.

6743'

{35.415.

59 FR Amended to include human research subjects. Paragraph A.5, regarding.

l

61767, patient release requirements, is removed, and language in introduction and l

59 FR paragraph A.1 is slightly modified to include new patient release guidelines.

65243-0 62 FR 4120 6744

$35.406 '

59 FR-Amended to include human research subjects.

61767,

.g(

59 FR 65243

.5745.

s35.404 59 FR Amended to include human research subjects.

61767, E

-0 '

59 FR ~

65243

~5750.

%35.610 59 FR Amended to include human research subjects.

61767, 1

61 59 FR 65243 9753 f35.615 59 FR Amended to include human research subjects.

61767,

. D g' 59 FR 65243 5754 535.615 59 FR Amended to include human research subjects.

l

61767, b

59 FR 65243 l

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NE020 Abstract, Page 7 i

ERC 10 CFR FED' AMENDMENT ABSTRACT SECTION--

SECTION -

REG.

.6763

- Training 59 FR Renumbered several sections (all involving training) and incorporated them as sections of

61767, subsections in 5763. This was necessary to make room for NRC insertions.

. Part 35 59 FR '

The sections involved are as follows:

65243 h

BEFORE/NOW f763 / 763.A

1. 764 / 763.B l765 / 763.C 766 / 763.D 5767 / 763.E 1768 / 763.F 6769 / 763.G 5770 / 763.H 6771/763.I l772 / 763.J

. l773 / 763.M s774 / 763.N-

1. 775 /763.0 6763.

635.980.'

59 FR -

Inserted nuclear pharmacist training requirements as Subsection K.

61767,.

Oh 59 FR

-65243 5763-535.981-59 FR Inserted experienced nuclear pharmacist training requirements as Subsection

61767, L.'

. h__

59 FR l

65243 6763 135.900-59 FR.

Added new qualifying certifications for Radiation Safety Officers in nuclear

61767, medicine. Redesignated section as Subsection l763.A.

p 59 FR-65243

+

5765-

- i35.910:

59 FR Added new qualifying certification for training in nuclear medicine, and

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- g-61767,-

amended to include human research subjects. Redesignated section as 59 FR -

Subsection 6763.C. ~

d 65243

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NE020 Abstract, Page 8 ERC 10 CFR.

FED AMENDMENT ABSTRACT SECTION SECTION REG.

6766-635.920 59 FR Added new qualifying certification for training in nuclear medicine, and

61767, amended to include human research subjects. Redesignated section as f'g

'h 59 FR Subsection Q763.D.

65243

.f767

-%35.930 59 FR '

Added new qualifying certification for training in nuclear medicine.

/

61767, Redesignated section as Subsection s763.E.

'()k 59 FR 65243 6770s

~ 635.950 59 FR.

Added new qualifying certification for training in nuclear medicine.

61767,.

Redesignated section as Subsection $763.H.

0E 59 FR 65243 6771 635.960 59 FR Added new qualifying certification for training in nuclear medicine, and

61767, amended to include human research subjects. - Redesignated section as gp_

59 FR' Subsection l763.I.

65243

.f775:

Q35.972 59 FR NRC changed their recentness of training requirement to 7 years, but ours can

/

617675 and will remain 5 years. Redesignated section as Subsection ;3.0.

-h 4-9 FR 0

65243, 6777 635.32 59 FR Amended to include human research subjects.

J/

61767, V

59 FR 65243

.61012 619.12 60 FR:

Replaced the phrase "All individuals working in or frequenting any portion of 36038 a restricted area" with " All individuals who in the course of employment are Ob likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv)," and rearranged the paragraphs to be more readable.

s1013 620.2205 60 FR Replaced the term " individual" with the phrase, " identified occupationally

~

36038 e'xposed individual, or an identified member of the public," to the Dp' i

requirements for reporting incidents, planned special exposures, and exposures exceeding limits, in order to clarify requirements.

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NE020 Abstract, Page 9 ERC'-

10 CFR FED

-AMENDMENT ABSTRACT SECTION SECTION REG.

s1307 f61.12 60 FR1 Inserted requirement for electronic media.

15649,'

CD 60 FR 25983

51333

{61.80 60 FR Inserted requirement for electronic media, as well as requirements for further

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15649, information on manifests.

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60 FR 25983

'l701, 10 CFR 36 58 FR Added new chapter on irradiators, in accordance with SSRCR part Q (see 1

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s 7715 addition to 5326).

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