Dear List Members: Due to the table I am forced to put this report in html format. If your mail client is not able to read this message, I will have in on our website at http://www.anbex.com at outline 4.5 by this evening. John NUCLEAR REGULATORY COMMISSION ESTIMATES

To appreciate the US Nuclear Regulatory Commission's policy on KI, it is important to understand the estimates made in their document, Examination of the Use of Potassium Iodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents. (NUREG/CR-1433, Sandia National Laboratories, Albuquerque, New Mexico, 1980). This report describes the health effects of a nuclear accident in detail, and provides casualty estimates at various distances from a reactor. Although the report is highly technical and difficult to read, buried in its pages of statistics is the acknowledgment that a "Core-Melt Atmospheric" accident (that is, an accident like Chernobyl which releases a large portion of the reactor core into the atmosphere) could threaten millions of people. NUREG-1433 points out that thyroid growths (nodules) and other thyroid damage would be expected to occur for hundreds of miles downwind after an accident through breathing. This is described in tables 3 and 4 of the report, as shown below: EFFECTS OF CORE-MELT ATMOSPHERIC ACCIDENTS BY DISTANCE Distance in miles Mean Thyroid Dose (REM) for Exponsed Adult Outdoors Probability of Thyroid Damage to Exponse Adult Located Outdoors MI REM % 1 13,500 60% 5 5,800 70% 10 3,200 70% 25 1,100 40% 50 380 13% 100 100 3% 150 36 1% 200 16 0.5%

For children, increase dose and probability of damage by an approximate factor of two.

Weather conditions based on calculated probability distributions.

Thyroid damage includes thyroid nodules (both benign and cancerous) and ablated thyroid.

Assumed risk coefficient of 334 thyroid nodules per million person-rem to the thyroid.

Includes inhalation dose only. Does not include ingestion.

Probabilities conditional on accident occurring.

But the NRC limits its accident planning to 10 miles. In other words, there is nothing to protect people who, for example, are 50 miles away, despite the probability that 13% of all exposed adults (and about a quarter of the children) at this distance could be injured. Yet use of KI would prevent thisa fact the NRC does not dispute. (See NRC notice regarding "radiation emergency potassium iodide" below.)

NEXTNRC INFORMATION NOTICE

UNITED STATES NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555

April 18, 1988

NRC INFORMATION NOTICE NO. 88-15: AVAILABILITY OF U.S. FOOD AND DRUG ADMINISTRATION (FDA)-APPROVED POTASSIUM IODIDE FOR USE IN EMERGENCIES INVOLVING RADIOACTIVE IODINE.

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

Purpose: This notice is intended to provide information on the storage and use of potassium iodide as a thyroid blocking agent in incidents involving exposure to radioactive iodine. It is expected that licensees will review this information for applicability to their licensed activities and distribute this notice to responsible radiation safety staff. However, suggestions contained in this information notice do not constitute new NRC requirements, and no written response is required.

Description of Circumstances: During a nuclear pharmacy inspection, NRC and the licensee discussed the possibility of maintaining a supply of potassium iodide at each pharmacy location. This supply would be used as a thyroid blocking agent in case of an iodide-131 sodium iodide spill with possible personnel contamination. The licensee asked for a statement of NRC's policy regarding on-site storage of potassium iodide for use in incidents involving radioactive exposures. There is an NRC and Federal Emergency Management Agency (FEMA) policy addressing on-site storage of FDA-approved "radiation emergency potassium iodide" 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 "radiation emergency potassium iodide" (i.e., the generic drug nomenclature). However, as discussed below, licensees may wish to provide for its availability in case of an emergency.

The FDA has evaluated the medical and radiological risks of administering potassium iodide for thyroid blocking under emergency conditions. The FDA has concluded that FDA-approved "radiation emergency potassium iodide" is safe and effective and has approved it for over-the-counter sale for this purpose (Federal Register, Vol. 50. No. 142, p.30258, July 24, 1985). FDA guidance states that risks of side effects, such as allergic reactions, from the short-term use of relatively low doses of potassium iodide for thyroid blocking in a radiation emergency, are outweighed by the risks of radioiodine induced thyroid nodules or cancer, if the projected dose to the thyroid gland is 25 rems or greater. Because FDA has authorized the non-prescription sale of "radiation emergency potassium iodide," it is legally available to organizations or individuals who, based on their own corporate or personal analysis, choose to have the drug immediately available.

At this time, ANBEX, Inc. [PMB 284, 35246 US Hwy. 19 N, Palm Harbor, FL 34684] and Carter-Wallace, Inc. (P.O. Box 1001, Cranbury, NJ 08512) are the only companies that have received FDA new drug application (NDA) approval for their non-prescription "radiation emergency potassium iodide" drugs. These drugs are not stocked in pharmacies and must therefore be ordered directly from the companies. The non-prescription "radiation emergency potassium iodide" is manufactured at the proper adult dosage for thyroid blocking, is readily absorbed by the body, and has a package insert providing information on the dosage, method of action, warnings and storage. The directions in the package insert should be followed. Other forms of potassium iodide are available by prescription only.

Potassium iodide is effective as a thyroid blocking agent. It reduces thyroid gland accumulation of radioiodine that has entered the body through inhalation or ingestion if the potassium iodide is administered before, or immediately after, exposure to the radioiodine. If potassium iodide is administered later than four hours after an individual has suffered an acute ingestion or inhalation of radioiodine, its effectiveness as a thyroid blocking agent is less 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 available), and guidelines should be developed to ensure rapid determination of whether a radioactive iodine spill or leak warrants administration of the potassium iodide. The guidelines should also address the more detailed measurements, surveys, and other follow-up procedures needed to determine whether continued treatment with potassium iodide is needed.

It is important to stress that the use of potassium iodide is not a substitute for preventive measures; e.g., proper handling techniques, control measures, and emergency procedures that protect the individual from exposure to radioactive material.

Licensees are also advised that although FDA has approved "radiation emergency potassium iodide" for non-prescription sales, licensee or individuals still may wish to consult with a physician about any medical risks of use in an emergency.

No specific action or written response is required by this information notice. If you have any questions regarding this matter, please contact the person listed below or the appropriate NRC regional office.

Richard E. Cunningham, Director

Division of Industrial and Medical Nuclear Safety

Office of Nuclear Material Safety and Safeguards

Technical Contact

Donna-Beth Howe, NMSS

(301) 492-0636

-- Rickjohn (rickjohn1@yahoo.com), July 26, 1999

Answers

uoops

The table got all screwed up. If someone has problems reading it just go to the website given in the article :-)

-- Rickjohn (rickjohn1@yahoo.com), July 26, 1999.