View source for Information Notice 1988-15, Availability of Us Food & Drug Administration (FDA) Approved Potassium Iodide for Use in Emergencies Involving Radioactive Iodine

{{Adams
| number = ML031150486
| issue date = 04/18/1988
| title = Availability of Us Food & Drug Administration (FDA) Approved Potassium Iodide for Use in Emergencies Involving Radioactive Iodine
| author name = Cunningham R E
| author affiliation = NRC/NMSS/IMNS
| addressee name = 
| addressee affiliation = 
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| license number = 
| contact person = 
| document report number = IN-88-015, NUDOCS 8804120097
| document type = NRC Information Notice
| page count = 10
| revision = 0
}}
{{#Wiki_filter:UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555April 18, 1988NRC INFORMATION NOTICE NO. 88-15: AVAILABILITY OF U.S. FOOD AND DRUGADMINISTRATION (FDA)-APPROVED POTASSIUMIODIDE FOR USE IN EMERGENCIES INVOLVINGRADIOACTIVE IODINE

==Addressees==
:Medical, Academic, and Commercial licensees who possess radioactive iodine.

==Purpose==
:This notice is intended to provide information on the storage and use ofpotassium iodide as a thyroid blocking agent in incidents involving exposureto radioactive iodine. It is expected that licensees will review this infor-mation for applicability to their licensed activities and distribute this noticeto responsible radiation safety staff. However, suggestions contained in thisInformation notice do not constitute new NRC requirements, and no writtenresponse is required.

==Description of Circumstances==
:During a nuclear pharmacy inspection, NRC and the licensee discussed thepossibility of maintaining a supply of potassium iodide at each pharmacylocation. This supply would be used as a thyroid blocking agent in caseof an iodine-131 sodium iodide spill with possible personnel contamination.The licensee asked for a statement of NRC's policy regarding on-site storageof potassium iodide for use In Incidents involving radioactive exposures.There is an NRC and Federal Emergency Management Agency (FEMA) policy ad-dressing on-site storage of FDA-approved "radiation emergency potassiumiodide" as a thyroid blocking agent for power reactor emergency workers(Federal Register, Vol. 50, No. 142, p. 30258, July 24, 1985).Discussion:There is no NRC policy on non-reactor licensees using FDA-approved "radiationemergency potassium iodide" (i.e., the generic drug nomenclature). However,as discussed below, licensees may wish to provide for its availability in caseof an emergenc IN 88-15April 18, 1988 The FDA has evaluated the medical and radiological risks of administeringpotassium iodide for thyroid blocking under emergency conditions. The FDAhas concluded that FDA-approved "radiation emergency potassium iodide" issafe and effective and has approved it for over-thelcounter sale for thispurpose Re ister, Vol. 50, No. 142, p. 30258, July 24, 1985). FDAguidance states that risks of side effects, such as allergic reactions, fromthe short-term use of relatively low doses of potassium iodide for thyroidblocking in a radiation emergency, are outweighed by the risks of radioiodine-induced thyroid nodules or cancer, if the projected dose to the thyroid glandis 25 rems or greater. Because FDA has authorized the non-prescription saleof "radiation emergency potassium iodide," it is legally available to organi-zations or individuals who, based on their own corporate or personal analysis,choose to have the drug immediately available.At this time, ANBEX, Inc. (Box 863, Radio City Station, New York, NY 10019)and Carter-Wallace, Inc. (P.O. Box 1001, Cranbury, NJ 08512) are the onlycompanies that have received FDA new drug application (NDA) approval fortheir non-prescription "radiation emergency potassium iodide" drugs. Thesedrugs are not stocked in pharmacies and must therefore be ordered directlyfrom the companies. The non-prescription "radiation emergency potassiumiodide" is manufactured at the proper adult dosage for thyroid blocking,is readily absorbed by the body, and has a package insert providing infor-mation on the dosage, method of action, warnings and storage. The directionsin the package insert should be followed. Other forms of potassium iodideare available by prescription, only.Potassium iodide is effective as a thyroid blocking agent. It reduces thyroidgland accumulation of radioiodine that has entered the body through inhalationor ingestion if the potassium iodide is administered before, or immediatelyafter, exposure to the radiolodine. If potassium iodide is administered laterthan four hours after an individual has suffered an acute ingestion or in-halation of radiolodine, its effectiveness as a thyroid blocking agent isless than 50 percent.If the licensee wants to implement a potassium iodide thyroid blocking program,the potassium iodide should be on hand (because it is not readily available5,and guidelines should be developed to ensure rapid determination of whethera radioactive iodine spill or leak warrants administration of the potassiumiodide. The guidelines should also address the more detailed measurements,surveys, and other followup procedures needed to determine whether continuedtreatment with potassium iodide is needed.It is important to stress that the use of potassium iodide is not a substitutefor preventive measures; e.g., proper handling techniques, control measures,and emergency procedures that protect the individual from exposure to radio-active materia IN 88-15April 18, 1988 Licensees are also advised that although FDA has approved "radiation emergencypotassium iodide" for non-prescription sales, licensees or individuals stillmay wish to consult with a physician about any medical risks of use in anemergency.No specific action or written response is required by this information notice.If you have any questions regarding this matter, please contact the personlisted below or the appropriate NRC regional office.Richard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Donna-Beth Howe, NMSS(301) 492-0636

===Attachments:===
1. Federal Policy on Distribution of PotassiumIodide Around Nuclear Power Sites for Useas a Thyroidal Blocking Agent2. List of Recently Issued NRC Information Notices Attachment 130258Federal ReRister / Vol. 50. No. 142 / Wednesday. July 24. 1985 / Notices.. I .---.--___FEDERAL EMERGENCYMANAGEMENT AGENCYFederal Policy on Distribution ofPotassium iodide Around NuclearPower Sites for Use as a ThyroidalBlocking AgentAGENCY: Federal EmergencyManagement Agency.ACTION: Notice of Issuance of FederalPolicy-correction.6UMMARr. The Federal RadiologicalPreparedness Coordinating Committee(FRPCC) is publishing this notice toprovide guidance to State and localagencies responsible for radiologicalemergency planning and preparednessregarding the distribution of potassiumiodide for use as a thyroidal blockingagent by the general public in thevicinity of nuclear power plants. TheFederal Emergency ManagementAgency (FEMA) chairs the FRPCC,thereby assuming the responsibility for-this publication.In FR Doc. 85-14810 beginning on page25624 in the issue of Thursday June 20,1985, the statement of Federal Policywas inadvertently not included. Thecomplete policy is stated herein. Inaddition, a portion of the SupplementaryInformation has been deleted because itwas inconsistent with previouslypublished Food and DrugAdministration policy..FOR FURTHER INFORMATION 

==CONTACT==
.Gerard W. Smith, TechnologicalHazards Division, Office of Nationaland Technological Hazards Programs.State and Local Programs and Support,Federal Emergency ManagementAgency, 500 C Street SW., Washington.D.C 20472 202-846-2869.SUPPLEMENTARY INFORMATION:BackgroundThis guidance on distribution ofpotassium iodide as a thyroidal blockingagent to the general public in thevicinity of nuclear power plants is partof a Federal interagency effortcoordinated by the Federal EmergencyManagement Agency (FEMA) for theFederal Radiological PreparednessCoordinating Committee (FRPCC).FEMA issued a final regulation in theFederal Register of March 11, 1982, (47FR 10758). which reflected governmentalreorganizations and reassigned agencyresponsibilities for radiological incidentemergency response planning. 44 CFR351 A responsibility assigned to theDepartment of Health and HumanServices (HHS) and in turn delegated tothe Food and. Drug Administration(FDA) is the responsibility to provideguidance to State and local governmentson the use of radioprotective substancesand prophylactic use of drugs (e.g.potassium iodide) to reduce radiationdose to specific organs including dosageand projected radiation exposures atwhich such drugs should be used.In the Federal Register of June 29,19M2(47 FR 28158). FDA publishedrecommendations for State and localagencies regarding the projectedradiation dose to the thyroid gland atwhich State and local health officialsshould consider the use of potassiumiodide.The guidance published here containsthe rationale on the use of potassiumIodide for emergency workers andinstitutionalized individuals. It alsoincorporates the considerations thatshould be made in deciding toimplement the distribution and use ofpotassium iodide for the generalpopulation. The decisions ondistribution and use of potassium Iodidefor thyroidal blocking to protect thepublic health and safety resides with theState and, in some cases, local healthauthorities. It suggests that any decisionby State and local authorities to usepotassium iodide should be based on thesite environment and conditions at thetime of an emergency for the specificoperating commercial nuclear powerplant and should include detailed plansfor distribution, administration, andmedical assistance.The Federal position with regard tothe predistribution or stockpiling ofpotassium iodide for use by the generalpublic is thatit should not be required.Policy on Distribution of PotassiumIodide Around Nuclear Power Sites forUse as a Thyroldal Blocking AgencyThe purpose of this document is toprovide Federal policy and guidancewith regard to distribution of potassiumiodide (IG) and its usage as a thyroidblocking agent around operating nuclearpower sites. The issue has beenaddressed in terms of two componentsof the population that might require ordesire potassium iodide use: (1)Emergency workers andinstitutionalized individuals, and (2)general population. This guidance isadvisory to State and local governmentswho, within the limits of their authority,should consider these recommendationsin the development of emergency plansand in determining appropriate actionsto protect the general public. Insummary, the policy recommends thestockpiling or distribution of KI duringemergencies for emergency workers andinstitutionalized persons, but does notrecommend requiring predistribution orstockpiling for the general public. Thebases for these recommendations aregiven below. It is recognized, however,that options on the distribution and useof la rests with the States, and hence.the policy statement permits State andlocal governments, within the limits oftheir authority, to take measures beyondhose recommended or requirednationally.The US. Nuclear RegulatoryCommission (NRC) and the FederalEmergency Management Agency(FEIA) have already issued guidanceto State and local authorities as well aslicensees of operating commercialnuclear power plants in NUREG-0654/FEMA-REP-1, Rev. 1. recommending thestockpiling and distribution duringemergencies of la for thyroidal blockingto emergency workers and toinstitutionalized individuals. Thatrecommendation is endorsed as anavailable protective action in the eventof an incident at a nuclear power plant.Thyroid blocking for emergency workersand institutionalized individuals wasrecommended because:(1) These individuals would be morelikely to be exposed to the radioiodinein an airborne radioactive release fromthe plant in the event of an accident;(2) The number of individualsinvolved at any site is relatively smalland requires a limited supply of IU thatcan be readily distributed;(3) The storage, distribution, andadministration of la can be readilycontrolled.(4) The known sensitivity topotassium iodide of this limited numberof individuals can be reviewed; and(5J These Individuals can be readilymonitored for adverse side effects bymedical personnel.The Federalposition with regard to thepredistibution or stockpiling ofpotassium Iodide for use by the generalpublic is that it should not be requiredWhile valid arguments may be made forthe use of KI the preponderance ofInformation Indicates that a nationwiderequirement for the predistribution orstockpiling for use by the general publicwould not be worthwhile. This is basedon the ability to evacuate the generalpopulation and the cost effectiveness ofa nationwide program which has beenanalyzed by the NRC and DOE NationalLaboratories (NUREG/CR-1433). Whilethe use of KI can clearly provideadditional protection in certaincircumstances, the assessment of theeffectiveness of Kl and other protective-actions and their implementationproblems indicates that the decision touse Kl (and/or other protective actions)should be made by the States and, ifappropriate, local authorities on a sitespecific basi Federal Register / Vol. 50. No. 142 / Wednesday, July 24, 1985 / Ndtices30259It is important to stress that the use ofpotassium iodide in a radiationemergency is not a panacea in that itdoes not block the uptake of otherradionuclides and does not protectagainst external radiation. Furthermore,Its use needs to be balanced against thecost and effectiveness of otherprotective measures such as shelteringand evacuation. This recommendation ismade in full recognition of the potentialpositive effects of the drug, action by theFDA permitting XI over-the-countersales, and the authority of State andlocal health officials to elect todistribute and use the drug based on thespecific needs of individual sites.The use of Jl is effective as athyroidal blocking agent in reducingaccumulation by the thyroid gland ofradioiodine which has entered the bodythrough Inhalation or ingestion.Radiolodine accumulation in the thyroidcan be reduced to less than 10 percent ofwhat it would be without a blockingagent by a daily oral intake of (130milligrams for adults, 65 milligrams forinfants) 1a providing administration isstarted before or immediately after theexposure to the radiolodine. andtreatment continues for at least 48 hoursbeyond the time of the last exposure.This effectiveness decreases to less than50 percent blocking of the radiolodineuptake, if administration of the la isdelayed until 4 hours after an acuteingestion or inhalation.It is recognized that the options ondistribution and use of Xl for thyroidalblocking to protect the public health andsafety resides with the State and, insome cases, local health authorities.Therefore, with the exception of Federalagency and utility personnel, thedecision for use of XI during an actualemergency by the general public is theresponsibility of these authorities. Indeciding whether to distribute and usela for the general population, theseauthorities must consider a number offactors.One of the considerations in decidingwhether to implement the distributionand use of la for the general populationis that la blocking effectively reducesthe radiation exposure of only thethyroid gland. While this is an importantcontribution to the health and safety ofthe individual, it is not nearly aseffective as measures which protect thetotal body of the individual fromradioactivity. Both in-place shelteringand precautionary evacuations canreduce the exposure to the thyroid andtotal body. The use of IC for thyroidalblocking is not an effective means byitself for protecting individuals from theradioactivity in an airborne releaseresulting from a nuclear power plantaccident and, therefore, should only beconsidered in conjunction withsheltering, evacuation, or otherprotective methods.The Food and Drug Administration(FDA) has evaluated the medical andradiological risks of administering XI forthyroidal blocking under theseemergency conditions and hasconcluded that it is safe and effectiveand has approved over-the-counter saleof the drug for this purpose. FDAguidance states that risks from the shortterm use of relatively low doses of XI forthyroidal blocking in a radiationemergency are outweighed by the risksof radioiodine induced thyroid nodulesor cancer at a projected dose to thethyroid gland of 25 rem or greater. SinceFDA has authorized the nonprescriptionsale of lI, it is legally available toindividuals who, based on their ownpersonal analysis, choose to have thedrug immediately available.Other considerations and problems tobe evaluated by the State and localauthorities in deciding whether toinstitute this program include: (1)Whether the KX should be distributed tothe population before an accident occursor as soon as possible after an accidentoccurs; (2) whether the risks of exposureto radioactivity will be lower If theevacuation of the general population isinitiated or if the general population issheltered-and the administration of lIinitiated; (3) how the la will bedistributed during the emergency; (4)what medical-assistance will beavailable to assist the individuals whomay have some adverse reaction to KI;(5) how medical authorities will advisethe population to take Xl and underwhat circumstances this advice will begiven: (a) if }a is predistributed, whatassumptions should be made about itsactual availability and use in the eventof an incident; (7) how the authoritieswill provide Ma to transient populations;and (8) whether use of other respiratoryprotection (e.g., dust masks, or breathingthrough wet towels) may be equallyeffective, especially in conjunction withsheltering.In summary, the use of Kl to preventradioldine from accumulating in thethyroid gland can be an effectiveancillary protective action during anuclear power plant accident. However,many factors make stockpiling and/orpre-distribution to the general publicquestionable. Whether XI should bestockpiled and distributed to-the generalpublic around a particular site dependson local conditions. Additionally,decisions on its use or the use ofalternative protective measures duringan emergency depends on accident andenvironmental conditions that mayprevail at the time. Any decision byState and local authorities to use Klshould be based on the conditions andsite environment for the specificoperating commercial nuclear powerplant and should include detailed plansfor distribution, administration. andmedical assistance. The followingreference are intended to assist Stateand local authorities in decisions relatedto use of la.1. National Council on RadiationProtection and Measures (NCRP),Protection of the Thyroid Gland in theEvent of Releases of Radiolodine. NCRPReport No. 55. August 1.1977.2. Food and Drug Administration(HEW), Potassium Iodide as a Thyroid-Blocking Agent in a RadiationEmergency. 43 FR 58798, December 15.197&3. Halperin, JA. B. Shleien. S.E.Kahana, and i. M. Bilstad, BackgroundMaterial for the Development of theFood and Drug Administration'sRecommendations on Thyroid-Blockingwith Potassium Iodide, FDA 81-815&U.S. Dept. of Health and HumanServices (March 1981).4. Food and Drug Administration.Potassium Iodide as a Thyroid-BlockingAgent in a Radiation Emergency- FinalRecommendations en Use; (Notice ofAvailability) 47 FR 28158 June 29,1982.5. Food and Drug Administration,Potassium Iodide as a Thyroid-BlockingAgent in a Radiation Emergency.Recommendations on Use. (April 1982)Prepared by the Bureau of RadiologicalHealth and Bureau of Drugs. Food andDrug Administration, Department ofHealth and Human Services.0. Nuclear Regulatory Commission.Examination of the Use of PotassiumIodide (XI) As an Emergency ProtectiveMeasure for Nuclear Reactor Accidents(NUREG/CR-1433, March 1980).Prepared by Sandia NationalLaboratories for the NRC.Richard W. xrmm.Chairman, FederalRadiologicalPreparedness Coordinating Committee.[FR Doc. 85-17171 Filed 7-23-85; 8:45 am]BNLiNG CODE $705114-1- yAttachment ?IN 88-15April 18, 1988 LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to88-1488-1388-1288-11Potential Problems withElectrical RelaysWater Hammer and PossiblePiping Damage Caused byMisapplication of KerotestPackless Metal DiaphragmGlobe ValvesOvergreasing of ElectricMotor BearingsPotential Loss of MotorControl Center and/orSwitchboard Function Dueto Faulty Tie BoltsMaterials Licensees: Lackof Management Controls OverLicensed ProgramsThimble Tube Thinning inWestinghouse ReactorsReduced Reliability ofSteam-Driven AuxiliaryFeedwater Pumps Causedby Instability of WoodwardPG-PL GovernorsChemical Reactions withRadioactive WasteSolidification Agents4/18/884/18/884/12/884/7/883/28/883/28/883/18/883/14/8888-10All holders of OLsor CPs for nuclearpower reactors.All holders of OLsor CPs for nuclearpower reactors.All holders of OLsor CPs for nuclearpower reactors.All holders of OLsor CPs for nuclearpower reactors.All NRC licenseesauthorized to usebyproduct material.All holders of OLsor CPs for nuclearpower reactors thatemploy a WestinghouseNSSS.All holders of OLsor CPs for nuclearpower reactors.All NRC licenseesgenerating or pro-cessing low levelradioactive waste.87-44,Supp. 188-0988-08OL -Operating License-CP = Construction Permit IN 88-15April 18, 1988 Licensees are also advised that although FDA has approved "radiation emergencypotassium iodide" for non-prescription sales, licensees or individuals stillmay wish to consult with a physician about any medical risks of use in anemergency.No specific action or written response is required by this information notice.If you have any questions regarding this matter, please contact the personlisted below or the appropriate NRC regional office.0r6In2l Sigred byRichard EL CunnintailRichard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Donna-Beth Howe, NMSS(301) 492-0636

===Attachments:===
1. Federal Policy on Distribution of PotassiumIodide Around Nuclear Power Sites for Useas a Thyroidal Blocking Agent2. List of Recently Issued NRC Information NoticesEditor* DOEA* IMAB* IMAB*EKraus MKing NLMcElroy VLMiller/ /88 4/12/88 / /88 / /88*See previous concurrencesOFC: IMOB* :IMAB* :IMOB* :14OB* :IMNS* :IMNS-_____________________________________________________________________________NAME:JRMetzger/ll:DBHowe :DCool :JHickey :GSjoblom:RECunningham____________________________-_______________________________________________-_DATE: / /88 : /88: / /88: 1188: 88: / 88mFFICIAL KECURD COPY IN 88-March ,1988 Licensees are also advised that although FDA has approved "radiation emergencypotassium iodide' for non-prescription sales, licensees or individuals stillmay wish to consult with a physician about any medical risks of use in anemergency.No specific action or written response is required by this Information Notice.If you have any questions regarding this matter, please contact the personlisted below or the appropriate NRC regional office.Richard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Donna-Beth Howe(301) 492-0636

===Attachment:===
List of recently issued NRC Information NoticesEdi tor*EKrausDOEA*MKingIMAB*NLMcElroyIMAB*VLf~i ler/ /88 / /88 /88 /88 > Se-*See previous concurrencesOFC: IMOB* :IMAB* :IMOB* :IMOB* :IMNS* :IMNS g :0OG.--NAME:JRMetzger/ll:DBHowe :DCool :JHickey :GSjoblom:RECunningham :jtwkSk"A,DATE: / /88 :/ /88: / /88: //188: / 88: 9/ 88: A/OFFICIAL RECORD COPY IN 88-March ,1988 Licensees are also advised that although FDA has approved "radiation emergencypotassium iodide" for non-prescription sales, licensees or Individuals stillle r m ef nsut fing with a physician about any medical risks of use?7in an emergencyNo specific act n or written response is required by this Information Notice.If you have any q stions regarding this matter, please contact the personlisted below or th appropriate NRC regional office.Richard E. Cunningham, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Donna-Beth we(301) 492-06

===Attachment:===
List of recently issue NRC Information NoticesEditorv DOEA IMAB IMAB W'\EKraus MKing NLMcElroy VLMiller/ /88 / /88 / /88 / /88(See previous concurrence)OFC: IMOB ,- :IMAB ,- :IMOB v- :IMOBV :IMNS :!I4NS-_________________-___-___-________-__-_-__________-_________________________NAME:JRMetzger/ll:DBHowe :DCool :JHickey :GSjoblom:RECunninghamDATE: / /88 :/ /88: / 88: /88: / 88 :/88OFFICIAL RECORD COPY IN 88-March ,1988 Licensees are also advised that although FDA has approved 'radiation emergencypotassium iodide' for non-prescription sales, licensees or ind viduals stillhave the choice of consulting with a physician about any mede al risks of usein an emergency.No specific action or written response is required by th s Information Notice.If you have any questions regarding this matter, please contact the personlisted below or the appropriate NRC regional office.Richard E. C ningham, DirectorDivision of ndustrial andMedical ' clear Safety

===Technical Contact:===
Donna-Beth Howe(301) 492-0636

===Attachment:===
List of recently issued NRC nformation NoticesEditor DOEA I AB "'A'EKraus CVP4' MKing Nf roy VLMil3/T4/88 / /88 3/2/188 ) %9/88OFC: IM :IHAB :IMOB :IMB IMNNAME:A etzger/ll:DBU,, _ 6* 6ri :J key : < ob * :RECunninghamDATE t3 Z/88 :3/ l/88: V/A1/88: ) /!"I88: 3k688 : / 88OFFICIAL RECORD COPY}}

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