ML033000212

Revision 16 to EAP-14.6, Habitability of the Emergency Facilities and Revision 23 to EAP-19, Emergency Use of Potassium Iodine (Ki).

ML033000212
Person / Time
Site:	FitzPatrick
Issue date:	09/29/2003
From:	Izyk C Entergy Nuclear Northeast
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
Download: ML033000212 (44)

Text

ENTERGY NUCLEAR NORTHEAST

-JAMES A. FITZPATRICK NUCLEAR POWER PLANT!.:

- P.O. BOX110; LYCOMING, NY-13093:

~.: >:; --- DOCUMENTTRANSMITTAL-AND RECEIPT ACKNOWLEDGEMENT FORM DATE: September 29, 2003 CONTROLLED COPY NUMBER: 34 TO: U.S.N.R.C. Document Center/Washington, DC FROM: CATHY IZYK - EMERGENCY PLANNING DEPARTMENT

SUBJECT:

EMERGENCY PL AN AND IMPLEMENTING PROCEDURES Enclosed are revisions to your assigned copy of the JAFNPP Emergency Plan and Implementing Procedures.

Please remove and DISCARD the old pages. Insert the attached, initial and date this routing sheet and return the completed routing sheet to Cathy Izyk in the Emergency Planning Department within 15 days.

If this transmittal is not returned within 15 days, your name will be removed from the controlled list.

THESE PROCEDURES ARE EFFECTIVE Tuesday September 30, 2003

_-__I___-_

-___-

_. VOLUME 2 Update List Dated September 30. 2003 -:-_--_;:  :  ;

DOCUMENT PAGES REV. INITIALS/DATE EAP-14.6 REPLACE ALL 16 EAP-19 REPLACE ALL 23 04S

EMERGENCY PLAN IMPLEMENTING PROCEDURESNOLUME 2 UPDATE LIST I CONTROLLEnD COP *y'* W/ I I ___ ___ - .. Z;er 1, Date of Issue: SEPTEMBER 30. 2003 Date of Procedure Procedure Revision Ls Use of

-Number -Title Number -Procedure N/A TABLE OF CONTENTS REV. 19 02/98 NIA IAP-I EMERGENCY PLAN IMPLEMENTATION REV. 31 08/03 Informational

___ ___ __ CHECKLIST IAP-2 CLASSIFICATION OF EMERGENCY REV. 24 05/03 Informational

___ ___ __ CONDITIONS EAP- 1.I OFFSITE NOTIFICATIONS REV. 49 08/03 Informational EAP-2 PERSONNEL INJURY REV. 26 01/03 - Informational EAP-3 FIRE REV. 23 08/02 Informational EAP-4 DOSE ASSESSMENT CALCULATIONS REV. 33 06!03 Informational EAP-4.1 RELEASE RATE DETERMINATION REV. 16 05/03 Informational EAP-5.1 DELETED (02/94)

EAP-5.2 DELETED (04/9 1)

EAP-5.3 ONSITE/OFFSITE DOWNWIND SURVEYS REV. 9 08/02 Informational AND ENVIRONMENTAL MONITORING REV._9_08/0-'_Informationa EAP-6 IN-PLANT EMERGENCY SURVEY/ENTRY REV. 17 05/03 Informational EAP-7.1 DELETED (02/94)

EAP-7.2 DELETED (02/94)

EAP-8 PERSONNEL ACCOUNTABILITY REV. 62 08/03 Informational EAP-9 SEARCH AND RESCUE OPERATIONS REV. 11 05/03 Informational EAP-10 PROTECTED AREA EVACUATION REV. 17 05/03 Informational EAP-I I SITE EVACUATION REV. 19 05/03 Informational DOSE ESTIMATED FROM AN ACCIDENTAL EAP-12 RELEASE OF RADIOACTIVE MATERIAL TO REV. 11 04/02 Informational LAKE ONTARIO EAP-13 DAMAGE CONTROL REV. 15 09/03 Informational EAP-14.1 TECHNICAL SUPPORT CENTER REV. 23 05/03 Informational

____ ____ ACTIVATION _ _ _ _ _

EAP-14.2 EMERGENCY OPERATIONS FACILITY REV. 21 05103 Informational

_____14.5 ACTIVATION RV10/Ifrtn EAP-14.5 OPERATIONAL SUPPORT CENTER REV. 14 03/00 Informational

____ ____ ACTIVATION _ _ _ _

Page I of 2

IL EMERGENCY PLAN IMPLEMENTING PROCEDURES/VOLUME 2 UPDATE LIST Date of Issue: SEPTEMBER 30, 2003 Procedure Procedure Revision Date of Use of Number Title Number L Procedure

__ _ _ __ __ __ _ _ __ _ _ __ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ R e v i e w_ _ _ _ _ _ _

EAP-14.6 HABITABILITY OF THE EMERGENCY REV. 16 09/03 Informational

_ _ __ _ _ _ _ F A CIL IT IE S_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

EAr-IS EMERGENCY RADIATION EXPOSURE REV. 11 06102 Informational

________ CRITERIA AND CONTROL _ _ _ _ _ _ _ _ _ _ _

EAP-16 PUBLIC INFORMATION PROCEDURE REV. 7 05/03 Informational EAP-16.2 JOINT NEWS CENTER OPERATION REV. 3 09/03 Informational EAP-17 EMERGENCY ORGANIZATION STAFFING REV. 107 08/03 Informational EAP-18 DELETED (12/93)

EAP-19 EMERGENCY USE OF POTASSIUM IODINE REV. 23 09/03 Informational

__ _ _ _ _ _ _ _ (KI)_ _ _ _ _ _ _ _ _ _ _

EAP-20 S TI ACCIDEN T A MPL E, REV. 9 06/02 Informational SHIPMENT AND ANALYSIS __________

EAP-21 DELETED (12/85)

EAP-22 DELETED (02/98) V EAP-23 EMERGENCY ACCESS CONTROL REV. 12 09/03 Informational EAP-24 EOF VEHICLE AND PERSONNEL REV. 9 06/02 Informational EAP-25 DELETED (02/94)

Page 2 of 2

ENTERGY NUCLEAR OPERATIONS, INC.

JAMES A. FITZPATRICK NUCLEAR POWER PLANT EMERGENCY PLAN IMPLEMENTING PROCEDURE HABITABILITY OF THE EMERGENCY FACILITIES EAP-14.6 REVISION 16 APPROVED BY: 1/ ' vAz Z<Zj< ) DATE:

RESPONSIBLE PROCEDURE OWNER EFFECTIVE DATE: A

__________30__ta FIRST ISSUE 0 FULL REVISION 0 LIMITED REVISION El

• INFORMATIONAL USE *

• TSR *

• *~~~~~~~~~~~_

• ADMINISTRATIVE

• CONTROLLED COPY #

• I PERIODIC REVIEW DUE DATE: MAY 2008

HABITABILITY OF THE EMERGENCY FACILITIES EAP-14.6 REVISION

SUMMARY

SHEET REV. NO.

16

• Revised values in section 4.4.3 to reflect child thyroid per NY state law.

15

• Changed Emergency Director to Emergency Plant Manager.

• Clarified Rad Monitor Setpoints in Step 3.3.2.

• Added issuance of KI to Step 4.4.3.

14

• Added "OSC Manager, Rad Support Coordinator" to Section 4.3 on page 5.

• Added note to section 4.4.1, page 5, advising of potential for increased dose following a refuel accident.

13

• Reformat per AP-02.01, Rev. 5.

• Level of use changed to "Informational" for consistency with AP-02.04, Control of Procedures V1::

I I Rev. No. 16 Page 2 of 7

HABITABILITY OF THE EMERGENCY FACILITIES EAP -14. 6 TABLE OF CONTENTS SECTION PAGE 1.0 PURPOSE.................. .......... 4

2.0 REFERENCES

............................ 4 2.1 Performance References ............................ 4 2.2 Developmental References ............................ 4 3.0 INITIATING EVENTS ............................. 4 4.0 PROCEDURE .............................. 5 5.0 ATTACHMENTS ............................ 7 Rev. No. 16 Page 3- of 7

HABITABILITY OF THE EMERGENCY FACILITIES EAP -14. 6 Ii 1.0 PURPOSE The purpose of this procedure is to describe the necessary radiological checks to determine the radiological habitability of the Control Room, TSC, OSC, and Security Building areas.

2.0 REFERENCES

2.1 Performance References 2.1.1 EAP-6, IN-PLANT EMERGENCY SURVEY/ENTRY 2.1.2 EAP-15, EMERGENCY RADIATION EXPOSURE CRITERIA AND CONTROL 2.2 Developmental References 2.2.1 IAP-2, CLASSIFICATION OF EMERGENCY CONDITIONS 2.2.2 EAP-6, IN-PLANT EMERGENCY SURVEY/ENTRY 2.2.3 EAP-14.1, TECHNICAL SUPPORT CENTER ACTIVATION 2.2.4 EAP-14.5, OPERATIONAL SUPPORT CENTER ACTIVATION AND OPERATION 2.2.5 EAP-15, EMERGENCY RADIATION EXPOSURE CRITERIA AND CONTROL 2.2.6 EPA-400-R-92-001, May 1992, Manual of Protective Action Guides and Protective Actions for Nuclear Incidents 3.0 INITIATING EVENTS 3.1 An Unusual Event or higher classification has been declared in accordance with procedure IAP-2, CLASSIFICATION OF EMERGENCY CONDITIONS, and; 3.2 The TSC and/or OSC are operational, and; 3.3. Abnormal radiological conditions exist as indicated by one or more of the following or the Emergency Plant Manager or TSC Manager feel that habitability monitoring is warranted.

3.3.1 Control Room inlet ventilation radiation monitor and/or ARM #3 exceeds alarm setpoint.

Rev. No. 16 Page 4 of 7

-HABITABILITY OF THE EMERGENCY FACILITIES EAP-14.6 A

3.3.2 TSC area radiation monitor exceeds alarm setpoint of 5 mR/hr or either of the-CAMs (IM-lA for iodine/AMS-3 for particulate) in the TSC hallway exceeds their alarm setpoint of 500 cpm greater than background.

3.3.3 A refuel accident is in progress.

3.3.4 OSC ARM #1 and/or portal monitors exceed alarm setpoints, or general area radiation monitor exceeds 5 mR/hr.

3.3.5 Security Building portal monitors exceed alarm setpoint.

OR 3.4 Abnormal radiological conditions exist, are suspected, or are projected as determined by the Rad Support Coordinator (RSC), or designee.

4.0 PROCEDURE 4.1 The Emergency Plant Manager, Rad Support Coordinator, or designee shall:

4.1.1 Instruct personnel not to eat, drink or smoke until it is determined that abnormal radiation conditions do NOT exist.

4.1.2 Dispatch Radiation Protection Technician(s) to perform continuous habitability surveys in accordance with:procedure EAP-6,. IN-PLANT EMERGENCY SURVEY/ENTRY, in the Control Room, TSC, OSC and Security Building. Surveys-shall be performed approximately 'every 30'minutes as-long as abnormal radiological conditions-:-exist ort'are suspected. Surveys should include dose rate

-'surveys and'air samples.

4.1.3 Instruct personnel' in the'Control'Room, TSC, OSC,

-andSecurity Building:to notify the-Rad Support

-:Coordinator'if alarm setpoints~in Section 3.3 are.

exceeded.

4.1.4 Consider issuing DRDs and TLDs to personnel who do not already have them.- -- '-

Rev. No. 16 Page 5 of 7

HABITABILITY OF THE EMERGENCY FACILITIES EAP-14.6 4.1.5 Inform the Emergency Plant Manager and other personnel of potential radiological hazards determined as a result of habitability surveys.

4.1.6 If access is needed to areas other than those surveyed in Step 4.1.2 (such as the Warehouse),

then assign a Radiation Protection Technician to accompany personnel in accordance with EAP-6, IN-PLANT EMERGENCY SURVEY/ENTRY.

4.1.7 Determine the suitability of area environments using information gathered by the following sources:

A. EAP-6, IN-PLANT EMERGENCY SURVEY/ENTRY B. EAP-15, EMERGENCY RADIATION EXPOSURE CRITERIA AND CONTROL C. Habitability guidance listed in Section 4.4 of this procedure.

4.1.8 Repeat the above steps as necessary when a release is ongoing.

4.2 The Radiation Protection Technician shall:

4.2.1 Perform habitability surveys as directed.

4.2.2 Record and report results of habitability surveys to RSC or designee.

4.2.3 Notify the Rad Support Coordinator if alarm setpoints in Section 3.3 are exceeded.

4.3 The Emergency Plant Manager, OSC Manager, Rad Support Coordinator, or designee shall:

4.3.1 Relocate the OSC to the Alternate OSC (AOSC)if the OSC environment is unacceptable and the AOSC environment is surveyed and found to be acceptable. The Work Center portion of the AOSC is within the Control Room Ventilation System boundary.

4.3.2 Restrict access to areas in the TSC if the environment is unacceptable.

Rev. No. 16 Page 6 of 7

HABITABILITY OF THE EMERGENCY FACILITIES EAP-14.6 4.4 Habitability Guidance 4.4.1 Various factors and conditions must be considered when deciding on the habitability of the areas, such as:

NOTE: A refuel accident may cause dose in the TSC to increase shortly following the accident.

A. whole body, beta and iodine doses B. accident conditions and circumstances C. status of release (duration, termination, etc.)

D. advantages and disadvantages of facility relocation E. dose projections, prior to any relocation offsite.

4.4.2 Beta and Gamma External Dose Guidance A. If a dose rate of greater than 10 mR/hr is present in a facility, relocate that facility if feasible.

B. If a dose rate of greater than 500 mR/hr is present in a facility, relocate that facility.

4.4.3 Iodine Dose Guidance

.A. Determine CDE child Thyroid using I-131 air sample results as follows:

DE-Thyroid(Rem) = I-131 Conc.(pCi/cc) x time breathed(hr) x 2.6 x 106 (Rem/hr/pCi/cc)

B. If CDE child Thyroid is greater than 5 Rem, then consider relocation of that facility, or issuance of KI in accordance with EAP-19.

5.0 ATTACHMENTS NONE Rev. No. 16 Page 7 of 7

ENTERGY NUCLEAR OPERATIONS, INC.

JAMES A. FITZPATRICK NUCLEAR POWER PLANT EMERGENCY PLAN IMPLEMENTING PROCEDURE EMERGENCY USE OF POTASSIUM IODIDE (KI)

EAP-19 REVISION 23 APPROVED BY: DATE: O/z "

// /.

EFFECTIVE DATE: ____ ____ ____

FIRST ISSUE Dl FULL RE 'V'ISION E] LIMITED REVISION [El

• INFORMATIONAL USE * * .TSR *

• ADMINISTRATIVE

• PERIODIC REVIEW DUE DATE: MAY 2008

-tw;!1f EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 IE REVISION

SUMMARY

SHEET j'

REV. NO.

23

• Revised sections 4.2.1, 4.2.2, 4.2.3, and 4.2.4 to change adult thyroid to child thyroid.

• Revised Attachment 3 for child thyroid values.

22

• Complete rewrite to implement the use of KI as a protective action during a general emergency.

• Added attachments 5 and 6

• Updated procedure references

• Updated reference in 2.1 with current Rad Protection procedures and current name of mini scaler.

• Updated attachment 2 with additional personnel allergic to potassium iodide.

• Changed threshold level for KI use form for 25 rem to 5 rem CDE thyroid.

• Updated Attachment 3 for 5 Rem CDE thyroid.

21

• The company name on the coversheet has been changed due to a recent sale of.

• In Section 1.0, the reference to New York Power Authority employees has been changed to James A.

Fitzpatrick employees due to the sale.

• References to NYPA in Sections 4.1.2 and4.2.3 have been changed to JAF.

• In Section 4.2.4 the references to "The Authority's" were changed to "the site's".

• Updated attachment 2 - added/omitted personnel with an allergy to KI.

Rev. No. 23 Page 2 of 34

. i: - 1, ! 1; '-, " .,

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 TABLE OF CONTENTS SECTION PAGE 1.0 PURPOSE ................................................ 4

2.0 REFERENCES

.............................................. 4 2.1 Performance References ................................. 4 2.2 Developmental References ............................... 4 3.0 INITIATING EVENTS ...................................... 5 4.0 PROCEDURE ...................

............................ 5 5.0 ATTACHMENTS ............................................. 7

1. PATIENT PACKAGE INSERT FOR THYRO-BLOCK POTASSIUM IODIDE ............................................. 8

2. MEMO RE: POTASSIUM IODIDE ALLERGY ................. 9

3. STAY TIME VS I-131 CONCENTRATION RESULTING IN 5 REM CDE CHILD THYROID ................................. 10

4. IMPLEMENTATION OF USE OF KI ......................11

5. USE OF KI DURING RADIOLOGICAL EMERGENCIES: Q&A .... 27

6. DOH: USE OF KI DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC ........................ 33 Rev. No. 23 Page 3 .of .34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 1.0 PURPOSE The purpose of this procedure is to provide instructions for the use of thyroid blocking Potassium Iodide (KI).

2.0 REFERENCES

2.1 Performance References 2.1.1 EAP-1.1, OFFSITE NOTIFICATIONS 2.1.2 EAP-4, DOSE ASSESSMENT CALCULATIONS 2.1.3 EAP-5.3, ONSITE/OFFSITE DOWNWIND SURVEYS AND ENVIRONMENTAL MONITORING 2.1.4 EAP-6, IN-PLANT EMERGENCY SURVEY/ENTRY 2.1.5 RP-INST-02.09, MINI-SCALER MS-2 and MS-3 i 2.1.6 RP-RESP-04.02, PORTABLE AIR SAMPLERS 2.1.7 AM-03.04, RADIOIODINE CARTRIDGE ANALYSIS USING GAMMA SPECTROSCOPY 2.2 Developmental References 2.2.1 National Council on Radiation Protection and Measurements Report No. 55. PROTECTION OF THE THYROID GLAND IN THE EVENT OF RELEASES OF RADIOIODINE.

2.2.2 -Manufacturer's (Wallace Laboratories)

Recommendations on Use of Thyro-Bl6ck Tablets.

2.2.3 EPA-400-R-92-001, MANUAL OF PROTECTIVE ACTION GUIDES AND PROTECTIVE ACTIONS FOR NUCLEAR INCIDENTS 2.2.4 New York State Nuclear Emergency Preparedness Subcommittee Technical Issues Task Force, IMPLEMENTATION OF THE USE OF KI AS A PROTECTIVE ACTION FOR THE PUBLIC.

Rev. No. 23 Page 4 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 3.0 INITIATING EVENTS 3.1 Abnormal radiological conditions are indicated in the plant or environs, or:

3.2 A General Emergency has been declared.

4.0 PROCEDURE NOTE: The Emergency Director is the only individual who can authorize the use of KI for personnel in the JAF Owner Controlled Area-and other JAF Emergency Workers who may be located outside the Owner Controlled Area 4.1 The TSC and EOF Radiological Support Coordinators shall maintain an awareness of onsite/in-plant and offsite radiological conditions, respectively.

4.2 If abnormal radiological conditions exist, then the appropriate Radiological Support Coordinator shall:

4.2.1 Determine the projected child thyroid dose to personnel in the affected area(s) using Attachment 3 as a guide.

4.2.2 If the projected child-thyroid dose exceeds 5 Rem CDE child thyroid to any personnel, then obtain Emergency Director authorization to issue KI to those personnel for use on a voluntary basis.

NOTE: For those personnel known to be allergic to KI as listed on Attachment 2,' consider use of alternate personnel prior .to issuing KI.

4.2.3 Issue one (1) 130 mg KI tablet and a copy of Attachment 6, Use of KI During Radiological Emergencies - Information for the Public, to each individual projected to receive,> 5 Rem CDE child thyroid. KI tablets are available in the TSC, OSC, EOF, Training Building,.Security, and in Field Team Survey Kits.

4.2.4 Continue to issue one (1) 130 mg KI tablet and a copy of Attachment 6 once per day, if appropriate, as long as the personnel are expected to receive

> 5 Rem CDE child thyroid.

Rev. No. 23 Page 5 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 4.3 If a General Emergency is declared, then all personnel in the owner controlled area are authorized for voluntary use of KI by the Emergency Director via a site announcement.

4.3.1 The TSC Radiological Support Coordinator shall ensure that KI is made available to all personnel in the JAF Owner Controlled Area. This shall include Security personnel, National Guard, personnel in the Training Building, and other personnel who may be in outlying areas at the JAF site. KI tablets are available in the TSC, OSC, EOF, Training Building, Security, and in Field Team Survey Kits.

4.3.2 Consider distribution of KI during the Accountability process, if practical.

4.3.3 The EOF Radiological Support Coordinator shall ensure that KI is made available to all JAF emergency personnel offsite within the 10-mile EPZ. This shall include downwind survey field teams and may include EOF/JNC personnel as applicable. KI tablets are available in the TSC, OSC, EOF, Training Building, Security, and in Field Team Survey Kits.

4.3.4 Continue to issue one (1) 130 mg KI tablet and a copy of Attachment 6 once per day as necessary to personnel for the duration of the General Emergency.

4.3.5 After the initial issuance of KI, consideration may be given to discontinue ongoing issuance of KI if a release is no longer occurring or is unlikely.

Rev. No. 23 Page 6 of 34

': -I , , 1, -I.

T . .. 1"... .: .

I EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP- 19 5.0 ATTACHMENTS

1. PATIENT PACKAGE INSERT FOR "THYRO-BLOCK" POTASSIUM IODIDE

2. MEMO RE: POTASSIUM IODIDE ALLERGY

3. STAY TIME VS I-131 CONCENTRATIONS RESULTING IN 5 REM CDE CHILD THYROID I

4. IMPLEMENTATION OF THE USE OF POTASSIUM IODIDE (KI) AS A PROTECTIVE ACTION FOR THE PUBLIC -

5. USE OF POTASSIUM IODIDE DURING RADIOLOGICAL EMERGENCIES: QUESTIONS & ANSWERS

6. DOH: USE OF POTASSIUM IODIDE DURING RADIOLOGICAL EMERGENCIES - INFORMATION FOR THE PUBLIC Rev. No. 23. Page. 7 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 1 Page 1 of 1 PATIENT PACKAGE INSERT FOR THYRO-BLOCK POTASSIUM IODIDE iOSAT' WHO SHOULD NOT TAKE POTASSIUM IODIDE Tablets The only people who should not take potassium Iodide (Potassium Iodide Tablets, U.S.P.) are people who know they are allergic to iodide You (Pronounced poo-TASS-9-um EYE-oh-dyedl may take potassium iodide even if you are taking (Abbrevlated KSl medicines for a thyroid problem (for example, a thyroid hormone or anhtihyroid drug). Pregnant and TAKE POTASSIUM IODIDE ONLY WHEN PUBLIC nursing women and babies and children mIayalso HEALTH OFFICIALS TELL YOU. IN A RADIATION take this drug.

EMERGENCY RADIOACTIVE IODINE COULD BE RELEASED INTO THE AIR. POTASSIUM IODIDE (A HOW AND WHEN TO TAKE POTASSIUM IODIDE FORM OF IODINE) CAN HELP PROTECT YOU. Potassium iodide should be taken as soon as possible after public health officials tell you. You should lake IF YOU ARE TOLD TO TAKE THIS MEDICINE. 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 riot help you IT ONE TIME EVERY 24 HOURS. DO NOT TAKE IT because the thyroid can hold" only limited amouints oh MORE OFTEN MORE WILL NOT HELP YOU AND iodine. Larger doses will increase Ihe risk of side MAY INCREASE THE RISK OF SIDE EFFECTS. DO effects. You will probably be told not to take the drug NOT TAKE THIS DRUG IF YOU KNOW YOU ARE for more than 10 days.

ALLERGIC TO IODIDE (SEE SIDE EFFECTS BELOW). SIDE EFFECTS Usually, side effects of potassium iodide happen when INDICATIONS people take higher doses for a long time. You shoula THYROID BLOCKING IN A RADIATION EMERGENCY be careful nol to lake more than the recommended ONLY dose or lake it for longer than you are told Side effects are unlikely because of the low dose and Ihe DIRECTIONS FOR USE short lime you will be taking the drug Use only as cfirucled by Slate or lrical public health authorities In tho event of a radiation ermorgoncy Possible side effects include skin rashes, swelling of DOSE thle salivary glands, anrd 'iodism (mnetallic lasie, ADULTS AND CHILDRiEN ONE YEAR OF AGE OR burning moutlr and throat, sore teeth and qums.

OLDER. One (1j tablet oice a day. Crush for smnall symptoms of a head cold. and sometimnes stomachi children. upset andl dianiea).

BABIES UNDER ONE YEAR OF AGE Onl:.illII(1.2) A few people have an allergic reaction with more lablet once a day. Crush first. serious symptorms. These could be lever andl loinl DOSAGE: Take for 10 dlays unless directed oliherwiso pains. or swelling of parts of the lace and body anrd at by State or local public health authorities Store at times severe shortnesq of breath requirring immediale controlled room teiriperaltue between 15- and 30'C medical attention.

159- and 86 Fl. Keep package dry and loil packeIl intact. Taking Iodide may rarely cause overactivily of the thyroid gland. uinderactivity of the thyioid gland, or WARNING onfargermen of tlh thyroid gland (goiter).

POTASSIUM IODIDE SHOULD NOT B3EUSED BY PEOPLE ALLERGIC TO IODIDE. Keep out of the WHAT TO DO IF SIDE EFFECTS OCCUR roach of children. In caso of overdiose or allergic If the side eflects are severe or it you have an allergic reaction. contact a physician or public health authoitly. reaction. stop taking potassium iodide. Then, if DESCRIPTION possible, call a doctor or public health authority foi Each IOSAT'" TablMt contains 130 mg of potassium Instructions.

iodide.

HOW SUPPLIED HOW POTASSIUM IODIDE WORKS IOSAT Tablets (Potassium Iodide Tablets. U.S.P.)

Certain forms of iodine help your thyroid gland work packages of 14 tablets (NDC51803-001-01) Each right. Most people gel tire iodine they need from foods white. round. scored tablet contains 130 mig. polassiri like iodized salt or lish The thyroid can store" or iold iodide.

only a certain aiounl of iodine.

In a radiation emergency, radioactive iodine may be Distributed by released in the air. This material may bo breathed or swallowed. It may enter ilth thyroid glanii and damage ANBEX, INC.

it. The damage would probably nol show itself for 10 East 40th Street years. Children are most likely to have thyroid damiage. Now York, N.Y. 10016 www-anbox.com 11you take potassium iodide, it will fill up your thyroid rymioa i T i ods i !1,vl th r i in arm ful hla radioactive iodine wil1 enter the tilyroid gland.

Rev. No. 23 Page 8 of 34

~~~~~~~~~r-I EE CS PS IID KI EAP-19 EMERGENCY USE OF POTASSIUM IODIDE (KI) .EAP-19 ATTACHMENT 2 Page 1 of 1 MEMO RE: POTASSIUM IODIDE ALLERGY Inieroffice M.~~y  ?* 2L)03~~C orres ponrdence MEM~ORANDUtM4 0 NICHOLAS AVRAKOTOS E-RuDl. 0!: nRAJi CAL.TAD lAND. RN SUB.IFC7V POTASIksUM_1t1IQDIDE A-~LLERGW Thn fuitwih o ,ir.mi sp1.4IEcl Itsl;tiqr ni Iin:ic-ialsille;~ ~rgic to Pr~snIj tamn uindido~.

DF,~Snrrr.Anhii LI~ Gujdllt. Luiz C 71~ .2Af;im.,' T~ri~

Sa L.

1S. iwi:i, Pauti S I 6. WamcIlcI. M~winti-e J.

DEB3RA J. CALTAIJIAtNO. P1,OIT 4 O(CCIIPAI K)NAL. HEAL I F NURSE Cc, J. RL'cciw C ty Rev. .No.. 23 ~ Page 9.--of -.-

34

I j

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 3 Page 1 of 1 STAY TIME VS I-131 CONCENTRATION RESULTING IN 5 REM CDE CHILD THYROID Given: DCF for I-131 = 2.6E6 rem/hr/pCi/cc (a factor of 2 applied for child thyroid)

DCF is in terms of committed dose equivalent (CDE) from EPA-400-R-92-100 In developing DCF, the adult lung class that resulted in the most restrictive value was selected.

The DCF is for dose due to inhalation only.

No credit is taken for radioactive decay.

Stay Time (minutes) I-131 Concentration pCi/cm3

,<y 96 1. 20E-6 84 1.37E-6 72 1. 60E-6 60 1.92E-6 48 2 .40E-6 36 3 .21E-6 24 4. 81E-6 12 9.62E-6 9 1.28E-5 0 .1.92E-5 3 3. 85E-5 Rev. No. 23 Page 10 of -34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19

- - ATTACHMENT:4 - IMPLEMENTATION OF.USE OF KI New York State Nuclear Emergency Preparedness Subcommittee Technical Issues Task Force Implementation of the Use of Potassium Iodide (KI) as a Protective Action frthe PubIic  !-,  ;

I Rev. No. 23 Page 11 . of .34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-l9 I

ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

The following individuals and orgalnizallons participated in the development of this position paper. and agree to its putrose anid contents. All participants agree to iniplenict the t-iuilance contained herein. to the extent possible.

Constellhition Energov Group (Nine Mile Poinzt)

James 1). Joncs - rnm- hV-11/-L-Name Itir11: Date En tergy Nuiclea:r Northeaist (J.A. Fitzilatrick and Indian Pointi Eniergy Center)

Mic chal Sloboidhe ZkI 31 MTrhdi 2-003 Name JlAr / i Date Rochiester Gas and Electric (R.E. Ginima Station)

TinothN, Latursen Lib:) i( D-3 Name Si,-inare Date Newv York State Emergenicy Manaigemnwt Office Iate 3)

Andrew Feenev ______ _ _ -_ . 1 Name Signature F). Iic New York State Hcalth I I)Department Adela Salime-Alfie. Ph.D.

Namnie Sign.ItLre Date Rev. No. 23 Page 12 of 34

t; ;-, ': -,i' I EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4.IMPLEMENTATION OF USE OF: KI (continued)

EXECUTIVE

SUMMARY

Utility and State members of the Potassium Iodide (KI) Task Force (KI Task Force) developed this position paper to detail the decision process by which several recommendations regarding KI distribution will be made. The Task Force agreed that upon declaration of a General Emergency by the utility, a recommendation to evacuate and take KI would be made simultaneously. It was also agreed'that a single trigger'level would be used (projected dose of 5-rem child thyroid). This paper discusses several approaches to determine doses/iodine concentrations and whether one approach was selected over the others due to effectiveness, timeliness, ease of implementation, etc.

The following five specific recommendations were agreed upon by the KI Task Force:

1. "Upon declaration of a GeiieralEmtergenicy, n11embers of thepublic that are directedto evacuate shall also be directed to take KI. Captivepopulations wvitlin the evaciuated area shall also be directedto take KI".

2. "Metntbers of the public anzd captive populations witho are directed to take KI shall be directed to take one 130-m)g tabletper person if they are over oneyear of age. Persons less than one year of age are directed to take 65 mg (1/2 of a 130-nmg tablet) ".

3. "As part ofapre-distributioneffort, each msemtber of the public should be offered a quantiti' ofKI tablets equivalent to thefollowing: AMavitimum ETE (in days-rountdedup) x I KI tablet/day"

4. "Only members of the public who have been directedto evacuate shall be directed to take KI. Emzergenicy workers and captive populations in the evacuated areashould also be directed to take KI".

5. "Iftle intdications detailed ill section 4.1 arepresent, emergentcy workers itll be directed to take KI (onie 130 nig tablet every 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) at the same timtte as the geineralpublic".

Rev. No. 23 Page 13 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

The group recognizes that a strong public information campaign and clear messages during the emergency is key to a successful KI implementation program. Some implementation guidance is provided at the end of the document.

1. Purpose The purpose of this paper is to document a technical assessment of issues associated with the distribution of Potassium Iodide (KI) to the general public, emergency workers and captive populations, and to provide implementation guidance for:

• Usage

• General Public

• Emergency Workers

• Captive Populations

• Dosage and frequency

• Pre-distribution criteria

2. Regulatory Requirements and Guidance 2.1 Applicable regulations The NRC amended emergency planning regulations to require that States consider including the prophylactic use of KI as a protective measure for the general public in the plume exposure pathway Emergency Planning Zone in 66 FR 5427 on 19 Jan 2001. (Ref.

1)

FEMA provided notice that the FRPCC revised its 1985 Federal policy regarding KI use in 67 FR 1355 on 10 Jan 2002. (Ref. 2) 2.2 Current guidance The FDA issued guidance on the use of KI in radiation emergencies in December 2001 (Ref. 3). This document concludes "Short-term administration of KI at thyroid blocking doses is safe..." (Ref. 3 IV.A.) and indicates KI dosage is dependent on age and "Predicted Thyroid Exposure" (Ref. 3 IV.B.). This document states that "The recommendation should be interpreted with flexibility as necessary to allow optimally effective and safe dosing..." Additionally, "...the overall benefits of KI far exceed the risks of overdosing. . ." (Ref. 3 IV.B.).

Rev. No. 23 Page 14 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) . EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued) 2.3 New York State Position In 2002, New York State, in its consideration of the subject CFR, chose to incorporate KI as an adjunct to the current range of protection actions for the public. The New York State Revised KI Policy was issued in April 2002.

2.4 Upcoming Guidance This Position Paper will be revised as necessary to accommodate any new Federal guidance.

3. Assumptions

• For optimal protection against inhaled radioiodine, KI should be administered before or immediately coincident with passage of the radioactive cloud, though KI may still have a substantial protective effect even if taken 3 or 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after exposure. (Ref. 3. V.).

• The recommended daily dose protects the user from radioiodine uptake for approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

• KI should be taken until the person is no longer exposed to radioiodine.

• Radioiodine would only be present in the environment in sufficient quantities to exceed 5 rem child thyroid dose (CDET), which is the minimum dose at which KI is recommended, if a General Emergency had been declared at the facility from which the source term originates.

This assumption is based on the fact that radioiodine can only be present in quantities capable of producing 5 rem child CDET in the presence of significant core damage and loss of primary containment, which are criteria that constitute a General Emergency (GE).

• There will only be one trigger level to recommend KI: 5 rem to the child thyroid (CDET).

This trigger level applies to the general public, emergency workers and captive populations.

4. Implementation Analysis .

This section presents five recommendations as well as the rationale, benefits and risks associated with each. Recommendations are presented for when to issue a KI recommendation, dosage, and criteria for pre-distribution. These analyses apply to members of the public, emergency workers and captive populations.

Rev. No. !23. Page. 15. of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued) 4.1 Task Force Recommendation # 1 "Upon declaration of a General Emergency, members of the public that are directed to evacuate shall also be directed to take KI. Captive populations within the evacuated area shall also be directed to take KI".

Analysis:

Three methods were investigated to arrive to this recommendation:

• Use of a dose value,

• Use of deterministic methods, and

• Use of emergency classification.

Each analysis is described separately.

Using Dose Value This analysis examines a method that utilizes projected dose to the thyroid as an indication of recommendation of KI use by the public (specifically, Committed Dose Equivalent to the child thyroid (CDET)). In accordance with FDA Guidance (Ref. 3), child CDET > 5 rem is the indication at which KI use should be recommended.

To date, none of the New York State nuclear power facilities utilize real-time iodine monitoring.

Hence, releases of radioiodine to the environment during an emergency are inferred from either grab samples or back calculated from field data. Both of these methods require several steps that need, at a minimum:

• Allocation and briefing of personnel, or

• Assembling equipment and procedures to enter the field to collect and analyze samples, reporting the results to an emergency facility, and performing calculations to determine child CDET.

These steps are routinely performed during emergency drills, and our experience indicates that it may take anywhere from 30-90 minutes to calculate the child CDET once a decision has been made to obtain a sample.

Rev. No. 23 Page 16 of 34

EMERGENCY USE OF POTASSIUM IODIDE :(KI) EAP-19 ATTACHMENT 4-IMPLEMENTATION OF USE OF KI (continued)

Normally, the calculation of the child CDET takes place after the completion of protective action recommendations (PARs) based on "plant conditions". The PARs for a General Emergency (GE) are to evacuate people within two-miles around and five miles downwind of the site, and shelter (for heightened awareness) all other ERPAs. Additionally, the emergency facilities that implement this analysis must be activated within 60 minutes of a declaration of an emergency.

Given the above:

• Child CDETwould likely be calculated and provided to the County and the State within 105-165 minutes after the declaration of the GE.

• If the County decides that the use of KI is appropriate, this instruction could be provided to the public in 150-210 minutes after the declaration of the GE.

Use of Deterministic Methods In this case, methods that determine child CDET utilizing parameters such as containment high range monitor status, gross core damage estimate, and/or reactor pressure vessel and containment integrity were considered. Unfortunately, the data needed to make even rough estimations of these parameters would typically be assessed after the GE-related recommendations. Hence, the time-delay risks of such a method still apply.

Benefits of this method Administration of KI would occur only in the presence of radioiodine in quantities that'meet or exceed the "Predicted thyroid exposure guidance" in Reference 3.

Risks of this method

• Administration of K] would occur after the release of radioiodine, decreasing the effectiveness of the prophylaxis.

• Administration of KI would likely occur after other protective actions (that is evacuation) have already been recommended to the public. It is unknown if the public would comply with instructions to bring KI with them.

• If two separate protective actions are issued to the public (for example, an order to evacuate not accompanied by a recommendation to take KI), compliance with the respective -:

recommendations is unknown. It is possible that the public will not differentiate between the protective actions and, when told to evacuate, may take KI as well. The risk is that the public sees these as two separate protective actions, potentially providing confusion and non-compliance.

Rev. No.* 23 Page 17. of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

Use of Emergency Classification This analysis examines a method that would use the emergency classification level as the indication for KI use. Specifically, the indication for KI use is a declaration of a General Emergency (GE).

• The General Emergency classification is currently used to determine evacuation PARs.

• If the KI use was always implemented concurrently with the "plant condition" protective actions, the public would receive the recommendation to take KI at the same time they received the order to evacuate; that is, within an hour of the declaration of the General Emergency.

• The declaration of a General Emergency presumes that "Events are in process or have occurred which involve actual or imminent substantial core degradation or melting with potential for loss of containment integrity. Releases can be reasonably expected to exceed EPA Protective Action Guideline exposure levels offsite for more than the immediate site area." (Ref. 8).

• The EPA Protective Action Guideline is to evacuate populations whose actual or projected exposure level equals or exceeds 5 rem Committed Dose Equivalent to the (adult) thyroid (Ref. 9).

• New York State nuclear power plant licensees calculate CDETtO the child thyroid, and provide this number to the counties and state for comparison against the PAG's (Ref. 10).

• Hence, when the licensee recommends evacuation due to a General Emergency declaration, a child CDET2 5 rem either exists or is anticipated to exist at the site boundary or beyond.

Though there are exceptions to this (such as GE's declared due to security issues or electrical problems) all GE's have the potential to exceed the 5-rem child CDET level. Calculations performed by New York State on a variety of plant conditions postulated to exist during a GE provide confirmation of this (Ref. 7).

• Given the above, it can be reasonably assumed that the radiological conditions present within the context of a General Emergency wvill result in meeting or exceeding the child CDET2 5 rem, which is also the thyroid exposure at which the FDA recommends the use of prophylactic KI.

Rev. No. 23 Page 18 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

Benefits of this method

• The recommendation to take KI could be issued earlier than the other indication methods, concurrently with evacuation, and would likely occur prior to the presence of radioiodine in the environment, providing maximum loading dose of stable iodine to the thyroid.

• Compliance in taking KI is more likely since all protective actions are being implemented at once. Also, people would be more likely to have access to pre-distributed KI.

Risks to this method

• KI could be ingested without significant radioiodine ever being present in the environment.

For example, the accident may not result in a release of radioiodine to the environment.

Hence the public incurs the risk of taking KI without benefit.

Risk Analvsis

• The risk of taking KI is minor (Ref. 3. IV.B.).

• A GE condition carries a risk of radioiodine release to the public.

• KI should be taken as soon as possible once the risk of radioiodine exposure is present.

• Using projected child CDET could significantly delay KI administration.

Providing the public with a recommendation to take KI concurrent with an order for evacuation or sheltering provides the earliest and most effective thyroid protection with the greatest likelihood of compliance.

4.2 Task Force Recommendation # 2 "AMembers of the plblic and captive populationswiho are directed to take KI shall be directed to take one 130-mng tabletperperson if th ey are over one year of age. Persons less than onle year of age are directed to take 65 mg (1/2 of a 130-mig tablet)".

Analysis.

The FDA guidance (Ref. 3) contains a number of age dependent doses. These recommendations are the lowest effective dose. Emergeicy 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.

Rev. No. 23 Page 19 of 34

I r

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

Threshold Thyroid Radioactive Exposures and Recommended Doses of XI for Different Risk Groups IKI dose (mg) # of 130 mg i of 65 mg tablets tablets Adults over 40 yrs 130 1 2 Adults over 18 through 40 yrs Pregnant or lactating women dolescents. over 12 65 1/2 1 through 18 yrs*

Children over 3 through 12 yrs Over 1 month through 3 32 1/4 1/2 years Birth through 1 month 16 1/8 1/4

• Adolescents approaching adult size (> 70 kg) should receive the full adult dose (130 mg).

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 KI instead of the lower doses recommended for certain age groups far exceed the small risks of overdosing. However, where feasible, adherence to FDA guidance should be attempted when dosing infants. Excess iodine intake can lead to transient iodine-induced hypothyroidism. Individuals who are intolerant of KI at protective doses, as well as neonates, pregnant, and lactating women, should be given priority with regard to other protective measures (i.e., sheltering, evacuation, and control of the food supply) (Ref. 11).

Rev. No. 23 Page 20 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4. IMPLEMENTATION OF USE OF KI (continued)

This analysis recognizes:

• Potential confusion relating these doses to the public.

• Practical issues associated with delivering doses based on fractions of a tablet. This would require sectioning small KI tablets in order to achieve a desired delivered dose.

• Likely lack of compliance regarding dose given the above issues.

Benefits to this method

. Instructions for a two dosages (example: "take one tablet for each person in the household over one year of age and a half tablet for infants under one year of age") are easily related in public information material.

• Simple instructions are more likely to be complied with.

Risks to this method This recommendation would provide a dose to children significantly in excess of the FDA requirements. In accordance with Reference 3, neonates who receive KI should be medically monitored for adverse affects. This action should be incorporated into the State plan.

Risk Analysis

• The risk associated with excessive KI is less than the risk of exposure to radioiodine (Ref. 3).

• The public is more likely to comply with simple dose instructions.

• The FDA has indicated that the use of a single 130-mg dose for all members of the public is safe, regardless of age.

4.3 Task Force Recommendation#33 - . -  :.

"As part of a pre-distribution effort, each member of the public should be offered a quantity of KI tablets equivalent to the following:

Maximum ETE (in days-rounded up) x1 KI tablet/day.;  ; I . ? . - ., .

,; .. *Jo

., . -:. .1

.- ;1 .

Rev. No. 23 Page -21 of .34.

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 I !

ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

Analvsis

• The public should be provided with sufficient KI to assure that thyroid prophylaxis is available to accommodate an expected duration of exposure to radioiodine

• Given that evacuation of the public is the preferred method of preventing exposure, in an incident that could result in the release of radioiodine, the public could be expected to be exposed for a period of time equal to the greatest Evacuation Time Estimate (ETE) for the facility in question.

It is possible that impediments to evacuation may prevent the egress of portions of the population that would othenvise be evacuated (examples are road impediments such as heavy snowvfall or transportation resource shortfalls), however, those conditions are accommodated in each nuclear facility's ETE.

Given the above, pre-distribution efforts should provide sufficient KI in accordance with the following:

Maximum ETE (in days-rounded up) x I KI tablet/day =# KI tablet(s) per person that should be pre-distributed Example: At Nine Mile Point, the maximum amount of time it would take to evacuate any member of the public is 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />, as indicated in that facility's ETE (Ref. 4). Rounded up, that is equivalent to I day. Plugging this into the above formula:

I day x I KI tablet/day = I tablet In this example, one tablet per person should be offered in a pre-distribution method.

4.4 Task Force Recommendation i 4 "Onily memibers of the public wvho have beei directed to evacuate shall be directed to take KI. Emergency workers and captive populations in the evacuated area should also be directed to take KI".

Analvsis The recommendation to take KI should be given to any persons likely to be exposed to radioiodine in quantities that may exceed the "Predicted thyroid exposure guidance" presented in Reference 3.

Rev. No. 23 Page 22 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

• This analysis suggests that persons who are ordered to evacuate due to plant conditions or due to subsequently determined projected dose may exceed the predicted thyroid dose, and should take KI.

• For the population who has been told to shelter for the purposes of bringing them to a heightened state of awareness, the risk of radioiodine exposure is low. The reasons for this are:

• Due to the distance from the reactor, this population is at significantly less risk from radiation exposure from all sources, versus person closer to the reactor.

• Sheltering is used for projected doses of< 1 rem TEDE or < 5 rem CDET. Hence this population is not at risk of significant exposures to radioiodine.

• Populations who took, or were recommended to take KI coincident with the order to shelter are at risk of depleting their pre-distributed KI supply, making it unavailable in the event of radioiodine exposure.

• If it has been determined that an impediment to evacuation exits (lack of transportation resources or road impediment) then the county or state may decide to shelter for the purpose of reducing dose. In this case, KI should be recommended when the projected child CDET exceeds 5 rem.

The conclusion is that the recommendation to take KI should only apply to those persons ordered to evacuate. The above argument assumes that sheltering is being done to bring the public to a heightened state of awareness and not as a means of dose reduction. The above does not apply to sheltering being done in place of evacuation.

4.5 Task Force Recommendation #5 .

"Ifthe indicationsdetailed in section 4.1 arepresent, emtergency rt'orkers will be directedto take KI ('one 130 nig tablet every 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) at the sallme timle as the general public". . .,

Analvsis Though currently the trigger levels for emergency worker KI use vary within New York State, all methods use trigger levels greater than the 5 rem child CDET that is associated with the general public.  :  ; - -

• The KI Task Force has agreed that there will be one trigger level to recommend KI, and that

.trigger level will be 5 rem child CDET.  ; - .:

- . ) ,. .:  :... c  ; -.

Rev. No. 23 Page 23 of .34:

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

Most emergency workers are members of the public, and many will encounter the evacuating public, who will have been told to take their KI. Additionally, emergency workers have access to the same public infonnation that would be instructing the public to take KI. These emergency workers:

• May not differentiate themselves from the public in the presence of instructions regarding KI.

• May not comply with directions that differ from those being broadcast to the public.

• Using the same arguments as in section 4.1, if current methods are continued, emergency workers would receive a recommendation to take KI while in the field. This method:

• Is likely to result in a recommendation to take KI after exposure to radioiodine has already occurred.

• Has potential delays due to the communications lag present when contacting several hundred emergency workers in the field.

• Directing emergency workers to take KI in the absence of radioiodine has the same risks and benefits detailed in section 4.1.

5. Implementation Considerations This section provides suggestions for implementing the recommendations contained above.

5.1 Licensee actions The Part I Notification Fact Sheet item 7.8. should be modified to read, "Evacuate and implement the KI plan for the following ERPA's". This action should be completed by 5 May 2003.

5.2 County and State actions Emergency plans should be modified to include:

• The addition of KI as a protective action for the public

• The above protective action may be implemented for the evacuating public upon declaration of a General Emergency

• If the public is sheltered in place, KI may be recommended if any population may be subject to a dose > 5 rem child CDET Rev. No. 23 Page 24 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE.OF KI (continued)

• The recommended dose will be one tablet (130 mg) per person every 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for persons over one year of age; L/2 tablet (65 mg) per person every 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for persons under one year of age.

• Emergency workers will be instructed to take KI upon declaration of a General Emergency (that is, concurrent with the recommendation to the evacuating population)

Public information plans should be modified to include:

• KI purpose, dose, distribution methods (pre- and post-event) and precautions (consistent with NYS and FDA guidance) in public education materials

• Incorporation of KI protective action details into EAS follow-up messages

i' -'; ':

Rev. No. _23 Page '25 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 4 IMPLEMENTATION OF USE OF KI (continued)

6. References (Ref. 1) 66 FR 5427 (19 Jan 2001).

(Ref. 2) 67 FR 1355 on (10 Jan 2002).

(Ref. 3) Guidance: Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies: U.S.F.D.A, Dec 2001.

(Ref. 4) Evacuation Travel Time Estimates, James A. FitzPatrick/Nine Mile Point Emergency Planning Zone, July 1993 (Harborfest Weekend Scenario, Adverse Weather).

(Ref. 5) EPA 400-R-92-001, Manual or Protective Action Guides and Protective Actions for Nuclear Incidents, U.S.E.P.A, May 1992.

(Ref. 6) Evacuation Travel Time Estimates, James A. FitzPatrick/Nine Mile Point Emergency Planning Zone, July 1993.

(Ref. 7) (NYSDOH RASCAL calculation).

(Ref. 8) NUREG-0654 FEMA REP 1: Appendix 1.

(Ref. 9) EPA 400-R-92-001, Manual or Protective Action Guides and Protective Actions for Nuclear Incidents, U.S.E.P.A, May 1992, Table 2-2 footnote b.

(Ref. 10) Implementation of the new EPA Protective Action Guides in Existing Emergency Programs for Nuclear Power Plants in New York State, March 1994.

(Ref. 11) Guidance for Industrv: KI in Radiation Emergencies - Questions and Answers, Revision I, USFDA, December 2002.

Rev. No. 23 Page 26 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 5 - USE'-OF KI DURING RADIOLOGICAL EMERGENCIES: Q&A USE OF POTASSIUM IODIDE DURING RADIOLOGICAL EMERGENCIES: Q&A

1. Purpose In December 2001 the Food and Drug Administration (FDA) issued new recommendations for the administration of potassium iodide (KI)'to the general public as a supplement to evacuation and sheltering during a radiological emergency. The State of New York in turn has revised its 1982 KI Policy to reflect this new guidance. This fact sheet presents general information on KI for members of the public.

2. What is potassium iodide and what is it used for?

Potassium iodide (KI) is a chemical compound that can be used to protect the thyroid gland from possible radiation injury caused by radioactive iodine (radioiodine). Some radiological emergencies may release large amounts of radioiodine to the environment. Since iodine concentrates in the thyroid gland, inhalation or ingestion of food contaminated with the radioiodine can lead to radiation injury to the thyroid, including increased risk of thyroid cancer and other thyroid diseases. Thyroid cancer is curable in most cases, but taking measures that reduce the chance of developing cancer are still preferable.

3. How does potassium iodide work?

Taking KI saturates the thyroid gland with stable (non-radioactive) iodine. This prevents or-reduces the amount of radioiodine that can be taken up by the thyroid.

4. What age group is at the highe'st risk from exposure to radioiodine?' '

Children are the group with'the'highest risk. A significant late increase in the incidence of thyroid cancer amon'g children in Belarus, Ukraine and Russia was observed as a result of exposure to radioiodine from the Chernobyl accident. The younger the children, the higher the observed risk. No similar increase was reported for adults.

Rev. No. 23 Page :27 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 5 USE OF KI DURING RADIOLOGICAL EMERGENCIES: Q&A (CONTINUED)

5. At what radiation dose is KI indicated?

On December 10, 2001, FDA issued new guidance that sets different radiation doses for different risk groups as follows:

Age Groups Projected Radiation Dose to the Thyroid 0 - 18 years 5 rem Pregnant and Lactating 5 rem Women Over 18 - 40 years 10 rem Over 40 years 500 rem

6. When should KI be taken?

To be most effective, KI should be taken before or shortly after exposure to radioiodine. Even if taken three to four hours after exposure, it still would reduce the uptake of radioiodine by the thyroid. However, its effectiveness would be reduced.

7. How will one know if the use of KI is indicated in an emergency?

The use of KI is only indicated in emergencies where the public is likely to be exposed to radioiodine. The State and County health departments monitor all radiation emergencies and will issue advisories informing the public whether KI should be taken. In those cases where KI is indicated, the health departments will also issue advisories on when the administration of KI is no longer needed.

Rev. No. 23 Page 28 of 34

EMERGENCY USE OF POTASSIUM IODIDE (RI) EAP-19 ATTACHMENT 5 USE OF RI DURING RADIOLOGICAL EMERGENCIES: Q&A (CONTINUED)

8. Is KI effective in all radiation emergencies?

• RI is quite effective in reducing the radiation dose to the thyroid that could result from the intake of radioiodine;

• KI does not protect other organs or tissues;

• KI does not protect against radiation doses received from sources external to the body, such as the radiation dose from the radioactive plume or from exposure to radioactive materials'deposited on the ground; and

• RI does not protect against radioactive materials, other than iodine, which are inhaled or ingested.

9. What are other protective measures that can be taken in an emergency?

The existing emergency response plans in New York State rely on evacuation and sheltering of potentially affected populations to prevent their exposure to the radioactive K.) materials that could be released in an accident. Evacuation would continue to be the primary protective measure in such accidents along with sheltering individuals who cannot relocate (captive populations). RI, if used, would only supplement evacuation and sheltering. Also, ingestion of contaminated milk or other food products can lead to significant intake of radioiodine. The-primary protective measure for the ingestion pathway is the control of the food supply to prevent ingestion of contaminated products.

10. Does KI have side effects?

A study of a sample of those who were administered KI in Poland, following the Chernobyl accident, provides:

information on side effects of RI. A rate of one in.270 of the newborns receiving 15 mg KI showed transient biochemical hypothyroidism. The effects observed in adults and children were generally of little clinical significance. Observed side effects included gastrointestinal distress in about 2% and rash in about 1%. In two cases, adults with known iodine sensitivity were hospitalized. FDA's position is that the overall benefits of RI far exceed the risks of KI overdosing, especially in children.

Rev. No. 23 Page 29 of 34

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 5 1 USE OF KI DURING RADIOLOGICAL EMERGENCIES: Q&A (CONTINUED)

11. Should any precautions be considered if KI is recommended for public use?

• Because of possible side effects, individuals with known iodide sensitivity or who have conditions associated with increased risk of iodine hypersensitivity should avoid taking KI;

• Individuals should consult their physicians to determine if they have iodine sensitivity or conditions that may increase their risk of developing iodine hypersensitivity. Such information should be obtained prior to an emergency, since, to be effective, KI needs to be taken within a narrow time window from exposure.

• Because some newborns may develop transient hypothyroidism, newborns given KI should be monitored for hypothyroidism symptoms, and treated if such symptoms are observed. FDA recommends that neonates (newborn to one month), pregnant and lactating women, and those with known iodine sensitivity, should be given priority with regard to other protective measures.

12. What dosage of KI should be administered?

In December 2001, FDA issued a revised guidance document, which recommends the following lowest effective dosages for the different age groups:

Age Group KI Dosage of 130 mg Adults over 18 years 130 mg 1 Over 3 - 18 years 65 mg 1/2 Over 1 month to 3 years 32 mg 1/4 Birth to 1 month 16 mg 1/8 Rev. No. 23 Page 30 of 34

EMERGENCY USE OF POTASSIUM IODIDE'(KI) EAP-19 ATTACHMENT 5 USE OF KI DURING-RADIOLOGICAL EMERGENCIES: .Q&A (CONTINUED)

At the time of this writing, the only currently available FDA-approved over-the-counter formulation is in the 130 mg tablets. Since it is hard to cut many pills, the State Health'Commissioner says that, in an emergency, it is safe for children at school-or day care centers to take the whole pill. Due to the logistics involved in cutting multiple pills, the New York State Commissioner of Health supports the administration of the 130 mg tablet for children in settings such 'as schools or childcare centers in the event of emergencies. This dose is safe and well within the recommended therapeutic range of KI for other indications. The blocking effect of iodide on the thyroid lasts only a few days and any suppressive effect of KI on thyroid function has been shown to be minimal, even in young children. For children or babies who cannot take pills, parents and caregivers can cut or crush the pill to make lower doses. For example, if a 130 mg pill were dissolved in 8 ounces of juice or other liquid, one ounce would contain 16 mg of KI.

13. How often should KI be taken?

Administered KI is effective for about 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. The State or local health department will issue instructions regarding how long to continue taking KI. Once individuals are removed from the areas affected by the release, there is no need to continue taking KI.

14. Does KI come in'liquid or pill form?

It could be in either form. For prophylactic use in nuclear power plant emergencies in.the US it is marketed' in a tablet form. After the 1986 Chernobyl-accident, Poland used the liquid form to administer-KI to its' population. Currently, the FDA has only approved the 130 mg KI in tablet form.' New York State has requested FDA to expedite approval of other dosages, as well as liquid form.

Rev. No. 23 Page 31 of 34'

i EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 5 USE OF KI DURING RADIOLOGICAL EMERGENCIES: Q&A (CONTINUED)

15. Is there a shelf life for KI?

The shelf life approved by FDA for different manufacturers of the drug ranges from three to five years. However, if properly stored (protected from air, heat, light and moisture), KI can maintain its form for many years without significant degradation.

16. Does one need a prescription to obtain KI?

No. FDA approved the distribution of KI for prophylactic use as an over-the-counter drug.

17. Can KI be purchased at local pharmacies?

Despite FDA's approval to distribute it over-the-counter, the vast majority of pharmacies do not have it for sale over-the-counter. Individuals can purchase it over the Internet. New York State has requested a supply of KI for individuals who live within ten miles of a nuclear power plant in New York State (Monroe, Orange, Oswego, Putnam, Rockland, Wayne or Westchester Counties). Information regarding pre-distribution and availability will be provided with the annual emergency planning booklet or calendar distributed by either the power company or county government.

For additional information contact:

New York State Department of Health Hotline 1-800-458-1158 ext.

2-7550 or berp~health.state.ny.us Other source of information www.fda.gov/cder/guidance/4825fnl.htm www.who.int/environmental informaiton/Information resources/docu ments/Iodine/guide.pdf www.health.state.ny.us/nysdoh/consumer/environ/homeenvi.htm Rev. No. 23 Page 32 of 34

.; !. 'r , - ...,J, EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP -19 EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19

.ATTACHMENT.6 Page 1 of 2 DOH: USE OF KI DURING:RADIOLOGICAL EMERGENCIES INFORMATION FOR

- . :, f-THE PUBLIC 00*N Use of Potassium Iodide (KI) During Radiological Emorgencies Information for the Public This fact street is aboLut a now policy for people, especially those who live witlhin ten

-.9...~- mnriles of a nuclear power plant, who may be exposed to radiation from a niuclear plint emergency.. In December 2007. the Federal Food and Drug Administration (FDA) said if there was a radiological emergency, people should take a drwg that would holp protect them from thyroid cancer. This WVtv _ drug is called potassium iodide (KI). The New York State Health

______ Department agrecs. The questions and answers below will give you more information.

1. What is potassium iodide (KI) and 6. Does KI work in all radiation what is it used for? emergencies?

If there is a radiological emergency from a KI will only protect you from radioactive nuclear plant. large anmounts of somethirnj iodine. It does not protect you from other called radioiodine could be put into the air. kinds of radioactive material. KI works very and this could hurt your th yroid gland, -or well to protect your thyroid gland However.

even cause thyroid cancer later on. You it protects only your thyroid, not other parts could breathe in the radioiodine or eat food of your body.

that has some radioiodine in it. When you take the KI pill, it protects your thyroid gland 7. What will happen in an emergency?

from being harmed. You will be told what, if any, actions you should take to protect yourself. This might

2. How does potassium iodide work? include leaving the area. staying inside with When you take the Kl pill, it fills your thyroid your windows closed and/or taking KI.

with a kind of iodine that prevents your thyroid gland from taking in any of the 8. Can people have reactions to KI?

radioactive kind of iodine. In general, most people who have taken KI have not had any reactions (side effects) If

3. What age group has the highest risk people did have a reaction. it did not last from exposure to radioiodine? very long. In a few cases. babies had a Young children have the highest risk. We reaction in their thyroids. Adults who had have learned this fromn looking at children in - -reactions had stomach problems or a rash Russia and other areas who were exposed The federal government thinks the benefits to the radioodino froui the Chernobyl of taking KI arermuch greater than the risks.

nuclear power plant accident.

9. Are there some people who should

4. When should KI be taken? not take KI?

You need to take KI before or just after you Most people can take KI. but you should talk:

are exposed to radiowdine. You caln also to your doctor before takirig it. Talk to your 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 riot bK as doctor before an emergency occurs. It is not helpful. a good idea to take it if you havo certain medical conditions or problerims. Babies

5. How will I know if I should take Ki? need to be watched carefully if they take KI.>

If there Is an emergency, you will hear an announcement from your local or state 10. How much KI do I take?

heallh officials. Your local health The table below shows the smallest KI dose department will tell you when you should that different ago groups can tako which will start taking KI and they will also tell you protect the thyroid. At the rorment, the pill when you can stop taking it. only comes in a 130 mg tablet.I Since it is hard to cut many pills. the State Health Commissioner says that, in an emergency, it is safe for children at school or day carae centers to take the whole pill. For children or Rev. No.-,23 Page -33 .. of 34;

EMERGENCY USE OF POTASSIUM IODIDE (KI) EAP-19 ATTACHMENT 6 Page 2 of 2 USE OF KI DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC babies who cannot take pills, parents and 12. Does KI come in liquid or pill form?

caregivers can cut or crush the pill to make KI can come as a pill or a liquid, but right lower doses. For example, if a 130 mg pill now it is only available as a pill. It may also were dissolved in 8 ounces of juice or other be available as a liquid soon.

liquid, one ounce would contain 16 mg of KI.

13. If KI has been stored for a while, Is it Age KI Dosage Number of 130 still OK to use?

Group mg tablets The manufacturers say KI stays fresh" for Adults 130 mg 1 3-5 years. If you keep it in a dry, dark and over 18 cool place, it should last for many years.

years Over 3 - 65 mg 1/2 14. Do you need a prescription to get Kl?

18 years - No. You are allowed to get it over-the-Over 1 0 32 mg 1/4 counter.

mnonth to 3 years 15. Can KI be purchased at local Birth-1 i 6 mg 8 pharmacies?

month It is not widely available in drugstores yet.

but since it is not a prescription drug, you can buy it over the Internet. We hope to give

11. How often should KI be taken? a supply of K<to people who live within 10 KI 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 miles of a nuclear power plant in New York keep taking it until the health department State.

says to stop. or you are out of the emergency area.

For additional information contact:

New York State Department of Health Infoline, 1-B00-458-1 158, extension 2-7550 or BERP(6heaIth.state. nv.us Other sources of Information:

wmw.ldagov1Cder/c OudanceI4825Wnl.him www.whio.intenvironmnental informalionrl riormalior resourcesldortimen S/d nplgliid..opdI www.health slale.nv.us/nysdoh/consumer/environlhorneeivi.thihi-June 2002 Rev. No. 23 Page 34 of 34