ML19344A443

IP-EP-420, Rev. 7, Use of Potassium Iodide by Indian Point Personnel During an Emergency

ML19344A443
Person / Time
Site:	Indian Point
Issue date:	11/22/2019
From:	Leveque J Entergy Nuclear Operations, Indian Point
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
EP-19-0039 IP-EP-420, Rev. 7
Download: ML19344A443 (33)

Text

Indian Point Energy Center Document Control 450 Broadway Buchanan, NY 10511 TO:

DISTRIBUTION CONTROLLED DOCUMENT TRANSMITTAL FROM: IPEC DOCUMENT CONTROL - 3RD FLOOR ADMIN BLDG - JANEENE LEVEQUE X2903 TRANSMITTAL#: EP-19-0039 The Document(s) identified below are forwarded for use. Please review to verify receipt, Incorporate the document(s) into your controlled document file, properly disposition superseded, voided, or inactive document(s).

THE FOLLOWING PROCEDURE(S) HAVE BEEN REVISED. PLEASE REMOVE YOUR CURRENT COPY AND REPLACE WITH ATTACHED UPDATED PROCEDURE:

IP-EP-420, REVISION 7 RECEIPT OF THE ABOVE LISTED DOCUMENT(S) IS HEREBY ACKNOWLEDGED. I CERTIFY THAT ALL SUPERSEDED, VOID, OR INACTIVE COPIES OF THE ABOVE LISTED DOCUMENT(S) IN MY POSSESSION HAVE BEEN REMOVED FROM USE AND ALL UPDATES HAVE BEEN PERFORMED IN ACCORDANCE WITH EFFECTIVE DATE(S)

(IF APPLICABLE) AS SHOWN ON THE DOCUMENT(S).

NAME (PRINT)

SIGNATURE DATE COPY LOCATION U.S. NUCLEAR REGULA TORY COMMISSION ATTN: DOCUMENT CONTROL DESK 11555 ROCKVILLE PIKE ROCKVILLE, MD 20852

IPEC EMERGENCY PLAN DISTRIBUTION LIST Page 1 or 2 IP3 CONTROL ROOM DELIVERED BY DOCUMENTS IP3 53FT. CCR IP3 SHIFT MANAGER DELIVERED BY DOCUMENTS IP3 53FT. ELEVATION IP2 CONTROL ROOM DELIVERED BY DOCUMENTS IP2 53FT. CCR IPECTSC DELIVERED BY DOCUMENTS IP2 53FT. ELEVATION IP2 SIMULATOR DELIVERED BY DOCUMENTS IP2 SIMULATOR BLDG.

IP2 SIMULATOR - CLASSROOM 4 DELIVERED BY DOCUMENTS IP2 SIMULATOR BLDG.

IP2 SIMULATOR-CLASSROOM 5 DELIVERED BY DOCUMENTS IP2 SIMULATOR BLDG.

NRC RESIDENT INSPECTOR NRC IP2 88FT. ELEVATION OFFSITE NRC JAMES DANNA OFFSITE NRC DEPUTY DIRECTOR OFFSITE NEW YORK STATE OEM TED FISCH WESTCHESTER COUNTY OEM DENNIS DELBORGO OFFSITE ROCKLAND COUNTY FIRE AND NICHOLAS LONGO OFFSITE EMERGENCY SERVICES ORANGE COUNTY EMERGENCY SHANNON FISHER OFFSITE SERVICES CENTER PUTNAM COUNTY BUREAU OF KEN CLAIR OFFSITE EMERGENCY SERVICES 1 COPY OF ALL EP'S 1 COPY OF AU EP'S 1 COPY OF ALL EP'S 1 COPY OF ALL EP'S 1 COPY OF ALL EP'S 1 COPY OF ALL EP'S 3 COPIES OF ALL EP'S EXCEPT E-PLAN 1 COPY OF ALL EP'S 1 COPY OF ALL EP'S AND GENERAL RECORDS EXCEPT IP-EP-115 1 COPY OF AU EP'S AND GENERAL RECORDS EXCEPT IP-EP-115 1 COPY OF ALL EP'S AND GENERAL RECORDS EXCEPT IP-EP-115 1 COPYOFTHE FOLLOWING:

E-PLAN, IP-EP-115, 120, 210,220,230,250,310, 320,340,360,410,420, 430, 620 & IP-1055 1 COPY OF E-PLAN, IP-EP-310 & 340 & 410 1 COPY OF E-PLAN, IP-EP-310 & 340 & 410 1 COPY OF E-PLAN, IP-EP-310 & 340 & 410 1 COPY OF E-PLAN, IP-EP-310 & 340 & 410

Page 1 of 2 1 OCFR50.54(Q)(2) Review Procedure/Document Number: IP-EP-420 I Revision: 7 Equipment/Facility/Other: Indian Point Energy Center

Title:

Use of Potassium Iodide by Indian Point Personnel During an Emergency Part I. Description of Activity Being Reviewed (event or action, or series of actions that have the potential to affect the emergency plan or have the potential to affect the implementation of the emergency plan):

See attached revision matrix.

Part II. Emergency Plan Sections Reviewed (Ust all emergency plan sections that were reviewed for this activity by number and title. IF THE ACTIVITY IN ITS ENTIRETY IS AN EMERGENCY PLAN CHANGE, EAL CHANGE OR EAL BASIS CHANGE, ENTER THE SCREENING PROCESS. NO 10CFR50.54(q)(2) DOCUMENTATION IS REQUIRED.

Part 2 Section H: Emergency Facilities and Equipment Part 2 Section I: Accident Assessment Part 2 Section J: Protective Response Part 2: Section K: Radiological Exposure Control Part Ill. Ability to Maintain the Emergency Plan (Answer the following questions related to Impact on the ability to maintain the emergency plan):

1.

Do an..1. elements of the activity change Information contained in the emergency plan (Section 3.0 Step 6)?

YES LJ NO t8l IF YES, enter screening process for that element

2.

Do any elements of the activity change an emergency dassification Initiating Condition, Emergency Action Level (EAL), associated EAL note or associated EAL basis information or their underlying calculations or assumptions?

YES D NO r8l IF YES, enter screening process for that element

3.

Do any elements of the activity change the process or capability for alerting and notifying the public as described in the FEMA-approved Alert and Notification System deslgn report?

YES0 NO [8J IF YES, enter screening process for that element

4.

Do any elements of the activity change the Evacuation Time Estimate results or documentation?

)

YES0 NO l8l IF YES, enter screening process for that element

5.

Do any elements of the activity change the Onshift Staffing Analysis results or documentation?

YES0 NO ~ IF YES, enter screening process for that element EN-EP-305 ROO?

Page 2 of 2 1 OCFR50.54(Q)(2) Review Procedure/Document Number: IP-EP-420 Revision: 7 Equipment/Facility/Other: Indian Point Energy Center

Title:

Use of Potassium Iodide by Indian Point Personnel During an Emergency Part IV. Maintaining the Emergency Plan Conclusion The questions in Part Ill do not represent the sum total of all conditions that may cause a dlange to or impact the ability to maintain the emergency plan. Originator and reviewer signatures In Part V document that a review of all elements of the proposed change have been considered for their Impact on the abflfty to maintain the emergency plan and their potential to change the emergency plan.

1.

Provide a bnef conclusfon that descnbes how the conditions as described In the emergency plan are maintained with this activity.

2.

Check the box below when the 1 OCFR50.54(q)(2) review completes all actions for all elements of the actMty-no 10CFR50.54(q)(3) screening or evaluation is required for any element. Otherwise, leave the checkbox blank.

~ I have completed a review of this activity In accordance with 10CFR50.54(q)(2) and determined that the-effectiveness of the emergency plan Is maintained. This acttvlty does not make any dlanges to the emergency plan. No further actions are required to screen or evaluate this activity under 1 OCFR50.54(q)(3).

A review of this activity In accordance with 10 CFR 50.54(q)(2) has been completed and determined that the effectiveness of the emergency plan is maintained. This revision to the procedure titled: Use of Potassium Iodide by Indian Point Personnel During an Emergency" clarifies the conditions and Implementation of Kl administration for JPEG Emergency Response Organization (ERO) and other emergency support personnel who may be on site at the time of an emergency, as well as referenclng current procedures and the current form to be used for documentation of Kl consent and approval. None of the changes affect the activation and notification of the Emergency Response Organization (ERO) or the requirements assoetated with classificabon, notification or protective action recommendations. The changes made to IP-EP-420 do not require a change to the Emergency Action Level sdleme, On shift staffing study, or the I PEC Emergency Plan. No further actions are required to screen or evaluate this activity under 10 CFR 50.54(q)(3).

Part V. Signatures:

Preparer Name (Print)

Kevm Robinson (Optional) Reviewer Name (Pnnt)

Reviewer Name (Print)

Timothy F. Garvey Nuclear EP Project Manager Approver Name (Print)

Frank J. Mitchell Emergency Planning Manager or designee Reviewer Signature

--r~

Date:

..::* 1 ~-,,

I Date:

Date:

EN-EP-305 ROD?

Change No.

1.

aP-420, Use of Potassium Iodide by 1.An Point Personnel During an Emergel,,

Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justifv If NO.

COVER PAGE Rev6 Rev7 Yes No-This is an editorial change to the Revision number and effective date.

The meaning or intent of description in the emergency plan, facilities or equipment

(

described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

1

Change No.

2.

, aP-420, Use of Potassium Iodide by 1An Point Personnel During an Emerge.,

Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justffv If NO.

No No-The clarification "if requiredD at the end of the sentence was added because by procedure, Kl issuance may be automatically recommended for ingestion if 4.3 Radiological Assessment 4.3 Radiological Assessment a General Emergency has Coordinator is responsible to Coordinator is responsible to been declared. In this case, Step 4.3 supply Emergency Director dose supply Emergency Director dose no calculation is required to assessment calculations to assessment calculations to be performed.

(page 3) determine issuing of Potassium determine issuing of Potassium The meaning or intent of Iodide to personnel outside the Iodide to personnel outside the description in the emergency protected area.

protected area, if required.

plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

2

Change No.

3.

.P-420, Use of Potassium Iodide by 1&n Point Personnel During an Emerge.,

Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justify If NO.

No No-The clarification "if required" at the end of the sentence was added because by procedure, Kl issuance may be automatically recommended for ingestion if 4.4 TSC Radiological 4.4 TSC Radiological a General Emergency has been declared. In this case, Coordinator is responsible to Coordinator is responsible to no calculation is required to Step 4.4 supply the Emergency Plant supply the Emergency Plant be performed.

(page 3)

Manager dose assessment Manager dose assessment The meaning or intent of calculations to determine issuing calculations to determine issuing of Potassium Iodide within the of Potassium Iodide within the description in the emergency Protected Area.

Protected Area, if required plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

3

Change

~o.

4.

5.

aP-420, Use of Potassium Iodide by 1An Point Personnel During an Emergel,,

Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program

~

elements? Justify if NO.

No No-The wording of this statement was clarified to better align with the conditions described in Step 5.3.

5.1 Activation of the IPEC 5.1 The IPEC Emergency The meaning or intent of Step 5.1 Emergency Response Response Organization has description in the emergency Organization has occurred and a been activated and a release of plan, facilities or equipment (page 4) described in the Emergency release of radioactivity has radioactivity has occurred or Plan or a process described in occurred.

may occur.

the Emergency Plan are not affected by this change. No further evaluation is required for this change.

No No-This change was made to There are two (2)

There are two (2) further specify the projected Step 5.3 5.3 5.3 thyroid dose-based conditions where Kl may be conditions where Kl may be requirement for Kl.

(page 4) issued: a declared General issued: a declared General The meaning or intent of Emergency and/or abnormal Emergency and/or abnormal description in the emergency radiological conditions.

radiological conditions that may plan, facilities or equipment result in a projected dose described in the Emergency exceeding 5 REM CDE child Plan or a process described in

~

thyroid.

the Emergency Plan are not affected by this change. No further evaluation is required for this change.

4

Change No.

6.

tle:P-420, Use of Potassium Iodide by 1An Point Personnel During an Emerge.,

Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justlfv ff NO.

5.5 IF a General Emergency is 5.5 IF a General Emergency is No No - The additional condition declared, THEN all personnel in declared or the projected COE of a projected 5 REM COE the Protected Area are child thyroid dose exceeds 5 thyroid dose for Kl issuance authorized for voluntary use of Kl REM, THEN all personnel in the was added to be consistent by the Emergency Plant Manager Protected Area are authorized with step 5.3 in the procedure.

via a Site announcement.

for voluntary use of Kl by the The meaning or intent of Step 5.5 Emergency Plant Manager yia a description in the emergency (page 4)

Site announcement.

plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

5

Change No.

7.

tleP-420, Use of Potassium Iodide by 1r&n Point Personnel During an Emerge.,,,

Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justifv ff NO.

5.6 During a declared General 5.6 During a declared General No No - The wording was Emergency, the Radiological Emergency OR if conditions clarified to refer to the 2 Assessment Coordinator SHALL warrant, the Radiological previously cited conditions for ensure that Kl is issued to Assessment Coordinator SHALL Kl issuance. In addition, the Entergy workers outside the ensure that Kl is issued to reference to State Police and Protected Area. This SHALL Entergy workers outside the National Guard was updated include the Offsite Monitoring Protected Area. This SHALL and broadened to include any Teams, EOF personnel, Security, include the Offsite Monitoring outside agency support ICP, State Police and National Teams, EOF personnel, personnel who may be on Step 5.6 Guard personnel. Kl tablets are Security, ICP and outside site.

-(page 4) available at the EOF. If agency support personnel on necessary assign a member of site. Kl tablets are available at Dose Assessment to distribute the.EOF. If necessary assign a The meaning or intent of the Kl.

member of Dose Assessment to description in the emergency distribute the Kl.

plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

6

Change No.

8.

tle:P-420, Use of Potassium Iodide by Ir.an Point Personnel During an Emergefy, Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justlfv ff NO.

5.9 To all personnel who are 5.9 To all personnel who are No No-This change was made to issued Kl, issue one (1) 130 mg issued Kl, issue one (1) 130 mg clarify that one 130 mg dose Kl tablet and if requested, Kl dose, a copy of Form EP is required. This accounts for provide a copy of Attachment 9.1, ALL for completion and if other potential tablet sizes Insert for Thyro-Block Potassium requested, provide a copy of and brands of Kl (e.g., 65-mg)

Iodide and Attachment 9.3, Use.1, Insert for Thyro-which may require different of Kl During Radiological Block Potassium Iodide (or tablet quantities to be Emergencies-Information for the similar) and Attachment 9.3, ingested. A change was also Public.

Use of Kl During Radiological made to allow the use of Kl Emergencies-Information for the usag.e instructions similar to Public..1 in the event that a different brand of Kl other than Thyro-Block is available in the Mure. Form Step 5.9 EP-8-ALL was also included which provides Kl (page 5) administration and distribution instructions including briefing acknowledgement information.

The meaning or intent of description in the emergency plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

7

Change No.

9.

.EP-420, Use of Potassium Iodide by 1.lan Point Personnel During an Emergef y, Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justify If NO.

No No-This change was made to clarify that one 130 mg dose is required. This accounts for other potential tablet sizes of Kl (e.g., 65-mg) which may require different tablet 5.10 Continue to issue one (1) 5.10 Continue to issue one (1) quantities to be ingested. The 130 mg Kl dose and a copy of

">" sign was replaced by 130 mg Kl tablet and a copy of.1 once per day as "greater than" for clarity to the Step 5.10.1 once per day as long as the personnel are reader.

{page 5) long as the personnel are expected to receive greater than The meaning or intent of expected to receive >5 Rem COE child thyroid.

5 Rem COE child thyroid description in the emergency plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

8

Change No.

10.

_)

.EP-420, Use of Potassium Iodide by,.ttan Point Personnel During an Emerge.y, Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justify tf NO.

Section 6.0 No - IP-EP-250 was replaced 6.2 EN-EP-609, Emergency No by EN-EP-609 and IP-EP-230 Interfaces 6.2 IP-EP-250, Emergency Operations Facility (EOF) was replaced by EN-EP-610.

Operations Facility Operations (Pg. 5)

The meaning or intent of 6.3 IP-EP-230, Operations Support 6.3 EN-EP-610, Technical description in the emergency Center Support Center (TSC) plan, facilities or equipment Operations described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

9

Change No.

11.

.EP-420, Use of Potassium Iodide by I.an Point Personnel During an EITlergefy, Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justify if NO.

Section 6.0 No - Form EP-8-ALL is a new No Fleet form that provides Kl Interfaces 6.5 Form EP-8-ALL, Kl administration and distribution Instructions and Briefing instructions including briefing (Pg. 5) acknowledgement information.

The meaning or intent of description in the emergency plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

10

Change No.

12.

.EP-420, Use of Potassium Iodide by I.an Point Personnel During an Emerge.y, Revision 7 Matrix Page/Section Previous Revision (6)

New Revision (7)

Editorial Effect on 10 CFR 50.47(b)

Change Planning Standards or NUREG-0654 program elements? Justlfv If NO..3 No - The addition of DOH: USE OF Kl DURING DOH: USE OF Kl DURING No (Title)

RADIOLOGICAL EMERGENCIES RADIOLOGICAL EMERGENCIES "excerpts" was added to INFORMATION INFORMATION clarify that only key portions of (Pg. 9)

FOR THE PUBLIC FOR THE PUBLIC (Excerpts)

NYS Dept of Health Kl guidance are included in the attachment.

The meaning or intent of description in the emergency plan, facilities or equipment described in the Emergency Plan or a process described in the Emergency Plan are not affected by this change. No further evaluation is required for this change.

11

• Entergy IPEC NON-QUALITY RELATED IP-EP-AD2 Revision 12 EMERGENCY PLAN PROCEDURE ADMINISTRATIVE PROCEDURES REFERENCE USE Page 1.1 Emergency Planning Document Change Checklist Form (All sections must be completed, NIA or place a check on the line where applicable)

Section 1 Doc/Procedure Type:

Administrativen lmplementinQ [X]

EPLAN n Doc/Procedure No:

IP-EP-420 of 1

N/An Doc/Procedure

Title:

Use of Potassium Iodide by Indian Point Personnel During an Emergency New revision number:

7 Corrective Action:

Yes LJ No LJ NIA~

Effective date:

12/2/2019 Section 2 Change Description

1.

Ensure the following are completed, or are not applicable and are so marked:

2.

3.

4.

5.

6.

7.

8.

9.

a.

50.54q

b.

EN-FAP-OM-023

c.

IP-SMM-AD-102

d.

OSRC

e.

NRC Transmittal (within 30 days)

N/AO N/AO N/AO N/A r8J N/A r8J List any other documents affected by this change:

Transmittals are completed: D N/A D Date:..Ll.#J /J.o,q Ensure the proper revision is active in eB Ref. Lib.: ~ NIA D Approved doc/procedure delivered to Doc. Control for distribution: 15(1 N/A D Date: 11fUI a..c/1 Position Binders updated: D NIA D Date. uµl /a~ /9 Copy of EPDCC placed in EP file: D N/A D Date: __

Sup,eorti/19 documentation is submitted as a general record in eB Ref. Lib.: D N/A D Date:

.!.lfr).1-I c)_ () 19 Word flies are mo~;fa7f working drafts folder to current revision folder in the EP drive:

D N/A D Date:

~b l't Sheet 1 of 1

IP-SM M-AD-102 Rev:16 IPEC IMPLEMENTING PROCEDURE PREPARATION, REVIEW, AND APPROVAL Page 35 of 44 ATTACHMENT ERROR! REFERENCE SOURCE NOT FOUND.10.2 IPEC PROCEDURE REVIEW AND APPROVAL (Page 1 of 1)

Procedure

Title:

Use of potassium Iodide by lndjan Point personnel During an Emergency Procedure No*

IP-EP-420 Existing* ~

New* Rey: 7 ORN/EC No* DRN-19-00971 Prncedure Actlvl~

Tem~@!Y Procedurn Cbange (MARK Applicable)

D Converted To IPEC, Replaces:

(MARK Applicable)

D NEW PROCEDURE Unit 1 Procedure No:

D EDITORIAL Temporary Procedure Change D GENERAL REVISION IEI PARTIAL REVISION Unit 2 Procedure No:

D ADVANCE Temporary Procedure Change D EDITORIAL REVISION D CONDITIONAL Temporary Procedure Change D VOID PROCEDURE Terminating Condition:

D SUPERSEDED Unit 3 Procedure No:

D RAPID REVISION Document in Microsoft Word:

D VOID DRN/TPC No(s):

D Yes D No Revision Summa!Y N/A - See Revision Summary Matrix.

Implementation Requirements Implementation Plan? D Yes ~ No Fom,al Training? D Yes l!J No Special Handling? D Yes ~ N RPO Dept:

Emergency Planning Writer (Print Name/ Ext/ Slgn):...,_,,,""'v,U.1...J.""""""-1 ="-'-'x:>.!7.!<6"'-1.L__+-.£+1>-"------

Revlew and Approval (Per Attachment 1!U.,, IPEC Review And Approval Requirements)

1. ~

(Print Name/ Signature/ Date)

2. D Cross-Dlscipllnary Reviewers:

3. 00

4. D Dept:

Reviewer. -------..,.,e-e--..,.,,-----,-==--,--....,.-c=--,-----------

(Print Name/ Signature/ Date)

Dept* ______ Reviewer. ------.......,.,,,....,....-e-,---,-,::-:----,,--e-:--.,-----------

~Pri~ ~~~re/ Date)

RPO-Responslbflltles/Checkllst F. Mitchell ~

~

lifrf< f

"'"" 1" (Print Name/ Signature/ Date)

<P-.815"AD required and is complete (PAD Approver and Reviewer qualifications have been verified)

)(._Previous exclusion from further Ll-1 OD Review is still vand D PAD not required due to type of change as defined in 4.6 Non-Intent Determination Complete: -------=-e---,-,--~,----,---,,=-~----------

(Print Name/ Signature/ Date)

NO change of purpose or scope NQ reductlon in the level of nuclear safety NO voiding or canceling of a procedure, unless requirements are Incorporated Into another procedure or the need for the procedure was eliminated via an alternate process.

NQ change to less rastrlctlve acceptance criteria NO change to steps previously identified as commitment steps NQ deviation from the Quality Assurance Program Manual NQ change that may result In deviations from Technical Specifications, FSAR, plant deslgn requirements or previously made commitments.

5. D On-Shift Shift Manager/CRS:

6. D User Validation: User:

(Print Name/ Signature/ Datel

CHANGE MANAGEMENT NOTICE IP-EP-420 Rev. 7 (Use of Potassium Iodide by Indian Point Personnel During an Emergency)

WHO is affected?

All lPEC ERO Personnel WHAT is the change?

Please see the attached matrix for a summary of all the changes.

This revision is of "Low Risk/Complexity."

WHY is the change occurring?

These changes were made as part of a periodic review of this implementing procedure.

The changes were found to enhance and clarify the procedure steps described in the matrix.

WHEN is the change effective?

December 2, 2019 CONTACTS:

Kevin Robinson, x 7116 Frank Mitchell, EP Manager, x 5236

e IPEC NaN-QUALITY RELATI;D IP-EP-420 Revision 7

-=-Entergy~

EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 1

of 15 CONTROLLED Use of Potassium Iodide by Indian Point Personnel During an Emergency Prepared by:

Approval:

IP-EP-420 (Kl) R7.doc_

Kevin Robinson Pnm Name Frank J. Mitchell PnmName

/}J_--

~ -

ro*l)-1 t,

~gnafure Date k/./(~ ~

Effective Date: December 2, 2019 This procedure excluded from further Ll-100 review

~

IPEC NON-QUALITY RELATED IP-EP-420 Revision 7

-Entergy. ( EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page

~

of 15 Table of Contents 1.0 PURPOSE......................................................................................................................................... :........ 3

2.0 REFERENCES

........................................................................................................................................... 3 3.0 DEFINITIONS............................................................................................................................................. 3 4.0 RESPONSIBILITIES................................................................................................................................... 3 5.0 DETAJLS..................................................................................................................................................... 4 6.0 INTERFACES-............................................................................................................................................. 5 7.0 RECORDS.................................................................................................................................................. 5 8.0 REQUIREMENTS AND COMMITMENT CROSS-REFERENCE............................................................... 5 9.0 ATTACHMENTS......................................................................................................................................... 6 9.1 INSERT FOR THYROID BLOCK POTASSIUM IODIDE...................................................................................... 7 9.2 LOCATIONS OF POTASSIUM loDIDE............................................................................................................ 8 9.3 DOH: USE OF Kl DURING RADIOLOGICAL EMERGENCIES-INF70RMATION FOR THE PUBLIC............................ 9 9.4 NEW YORK STATE POLICY ON POTASSIUM IODIDE...................................................................................... 11

IPEC NON-QUALITY RELATED IP-EP-420 Revision 7

-=-Entergy'!>

EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page A

of 1§.

Use of ~otassium Iodide by Indian Point Personnel During an Emergency 1.0 PURPOSE The purpose of this procedure is to provide instructions for the use of thyroid blocking Potassium Iodide (Kl) by Indian Point Energy Center personnel during an emergency.

2.0 REFERENCES

2.1 New York State Implementation of the use of Potassium Iodide (Kl) as a Protective Action for the Public.

2.2 EPA-400-R-92-001, Manual of Protective Action Guides and Protective Actions for Nuclear Incidents.

3.0 DEFINITIONS 3.1 EOF is the Emergency Operations Facility 3.2 TSC is the Technical Support Center 3.3 OSC is th_e Operations Support Center 3.4 COE is Committed Dose Equivalent 3.5 TEDE is Total Effective Dose Equivalent 3.6 Kl is Potassium Iodide 4.0 RESPONSIBILITIES 4.1 Emergency Plant Manager is to approve issuing Potassium Iodide to Entergy workers within the Protected Area.

4.2 Emergency Director is to approve issuing Potassium Iodide to Entergy personnel outside the Protected Area.

4.3 Radiological Assessment Coordinator is responsible to supply Emergency Director dose assessment calculations to determine issuing of Potassium Iodide to personnel outside the protected area, if required.

4.4 TSC Radiological Coordinator is responsible to supply the Emergency Plant Manager dose assessment calculations to determine issuing of Potassium Iodide within the Protected Area, if required.

4.5 Emergency Planning is to maintain a stock of Potassium Iodide at each identified location to assure enough is available to !3nsure the distribution of Kl for every employee, contractor and visitor for a single adult dose of 130 milligrams and additional supplies exist for ERO members for up to 4 days usage at a dosage of 130 milligrams per 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period or 2800 single adult doses, whichever is greater.

~

IPEC NON-QUALITY RELATED IP-EP-420 Revision 7

-=-Entergy~

EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page of 1§ 5.0 DETAILS 5.1 The IPEC Emergency Response Organization (ERO) has been activated and a release of radioactivity has occurred or may occur.

5.2 Emergency Facilities are staffed as outlined in the IPEC Emergency Plan.

5.3 There are two (2) conditions where Kl may be issued: a declared General Emergency and/or abnormal radiological conditions that may result in a projected dose exceeding 5 REM COE child thyroid.

5.4 The TSC Radiological Coordinator and the Radiological Assessment Coordinator SHALL maintain an awareness of onsite and offsite radiological conditions respectively.

5.5 IF a General Emergency is declared or the projected COE child thyroid dose exceeds 5 REM, THEN all personnel in the Protected Area are authorized for voluntary use of Kl by the Emergency Plant Manager via a Site announcement.

5.5.1 The TSC Radiological Coordinator SHALL ensure that Kl is issued to all personnel within the Protected Area. This SHALL include Security personnel and personnel at the Emergency Response Facilities.

5.6 During a declared General Emergency OR if conditions warrant, the Radiological Assessment Coordinator SHALL ensure that Kl is issued to Entergy workers outside the Protected Area. This SHALL include the Offsite Monitoring Teams, EOF personnel, Security, ICP and outside agency support personnel on site. Kl tablets are available at the EOF. If necessary assign a member of Dose Assessment to distribute the Kl.

5.6.1 The Assembly Area Coordinators SHALL issue Kl to personnel in the GSB/EEC.

(

5.6.2 Consider distribution of Kl during accountability process if radiological conditions warrant.

5.7 The following areas, other than the Assembly Areas, are outside the Protected Area where personnel may be located. In the event that Kl is to be issued the Assembly Coordinator will contact those personnel in the Material and Services Building, IPEC Warehouse, the Maintenance Training Center, the Unit 2 Simulator to relocate to one of the Assembly Areas.

5.8 If abnormal radiological conditions exist either onsite or offsite:

5.8.1 Determine the projected child thyroid dose to personnel as outlined in IP-EP-310, Dose Assessment.

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of 15 5.8.2 If the projected child thyroid dose exceeds 5 REM COE child thyroid to any personnel, then obtain authorization to issue Kl to those personnel for use on a voluntary basis.

NOTE:

For those individuals known to be allergic to Kl consider use of alternative personnel prior to issuing Kl 5.9 To all personnel who are issued Kl, issue one (1) 130 mg Kl dose, a copy of Form EP-8-ALL for completion and if requested, provide a copy of.1, Insert for Thyro-Block Potassium Iodide (or similar) and.3, Use of Kl During Radiological Emergencies-Information for the Public. Kl tablets are available in the Control Rooms, Technical Support Center/Operations Support Center, EOF, Assembly Area in the Generation Support Building/Energy Education Center, and Assembly Area in the IPEC Training Building.

5.10 Continue to issue one (1) 130 mg Kl dose and a copy of Attachment 9.1 once per day as long as the personnel are expected to receive greater than 5 Rem COE child thyroid.

5.11 After the initial issuance of Kl, consideration may be given to discontinue ongoing issuance if a release is no longer occurring or is unlikely. Receive concurrence from Emergency Director and Emergency Plant Manager.

6.0 INTERFACES 6.1 IP-EP-410, Protective Action Recommendations 6.2 EN-EP-609, Emergency Operations Facility (EOF) Operations 6.3 EN-EP-610, Technical Support Center (TSC) Operations 6.4 IP-EP-310, Dose Assessment 6.5 Form EP-8-ALL, Kl Instructions and Briefing 7.0 RECORDS NONE 8.0 REQUIREMENTS AND COMMITMENT CROSS-REFERENCE NONE

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of 15 9.0 A TI ACHMENTS 9.1 Insert for Thyroid Block Potassium Iodide 9.2 Locations of Potassium Iodide 9.3 DOH: Use of Kl during Radiological Emergencies-Information for the Public 9.4 New York State Policy on Potassium Iodide (updated June 2009)

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of 1§.1 PATIENT PACKAGE INSERT FOR THYRO-BLOCK POTASSIUM IODIDE Sheet 1 of 1 losat' Tablets (Potassium Iodide Tablets, U.S.P.)

Pronounced poe-TASS-e-um EYE-oh-dyed)

(Abbreviated Kl)

TAKE POTASSIUM IODIDE ONLY WHEN PUBLIC HEAL TH

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OFFICIALS TELL YOU. IN A RADIATION EMERGENCY RADIOACTNE IODINE COULD BE RELEASED INTO THE AIR POTASSIUM IODIDE (A FORM OF IODINE) CAN HELP PROTECT YOU IF YOU ARE TOLD TO TAKE THIS MEDICINE. TAKE IT ONE TIME EVERY 24 HOURS. DO NOT TAKE IT MORE OFTEN. MORE WILL NOT HELP YOU AND MAY INCREASE THE RISK OF SIDE EFFECTS DO NOT TAKE THIS DRUG IF YOU KNOW YOU ARE ALLERGIC TO IODIDE (SEE SIDE EFFECTS BELOW).

INDICATIONS THYROID BLOCKING IN A RADIATION EMERGENCY ONLY DIRECTIONS FOR USE Use only as directed by State or local publ!c health authontles In the event of a rad1at10n emergency.

DOSE ADULTS AND CHILDREN ONE YEAR OF AGE OR OLDER One (1) tablet once a day. Crush for small children.

BABIES UNDER ONE YEAR OF AGE One-half (1/2) tablet once a day. Crush first DOSAGE: Take for 10 days unless directed otherwise by State or local public health authorities. Store at controlled room temperature between 15* and 30* C (59" and 86° F) Keep package dry and foil packets Intact.

WARNING POTASSIUM IODIDE SHOULD NOT BE USED BY PEOPLE ALLERGIC TO IODIDE. Keep out of the reach of chndren. In case of overdose or allergic reaction, contact a physician or public health authority.

DESCRIPTION Each IOSA T' Tablet contains 130 mg of potassium iodide HOW POTASSIUM IODIDE WORKS Certain forms of 1odtne help your thyroid gland work right Most people get the Iodine they need from foods like Iodized salt or fish.

The thyroid can "store* or hold only a certain amount of Iodine In a radiation emergency, radJOactlve Iodine may be released in the air This material may be breathed or swallowed. It may enter the thyroid gland and damage It Children are most likely to have thyroid damage.

If you teke potassium iodide, ft will fiU up your thyroid gland. This lessens the chance that hannful radioactive Iodine will enter the thyroid gland.

WHO SHOULD NOT TAKE POTASSIUM IODIDE The only people who should not take potassium Iodide are people who know they are allergic to Iodide. You may take potassium Iodide even If you are taking medicines for a thyroid problem (for example a thyroid hormone or antithyroid drug). Pregnant and nursing women and babies and children may also take this drug.

HOW AND WHEN TO TAKE POTASSIUM. IODIDE Potassium Iodide should be taken as soon as possible after public health officials tell you. You should take one dose every 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

More will not help you because the thyroid can "hold" only limited amounts of Iodine. Larger doses will Increase the risk of side effects.

You wiD probably be told not to take the drug for more than 10 days.

SIDE EFFECTS Usually side effects of potassium Iodide happen when people take higher doses for a long time. You should be careful not to take more than the recommended dose or take ft for longer than you are told.

Side effects are unlikely because of the low dose and the short time you will be taking the drug.

Possible side effects Include skin rashes, swelling of the salivary glands, and iodJSm" (metallic taste burning mouth and throat, sore teeth and gums symptoms of a heed cold, and sometimes stomach upset and diarrhea).

Taking Iodide may rarely cause overactlvfty of the thyroid gland, underactlvity of the thyroid gland, or enlargement of the thyroid gland (goiter).

WHAT TO DO IF SIDE EFFECTS OCCUR If the side effects are severe or If you have an allergic reaction, stop taking potassium lodk:le. Then, If possible, call a doctor or public health authonty for Instructions.

HOW SUPPLIED IOSATTW Tablets (Potassium Iodide Tablets, U S.P.) packages of 14 tablets (NDC51803-001-01) Each white round scored tablet contains 130 mg potassium Iodide.

Distributed by ANBEX INC 10 East 40lh Street New York, NY 10016 WWW anbex com

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-=-Enlergye IPEC NON-QUALITY RELATED IP-EP-420 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page.2 LOCATIONS OF POTASSIUM IODIDE Sheet 1 of 1 Revision 7 of 1§ Potassium Iodide is to be stored in the following locations for issuance during a declared emergency.

1.

2.

3.

4.

5.

6.

Unit 2 Central Control Room Unit 3 Central Control Room Technical Support Center/Operations Support Center Assembly Area in the Generation Support Building/Energy Education Center Assembly Area in the IPEC Training Building Emergency Operations Facility

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of 15.3 DOH: USE OF Kl DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC (Excerpts)

Sheet 1 of 2 Use of Potassium Iodide (Kl) During Radlologlcal Emergencies Information for the Public This fact sheet ls about the NYS policy for people, aspeclaJly those who live wfthin ten miles of a nuclear power plant, who may ba axposad to racfation from a nuclear plant emargancy. In December 2001, the Federal Food and Drug Administration (FDA) SBid If thera was a radlologcal emergency paopla should take a drog that wotid help protect them from thyrotJ cancer.

This drug ls called potassium /odlde (Kl). The New York Sista Haa./th Department agrees.*

7116 questions and answers below w/D give you more Information.

1. What Is potassium iodide {Kl) and what is It used for?

If there is a radiological emergency from a nuclear plant, large amounts of something called radiolodine could be put into the air and this could hurt your thyroid gland, or even cause thyroid cancer later on. You could breathe in the radlolodlne or eat food that has some radlolodine In it.

When you talce the Kl pill, it protects your thyroid gland from being harmed.

2. How does KJ work?

When you take the Kl pill, It fills your thyroid with a kind of Iodine that prevents your thyroid gland from taking In any of the radioactive kind of Iodine.

3. What age group has the highest risk from exposure to radioiodine?

Young children have the highest rlsk. We have learned this from looking at children In Russia and other areas who were exposed to the radlolodlne from the Chernobyl nuclear power plant accident

4. When should Kl be taken?

You need to take Kl before or just after you are exposed to radioiodlne. You can also take it 3 or 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> later, but it will not be as helpful.

5. How wlll I know If I should take KJ?

If there Is an emergency, you will hear an announcement from your local or state health officials. Your local health department will tell you when you should start taking Kl and they will also tell you when you can stop taking it.

6. Does Kl work In all radiation emergencies?

Kl wlll only protect you from radioactive iodine. It does not protect you from other kinds of radioactive material. Kl works very well to protect your thyroid gland. However, It protects only your thyroid, not other parts of your body.

7. What will happen In an emergency?

You wlll be told what If any actions you should take to protect yourself. This might Include leaving the area, staying Inside with your windows closed and/or taking Kl.

8. Can people have reactiol18 to Kl?

In general, most people who have taken Kl have not had any reactions (side effects) if people did have a reaction It did not last very long. In a few cases, babies had a reaction in their thyroids. Adults who had reactions had stomach problems or a rash. The Federal Government thinks the benefits of taking Kl are much greater than the risks.

9. Are there some people who should not take KJ?

Most people can take Kl, but you should talk to your doctor before taking It Talk to your doctor before an emergency occurs. It is not a good Idea to take it If you have certain medical conditions or problems. Babies need to be watched carefully if they take Kl.

10. How much Kl do I take?

The table on the next page shows the smallest Kl dose that different age groups can take which will protect the thyroid.

Kl comes in liquid, 65-mg tablets and 130-mg tablets. Since it is hard to cut many pills, the State Health Commissioner says that, in an emergency, it Is safe for chUdren at school or day care centers to take the whole pill. It's better for children under 12 years old to take the 65-mg pill, but It is safe to take the 130-mg pill if that Is the only one you have.

For children or babies who cannot take pills, parents and caregivers can cut or crush the pill to make lower doses, or give the liquid form of Kl.

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IPEC NON-QUALITY RELATED IP-EP-420 Revision 7 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 1Q of 16.3 DOH: USE OF Kl DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC Sheet2 of2 Use of Potassium Iodide (Kl) During Radiological Emergencies lnfonnatlon for the Public Recommended Doses of KI for Different Ae;e Gron 1s Number of ml Number of Number of Age Group KI Dosage liquid 65-mg (65 ml!l'ml) tablets 130-mg tablets Adults over 18 years 130 mg Over 12 -18 years and over 130 mg 150 pounds Over 12 -18 years and less 65 mg than 150 pounds Over 3 -12 vears 65 mg Over 1 month to 3 years 32mg Birth -1 month 16mg

11. How often should Kl be taken?

Kl Is helpful for about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. You should keep taking It once a day until the health department says to stop, or you are out of the emergency area.

12. Does Kl come In liquid or plll fonn?

Kl can come as a pill or a llquid. Pills are available In 65-mg or 130-mg doses. Kl Is also available as a liquid.

13. If Kl has been stored for a while, is it still OK to use?

The manufacturers say Kl stays "fresh" for 5-7 years. If xou keep It In a dry, dark and cool place, it should last for many years.

For additional lnfonnation contact:

2 2

1 I

0.5 0.25 2

1 2

1 1

112 1

112 Y:i 1/4 V4 1/8

14. Do you need a prescription to get Kl?

No. You are allowed to get it over the counter.

15. Can Kl be purchased at local pharmacies?

Yes, though it may not widely avallable In drugstores near you. Since It Is not a prescription drug, you can buy It over the Internet As with other drugs, make sure the Kl you buy has been approved by the FDA. A supply of Kl has been made avallable to people who live within 10 miles of a nuclear power plant In New York State. If you live within 10 miles of a nuclear power plant and dld not receive Kl, contact your local Office of Emergency Management.

New York State Deparbnent of Health lnfoline at 1-800-458-1158, extension 2-7550 ore-mall BERP@health ny gov Other sources of Information:

https://www fda gov/downloads/drugs/gu1dancecomplianceregulatoryinformatlon/quidances/ucm080542 pdf https * / twwvv. fda. gov/drugs/ emergencyprepared ness/b10 terroris man d drug pre pared n ess/ ucm 07 2265. htm https./ /www. fda gov Id rugs/ emerqencypreparedness/bioterrorismanddruqpreparedness/ucm 072261 htm https //emergency cdc.gov/radiation/ki.asp http"//y,.rww who lnt/1onizing radiation/pub meeUtech bnefings/potassium 1od1de/en/

http://W'NW health.ny gov/environmental/rad1olog1cal/pota2sium iodide/.4 Rav. 3-A 1 2017

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Introduction IPEC NON-QUALITY RELATED IP-EP-420 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page New York State Policy on Potassium Iodide (Updated June 2009)

Page 1 of 5 Revision 7 11 of 15 This Policy updates the 1982 New York State Policy on the use of potassium iodide (Kl) for the general public to reduce the risk of thyroid cancer in radiation emergencies involving the release of radioactive iodine. The recommendations in this policy address Kl dosage and the projected radiation exposure at which the drug should be used.

These recommendations are based on guidance provided by the United States Food and Drug Administration (FDA), "Guidance on Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies", in December of 2001.

Background

The FDA has provided guidance previously on the use of Kl as a thyroid blocking agent. First, in 1978, the FDA announced its conclusion that Kl is a safe and effective means by which to block uptake of radioiodines by the thyroid gland in a radiation emergency under certain specified conditions of use.

In 1982 FDA announced final recommendation on the administration of Kl to the general public in a general emergency. Those recommendations were formulated after reviewing studies relating the radiation dose to thyroid disease risk that relied the radiation dose to thyroid disease risk that relied on estimates of external thyroid irradiation after the nuclear detonation at Hiroshima and Nagasaki and analogous studies among children who received therapeutic radiation to the head and neck. The former New York State Policy on Kl was based on previous FDA recommendations for administering Kl t<;>

emergency workers and selected captive populations. This fonner policy which stated: "The FDA recommends that potassium iodide in doses of 130 mg per day per adult and children above one year, and 65 mg per day for children below one year of age, be considered for thyroid blocking in radiation emergencies in those persons who are likely to receive a projected radiation dose of 25 rem or greater to the thyroid gland from radioiodines released to the environment. The decision to administer Kl will be made with the concurrence of local and State Health officials."

The policy that follows revises New York State's 1982 policy recommendation on the use of Kl* for thyroid cancer prophylaxis based on the recent FDA's recent comprehensive review of the data relating radioiodine exposure to thyroid cancer risk, accumulated in the aftermath of the 1986 Chernobyl reactor accident.

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IPEC NON-QUALITY RELATED IP-EP-420 Revision 7 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 12 of 1§.4 New York State Policy on Potassium Iodide (Updated*June 2009)

Page 2 of 5 Rationale for Revising the Existing Kl Policy The New York State Deparunent of Health (NYSDOH) has reviewed the new guidance for prophylactic use of Kl prepared by the FDA and is hereby recommending that the New York State Policy on Kl distribution to the general public be revised. The rationale for the revision is given below.

Studies conducted after the Chernobyl accident in 1986 have provided the most reliable information available to date on the relationship between internal thyroid radioactive dose and cancer risk. These studies suggest that the risk.of thyroid cancer is inversely related to age, and that, especially in young children, it may accrue at very low level of radioiodine exposure. The FDA relied on Chernobyl data to formulate its specific recommendations.

The effectiveness of Kl s a specific blocker of thyroid radioiodine uptake is well established, as are the doses necessary for blocking uptake. As such, it is reasonable to conclude that Kl will likewise be effective in reducing the risk of thyroid cancer in individuals or populations at risk for inhalation or ingestion of radioiodines.

Short-term administration of Kl at thyroid blocking doses is safe and, in general, more so in children than adults. The risks of stable iodine administration are detailed in the FDA guidance document (FDA01 ).

The NYSDOH, in consultation with its Radiological Health Advisory Committee, concluded that there was no medical reason not to make Kl available to the general public during a radiological emergency where a large release of radioiodines had taken place.

In August 1998, the NYSDOH Commissioner (Dr. DeBuono) made that recommendation to Mr. Edward Jacoby, then Chairman of the Disaster Preparedness Commission (DPC).

The present NYSDOH Commissioner, Dr. Novello, reiterated that recommendation when the FDA released its final guidance on the use of Kl for the general public in December, 2001.

Based on information available to date, New York State has decided to revise its Kl policy to reflect current FDA recommendations.

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~MERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 13 of 15.4 New York State Polley on Potassium Iodide (Updated June 2009)

Page 3 of 5 New Policy The New York State Plan endorses the 2001 FDA recommendation regarding Kl. The revised New York State Policy on Kl is revised as follows:

"The New York State Department of Health states that Kl is a safe and effective means by which to prevent radioiodine uptake by the thyroid gland, under certain specified conditions of use, and thereby reduce the risk of thyroid cancer in the event of a radiation emergency. The Department will follow the FDA's lower radioactive exposure thresholds for Kl prophylaxis as well as lower doses of Kl for neonates, infants, and children than those previously recommended in 1982 (see Table 1). The recommendation to take Kl by the general public will be issued by the Local or State C'ommissioner of Health, or his/her designee, during a radiological emergency where the potential to exceed the new FDA dose limits may be exceeded by the general public. This recommendation will be based on a projected thyroid dose to one-year old child of 5 Rem.

The NYSDOH continues to recommend that the radiation emergency response plans include:

• Provisions (in the event of a radiation emergency) for informing the public about the magnitude of the radiation hazard;

• The manner of use of Kl and its potential benefits and risks; and

• ~edical contact, reporting, and assistance systems.

The NYSDOH recognizes FDA recommendations on availability as well as administration of Kl in advance of exposure to radioiodine. The NYSDOH stresses that Kl provides protection only for ttie thyroid from radioiodines. It has no impact on the impact on the uptake by the body of other radioactive materials and provides no protection against external irradiation of any kind.

The NYSDOH emphasizes that the use of Kl should be as an adjunct to recommended protective actions such as evacuation (itself not always feasible), sheltering, and control of foodstuffs."

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IPEC NaN-QUALITY RELATED IP-EP-420 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page.4 New York State Policy on Potassium Iodide (Updated June 2009)

Page 4 of 5 Dosing Guidelines Revision 7 M

of jj In addition to 130 mg tablets, Kl is now FDA-approved and available in 65 mg tablets and liquid (65 mg/ml).

The FDA guidance contains a number of age dependent doses (see Table 1). These recommendations are the lowest effective dose. Emergency planners and others should understand that absolute precision in dosing is generally not critical to safety or efficacy.

Higher doses (e.g., up to 130 mg) would be equally effective and, particularly among school-age children, extremely safe.

Table 1 Threshold Thyroid Radioactive Exposures and Recommended Doses of Kl for Different Risk Groups Kl dose

1. ml liquid

1. of 65 mg

1. of 130 (mg)

(65 mg/ml) tablets mg tablets Adults over 40 yrs 130 2

2 1

Adults over 18 through 40 yrs Pregnant or lactating women Adolescents over 12 through 18 130 2

2 1

yrs who weigh at least 150 pounds Adolescents over 12 through 18 65 1

yrs 1

1/2 who weigh less than 150 pounds Children over 3 through 12 yrs 65 1

1 1/2 bver 1 month through 3 years 32 1/2 1/4 Birth through 1 month 16 1/4 1/8

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IPEC NON-QUALITY RELATED IP-EP-420 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE Use Page.4 New York State Policy on Potassium Iodide (Updated June 2009)

Page 5 of 5 Revision 7 1§.

of 15 A scheme of graded dosing may be difficult to implement during a radiological emergency involving large numbers of people. If local emergency planners conclude that graded dosing is logistically impractical, for populations at risk for radioiodine exposure, the overall benefits of taking up to 130 mg of Kl instead of the lower doses recommended for certain age groups far exceed the small risks of overdosing. NYSDOH supports the administration of the 130-mg tablet for children in settings such as schools or childcare centers in the event of emergencies.

This is in agreement with FDA statements. (Ref) This dose is safe and well within the recommended therapeutic range of Kl for other indications. The blocking effect of iodide on the thyroid lasts only a few days (daily dosing is needed as long as the child is exposed to radioiodine) and any suppressive effect of Kl on thyroid function has been shown to be minimal, even in young children. However, where feasible, adherence to FDA guidance should be attempted when dosing infants due to the potential for a transient hypothyroidism, which can impact intellectual development.

The logistics of providing Kl to persons too young to take pills are more complicated. Kl tablets can be crushed and dissolved in small amounts of juice or formula. For instance, if a 130-mg tablet were dissolved in 8 ounces of liquid, one ounce would contain 16 mg of Kl. The FDA has noted that absolute precision in dosing is generally not critical to safety or efficacy, and has emphasized in their guidance document that a~ross populations at risk for radioiodine exposure, the overall benefits of Kl far exceed the risks of overdosing, especially in children.

Reference FDA01 Guidance, Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies, US,Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. December 2001.

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