ML19323C282

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Advises That NRC Has Received Info from Omnidine Corp Describing Alternative to Potassium Iodine Thyroid Blocking Agent to Be Used in Event of Radioiodine Release
ML19323C282
Person / Time
Issue date: 04/21/1980
From: Harold Denton
Office of Nuclear Reactor Regulation
To: Deal J
ENERGY, DEPT. OF
References
NUDOCS 8005150257
Download: ML19323C282 (1)


Text

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WASHING TON, D. C. 20555 5

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April 21, 1980 Mr. Joe Deal Environmental Protection Mail Stop E-201, GTN Department of Energy Washington, DC 20545 Dear Mr.

A.

We have received information from the Omnidine Corporation describing an alternative to the potassium iodine (KI) thyroid blocking agent to be used in the event of a nuclear emergency resulting in the release of radioiodine to the atmosphere. A copy of the letter from Omnidine describing the device is attached.

We will be following the results of the FDA application and want to insure that you are aware of the Omnidine research.

Sincerely, N

Harold R. Denton, Director Office of Nuclear Reactor Regulation

Enclosure:

Letter from Omnidine dtd. 2/15/80 i

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hrp OMNIDINE C:rporatic n 9111 Park Drive Miami Shores' FL 33138 Tcl.: 305-754-7460 800402067 February 15, 1980 Dr. John Ahearne, Commissioner Nuclear Regulatory Commission 1917 H Street, NW Washington, D.C.

20555

Dear Dr. Ahearne:

I am writing to you at the suggestion of Frank von Hiopel, Dh.D.,

nuclear physicist at the Center for Environmental Control, Drinceton University. Dr. von Hippel mentioned to me that you would be interested in learning of the iodine device I have desianed for Omnidine Corporation as the alternative to potassium iodide (MI) f : anemeroencysourceofthyroidblock{ggagent in the event of nuclear mishap with radioactive iodine

(

I) release to the atmo-sphere.

The Omnidine device (patent pendino) is based on the controlled, minimal solubility of elemental iodine (I2) in water: 300 mg/l G 0

20 C.

It consists of a squeezeable bottle, dispensing tio, extended overcap and contains pure iodine crtstals in a special retainer. The device generates " free" or molecular, diatomic iodine, recognized by thyroidologists as an effective thyroid blockina agent.

As you are aware, KI tablets have been criticized in that iodine availability or potency must be checked on a periodic basis. Published reports show cost estimates of S100.000,000 annually for potency evaluation, nationwide. And, even w:.th potency established at a particular date, there exists the passibility of iodine loss between then and the next check. Should iod.ine be required for thyroid blocking due to an emergency during the interim, thyroid orotection could be lacking.

The materials used in the Omnidine device have been selected for compatability with iodine. Material compatability combines with iodine's limited water solubility to produce an extremely inportant effect: the Omnidine device has a virtually unlimited shelf life in storage. The iodine in the device is ever ready for use when necessary. Therefore, the periodic checking costs for KI cotencv are completely obviated, resulting in highly significant orocram cost savings.

Additional savings are provided, too. I have frequently heard the KI initial cost figure quoted at 50 cents per person, or S2.00 for a family of four. In quantity, the Omnidine device can be suoplied at a cost very much less expensive that KI tablets.

4WL.

Dr. John Ahearne, Februcry 15, 1980.,

pnge 2.

Yet another benefit is available with use of the Omnidine device.

During nuclear emergency, it is quite likely that electricity in the area served by the nuclear power plant will be curtailed dras-tically or cut off. Municipal water supplies will therefore be subject to lapses in disinfection protection, thereby raising the problem of water-borne diseases. The same condition applies to private and farm wells dependent on municipal power.

The efficacy of elemental iodine as a broad-spectrum water disinfect-ant is very well established. Liquid " free" iodine dispensed from the device into a container of water rapidly renders the water ootable for family use in drinking and cooking. This important benefit is simply not available with KI.

Another interesting aspect of the Omnidine unit is that in dispensing liquid iodine, it is simple and easy to correctly supply the reduced iodine dose requirements for infants and small children. Obviously, it is difficult and dangerous to attempt administration of a tablet to an infant. Certainly, the KI tablet could be broken and dissolved in liquid prior to feeding, but there is little doubt that during a nuclear emergency many people will panic. Under traumatic circum-stances, the difficulty of administering KI tablets to the very young could produce untoward results, including overdosing.

Omnidine is now preparing to submit application to FDA for permission to make the demonstrable, desirable benefits of its device available to the American public. Should you be interested, we will be cleased to keep you informed of our progress.

Please feel free to contact me at Omnidine for any additional informa-tion you may require.

Sincerely, h.

Richard D. Polley /

President RDP/rs PS: As you are aware, FDA requires daily adult dosing of 100 mg I-from KI. Current thyroid research indicates that this dose is sig-nificantly higher than that actually required to inhibit thyroid uptake of 131I. I'll be pleased to forward this information when it becomes available.

cc:Dr John Kemeny, Dartmouth Univ.

Chairman Hendry, Nuclear Regulatory Senator Gary Hart, U.S. Senate Commission Representative Morris Udall, U.S.

Commissioner Gilinsky, NRC House of Representatives Commissioner Kennedy, NRC Senator Paul Tsongas, U.S. Senate Commissioner Bradford, NRC S.H. Ingbar, M.D.,

Harvard Medical School

_.