ML20212E649

Requests Commission Approval of Option to Resolve PRM-50-63 That Requested Changing NRC Regulations Re Emergency Planning

ML20212E649
Person / Time
Issue date:	10/23/1997
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-97-245, SECY-97-245-01, SECY-97-245-1, SECY-97-245-R, NUDOCS 9711040011
Download: ML20212E649 (50)

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J RULEMAKING ISSUE (Notation Vue)

October 23.1997 SECY-97-245 EQB:

The Commissioners FROM-L. Joseph Callen

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Executive Director for Operations

SUBJECT:

STAFF OPTIONS FOR RESOLVING A PETITION FOR RULEMAKING (PRM-1 50-63) RELATING TO A RE-EVALUATION OF THE POLICY REGARDING USE OF POTASSIUM IODIDE (KI) AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT PURPOSE:

l To obtain Commission approval of an option to resolve a petition for rulemaking that requested changing the NRC regulations regarding emergency planning.

BACKGROUND:

On September 9,1995, a petition for rulemaking (PRM-50-63) was submitted to the NRC by Mr. Peter Crane. The petitioner requestod that the NRC amend its emergency planning regulations to include a requirement that the range of protective actions include the prophylactic use of potassium iodide as well as sheltering and evacuation. Then specdic request was to amend one of the 16 planning stande.ds in 10 CFR 50.41 to assure that the option of using potassium iodide be included in emergency plans. The planning standards currently do not identify specific protective actions that must be included in emergency plans prepared t'y licensees or the States.

The current Federal guidance to State and local govemments on the distribution of Ki was promulgated in 1985 by the Federal Emergency Management Age g

Chair of the Federal Radiological Preparedness Coordinating Committee (FRPCC)

I (50 FR 30285; July 25,1985) and as the Federal agency charged with establishing policy and L

providing leadership via the FRPCC (44 CFR 351 Subpart C). The FRPCC was established to i

coordinate all Federal responsibilities for assisting State and local govemments in emergency 1f i

Commission was provided a proposed revision to the Federal policy regarding the use of

.. j planning and preparedness for peacetime radiological emergencies. On June 16,1997, the j

CONTACT:

NOTE: TO BE MADE PUBLICLY AVAILABLE S

Mike Jamgochian, RES/DRA WHEN THE FINAL SRM IS MADE AVAILABLE

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potassium lodide (SECY-97-124). The Commission approved the staff's option of endorsing the FRPCC recommendations. The Commission informed the staff not to view its approval of this option as a denial of the petition for rulemaking (PRM 50-63) and directed the staff to prepare an assessment of the petition and submit it to the Commission for its consideration.

DISCUSSION-On November 27,1995 (60 FR 58256), a Notice of Psceipt of the Petition for Rulemaking was published in the Endatal Reaister requesting public comment. A total of 63 comment letters were received of which 20 utilities,9 State govemmental agencies,2 utility interest organizations,1 letter signed by 12 health physicists,2 State 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 groups,22 members of the public (including 1 from the petitioner), and the American Thyroid Association. None of the State govemmental agencies that commented on the petition for rulemaking supported granting the petition. (See the for a detailed analysis of the public comments.)

The petitioner requested that the " planning standard"in 10 CFR Part 50, section 50.47(b)(10) be revised to read.

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(10) A range of protective actions includina shelte-ina. evacuation. and orochviactic use of iodine. have been developed for the plume exposure l

pathway EPZ [ emergency planning zone] for emergency workers and the public.

Guidehnes for the choice of protective actions during an emergency, consistent with Federal guidelines are developed and in place, and protective actions for j

the ingestion exposure pathway EPZ appropriate to the locale have been j

c'eveloped.

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The petitioner also requested that "the NRC also bsue, either on its own or in conjunction with other agencies, a policy stctement declaring that Ki stockpiling is e sensible and prudent measure, necessary to assure that the drug will be available in the event of a major accident.

This statement would make clear that KI, while no panacea, can be used in conjunction with evacuation and sheltering to maximize protection to the public." The full text of the petitioner's request can be found in Enclosure 2.

The staff has evaluated the various options for addressing the petitioner's concems and is providing three options for the Commission's consideration in resolving this petition. The first option would grant the petition as requested by the petitioner. The second option would deny the petition for rulemaking. However, the NRC in coordination with the States and other Federal agencies would develop guidance to address planning for Kl distribution for those States that include Kl in their planning basis, consistent with the FRPCC policy. In the third 1 The petitioner further stated that, "I am not proposing house-to-house predistribution of KI, which I think would be ineffective and a source of confusion during an actual emergency.

Rather, I am suggesting that state and local authorities have ready access to supplies of the drug so that they can administer it if it is needed."

9 The Commissioners 3

option the staff proposes to deny the requested petition for rulemaking but would pursue a modification to the regulations to require licensees to address planning for Kl distribution for those States that include Kl in their planning basis.

DatiplL1:

To grant the petition for rulemaking strictly in accordance with the petitioner's request.

The petitioner proposed that section 50.47(b)(10) be amended to read as follows:

A range of protective actions includina shelterina. evacuation. and orochvfactic use of iodine. have been developed for the plume exposure pathway EPZ

[ emergency planning zone] for emergency workers and the public. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidelines are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed. [the underlined text would be added to the existing standard in 50.47)

Pros:

1. Would resolve the issue as requested by the petitioner. Advantages of this option as identified by the petitioner are: a.) would establish a uniform Federal policy on Kl and b.) would ensure that emergency plans address the prophylactic use of Kl.

Cons:

1. By requiring Kl as a protective measure this opt'on would contradict the June 30,1997, SRM and the 1997 proposed FRPOC recommendations that States should have the option of using Ki as a protective measure.

2. Revising the regulation as requested by the petitioner would mean that licensees and States would be required to incorporate all three protective actions into their emergency plans. Failure to do so by a State would result in a situation where a State's decision would conflict with the new requirement.

3. May give the appearance that the use of KI, as a protective measure, could be equated to the use of evacuation and sheltering.

4. Would require NRC and FEMA resources to revise the regulations and guidance documents, and to review revised plans and procedures.

S. The Rulemaking required by this option would be protracted in that extensive coordination with the States, other affected Federal agencie.5, licensees and the public would be required prior to adoption as a final rule.

6. During the public comment period, state governments identified significant implementation problems associated with this option.

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. Ootion 2:

Deny the petition for rulemaking as requested by the petitioner. However, NRC in coordination with the States and other Federal agencies would develop guidance to address planning for Kl distribution for those States that include Kl in ll their planning basis.-

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Pros:

1c Would be consistent with the June 30,1997, SRM endorsing the draft FRPCC

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- policy discussed in SECY-97-124 to fund the purchase of Kl for States at their request.

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2. The' proposed FRPCC policy addresses some of the petitioner's concems.

This is based on the following aspects of the proposed policy: 1) nagional _

- stockpiles will be made available to the States that request them in the event of E

an emergency, and 2) the Federal govemment will purchase Kl for any State requesting it.

3. No NRC and FEMA review of a State's decision would be required.

- t Cons:

1. Does not resolve the petition in the manner requested by the petitioner.-

Ophon 3' Deny the petition for rulemaking as requestod by the petitioner. However under this option a modification to the regulations would be pursued to require -

licensees to address planning for Kl distribution for those States that include K1 in their planning basis.

Pros:

1. Would be consistent with the current and proposed federal policy on KI, that States should have access to Kl as a protective measure.

2. Retains the States' prerogative to incorporate the use of Kl into their emergency protection measures in the event of an accident.

-3. Codifies the relief given in Option 2.

J Cons:

. 1. The rulemaking required by this option may r,e protracted in that extensive coordination with the States, other affected Federal agencies, licensees and the public would be required rior to adoptior' as a final rule

2. Would require NRC and ' NIA resources to revise the regulations and guidance documents, andl a tiew revised plans and procedures.

Staff position-7 It is the staffs position that a revision to the regulations is not necessary to assure that KI, as a L protective measure for the public, is available for use by the States. This position would

support the Commission decision in its SRM dated June 30,1997 to endorse the draft FRPCC policy on the distribution of Kl.

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The staff favors Option 2 because it is consistent with proposed Federal policy hs endorsed by-the Commission and addresses the overall policy change requested oy the petitioner, i.e., the willingness of the Federal govemment to provide a stockpile of Kl to the States upon request.

This would be accomplished without the burden of a rulemaking, Nonetheless, the staff has developed Option 3 should the Commission wish to codify these proposed policy changes in a rulemaking, which would involve coordination with the States, other Federal agencies, licensees and the public.

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RESOURCES:

_ The resources raeded to resolve this petition in accordance with Option 2 are included in the current budget. Resources to conduct rulemaking (Options 1 and 3) as well as resources to _.

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purchase Kl have not been included in the current budget.

Under any of these options the Commission must make a determination that NRC funding for l_

purchases of Kl at the request of States would make a direct contribution to fulfilling the NRC's j.

regulatory responsibility to protect the public health and safety during a radiological emergency.

This determination provides the necessary legal basis for NRC expending appropriated funds for the purchase of Kl. The NRC would also have to obtain Congressional reprogramming l

approval.-

p Additionally, the cost considerabons of purchasing Kl were fully discussed in SECY g7-124.

f COORDINATION:

l' The Office of the Chief Financial Officer has reviewed this Commission Paper for resource implications and has no objections. A copy of this paper was sent to the ACRS and the CRGR forinformation.

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The Commissioners 6

RECOMMENDATION:

That the Commission:

Acorove an option to resolve the Petition for Rulemaking (PRM-50-63).

L. J eph Callan Executive Director for Operations

Enclosures:

As stated Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Friday, November 7, 1997.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT October 31, 1997, with an information copy co the Office of the Secretary.

If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

DISTRIBUTION:

Commissioners OGC OCAA OIG OPA OCA CIO CFO EDO SECY ve s

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ENCLOSURE 1 DETA! LED INFORMATION RELATING TO Ki STOCKPILING d

W Encicsure 1 Detailed information Relating to Kl Stockpiling o

FRPCC Members y

Federal agencies which participate in the FRPCC are: Federal Emergency

' Management Agency (FEMA), Nuclear Regulatory Commission (NRC), Environmental '

' Protection Agency (EPA), Department of Health and Human Services (HHS),

Department of Energy (DOE), Department of Transportation (DOT), Department of Agriculture (USDA), Department of Defense (DOD), Department of Commerce (DOC),

Department of Interior (dol), Department of State (DOS), Department of Veterans Affairs (DVA), General St tvices Administration (G SA), National Communication System (NCS), and National Aeronautics and Space Administration (NASA).

o Detailed Analysis of Public Comments t

l Opposition to granting the petition for rulemaking could generally be characterized by the following comments:

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1.

"There is simply no conceivable means to distribute potassium iodide to potentially affected members of the public within the appropriate time after initiation of a hypothetical nuclear accident. Predistribution is completely out of h

the question, since there would be no means to control misuses,' overdoses,-

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shelf life, etc."

l 2.

"A radioactive release from a nuclear power plant that results in a substantial thyroid dose would undoubtedly include a significant whole body dose as well.

Potassium iodide offers no protection for this dose. If plans were in place to l

administer potassium iodide to the public, the potential would be created for evacuation orders to be _ ignored due to perceived protection by potassium -

iodide."

3.

"The logistics for advanced distribution of Kl to the general public within the

_ plume EPZ { plume exposure pathway Emergency Planning Zone) 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 problems associated with advanced KI distribution that would need to be addressed 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 would have retained the Kl after 3 months? 6 months? 1 year? Would 100 percent distribution to all households have to be made each year to ensure that a supply is available? What percentage of households would have to demonstrate ready availability to satisfy Federal requirements? Who would assume liability if the KI was used prior to the

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Govemor ordering its use?"

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. Potassium iodide is a drug with side effects, some of which are profounda The following contraindications are listed in the medical literature: hypersensitivity to lodides, acute bronchitis, hyperthyroidism, Addison's disease, acute or chronic.

renal disease, tuberculosis acute dehydration. The following precautions are i

- listed in the medical literature: use cautiously or avoid use in patients with a i_

history oi thyroid disease; use care during initial administration of potassium

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lo:lide because of risk of hypersensitivity; persons with goiter or autoimmune tt:yroid disease are at particular risk for adverse reactions; administration of

- potassium iodide during pregnancy may cause fetal harm, abnormal thyroid

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function and goiter."

5.

"If the NRC adopts a policy of issuance of Kl to the general public as a protective action recommendation, it will be considered as being contrary to State policy and will not be acceptod This will have the net result of negating rr' ofthe planning and preparedness effort of Federal, State and local govemments since Three Mile Island."

6.

The added function of distributing Kl 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 evacuees and emergency workers."

Support for granting the petition for rulemaking could generally be characterized by the' following comments:

1.

"A host of countries-France, Germany, Belarus, Russia, Switzerland, Austria, the Czech Republic, Japan, Great Britain, Sweden, Slovakia, and others-protect themselves with stockpiles of Kl. Soaring rates of thyroid cancer are appearing in children in the Soviet Union who were exposed to the.Chemobyl nuclear -

accident, but received too little potassium iodide, and too late."

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 drug to much of the affected population within a short time after an accident.

The EPA Manual [ Manual of Protective Action Guides and Protective Actions for.

Nuclear incidents, EPA-400-R-92-001 (May 1992)] quotes the Food and Drug Administration as stating that potassium iodide 'will have substantial benefit even if it is taken 3 or 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 m_illion 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 leaming that our govemment was willing to spend millions to study radiation-caused thyroid disease abroad, while balking at spending a fraction of that amount to prevent radiation caused thyroid disease at home."

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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 poPcy -

aanman that thic will not even be an option."

5.

"Just because there are other lethal radionuclides to which people may be exposed, why deny them the availability of KI, which can counteract 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.'"

6.

"Every drug has contraindications and the potential for allergic reactions. In an 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 choi::e of making an informed decision and assuming possible -

risk."

o The 1996 FRPCC Ad-Hoc Subcommittee on Kl Recommendations:

1.

Without changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether to use KI, the Federal Govemment (NRC, or NRC through FEMA) should fund the purchase of a stockpile for a State that '

decides to incorporate KI as a protective measure for the general public; 2.

The Subcommittee believes the language in the 1985 policy should be softened -

to be more flexible and balanced. For example, the problem many intervenors -

observe with the Federal policy is the Italicized statement "The Federal position with [ respect to)... potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were reworded to state fit [ potassium lodide for use by the general public) is not required, but may be selected as a protective measure at the option of the State or, in some cases, local govemments."

3.

. The subcommtee recommends that local jurisdictions who wish to incorporate -

KI as a protective action for the general public should consult with the State to determine if such arrangements are appropriate = If local govemments have the -

authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include such a measure in their emergency :

plans.

o-The -Highlights of the 1997 proposed FRPCC Federal Policy on Kl:

'1.

K1 should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear.

facilities, the best technical information indicates that evacuation and in-place

4 sheltering provide adequate protection for the general public. However, the State (or in some cases, the local Govemment) is ultimately responsible for the protection of its citizens. Therefore, the decision for local stockpiling and use of Kl as a protective measure for the general public is left to the discretion of the State or, in some cases, the local govemment.

2.

The Federal Govemment will establish funding for the purchase of a supply of Kl.

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It is recognized that the State or the local Govemment, within the limits of their authority, can take measures beyond those recommended or required. The availability of Kl as a protective measure for the general public supplements other options for public officials responsible for protective action decisions. A few States have indeed included Kl as a protective action for the general public, The FRPCC does not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public. Therefore, to ensure that States have available to them the option to use KI if they so elect, the Federal Govemment will be prepared to provide funding for the purchase of a supply of KI. Any State or local govemment which solects the use of Kl as a protective measure for the general public may notify FEMA and request funding for the purpose of purchasing a supply of Kl. Guidance would have to be developed in this area jointly with FEMA.

3.

A stockpile of Kl is being established by the Federal Govemment. The Federal Govemment is required to prepare for a wider range of radiological emergencies'. To that end, and as an added assurance for radiological emergenc.es in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of Kl is being established by the Federal Govemment. This Federal stockpile will be available to any State for any type of radiological emergency at any time.

4.

Those States or local govemments which opt to include Kl for the general population will be responsible for the maintenance, distribution, and any subsequent costs associated with this program.

5.

The incorporation of a program for Kl stockpiling, distribution, and use by any State or local govemment into the emergency plans will not be subject to Federal evaluation. This is based on the recognition that the use of Kl by the State for the general public is a supplemental protective measure, and that the existing emergency planning and preparedness guidance for nuclear power plants are i In response to new threats, the Federal Government broadened the scope of emergency response preparedness to include terrorism involving nuclear, biological, and chemical agents. As a result, and in support of State and local governments, new resources were identified to be needed in response to such events.

Twenty-six Metropolitan Medical Strike Teams (MMST) are being established for response to such events, each with a cache of medicinal supplies. Medical supplies, including KI, are also being stockpiled nationally for the use by MMSTs in three locations: Es.st coast (Washington, DC), Central (Denver), and West coast (Los Angeles). The quantity of supplies stockpiled uses a planning basis of loo,ooo people for a period of two days.

5 effective and adequate to protect the public health and safety.

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4 ENCLOSURE 2 FETITION OF PETER G. CRANE FOR RULEMAKING TO IMPLEMENT THE RECOMMENDATION OF-l- :

. THE PRESID6NTS COMMISSION ON THE ACCIDENT AT THREE MILE ISLAND (KEMENY COMMISSION)

L THAT THE UNITED STATES STOCKPILE THE DRUG POTASSIUM IODIDE FOR THYROID PROTECTION DURING NUCLEAR ACCIDENTS 4)

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4809 Drummond Avenue Chevy Chase, MD 20815 September 9, 1995 Mr.-John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C.

20555 Re:

Petition of Peter G. Crane for rulemakina to implement the recommendation of the President's Comni_ssion on the Accident at Three Mile Island (Kemeny Commission) that the United States stockpile the drua potassium iodide for thyroid protection durina nuclear accidents

Dear Mr. Hoyle:

t Enclosed for filing please find the above-captioned petition.

Please note that it is submitted in my capacity as a member of the public, not in my official capacity as Counsel for Special Projects in the NRC's Office of the General Counsel.

It was written on my own time, at home, using information available to the public in the NRC's Public Document Room.

Sincerely, tL Peter G.

Crane

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. 3 SEp i t $95 omee ot the secretary S

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s BEFORE THE UNITED STATES NUCLEAR REGULATO'Y COMMISSION Petition of Peter G. Crane for rulemah.ino to implerent the recommandation of the President's Commission on the Accident et Three Mile Island (Kemeny Commission) that the United States stockpile the drua potassium iodide for thyroid protection durino nuclear accidents I.

Summary The subject of this petition should bu of nationwide concern:

the fact that the United States, unlike virtually all other countries in the developed world, does not stockpile the drug potassium iodide (KI) to prevent thyroid cancer and other thyroid diseases after nuclear accidents.

KI prevents the absorption of harmful radioactive iodine by saturating the thyroid gland with iodine in a harmless ferm.

The drug is extremely inexpensive.

In recommending stockpiling in 1994, the NRC technical staff estimated that a supply sufficient to protect the population nearest to all U.S. nuclear plants could be I

established for a total of at most "a few hundred thousand dollars," or ten cents per year for each person protected.

Present U.S. policy, adopted in 1985 by an interagency policy statement, with NRC concurrence, holds that it is "not worthwhile" to require KI stockpiling.

The policy reflects a

" cost-benefit analysis" which calculated that the drug was not l

likely to pay for itself over time, and that it would be cheaper in the long run to refrain from buying KI, and treat the resulting thyroid disease, than use KI to prevent the disease.

Looking only at dollar costs, the analysis did not take into account what we all know intuitively:

that the worst part of illness is~not necessarily the economic consequences.

Currently, the federal government is sending confused and confusing messages both about whether KI is useful and whether it is available.

In September, 1994, the Federal Emergency Management Agency issued a proposed Federal Radiological Emergency Response Plan describing the duties of federal agencies during nuclear emergencies.

The NRC, as the lead agency for accidents at nuclear power plants, is to advise state and local governments about " measures that they should take to avoid or reduce exposure of the public to radiation," including " emergency actions such as sheltering, evacuation, and oronhvlactic use of iodine."

In an emergency, an interagency panel will offer guidance to the NRC on when KI should be~used.

While the authors of the Plan plainly understand the drug's value in radiological emergencies, they seem not to realize that because of the 1985 policy, all the elaborate procedures for making decisions about I

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2 KI are pointless:

in an emergency, there will be none_tolgive out..

The 1985 policy statement was the comp 1.ete rejection of.one of the major-recommendations of the President's' Commission on-the-Accident at Three_ Mile Island (Kemeny Commission).

During the TMI accident, state _and federal officials looked for KI and discovered _that none was available.

The drug had to be manufactured on short notice.

The Kameny. Commission strongly

-criticized-the failure to-stockpile, and recommended that regional stockpiles be established.

Its report recognized that evacuation is not invariably the preferred response to an and'that even when evacuation is desirable, it may not emergency, be feasible.

A KI stockpile means that emergency response officials have three arrows in their quiver:

evacuation, sheltering, and iodine.

-Initially, in 1979, the NRC warmly endorsed the Kemeny Commission's position on KI and announced that it intended to make-the availability of KI for the general public a necessary part of every emergency-response plan.

As_ late as September 1982, all-the-responsible federal agencies were in agreement that MI stockpiling was desirable.

A dreft federal policy _. statement oto-that effect was circulated for agency approval.. Only a few

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weeks later, for reasons still unclear, FEMA and the NRC staff

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did-a complete about face.

FEMA cancelled its plant to purchase KI, the draft policy statement was withdrawn, and the NRC_ staff i

adopted a strongly negative stance toward KI.

The NRC Commissioners acceptance of the NRC staff's changed position case after a November 1983-briefing in which staff officials, none of whom is now with NRC,-offered a seriously

. inaccurate description of the nature of the disease that KI could be expected to prevent.

Never discussing cancers or fatalities, the briefers-advised the Commissioners and the audience that if a member.of the public was exposed to radioactive iodine during an accident, the result could be a " nodule," easily ramoved, that would maan "a few days" of absence from_ work.

The briefers did not mention that 40% of-those radiation-caused nodules would be and that-5-to 10% of the cancers would be fatal.

cancerous, The actual-consequences of radiation-caused. thyroid disease are far more serious than "a few days" away from work, as the.

recent news reports:on the young victims of Chernobyl make grimly clear.

Though usually curable, thyroid cancer is-lethal enough

.toikill 1,120 Americans each year, according to T.merican Cancer Society figures.

Even when non-fatal, the disease and related

-tests and treatment can severely affect the quality of life.

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In 1986, only a year after the policy statement was issued, the Charnobyl accident demonstrated how dangerously flawed the new U.S. policy was.

In Poland, where the authorities moved vigorously to administer KI, 18 million doses were given out, with the result that 97% of all Polish children were protected and an upsurge of disease was averted.

In the then Soviet Union, on the other hand, too little KI was given out, too late.

Russia, Belarus, and Ukraine are now experiencing soaring rates of childhood thyroid cancer -- in some places, 200 times pre-accident levels -- and the worst may be yet to come.

U.S. policy did not change in respot.se to the Chernobyl accident, however, despite an urgent request from the American Thyroid Association in 1989.

In 1991, the World Health Organization declared that thyroid protection was " critical" during accidents, and said, " Stocks of iodine should be stored strategically at points including hospitals, schools, and fire and police stations."

France, Germany, Belarus, Russia, Switzerland, Austria, the Czech Republic, Japan, Britain, Sweden, Slovakia, and a host of other countries now protect their children with stockpiles of KI.

They follow the " International Basic Safety Standards," issued by the International Atomic Energy Agency in 1994, which provide for giving out KI when projected doses exceed specified guidelines.

The U.S. Government supported adoption of the Basic Safety Standards, which represent the consensus judgment of the world's radiation safety experts, but ignores them where KI is concerned.

The current policy goes against the best judgment of the NRC's own technical staff, which in 1994 declared, commendably, that " prudence" called for KI stockpiling and recontmended to the NRC Commissioners that the U.S. Government buy the drug and make it available to states at no cost.

While the NRC staff's proposal for a change in policy was pending before the Commissioners, Senators Alan K. Simpson and Joseph I. Lieberman, in an April 20, 1994 letter, urged the Commission to bring American policy on KI into line with the recommendations of medical and scientific experts and international practice.

They also stressed the " moral responsibility" of the federal government to be candid with the public about the risks of federally-licensed activities and ways of lessening those risks.

The only group to endorse the existing policy was an industry trade association, which urged among other things that stockpiling KI might make the public fear that nuclear plants were unsafe.

And so the lines were drawn:

on the one side, the Kemeny Commission, the American Thyroid Association, the World Health Organization, the two Senators, the NRC's own technical

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staff, and the example of the rest of the developed world; on the other side, the industry trade association.

When the Commissio..cra cast their votes, the outcome was a 2-2 tie.

Under NRC procedures, the deadlock meant that the NRC staff proposal failed.

The old discredited policy remains in place today.

FEMA's 1994 Federal Radiological Emergency Response Plan takes the worst of all possible approachas, for it gives states and the public the illusion of KI protection without the reality.

The Government must choose:

either to create stockpiles of KI, thereby making the Plan accurate, or revise the Plan and publicly explain that because of the existing federal policy, use of the drug will not be an option in a nuclear emergency.

This petition wou3d resolve the dilemma by improving protection rather than correcting the Plan.

It requests that the Commission amend its rules (10 CFR Section 50.47(b)(10)) to specify that the " range of protective actions" required to be set forth in State and local emergency plans includes sheltering, evacuation, and provision to administer KI, as envisioned by the Federal Radiological Emergency Response Plan.

It asks the NRC to issue a policy statement explaining that KI is a sensible and prudent emergency planning measure, when used in conjunction with evacuation and sheltering, and declaring NRC support for federal funding of local and regional stockpiles.

This approach would cost utilities nothing, and should not burden them in any way.

For a pittance, it could save thousands of Americans from thyroid cancer and other diseases if a major nuclear accident occurred.

I KI may be compared to the lifejackets on a ferryboat:

needed only rarely, but vital if the need does arise.

We require ferries to carry lifejackets not because we expect them to pay

~

for themselves over time, but because it is the reasonable and prudent' thing to do.

Likewise, we vaccinate our children against polio and diphtheria to prevent needless suffering and deaths, not because we have calculated that this is a way to save money.

The U.S. Government recently agreed to spend $15 miin :,a over 15 years studying radiation-related thyroid cancer in Ukrainian children.

This was sensible and appropriate.

But can a rational Government decide that it is worthwhile to spend $15 million to study thyroid cancer in Ukrainian children, and not worthwhile to spend a fraction of that Laount to prevent the same dicease in American children?

This petition says that it can't.

America's families deserve no less protection from radiation than is provided to children and their parents throughout the rest of the developed world.

The NRC staff has pointed the way, and the Commission and the U.S. Government should follow.

3 4

5 II.

Factual Backcround A.

Potassium iodide and its uses.

Potassium iodide (KI) protects the thyroid gland -- which, especially in children, is highly sensitive to radiation -- from the radioactivo iodine that would be released in extremely serious nuclear accidents.

By saturating the gland with iodine in a harmless form, potassium iodide prevents any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead to thyroid cancer or other illnesses.

In addition to preventing deaths from thyroid uncer,' KI prevents radiation-caused illnesses tnat although not fatal, can disrupt and even blight a person's life.

Thyroid cancer, curable in 90-954 of cases, generally means surgery, radiation treatment, and a lifetime on medication.'

The changes of medication that go with periodic scans put many patients on a physiological and The American Cancer Society estimates the number of new cases in 1995 at 13,900, and the number of deaths at 1,120.

l Thyroid cancer represents about 1

percent of cancer cases nationwide.

See letter of Joseph E. Rall, M.D.,

Ph.D., Deputy Director for Intramural Research, National Institutes of Health, to Central Docket Section, Environmental Protection Agency, February 9, 1990:

In the United States, there are approximately 10,000 new cases of thyroid cancer per year. Af ter initial surgical removal, ablation with I-131 is used to complete the thyroidectomy in in at least half of these patients (i.e.

~5000) in doses ranging from 30 to 150 mci.

Most of these patients then receive one or more test doses of I-131 (2 to 10 mci) to detect the occurrence of metastassa.

A conservative estimate of the number of patients who develop metastatic thyroid cancer who could benefit from -

I-131 therapy is 2000 cases per year.

These patients receive from one to ten treatment doses of 150 to 300 mci over a period of up to 20 years or more.

This treatment is curative in some cases and prolongs disease-free survivial in many cases.

It should also be noted that unlike some cancers, which if they have not recurred within a set period (such as five years) can be considered cured forever, the thyroid cancer patient must be monitored for life.

6 psychological rollercoaster.'

Hypothyroidism (an in1ufficiency of thyroid hormone, which can result from radiatinn damage to the gland) can cause permanent retardation in children and, if i

~

undiagnosed, can condemn adults to a lifetime of fatigue, weakness, and chills.'

The drug has a long shelf life -- at least five years -- and causes negligible side effects.'

B.

U.S. colicy on KT orior to the Three Mile Island

accident, l

In December 1978, the Food and Drug Administration announced i

that it had determined that potassium iodide was safe and effective for thyroid protection in nuclear accidents.

The issue attracted little attention, however, and the NRC and the Federal Government as a whole took no public position on the drug.

Barely three months later, on March 28, 1979, the Three Mile Island accident began to unfold.

After two days of unsuccessful efforts to bring the reactor under control, it was still uncertain whether a major release of radioactivity could be averted.

Federai and state officials, searching for supplies of KI in case it should be needed, discovered that there was none to l

be had, in Pennsylvania or elsewhere.

A supply therefore had to i

l Some years ago, for example, Set.ator John East of North 8

Carolina committed suicide because, according to his widow, an incorrectly treated thyroid imbalance had made his life j

unendurable.

President George Bush, after being treated with l

radioactive iodine for an overactive thyroid (Graves' disease),

displayed symptoms characteristic of patients returning to thyroid hormone after the hypothyroidism caused by radiciodine treatments:

physical exhaustion, frequent talkativeness, and a tendency to emotionalism.

The media may have missed the story (as President Bush's former press secretary observed in recently published memoirs), but at the time, old thyroid patients understood exactly what was going on.

• As I had occasion to see when I was in the Marshall Islands as an administrative judge with the Nuclear Claims Tribunal in 1991, many people who are chronically chilly and exhausted from hypothyroidism may be unaware that their problems are symptoms of a treatchle illness.

As a result, they may never receive the drug (synthetic thyroid hormone) that would quickly relieve their symptoms and allow them to live a normal life.

" Iodide Prcphylaxis in Poland after the Chernobyl Reactor Accident:

Benefits and Risks," Janusz Nauman, M.D.,

Ph.D.,

Jan

Wolff, M.D., Ph.D., The American Journal of Medicine, Vol. 94, p.

524 (May, 1993).

. - - ~ _... _.

- -. -. ~.. -.. - -

p.' ' :.!

h'-

)

Y 7

'be manufactured, literally: overnight.

At 3 a.m. on Saturday, P

. March 31,.a Food and Drug Administration official arranged with the Mallinckrodt-Chemical Company for the immediate production of l

~250,000 doses of KI.

Without a: written contract or a purchase-order, the company began _ production (Parke-Davis soon followed L

suit), and the first shipment-of the drug arrived in Pennsylvania j

24-hours later.'

2 C.

The President's Commission on the Three Mile Island j

accident rec.

nds KI stockpilina.

(

{

_After the_ accident, President Carter appointed John Kemeny, j

President of-Dartmouth College, to-head-a_ commission to, j_

investigate the accident.

Its report, issued in October, 1979,-

-j was'strongly-critical-of the failure to stockpile KI.

It said:

i-i; For over 25 years, the use of blocking agents such as ll potassium iodide to-prevent the accumulation of radioiodine in the thyroid gland has been known.

The effectiveness _of potassium iodide administration for thyroid gland protection.in the event-of releases of-F radiciodine was recognized by the National Council on

[

Radiation Protection and Measurement in 1977.

The Food and Drug Administration authorized use of potassium I

iodide as a thyro)d-blocking agent for the general public in December 1978.

However,-at the time of.the f

TMI accident, potassium iodide for this use was not

[

commercially available in the United States in quantities sufficient'for the population within.a '

mile-radius of'TMI.'

L Among the Kemeny Commission's major recommendations was the l[

following:

i 1

" Report of the Office of Chief Counsel on Emergency Response to the President's Commission on the Accident at Three Mile.

Island," -. (October 1979 ), - p.

91. _ See. also Dr. Jerome Halperin,

" Potassium Iodide e as : a ' Thyroid Blocker -- Three Mile Island to Today,"-DICP, The Annals of Pharm ctherapy, Vol. 23 (May 1989),

.which includes'an insider's account of the effort to procure not only supplies of the drug,.but also bottles, labels, and. droppers, and get them to Pennsylvania.

Report - of the._ President's Commission on the Accident-at Three Mile Island,' October 1979, at--41-42.

With a single change -

this would be also be an accurate from 25. years to 40 statement of_ current preparedness to administer KI.

i 8

An adequate supply of the radiation protective (thyroid blocking) agent, potassium iodide for human use, should be available regionally for distribution to the general population and workers affected by a radiological i

emergency.'

Elsewhere in its report, the Kameny Commission explained that different types of accidents, depending on their particular circumstances, might require different kinds of emergency response:

A variety of possible accidents should be considered during siting, particularly " smaller" accidents which have a higher probability of occurring.

For each such accident, one should calculate probable levels of l

radiation releases at a variety of distances to decide the kinds of protective action that are necessary and feasible.

Such protective actions may range from evacuation of an area near the plant, to the j

distribution of potassium iodide to protect the thyroid gland from radioactive iodine,_to a simple instruction

]

to people several miles from the plant to stay indoors for a specified period of time.... Emergency plans must have built into them a variety of responses'to a variety of possible kinds of accidents.'

The last point is particularly significant, because it shows the Kemeny Commission's recognition that in some accident situations, evacuation may not be the emergency planning measure of choice.

D.

The federal acencies back the Kemeny Commission recommendation.

Initially, the Kemeny Commission's recommendation in favor of KI stockpiling seemed so obviously sensible as to be non-1 controversial.

In NUREG-0632, "NRC Views and Analysis of the Recommendations of the President's Commission on the Accident at Three Mile Island," issued in November, 1979, the NRC declared:

The President's Commission recommends that an adequate supply of potassium iodide be available for both workers and the general public.

NRC agrees and is

• Id. at 75.

' Id. at 16-17.

I 9

planning to require licensees to have adequate supplies of this agent available for nuclear power plant workers..-For the-general population, NRC expacts to-include the. availability of potassium iodide as a necessary part of-anLacceptable State emergency response plan.

Plans have not been finalized as to exactly how and to what-extent the agent should be l

stockpiled and distributed, but studies are underway to resolve this matter.at an early date, For the next several years, the three agencies most D

concerned -- the Food and Drug Administration, responsible for approving drugs; NRC, - expert in radiation protection; and the Federal Emergency Management Agency, with responsibilities for emergencies-generally -- were all on the same track, favoring the stockpiling of potassium iodide.

In May 1982, however, the

~ Atomic Industrial Forum, a nuclear industry trade association, declared itself against potassium iodide."

The NRC' staff _was strongly in favor of KI stockpiling as late as September 27, 1982, when it sont the Commissioners a memorandum numbered SECY-82-396

(" Development of a Federal Policy

-Statement on the Distribution and Use-of Potassium Iodide for-Thyroidal Blocking in the Event of a Nuclear Power Plant Accident").

In that-paper, the staff proposed that the Commission agree with a draft interagency policy statement supporting KI= stockpiling.

The draft policy statement is worth quoting at length, because it describes with clarity and accuracyLboth the benefits

-of-KI and the limitations of the drug.

It says:

....KI blocking only effectively reduces the: radiation exposure of the thyroid gland.

While-this is-an.

s important contribution to the health and safety of the-individual, it is not nearly as' effective as measures which protect the total body of the individual from radioactivity._ Both in-place sheltering and precautionary' evacuations can reduce the exposure to the total body.

As an example, if a precautionary evacuation can be instituted with little or no radiation exposure, this may be the most effective-

" Statement on the Use of Potassium Iodide by the Atomic Industrial-Forum Committee on Environment," cited in the " Industry White' Paper, Review of' Federal Policy on Use'of Potassium Iodide,"

December 1993, at 7.

i 10 protective action.

However, there are instances where evacuation may not be preferred.

Evacuation ray be unnecessary beause the amount of protection afforded by in-place sheltering is adequate....There are also possible situations when evacuation cannot be accomplished in time to prevent exposing large numbers of individuals to a significant amount of radiation during the evacuation.

In those instances where shelter is used because the evacuation cannot be completed in time to avoid a substantial radiation insult, the. administration of KI could be a useful ancillary protective action which could provide some additional exposure reduction to the thyroids of the exposed individuals.

The use of KI for thyroidal blocking is not an effective means by itself for protecting individuals from an airborne release of radioactivity from a nuclear power plant accident and therefore should be used in conjunction with sheltering, evacuation or other protective methods.

In summary, the use of KI to prevent radiciodine from accumulating in the thyroid gland can be an effective ancillary protective action during a nuclear power plant accident.**

E.

The NRC and FEMA reverse themselves.

For reasons that have never been explained publicly, the policy statement was almost immediately scuttled.

Less than three weeks after sending the draft policy statement to the Commission for approval, the staff sent a supplementary paper,

.SECY-82-396A (October 15, 1982), withdrawing _the September 27 memorandum.

The new memo informed the Commissioners that NRC's Office of Research could, by January 1, 1983, produce a paper showing that KI was "significantly less cost beneficial than previously assumed."

The staff proposed sending this document, when completed, to the cther federal agencies "with a recommendation that a policy statement recommending against the stockpiling and distribution of potassium iodide for the general public be developed."

The staff paper added a significant piece of information:

"The Commission should also be aware that FEMA has recently reversed its previous decision to purchase a large quantity of potassium iodide for a national stockpile."

The reason for FEMA's action was not stated, however.

In a November 22, 1983 Commission meeting, open to the

SECY-A2-396 (September 27, 1982), Attachment 3, at 3-4.

a

11 public, Jack Zerbe, head of the NRC's Office of Policy Evaluation, expressed his unease at the NRC staff's sudden about-face:

I guess one of the things that was of concern to us was that in 9/27/82, the staff had recommended that they adopt this thing that had been worked on for four years by the three agencies, and essentially two weeks later they shifted that recommendation to go in just the i

opposite direction.

l Transcript at 79.

The implied question -- why the reversal had occurred --

went unanswered.

No claim was made, then or later, that the change was based on new scientific, technical, or medical information.

The purpose of the November 22, 1983 meeting was for the NRC staff to brief the Commissioners on the staff's proposal to take a strong position acainst KI.

At the outset, the three staff briefers" emphasized that the NRC had the primary role within the U.S. Government as a source of technical expertise on the KI issue."

One of the briefers explained:

We, at the NRC, have the responsibility to provide the technical rationale and make some recommendation either for potassium iodide, a neutral statement one way or another, or against it.

And that's where we have to come down, in some sense.

It is our responsibility to t

prov.ide that technical information.

Transcript at 7.

A problem for the briefers, in making the case against KI, was that the Commissioners had been hearing ever since the Three Mile Island accident that stockpiling the drug was a cheap, effective, and sensible protective measure.

As Commissioner Bernthal commented at one point, "I just think stockpiling is such a cheap and easy preventative, that even if the odds are 1 percent, why not?"

(Transcript at 28.)

The briefers undertook to prove that even though KI might cost only ten cents per pill, it was nevertheless not " cost-effective."

4

" None of the three is still with the NRC.

" This was correct then and remains so today.

-.B, ' ' '

r i

12 1

The briefers' central claim was that it would take 4'

$10,000,000 worth of KI to prevent each " nodule,""fwhereas if KI-were B21 used, the cost of dealing with each nodule that did occur wouldlbe at most $20,000.-'The,tranecript is clear on this point:-

-At the bottom of this [ slide), you see a dashed Aine at 3_

about:the $20,000 figure, and that represents what we feel the cost-benefit breakpoint would be.

If the cost

!~

{

of_ averting one nodule is on the order.of $20,000, that's the cost that will be represented by the medical l

treatment and the loss of productivity of an individual if he had a thyroid nodule.

And it's on the upper end of the values which we have seen.

There's a few days' loss-from -- it's a relatively simple operation that's involved in removino the' thyroid or removina the-nodules" ---

[ Emphasis added.]

Transcript at 52-53.

-The:briefers claimed to have performed the analysis "with a bias in favor of potassium iodide if anything."

(Transcript at

'53.).

They continued:

And our' analysis still-comes down and shows that even s

if our most optimistic view -- which is the bottom line of these curves -- would indicate that this is not a viable measure to be taken, it is not something that we should consider in terms of policy.

As far as we're concerned, the message couldn't be any clearer.

We have taken every f actor that we can think of -into account; it's not just single arguments that we throw-at each other; Ewe have factored in all the' uncertainties that we can think about, and this is

-where we come down to it, and the message is clear.

Transcript at 54.

The transcript.shows the Commissioners' response:

The $10,000,000 figure reflected the assumption that an accident in which KI would be useful could occur only once a millenium.

" Compare' this description of thyroid disease with th,at quoted

'in-footnote-2, above.

d _. '

+:.

i-13

.CKAiRMANfPALLADINO:'

But it-sounds crass.

It doesn't satisfy.me~as an-individual'.

2 --

1:

COMMISSIONER:ASSELSTINE:

'I must say I-share.that view..

3 1

CHAIRMAN PAI.LADINO: -Something just-does not sit with me I

right.

~

[ Staff briefer):

Let's move on'to the next slide.

a

. Laughter.)

(

.e l

Transcript at-54.

The' Commissioners' misgivings were:well-founded.

While the E

briefers' clear and unequivocal message was that the worst consequence of failing to stockpile KI was that a " nodule" might

};

- appear, 'they neglected-to mention that their figures were based-not on-All nodules,1but only on-harmless benign ones.

Their own i

~ analysis showed that some-40% of all accident-caused nodules will' turn'out to-be cancerous, and that 5% to 10% of the-cancers will

' be fatal.

~

I Chairman.Palladino persisted.

Told that the NRC should j'

provide its cost-benefit analysis to other-federal agencies and state and local governments "because these other agencies do look to-the: Nuclear Regulatory Commission," (Transcript-_at 57), he

- replied:

b; I

I'm not ready yet to.even address that because I don't-l:

Lunderstand'in the cost analysis -- for example,-you say it costs -- what were your dollars?

$10 million per-

-nodule averted, and you said boy,::that's pretty.high-

-But then you.tell me it's a low cost operation..So now i

to me, for example, as an-individual,.what would it-cost me for my pill.

Twenty cents.

... As:-an-Lindividual, I say boy, that's among the lowest-cost 6

~ protection.

....ILguess I was-taking a'more personal view of cost-

-benefit.. 20 cents or some nominal amount of money.

every year or everyLfive years:to_ replace them seems J

• • " This f act - was buried in the fine print of the thick memorandum,that accompanied the briefing.

The transcript suggests that1the Commissioners had not picked up on this critical point.

f 4

i

\\

14 like small change compared to the risk, from my perception.

Transcript at 57, 59, 60-61.

One of the staff briefers responded by comparing potassium iodide to insurance policies with low premiums but with coverage that turns out, on close examination, to require "that there has to be a stampeding elephant that kills you."'

(Transcript at 61.)

CHAIRMAN PALLADINO:

...You said something that bothers me a little bit.

You said that we were paying a low cost for something that wasn't worthwhile.

You related it to a worthless insurance policy.

But as an individual, I may say the potential benefit is that I which I might survive a nuclear accident at that plant, live near.

COMMISSIONER ASSELSTINE:

Or that you may not have to go through an operation --

[ Staff briefer):

Except that -- the survivina cuestion is not the cuestion, and that's the piece that really l

should also be emphasized."

(Emphasis added.]

CHAIRMAN PALLADINO:

All right, survive in the terms of I avert --

[Another staff briefer):

An illness.

I will avert an illness which I.might incur.

But my father's argument He in buying his insurance policies was the very same.

might leave my mother $10,000 from an accident insurance policy.

There was a residual chance that he would be killed by that stampeding elephant.

It was not a well thought-out choice.

" The clear implication of this statement was that potassium iodide - cannot save lives.

The staff briefer treated Chairman Palladinu's comment as referring only to immediate, short-1.erm survival.

To be sure, potassium iodide will not prevent quick deaths during an accident (if-people die from radiation in the

-short term, it will be because of whole-body doses, not thyroid doses), but it may prevent slow deaths from cancer in the years afterwards.

For the threa or four Americans who die of thyroid cancer each day, and all the thyroid cancer patients who, being human, worry that the disease may kill them, "the surviving question" is thus very much the question.

l 15 Transcript at 63.

Continuing the theme that the drug was a useless remedy against a non-existent problem, one of the staff briefers added that the staff did not feel it necessary to come out in opposition to the purchase of KI by individuals:

"If somebody wants to wear that amulet and have that available to them, that's their business...."

(Transcript at 68.)

The issue was not finally resolved that day, but in the end, the NRC's negative views on the drug were communicated to an

~,

interagency group studying the issue."

The result was the 1985 Policy Statement, still in effect today, which declared:

While va?id arguments may be made for the use of KI, the preponderance of information indicates that a nationwido requirement for the predistribution or stockpiling fo-use by the general public would not be worthwhile.

This is based on the ability to evacuate the general population and the cost effectiveness of a nationwide program which has been analyzed by the NRC...."

The net effect of the Policy Statement was to dispose of the Ketteny Cor. mission's recommendation in f avor of "I stockpiling, I do not mean to suggest that the Commissioners remained under the impression that thyroid cancer was nevar fatal.

As I described in my Differing Professional Opinion, the Office of General Counsel pointed out to the Commission that the staff's figure of $20,000 referred only to the costs associated with having

- a harmless benign thyroid nodule.

In reply, the staf f acknowledged that if both benign and malignant nodules were taken into account, the costs would go up by a factor of five, to $100,000.

No public announcement of this was made, however, so the recalculation would have been of no benefit to those members of the public who attended the Novawber 22 briefing at which the $20,000 figure was touted.

" "Feoeral Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Th).oidal Blocking Agent," 50 Fed.

Reg. 30258 (July 24, 1985).

Note that tb Policy Statement does not say that XI itself is not worthwhile it is the recuirement to stockpile or predistribute the drug at is described as not worthwhile.

But the ardinary renocr il not notice this artful distinction, and will understand the

>vernment tr say that the drug itself is worthless.

Note also ie implication t3at it will always be possible to evacuate th affected populr< -on if an accident occurs.

16 seemingly once and for all.

What could r.ot have been predicted, however, was that only a year later, a nuclear catastrophe in the Soviet Union would give tangible proof of the value of the drug in radiological emergencies.

~

F.

Chernobyl and its aftermath During the Chernobyl accident of 1986, the damaged reactor spewed radioactive iodine not only into the immediate vicinity of the plant (located near Kiev in Ukraine), but also over wide areas of the Soviet Union and nearby Poland.

Russia, Ukraine, and Belarus, where the distribution of KI was inadequate and untimely, are now experiencing extraordinarily high levels of childhood thyroid cancer, as recent newspaper articles have described."

The reports from Eastern Europe make clear that "Chernoby1's Young Victims Pay Toll Thyroid, Other Cancers Are Belarus's Legacy of Nuclear Disaster,"

a front page article in The Washington Post, June 24, 1995:

"In 1986, before Chernobyl, according to Yevgeny Demidchuk, director of the republic's Scientific and Practical Center of Thyroid Cancer in Hinck, Belarus registered just two cases of thyroid cancer in children under 14, about a typical number for a country its size.

By 1992 that number had soered to 66 cases and last year to 82, a surge so sudden and severe that international experts, initally skeptical about Belarus's post-Chernobyl health

claims, now acknowledge it can only be explained by Chernobyl f allout.... Pre-cancerous thyroid conditions in children are even more widespread.

'This is on a mass scale, several million kids who might develop thyroid cancer,'

said Konoplya

{ director of the Radiobiology Institute of Belarus's Academy of Sciences)."

See

also,

" Cancers Soar in Region of Chernobyl,"

The Washington Post, March 25, 1995:

"The rate of thyroid cancer in a region north of the Chernobyl nuclear plant is nearly 200 times higher than normal, according to research published in the British Medical Journal.

Scientists from Russia, Ukratne, Belarus and the World Hre.lth Organization said abnormally high rates of thyroid cancer in children had been detected farther away in the northern Ukraine and parts of Russia.

... The cancer has appeared most in children because they are more sensitive to radiation and their thyroid glands are smaller, so a given amount of radioactive iodine represents a larger dose fcr a child's thyroid gland than for an adult's.

In Gomel, a city in Belarus 70 miles north of Chernobyl, 143 cases of thyroid cancer were diagnosed between 1991 and 1994 in children under 15, the scientists said.

That was a rate of 96.4 per million, compared with the normal rate of 0.5 per million."

17 radiation-caused thyroid disease entails much more than "a few days off."

In Poland, on the other hand, where XI was

- administered to 97% of the nation's children, there has been no i

similar increase in thyroid cancer.

The Polish example is proof l

positive of the benefits of a well-prepared XI program."

4 In view of the grave medical news tros the former Soviet Union, the United States Government is currently spending many millions of dollars -- some of it supplied by the NRC ---to study radiation-caused thyroid cancer in Ukraine and Belarus.

Announcing a $15 million, 15-year program that will follow 70,000 children in Ukraine, the Department of Energy _ declared, in a June 13, 1995 press release, that the studies "provida a unique opportunity to understand the thyroid cancer risk of exposure to radiciodine."

The DOE press release explained:

"The release of radioiodine is likely to figure prominently in any nuclear power plant disaster and_nnowledge of its carcinogonic potency is inadequate, especially in children."

In addition, the U.S. Government has spent generously to bring Ukrainian doctors to this country for training in thyroid surgery, because mishandled operations can mean damaged nerves and larynxes, and children rendered permanently mute.

There could not-be a better example of wise and humane foreign aid.

-G.

Eggt:Chernobv1.develonnents on KI policy.

The Chernobyl accident demonstrated beyond the shadow of a doubt that potassium iodide worked; that it was no mere " amulet,"

as one of-the briefers had scornfully described-it to the Commissioners; and that countries which failed to stockpile and distribute it'could find themselves with surious public health

' problems on their hands.

The NRC staff, however, war, not immes lately ready to acknowledge that the now inforreation from Chernobyl called for a revision of U.S. policy.

In early 1989, the NRC. issued NUREG-1251, " Implications of the Accident at Chernobyl for Safety Regulation of Commercial Nuclear Power Plants in the United States," in which it concluded that the Chernobyl ex erience did not suggest a need for changing U.S. policy on KI.

" Evacuation-is_ generally feasible," it said, "and when carried out is more effective in dose reduction than administration'of KI, since it can reduce the dose for all-body organs and not merely the thyrold gland.... The apparently

ggt Nauman & Wolf f, footnote 5 above.

lr.

l I

i i

18-i successful use of KI at Pripyat (a city close to Chernobyl) does L

I not alter the validity of guidance that recognires that evacuation _of the general public in the affected area could l

,~

result in a greater overall dose reduction.""

It is worth l

noting that no claim was.made that. evacuation was always l

feasible, just "ganerally" feasible.

i H.

The NRC recanaiders the KI issue.

l i

i In June 1989, in accordance with NRC procedures, I filed a

" Differing Professional Opinion" urging a change in policy on potassium iodide.

In order to allow the reader to understand any bias that I might bring to-the issue, I made clear my own personal interests-in 1973, when I was 26, I had surgery for a e

malignant thyroid tumor, the probable result of x-ray treatment In for enlarged tonsils and adenoids when I was.two years old.

11988, my_ doctors detected a: recurrence, which required five.

radiation treatments over a three-year period to be eradicated.

On November 27, 1989, the American Thyroid Association wrote to the Commission, urging XI stockpiling on a nationwide basis, j

In 1990, the NRC-announced that it was' reconsidering the existing federal policy."

While the issue was under consideration at NRC, the World Health Organization's " Working Group on Strategy for Public Health Action in Relation to Nuclear Emergencies" issued a report-stating that " implementation of (KI) prophylaxis

.is critical," and stating:

" Stocks of iodine should be stored strategically-at pointh including hospitals, schools, and fire and police stations.""

.In April 1992, a contractor under the sponsorship of HRC's Office of Research issued a report which included-a revised cost-j benefit analysis of the use of potassium iodido.

To the credit 7

of the contractor and the NRC staff, this included a serious attempt.to rectify the past downplaying of the consequences of radiation-caused thyroid disease.

As far as its weighing of.

costs and benefits, however, it was bound by the staff's estimates of accident probabilities.

Using those figures, the report concluded that stockpiling continued to be non-cost-effective, but that_the difference between costs and benefits was j

" NUREG-1251, Section 4.2.3,

" Assessment."

" 55 Fed. Reg. 39768 (September 28, 1990).

World Health Organization, EUR/ICP/CEH 102(S),

Section 4.3.3.

(1991).

m

i 1

19 4

l significantly narrower than had been calculated by the NRC staff f

.in the early 1980's.

For the population within a 5-mile radius, 4;-

"the cost-benefit ratio for use of potassium iodide by the general pu' lic approaches a value of two," the staff reported in l

i November 1993."

i In December 1993, an industry trade group, the Nuclear j

i Management and Resources Council, sent a " White Paper" to the

{

Commission arguing against any change in current KI policy.

(It j

was the only group to do so.)

The White Paper suggested that a i

change in policy would cause members of the public to "want to know if the federal policy is being changed because the plants j

are less safe."

It added:

"Public-confidence in the technology j

could be affected by the decision.""

i l

The industry White Paper also quoted Dr. David Becker, an eminent thyroidologist who is currently heading the NRC-sponsored researth into thyroid cancer in Belarus, in such a way as to make j

it appear that he opposed KI stockpiling.

This was taking a I

i

" SECY-93-318, p.

4.

Thus by these. calculations, KI almost pays ' for itself for the closest-in populations.

This averaged d

figure does not take into account either the difference in safety i

between plants of different designs or the wide margin of error-(a factor of 100) in the estimates of accident probability.

If accidents are.100 times mort probable than estimated, then KI-for these nearby residents will pay for itself 50 times over, by the l

NRC staff's own calculations.

My contention, however, is not that KI will necessarily pay for itself.

Rather, it is that the uncertainty.. in the actual probability of major accidents makes i

these cost-benefit calculations of little value, and argues for-letting prudence and good judgment drive the decision on KI.

" " Review of Federal Policy on Use of Potassium Iodide,"

Nuclear Management and Resources Council (December 1993),

p.

8.

a l,

The industry's argument echoes the claim of environmentalists and residents of the Three Mile Island area, in the early 1980's, that 3

the NRC was required to consider the fears of the local population, l

and the probable " psychological impacts" on them, in determining whether to allow resumed operation of the Three Mile Island Unit f

h 1 reactor.

The NRC, supported by Andustry, took the position that a scientific and technical agency should base its decision on the

- best available scientific and technical evidence, not on people's fears.

A unanimous-Supreme Court upheld the NRC, after I briefed, i

argued, and lost the case in the D.C. Circuit Court of Appeals.

Metropolitan Edison Co. v. People Aaminst Nuclear Enerov, 460 U.S.

766 (1983), reversing People Aaainst Nuclear Enerav v. NRC, 678 4

L

.F.2d 222 (D.C. Cir. 1982).

i

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20 l

I chance, in light of the fact that Dr. Becker was one of_the signers of the November 1989 American Thyroid Association letter urging KI stockpiling, and the New York Times had published a l

letter from him to the same effect.

After Dr. Becker protested, a senior NRC official sent a letter of rebuke to the industry l

group, declaring that its characterization of Dr. Becker's views l

was " completely contrary" to his actual position.

Copies were j

sent to Dr. Becker and the NRC's Public Document Room."

1.

The NRC staff backs KI stocknilina, but its cronosal for a channa in policy is blocked when the C.

insioners deadlock.

On March-29, 1994, the NRC staff declared its support for XI stockpiling; In-its final memorandum to the Commission on--the subject, it wrote:

Although a reactor accident requiring KI is unlikely and KI is only effective as a-protective measure for the dose to the-thyroid due to radioactive iodine, the cost to purchase and stockpile amounts sufficient to administer to populations within five milen of operating nuclear power plants is relatively low.

(In a footnote, the staff estimated the cost at S.10 per person per year.)

Consequently, it annaars nrudent to stocknile KI for limited populations located close to the_ operating nuclear power plants. [ Emphasis edded.)

The staff reported that it had engaged in-dialogues with FEMA-and the Department of Health and Human Services, and that the two agencies "would cooperate with the NRC in working toward adoption of a revised federal policy on KI."

The staff-proposed that the federal government buy the drug and make it=available through FEMA to the states, which would be encouraged (but not compelled) to stockpile it.

On April 20, 1994, while the issue was pending before the Commissioners, Senators Alan Simpson, Republican of Wyoming, and

" _ Letter of June 1,

1994, from James L.

Milhoan, Deputy Executive-Director for Nuclear Reactor Regulation, Regional Operations and Research, to J. Phillip Bayne, President and_.CEO, Nuclear Energy Institute (NEI). NEI was the successor organization to NUMARC,1which was in turn the successor to the Atomic Industrial Forum of the early 1980's.

SECY-94-087, = Addendum to SECY-93-318 Re-evaluation of Policy Regarding Use of Potassium Iodide After a Severt Accident at'u Nuclear Power Plant," at'2.

1 21

. Joseph.Lieberman, Democrat of Connecticut, wrote a concise and forceful letter to the Commission, urging that U.S. policy on potassium iodide be brought into line with expert opinion and international practice.

After marshaling the many arguments for KI, they dealt with the claim that KI stockpiling could result in

" negative public perception."

They wrote:

[N]o evidence has been provided that any of the existing policies in other nations or in the states that provide for the use of KI by the general-population has caused any undue panic or apprehension to the general public.

Moreover, the. federal government has a moral; responsibility to provide the public with complete and accurate information regarding the risks from federally-licensed activities and ways in which those risks may be reduced."

When the staff proposal came to a vote, however, the four Commissioners divided 2 to 2," and under NRC internal procedures, a tie vote on a proposal means that it fails.

There was, therefore, no decision on the merits of the NRC staff's-recommendation.

J.

KI'and the federal aovere--nt -- current status.

The tie vote on the staff's proposal-for a change in policy seems to have been misunderstood completely by an interagency committee considering the KI issue.

The February 1995 issue of "CRCPD Newbrief," the newsletter of the Conference of Radiation Control Program Directors, reported that at-a December-1994-meeting of the Federal Radiological Preparedness and Coordination Committee-(FRPCC), an ad hoc subcommittee on KI presented and discussed-a report on the drug.

According to the newsletter, "the subcommittee indicated that there is a lack of new data challenging the (1985] FRPCC Federal Policy" on KI.

The story continued:

"A lack-of justification for a federal stockpile was identified by the subcommittee.

There is also a lack of support for federal stockpile initiative by-the states and the primary

" A copy,of the letter is attached to this petition.

" The Commission's " Staff Requirements Memorandum" of May 6, 1994 recorded Commissioner Rogers's vote in favor of the staff recommendation but was silent as to the individual positionk of the other three' Commissioners.. Commissioner Rogers is the only one of the four still on the Commission.

i

\\

i 22 i

federal regulatory agency (NRC).""

The FRPCC subcommittee's position is all the harder to l

fathom in light of the publication by FEMA in September 1994 of a i

proposed " Federal Radiological Emergency Response Plan"" which expressly envisions-the use of KI during radiological emergencies.

Clearly, this implies that the authors of the Plan recognise the drug's usefulness.

Under the Plan, NRC will be the

" Lead Federal Agency" during emergencies at nuclear power plants, and its duties will include providing t

... advice to State and local governments on measures that they should take to avoid or reduce exposure of the public to radiation from a release of radioactive material.

This includes emergency actions such as Ebelterina, evacuation, and crophylactic use of iodine."

The Plan further provides for an interagency " Advisory Team for Environment, Food, and Health" to help the " Lead Federal Agency" formulate its advice, by providing, among other things, Guidance on the use of radioprotective substances _(e.g.

thyroid blocking agents), including dosage and projected radiation doses that warrant the use of such drugs."

Thus the now Plan envisions that in an emergency, the interagency panel will advise the NRC on when KI should be used, the NRC will then advise the state and local governments, and the

" One has to wonder where the subcommittee has been getting its information if it is unaware of any "new data challenging" the 1985 policy.

The subcommittee might begin by reading the American Thyroid Association's letter of 1989; the March 1994 memorandum by the NRC staff, endorsing a change in federal policy; the April 1994 letter from - Senators Simpson and Lieberman, summing up the arguments for KI stockpiling; the International Basic Safety Standards, adopted in 1994 with-U.S. Government support; and the which regularly carry articles on Chernobyl-related newspapers, thyroid disease in'the former Soviet Union.

" 59 Fed. Reg. 46086 (September 6, 1994).

" 59 Fed. Reg.- at 46091.

" J.d.

-.. ~. -

l j

l l

23 states and localities will then administer the drug.

What the j

l Plan's authors either do not realise or do not choose to mention j

is that in a real emergency there will be no KI to give out, l-thanks to the current, federal policy on the drug."

Also in 1994, the Board of Governors of the International

[

l i

Atomic Energy Agency, with U.S. Government support, adopted new l

" International Basic Safety Standards."

These standards represent the consensus of the world's experts on radiation i

safety.

With regard to emergency planning, they provide, among 4

other things:

" Intervention levels for immediate protective actions,.includina ahmiterina, evacuation, and iodine grophylaxis, shall be specified in emergency plans...." "

l Thus the international radiation protection community, like the l

Kameny Commission in 1979 and the short-lived draft federal policy statement of 1982, recognised that effective preparedness for radiological emergencies meant having three arrows in the 1

quiver, not just-one or two.

t t.

+

f I

t i

i l

I i

Several years ago, Dr. Jerome Halperin, who as an FDA official was involved in the effort to obtain KI during the Three Mile Island accident lamented in a medical: journal article that L

the : nation was still in a pre-THI state of readiness for l

emergencies requiring the drug.

"Potrassius Iodide as a Thyroid Three Mile Island to Today," DICP, The Annals of Blocker Pharmacotherapy, Vol. 23, May, 1989.

His statement was accurate at'the time he wrote and remains so today.

{

^

" International Basic Safety Standards for Protection Against l

Ionizing Radiation and for the Safety of Radiation Sources (interim edition),-International Atomic Energy Agency (Vienna,1994), at 73.

l --

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. _ _ _. _.,. ~. -... _ - _ - _ _ _

24

,111.

Aroument 1.

The U.S.

Government cannot rationally conclude that it is worthyhile to soend $15 million to study radiation-caused i

thyroid cancer in Ukraine, but not worthwhile to spend a much ABAller sum to orevent radiation-caused thyroid cancer in this country.

The project now underway to study thyroid cancer in Ukrainian children will cost the United States about $200.00 for each child studied.

At the same time, the U.S. Government refuses to spend $.10 per child to prevent thyroid cancer in American children.

To make clear, I am not criticizing the expenditure on the study in Ukraine, I applaud it.

But I question whether, at $15 million dollars, it is 50 or 60 times more valuable to the American people than would be a national potassium iodide stockpile, conting a few hundred thousand dollars, that could prevent large numbers of cancers, some of them fatal, in the event of a serious accident.

The United States should be able to afford both."

The NRC staff has estimated that KI is so cheap that buying the drug would cost less than continuing to study whether it is cost-effective to buy it.

Nuclear accidents can happen, here as well as abroad.

If accidents gan happen, that means that given enough time, eventually they Eili happen.

If a major accident ever occurs in this country, we do not want American children go through what i

the children of Belarus, Ukraine, and Russia are suffering today.

A stockpile of KI can help assure that they do not.

This is not a radical proposition by any means.

As noted above, all the relevant agencies of the United States Government, including the NRC, initially agreed with the Kemeny Commission recommendation that KI stockpiling was sensible, prudent, and worthwhile.

The wisdom of that recommendation was confirmed by Chernobyl in 1986.

Whatever the reason for the Government's abrupt reversal late in 1982, it was a serious mistake, and correction is long overdue.

It need hardly be added that if there in ever a major nuclear release in this country, we will spend hundreds of millions of dollars identifying, treating, and compensating harm that might have been prevented by the timely expenditure of that few hundred thousand dollars.

O 25 2.

Evacuation is not nacessarily the orotective measure of choice in every emeroency. and even when it is the oreferred oDtion, it is not alWays feasible.

The 1985 federal policy statement, declaring that KI stockpiling would not be worthwhile, explained:

"This is based on the ability to evacuate the ceneral oooulation and the cost effectiveness of a nationwide program which has been analyzed by the NRC...."

There are two problems with the underlined portion of this statement.

It implies (1) that evacuation is necessarily the protective measure of choice in every emergency, and (2) that authorities would always have the " ability to evacuate the general population."

Both propositions are false, and the existing policy may therefore give states and the public a false sense of security.

As the Kemeny Commission report explained (see p. 8 above),

different types of accidents, and the particular circumstances presented, may call for different protective measures.

A KI stockpile assures that responsible authorities have an additional type of protection in their arsenal.

The NRC has never claimed, nor could it claim, the " ability to evacuate the general population" whenever a serious accident occurs.

On the contrary, it has repeatedly made clear that a finding of adequate emergency planning does not translate into a guarantee that the entire affected public can necessarily be evacuated.

The most NRC that asserts (for example, in NUREG-1251, issued in 1989) is that evacuation is " generally" feasible.

In the rea'l world, unexpected things happen, such as severe weather conditions or blocked highways, that can make complete evacuation impracticable.

This means that sometimes, either by choice or necessity, authorities may be sheltering people or telling them to remain indoors rather than evacuating them.

Any time that people are sheltered or told to stay indoors, it may be desirable to administer KI.

In addition, any time that evacuation routes may take people through areas of radiological contamination, it makes sense to give them KI.

Finally, any time (as in the case of Chernobyl) that there is a large airborne releana high in the atmosphere, with uncer'.ainty about where the radiological contamination will descend, it makes sense to be ready to administer the drug, since one cannot know whom to ovacuate.

Obviously, you do not have the option of administering KI if

26 there is none to administer."

The opponents of KI often make the argument that to be in favor of KI stockpiling amounts to downplaying the importance of evacuation.

Evacuation protects the whole body, they say, whereas KI protects only the thyroid gland, so to support stockpiling is to indicate a willingness to leave the rest of the body at risk from radiation, thereby diminishing public protection.

This argument is factually incorrect, illogical, and disingenuous.

The advocates of KI stockpiling, from the Kemeny Commission through the International Basic Safety Standards, have always envisioned the drug as complementing other emergency planning measures, not replacing them.

There is no way that the availability of KI could increase risk to the public.

Would the existence of a supply of pills on a shelf in local schools and firehouses cause all the public officials responsible for managing radiological emergencies to forget about evacuation as an option if an emergency occurred?

Would it impede an evacuation?

Of course not.

3.

The decision on stockpilino KI should turn on whether, civen the enormous consecuences of beina without it in a maior ggsident. it is a_ prudent measure, not on whether the drua will necessarily pay for itself over timq2 The opponents of KI have framed the issue in terms of whether the drug is " cost-effective" -- that is, whether it would pay for itself over time in terms of reduced medical expenditures to treat radiation-caused thyroid disease.

The implied premise is that if KI is not cost-effective in dollar terms, it is therefore not worth having.

That premise, however, is false.

KI, like all other emergency planning measures, represents a kind of catastrophic-coverage insurance policy, offering protection for events which, while they occur only rarely, have such enormous consequences when they do occur that it is sensible to take special

" Compare the point made by Commissioner Rogers, in voting for the staff's recommendation, as recorded in the NRC Secretariat's

" staff requirements memo" of May 6, 1994:

" Commissioner Rcgers believes that, in order for FEMA, State or local authorities to have a viable option for a KI program, it would be prudent for the U.S. government to assure the availability of a supply of KI."

27 precautions."

Health and life insurance policies are not intended to be cost-effective for the average purchaser.

(If they ggIs cost-effective, every insurance company would go bankrupt.)

Does that mean that people are foolish to carry insurance?

Of course not; it is the people who fail to carry insurance who are considered foolhardy.

In addition to buying insurance, we ripend money on countless other preventive measures in everyday life -- vaccinations for our children, smoke detectors and fire extinguishnrs for the home, a first aid kit for the car -- because they are sensible, not because we necessarily expect them to pay for themselves.

The best analogy to KI may be the lifejackets that ferryboats carry.

We start with the assumption that ferryboat sinkings are unlikely, and we readily acknowledge thet if an accident does occur, it is better to leave the ship in a lifeboat than bob in a lifejacket in the water.

But sometimes things do not happen in r9a1 life the way they happen in drills.

If there is no lifeboat available when the ferry sinks, the lifejacket may keep you from harm while waiting to be rescued, and if no lifeboats can be launched, you are better off with a lifejacket than with nothing at all.

So we equip our ferries with lifejackets; we do not spend more money than the lifejackets themnelves would cost studying whether to buy them; and we do not find the ferry operators writing White Papers to prove that if passengers knew that there were lifejackets on board, they would be too frightened to travel by boat.

4.

The estimates of KI's " cost-effectiveness" all deoend on estimates that are no more than informed ouesses about the RIgbability of severe accidents.

The cost-benefit analysis upon which the current KI policy is based relies on certain assumptions about the probability of severe accidents.

Those assumptions need to be recognized for what they are:

informed guessas, not hard facts.

The NRC's cost-benefit analysis of the early 1980's was based on the assumption that a=cavere accident with a major release of

" At the 1983 Ccmmission meeting on KI, one of the briefers compared KI to an insurance policy which, when you read the fine print, covers only death by stampeding elephants. The problem with this analogy is that the United States has never to my knowledge experienced an elephant stampede, and it is never likely to.

The United States has, however, experienced the partial meltdown of a nuclear power plant (at Three Mile Island), and it could do so again.

~ _ -

t

• t t

28 radioactivity could occur in this country only once every 1000 i

years (with 100 reactors operating).

But the all-important-i margin of uncertainty was huge:- the agency acknowledged that l

~

accidents might be as much as 100 times more likely than that.

j In.the past, optimistic predictions have not always been borne

.l out by events.

The Three Mile Island accident was also

[

considered highly improbable, until it happened.

j If it were really true that serious accidents with a release of radioactivity "can't happen here," then there would be-good reason not only not to' reject stockpiling of KI, but also to dispense with all the rest of emergency planning.

One could then 1

ignore Chernobyl, and disregard the use of KI in the rest of the developed world,-by saying that while foreign reactors may suffer serious accidents, ours will not.

But the NRC has never claimed that accidents in this country are impossible.

In 1985, the same i

year that the current policy statement was adopted, the NRC i

Commissioners waro advising the: Congress that the estimated likelihood of a-core melt accident et a-U.S. reactor by the year

-l 2000 was 45%.*'

i Granted, not every accident results in a core melt, and.not avery core melt accident necessarily leads to offsite releaser.

One can be quite sure, however, whenever there is a serious accident, authorities will be looking for KI just in. case it-

_ progresses to the point of a large offsite release.

(We can' assume that for every catastrophic accident, there will be a number of these lesser accidents.)

Thus it is not sufficient to say that_ accidents with major offsite releases occur only rarely; the more relevant question-isJthe chance of an accident-serious

[

enough to make authorities start hunting for a supply of Kl.

-{

5.

If KI is not cgst-effeptive, the rest of nuclear manraancy plannina is ornh=hly not cost-effective either.

j The argument that KI should not be part of radiological

~

emergency planning because it is not " cost-effective" carries the

-implication that those measures which gra currently part of NRC-required emergency planning (sirens, exclusion sones, periodic emergency exercises, etc.) have been found to be cost-effective.

This is not the case.

KI'is the only emergency planning measure to have been scrutinized with a cost-benefit analysis.

The NRC's Advisory Committee on Reactor Safeguards pointed out long ago that all the other elements.of the NRC's emergency planning requirements (such as sirens and periodic emergency exercises) i

The New York Times, P.pril 17, 1985.

s l

l

=

[..

29 were put in place without a cost-benefit analysis and might well not pass that test."

If serious accideats are really possible only every o'ne or two thousand years, it is unlikely that any element of current nuclear emergency planning could be found

" cost-effective," in the sense of being likely to pay for itself over time.

Does that mean that the United States should leave the public at even greater risk by declaring that for American reactors, no emergency planning whatsoever is necessary?

Of Course not.

6.

Cost-benefit analysis is a techniaue that needs to be Apo ied with oood sense, especially where public health measures are concerned.

Cost-benefit analysis, as valuable a tool as it can be when properly applied, needs to be performed with a measure of good sense, which includes a recognition that sometimes, costs and/or benefits may not lend themselves to quantification in dollar terms.

This is particularly true in the area of public health.

Here, the evaluation of KI that preceded the 1985 federal policy statement was of a kind to give cost-benefit analysis a bad name.

Strictly limited to economics -- the dollar costs of KI pills on the one hand, the dollar costs of having radiation-caused thyroid disease on the other -- it wholly ignored the quality-of-life impacts of thyroid cancer and other radiation-caused diseases.

Common sense tells us that if given a choice between a case of disease prevented and a case of disease cured, we would allBut prefer the former, even if the cure did not cost us a penny.

the cost-benefit analysis of KI proceeded from the assumption that there was no difference in desirability between prevention of sadiation-caused thyroid disease and cure; thus the only factor to be considered in evaluating KI was the difference in cost.

The old proverb that an ounce of prevention is worth a pound of cure went out the window, as the U.S. Government

" The ACRS said:

"The risk-benefit analyses conducted by the NRC Staff on this subject do not appear to be compatible with (or comparable to) approaches used in evaluating other aspects of nuclear emergency planning.

For example, if the same evaluations were made, would there be justification for the conduct of emergency drills'or the installation of warning sirens?

Similarly the question could be raised as to whether there would be justification for population evacuations." Attachment to SECY 362 (August 30, 1983).

1

4 30 determined that instead of spending money to prevent radiation-caused thyroid disease, society should spend its money treating the disease if and when it occurred.

~

Any child knows that the negative impacts of illness are not limited to the economic costs.

Any parent knows that people do not immunize their children against polio and diphtheria primarily to save money.

In the real world, people pay to immunize their children against diseases first and foremost to spare them the misery and the danger that go with these illnesses.

But the cost-benefit analysis of KI ignored that obvious point, and an a result, it was valueless from the start.

Indeed, it was worce than valueless, because it provided a rationalization for ignoring the Kemeny Commission's sensible recommendation in favor of KI stockpiling.

The non-economic impacts of illness may be difficult to translate into dollar terms, but that does not mean that they can be ignored.

7.

The existino policy on KI was defective from the start.

as it was based in part on inaccurate information provided to the NRC Commissioners.

Decisionmakers who must weigh cor+ = and benefits also need accurate data.

The transcript of the 1983 stuf# briefing makes claar that the information provided to the NRC Commissioners seriously understated the significance of radiation-caused thyroid disease and thereby understated to an equal degree the value of KI.

The briefers' central failure was to mention that when referring to " nodules," they were not taking into account the 40% of nodules that would be cancerous.

It is as though staff members of the Department of Transportation informed the Secretary that airbags were of no value in " collisions" without mentioning that their definition of the word excluded every collision more serious than a fender-bender.

Whatever additional information the Commissioners later received on the subject of thyroid disease, it is not at all clear that the Commission had any idea of the real nature of post-accident thyroid disease at the time tney adopted an anti-KI position.

Certainly, the public never received notice that the information provided at the 1983 meeting was erroneous.

8.

Existino policy purports to leave the iudament on stockpilina KI to the states. but assures that the states do r.,

have an adeauate basis for makinc informed decisions.

In theory, the existing federal policy un KI leaves the I

31 decision on stockpiling to the states.

Since 1983, however, the federal government, and NRC in particular, have failed to provide the states with sound technical advice on the subject.

Without accurate and current information on KI -- including the Chernobyl experience and the consensus of international experts -- states cannot make an informed judgment.

In their April 1994 Aetter to the Commissioners, Senators Simpson and Lieberman said pointedly that "the federal government has a moral responsibility to provide the public with complete and accurate information regarding the risks from federally-licensed activities and ways in which those risks may be reduced."

Since that time, however, the government's record on providing the public with " complete and accurate information" has actually taken a turn for the worse, with the publication in September 1994 of FEMA's " Federal Radiclogical Emergency Response Plan."

As described above, at p. 22, the Plan provides that in an emergency at a nuclear power plant, an interagency Advisory Team will provide guidance on KI to the NRC, and the NRC will

" provide advice to State and local governments on measures that they should take to avoid or reduce exposure to the public,"

including " sheltering, evacuation, and prophylactic use of iodine."

No state or local official or mamber of the public, reading this Plan, could possibly imagine that in a real emergency, there would be no iodine to administer.

This raises a number of questions.

If KI stockpiling is not worthwhile, why is administration of the drug one of the p.otective measures identified in the Plan?

If KI in worthwnile, as the Plan implies, why isn't something being done to make sure that it is available?

Does FEMA not know the actual state of KI preparedness?

The federal government cannot have it both ways.

Either it should change the 1985 policy, and make the use of KI a viable option in a real emergency, or it should explain loud and clear why the United States has decided that K1 will not be an option.

What it cannot responsibly do is withhold protection, on the one hand, and on the other hand, represent to the public that this protection is already in place.

i..,.

i 3

i 32 l

IV.

The Remedy i

The purpose of this petition, which takes the form of a l

i~

rulemaking petition under 10 CFR 5 2.802, is to raise the potassium iodide _ issue before the Commission and ensure that it 1

i receives a definitive resciution.

the specific request is for a minor change in the NRC's existing emergency planning rules, 10 CFR 5 50.47.

These_ rules i

-include 16' planning standards by which emergency plans'are to be evaluated.

The tenth of these standards reads as follows:

(10)

A range of protective actions have?been developedt for the plume exposure pathway EPZ [ Emergency Planning Zone) for emergency workers and the-public.

Guidelines L

for the choice of protective actions during an

l emergency, consistent with Federal guidelines, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed.

I propose that the NRC. emend this provision to read, "A range of protective-actions, includina shelterina; evacuation.

and prochvlactic use of-iodine, have bonn developed..."

This language _is.taken verbatim from FEMA's September 1994

--Federal Radiological Emergency Response Plan.

If this change is adopted, the Plan.will become an accurate description of emergency preparedness for radiological 'amergenci~os; the recommendation of the Romany Comalssion will-at'last be implemented;'and the United States will be in compliance with the International Basic Safety Standards.

4 i

?I suggest that the NRC also issue, either or its own or in i

i conjunction with other agencies, a policy statement declaring Lthat K1 stockpiling is a, sensible and prudent measure, necessary to assure that the drug will be available in the' event of a major accident.

(This policy statement could be modeled on the excellent draft statement of 1982, which rey.ettably was withdrawn.)- This statement would make clear that KI, while no panacea, can be-used in conjunction with evacuation and-sheltering to maximize protection to the public."

i I am.not proposing house-to-house predistribution of KI, which I think would be ineffective and a source of confusion during an actual' emergency.

Rather I am suggesting that state and local authorities have ready access to supplies of the drug so that they fg AWW lb A h }-s M Y*

. [a ' ',

7, 33 The policy statement would also state _the willingners cf the NRC to provide a stockpile of the drug to states and localities upon request (unless FEMA or some other federal agency is prepared to do so).

In addition, the statement would support the Kameny Commission's recommendation for the creation of regional stockpiles of the drug as a backup for emergencies.

This policy would mean negligible cost to utilities.

Contrary to the apprehensions of the nuclear industry, it would not send a message that nuclear plants have suddenly become more i

dangerous; it would simply mean that the U.S. Government, figuratively speaking, was putting a first aid kit into the car, after having neglected to do so for far too many years.

Would members of the public suddenly _become newly frightened-of nuclear accidents because all is being stockpiled?

As Senators Lieberman and Simpson pointed out, the presence of KI does not seem to have panicked the population in the places where it is stockpiled today,--and there is no reason why it should.

If the World Health Organization recommendation'is followed, and KI is stored strategically in firehouses, hospitals, police stations, etc.,

few people are likely even to be aware that the drug is being j

stockpiled.

i The amount of potassium iodide stockpiled around each nuclear plant would not be great.

Most nuclear plants are sited away from large concentrations of population in order to keep down the risk to the public.

In an emergency, the drug might be needed in a wider area than just the immediate radius around the i

plant (at Chernobyl, for example, much of the radioactive iodine l

came to ground far downwind), but the existence of regional stockpiles would mean that the nation had a backup supply _to draw upon in c'se of need.

l a

If thora should ever be a nuclear accident in this country serious enough to make authorities need KI, or even consider its

(

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_use, and there was no KI to be found, what would the American people say?

The anger und recrimination afterwards would be L

enormous, both for the failure to protect and the failure to inform.

NRC, having promised in 1979 to put a KI program in

_ place and then not done so, would have ths most to answer for, i-especially in light of the the wealth of.recent data from l.

Chernobyl-on thyroid effects and the 1994 recommendation of its i

own technical staff in favor of stockpiling.

FEMA would be in 4

the unenvjable position of having to explain why its 1994 Plan implies not only that KI is valuable in emergencies, but also i

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can administer it if it is needed.

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e 34 that it is currently available.

But. pointing fingers after the fact will do no good-to any child who-got a dose of radioactive iodine in the thyroid because a

M11vas lacking wh6n it was needed.

We cannot afford to wait until another:accAdent or near-accident, and the resulting hue and cry, compa*, e change of policy.

There is ample evidence now that tho c!irceAt palicy is ill-founded, irrational, and dangerously Edmulacent.

The time to put a Jock on the barn door is before the hoche is stolen.

If it should turn out that no attempt to rob the barn is made in our lifetimes, so much the better -- it's a very cheap lock.

Today, the Nuclear Regulatory Commission has the opportunity and the responsibility to resolve the KI issue sannibly and straightforward 1y, as the NRC staff proposed doing in 1994.

There ir no good reason why American children should continue to be ur. protected with KI, when the governments of other developed countries around the globe provide this cheap and effective protection for their children as a matter of course.

The NRC staff has pointed the way, and the Commission and the Federal Government should follow.

Attachment:

Letter of Senators Alan K. Simpson and Joseph I.

Lieberman, April 20,.

1994 4

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r April 30,1994 l

l i.

The Monerable Tvan salin Chairman r

l U.S. Nuclear Regulatory Comunission washingtone DC 20555 I

l

Dear Chairman Selin:

l We are writing to urge the Nuclear Regulatory Commission (NRC) to revise its current policy regarding the availability and use of potassium iodide (KI) in the event of an emergency at (4 nuclear power plant.

The NRC's current policy is that state and local governments should consider stockpiling KI for emergency use by emergency workers and institutionalized persons, but not for the general i

public.

This policy was established in the early 1980's.

Since t

that time, however, new information has arisen and additional experience has been gained on the costs and benefits of the prophylactic use of KI by the general population.

We believe that this new infomation and expsrience requires a new approach to this issue.

1 It le well established scientAfically that KI is extremely

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effective in preventing the uptake of radioactive iodine by the j

thyroid.

If taken in the prcper dose prior to exposure to j

radioactive iodine, KI can completely block the uptake of the radioactive iodine.

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The distribution of KI to the general population in the i

event >f a nuclear emergency is a widely accepted protective j

measu::.

The world Mealth organisation has recomunended its une i

for people living near a nuclear power plant if nointion levels are expected to exceed a predetermined dose.

A number of foreign 1

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governmaats including the United Kimr+n, the Czech Republic, i

$witserland, cansdian provinces wf,th nuclear power plants, and i

i the former Soviet Union stockpile EI for distribution to and use

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by the q,eneral public in the event of a nuclear emergency.

In i

ethe U.S.,

three states Alabama, Tannessee, and Arizona have plans to distribute or already have distributed KI to people i

117 tag near one or more nuclear power plants within those states.

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sums a speeswa i

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A recent oost benefit study of this issue conducted for t.he i

Ikc indicates that the costs of stockpiling KI for people Who i

live within five miles of a nucisar power plant are minimal -

approniantely ten cents per person per year.

This asans that for I

a typical population of 10,000 people living within five miles of a nuclear power plant, it would cost approximately $1,000 to make EI available for distribution.

The ame staff projects that t,he

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coat of stockpiling II for everyone in the eeuntry within five miles of a nuclear power plant would be on the order of several j

hundred thousand dollars per year.

This is only a small irection of the expenses already spent on emergency planning.

As the NRC 1

)

staff has acted, *(cloats in this range present no significant 1

barrier to steekpiling and are probably less than the east of the l

continued studies.'

l some concern has been expressed that public education on the I

use of KI may result in a potentially significant negative public 1

perception.

Nowever, no evidence has been provided t. hat any of l

the existing policies in other nations or in the states that provide for the use of KI by the general population has caused j

any undue panic or apprehension to the ganaral public.

Moreover, the federal government.has a moral responsibility to provide the public with complete and accurate information regarding the risks from federally licensed activities and ways in which those risks may be reduced.

In sum, therefore. KI can be an extremely offactive counterinessure to prevent damage to the thyroid in the event of a j

radiological emergency.

It can also be made available for the general population living near a nuclear power plant for minimal costs.

The NRC should revisa its policy to provide this additional potential protective measure for nuclear emergency

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planning.

l we thank you for your time and consideration.

l Sincerely, l

_m t-v

(

iph I. Lieberman Alan

. "inipson Ranking Minority Member ruan sub~=mittee on Clean Air tubconmittee on Clean Air and Wuclear Regulation and Nuclear Regulation

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