Consideration of Potassium Iodide in Emergency Plans

NUCLEAR REGULATORY COMMISSION

10 CFR Part 50

RIN 3150-AG11

Consideration of Potassium Iodide in Emergency Plans

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing an

amendment to its emergency planning regulations governing the domestic

licensing of production and utilization facilities. The proposed rule

would amend the current regulations to require that consideration shall

be given to including potassium iodide (KI), as a protective measure

for the general public that would supplement sheltering and evacuation.

KI would help prevent thyroid cancers in the unlikely event of a major

release of radioactivity from a nuclear power plant. The proposed rule

responds to petitions for rulemaking submitted by Mr. Peter G. Crane

concerning the use of KI in emergency plans.

DATES: Submit comments by September 13, 1999. Comments received after

this date will be considered if practical to do so, but only those

comments received on or before this date can be assured of

consideration.

ADDRESSES: Comments may be sent to the Secretary of the Commission,

Attention: Rulemakings and Adjudications Staff, U.S. Nuclear Regulatory

Commission, Washington, DC 20555, or may be hand-delivered to One White

Flint North, 11555 Rockville Pike, Rockville, MD 20852, between 7:30

a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be

examined at the Commission's Public Document Room at 2120 L Street NW

(Lower Level), Washington, DC.

You may also provide comment via the NRC's interactive rulemaking

web site on the NRC home page (http://www.nrc.gov). This site provides

the availability to upload comments as files in any format that the NRC

web browser supports. For information about the interactive rulemaking

site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail [email protected]

FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of

Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001. Telephone: (301) 415-3224. Internet:

[email protected]

SUPPLEMENTARY INFORMATION: By undertaking this rulemaking, the

Commission, while not adopting the exact language suggested by the

petitioner, is proposing to grant a petition for rulemaking (PRM-50-

63A) submitted by Mr. Peter Crane on November 11, 1997. That petition

is a revision of a petition (PRM-50-63) that he submitted on September

9, 1995.

Considering all public comments received, the information available

in the literature, 20 years of experience gained in evaluating licensee

emergency preparedness plans, and the arguments presented by the

petitioner, the Commission has decided to grant the petition for

rulemaking and to proceed

[[Page 31738]]

with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the following

sentence, after the first sentence: ``In developing this range of

actions, consideration has been given to evacuation, sheltering, and,

as a supplement to these, the prophylactic use of potassium iodide

(KI), as appropriate.'' In addition, the preamble for this proposed

rule includes a statement to the effect that State and local decision

makers, provided with proper information, may find that the use of KI

as a protective supplement is reasonable and prudent for specific local

conditions. When the Commission amended its emergency planning

regulations on November 3, 1980, it stated that ``any direct funding of

State or local governments solely for emergency preparedness purposes

by the Federal government would come through FEMA.'' In its decision on

June 30, 1997, the Commission also noted that, the Federal government

(most likely the NRC) is prepared to fund the purchase of a stockpile

of KI for the States, upon request. The Commission has determined that

notwithstanding the June 30, 1997, intention that ``most likely the

NRC'' would fund the purchase of State stockpiles of KI, the NRC budget

has continued to decrease and offers little margin for the Commission

to divert resources to new initiatives. Historically, funding for State

and local emergency response planning has been the responsibility of

those governments usually working with licensees. The Commission notes

that the Petitioner has not requested the Federal funding of stockpiles

of KI. In the alternative, the NRC will work with other relevant

agencies to ensure that there are established robust, pre-positioned

regional stockpiles of KI, to be effectively and timely used by states

that have not established local stockpiles and wish to make use of the

regional stockpiles in the event of a severe nuclear power plant

accident.

On November 27, 1995 (60 FR 58256), the Nuclear Regulatory

Commission (NRC) published a Notice of Receipt of a petition for

rulemaking (PRM-50-63) filed by Mr. Peter G. Crane on his own behalf.

The petitioner requested that the NRC amend its regulations concerning

emergency planning to include a requirement that emergency planning

protective actions include the prophylactic use of potassium iodide

(KI), which the petitioner notes prevents thyroid cancer after nuclear

accidents.

On November 11, 1997, the petitioner submitted a revision to his

original petition (PRM-50-63A). The NRC published a Notice of Receipt

of the amended petition on December 17, 1997 (62 FR 66038). In the

amended petition, the petitioner requested that:

A statement [be made] clearly recommending stockpiling of KI as

a ``reasonable and prudent'' measure, and;

A proposed rule change to 10 CFR 50.47(b)(10) which would be

accomplished by inserting the following sentence after the first

sentence: ``In developing this range of actions, consideration has

been given to evacuation, sheltering, and the prophylactic use of

potassium iodide (KI), as appropriate.''

The petitioner also provided a marked-up version of the NRC staff's

proposed Federal Radiological Preparedness Coordinating Committee

(FRPCC) Federal Register notice concerning Federal policy relating to

the use of KI for the general public.

On June 26, 1998 (SRM 98-061), the Commission decided to grant the

portion of the petition for rulemaking PRM-50-63A regarding the

requested amendment to 10 CFR 50.47(b)(10). The Commission also

directed that the preamble for the proposed rule include a statement to

the effect that State and local decision makers, provided with proper

information, may find that the use of KI as a protective supplement is

reasonable and prudent for specific local conditions. The NRC staff is

also preparing a technical report and an information brochure to enable

State and local decision makers to make an informed decision in this

matter.

Petitioner's Basis for Requesting Potassium Iodide

The petitioner stated that potassium iodide (KI) protects the

thyroid gland, which is highly sensitive to radiation from the

radioactive iodine that would be released in extremely serious nuclear

accidents. By saturating the gland with iodine in a harmless form, KI

prevents any inhaled or ingested radioactive iodine from lodging in the

thyroid gland, where it could lead to thyroid cancer or other

illnesses. The petitioner stated that the drug itself has a long shelf-

life, at least 5 years, and causes negligible side effects.

The petitioner further stated that, in addition to preventing

deaths from thyroid cancer, KI prevents radiation-caused illnesses. The

petitioner notes that thyroid cancer generally means surgery, radiation

treatment, and a lifetime of medication and monitoring. The petitioner

asserted that the changes in medication that go with periodic scans put

many patients on a physiological and psychological roller coaster. The

petitioner stated that hypothyroidism can cause permanent retardation

in children and, if undiagnosed, can condemn adults to a lifetime of

fatigue, weakness, and chills.

The Petitioner's Discussion of the Three Mile Island Accident (TMI)

The petitioner noted that in December 1978, the Food and Drug

Administration (FDA) announced that it had determined that KI was safe

and effective for thyroid protection in nuclear accidents. The

petitioner stated that the issue attracted little attention, that the

NRC and the Federal Government as a whole took no public position on

the drug, and that three months after the FDA announcement, on March

28, 1979, the TMI accident began to unfold. The petitioner stated that

Federal and State officials, searching for supplies of KI in case it

should be needed, discovered that none was to be had and that a supply

had to be manufactured, literally overnight. The petitioner indicated

that at 3:00 a.m. on Saturday, March 31, 1979, an FDA official arranged

with the Mallinckrodt Chemical Company for the immediate production of

250,000 doses of KI.

The petitioner also discussed the Report of the President's

Commission on the Accident at Three Mile Island (the Kemeny Commission

report), issued in October 1979, and stated that the report was

strongly critical of the failure to stockpile KI. The petitioner noted

that among the Kemeny Commission's major recommendations was that an

adequate supply of the radiation protective agent, KI for human use,

should be available regionally for distribution to the general

population and workers affected by a radiological emergency.

The Petitioner's Discussion of the Potassium Iodide Policy

The petitioner stated that in NUREG-0632, ``NRC Views and Analysis

of the Recommendations of the President's Commission on the Accident at

TMI,'' issued in November 1979, the NRC agreed with the findings of the

Kemeny Commission and planned to require nuclear power plant licensees

to have adequate supplies of KI available for nuclear power plant

workers and the general public as part of State emergency response

plans.

According to the petitioner, the three agencies most concerned, the

FDA, the NRC, and the Federal Emergency Management Agency (FEMA),

favored the stockpiling of KI for the next several years. The

petitioner stated that the Atomic Industrial Forum, a nuclear industry

trade association, declared itself against the stockpiling of KI in May

1982.

The petitioner indicated that the NRC staff was strongly in favor

of KI

[[Page 31739]]

stockpiling as late as September 27, 1982, when the NRC staff submitted

a memorandum to the Commissioners proposing that the Commission agree

with a draft interagency policy statement supporting KI stockpiling.

The petitioner further stated that on October 15, 1982, less than 3

weeks after sending the draft policy statement to the Commission for

approval, the NRC staff sent a supplementary memorandum withdrawing the

memorandum of September 27. The later memorandum informed the

Commissioners that NRC's Office of Nuclear Regulatory Research (RES)

could, by January 1, 1983, produce a paper showing that KI was

significantly less cost-beneficial than previously assumed. The NRC

staff proposed sending this document to the FDA and FEMA with the

recommendation not to stockpile and distribute KI. The petitioner

indicated that the NRC staff briefed the Commission in November 1983 on

the NRC staff's proposal to take a strong position against KI. A policy

statement was later issued that disposed of the Kemeny Commission's

recommendation which favored stockpiling KI. According to the

petitioner, only a year later, the Chernobyl accident would give

tangible proof of the value of the drug in radiological emergencies.

The Petitioner's Discussion of the Effects of Chernobyl

The petitioner stated that during the Chernobyl accident of 1986,

the damaged reactor spewed radioactive iodine over a wide area of what

was then the Soviet Union and Poland. The petitioner further stated

that in Russia, the Ukraine, and Belarus, where the distribution of KI

was inadequate and untimely, the population in these countries is now

experiencing extraordinarily high levels of childhood thyroid cancer.

However, in Poland, where KI was administered to 97 percent of the

nation's children, there has been no similar increase in thyroid

cancer. The petitioner noted that Poland is a proof-positive example of

the benefits of a well-prepared KI program.

The petitioner stated that the U.S. Government is spending money to

study radiation-caused thyroid cancer in the Ukraine and Belarus, and

the Department of Energy (DOE) announced a $15 million, 15-year program

that will follow 70,000 children in the Ukraine, to understand the

thyroid cancer risk of exposure to radio iodine. The petitioner further

stated that the U.S. Government has spent generously to bring Ukrainian

doctors to the United States for training in thyroid surgery because

mishandled operations can result in damaged nerves and larynxes,

rendering patients permanently mute.

The petitioner discussed post-Chernobyl developments on KI policy.

He stated that the Chernobyl accident demonstrated that KI worked and

that countries that failed to stockpile and distribute it are

experiencing serious public health problems.

The Petitioner's Discussion of the NRC's Reconsideration of

Potassium Iodide

The petitioner notes that in June 1989, the NRC reconsidered the KI

issue after the petitioner filed a Differing Professional Opinion

urging a change in policy. On November 27, 1989, the American Thyroid

Association wrote to the NRC urging KI stockpiling on a nationwide

basis and, in 1990, the NRC announced that it was reconsidering the

existing Federal policy. In April 1992, a contractor under the

sponsorship of the NRC Office of Nuclear Regulatory Research issued a

report that included a revised cost-benefit analysis of the use of KI.

The petitioner described the report as concluding that stockpiling KI

continued to be not cost-effective, but that the difference between

costs and benefits was narrower than had been calculated by the NRC

staff in the early 1980s. The petitioner further indicated that, in

December 1993, an industry trade group, the Nuclear Utility Management

and Resources Council, sent a report entitled ``Review of Federal

Policy on Use of Potassium Iodide,'' to the Commission arguing against

any change in current KI policy.

The petitioner noted that, in March 1994, the NRC staff declared

its support for KI stockpiling. However, the NRC staff proposal for a

change in policy was not adopted, the Commissioners having voted 2 to 2

on the staff's proposal in May 1994. (Under Commission procedures, a

tie vote means that a proposal fails.)

The Petitioner's Discussion of Additional Support for Granting the

Petition for Rulemaking

The petitioner described a September 1994, FEMA publication

proposing a ``Federal Radiological Emergency Response Plan'' that

envisioned the use of KI during radiological emergencies. Under the

plan, the NRC would be the lead Federal agency during emergencies at

nuclear power plants and would advise State and local governments

whether or not to distribute KI (based on advice received from an

interagency panel). The States and localities would then administer the

KI, if necessary.

The petitioner also indicated that the Board of Governors of the

International Atomic Energy Agency, with U.S. Government support,

adopted new International Basic Safety Standards in 1994. The

petitioner stated that these standards represented the consensus of the

world's experts on radiation safety and the standards provide, among

other things, that intervention levels of immediate protective actions,

including sheltering, evacuation, and iodine prophylaxis, shall be

specified in emergency plans. Thus, the petitioner stated, the

international radiation protection community, like the Kemeny

Commission in 1979 and the short-lived draft Federal policy statement

of 1982, recognized that effective preparedness for radiological

emergencies means having three actions to consider [evacuation,

sheltering and iodine prophylaxis].

The Petitioner's Discussion of the Merits of the Petition for

Rulemaking

The petitioner believes the NRC should implement the recommendation

of the Kemeny Commission and that the United States should maintain the

option of using the drug KI for public thyroid protection during

nuclear accidents. The petitioner requested that the Commission

definitively review and decide on the issue rather than simply having

the NRC staff decide not to propose it to the Commission.

The petitioner stated that evacuation is not necessarily the

protective measure of choice in every emergency, and even when it is

the preferred option, it is not always feasible. The Kemeny Commission

report explained that different types of accidents, and the particular

circumstances presented, may call for different protective measures.

The petitioner notes that maintaining a KI option ensures that

responsible authorities have the option of additional protection at

their disposal.

The petitioner indicated that NRC has made it clear that a finding

of adequate emergency planning does not translate into a guarantee that

the entire affected public can be evacuated, but that evacuation is

generally feasible.

The petitioner believes that sometimes, either by choice or

necessity, authorities may decide to shelter people or tell them to

remain indoors rather than evacuate them. The petitioner points out

that it may be desirable to administer KI any time people are sheltered

or told to stay indoors, when evacuation routes would take people

through areas of radiological contamination, and when there has been a

large airborne release of radioactive iodine to the atmosphere.

The petitioner believes that the decision on stockpiling KI should

turn on whether, given the enormous

[[Page 31740]]

consequences of being without it in a major accident, the drug is a

prudent measure; not on whether it will necessarily pay for itself over

time. The petitioner further believes that KI represents a kind of

catastrophic-coverage insurance policy offering protection for events

which, while they occur only rarely, have such enormous consequences

that it is sensible to take special precautions.

The petitioner stated that the estimates of KI's cost-effectiveness

depend on estimates that are no more than informed guesses about the

probability of severe accidents and that the NRC's cost-benefit

analysis of the early 1980s was based on the assumption that a severe

accident with a major release of radioactivity could occur in this

country only once every 1 or 2 thousand years.

The petitioner believes that if it were really true that serious

accidents with a release of radioactivity were so unlikely, there would

be good reason not only to reject stockpiling of KI but also to

dispense with all emergency planning. The petitioner also stated that

if KI is not cost-effective, then the rest of nuclear emergency

planning is probably not cost-effective either.

The petitioner believes that cost-benefit analysis is a technique

that should be applied with good sense, especially where public health

measures are concerned. According to the petitioner, the cost-benefit

analysis of KI proceeded from the assumption that there was no

difference in desirability between prevention of radiation-caused

thyroid disease and cure. Thus, the only factor to be considered in

evaluating KI was the cost. The petitioner also believes that the U.S.

Government determined that instead of spending money to prevent

radiation-caused thyroid disease, society should spend its money

treating the disease if and when it occurs.

The petitioner believes that the existing policy on KI was

defective from the start because it was based, in part, on inaccurate

information provided to the NRC Commissioners. He stated 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 petitioner also believes that it was not clear that the

Commission had any idea of the real nature of post-accident thyroid

disease at the time it adopted an anti-KI position.

The petitioner stated that existing policy left the judgment on

stockpiling KI to the States. The petitioner asserts that this policy

also ensures that the States do not have an adequate basis for making

informed decisions. He believes that the Federal Government, and NRC in

particular, has failed to provide the States with sound technical

advice on the subject. The petitioner also believes that without

accurate and current information on KI--including the Chernobyl

experience and the consensus of international experts--States cannot

make an informed judgment.

The petitioner believes that no State or local official or member

of the public could imagine that in a real emergency, there would be no

KI to administer. The petitioner raised the question: If KI stockpiling

is not worthwhile, why is the administration of the drug one of the

protective measures identified in the 1994 Federal Emergency Response

Plan? He also asked why, if KI is worthwhile, as the plan implies,

something is not being done to make sure that it is available.

The petitioner believes that the Federal Government should either

change the 1985 policy and make the use of KI a viable option in a real

emergency, or it should explain why the United States has decided that

KI will not be an option.

The Petitioner's Proposed Amendment to the NRC Regulations

In the original petition (PRM-50-63) that was submitted on

September 9, 1995, the petitioner requested that 10 CFR Part 50 be

amended to include language taken from FEMA's Federal Radiological

Emergency Response Plan of September 1994, and recommended the

following revision to the regulations.

The petitioner proposed that Section 50.47(b)(10) be amended to

read as follows:

(10) A range of protective actions including sheltering,

evacuation and prophylactic 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.

In the revised petition (PRM-50-63A) that was submitted on November

11, 1997, the petitioner requested that 10 CFR 50.47(b) (10) be revised

to read:

(10) A range of protective action have been developed for the

plume exposure EPZ for emergency workers and the public. In

developing this range of actions, consideration has been given to

evacuation, sheltering, and the prophylactic use of potassium iodide

(KI), as appropriate. 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 petitioner believes that if this revised change is adopted, the

plan will become an accurate description of emergency preparedness for

radiological emergencies; the recommendation of the Kemeny Commission

will at last be implemented; and the United States will be in

compliance with the International Basic Safety Standards.

The petitioner suggested that the NRC, either on its own or jointly

with other agencies, issue a policy statement declaring that KI

stockpiling is a reasonable and prudent measure that is necessary to

ensure that the drug will be available in the event of a major

accident. The petitioner believes that this statement would clarify

that KI can be used in conjunction with evacuation and sheltering to

maximize protection to the public.

The petitioner also believes that the policy statement would show

the willingness of the NRC to provide a stockpile of the drug to States

and localities upon request, and would support the Kemeny Commission's

recommendation to create regional stockpiles of the drug as a backup

for emergencies.

Discussion

Stockpile of Medicinal Supplies for Nuclear, Biological, and Chemical

Agents (1995)

In June 1995, the President issued Presidential Decision Directive

39 (PDD-39) on U.S. Policy on Counter Terrorism. The PDD-39 directed

Federal agencies to take a number of measures to reduce vulnerability

to terrorism, to deter and respond to such acts, and to strengthen

capabilities to prevent and manage the consequences of terrorist use of

nuclear, biological, and chemical (NBC) weapons, including weapons of

mass destruction. The PDD-39 assigned to FEMA the task of ensuring that

the Federal Response Plan (FRP) was adequate to respond to the

consequences of terrorism.

FEMA, in coordination with the Catastrophic Disaster Response Group

(CDRG) \1\, developed a draft report to the President entitled, ``An

Assessment of Federal Consequence Management

[[Page 31741]]

Capabilities for Response to Nuclear, Biological or Chemical (NBC)

Terrorism,'' dated June 12, 1996. The report recommended, among other

things, that the Federal Government purchase and stockpile thyroid

blocking agents (KI) for the general public that could be used in the

event of a nuclear terrorist event. The NRC was a member of the Core

Group which generated the recommendations and was instrumental in

adding KI to the list of medical supplies to be stockpiled nationally.

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\1\ The CDRG is the headquarters senior-level coordinating group

which addressees policy issues regarding the Federal Response Plan

(FRP). The CDRG is chaired by FEMA and comprises of representatives

of Federal departments and agencies with responsibilities under the

FRP. The NRC is represented by the Incident Response Division

Director, AEOD.

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The Core Group concluded that as the result of recent events,

significant threats over the past few years, and the increased

availability and proliferation of NBC materials, there is an increasing

concern for the potential of terrorist incidents. NBC events, the

report continued, may occur as a local event with potentially profound

national implications. In responding to these events, the first

responders must be able to provide critical resources to the victims.

These include, but are not limited to, chemical nerve antidotes,

vaccines for anthrax, and antibiotics. The Core Group identified the

need to purchase and preposition stockpiles of adequate medical

supplies at the Federal, State, and local level. While KI was not

considered as vital as chemical nerve antidotes and vaccines, the NRC

staff was successful in getting KI included with other medical supplies

for NBC events because of the unusual characteristics of these events.

Because of the special characteristics of NBC events, the Core

Group recommended a broader range of protective actions. The NRC

concurred in the findings of the report in a letter dated September 25,

1996, from the Director of NRC's Office of Analysis and Evaluation of

Operational Data to FEMA's Director. The report was subsequently

presented to the President in February 1997, and approved for

distribution in May 1997. However, FEMA recently reported that the

federal stockpiles of KI are few and stocked only for first responders

to terrorist action. As things stand now, needs of members of the

public for KI on an ad hoc basis would have to be supplied from other

sources. As stated above, the Commission intends to work with FEMA to

assure that stockpiles contain adequate supplies of KI.

FRPCC Subcommittee on KI (1996)

Along with petitioning the NRC, Mr. Crane also requested that FEMA

review his petition and reconsider the Federal policy. In early 1996,

the FRPCC convened an Ad-Hoc Subcommittee on Potassium Iodide to

request and review new information on this matter from interested

parties. The subcommittee conducted a public meeting on June 27, 1996.

The subcommittee evaluated all comments from the June 27 public meeting

and made the following recommendation regarding the Federal KI policy:

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 Government (NRC, or 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 interveners observe with the Federal policy is the

italicized statement ``The Federal position with * * * 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 ``it [potassium iodide 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 governments.''

3. The subcommittee recommends that local jurisdictions that

wish to incorporate KI as a protective action for the general public

should consult with the State to determine if these arrangements are

appropriate. If local governments have the authority or secure the

approval to incorporate KI as a protective measure for the general

public, they would need to include this measure in their emergency

plans.

Analysis of Issues Raised by Public Comments

The Commission has considered the KI policy question on numerous

occasions since 1984. The voting history of the Commission shows that

reaching consensus on this policy question has been an elusive goal. An

important reason for this historical lack of consensus is that this

policy question is not a clear cut one. Individual Commissioners, past

and present, have differed in their views with respect to the relative

importance to be given to factors bearing on the KI issue. These honest

differences have led to divided Commission views on how to resolve the

policy question. The Commission is agreed that its historical

difficulty to reach consensus on the KI policy question underscores the

reality that this policy question is not a simple one, is not one that

is easily resolved and, as a result, has been the subject of protracted

deliberation.

On November 5, 1997, the Commission held a public meeting with its

staff, FEMA representatives, and the author of the 1995 rulemaking

petition to consider the petition and proposed changes to the Federal

policy on the use of KI. In part as a result of the meeting, the

petitioner amended his petition to ask for a rule that would require

that consideration would be given in the formulation of emergency plans

to the use of KI as a supplement to evacuation or sheltering, and on

June 26, 1998, the Commission granted the amended petition, and

directed the NRC staff to initiate the requested rulemaking. The

Commissioners also decided that the FRPCC Federal Register notice on

Federal KI policy should include a statement to the effect that the

State and local decision makers, provided with proper information, may

find that the use of KI as a protective supplement is reasonable and

prudent for specific local conditions. On September 30, 1998, the

Commission approved a draft Federal Register notice and directed that

it be sent to the FRPCC.

On November 27, 1995 (60 FR 58256), a Notice of Receipt of the

Petition for Rulemaking was published in the Federal Register

requesting public comment. A total of 63 comment letters were received,

of which 20 utilities, 9 State governmental 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.

On December 17, 1997 (62 FR 66038), the Commission published a

request for public comment on the revised petition in the Federal

Register. In response to several requests, the comment period was

extended until February 17, 1998, by a Federal Register notice

published on January 21, 1998 (63 FR 3052). A total of 82 comment

letters were received, of which 13 utilities, 3 State governmental

agencies, 1 utility interest association, and 1 member of the public

were against granting the petition for rulemaking. The letters in favor

of granting the petition came from 8 public interest groups, 46 members

of the public (including 1 from the petitioner), 3 physicians, 2 U.S.

Senators, and 1 State Representative. The following issues were raised

by the public commenters with an accompanying NRC staff response:

Issue 1: Nearly all nations with nuclear power protect their

citizens by having KI readily available and the logistics of

distribution do not seen to pose any significant problems. Would

implementing a policy of using KI for the general public be so

difficult?

Staff Response: At the November 5, 1997, Commission meeting, senior

NRC

[[Page 31742]]

staff members told the Commission: ``We recognize that there are

difficulties in distribution, but they are not insurmountable. If a

decision is made by the State to do it [stockpile and/or predistribute

KI] we can figure out a way to do it.'' It is the staff's perception

that if the State decides to include KI as a supplemental protective

measure for the general public, one possible method of implementation

could be that the State could make KI readily available where other

over-the-counter drugs can be purchased. The public could be informed

of the drug's availability through the yearly emergency preparedness

information brochure that is mailed out to all residents throughout the

10 mile EPZ. It would then be up to individual members of the public to

obtain and store this supply of KI, which should then be available for

use in the event of an emergency. The administration of the KI could be

at the direction of the State Medical Officer.

Issue 2: It is ``factual that the 1986 Chernobyl accident clearly

demonstrated the benefit of having KI readily available. In Poland,

where authorities expediently administered 18 million doses of KI, 97

percent of all Polish children were protected from thyroid disease. In

contrast, there are soaring rates of childhood thyroid cancer, 200

times pre-Chernobyl levels, in the former Soviet republics of Russia,

Belarus, and the Ukraine because very little KI was administered, too

long after exposure.''

Staff Response: The Chernobyl reactor (a RBMK-1000 design) is

located in the Ukraine close to Belarus. The accident occurred at 01:23

on Saturday, 26 April 1986, when explosions destroyed the reactor core

and reactor building. The explosions sent debris from the core flying

into the air and exposed the reactor core to the atmosphere. The

heavier debris from the plume was deposited close to the site. In

general, the initial release is thought to have risen to over 1 km in

altitude, thereby resulting in much lower doses close to the site than

those expected from a ground level release. The major release lasted 10

days, during which most of the noble gases and more than 40 percent of

the iodines are estimated to have been released. The varying

meteorological conditions, release rates, and release heights resulted

in very complex dose and ground deposition patterns.

It is often assumed that ingestion was the major source of thyroid

dose early in the accident. However, the contribution of inhalation

cannot be assessed because air sampling was not effectively conducted

early in the accident. As of 1996, except for thyroid cancer, there has

been no confirmed increase in the rates of other cancers, including

leukemia, among the first responders, liquidators,\2\ or the public,

that have been attributed to release from the accident.

---------------------------------------------------------------------------

\2\ Liquidators are a large number (about 200,000) of workers

and military personnel who performed cleanup, construction of the

sarcophagus, and other operations in the contaminated zones

following the accident.

---------------------------------------------------------------------------

Belarus Experience. With the Chernobyl plant located only 4 miles

(7 km) away, Belarus was heavily impacted by the accident. This impact

was heightened by the fact that protective actions were not implemented

in Belarus during the first six days after the accident. Several

authors have stated that KI was distributed to the population in

Belarus during the first week following the accident.\3\ However, there

is no confirmed published data on the dosage, coverage, or other

details concerning the implementation of the thyroid blocking in

Belarus.\4\ In addition, cows typically grazed in Belarus at the time

of year when the accident occurred, and yet no efforts were taken to

restrict the consumption of contaminated milk for the first 10 days

following the accident.

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\3\ Personal communication, E. Buglova M.D., Head Laboratory of

Radiation Hygiene and Risk Analysis, Ministry of Health, Republic of

Belarus, December 1997.

\4\ ``Thyroid Cancer in Children Living Near Chernobyl, Expert

Panel Report on the Consequences of the Chernobyl Accident''--

Williams D. et al., K.H. ECSL-EAEC, Report EUR 15248 EN, Brussels-

Luxembourg, 1993, p. 108.

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On May 2 (day 7 following the accident) the decision was made to

evacuate the areas of Belarus and Ukraine within 18 miles (30 km) of

the plant (30 km zone). The evacuation was completed on May 5, 1986.

Since 1990, a rapid increase has been observed in the incidence in

thyroid cancer among Belarus children who were 0 to 14 years old at the

time of the accident. Before the accident, the rate of thyroid cancer

among this cohort was about 0.4 per 100,000; by 1996, this rate had

risen to 3.9 per 100,000.5,6 This included

approximately 3,000 children, 0 to 18 years old, that were evacuated

from the 30-km zone within Belarus. Among this group, four thyroid

cancer cases have been detected since the accident. All of these cases

were registered after the end of the latent period for radiation-

induced thyroid cancer. Taking into account the spontaneous rate of

this disease in this age group and the number of evacuated persons, all

of these cases are considered accident-induced.

---------------------------------------------------------------------------

\5\ E. Buglova et al., ``Thyroid Cancer in Belarus After the

Chernobyl Accident; Incidence, Prognosis, Risk Assessment.'' Low

Doses of Ionizing Radiation: Biological Effects and Regulator

Control, Spain, November 1997, Contributed Paper, pp. 280-284.

\6\ ''Thyroid Cancer Incidence Rate in the Republic of

Belarus.'' Okeanov A. et al., Radiation and Risk Bulletin of

National Radio-Epidemiological Registry, Obninsk., 1995, Issue 6,

pp. 236, 239.

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The total number of excess thyroid cancers in Belarus children is

currently about 750, and is estimated to reach a maximum of more than

3500 over the lifetime of this cohort.3, 4, 6 The vast majority of the

thyroid cancers were diagnosed among those living more than 50 km (31

miles) from the site.

The increase in the rate of thyroid cancers in Belarus is

concentrated among those who were youngest at the time of the accident.

Fortunately, these cancers respond favorably to early treatment; to

date, two or three of the Belarus children diagnosed with thyroid

cancer have died as a result of that disease.\6\

Poland Experience. Poland detected increased levels of airborne

radioactive contamination on the night of April 27, 1986 (day 2).

Although there was no official notification of the accident by the

USSR, it was assumed, on the basis of Tass News Agency reports, that

the increases were attributable to the accident at Chernobyl. On April

28 (day 3), the country formed a governmental commission to recommend

protective actions. Among these actions, the commission recommended

intervention levels for taking protective actions on the morning of

April 29 (day 4).7

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\7\ The Implementation of Short-term Countermeasures After a

Nuclear Accident, Proceeding of an NEA Workshop Stockholm,'' Sweden,

1-3 June 1994, OECD 1995.

---------------------------------------------------------------------------

On April 29, Poland's Minister of Health gave orders to prepare and

distribute KI to the 11 provinces most affected. KI was to be made

available through hospitals, public health centers, schools, and

kindergartens. The country used its mass media to announce the

protective action and to appeal for volunteers to assist in the

nationwide distribution.

The Commission then instituted the following additional protective

measures: 8

\8\ Manual on Public Health Actions in Radiation Emergencies,

WHO, European Center of Environmental and Health, Rome Division,

1995.

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Feeding of cows on pastures or with fresh fodder was

banned countrywide until May 15, 1986.

Fresh milk with radioactivity concentration above 1,000

Bq/L was banned for consumption by children and pregnant or

lactating women.

All children under the age of 4 were given powdered

milk through numerous distribution centers.

Children and pregnant or lactating women were advised

to eat a minimum of fresh leafy vegetables (until May 16, 1986).

[[Page 31743]]

The distribution of KI was initiated on April 29 (day 4) and was

virtually completed by May 2 (day 7). This included the distribution of

KI to more than 90 percent of the children under the age of 16 and

about a quarter of the adults. A total of 10.5 million doses of KI were

given to children and 7 million doses were given to adults. Multiple

doses, although not recommended, were taken in a number of cases.

Because of diminishing air contamination, the KI prophylaxis was not

repeated. In the second phase of the response, powdered milk was made

available to all children less than 4 years of age. This program

effectively started on May 3 (day 8).

It is estimated that approximately a 40-45 percent reduction in

thyroid burden was achieved by thyroid blocking and milk restrictions

in the 11 provinces treated.\7\ Had the Russian authorities given

prompt warning, the 24- or 48-hour gain in time might have improved the

effectiveness of their response.

There were no reported serious adverse reactions except for two

adults with known iodide sensitivity. About 36,000 medically

significant reactions were also reported (mostly nausea).9

Because of the low iodine concentrations in Poland it is doubtful that

epidemiological studies could detect excess cancers resulting from

intake of radio iodine.\8\

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\9\ A ``medically significant'' reaction was one for which the

person suffering the reaction consulted a physician more than once.

Nauman and Wolff, ``Iodide Prophylaxis in Poland After the Chernobyl

Reactor Accident: Benefits and Risks,'' The American Journal of

Medicine, Vol. 94, May 1993, p. 530. About .2% of the population

that received KI had ``medically significant'' adverse reactions to

KI. Id. However, ``[i]t should be pointed out that control values

for these side effects in a population not receiving KI are not

available.'' Id. That is, it is not known what the incidence of such

reactions would be in a population under similar stress, but not

receiving KI, and thus it is not known to what extent these adverse

reactions were the result of KI.

---------------------------------------------------------------------------

International Practices--During this assessment, the NRC staff

examined the current policies and practices regarding the use of

thyroid blocking during Nuclear Power Plant accidents for a number of

countries. The NRC staff accomplished this task primarily through

personal communication with colleagues in each country. In general, the

countries either are following or intend to implement systems that are

consistent with the guidance promulgated by the World Health

Organization (WHO). Specifically, the WHO recommends predistribution of

stable iodine close to the site and stockpiles further from the site.

These stocks should be strategically stored at points such as schools,

hospitals, pharmacies, fire stations, or police stations, thereby

allowing prompt distribution. A further description of the WHO guidance

is provided below, followed by a discussion of the guidance promulgated

by IAEA and a comparison between U.S. and international practice.

World Health Organization (WHO) Guidance. The main points of the

WHO Guidelines 10, 11 regarding the use of stable

iodine are as follows:

\10\ International Basic Safety Standards for Protection Against

Ionizing Radiation and for Safety of Radiation Sources, Safety

Series No. 115, IAEA, 1996.

\11\ ``Method for the Development of Emergency Response

Preparedness for Nuclear or Radiological Accident,'' Tecdoc-953,

IAEA, July 1997.

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Near field: Stable iodine should be available for

immediate distribution to all groups if the predicted thyroid dose

is likely to exceed national reference levels. Close to nuclear

installations iodine tablets should be stored or predistributed to

facilitate prompt utilization.

Far field: Stable iodine should be available for

distribution to pregnant women, neonates, infants, and children if

the predicted dose is likely to exceed reference levels.

Conclusion from Polish Experience. In Poland (1) Small amounts of

radioactive iodine were deposited as a result of the Chernobyl

accident, (2) no protective actions were taken for the first 2 days of

the accident, and (3) protective actions (except sheltering or

evacuation) were taken after the first 2 days of the accident. Because

of the low iodine concentrations in Poland and the protective actions

implemented, Poland has not detected excess cancers resulting from

intake of radio iodines.

Overall Chernobyl Conclusion. The World Health Organization, almost

every industrial country in the world with nuclear power plants, and

the American Thyroid Association, believe that the low iodine

concentrations, the banning of the consumption of fresh milk and the

distribution and administration of 90 million doses of KI contributed

to the observed lack of increase of childhood thyroid cancers in

Poland. Most industrial nations with nuclear power plants have decided

to stockpile KI around nuclear power for use by the general public.

In contrast to the Chernobyl experience, in the event of an

accident in the United States, our emergency planning calls for

protective actions, sheltering, evacuation, and removal of contaminated

food from consumption all of which significantly reduce the risk of

exposure of the public to all radionuclides. Making KI available to the

public for use during evacuation or especially sheltering could, under

certain conditions, reduce the risk resulting from exposure to one

important group of radionuclides, the radioiodines. That is why current

NRC guidance discusses KI for plant personnel, emergency workers, and

institutionalized persons unlikely to be evacuated promptly.

In this light the Commission agrees that the use of KI may be

determined by State and local emergency response planners to be a

supplementary protective measure.

Issue 3: ``Stockpiling or predistribution of potassium iodide (KI)

as a protective action would not add any significant public health and

safety benefit to the current level of protection provided by existing

emergency plans for commercial nuclear power plants. Our emergency

plans focus on evacuation as the key protective action to prevent

exposure since it protects against exposure to all radionuclides, not

just iodine. In addition, the potential for misadministration of KI is

present when predistributed to the general public, and incidents of

misadministration have been informally reported at industry meetings by

states which predistributed KI to the public.''

Staff Response: The Commission agrees that it is the State's

prerogative to decide to include stockpiling or predistribution of KI

as a protective action for the general public. The FDA concluded that

risks from short term use of relatively low doses of KI are out weighed

by the radiologically induced thyroid nodules or cancers at a projected

dose to the thyroid gland of 25 rem or greater. In so doing, the FDA

approved KI as an over-the-counter drug. The American Thyroid

Association fully endorses the use of KI and, as previously discussed,

there were only 2 significant adverse reactions and 36,000 medically

significant reactions (nausea) in 90 million doses of KI after the

Chernobyl accident. The taking of KI should require precautions similar

to those associated with any other over-the counter drug, and, of

course, the packaging instructions should be followed.

Issue 4: ``Evacuation is more feasible and practicable. Stockpiling

of KI has logistical problems which we feel renders this idea

impracticable and unmanageable.''

Staff Response: The staff agrees that evacuation is usually

``feasible and practicable'' and is the most effective protective

action. If the State decides to include KI as a supplemental protective

measure for the general public, one possible method of implementation

could be that the State could make KI readily available such as by

making it available where other over-the-counter

[[Page 31744]]

drugs can be purchased. The public could be informed of the drug's

availability through the yearly emergency preparedness information

brochure that is mailed out to all residents throughout the 10 mile

EPZ. Individual members of the public would be responsible for

obtaining and storing this supply of KI, which could then be available

for use in the event of an emergency. Another approach to

predistribution is to include stockpiling at reception centers for

distribution during an evacuation. Other countries have found ways to

effectively distribute KI when needed and the distribution issue is

certainly not unsurmountable. The administration of the KI should be at

the direction of the State Medical Officer.

Issue 5: The Three Mile Island experience has shown us that it is

not easy to obtain an adequate supply of KI in an emergency.

Staff Response: The commenter is correct, in that it was difficult

to obtain KI after the Three Mile Island accident. That is one reason

why the Commission believes that planners should consider stockpiling

KI, and why the Commission supports Federal stockpiles, so that States

that have chosen not to stockpile KI could have access, albeit ad hoc

and delayed, to an adequate supply in a radiological emergency at a

nuclear power plant. As noted elsewhere in this notice, the Commission

will work with other agencies to assure that there are Federal regional

stockpiles that contain adequate supplies of KI. Moreover, the general

availability of KI is greater now than at the time of the TMI accident,

partly because of the FDA's approval of KI as an over the counter drug.

Some States have elected to incorporate KI into the emergency response

plans and have obtained adequate supplies for this purpose. The

Commission is not aware of any factors that would constrain the

availability of KI for stockpiling purposes. The Commission believes

that an adequate supply of KI could be obtained.

Issue 6: Even though KI administration before any exposure is

ideal, the Chernobyl experience also has shown that the exposure can

continue for days. Is the institution of KI blockade at any time in

this period beneficial?

Staff Response: The administration of KI is most effective if done

before or immediately after (within 2 to 4 hours) a release.

Nonetheless, during a chronic exposure of several days, the

administration of KI any time during the exposure period may block some

uptake of radioactive iodine. However, the benefit diminishes quickly

over time and may be very small if administered late. If a release is

expected to continue for several days, the NRC anticipates that the

public would be evacuated or other protective action would be taken,

depending on the level of release. KI could nevertheless serve as a

useful supplemental and complement to these primary protective actions.

Issue 7: KI is an effective thyroid blocking agent only when

administered immediately before or after an exposure to radioactive

iodine (that is, within one to two hours). Distribution of KI in a

timely fashion to the general public following an accident could

further complicate and decrease the effectiveness of implementing

evacuation or residential sheltering.

Staff Response: The staff disagrees with this position. If a State

chooses to include KI as an additional protective measure, it is

anticipated that the State could make KI readily available to the

public where other over-the-counter medicines are available or by other

distribution means and that the public be made aware of its (the KI)

availability, not at the time of an emergency, but KI could be made

available year round.

Issue 8: One of the major impediments to distribution of KI to

school children is coordination and administration of the program,

e.g., the actual decision making process to administer KI or evacuate,

parental approval and recordkeeping, identification and documenting

allergic reactions, and the availability of a qualified medical

professional to administer the potassium iodide.

Staff Response: The staff disagrees. Upon declaration of a general

emergency there should be NO decision ``to administer KI or evacuate.''

The preferred protective action for the close-in population should be

evacuation. The administration of KI should be treated in the same

fashion as any other over-the-counter medication that might be given to

children while away from home, after observing the instructions

provided with the KI packaging. Prior parental approval to administer

KI in the event of an emergency can and should be addressed in the

planning process for any State that decides to use KI. The individual

State may provide the appropriate guidance and establish a system for

obtaining parental approval before the taking of other protective

actions that are currently being followed in the EPZ around nuclear

power plants.

Issue 9: Does the post-Chernobyl Polish experience show that large-

scale deployment of KI is safe?

Staff Response: Approximately 18 million doses of KI were

distributed primarily, but not exclusively, to children. The bulk of

the distribution took about three days. There were no reported serious

adverse reactions except for two adults with known iodide sensitivity.

The rate of serious side effects (10-7) is consistent with

the frequency seen during routine use of KI for medical treatment of

respiratory disease. The incidence of medically significant, but not

serious, reactions to this single dose of KI was also very low (0.2

percent). In addition, no detectable long-term disturbance in

children's thyroid function was detected as of 1989. Additionally, the

FDA has approved KI for over-the-counter distribution. The staff,

therefore, agrees that the post-Chernobyl experience has shown that

large-scale deployment of KI is relatively safe.

Issue 10: Several comments raised the question of liability: ``Is

the NRC prepared to address the number of legal implications should a

member of the general public be given KI at their directive or

recommendation and the individual have an extreme allergic reaction,

possibly death?''; ``The Federal Register Notice does not address legal

issues for states who decide to adopt KI and states who do not decide

to adopt or administer KI to the public.''; ``The issue of legal

liability should not be dismissed lightly. If the NRC decides to

require stockpiling of KI for the general public, has NRC considered

what liability may arise from any adverse health effects? No initiative

such as this should be undertaken without resolution of this issue.'';

``Who would assume liability if the KI was used prior to the Governor

ordering its use?'

Staff Response: The comments focus principally on concerns that

State and local governments involved in distribution and administration

of KI may be liable in tort if an individual receiving the KI has a

significant adverse medical reaction to the KI. To the extent that

commenters are raising the potential for federal government liability

for the promulgation of this proposed rule, the NRC believes that

whether the Commission may be subject to tort liability through the

implementation of a KI program depends upon a number of factors.

However, it would appear that a Commission decision to require state

and local emergency planning officials to consider stockpiling KI for

public distribution should be subject to the ``discretionary function''

exception to the Federal Tort Claims Act, 28 USC

[[Page 31745]]

2671, et seq.,12 which protects the Federal Government from

liability. The question of whether a State or locality might be liable

for involvement with administration of KI to the general public can

only be answered by reference to the laws and precedents of particular

States. The NRC presumes that this would be part of the

``consideration'' that States and localities will undertake if this

rule is promulgated. The NRC has not undertaken this analysis.

---------------------------------------------------------------------------

\12\ This exception from waiver of sovereign immunity provides

that:

Any claims based upon an act or omission of an employee of the

Government, exercising due care, in the execution of a statute or

regulation, whether or not such statute or regulation be valid, or

based upon the exercise or performance or the failure to exercise or

perform a discretionary function or duty on the part of a federal

agency or an employee of the Government, whether or not the

discretion involved be abused.

28 USC 2680(a). United States v. Varig Airlines, 467 U.S. 797,

808 (1984); Berkovitz v. United States, 486 U.S. 531 (1988).

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Issue 11: Does the Commission consider stockpiling and using KI as

a reasonable and prudent protective measure for the general public?

Staff Response: The Commission believes that State and local

decision makers, provided with proper information, may find that the

use of KI as a protective supplement to evacuation and sheltering is

reasonable and prudent for specific local conditions.

Commission Decision

KI is a reasonable, prudent, and inexpensive supplement to

evacuation and sheltering for specific local conditions. Therefore, the

Commission's guidance on emergency planning has long taken KI into

consideration (NUREG-0654/FEMA-REP-1, Rev. 1, p. 63, items e and f.).

However, since the last revision of that guidance, there has been

experience with the mass distribution of KI during a radiological

emergency, and though the record on that distribution is not complete,

the indications thus far are that mass distribution is effective in

preventing thyroid cancer and causes remarkable few threatening side

effects. Moreover, many nations in Europe and elsewhere, nations as

different in their circumstances, politics, and regulatory structures

as France, Canada, and Japan, have stockpiled KI and planned for its

use. So have some U.S. States. The World Health Organization and the

International Atomic Energy Agency recommend its use. Therefore, in

order to achieve greater assurance that KI will receive due attention

by planners, it seems reasonable to take a small further step and,

continuing to recognize the authority of the States in matters of

emergency planning, explicitly require that planners consider the use

of KI.

The proposed rule change should not be taken to imply that the NRC

believes that the present generation of nuclear power plants is any

less safe than previously thought. On the contrary, present indications

are that nuclear power plant safety has improved since the current

emergency planning requirements were put in place after the Three Mile

Island accident.

The use of potassium iodide is intended to supplement, not to

replace, other protective measures. This rule change thus represents no

alteration in the NRC's view that the primary and most desirable

protective action in a radiological emergency is evacuation of the

population before any exposure to radiation occurs, whenever that is

feasible. (Evacuation protects the whole body, whereas potassium iodide

protects only a single gland, the thyroid.) Depending on the

circumstances, KI may offer additional protection if used in

conjunction with evacuation and/or sheltering.

The NRC recognizes that the decision to stockpile KI presents

issues of how best to position and distribute the medicine, to ensure,

e.g., that optimal distribution takes place in an emergency, with first

priority given to protecting children; that persons with known

allergies to iodine not take it; that members of the public understand

that KI is not a substitute for measures that protect the whole body;

etc. To date, these issues have been addressed in different ways in the

numerous countries that currently stockpile KI. The NRC is working with

States and localities to develop guidance on these and other points

relating to the use of KI. The NRC believes that these implementation

issues can be solved, given the level of expertise in the relevant

Federal and State agencies, and the experience of numerous nations that

have built KI into their emergency plans.

It is expected that States will inform FEMA and the NRC of the

results of their consideration of whether to opt for stockpiling. This

will enable the Federal government to engage in better contingency

planning for States that decide against stockpiling KI.

The Commission decision is implemented by publication of this

proposed rule that would change 10 CFR 50.47(b)(10) with a 90-day

public comment period. If the proposed rule is adopted in final form,

the petition would be granted in part and denied in part and NRC action

would be completed on PRM 50-63 and PRM 50-63A.

Commission Conclusions or Issues Raised by the Petitioner and Public

Commenters

The Commission having reviewed the issues raised by the petitioner

and the public commenters, has reached the following conclusions:

A. The Commission agrees that KI, when determined by State and

local emergency response planners and if administered in a timely

fashion, could protect the thyroid gland from exposure to radioiodines

inhaled or ingested following a major radiological accident. This is

the basis for stockpiling it and distributing it to emergency workers

and institutionalized persons during radiological emergencies. The

petitioner believes that the distribution of KI was inadequate and

untimely in the Ukraine and Belarus after the Chernobyl accident in

1986 and that this accounts for the increased incidence of thyroid

cancer in these areas. He also argues that distribution of KI in Poland

was timely and effective and that no similar increase in the incidence

of thyroid cancer was seen. The Commission considered all of the above

information in deciding to grant the petitioner's requested actions.

B. The Kemeny Commission criticized the failure to stockpile KI and

recommended that regional stockpiles be established. The Kemeny

Commission's report recognized that evacuation was not invariably the

preferred response to an emergency and that even when evacuation was

desirable, it might not be feasible. The Commission believes that

prompt evacuation and/or sheltering are the generally preferred

protective measures for severe reactor accidents. In developing the

range of public protective actions for severe accidents at commercial

nuclear power plants, evacuation and in-place sheltering provide

adequate protection for the general public. The Commission believes

that KI for the general public should not replace evacuation and

sheltering, but supplement them.

C. The Federal Radiological Emergency Response Plan (FRERP) is the

plan that would be used by the Federal Government to support State and

local officials in responding to any peacetime radiological emergency.

Such emergencies range from transportation accidents involving

radioactive materials to terrorist events involving nuclear materials.

The FRERP includes a range of protective actions commensurate with the

risks associated with the range of emergencies for the

[[Page 31746]]

general public and emergency workers. These protective actions include

evacuation, sheltering, and the prophylactic use of stable iodine. With

respect to protective actions for nuclear power plants, the NRC and

FEMA have issued Draft Supplement 3 to NUREG-0654/FEMA-REP-1, Rev. 1,

to provide updated guidance for the development of protective action

recommendations for severe reactor accidents. This document emphasizes

that prompt evacuation is the preferred protective action for actual or

projected severe core damage accidents.

D. The Commission recognizes that in 1994 the Board of Governors of

the IAEA adopted new International Basic Safety Standards. With respect

to emergency planning, these standards provide, among other things,

``intervention levels for immediate protective action, including

sheltering, evacuation, and iodine prophylaxis.'' It is important to

note that each country bases its response plans on local and regional

characteristics. For example, Italy and France, using the same

international standards and guidelines, implement them differently.

E. Although the cost of KI tablets has doubled, the Commission

agrees with the NRC staff estimate and other nations' experience, that

the purchase of KI tablets is relatively inexpensive. KI-related costs

increase when the cost of maintenance, distribution, and public

education are considered. However, the overall cost is minimal when

placed in the context of emergency planning and should not be a

deterrent to stockpiling KI for use by the general public should State

and local decision makers determine that the prophylactic use of KI as

a supplement to evacuation and sheltering is appropriate.

F. The Commission believes that robust regional stockpiles should

be established to enable use by States that have not established local

stockpiles and wish to make use of KI in the event of a severe nuclear

power plant accident.

Commission Decision To Fund KI

On June 30, 1997, the Commission voted to approve the NRC staff

recommendation to endorse the FRPCC recommendations for the Federal

Government to fund the purchase of potassium iodide (KI) for States at

their request and endorsed the FRPCC recognition of the availability of

the Federal stockpile of KI to State and local governments for purposes

of mitigating the consequences of terrorist use of nuclear, biological,

or chemical (NBC) weapons. At that time it was believed that the NRC

was the likely Federal agency to fund the stockpiling. Historically,

funding for State and local; emergency response planning has been the

responsibility of those governments usually working with licensees and,

absent Congressional funding specifically for this purpose, NRC is not

prepared to fund stockpiling of KI.

Findings

Metric Policy

On October 7, 1992, the Commission published its final Policy

Statement on Metrication. According to that policy, after January 7,

1993, all new regulations and major amendments to existing regulations

were to be presented in dual units. The amendment to the regulations

contains no units.

Environmental Assessment and Finding of No Significant Impact for

Granting the Petition for Rulemaking Relating To the Use of Potassium

Iodide (KI)

I. Introduction

On September 9, 1995, a petition for rulemaking (PRM 50-63) was

filed with the NRC by Mr. Peter Crane. The petitioner requested that

the NRC amend its emergency planning regulations to require that

emergency plans specify a range of protective actions to include

sheltering, evacuation, and the prophylactic use of KI.

In SECY 97-245, dated October 23, 1997, the staff provided three

options for the Commission's consideration in order to resolve PRM 50-

63.

On November 5, 1997, the Commission was briefed by the NRC staff,

the Federal Emergency Management Agency (FEMA), and the petitioner

regarding the options available for resolving the petition for

rulemaking. During the meeting, the Commission invited the petitioner

to submit a modification to his petition in order to address views he

discussed during the meeting.

On November 11, 1997, the petitioner submitted a revision to his

petition PRM 50-63A, which requested two things:

1. A statement clearly recommending stockpiling of KI as a

``reasonable and prudent'' measure, and

2. A proposed rule change to 10 CFR 50.47(b)(10) which would be

accomplished by inserting the following sentence after the first

sentence: ``In developing this range of actions, consideration has

been given to evacuation, sheltering, and the prophylactic use of

potassium iodide (KI), as appropriate.''

On June 26, 1998, the Commission disagreed with the staff

recommendation to deny the petition for rulemaking PRM 50-63A by

revising 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in

response to this directive.

Alternatives were essentially considered in previous documents. In

SECY-97-124 (June 16, 1997), on the ``Proposed Federal Policy Regarding

Use of Potassium Iodide after a Severe Accident at a Nuclear Power

Plant.'' The staff identified three options, one of which contained

three sub-options, concerning a proposed change in the Federal policy

regarding the use of potassium iodide (KI) as a protective measure for

the general public during severe reactor accidents. Next, in an SRM

dated June 30, 1997, the Commission approved an option that endorsed

the Federal offer to fund the purchase of KI for States at their

request and endorsed the Federal Radiological Preparedness Coordinating

Committee (FRPCC) recognition of the availability to State and local

governments of the Federal stockpiling of KI.

II. Need for Action

In SECY-97-245, the staff proposed options for resolving the

referenced petition for rulemaking. In SRM 98-061, the Commission

directed the staff to proceed with the rulemaking.

III. Environmental Impact of the Proposed Action

The environmental impacts of the proposed action and its

alternative are considered negligible by the NRC staff. Given the

proposed action would only add the sentence: ``In developing this range

of actions, consideration has been given to evacuation, sheltering, and

the prophylactic use of potassium iodide (KI), as appropriate.'' The

staff is not aware of any environmental impact as a result of this

proposed action.

IV. Alternative to the Proposed Action

The alternative to the proposed action at this time is to deny the

petitions and take no action with respect to the use of KI by the

public. Should this no-action alternative be pursued, the staff is not

aware of any resulting environmental impact.

V. Agencies and Persons Consulted

Cognizant personnel from the Federal Emergency Management Agency

were consulted, as was the petitioner, as part of this rulemaking

activity.

VI. Finding of No Significant Impact: Availability

The Commission has determined under the National Environmental

Policy Act of 1969, as amended, and the Commission's regulations in

Subpart A of 10 CFR Part 51, that the amendment is not a major Federal

action

[[Page 31747]]

significantly affecting the quality of human environment, and

therefore, an environmental impact statement is not required. This

amendment will require that emergency plans specify a range of

protective actions to include sheltering, evacuation, and the

prophylactic use of KI. This action will not have a significant impact

upon the environment.

Paperwork Reduction Act Statement

This proposal rule does not contain a new or amended information

collection requirement subject to the Paperwork Reduction Act of 1995

(44 U.S.C 3501 et seq.). Existing requirements were approved by the

Office of Management and Budget (OBM) approval numbers 3150-0009 and

3150-0011.

Public Protection Notification

If an information collection does not display a currently valid OMB

control number, the NRC may not conduct or sponsor, and a person is not

required to respond to, the information collection.

Regulatory Analysis of the Proposed Rulemaking Granting In Part A

Petition for Rulemaking (PRM 50-63A) Relating to the Use of

Potassium Iodide (KI)

On September 9, 1995, a petition for rulemaking (PRM 50-63) was

filed with the NRC by Mr. Peter Crane. The petitioner requested that

the NRC amend its emergency planning regulations to require that

emergency plans specify a range of protective actions to include

sheltering, evacuation, and the prophylactic use of KI.

In SECY 97-245, dated October 23, 1997, the staff provided three

options for the Commission's consideration in order to resolve PRM 50-

63.

On November 5, 1997, the Commission was briefed by the NRC staff,

the Federal Emergency Management Agency (FEMA), and the petitioner

regarding the options available for resolving the petition for

rulemaking. During the meeting, the Commission invited the petitioners

to submit a modification to his petition in order to address views he

discussed during the meeting.

On November 11, 1997, the petitioner submitted a revision to his

petition PRM 50-63A, which requested two things:

A statement clearly recommending stockpiling of KI as a

``reasonable and prudent'' measure, and

A proposed rule change to 10 CFR 50.47(b)(10) which would be

accomplished by inserting the following sentence after the first

sentence: ``In developing this range of actions, consideration has

been given to evacuation, sheltering, and the prophylactic use of

potassium iodide (KI), as appropriate.''

On June 26, 1998, the Commission directed the staff in SRM 98-061

to revise 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in

response to this directive.

Alternatives were essentially considered in previous documents. In

SECY-97-124 (June 16, 1997), titled ``Proposed Federal Policy Regarding

Use of Potassium Iodide after a Severe Accident at a Nuclear Power

Plant,'' the staff identified three options, one of which contained

three sub-options, concerning a proposed change in the Federal policy

regarding the use of potassium iodide (KI) as a protective measure for

the general public during severe reactor accidents. Next, in an SRM

dated June 30, 1997, the Commission approved an option that endorsed

the Federal offer to fund the purchase of KI for States at their

request and endorsed Federal Radiological Preparedness Coordinating

Committee (FRPCC) recognition of the availability to State and local

governments of the Federal stockpiling of KI.

In SECY-97-245, the staff proposed options for resolving the

referenced petition for rulemaking. In SRM 98-06, the Commission

directed the staff to proceed with the rulemaking.

Given that the Commission considered the options and directed the

staff to grant the petition, the only alternatives considered here are

the Commission approved option and the baseline, no-action alternative.

The proposed rulemaking does not ``require'' anything of licensees,

but States are to have shown ``consideration'' of the use of KI along

with evacuation and sheltering as protective actions. It is estimated

that 30 States will need to make this consideration. Further, the staff

estimates that the labor needed by the States could range from a staff-

week, to a half staff-year. The latter being the case if a State

decided to hold hearings on the issue.

If one assumes an average hourly salary of $70 (this estimate

includes benefits, pro-rated secretarial and managerial assistance, but

not overhead), the range of estimates would be from $2800 to $63,000.

Again using a base of 30 States, the range is from $84,000 to $1.9

million.

The Commission notes that when it amended its emergency planning

regulations on November 3, 1980, the regulatory standards for emergency

planning were a restatement of basic joint NRC-FEMA guidance to

licensees and to State and local governments incorporated in NUREG-

0654; FEMA-REP-1, ``Criteria for Preparation and Evaluation of

Radiological Emergency Response Plans and Preparedness in Support of

Nuclear Power Plants for Interim Use and Comment.'' This guidance was

cited in the regulation and speaks to radioprotective drugs including

their use by the general public including quantities, storage and means

of distribution and State and local plans for decision making with

respect to their use. The Commission removed the citations of the

guidance from the regulation in 1987 but the guidance has continued in

use for planning purposes and by the Federal agencies for evaluating

emergency plans. As a result, it is believed that all of the affected

States have at some point considered the use of KI. Some States have

made the decision to stockpile KI. Thus, in practical terms, the

projected costs will occur only in those States that have not elected

to stockpile KI and choose stockpiling in light of the Chernobyl

accident, recent international practice, and the NRC requirement to

consider the use of KI.

It is difficult to estimate the benefit of a State's consideration

to stockpile KI. However, we believe the benefit of such an action by

the States is summed up by the petitioner who stated that the decision

to stockpile KI should turn on whether, given the enormous consequences

of being without KI in a major accident, the drug is a prudent measure;

not on whether it will necessarily pay for itself over time. As the

petitioner further noted, KI represents a kind of catastrophic-coverage

insurance policy offering protection for events which, while they occur

only rarely, can have such enormous consequences that it is sensible to

take special precautions, especially where, as here, the cost of such

additional precautions is relatively low.

As stated above, this analysis focuses on the rule being proposed

as the result of a petition. Also, since the Commission has directed

the staff to pursue the FRPCC results with respect to KI and has

directed the staff to pursue the rulemaking, the regulatory analysis

presented here is for the edification of the decision makers so they

can make an informed decision on the proposed rule.

The above constitutes the regulatory analysis for this action.

Regulatory Flexibility Certification

In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C.

605(b), the Commission hereby certifies that this rule, if adopted,

will not have a significant economic impact on a substantial number of

small entities. This proposed rule would affect only

[[Page 31748]]

the licensees of nuclear power plants. These licensees, do not fall

within the scope of the definition of ``small entities'' set forth in

the Regulatory Flexibility Act. 5 U.S.C. 601, or the size standards

adopted by the NRC (10 CFR 2.810).

Backfit Analysis

The definition of backfit, as set forth in 10 CFR 50.109(a)(1), is

clearly directed at obligations imposed upon licensees (and applicants)

and their facilities and procedures. Section 50.109(a)(1) defines a

backfit as:

* * * the modification of or addition to systems, structures,

components, or design of a facility; or the design approval or

manufacturing license for a facility; or the procedures or

organization required to design, construct or operate a facility,

any of which may result from a new or amended provision in the

Commission rules or the imposition of a regulatory staff position

interpreting the Commission rules that is either new or different

from a previously applicable staff position * * *.

Section 50.109 is replete with references to ``facilities'' and

``licensees,'' which in their totality make clear that the rule is

intended to apply to actions taken with respect to nuclear power plant

licensees and the facilities they operate. See Section 50.109(a)(7),

``If there are two or more ways to achieve compliance with a license or

the rules or orders of the Commission, or with written licensee

commitments * * * then ordinarily the applicant or licensee is free to

choose the way that best suits its purposes [emphasis added].'' This

focus on licensees and their facilities is further confirmed by the

Statement of Considerations accompanying the backfit rule, 53 FR 20603

(June 6, 1988), where the Commission stated that backfitting ``means

measures which are intended to improve the safety of nuclear power

reactors * * *.'' 53 FR at 20604. The nine factors to be considered

under 10 CFR 50.109(c) further make clear that the rule is aimed at

requirements on licensees and facilities. These include: ``(2) General

description of the activity that would be required by the licensee or

applicant in order to complete the backfit; * * * (5) Installation and

continuing costs associated with the backfit, including the cost of

facility downtime or the cost of construction delay; [and] (6) The

potential safety impact of changes in plant or operational complexity.

* * * [emphasis added]''

The proposed rule imposes no new requirements on licensees, nor

does it alter procedures at nuclear facilities. Rather, it is directed

to States or local governments--the entities with the authority to

determine the appropriateness of the use of KI for their citizens--

calling upon the governments to ``consider'' KI as one of the elements

of their offsite emergency planning. Even as to states or local

governments, it imposes no binding requirement to alter plans and

procedures. Furthermore, the basic standard that emergency planning

must include consideration of a range of protective actions, is already

set forth in the existing wording of section 50.47(b)(10). On this

basis, the proposed rule in reality does not impose new requirements on

anyone. On a consideration of all of the above factors, no backfit is

involved and no backfit analysis is required.

Commission precedent also makes clear that the proposed rule change

does not constitute a backfit. The Commission's position was stated

explicitly in 1987, when the last major change took place in emergency

planning regulations. 52 FR 42078 (Nov. 3, 1987). The Commission's

final notice of rulemaking on this rule involving the ``Evaluation of

the Adequacy of Off-Site Emergency Planning for Nuclear Power Plants at

the Operating License Review Stage Where State and Local Governments

Decline to Participate in Off-Site Emergency Planning'' stated that the

emergency planning rule change in question ``does not impose any new

requirements on production or utilization facilities; it only provides

an alternative method to meet the Commission's emergency planning

regulations. The amendment therefore is not a backfit under 10 CFR

50.109 and a backfit analysis is not required.'' 52 FR at 42084.

Likewise, when the Commission altered its emergency planning

requirements in 1987 to change the timing requirements for full

participation emergency exercises (a change that, as a practical

matter, could be expected to result in licensees' modifying emergency

preparedness-related procedures to accommodate exercise frequency

changes), it stated: ``The final rule does not modify or add to

systems, structures, components or design of a facility; the design

approval or manufacturing license for a facility; or the procedures or

organization required to design, construct, or operate a facility.

Accordingly, no backfit analysis pursuant to 10 CFR 50.109 is required

for this final rule.'' 52 FR 16828 (May 6, 1987). The proposed

emergency planning rule change is of a similar nature and similarly

does not involve a backfit.

It has been argued by at least one commenter on the petition for

rulemaking that, although licensees are not directly burdened by the

proposed rule, they would be indirectly burdened because they would

feel called upon to explain the new policy to their customers. By this

logic, almost any Commission action that led an NRC licensee to issue a

press release could be considered a backfit. Such a position would

represent unsound law and policy. Here, the burden of public

information on licensees or applicants, if any, appears de minimis. It

plainly does not rise to the level of the type of concrete burden

contemplated by the Commission when it enacted the backfit rule. It

might also be argued that, if a State or local government were to

decide to stockpile and use KI for the general public, it would

undertake interactions with the affected licensee to coordinate offsite

emergency planning. Although this could result in some voluntary action

by the licensee to coordinate its planning, the proposed rule itself

does not impose any requirement or burden on the licensee. Accordingly,

the Commission concludes that the proposed rule, if adopted, would not

impose any backfits as defined in 10 CFR 50.109.

List of Subjects in 10 CFR Part 50

Antitrust, Classified Information, Criminal penalties, Fire

protection, Intergovernmental relations, Nuclear power plants and

reactors, Radiation protection, Reactor siting criteria, Reporting and

recordkeeping requirements.

For the reasons set out in the preamble and under the authority of

the Atomic Energy Act for 1954, as amended, the Energy Reorganization

Act of 1974, as amended, the National Environmental Policy Act of 1969,

as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the

following amendment to 10 CFR Part 50.

PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION

FACILITIES

1. The authority citation for 10 CFR Part 50 continues to read as

follows:

Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68

Stat. 936, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83

Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232,

2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stats. 1242,

as amended 1244, 1246, (42 U.S.C. 5841, 5842, 5846).

Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.

2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42

U.S.C. 5851). Sections 50.10 also issued under secs. 101, 185, 68

State. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102,

[[Page 31749]]

Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Section 50.13,

50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as

amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56

also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections

50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L.

91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also

issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section

50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).

Sections 50.80, 50.81 also issued under sec. 184, 68 Stat. 954, as

amended (42 U.S.C. 2234). Appendix F also issued under sec. 187, 68

Stat. 955 (42 U.S.C. 2237).

2. In Sec. 50.47, paragraph (b)(10) is revised to read as follows:

Sec. 50.47 Emergency plans.

* * * * *

(b) * * *

(10) A range of protective actions has been developed for the plume

exposure pathway EPZ for emergency workers and the public. In

developing this range of actions, consideration has been given to

evacuation, sheltering, and, as a supplement to these, the prophylactic

use of potassium iodide (KI), as appropriate. Guidelines for the choice

of protective actions during an emergency, consistent with Federal

guidance, are developed and in place, and protective actions for the

ingestion exposure pathway EPZ appropriate to the locale have been

developed.

* * * * *

Dated at Rockville, Maryland, this 3rd day of June, 1999.

For the Nuclear Regulatory Commission.

Annette Vietti-Cook,

Secretary of the Commission.

[FR Doc. 99-14584 Filed 6-11-99; 8:45 am]

BILLING CODE 7590-01-P