ML20138M885
| ML20138M885 | |
| Person / Time | |
|---|---|
| Issue date: | 02/20/1997 |
| From: | Martin T NRC (Affiliation Not Assigned) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| RULE-PRM-50-63 NUDOCS 9702260377 | |
| Download: ML20138M885 (11) | |
Text
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Cen b l FLs,
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t UNITED STATES s
j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30806 4 001 k*****/
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February 20, 1997 3;j-MEMORANDG T0:
David L. Morrison, Director Office of Nuclear Regulatory Research 4
]
.FRJN:
Thomas T. Martin, Director Division of Reactor Program Management Office of Nuclear Raactor Regulation SU8 JECT:
OFFICE REVIEW AND CONCURRENCE OF THE DENIAL OF PETITION FOR i'
RULEMAKING (PRM-50-63) P. ELATING TO RE-EVALUATION OF THE POLICY REGARDING THE USE OF POTASSIUM IODIDE AFTER A SEVERE 4
ACCIDENT AT A NUCLEAR POWER PLANT This is in response to your request of January 14, 1997, for review and l
concurrence of the subject Commission paper denying a petition for rulemaking to change the NRC policy regarding the use of potassium iodide (KI) as a radioprotective agent for the general public in the event of a severe reactor accident.
j
Background
1 j
In SECY-93-318 and SECY-94-087, the staff presented its recommendation for resolving a differing professional opinion (DPO) concerning the NRC policy regarding the use of KI as a protective nearure following a severe accident.
i The current Federal policy, which was issued in 1985 (50 FR 30285) by the Federal Radiological Preparedness Coordinating Committee (FRPCC) and supported by the NRC, recommends stockpiling or distributing KI for emergency workers and institutionalized persons but not for the general public. The staff
- e recommended in SECY-94-087 that the NRC, in coordination with FEMA and HHS, revise the Federal KI policy to make KI available to the States. The~
Commission deadlocked on the staff recommendation and, therefore, the NRC l'
position on KI was not changed.
i On December 6,1994, the FRPCC accepted the recommendation of its Ad-Hoc j
Subcommittee on KI which, after review of the issues affecting the purchase and stockpile of KI, found no basis for changing the 1985 Federal policy.
Current Situation 4
On Septenbar 9, 1995, petition for rulemaking was submitted to the NRC requesting that the NRL change its policy on KI and amend its regulations to 1
include ~ a requirement that emergency planning protective actions for the public include the use of KI.
In early 1996, the EDO directed RES to update and integrate SECY-93-318 and SECY-94-087 in order to resubmit to the Commission the original staff resolution of the DPO.
l b
In mid-1996 the FRPCC established a new Ad-Hoc Subcommittee on KI tc request-(
and review any new information on this matter. The Subcommittee conducted a 3l l
public meeting on June 27, 1996. Based on the information collected, th,e OP kkO%
l LW-I re,Uunk r
i
Contact:
Falk Kantor, PERB/NRR 301-415-2907
,, p p c. 2,_ g, 2 9/-J/
E gg
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r. February 20, 1997 i
Subcommittee concluded that there was no new information that seriously challenges the basis for the 1985 recommendations concerning public use of KI
-for radiological emergencies, however, the Subcommittee made several i
i recommendations to the FRPCC. The full FRPCC endorsed the Subcommittee's recommendations with some modifications.
FEMA, as the chair of the FRPCC, plans to issue a revised Federal policy statement on the use of KI in a j.
Federal Register notice.
l
-It is our understanding that, similar to the current policy, the revised Federal policy will state that KI should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, and that the decision for stockpiling and use of KI for the i
general public will be left to the discretion of the State governments..In addition, the revised policy will state that any State or local government 4.
that selects the use of KI as a protective measure for the general public may t
i so notify FEMA and may request funding for the purpose of purchasing an adequate supply. As an added assurance, for a broader range of radiological
' emergencies in which the location and timing of an emergency are unpredictable and for which, unlike nuclear power plants, there is little or no pre-planning, a stockpile of KI will be established by the Federal government.
f Discussion The proposed Commission ~ paper relies upon the report and recommendations of the FRPCC Ad-Hoc Subcommittee on KI to support the staff's position that a i
revision to the regulations is unwarranted because the approach of stockpiling KI and advising States of the stockpile substantially addresses the fundamental concerns behind the petition without the burden associated with requiring changes in all State and local emergency plans. We concur in the position taken in the proposed Commission paper, however, we recommend that the Commission' paper be revised to' endorse the final FRPCC position on KI rather than to ine.orporate the recommendations of the Subcommittee. We have been working closely with AE00 and RES to incorporate'the FRPCC's revised i
statement on KI as we currently understand it into the proposed Commission paper. A line-in,- line-out version of the Commission paper (without 4
enclosures) reflecting our comments, developed in_ conjunction with AE0D, is attached. We recommend that the subject Commission paper await the issuance and be revised to reflect the final FRPCC position on KI.
l-
Attachment:
As stated DISTRIBUTION Docket File R. Zimmerman T. Essig N. Olsen AThadani 1
PUBLIC T. Martin C. Miller B. Sweeney BSheron i
PERB Reading File F. Kantor P. Milano A. Mohseni WTravers NRR Mail Room (YT# 0970008)
F. Congel S. Droggitis S. Lewis M. Jangochian F. Miraglia D. Matthews DOCUMENT NAME: G:\\KIMEMO I Ta seestus e espy of this desument. inesees in the ben: *C' = Copy without ettechenent/ enclosure
- E* = Copy Mth ettMnt/ enclosure
'N' = No copy 0FFICE PERO:leRR,m/
l 6 PERS:NRedh l 5 PER8:HRR l ff D:DRl%.
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16AME FKantorU,A\\
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CMit ter ryt4 TMa@in 1
DATE 2/ H /97 2/ n /97' 2/ // /97 2/ 2.'/ /97 0FFICIAL RECORD COPY a
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Attachment l
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EDE:
The Commissioners FROM:
Hugh L. Thompson, Jr.
Acting Executive Director for Operations SUBJECI:
DkNIAL OF PETITION FOR RULEMAKING (PRM-50-63) RELAT RE-EVALUATION OF POLICY REGARDING USE OF POTASSIUM IODIDE AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT E1JBP_QSE:
To obtain Commission approval of a denial of Petition for Rulemaking to change the NRC 7 policy regarding the use of potassium iodide (KI) as a radioprotective agent for the general
. public in the event of a severe reactor accident.
BACKGROUND AND DISCUSSION:
in 1989, a Differing Professional Opinion (DPO) was filed by a member of the NRC'.s Office
- of the General Counsel staff requesting a re-evaluation of the NRC~ policy regarding the use of potassium iodide (Kl) after a severe accident at a nuclear power plant.
i in SECY-93-318 (November 23,1993) and SECY-94-087-(March 29,'1994), the staff.
presented its recommendation to resolve the DPO. The staff's recommendation was that the NRC, in coordination with.HHS and FEMA, revise current Federal Kl policy las a matter of prudencyl to make Kl available to the States.
The' Commission paper, SECY-94-087 /,1 documented that Peter Crane, the individual who filed the DPO and the subsequent Petition for Rulemakingr (PRM-50-63) concurred in the proposed revised policy statement.
CONTACT:
Mike'Jamgochian, RES/DRA (301) 415-6534
__.______.__._.._.m..
,'. C i
The Commissioners ?
i As documented in lan1 SRM dated Niay 6,1994, the Commission's vote on the above 2
staff recommendation was divided 2 to 2, and under NRC internal procedures, a tie vote 1
on a proposal means that it fails. There was, therefore, no decision on the merits of the l
NRC staff's recommendation.
1 a
On September 9,1995, a petition for rulemaking (PRM-50-63) was submitted to the NRC i
by Mr. Peter Crane, as a private citizen (the same individual who filed the DPO in 1989),
j requesting a rulemaking to implement the recommendation of the President's Commission j
on the Accident at Three Mile Island (Kemeny Commission) that the United States j
stockpile the drug potassium iodide for thyroid protection during nuclear accidents.
J l
The petitioner requested that the NRC amend its emergency planning regulations to include
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a requirement that emergency planning protective actions include sheltering, evacuation, j
and the prophylactic use~~of potassium iodide. The request would amend one of the 16 j
planning standards in 10 CFR 50.47, which licensee and offsite emergency plans are required to meet,in order to assure that the option of using potassium iodide is included in emergency plans.
In early 1996, the EDO directed RES to update and integrate SECY-93-318 and SECY 087 in order to resubmit to the Commission the original staff resolution of the DPO (which was concurred in by Mr. Crane). If approved by the Commission, the staff recommendation would provide a resolution to the DPO and to the overall thrust of the i
petition for rulemaking. The position stated that the Federal Government (HHS, FEMA or NRC) would purchase Kl and it would be made available to the States for potential use by i
j the general public.
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^dd:^! =!!y, il//n mid 1996 the Federal Radiological Preparedness Coordinating Committee (FRPCC) convened an Ad-Hoc Subcommittee on Potassium lodide to request and review new information on this matter from interested parties. The subcommittee conducted a 4
public meeting on June 27,1996. The subcommittee evaluated all comments from the June 27 public meeting and concluded (in its report to the FRPCC/ that "while the i
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viewpoints presented at the public meeting were compelling, the 1996 Subcommittee on Potassium lodide heard no new information that seriously challenges the bases for the j
1985 recommendation concerning public use of Kl." Nonetheless /however1, the i
Subcommittee made .: ':t':=i.^.;; /several1 recommendation (regarding the Federal KI j
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The full FRPCC C - 'tt:0 endorsed the subcommittee's recommendations (with some modifications 1 and plan /s/ to publish ^.: ':":c."..- /s/ revised Federal policy statement on Distribution of Potassium lodide, identical to the proposed policy statement attached to the proposed Federal Regi. ster notice (Appendix A). /The highlights of the FRPCC proposed policy are as follows:
"The FRPCC did not find any new information that would require a change in the basis of the existing Federalpolicy concerning the stockpile or pre-distribution of KI for the generalpublic. The policy is that KIshould be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, but leaves the decision for the stockpiling, distribution, and use of KI for the generalpublic to the ~ dis'cretion of State, and in some cases, localgovernments. Any State or localgovemment that selects the use of KI as a protective measure for the generalpublic may so notify D
i j
The Commirsioners o FEMA and may request funding for the purpose of purchasing an adequate supply. FEMA wiH coordinate the request for funds with the NRC.
The incorporation of a program for KIstockpiling, distribution, and use by l
any State or localgovemment into the emergency plans wiH not be subject to Federal evaluation. This is based on the Federal govemment's determination that the existing emergency planning andpreparedness guidance for nuclear power plants is effective and adequate to protect public health and safety.
i j
Those States orlocalgovemments who opt to include KI for the general
)
l population wiH be responsible for maintenance, distribution, and any subsequent costs or legalliabilities associated with this program.
As an added assur.once, for e broader range of radiological. emergencies in which the location and timing of an emergency are unpredictable and for i
which, unlike licensed nuclear power plants, there is little or no pre-planning, a i
i stockpile of KI wiH be established by the Federal government. Such a stockpile would consist of individual KI caches at VA hospitals in major metropolitan i
centers across the country. This supply would be available to any State or localgovemment for any type of radiological emergency. "1 i
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The staff recognizes that the actions expected to be recommended by the FRPCC 'do not address the specific requested actions by the petitioner in the petition for rulemaking. The l
petitioner requested that the Commission amend its regulations (10 CFR 50.47(b)(10)) to specify that the prophylactic use of K1 for the general population within the plume e
[
exposure pathway Emergency Planning Zone (EPZ) for each licensed nuclear power reactor be identified as one of the " range of protective actions" required to be set forth in State j
and local emergency plans. The FRPCC proposed stockpile of Kl would leave it up to the States and localities whether to include Kl in their emergency response plans. This may or i
may not resolve the issue to the satisfaction of the petitioner.
l However, it is the staff's position that a revision to the regulations is unwarranted because the approach of stockpiling KI and advising States of the availability of the stockpile
{
substantially addresses the fundamental concerns behind the petition, without the bur' den associated with requiring chr ages in all State and local emergency plans. This position is '
strengthened by the alreads sisting stockpile of Kl that was available for the Olympics and the national conventions along with the confidence that at least several States wW ~
/could1 avail themselves of the FRPCC's offer to provide KI to be used by the general public in the event of an emergency at a. nuclear power plant. The staff believes that given these circumstances, unlike the experience which occurred at the~ time of the TMI accident, that Kl could be made available //n a more timely mannerlif needed in the future.
. Therefore, the petition is being denied.
I j
1 J-
_ _ _ _._ _.m i.
,e The Commissioners,
A detailed discussion of background'information and alternative approaches is provided as PUBLIC COMMENTS:
l On November 27,1995, a Notice of Receipt of the Petition for Rulemaking was published l
in the Federal Register (60 FR 58256), requesting public comments by February 12,1996.
A total of 63 comment letters were received, of which 20 utilities,9 State governmental i
agencies, 2 utility interest companies,1 letter signed by 12 health physicists, 2 State j
universities and 1 member of the public were against the granting of the petition for rulemaking. Those letters in favor of granting the petition came from 5 environmental
{
3 j
groups,22 members of the public (including 1 from the petitioner), the American Thyroid Association and 1 video tape which was an enclosure to the letter from one of the
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' environmental groups. None of the State governmental agencies that commented on the petition for rulemaking were in favor of granting the petition.
Opposition to granting the petition for rulemaking could generally be characterized by the fo!!owing comments:
f 1.
"There is simply no conceivable means to distribute potassium iodide to potentially -
i affected members of the public within the appropriate time after initiation of a j
hypothetical nuclear accident. Predistribution is completely out of the question, since there would be no means to control misuses, overdoses, shelf life, etc."
2.
"A radioactive release from a nuclear power plant that results in a substantial ti.froid
}
dose would undoubtedly include a significant whole body dose as well. Potassium i
iodide offers no protection for this dose. If plans were in place to administer potassium iodide to the public, the potential would be created for evacuation orders to be ignored due to perceived protection by potassium lodide."
j 3.
"The logistics for advanced distribution of Kl to the general public within the plume EPZ would require a.significant initial and at least annual commitment of resources for a small increase in any potential dose savings. There are many questions and l
problems associated with advanced Kl distribution that would need to be addressed i-to ensure its availability in an emergency. How to ensure distribution to 100 percent
[
of all households (permanent, seasonal, and transient)? Would the Kl be kept in the households? Could they locate it in a emergency? What percentage of households i
would have retained tte Kl after three months? six months? one year? Would 100 l
percent distribution to all households have to be made each year to ensure that a i
supply is available? What percentage of households would have to demonstrate ready availability to satisfy Federal requirements? Who would assume liability if the
[
Kl was used prior to the Governor ordering its use?"
4.
" Potassium iodide is a drug with side effects, some of which are profound. The following contraindications are listed in the medicalliterature: hypersensitivity to 1
iodides, acute bronchitis, hyperthyroidism, Addison's disease, acute or chronic renal
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disease, tuberculosis' acute dehydration. The following precautions are listed in the medical literature: use cautiously or avoid use in patients with a history of thyroid i
i
_ _ _ ~ _ - _
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The Commissioners h disease; use care during initial administration of potassium iodide'because of risk of hypersensitivity; persons with goiter or autoimmune thyroid disease are at particular risk for adverse reactions; administration of potassium iodide during pregnancy may l
cause fetal harm, abnormal thyroid function and goiter."
I-5.
"If the NRC adopts a policy of issuance.of Kl to the general public as a protective j
action recommendation, it will be considered as being contrary to State policy and i-will not be accented. This will have the net result of negating much of the planning and preparedness effort of Federal, State and lccal governments since Three Mile island."
4 4
l 6.
"The added function of distributing KI during an evacuation will. increase the time required to complete the evacuation. This increase in evacuation time during a release from a nuclear power plant will result in an increased radiation exposure to i
evacuees and emergency workers."
i-Support for granting'the petition for rulemaking could generally be characterized by the
[
following comments:
h 1.
"A host of countries-France, Germany, Belarus, Russia, Switzerland, Austria, the Czech Republic, Japan, Great Britain, Sweden, Slovakia, and others--protect j
. themselves with stockpiles of Kl. Soaring rates of thyroid cancer are appearing in children in the Soviet Union who were exposed to the Chernobyl nuclear accident, l
but received too little potassium lodide, and too late."
i l
2.
"If the World Health Organization recommendation is followed, and the drug is stockpiled locally in firehouses, police stations, etc., it should be possible to get the i
drug to much of the affected population within a short time after an accident. The EPA Manual [ Manual of Protective Action Guides anii Prctective Actions for Nuclear i
Incidents, EPA 400-R-92-OO1 (May 1992)] quotes the Food and Drug Administration as stating that potassium iodide 'will have substantial benefit even if it is 'taken 3 or j
4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after acute exposure.'"
3.
"The U.S. is currently engaged in a $15 million study of radiation - caused thyroid disease in the Ukraine. I firmly believe that it is money well spent, but I can imagine how Americans would react, if there were ever a nuclear accident in this country, on l
learning that our Government was willing to spend millions to study radiation-caused
~
j thyroid disease abroad, while balking at spending a fraction of that amount to j
prevent radiation caused thyroid disease at home."
j 4.
"If stockpiled potassium iodide were available, it could be given to members of the public to protect them during the evacuation - but the current Federal policy gggggg j
that this will not even be an option."
i i
5.
"Just because there are other lethal radionuclides to which people may be exposed, i
why deny them the availability of Kl, which can cennteract the deadly effects of radioactive iodine? That's like saying, ' Don't ever make flu vaccine available--
because there are so many strains and they can mutate from year to year.'"
d J
4
'I The Commissioners 6.
"Every drug has contraindications and the potential for allergic reactions. In an l
emergency as dire as a reactor accident where people risk illness and death, a possible adverse reaction to Kl seems relatively minimal, and people absolutely should have the choice of making an informed decision and assuming possible risk."
COORDINATION:
)-
The Office of the General Counsel has reviewed this paper and has no legal objection. The ACRS and CRGR agree with the staff's recommendation. The Offices of NMSS, NRR, AEOD, SP, and ADM have concurred in the staff's recommendation. This paper'has also been coordinated with the Office of the Controller.
3 i
RECOMMENDATION:
l That the Commission:
l l
1.
[Endorsel Aeereve (the FRPCC policy on KI and ensure that funding would be available for the purchase of an adequate sup,)ly of KI for those States coordinating their request with FEMA]
'2.
IAnoroval publication loff a Federal Register notice (Enclosure 1) with a revised Federal Kl policy 'O mch: K! cr:!!:b': :: th; St:::: i.^;;:nd!
.^.) :: th: F d:::!
":;;!:::: 7: tic:), J1/T1this policy statement is identical to the policy statement that 1
the FRPCC intenos to publish in the Federal Reaister. The Federal Register notice includes : ::r!::d K! ;;!!:y :::::=:nt :!:n;; cf?. the ' denial of the Petition for Rulemaking j
(PRM 50-63).
2.
Ngia:
a.
The petitioner will be notified of the denial of the petition (Enclosure 3);
b.
A public announcement will be issued (Enclosure 4);
c.
The appropriate Congreasional committees will be informed (Enclosure 5).
Hugh L. Thompson, Jr.
l Acting Executive Director i
for Operations
Enclosures:
- 1. Federal Register Notice Denying the Petition for Rulemaking with Appendix A i _
- 2. Detailed Discussion of Ki i
Stockpiling Background i
information 4
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.c
,j:
- ~
The' Commissioners. 3. Letter to the Petitioner
- 4. Proposed Public Announcement
- 5. Proposed Letters to Congressional Committees -
l.
)
i 3
1 i-l Hugh L. Thompson, Jr.
i Acting Executive Director for Operations
Enclosures:
- 1. Federal Register Notice Denying the Petition for Rulemaking with Appendix A
- 2. Detailed Discussion of KI Stockpiling Background information
- 3. Letter to the Petitioner
- 4. Proposed Public Announcement -
- 5. Proposed Letters to Congressional Committees
' 'This package can include a revised KI policy statement if there is enough. time to coordinate it with HHS and FEMA'or just a commitment to revise the policy statement with a listing of specific elements that might be iri the new policy statement.
RECORD NOTE: A cony of this Denial of Petition was sent to OC and IG -
. for information on:
DOCUMENT NAME: OAJAMGOCHi\\lODIDE\\POTASS To receive a copy of this document, indicate in the box "C" = copy without attachment / enclosure, "B" '
= copy with attachment / enclosure, "N" = No copy
- See previous concurrence 0FC RDR:DRA RPHEB:DRA D:DRA I'RM EMSS NAME MJamgochian/aw*
CTrottier*
BMorris BJShelton CPgeriello DATE g
,,,, M 0FC.
The Commissioners -
o NAME DFRoss FMiraglia RBangart DLMeyer JLieberman umm M muum umma mumm 0FC OGC RES EDO NAME W0lmstead DMorrison HLThompson DATE
/
/97
/ /97
/ /97 0FFICIAL RECORD COPY (RES File Code) RES 1
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