ML20154D531

Responds to 980805 Memo to Commission Transmitting Task at Symposium on Radiation & Thyroid Cancer Held at Cambridge Univ in England on 980722

ML20154D531
Person / Time
Issue date:	10/01/1998
From:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Crane P NRC OFFICE OF THE GENERAL COUNSEL (OGC)
References
NUDOCS 9810070252
Download: ML20154D531 (12)

Text

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20665 4 001

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October 1, 1998 MEMORANDUM TO: Peter Crane, Counsel for Special Projects Office of the General Counsel FROM:

Hugh L. Thompson, Jr.

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Deputy Executive Directo 7 f

for Regulatory Program

SUBJECT:

YOUR TALK AT SYMPOSIUM ON RADIATIO D THYROID CANCER This rnemorandum is in response to your August 5,1998 memorandum to the Commission transmitting your talk at the symposium on radiation and thyroid cancer held at Cambridge University in England on July 22,1998. I agree that a history exists on potassium lodide that has been both confusing to the public and subject to misunderstanding. In addition, I concur that better and more efficient action is needed. Therefore, I am proposing that an open and unambiguous closure of this issue be done in an expeditious manner.

Now that the Commission has acted on your petition and issued a decision, I consider the prohibition for you to work on Commission papers and other Agency activities associated with t

potassium iodide to be no longer required by Commission procedures. As we informally discussed on the phone on August 17,1998, I have verified that OGC has no objection to this decision.

i I would welcome any assistance you may wish to provide in the future development of the rulemaking package and finalization of related regulatory guidance concerning the use of potassium lodide in emergency planning. However, I understand that, after further consideration, you would prefer to not be involved in the agency's specific rulemaking and i

policy statement development resulting from the Commission's action on your petition. I respect your preference in this regard. However, I will remain personally involved in these important activities and you should know that you may, at any time, bring to my attention areas I

that may need correction or clarification. in fact, in my efforts to ensure that we "do it right" and avoid the further introduction of inaccuracies and ambiguities, I may, from time to time, provide 3(o) draft materials to you in your official capacity as an OGC attorney with the request that you might advise me as to areas that you believe need correction or clarification. You may, of course, decline to comment on the materials that I provide to you, but I would reiterate that I would appreciate any assistance that you find appropriate to provide.

I look forward to working with you (to the extent that you may feel it appropriate) and the staff to carry out the Commission's decisions on Kl.

As you know, Dr.Janusz Nauman visited the United States recently on official business. I invited Dr. Nauman to make a presentation to the EDO, myself, and the NRC emergency i

planning staff and.others, so that we may directly benefit from the value of his experience during the eventsafter the Chernobyl accident. He accepted the invitation, and I believe the meeting helped us. understand more fully his work on the Polish experience with Kl.

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- With regard to NUREG-1633, it was issued for public comment in accordance with the Commission's SRM dated June 26,1998. However, as a result of a subsequent decision by the I

Commission in the SRM dated September 30,1998, NUREG-1633 will be withdrawn in order to j

revise it and incorporate an improved discussion of how the practical problems of Kl stockpiling, distribution, and use are handled by the States which already use Kl as a supplement. As we 4

redraft this guidance document, we will clearly take into account your comments and the others

. received on this' draft.

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.. Chairman Jackson l

Commissioner Diaz Commissioner McGaffigan j

SECY 2

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2 With regard to NUREG 1633, it was issued for public comment in accordance with the

~ Commission's SRM dated June 26,1998. However, as a result of a subsequent decision by the

- Commission in the SRM dated September 30,1998, NUREG-1633.will be withdrawn in order to revise it and incorporate an improved discussion of how the practical problems of Kl stockpiling, distribution, and use are handled by the States which already use Kl as a supplement. As we I

redraft this guidance document, we will clearly take into account your comments and the others received on this draft.

cc:

Chairman Jackson

. Commissioner Diaz Commissioner McGaffigan SECY OGC DOCUMENT NAME: G:\\pc081898.kl DISTRIBUTION Central Files PDR JThoma OGC LJCallan WDTravers GTracy SECY PGNorry JLBlaha DEDR R/F GT 980492 TMartin, AEOD AThadani, RES EDO R/F Scollins, NRR DEDR:TA NRR NRR OGC DbDR I6'I; k

• See previous concurrence J

EDO JThoma JRoe "SCollins JGray HLThompson LJCallan 8/19/98*

8/19/98*

8/19/98*

8/26/98

• 8/29/98

• 8/ 8/ /98 "

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With regard to NUREG-1633, it was issued for public com nt in accordance with the Commission's SRM dated June 26,1998. However, as esult of a subsequent decision by the Commission in the SRM dated September _,1998, REG-1633 will be withdrawn in order to revise it and incorporate an improved discussion of w the practical problems of Kl stockpiling, distribution, and use are handled by the States w h already use KI as a supplement. As we redraft this guidance document, we will clearly t e into account your comments and the others received on this draft.

cc:

Chairman Jackson Commissioner Diaz Commissioner McGaffigan SECY OGC i

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1 DOCUMENT NAME: G:\\pc081898.kl DISTRIBUTION Central Files PDR JThoma OGC LJCallan WDTravers GTracy -

SECY PGNorry JLBlaha DEDR R/F GT 980492 TMartin, AEOD AThadani, RES EDO R/F Scollins, NRR

• See previous concurrence DEDR:TA NRR NRR OGC DEDR EDO JThoma JRoe SCollins JGray HLThompson LJCallan 8/19/98*

8/19/98*

8/19/98*

8/26/98

• 8/ /98 8/ /98 1

2 With reg d to NUREG-1633, it was issued for public comment in accordance with the Commissi

's SRM dated June 26,1998. We will clearly take your comments and the others received on is draft. We will of course take the oppor1 unity at the meeting with Dr. Nauman, if we are able to chedule it, to address his efforts after Chernobyl as they relate to the purpose and context of REG-1633.

cc:

Chairman J kson Commissione Diaz Commissioner cGaffigan 4

DOCUMENT NAME: G:\\pc081898.ki DISTRIBUTION Central Files PDR JThoma OGC LJCallan WDTravers GTracy SECY 1

PGNorry JLBlaha DEDR R/F GT 98049 TMartin, AEOD AThadani, RES EDO R/F I

• See previous concurrence

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(f OCM DEDR:TA NRR NRR OGC DECF JThoma JRoe SCollins JGray HLTf ompson LJ glian SJackson 8/19/98*

8/19/98*

8/19/98*

8/26/98

• 8/$/98 8/3y98

/ /

MEMORANDUM TO: Pat:gr Crana, Counsil for Special Projscts Offics of th9 Ganarcl Counsrl i

FROM:

Hugh L. Thompson, Jr.

Deputy Executive Director for Regulatory Programs

SUBJECT:

YOUR TALK AT SYMPOSIUM ON RADIATION AND THYROID CAN R

This memorandum is in response to your August 5,1998 memorandum to the Commis n

transmitting your talk at the symposium on radiation and thyroid cancer held at Camb ' ge i

University in England on July 22,1998. I agree that a history exists on potassium i ide that j

has been both confusing to the public and subject to misunderstanding. In additi,Iconcur i

that better and more efficient action is needed.

Now that the Commission has acted on your petition and issued a decision consider the l

prohibition for you to work on Commission papers and other Agency acti ' ies associated with potassium iodide to be no longer required by Commission procedures.

s we informally 4

discussed on the phone on August 17,1998, I have verified that OG has no objection to this

[

decision.

f I would welcome any assistance you may wish to provide in th uture development of the rulemaking package and finalization of related regulatory gui nce concerning the use of potassium iodide in emergency planning. However, I under tand that, after further li consideration, you would prefer to not be involved in the ency's specific rulemaking and policy statement development resulting from the Commission' action on your petition. I respect your preference in this regard. However, I will remain pers nally involved in these important activities and you should know that you may, at any time, bri to my attention areas that may need correction or clarification. In fact, in my efforts to sure that we "do it right" and avoid the I

further introduction ofinaccuracies and ambiguiti s, I may, from time to time, provide draft j

materials to you in your official capacity as an C attorney with the request that you might advise me as to areas that you believe need rrection or clarification. You may, of course, decline to comment on the materials that I p vide to you, but I would reiterate that I would j

appreciate any assistance that you find it propriate to provide.

I look forward to working with you (to th extent that you may feel it appropriate), and the staff to carry out the Commission's decision o offering to provide Ki to the States.

I understand that Dr. Janusz Naum n will visiting the United States shortly on official business. I hava asked Charlie Miller to invite

r. Nauman to make a presentation to the NRC emergency planning staff so that we may dir etly benefit from the value of his experience during the events after the Chemobyl accident.

cc:

Chairman Jackson Commissioner Diaz Commissioner McG igan 1

DOCUMENT NAME: G:\\pc081898.ki DISTRIBUTION Centra Files PDR JThoma OGC LJCallan WDTravers GTracy SECY PGNorry JLBlaha DEDR R/F GT 980492 TMartin, AEOD AThadani, RES EDO R/F

• See previous concurrence DEDR:TA NRR NRR OGC DEDR EDO JThoma JRoe SCollins JGray HLThompson LJCallan 8/19/98*

8/19/98*

8/19/98*

8/26/98

• 8/ /98 8/ /98

MEMORANDUM TO: Pst:r Crans, Counssi for Special Projects Offico of ths Gansral Counssi FROM:

Hugh L. Thompson, Jr.

Deputy Executive Director i

for Regulatory Programs

SUBJECT:

SYMPOSIUM ON RADIATION AND THYROID CANCER 4

This memorandum is in response to your August 5,1998 memorandum to the Co ission transmitting your talk at the symposium on radiation and thyroid cancer held at mbridge i

University in England on July 22,1998. I agree that a history exists on potass' m iodide that has been both confusing to the public and subject to misunderstanding. In dition, I concur that better and more efficient action is needed. Now that the Commission as acted on your petition and issued a decision, I consider the prohibition for you to work Commission papers and other Agency activities associated with potassium iodide to be no nger required by

_ Commission procedures. As we informally discussed on the phone August 17,1998, I have verified that OGC has no objection to this decision.

l l would welcome any assistance you may wish to provide in the f ure development of the rulemaking package and finalization of related regulatory guida concerning the use of l

potassium iodide in emergency planning. However, I understa d that, after further j

consideration, you would prefer to not be involved in the age y's specific rulemaking and policy j

statement development resulting from the Commission's act' n on your petition. I respect your preference in this regard. However, I will remain personall involved in these important activities and you should know that you msy, at any time, bring to y attention areas that may need j

correction or clarification. In fact, in my efforts to ensur hat we "do it right" and avoid the further introduction of inaccuracies and ambiguities, I y, from time to time, provide draft materials to you in your official capacity as an OGC a orney with the request that you might advise me as to areas that you believe need correct' n or clarification. You may, of course, decline to comment on the materials that I provide you, but I would reiterate that I would appreciate any assistance that you find it appropri te to provide.

I look forward to working with you (to the extent hat you may feel it appropriate), and the staff to carry out the Commission's decision on offeri to provide Kl to the States. I understand that Dr. Janusz Nauman will visiting the United S tes shortly on official business. I have asked Charlie Miller to invite Dr. Nr. man to make presentation to the NRC emergency planning staff so that we may directly bene',t from the va e of his experience during the events after the Chernobyl accident.

cc:

Chairman Jackson Commissioner Diaz Commissioner McGaffigan DOCUMENT NAME: G:\\pc08189.ki DISTRIBUTION Central Files PDR JThoma OGC LJCallan WDTrave s GTracy SECY PGNorry JLBlaha DEDR R/F GT 980492 TMartin, AEOD AThad i,RES EDO R/F

• See previous concurrence DEDR:TA NRR NRR OGC DEDR EDO JThoma JRoe SCollins JGray HLThompson LJCallan 8/19/98*

8/19/98*

8/19/98*

8/26/98

• 8/ /98 8/ !38 s

MEMORANDUM TO: Pater Crans, Counssi for Special Projtcts Offics of the Gansral Counsal FROM:

Hugh L. Thompson, Jr.

Executive Director i

for Regulatory Programs

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SUBJECT:

SYMPOSIUM ON RADIATION AND THhROID CANCER This memorandum is in response to your August 5,1998 merhrandum to the Commission i

transmitting your talk at the symposium on radiation and thyroid cancer held at Cambridge l

University in England on July 22,1998. I agree that a histo exists on potassium iodide that has been both confusing to the public and subject to misun erstanding. In addition, I concur that better and more efficient action is needed. Now that e Commission has acted on your petition and issued a decision, I consider the prohibition f r you to work on Commission papers and other Agency activities associated with potassium i dide to be no longer required by j

Commission procedures. As we informally discussed n the phone on August 17,1998, I have verified that OGC has no objection to this decision.

I would welcome any assistance you may wish to p vide in the future development of the i

rulemaking package and finalization of related reg atory guidance conceming the use of potassium iodide in emergency planning. Howev r, I understand that, after further consideration, you would prefer to not be involve in the agency's specific rulemaking and policy statement development resulting from the Com ission's action on your petition. I respect your l

- preference in this regard. However, I will rema' personally involved in these important activities and you should know that you may, at any tim, bring to my attention areas that may need correction or clarification. In fact, in my effort to ensure that we "do it right" and avoid the further introduction of inaccuracies and ambiguities, I may, from time to time, provide draft materials to you in your official capacity as in OGC attorney with the request that you might advise me as to areas that you believe nef correction or clarification. You may, of course, decline to comment on the materials that provide to you, but I would reiterate that I would appreciate any assistance that you find it appropriate to provide.

I look forward to working with you (to t extent that you may feel it appropriate), and the staff to carryout the Commission's decision o offering to provide KI to the States. I understand that Dr. Janusz Nauman will visiting the U ited States shortly on official business. I have asked Charlie Miller to invite Dr. Nauman t make a presentation to the NRC emergency planning staff so that we may directly benefit from he value of his experience during the events after the Chernobyl accident.

cc:

Chairman Jackson Commissioner Diaz Commissioner McGaffiga l

DOCUMENT NAME: G:\\pc081 98.ki DISTRIBUTION Central Files PDR JThoma OGC LJCallan WDTravers GTracy SECY PGNorry JLBlaha DEDR R/F GT 980492 TMartin, AEOD AThadani, RES EDO R/F

/

• See previous concurrence DEDR:TA NRR NRR OGC DEDR EDO JThoma JRoe SCollins JGray HLThompson LJCallan 8/19/98*

8/19/98*

8/19/98*

8/26/98

• 8/ /98 8/ /98

)

MEMORANDUM TO: Peter Crane, Counsel for Special Projects Office of the General Counsel

/

l FROM:

Hugh L. Thompson, Jr.

Executive Director for Regulatory Programs

SUBJECT:

SYMPOSIUM ON RADIATION AND THYROID CA CER This memorandum is in response to your August 5,1998 memoran m to the Commission transmitting your talk at the symposium on radiation and thyroid cancer held at Cambridge University in England on July 22,1998. I agree that a history ey(sts on potassium iodide that has been both confusing to the public and subject to misundemtanding. In addition, I concur that better and more efficient action is needed. Now that the' Commission has acted on your and other Agency activities associated with potassium i plyou to work on C petition and issued a decision, I consider the prohibition f ide to be no longer required by Commission procedures. As we informally discussed n the phone on August 17,1998, I have verified that OGC has no objection to this decision.

1 I would welcome any assistance you may wish t provide in the future development of the i

rulemaking package and finalization of related gulatory guidance concerning the use of potassium iodide in emergency planning. Ho ever, I understand that, after further consideration, you would prefer to not be in Ived in the agency's specific rulemaking and policy statement development resulting from the ommission's action on your petition. I respect your preference in this regard. However, I will emain personally involved in these important activities

. and you should know that you may, at any time, bring to my attention areas that may need correction or clarification. In fact, in my' efforts to ensure that we "do it right" and avoid the further introduction of inaccuracies arp ambiguities, I may, from time to time, provide draft materials to you in your official capacity as an OGC attorney in the hope that you might advise me as to areas that need correction'or clarification. You may, of course, decline to comment on the materials that I provide to youj/ ut I would reiterate that I would appreciate any assistance b

that you find it appropriate to provide.

cc:

Chairman Jackson l

Commissioner Diaz Commissioner McGaffigan i

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DOCUMENT NAME:

c081898.ki j

DISTRIBUTION Central Files PDR LJCallan WDTravers i

PGNorry JLBlaha TMartin, AEOD AThadani, RES DEDR R/F GTracy JThoma EDO R/F j

• See previous concurrence QLo d

DEDR:TA NRR NRR OG DEDR EDO

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MEMORANDUM TO: Peter Crane, Counsel for Special Projects Office of the General Counsel

/

FROM:

Hugh L. Thompson, Jr.

/

Executive Director

/

for Regulatory Programs l

SUBJECT:

SYMPOSIUM ON RADIATION AND THYROID CANCER This memorandum is in response to your August 5,1998 m.

orandum to the Commission transmitting your talk at the symposium on radiation and t old cancer held at Cambridge j

University in England on July 22,1998. I agree that a hi ory exists on potassium iodide that has been both confusing to the public and subject to misunderstanding. In addition, I concur that better and more efficient action is needed. Now,tfiat the Commission has acted on your petition and issued a decision, I consider the prohibftion for you to work on Commission papers and other Agency activities associated with potaslium iodide to be no longer required by Commission procedures. As we informally disctissed on the phone on August 17,1998, I have verified that OGC has no objection to this decidion.

I look forward to your assistance in the fut e development of the rulemaking package and finalization of related regulatory guidancyconcerning the use of potassium iodide in emergency planning. I have assigned Jack Roe as y lead point of contact for potassium iodide issues and would prefer that you use Jack as yo normal point of contact. However, I will remain personally involved in this important etivity and as appropriate, you may continue to bring to my attention areas that may need clari scation.

cc:

Chairman Jackson Commissioner Diaz Commissioner McGatfigan DOCUMENT NAME: G:\\pc081898.ki

/

DISTRIBUTION f

Central Files

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PDR LJCallan WDTravers

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EDO Principal Correspondence Control FRON:

DUE: 08/21/98 2DO CONTROL: G980492 DOC DT: 08/05/98 FINAL REPLY:

P;tcr G. Crane TO:

Commission FOR SIGNATURE OF :

• • GRN CRC NO: 98-0748 Collins, NRR DESC ROUTING:

TECHNICAL ASSESSMENT OF POTASSIUM IODIDE (TALK AT Callan SYMPOSIUM ON RADIATION AND THYROID CANCER)

Thompson Travers i

Norry Blaha Martin, AEOD DATE: 08/12/98 Thadani, RES i

ASSIGNED TO:

CONTACT:

C SPECIAL INSTRUCTIONS OR REMARKS:

Add EDO and Commission on for concurrence. Chairman cnd Commissioners to review response prior to dicpatch.

C0crdinate with AEOD.

4

OFFICE OF THE SECRE7'ARY CORRESPONDENCE CONTROL TICKET PAPER NUMBER:

CRC-98-0748 LOGGING DATE: Aug 11 98 ACTION OFFICE:

EDO AUTHOR:

PETER CRANE AFFILIATION:

MARYLAND ADDRESSEE:

CHAIRMAN AND COMMISSIONERS LETTER DATE:

Aug 5 98 FILE CODE:

SUBJECT:

TALK AT SYMPOSIUM ON RADIATION AND THYROID CANCER ACTION:

Direct Reply DISTRIBUTION:

CHAIRMAN, COMRS, OIG, OGC SPECIAL HANDLING:

CONSTITUENT:

Chairman and Commissioners to review response before dispatch.

NOTES:

COMMISSION CORRESPONDENCE--VIA VIETTI-COOK DATE DUE:

Aug 25 98 SIGNATURE:

DATE SIGNED:

AFVILIATION:

EDO -- G980492

,d Peter G. Crane '4809 Brmanond Avenue Chey Chase, MD 20815 : 301-656-3998 pgcrane@erols.com C C O J T.w u.. d August 5,1998

. T i O N Rtlw $ w 5 0 -4 3 A Gmuo3s) W hnhg MEMORANDUM FOR:

Chairman Jackson GE Commissioner Diaz a

Commissioner McGaffigan g

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$R FROM:

Peter Crane 5

SUBJECT:

TALK AT SYMPOSIUM ON RADIATION O

AND THYROID CANCER v-On July 22,1998, I gave a talk at the first annual intemational symposium on radiation and thyroid cancer, held at Cambridge University in England. A copy of the talk is attached, in the form in which it is being sent to the printer.

As you will see, I applaud the Commission's decision to grant the rulemaking petition. I also praise FEMA for its willingness to speak up and correct factual errors and omissions by the NRC staff and others. I strongly criticize the NRC staff's " technical assessment," now out for public comment, which was part of SECY-98-%1. Among other things,I highlight the almost

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incredible omission from the document of any mention of the finding by the U.S. Food and Drug Administratiori that potassium iodide is " safe and effective," although this finding might have been expected 'o be the starting point of any assessment of the drug. In addition, I point to the authors' suggestion, unsupported by any evidence, that the report by Drs. Janusz Nauman and Jan Wolff on the Polish experience with K1 after Chemobyl should not be believed. I suggest in the paper that the NRC should withdraw the document, apologize contritely to Drs. Nauman and i

Wolff, and ent.ure that those principally responsible for the " technical assessment" are excused from further involvement with the K1 issue.

cc:

Senator Joseph Lieberman Senator Tom Harkin L. Joseph Callan, EDO Kay C. Goss, Associate Director, FEMA Dr. Janusz Nauman, Medical Center for Postgraduate Research, Warsaw, Poland JtEc'D Br srcy Dr. Jan Wolff,NIH Dr. Jacob Robbins,NIH Dr. David V. Becker, New York Hospital /Comell Medical Center gg g

Dr. Keith Baverstock, WHO, Rome, Italy Docket File, PRM-50-63,-63A

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POTASSIUM IODIDE PROPHYLAXIS AND THE UNITED STATES GOVERNMENT: A CASE STUDY PETER G. CRANE' On July 1.1998. the U.S Nuclear Regulaton Cornmission (NRC) announced that at Imd suted to grant e petition for rulenmkung Gwt will reyune states to cun>idet potassium iodide (Kli prophy laxis, along utth evacuauon and sheltenng. m emerscne) planning for nuclear power plant accidents 'Ilus decision,in a 31 wie of the Conmussioners. represents a major step in the U.S Gowrnrnent's 20.) ear consderauon of the K1 issue. A reucu of the NRC's actions mtr this 20-> car peikal piiuta up nesious derwiciwien in the lwndlung of tle imaw in tle NRC mal it, tecle.u:al staff. with the result that the United States is nou far behird other developed countnes in ensunng comprehensne protecuan for its ciuzens. especiall) its cluldren. in the cent of a major release of radioiodir es The reicu suggests that m gonmmemal decision making concernmg pubhc health cfrects of nuclear pmet p!.aut cuwiyriwies. tlw s icwn of puldw tw.dth myci eien ain) ensiycuey management agencies should tw g;,cn dorranant uraght On July 1,1998, the U.S. Nuclear Regulatory Commission (NRC) announced that it had granted a petition for rulemaking, filed by me, that would require states to consider the drug potassium iodide (KI) as part of their emergency plans for radiological mishaps at nuclear power plants? In voting to begin rulemaking, NRC Chairman Shirley A. Jackson and Commissioners Nils J. Diaz and Edward McGaffigan, Jr., rejected the recommendation of the NRC's own technical staff that the petition be denied.' K1 stockpiling is also bitterly opposed by the U.S.

nuclear power industry. The rule change will be coupled with a new U.S. polic), not 1 Counsel for Special Projects, Office of the General Counsel, U.S. Nuclear Regulatory Commission, former Member, Nuclear Claims Tribunal, Republic of the Marshallislands. This paper, submitted in the author's private capacity, represents his personal views only.

2 See NRC Fress Release of July 1,1998.

3 The vote was 3-1. Commissioner Greta J. Dicus, whose term expired June 30, 1998, sided with the NRC staff.

6-2-

yet final, under which stocks of K1 will be given to any U S. state that requests it.

The grant of the petition did not bring an instant change in the NRC's rules.

Before that can happen, the NRC must publish a proposed rule, receive and analyze comments from the public, and issue a final rule. Thus the three Commissioners' commendable decision represents not the end, but perhaps the beginning of the end, of the U.S. Government's protracted consideration of the Kl issue, a process that began some 20 years ago.

To the international community, it is well known by now that K1 stockpiling is routine throughout the developed world, that some nations, notably France and Switzerland, go further, with house-to-house predistribution'; that K1 has long had the backing of the World Health Organization' and the American Thyroid Association; that it is an element of the International Basic Safety Standardt sponsored by the International Atomic Energy Association and other organizations; and that its safety in actual use was proved in Poland, as Drs. Janusz Nauman and Jan Wolff described in their seminal 1993 paper.' The question that an international audience may be asking is how the United States could contrive to spend 20 years resohing an issue so straightforward and obvious that 20 weeks should have been more than enough time for a reasoned decision.

I will try to offer an answer to that question, through a case study of the handling of the K1 itsue by the United States Government. My purpose is to suggest the problems that can arise when public health decisions relating to radiation are placed in the hands of an agency whose primary expertise is not health, but nuclear technology.

I should interject that I am a lawyer, not a physician or a scientist. I make 4 Electricite de France and the Swiss Government both publicize their K1 policies through Internet sites.

5 World Health Organization, EUR/lCP/CEH 102(S), f 4.3.3. (1991) 6 International Basic Safety Standards for Protection Against lonizing Radiation and for the Safety of Radiation Sources (interim edition), International Atomic Energy Agency (Vienna,1994).

7 J. Nauman & J. Wolff, " Iodine Prophylaxis in Poland after the Chemobyl Reactor Accident: Benefits and Risks," American Journal of Medicine, Vol. 94, p. 524 (May, 1993).

j l

3 no pretensions to medical expertise, except insofar as I have gained it as a patient with thyroid cancer, presumably radiogenic.' My 15-year involvement in the K1 issue stems from my conviction bom of experience, that thyroid cancer is a disease well wonh preventing, especially if prevention can be achieved easily and cheaply.

Benjamin Franklin once wrote, "A child thinks that 20 shillings and 20 years can never be spent." Let me offer now a brief chronology of where the last 20 years went in the U.S. Government's consideration of Kl.

- 1978: The U.S. Food and Drug Administration (FDA) declares K1 " safe and effectin" for use in nuclear power plant emergencies, and approves its over the-counter sale?

- 1979. During the Three Mile Island accident, federal and state officials, fearing a major release, search for supplies of K1 and discover none exist. Later the President's Commission in;estigating the TM1 accident castigates the Govemment's failure to stockpile K1 and recommends stockpiling for the public and radiation' workers. A month later, the NRC a:nounces its agreement, declaring its intent to make the availability of KI a 'necessary pan of an acceptable State emergency response plan.'"

- 1982. The NRC technical staffrecommends that the Commissioners approve an interagency U.S. Government policy endorsing the use of K1 as a "useful 8 I was pan of the cohon of some 5000 children who, some 50 years ago, receised head and neck radiation'-in my case,750 rads of x-ray to my enlarged tonsils and adenoids - at Michael Reese Hospital in Chicago, Illinois in 1973,I had a panial j

thyroidectomy for papillary thyroid cancer;in 1983, had the thyroid remnant ablated, in 1988, was diagnosed with a recurrence; and in 1992. after five courses of radioiodine therapy, totaling 700 millicuries of1 131, was given a clean bill of heahh.

9 Food and Drug Administration," Potassium lodide as a Thyroid-Blocking, gent in a Radiation Emergency," 43 Federal Register 58798 (Dec.15,1978).

10 Repon of the President's Commission on the Accident at Three hn Island

("Kemeny Commission"), at 41-42.

I1 NUREG-0632, 'NRC Views and Analysis of the Recommrdations of the President's Commission on the Accidem at 1 hree Mile Island' (November,1979).

. ancillary protective action.'" Nineteen days later, without explanation, the NRC technical staswithdraws that r==amaad= tion, saying that it plans to prepare a new paper that will recommend against stockpiling and distribution of K1 on cost-benefit grounds."

- 1983: The NRC technical staff briefs the Commission in a public meeting on its new, anti-KI position. The gist of the NRC staffs argument is that though K1 is cheap, it will be even cheaper in the long run to treat radiation-caused illnesses after an accident than to spend even a small amount to prevent them with Kl. The comparison is exclusively in dollar terms: dollars for K1 pills vs. do!!ars for medical treatment, as though illness had no burdens other than the expense involved. The briefers mention neither cancer nor the possibility of fatalities."

- 1985: The U.S. Govemment issues a national policy on KI." Referring to the NRC's " cost-benefit analysis," it dismisses the idea of requiring K1 as "not j

worthwhile *

- 1989. As NRC internal rules allow, I file a " Differing Professional 12 SECY-82-396," Development of a Federal Policy Statement on the Distribution and Use of Potassium lodide for Thyroidal Blocking in the Event of a Nuclear Power Plant Accident"(September 27.1982), Attachment 3, at 3 4.

13 SECY-82 396A," Withdrawal of SECY-82 396 (Federal Policy Statement on Use of Potassium lodide)" (October 15,1982). The memorandum notes that the Federal Emergency Management Agency (FEMA) hasjust dropped plans to buy a large amount ofIG for stockpiling Unlike the NRC, which is an independent regulatory agency, FEhiA is part of the Executive Branch. i.e., under Presidential control.

14 The briefers refer instead to " nodules." They convey the impression that any thyroid illness resulting from an accident would be trivial: "There's a few days loss from - it's a relatively simple operation that's involved in remosing the thyroid or removing the nodules." Transcript of November 22,1983 meeting, at 52 53. When the NRC Chairman suggests that if he survives an accident because of K1, he will think the S.20 cost of the pills to be money well spent, the NRC staff corrects him, telling him that "the surviving question is not the question." Transcript at 63.

15 " Federal Policy on Distribution of Potassium lodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent," 50 Federal Register 30258 (July 24,1985).

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, Opinion," challenging the agency's K! policy. I argue that new information warrants reconsidering the K1 issue, and that existing policy was tainted from the stan by NRC stasmisinformation to the Commissioners and the public, l

- 1994: The NRC staff, wlule not addressing the issue of misinformation, recommends to the Commissioners that stockpiling K1 in the vicinity of nuclear plants "apper;rs prudent."" It proposes a new federal policy to buy KI and encourage states to establish stockpiles. The staff estimates that it would cost less (a few hundred thousand dollars) to buy a national stockpile of K1 than go on studying whether to do so. But the Commissioners then in office tie 2-2, so the old policy remains in place.

- 1995: Acting as a private citizen, on my own time, I file a petition for rulemaking, asking the NRC to require that K1 be among the " range of protective actions" included in state emergency plans. I also write to the Director of the l

Federal Emergency Management Agency, which chairs the interagency committee responsible for overall Kl policy.

- 1996: At a public meeting called by FEM A, several state officials describe K1 stockpiling as undesirable and unnecessary. An Illinois official explains,

" Loss of the thyroid is not life-threatening "" Several months later, the interagency -

committee headed by FEMA calls for a new federal policy that would give K1 at federal expense to any state requesting it."

16 SECY 94-087, " Addendum to SECY 93418 Re evaluation of Policy Regarding Use of Potassium lodide After a Severe Accident at a Nuclear Pcwer Plant" (March 29,1994), at 2.

17 The identical sentence appears in a separate statement Sled by a South Carolina official Later, the Illinois Depanment of Nuclear Safety, offended by my criticism of it, writes to the NRC that the State ofIllinois " stands firmly behind its contention that hundreds of thousands of people live normal, healthy lives without functioning thyroid glands." Letter from Thomas W. Onciger, Director, January 8,1998.

18 Despairing of persuading the Government to provide the states and the public with accurate and up-to-date information on KI, I decided in early 1996 to try to reach the public directly through newspaper anicles. The first, in the New York Times, was designed to coincide with the tenth anniversary of Chernobyl. Other anicles followed (I did not accept payment for them.) They helped stimulate citizen action at the state level, which in tum led to state meetings, in which I panicipated, in

4

, - 1997: The NRC staff proposes a drafi federal policy statement on KI to the Commissioners." While the policy would make K1 available to states requesting it, the notice includes no recommendation that they do so. It does not refer to Chernsyl or the Polish experience with Kl; states that there is 'no new information" warranting a change in existing policy; and mentions only near the end of the notice that the purpose of using KI is to prevent cancer. After a protest from FEM A, the NRC staff apologizes in a public Commission meeting for hasing " misrepresented" FEMA's position on K1 in its June 1997 paper.2"

- 1998: The NRC staff recommends to the Commission that it deny my petition. ' It offers a 40-page " technical assessment" of KI, offering its own highly equivocaljudgment of the drug's safety. Although the obvious starting point for any such analysis by a U.S. Government agency is the Food and Drug Administration's finding that KI is " safe and effective," the NRC staff" technical assessment" omits even to mention it.

The " technical assessment" appears calculated to raise alarm that K1 will have severe side effects, and that these side effects will expose state governments to legal liability. For example, it warns: "In the U.S, the implementation of a protective action may entail htiganon and liabihtyfor long after the accident. The TM1 accident is a casein point One can expect that administration ofKI on a mass basis would certainly entail hugation in this counny. whereas the government of Poland, which administered Kl on a mass-basis. did not appear to be faced with such Maine, Ohio, and New York. Maine and Ohio have decided in favor of stockpiling, and the issue remains under active consideration in New York State. Jn each of these states, great weight has been given to the advice of thyroid cancer experts from the American Thyroid Association.

19 SECY-97-124, " Proposed Federal Policy Regarding Use of Potassium lodide After a Severe Accident at a Nuclear Power Plant," June 16,1997.

20 At this meeting. believing that I did not have the votes to gr.in approval of my petition as written, I stated that I would be satisfied if states are required by rule to

" consider" K1 in developing their emergency plans. At the Commission's request, I submitted an amended petition a week later.

21 SECY-98-061, " Staff Options for Resohing a Petition for Rulemaking." March 31.1998.

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litigation." [ Emphasis added.)"

The authors of the "techmeal assessment" evidently recognize that the strongest empirical evidence for the safety of KI is the very low incidence of adverse medical reactions observed in Poland. Accordingly, in an apparent offon to disparage Nauman and Wolfs repon, the h7C " technical assessment" says ofit in passing, "to the extent that we believe the repon... "" The authors of the " technical assessment" cast this aspersion upon two internationally renowned medical expens without ofering any evidence to suppon the insinuation that the repon should not be believed.2' While the staffs paper is pending before the Commission, a FEM A official writes to the NRC to point out an erroneous statement about FEM A's position on K1 by the NRC stasand " misleading" comments by a nuclear industry lobbying group and an Illinois state agency." Her letter refers to the FDA's 1978 approval of Kl. and adds pointedly "This FDA approval was empirically reinforced by the 22 Technical assessment, at p. 22. Why a legaljudgment of this kind has any place in what purpons to be a technical assessment cf a panicular medication, and what qualifications the authors have io offer any legal opinion - particularly one as sweeping as that just quoted -- are unexplained. The authors' effon to invoke the specter oflegal liability may help explain the absence from the " technical assessment" of any reference to the Food and Drug Administration's finding on Kl. If state govemments were made aware that the FDA had approved K1 as " safe and efective," that fact would be doubly reassuring to thera First, it would indicate that the drug was safe. Second, it would mean that even if, as the NRC staff confidently predicts, use of K1 in a radiological emergency were to lead to lawsuits over side effects, states could defend themselves by showing that they had relied on the FDA's finding. The NRC stas" technical assessment" is careful not io address the point, often made by supponers of K1 stockpiling, myselfincluded, that states concemed about possible exposure to lawsuits relating to K1 should probably worry most about a different type oflawsuit: those that would be brought if an accident occurred and children developed thyroid cancer because KI had not been stockpiled.

23 Id. at 11.

24 The NRC, which has made the " technical assessment" public, should withdraw the document and oEer Drs. Nauman and Wolsa deep and contrite apology.

251.etter from Kay C. Goss, FEMA Associate Director, April 9,1998.

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expenence in Poland with KI, subsequent to the Chernobyl accident." It appears to be an implicit waming to the NRC that FEMA will not be a party to withholding key information on the safety of K1 from the public.

As I mentioned at the outset, the Commissioners rejected the staff recommendation and directed the NRC staff to begin a rulemaking that would incorporate into the NRC's rules a requirement that states " consider" iodine prophylaxis as a part of radiological emergency planning. This requirement would be coupled with an offer of free K1 from the Federal Government. As oflate July, 1998. Commission action on the draft policy statement was expected shortly.

Thus in the end, the Commissioners deci$ed wisely, and the United States may no longer be at odds with the rest of the civilized world on whether it is

" worthwhile" to protect children from thyroid cancer. In such cases,it is common to declare that "the system worked " But did it? To be sure,it speaks well for the American democracy that the citizen's right to seek redress of grievances is not an empty phrase. Likewise, it reflects no small credit on the NRC that it tolerated with such good grace the campaign that an NRC employee was conducting in his spare time.

By any other measure, however, the system did nor work, First and foremost, there is no excuse for American children still to have second class i

protection, so many years after the recommendations of the WHO. When nations rich and poor, from Japan to Armenia, can afford to buy KI, surely the U.S. can do the same. It is or should be a reproach to the richest nation on earth that its policy on protecting children from cancer should be based on the notion - a fallacious notion at that - that cure is cheaper than prevention.

The safety of American children should also not depend on citizens hammering on their Government to do what it promised to do almost 20 years ago.

Moreover, a system for allowing interested citizens to seek regulatory change that takes nine years even to approach fruition cannot be said to be working satisfactorily.

Finally, the record shows too many instances in which the NRC staff provided information to the Commissioners and the public that lacked balance, accuracy, and completeness. I have offered examples of the way in which facts that did not support the desired result have disappeared down the " Memory Hole," in George Orwell's well-known phrase. The NRC staffs treatment of pro-K!

26 FEMA is to be commended for having brought some of these, lapses to the NRC Commissioners' attention.

v s

l 1

9 comments, including those from internationally known medical experts representing the Amencen Thyroid Association,is another example The opportunity to submit views to a federal agency is oflittle value if the technical stafignores those comments it Snds difficult to rebut."

I have high confidence in the NRC staf to make sound, well-supponed and intellectually honest judgments about nuclear safety hardware, conditions of reactor operation, and the like. Sadly, the record does not permit a similar statement about the NRC stafs past handling of the K1 issue."

One can speculate that part of the underlying problem may be that the technical experts involved in cuclear safety decisions do not in their hearts view major accidents as credible, at least in the United States, and therefore regard all emergency planning as no more than a political concession to the public's irrational fears of nuclear power. If one stans from the premise that emergency planning is a pointless charade, then any upgrading of planning, even one as inexpensive as KI, J

may seem wonh resisting. By the same token, it may seem unnecessary to be overly j

punctilious in how one analyzes a health issue that one believes will never arise.

The cause of the phenomenon is beside the poim, however; the issue is what to do about it. I believe that one pan of the answer is to ensure a proper division of governmental responsibilities among different agencies The primary responsibility j

for radiological emergency planaing must be placed (or kept) in the hands of agencies whose mission is emergency preparedness. not nuclear regulation. In the U.S. context, this means FEMA. Such agencies know from experience that accidents can happen and can develop unpredictably. and they plan accordingly.

Likewise, decisions affecting human health should be made in the first ir4 stance by health agencies and health professionals. It seems unlikely, for example, 27 The NRC staffs recent memoranda to the Commissioners on the K1 issue illustrate how essential it is that Commissioners and their personal staffs read the actual comments that are submitted to the NRC on comroversial issues, rather than relying on the NRC staff to summarize the comments for them.

28 Now that the Commissioners have voted, it is reasonable to expect that the

- highest levels of NRC staff management will loyally accept the direction they have received. The more problematic issue concerns NRC staff management below the highest levels. Suffice it to say that the deficiencies of the " technical assessment" are of such a nature that it would be prudent to excuse the individuals principally responsible for that document from any further involvement with the K1 issue.

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e 10-that any medical do'etor, answerable to his or her peers, would ever discuss the consequences of radiation-caused thyroid disease in a public meeting without mentioning cancer. Nor would medical doctors presume to discuss the safety of a drug without reference to the Food and Drug Administration'sjudgment that it is

" safe and effective." The line between nuclear regulation and nuclear promotion is not an easy one to maintain, and needs to be guarded vigilantly, as must the line between science and prop 9pnda. Here, something went seriously wTong not once but repeatedly.

Thanks to the three NRC Commissioners now in office, the U.S.

Government's long mishandling of the K1 issue may now be nearing its end.

Nevenheless, it should be an object lesson within the U.S. and for authorities in other countries as well.

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. References JounalArticle:

Nauman J, WolffJ. Iodine Prophylaxis in Poland after the Chernobyl Reactor Accident: Benefits and Risks. Am JMed 1993; Vol. 94, p. 524.

Pubhcations ofhuenuticumi Organi:ations:

International Basic Safety Standards for Protection Against lonizing Radiation and for the Safety of Radiation Sources (interim edition).

Intemational Atomic Energy Agency (Vienna,1994)

World Health Organization Report EURt1CP/CEH 102(S)(1991)

U.S. Nuclear Regulatory Commission Pubhcations:

NUREG-0632,"NRC Views and Analysis of the Recommendations of the President's Commission on the Accident at Three Mile Island"(November.

1979).

SECY-82-396, " Development of a Federal Policy Statement on the Distribution and Use of Potassium 1odide for Thyroidal Blocking in the Event of a Nuclear Power Plant Accident"(September 27,1982).

SECY-82 396A," Withdrawal of SECY-82 396 (Federal Policy Statement on Use of Potassium Iodide" (October 15,1982)

SECY-94-087," Addendum to SECY 93-318 Re-evaluation of Policy Regarding Use of Potassium lodide After a Severe Accident at a Nuclear Power Plant"(March 29,1994)

SECY-97-124," Proposed Federal Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant"(June 16.1997)

SECY-98-061, " Staff Options for Resohing a Petition for Rulemaking" (March 31,1998) l l

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tI 12 Other U.S Gowrnment Publications:

" Federal Policy on Distribution of Potassium lodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent," 50 Federal Register 30258 (July 24,1985)

" Potassium lodide as a Thyroid-Blocking Agent in a Radiation Emergency,"

(U.S. Food and Drug Administration),43 Federal Register 58798 (Dec.15, 1978)

Report of the President's Conunission on the Accident at Three Mile Island (1979) l I