ML20003E465
| ML20003E465 | |
| Person / Time | |
|---|---|
| Issue date: | 03/25/1981 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Novich M FOOD & DRUG ADMINISTRATION |
| References | |
| NUDOCS 8104030546 | |
| Download: ML20003E465 (2) | |
Text
..
5(pa ucg[c, UNITED STATES
'fg Q~ j NUCLEAR REGULATORY COMMISSION W ASHING TON,0. C. 20555 gt C)
.WN y
c\\
/c g
v
+
March 25,1981 1\\
CHAIRf/AN
/
~
,0
[ -\\
j C
k h a~
by Dr. Mark Novich e%3g,9 Acting Comissioner of Food and Drugs t
(PKLN-1457) Food ann Drug Administration
,.3*
5600 Fishers Lane Rockville, Maryland 20857
Dear Dr. Novich:
The Comission has considered further the potential public risk from radiciodine that might be released in a nuclear power plant accident.
We realize that the FDA has been studying this matter for several years and has issued guidance in a Federal Register Notice (43 FR 58789) on December 15, 1978.
However, the Comission has concluded that further study is warranted concerning the use of potassium iodide as a protective measure for use by the general public -- in addition to shelter and evacuation -- to block thyroid gland uptake of radiciodine.
Among other things, the potential benefits, as well as the potential side effects, of using this drug in an emergency were at issue in considering its use.
We understand that, at the request of the NRC, FEMA and other members of the Federal Radiological Preparedness Coordinating Committee, the FDA has continued to develop guidance and information for State and local officials on the use of potassium iodide by the general public in the event of the release of radioiodine in a nuclear plant accident.
This guidance includes recomended values for projected thyroid dose the avoidance of which would warrant the use of. potassium iodide.
In coordination
.with EPA, we ask FDA also to examine whether specific (higher) protective action guides (PAGs) for sensitive population groups are appropriate or whether there are groups for whom use of KI would never be advisable.
In addition, it should include recommendations concerning an integrated system for disseminating information about its proper use, for reporting suspected or actual side effects and for obtaining medical assistance in nuclear facility emergencies. The Comission understands that FDA is presently staffing out the effort to develop such additional guidance on.
the use of potassium iodide blocking.
We are requesting FEMA to further study systems for the procurement, storage, and distribution of potassium iodide for use by the general public. NRC is continuing to review the likelihood of accident scenarios that might lead to significant radiciodine releases.
Efforts are underway 40 @
g0
eP Dr. Mark Novich,
by the NRC staff to provide within a month, an assersment of the state of current technology concerning accident fission product release information with special emphatis on iodine and aerosols.
The Comission will make no furtner decisien on the advisability of recomending stockpiling of KI for the generr.1 public until that information is received.
When the FDA, FEMA and NRC stuCes are completed, we believe that, along with EPA, the agencies should agree on a unified Federal policy and plan for the use of the potassium iodide as a protective measure in nuclear emergencies.
We would appreciate your thoughts on this proposal. We woula
.iappy to meet with you to explore the matter further.
Our staff ceacact for this matter is Mr. Brian K. Grimes (492-7415).
N Sincerely,
\\
i
\\s l
y ( u )t W, u c_
Qosehh M. Hendrie cc:
Roger Mattson, EPA Louis Guiffrida, FEMA f
'