NUREG-1633, Requests Review of Draft NUREG-1633,entitled, Assessment of Use of Potassium Iodide as Public Protective Action During Severe Reactor Accidents
| ML20236V069 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1998 |
| From: | Congel F NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | Friedman M FOOD & DRUG ADMINISTRATION |
| References | |
| RTR-NUREG-1633 NUDOCS 9807310284 | |
| Download: ML20236V069 (4) | |
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%,,,* July 29, 1998 i
Michael A. Friedman, M.D.
Acting Commissioner U.S. Food and Drug Administration 5600 Fishers Lane l Rockville, Msryland 20857 l
Dear Commissioner Friedman:
1 On July 20,1998, the NRC published for comment Draft NUREG-1633, entitled " Assessment of the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents" (copy enclosed). I am requesting that your agency review and provide your comments to us on the content in general and on the medical aspects of mass use of Kl in particular.
By way of background, the Federal policy on Ki was published in the Federal Reoister in 1985.
The 1985 policy recommended the stockpiling and distribution of Kl during emergencies to emergency workers and to institutionalized individuals, but did not require redistribution or stockpiling of K1 for use by the general public. In 1982, the Food and Drug Administratica (FDA) evaluated the medica! and radiological risks of administering Kl for thyroidal blocking and concluded that, under emergency conditions, KI is safe and effective. The FDA also stated that risks from the short-term use of relatively low doses of K1 in a radiation emergency are outweighed by the risks of radiciodine-induced thyroid nodules or cancer at a projected dose to the thyroid gland of 25 rem m greater. The 1985 policy indicated that since the FDA has authorized the noteprescrirdon sale of KI, it is legally available to individuals who, based on their own personal analysis, choose to have the drug immediately available.
The Nuclear Regulatory Commission (NRC) as a member of the Federal Radiological Preparedness Coordinating Committee (FRPCC) is participating in the revision of the Federal policy on the use of K1 by the general public in the event of a major reactor accident. The NRC, FDA, and 15 other Federal agencies with radiological response authorities comprise the FRPCC. Wnile the NRC has considerable expertise in nuclear accident phenomenology and health physics, we do not have much depth in medical fields. The NRC recently decided to propose rules that would require reactor licensees and therefore the States to formally consider, as appropriate, the use of Kl for the general public as a supplement to evacuation and sheltering. This required consideration could substantially increase the potential for KI use by the general public. Consequently, your updated advice regarding Kl as a radioiodine prophylactic during a nuclear accident is critical.
l j
Your recommendations on the benefits and risks associated with the use of Kl by the general public need to be considered in the context of its potential use during a reactor accident. As k
- stated in the enclosed report, it is clear that Ki is effective in reducing the uptake of radiciodines by the thyroid gland if administered in a timely manner. However, for the approximately 70 Q 0@ -
power plant sites in the U.S., the emergency response plans are designed to move people from 9' (i S d % ,<srg ,, yt W 9807310284 980729
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PDR NUREO 1633 C PDR K (, 4 f ' \ ) I 1
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l i 2 the potentially impacted areasanM to any release of radioactive materials. In addition, analyses of reactor accidents have shown that releases to the environment an be made up of a broad, unpredictable spectrum of radienuclide mixes. Some of these mixes contain a radioiodine component while others do not. For example, the TMl accident in 1979 resulted in the release of several hundred thousand curies of noble gases and only 5 - 15 curies of radioiodines. In order for Ki to be an effective contributor to general public dose reduction, it would have to be
- given prior to or just after exposure to radioiodine. A decision to recommend that Kl be taken by ,
l the general public would most likeiy be required without the knowledge that an exposure would l actually occur. We would not be able to predict with any certainty that a major release into the I
environment will occur, nor could we assess the magnitude of the potenfal dose with any precision, i.e., determine if the dose will exceed 25 rem, using current h;A recommendations. i in any casa, if K1 is recommended to be taken by the general public, it is likely that most of the people who take Kl would not be exposed or be minimally exposed to any radioiodine. It is in this context that the need your updated assessment.
We did a limited search of current medical references such as the Physicia'ns' Desk Reference and the U. S. Pharmacopeia. As discussed in the enclosed report, the contraindications and extensive cautions regarding the use of Kl raised concems about recommending its use by the general population without direct medical supervision. For example, do your 1982 recommendations apply to all age groups? Is the drug at the 130 mg dose level safe for
, pregnant women and nurkg mothers? What is the current advice for neonates? The latest j draft of the World Health Organization (WHO) recommendations regarding the use of Kl l contained some serious wamings on administering Kl to newboms. However, as stated earlier, l we are not medical professionals and therefore seek your counsel in this important public health i
area.
Your support in this effort is greatly appreciated. Please contact me at (301) 415-7476 or Aby Mohseni of my staff at (301) 415-6409 for additional information.
l Sincerely, ,
Odg'mMed'.W.'t.f.0sd Frank J. Congel, Director l
- Incident Response Division l Office for Analysis and Evaluation of Operational Data
Enclosure:
Draft NUREG-1633, " Assessment of the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents
- DISTRIBUTION w/o enclosure: !
File Center /NUDOCS AEOD R/F IRD R/F ER R/F PUBLIC WTravers RBarrett SRubin CWillis TMcKenna DISK / DOCUMENT NAME: h:\ ERB \MOHSENI\FDAREV.WPD
- See previous concurrences j To receive a copy of this document. Indicate in the box: "C' = Copy w/o attadment *A* = Oopy w/ attachment,"N" = NO COPY OFC IRD:AEOD C SC:lRD:AEOD C D:lRD:AEOD [ D:AEOD C NAME ASMohseni:Jc RTHogan FJCongelh T. Martin l DATE- 07/28/98* 07/28/98* 7/7/g/98 I 07/28/98*
OFFICIAL RECORD COPY l
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areas gigt to any release of radioactive materials. In addition, analy of reactor. accidents have shown that releases to the environment can be made up of a r d, ictable spectrum of radionuclides mixes. Some of these mixes contain a ra ine component while others do not. For example, the TMI accident in 1979 resulted in e release of several hundred thousand curies of noble gases and only 5 - 15 curies of radioi ines. In order for Kl to be an effective contributor to general public dose reduction, it woul ave to be given prior to orjust after exposure to radioiodine. A decision to recommend t t Kl be taken by the general public ,
would most likely be required without the knowledge th an exposure would actually occur. We l would not be able to predict with any certainty that a ajor release into the environment will occur, nor could we assess the magnitude of the tential dose with any precision, i.e.,
determine if the dose will exceed 25 rem, usin urrent FDA recommendations. In any case, if Kl is recommended to be taken by the gerer public, it is likely that most of the people who take Ki would not be exposed or be minimally posed to any radioiodine, it is in this context that we need your updated assessment.
We did a limited search of current edical references such as the Physicians' Desk Reference and the U. S. Pharmacopeia. contraindications and extensive cautions regarding the use of Kl left us with serious conce about recommending its use by the general population without direct medical supervision or example, do your 1982 recommendations apply to all age groups? is the drug at e 130 mg dose level safe for pregnant women and nursing mothers?
What is the current a ice for neonates? The latest draft of the World Health Organization (WHO) recommen tions regarding the use of Kl contained some serious warnings on administering Ki newboms. However, as tstated earlier, we are not medical professionals and therefore see our counsel in this important public health area. j l
Your su rt in this effort is greatly appreciated. Please contact me at (301) 415-7476 or Aby {
Mohseni'of my staff at (301) 415-6409 for additional information. j Sincerely, i
Frank J. Congel, Director incident Response Division Office for Analysis and Evaluation of Operational Data
Enclosure:
Draft NUREG-1633, " Assessment of the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents' DISTRIBUTION w/o enclosure:
File Center /NUDOCS AEOD R/F IRD R/F ER R/F PUBLIC
. WTravem RBarrett SRubin CWillis TMcKenna DISK / DOCUMENT NAME: H:\ ERB \MOHSENi\FDAREV.WPD i To recesvo a copy of this document, indicate in the box: "C' = copy w/o attachment. "A* = Copy w/ attachment. *N' = NO COPY OFC IRD AEOD C. SC:lRD:AEOD d- D:lRD:AEOD D:AEOD C NAME ASMohseni:$ RTHogg h
- FJC9ngel jikar[M DATE ~[lf[/98 o ;y /M / /98 [ 7 / 1 9798 OFFICIAL RECORD COPY 1h9 #4 r
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the poteritially impacted areas pri.p_r to any release of radioactive materials. In addition, analyses of reactor accidents have shown that releases to the environment can be made up of a broad, unpredictable spectrum of radionuclides mixes. Some of these mixes contain a radiciodine l component while others do not. For example, the TMI accident in 1979 resulted in the release I of several hundred thousand curies of noble gases and only 5 - 15 curies of radioiodines. In I order for Kl to be an effective contributor to general public dose reduction, it would have to be l given prior to or just after exposure to radioiodine. A decision to recommend that Kl be taken by the general public would most likely be required without the knowledge that an exposure would actually occur. We would not be able to predict with any certainty that a major release into the
. environment will occur, nor could we assess the magnitude of the potential dose with any precision, i.e., determine if the dose will exceed 25 rem, using current FDA recommendations.
In any case, if Kl is recommended to be taken by the general pub!ic, it is likely that most of the l people who take Kl would not be exposed or be minimally exposed to any radioiodine. It is in this context that we need your updated assessment.
We did a limited search of current medical references such as the Physicians' Desk Reference I and the U. S. Pharmacopeia. As discussed in the enclosed report, the contraindications and )
extensive cautions regarding the use of Kl raised concems about recommending its use by the general population without direct medical supervision. For example, do your 1982 recommendations apply to all age groups? Is the drug at the 130 mg dose level safe for pregnant women and nursing mothers? What is the current advice for neonates? The latest draft of the World Health Organization (WHO) recommendations regarding the use of Kl contained some serious wamings on administering Kl to newboms. However, as stated earlier, we are not medical professionals and therefore seek your counsel in this important public health area. i Your support in this effort is greatly appreciated. Please contact me at (301) 415-7476 or Aby Mohseni of my staff at (301) 415-6409 for additional information.
Sincerely, Frank J. Congel, Director Incident Response Division
, Office for Analysis and Evaluation cf Operational Data
Enclosure:
Draft NUREG-1633, " Assessment of the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents" l}