ML110050135

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Revision 2 to Emergency Plan Implementing Procedure IP-EP-420, Use of Potassium Iodide by Indian Point Personnel During an Emergency
ML110050135
Person / Time
Site: Indian Point  Entergy icon.png
Issue date: 12/10/2010
From: Glander L
Entergy Nuclear Operations
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
FOIA/PA-2011-0181, FOIA/PA-2011-0262 IP-EP-420, Rev 2
Download: ML110050135 (16)
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Text

. December 28, 2010 DISTRIBUTION CONTROL LIST Document Name: IPEC EMERGENCY PLAN CC# NAME DEPARTMENT LOCATION CC/STMP CROULET, DON INSTRUC TECH TRNG (E-PLAN ONLY) 48-2-A CC/STMP IRAOLA, TONY FOR THE JIC EOF CC/STMP SHIFT MANAGER OPERATIONS IP3 CC/STMP CONTROL ROOM OPERATIONS IP3 CC/STMP EOF E-PLAN (ALL EP'S) EOF CC/STMP PEREZ, ROSE E-PLAN (ALL EP'S) WPO-12D CC/STMP TSC (IP3) EEC BUILDING IP2 CC/STMP BARR, STEVE NRC (ALL EP'S) OFFSITE CC/STMP BARR, STEVE NRC (ALL EP'S) OFFSITE CC/STMP DOC CONTROL DESK NRC (ALL EP'S) OFFSITE CC/STMP DOC CONTROL DESK NRC FOR (E-PLAN ONLY) OFFSITE (USE ATTENTION TO DIRECTOR OF SPENT FUEL ADDRESS)

CC/STMP CULLINAN, P J A (PLAN ONLY) OFFSITE CC/STMP E-PLAN STAFF E-PLAN (ALL EP'S) GSB-2ND FL CC/STMP BRUNELLE, GREGORY ST. EMERG. MGMT. OFFICE (ALL) OFFSITE CC/STMP DELBORGO, D (PLAN ONLY) DISASTER & EMERGENCY OFFSITE CC/STMP LONGO, N (PLAN ONLY) EMERGENCY SERVICES OFFSITE CC/STMP KARSTEN,C (PLAN ONLY) DISASTER & CIVIL DEFENSE OFFSITE CC/STMP STIEBELING A (PLAN ONLY) OFF OF EMERG MANAGEMENT OFFSITE CC/STMP GRANT, LEAH SIMULATOR (TRAINING) 48-2-A CC/STMP GRANT,LEAH LRQ TRAINING 48-2-A CC/STMP CONTROL ROOM OPERATONS IP2 CC/STMP CHIUSANO, J SIMULATOR (TRAINING 5 COPIES) EEC CC/STMP CHIUSANO, J CLASSROOM 2 EEC CC/STMP CHIUSANO, J TRAINING 48-2-A CC/STMP NRC RESIDENT INSPECTOR US NRC (88' ELEVATION) ip2 TONY IRAOLA GETS:.... E-PLAN, IP-EP-115 (FORMS), IP-EP-260(JOINT CENTER INFORMATION) "NO FORMS GO TO THE OFFSITERS"

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FROM: IPEC DOCUMENT CONTROL: 9 or IP2 53'EL PHONE NUMBER: (914) 271-7054 AFFECTED DOCUMENT: IPEC EMERGENCY PLAN PROCEDURE DOC # REV # TITLE INSTRUCTIONS THE FOLLOWING PROCEDURE HAS BEEN REVISED, PLEASE REMOVE YOUR CURRENT COPY AND REPLACE WITH ATTACHED REVISIED PROCEDURE:

IP-EP-420 REV.2

                      • PLEASE NOTE EFFECTIVE DATE***********

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 I CERTIFY THAT ALL SUPERSEDED, VOID, OR INACTIVE COPIES OF THE ABOVE LISTED DOCUMENT(S) IN MY POSSESSION HAVE BEEN REMOVED FROM USE AND ALL UPDATES HAVE BEEN PERFORMED IN ACCORDANCE WITH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 E KIAr"vL a

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IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 IMPLEMENTING EMEREN P PROCEDUREP PRCDRSREFERENCE USE Page 1 of 1_44 Use of Potassium Iodide by Indian Point Personnel During an Emergency Prepared by: Lori Glander, ignatur Approval: Brian Sullivan Lr-n --om Dare Effective Date: December 22, 2010 IP-EP-420(KI) R2.doc

£ IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 2 of 14 Table of Contents 1.0 PURPOSE .............................. 3

2.0 REFERENCES

................................................................................ 3 3.0 DEFINITIONS ....................................................... 3 4.0 RESPONSIBILITIES ................................. 3 5.0 DETAILS ............................................................................. 4 6.0 INTERFACES ........................................................ 5 7.0 RECORDS .......................................................... 5 8.0 REQUIREMENTS AND COMMITMENT CROSS-REFERENCE .............................................. 5 9.0 A T T AC HME NT S ............................ ......... ................................................... 5 9.1 Patient Package Insert for Thyro-Block Potassioum Iodide ................................................ 6 9.2 Locations of Potassium Iodide ...................................................................................... 7 9.3 DOH: USE OF KI DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC ................. 8 9.4 New York State Policy on Potassium Iodide (Update June 2009) .................................... 10

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 EnI Orgy, EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 3 of 144 Use of Potassium 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 (KI) by Indian Point Energy Center personnel during an emergency.

2.0 REFERENCES

2.1 New York State Implementation of the use of Potassium Iodide (KI) 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 the Operations Support Center 3.4 CDE is Committed Dose Equivalent 3.5 TEDE is Total Effective Dose Equivalent 3.6 TODE is Total Organ Dose Equivalent 3.7 KI is Potassium Iodide 4.0 RESPONSIBILITIES 4.1 Emergency Plant Manager is to approve issuing Potassium Iodide to Entergy workers within the Owner Controlled Area.

4.2 Emergency Director is to approve issuing Potassium Iodide to off site Entergy workers.

4.3 Offsite Radiological Manager is responsible to supply Emergency Director dose assessment calculations to determine issuing of Potassium Iodide to personnel outside the protected area.

4.4 OSC Radiation Protection Team Leader is responsible to supply the Emergency Plant Manager dose assessment calculations to determine issuing of Potassium Iodide within the Protected Area.

4.5 Emergency Planning is to maintain a stock of Potassium Iodide at each identified location to assure enough is available to support workers for three (3) days.

EnfIergy, IPEC EMERGENCY PLAN NON-QUALITY RELATED PROCEDURE IP-EP-420 Revision 2 IMPLEMENTING PROCEDURES REFERENCE USE Page 4 of 14 5.0 DETAILS 5.1 Activation of the IPEC Emergency Response Organization has occurred and a release of radioactivity has occurred.

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

5.3 There are two (2) conditions where KI may be issued: a declared General Emergency and/or abnormal radiological conditions.

5.4 The OSC Radiation Protection Team Leader and the Offsite Radiological Manager SHALL maintain an awareness of onsite and offsite radiological conditions respectively.

5.5 If a General Emergency is declared, then all personnel in the Protected Area are authorized for voluntary use of KI by the Emergency Plant Manager via a Site announcement.

5.5.1 The OSC Radiation Protection Team Leader SHALL ensure that KI is available 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, the Offsite Radiological Manager SHALL ensure that KI is available to Entergy workers outside the Protected Area. This SHALL include the Field Monitoring Teams and EOF personnel. This SHALL include Security and National Guard personnel. KI tablets are available at the EOF. If necessary assign a member of Dose Assessment to distribute the KI.

5.6.1 The Assembly Area Coordinators SHALL distribute KI to personnel in the EEC and GSB.

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

5.7 The following areas, other then the Assembly Areas, are outside the Protected Area where personnel may be located. In the event that KI is to be issued the Assembly Coordinator will contact those personnel to relocate to one of the Assembly Areas: Material and Services Building, IPEC Warehouse, Unit 3 Warehouse, the Maintenance Training Center, the Unit 2 Simulator.

5.8 If abnormal radiological conditions exist either on site or off site:

5.8.1 Determine the projected child thyroid dose to personnel as outlined in IP-EP-31 0, Dose Assessment.

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

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 n gy EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 5 of 14 NOTE:

For those individuals known to be allergic to KI consider use of alternative personnel prior to issuing KI 5.9 To all personnel who are issued KI issue one (1) 130 mg KI tablet and a copy of Attachment 9.1, Insert for Thyro-Block Potassium Iodide and Attachment 9.3, Use of KI During RadiologicalEmergencies-Informationfor the Public, to each individual projected to receive >5 Rem CDE child thyroid. KI tablets are available in the Control Rooms, Technical Support Center/Operations Support Center, EOF, Assembly Area in the Energy Education Center, and Assembly area in the IPEC Training Building.

5.10 Continue to issue one (1) 130 mg KI tablet and a copy of Attachment 9.1 once, per day as long as the personnel are expected to receive >5-Rem CDE child thyroid.

5.11 After the initial issuance of KI, 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-41 0, Protective Action Recommendations 6.2 IP-EP-250, Emergency OperationsFacility 6.3 IP-EP-230, Operations Support Center 6.4 IP-EP-310, Dose Assessment 7.0 RECORDS NONE 8.0 REQUIREMENTS AND COMMITMENT CROSS-REFERENCE NONE 9.0 ATTACHMENTS 9.1 Insert for Thyroid Block Potassium Iodide 9.2 Locations of Potassium Iodide 9.3 DOH: Use of KI during Radiological Emergencies-Information for the Public 9.4 New York State Policy on Potassium Iodide (updated June 2009)

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 LEnkyY, EMERGENCY PLAN. PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 6 of 14 Attachment 9.1 PATIENT PACKAGE INSERT FOR THYRO-BLOCK POTASSIUM IODIDE

.Sheet I of 1 In a radiation emergency, radioactive iodine may be released in the iosatTM air. This material may be breathed or swallowed. It may enter the thyroid gland and damage it. Children are most likely to have thyroid Tablets damage.

(Potassium Iodide Tablets, U.S.P.) If you take potassium iodide, it will fill up your thyroid gland. This Pronounced poe-TASS-e-um EYE-oh-dyed) lessens the chance that harmful radioactive iodine will enter the (Abbreviated KI) thyroid gland.

TAKE POTASSIUM IODIDE ONLY WHEN PUBLIC HEALTH WHO SHOULD NOT TAKE POTASSIUM IODIDE OFFICIALS TELL YOU. INA RADIATION EMERGENCY RADIOACTIVE IODINE COULD BE RELEASED INTO THE AIR The only people who should not take potassium iodide are people POTASSIUM IODIDE (A FORM OF IODINE) CAN HELP PROTECT who know they are allergicto iodide.. You may take potassium iodide YOU. even if you are taking medicines for a thyroid problem (for example a thyroid hormone or antithyroid drug). Pregnant and nursing women IF YOU ARE TOLD TO TAKE THIS MEDICINE. TAKE IT ONE TIME and babies and children may also take this drug.

EVERY 24 HOURS. DO NOT TAKE ITMORE OFTEN. MORE WILL NOT HELP YOU AND MAY INCREASE THE RISK OF SIDE HOW AND WHEN TO TAKE POTASSIUM IODIDE EFFECTS DO NOT TAKE THIS DRUG IF YOU KNOW YOU ARE ALLERGIC TO IODIDE (SEE SIDE EFFECTS BELOW). 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 />.

INDICATIONS More will not help you because thethyroid can "hold" only limited amounts of iodine. Larger doses will increase the risk of side effects.

THYROID BLOCKING INA RADIATION EMERGENCY ONLY You will probably be told not to take the drug for more than 10 days.

DIRECTIONS FOR USE SIDE EFFECTS Usually side effects of potassium iodide happen when people take Use only as directed by State or local public health authorities in the higher doses for a long time. You should be careful not to take more than the recommended dose or take it for longer than you are told.

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

DOSE Possible side effects include skin rashes, swelling of the salivary ADULTS AND CHILDREN ONE YEAR OF AGE OR OLDER One (1) glands, and "iodism" (metallic taste burning mouth and throat, sore tablet once a day. Crush for small children. teeth and gums symptoms of a head cold, and sometimes stomach BABIES UNDER ONE YEAR OF AGE One-half (1/2) tablet once a upset and diarrhea).

day. Crush first DOSAGE: Take for 10 days unless directed otherwise by State or Taking iodide may rarely cause overactivity of the thyroid gland, local public health authorities. Store at controlled room temperature underactivity of the thyroid gland, or enlargement of the thyroid gland between 150 and 30° C (590 and 86' F). Keep package dry and foil (goiter).

packets intact.

WHAT TO DO IF SIDE EFFECTS OCCUR WARNING If the side effects are severe or if you have an allergic reaction, stop POTASSIUM IODIDE SHOULD NOT BE USED BY PEOPLE taking potassium iodide. Then, if possible, call a doctor or public ALLERGIC TO IODIDE. Keep out of the reach of children. In case health authority for instructions.

of overdose or allergic reaction, contact a physician or public health authority. HOW SUPPLIED T

DESCRIPTION IOSAT M Tablets (Potassium Iodide Tablets, U.S.P.) packages of 14 tablets (NDC51803-001-01) Each white round scored tablet Each IOSATTM Tablet contains 130 mg of potassium iodide. contains 130 mg potassium iodide.

HOW POTASSIUM IODIDE WORKS Distributed by ANBEX, INC Certain forms of iodine help your thyroid gland work right. Most 10 East 4 0th Street people get the iodine they need from foods like iodized salt or fish. New York, NY 10016 The thyroid can "store" or hold only a certain amount of iodine. www.anbex.com

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 7 of 14 Attachment 9.2 LOCATIONS OF POTASSIUM IODIDE Sheet 1 of 1 Potassium Iodide is to be stored in the following locations for issuance during a declared emergency.

1. Unit 2 Central Control Room
2. Unit 3 Central Control Room
3. Technical Support Center/Operations Support Center
4. Assembly Area in the Energy Education Center
5. Assembly Area in the IPEC Training Building
6. Emergency Operations Facility

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 E'-inIdergoy EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 8 of 14 Attachment 9.3 DOH: USE OF KI DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC Sheet 1 of 2 Use of Potassium Iodide (KI) During Radiological Emergencies Information for the Public This fact sheet is about a new policy for people, especially those who live within ten miles of a nuclearpowerplant, who may be exposed to radiationfrom a nuclearplant emergency. In December 2001, the FederalFood and Drug Administration(FDA) said if there was a radiological emergency people should take a drug that would help protect them from thyroid cancer.

This drug is called potassium iodide (KI). The New York State Health Departmentagrees."

The questions and answers below will give you more information.

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

If there is a radiological emergency from a nuclear plant, large amounts of something called radioiodine could be KI will only protect you from radioactive iodine. It does not put into the air and this could hurt your thyroid gland, or protect you from other kinds of radioactive material. KI even cause thyroid cancer later on. You could breathe in works very well to protect your thyroid gland. However, it the radioiodine or eat food that has some radioiodine in it. protects only your thyroid, not other parts of your body.

When you take the KI pill, it protects your thyroid gland from being harmed.

7. What will happen in an emergency?

You will be told what if any actions you should take to

2. How does potassium iodide work? protect yourself. This might include leaving the area, When you take the KI pill, it fills your thyroid with a kind of staying inside with your windows closed and/or taking KI.

iodine that prevents your thyroid gland from taking in any of the radioactive kind of iodine.

8. Can people have reactions to KI?

In general, most people who have taken KI have not had

3. What age group has the highest risk from exposure any reactions (side effects) if people did have a reaction if to radioiodine? did not last very long. In a few cases, babies had a Young children have the highest risk. We have learned reaction in their thyroids. Adults who had reactions had this from looking at children in Russia and other areas stomach problems or a rash. The Federal Government who were exposed to the radioiodine from the Chernobyl thinks the benefits of taking KI are much greater than the nuclear power plant accident. risks.
4. When should KI be taken? 9. Are there some people who should not take KI?

You need to take KI before or just after you are exposed Most people can take KI, but you should talk to your to radioiodine. 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 doctor before taking it. Talk to your doctor before an it will not be as helpful. 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 KI.

5. How will I know if I should take KI?

If there is an emergency, you will hear an announcement 10. How much KI do I take?

from your local or state health officials. Your local health department will tell you when you should start taking KI The table below shows the smallest KI dose that different and they will also tell you when you can stop taking it. age groups can take which will protect the thyroid. At the moment, the pill only comes in a 130 mg tablet. 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. For children or babies who cannot take pills, parents and caregivers can cut or crush the pill to make lower doses. For example, if 130 mg pill were dissolved in 8 ounces of juice or other liquid, on ounce would contain 16 mg of KI.

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 EntVg, EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 9 of 14, Attachment 9.3 DOH: USE OF KI DURING RADIOLOGICAL EMERGENCIES INFORMATION FOR THE PUBLIC Sheet 2 of 2 Use of Potassium Iodide (KI) During Radiological Emergencies Information for the Public

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

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

Over 3- 18 65 mg 1/2 years 14. Do you need a prescription to get KI?

Over 1 month to 32 mg 1/4 No. You are allowed to get it over the counter.

3 years Birth - 1 month 16 mg 1/8

15. Can KI be purchased at local pharmacies?

It is not widely available in drugstores yet, but since it is 11, How often should KI be taken? not a prescription drug, you can buy it over the internet.

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 keep taking it We hope to give a supply of KI to people who live within until the health department says to stop or you are out of 10 miles of a nuclear power plant in New York State.

the emergency area.

12. Does KI come in liquid or pill form?

KI can come as a pill or a liquid, but right now it is only available as a pill. It may also be available as a liquid soon.

For additional information contact:

New York State Department of Health info line 1-800-458-1158, extension 2-7550 or BERPthealth.state.ny. us Other sources of information:

www. Ida.gov/oder/quidance/4825fni.htm www./int/environmental information information resources.documentsliodine/quide.opf www.health.state.us/nysdoh/consumer/environ/homeenvi.htm June 2002

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 Jdg IL*-*/EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 10 of 14 Attachment 9.4 New York State Policy on Potassium Iodide (Updated June 2009)

Page 1 of 5 Introduction This Policy updates the 1982 New York State Policy on the use of potassium iodide (KI) 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 KI 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 KI as a thyroid blocking agent. First, in 1978, the FDA announced its conclusion that KI 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 KI 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 KI was based on previous FDA recommendations for administering KI to emergency workers and selected captive populations. This former 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 KI 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 KI 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.

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 ELntera EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 11 of 14 Attachment 9.4 New York State Policy on Potassium Iodide (Updated June 2009)

Page 2 of 5 Rationale for Revising the Existing KI Policy The New York State Department of Health (NYSDOH) has reviewed the new guidance for prophylactic use of KI prepared by the FDA and is hereby recommending that the New York State Policy on KI 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 KI 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 KI 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 KI 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 KI 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 KI for the general public in December, 2001.

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

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 12 of 14 Attachment 9.4 New York State Policy on Potassium Iodide (Updated June 2009)

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

"The New York State Department of Health states that KI 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 KI prophylaxis as well as lower doses of KI for neonates, infants, and children than those previously recommended in 1982 (see Table 1). The recommendation to take KI by the general public will be issued by the Local or State Commissioner 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 KI and its potential benefits and risks; and

" Medical contact, reporting, and assistance systems.

The NYSDOH recognizes FDA recommendations on availability as well as administration of KI in advance of exposure to radioiodine. The NYSDOH stresses that KI provides protection only for the 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 KI should be as an adjunct to recommended protective actions such as evacuation (itself not always feasible), sheltering, and control of foodstuffs."

IPEC NON-QUALITY RELATED IP-EP-420 Revision 2 EMERGENCY PLAN PROCEDURE IMPLEMENTING PROCEDURES REFERENCE USE Page 13 of 14 Attachment 9.4 New York State Policy on Potassium Iodide (Updated June 2009)

Page 4 of 5 Dosing Guidelines In addition to 130 mg tablets, KI 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 KI for Different Risk Groups KIdose # ml liquid # of 65 mg # of 130 (mg) (65 mg/mI) 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 whoweighless than_150 pounds Children over 3 through 12 yrs 65 1. 1 1/2 Over 1 month through 3 years 32 1/2 1/2 1/4 Birth through 1 month 16 1/4 1/4 1/8

Entergyo IPEC EMERGENCY PLAN NON-QUALITY RELATED PROCEDURE IP-EP-420 Revision 2 IMPLEMENTING PROCEDURES REFERENCE USE Page 1_4 of 14 Attachment 9.4 New York State Policy on Potassium Iodide (Updated June 2009)

Page 5 of 5 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. 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 KI 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 KI 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 KI to persons too young to take pills are more complicated. KI 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 KI. 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 across populations at risk for radioiodine exposure, the overall benefits of KI 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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