This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

5427

Vol. 66, No. 13

Friday, January 19, 2001

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

RIN 3150–AG11

Consideration of Potassium Iodide in

Emergency Plans

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is amending its

emergency planning regulations

governing the domestic licensing of

production and utilization facilities.

The final rule requires that

consideration 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 final rule

responds to petitions for rulemaking

(PRM 50–63 and PRM 50–63A)

submitted by Mr. Peter G. Crane

concerning the use of KI in emergency

plans.

EFFECTIVE DATES: April 19, 2001.

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:

MTJ1@nrc.gov.

SUPPLEMENTARY INFORMATION: Section

50.47 of the Commission’s regulations

establishes requirements for emergency

plans for nuclear power reactors to

provide reasonable assurance that

adequate protective measures can and

will be taken in the event of a

radiological emergency. Section 50.47(b)

contains 16 planning standards, and in

particular, § 50.47(b)(10) requires that

emergency plans include ‘‘a range of

protective actions’’ for the plume

exposure pathway emergency planning

zone (EPZ) for emergency workers and

the public. This provision does not

identify specific protective actions that

must be included in these emergency

plans.

The Petitioner’s Requested Amendment

to the NRC Regulations

On November 27, 1995 (60 FR 58256),

the NRC published a document

announcing the receipt of a petition for

rulemaking (PRM 50–63) filed by Mr.

Peter G. Crane on his own behalf and

requested public comment on the

suggested action. In the original petition

(PRM 50–63), 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. 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 stated prevents thyroid cancer

after nuclear accidents.

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 September 9, 1995, petition

(PRM 50–63), the petitioner stated that

he believes that if his proposed rule

change is adopted, the plan will become

an accurate description of emergency

preparedness for radiological

emergencies; the recommendation of the

Kemeny Commission to stockpile KI

will at last be implemented; and the

United States will be in compliance

with the International Basic Safety

Standards.

On November 11, 1997, the petitioner

submitted a revision to his original

petition (PRM 50–63A). In the revised

petition, the petitioner requested that 10

CFR 50.47(b) be amended to read: (10)

‘‘A range of protective actions 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 also provided a

marked-up version of the NRC staff’s

proposed Federal Radiological

Preparedness Coordinating Committee

(FRPCC) Federal Register document

concerning a revision to the Federal

policy relating to the use of KI by the

general public. The NRC published a

document announcing the receipt of the

amended petition on December 17,

1997, (62 FR 66038) and requested

public comment on the amended

petition.

As part of the petitioner’s comments

on the proposed rule, the petitioner also

stated that his original petition was

incorporated by reference and

resubmitted because the amended

petition was based in part upon the June

30, 1997, Commission decision to fund

State supplies for those States that

request it.

The petitioner also requested in PRM

50–63 that the NRC, either on its own

or jointly with other agencies, issue a

policy statement declaring that KI

stockpiling is a sensible and prudent

measure necessary to assure 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.

Commission Action Concerning the

Petitions

By staff requirements memorandum

(SRM) dated June 26, 1998, to SECY 98–

061, ‘‘Staff Options for Resolving a

Petition for Rulemaking (PRM 50–63

and 50–63A) Relating to Re-evaluation

of the Policy Regarding the use of

Potassium Iodide (KI) by the General

Public after a Severe Accident at a

Nuclear Power Plant,’’ the Commission

decided to grant the revised petition for

rulemaking (PRM 50–63A). The

Commission also directed that the

5428 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

1This was in contrast to previous Commission

statements, such as those made when the

Commission amended its emergency planning

regulations (45 FR 55402) on November 3, 1980,

wherein the Commission stated that any direct

funding of State or local governments solely for

emergency preparedness purposes by the Federal

government would come through the Federal

Emergency Management Agency (FEMA).

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.

By SRM dated April 22, 1999, to

SECY 98–264, ‘‘Proposed Amendments

to 10 CFR 50.47; Granting of Petitions

for Rulemaking (PRM 50–63 and 50–

63A) Relating to a Re-evaluation of

Policy on the Use of Potassium Iodide

(KI) After a Severe Accident at a Nuclear

Power Plant,’’ the Commission voted to

approve publication in the Federal

Register of a [7590–01-P] proposed rule

that would grant in part both the

original petition (PRM 50–63) and the

revised petition for rulemaking (PRM

50–63A). The proposed rule was

published for public comment on June

14, 1999 (64 FR 31737). That notice

provides greater detail concerning the

basis for the petition and the NRC’s

rationale for the proposed rule language

put forth for comment.

Other Activities Related to the

Rulemaking on KI

In its decision on June 30, 1997, the

Commission endorsed the Federal offer

to fund the purchase of KI for States at

their request. On June 26, 1998, in a

decision on this rulemaking petition,

the Commission again 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.1 However, in its April 22, 1999,

SRM, the Commission decided: (1) Not

to fund State stockpiles of KI; (2) to

direct the NRC staff to work with FEMA

to establish and maintain regional KI

stockpiles; and (3) to support NRC

funding of the purchase and resupply of

the regional KI stockpiles to the extent

that this cannot be covered by FEMA

under its initiatives. The Commission

determined that notwithstanding the

June 30, 1997, and June 26, 1998,

intention that ‘‘most likely the NRC’’

would fund the purchase of State

stockpiles of KI, NRC was not prepared

to fund State stockpiles of KI absent

Congressional funding specifically for

this purpose.

The Federal Radiological

Preparedness Coordinating Committee

(FRPCC) is responsible to coordinate all

Federal responsibilities for assisting

state and local governments in

emergency planning and preparedness

for peacetime radiological emergencies.

Federal agencies which participate in

the FRPCC include (among others): the

Federal Emergency Management Agency

(FEMA), NRC, the Environmental

Protection Agency (EPA), and the

Department of Health and Human

Services (HHS). The 1985 Federal Policy

recommends the stockpiling or

distribution of KI during emergencies

for emergency workers and

institutionalized persons, but does not

recommend requiring pre-distribution

or stockpiling for the general public. In

parallel with petitioning the NRC for

rulemaking, Mr. Crane requested that

the FRPCC policy be reconsidered. In

early 1996, the FRPCC convened a

subcommittee on Potassium Iodide. The

subcommittee recommended the

following to the FRPCC regarding the

Federal KI policy: (1) Without changing

the Federal policy that it is the State’s

prerogative to make its own decisions

on whether to use KI, the Federal

Government (NRC through FEMA),

should fund the purchase of a stockpile

for a State that, hereafter, decides to

incorporate KI as a protective measure

for the general public; (2) the language

in the 1985 policy should be softened to

be more flexible and balanced, as for

instance, rewording it 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;’’ and (3) local

jurisdictions that wish to use KI should

consult with the State to determine if

the 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 such

a measure in their emergency plans.

On June 16, 1997, the NRC staff

forwarded to the Commission a staff

version of the FRPCC-proposed Policy

Regarding Use of Potassium Iodide After

a Severe Accident at a Nuclear Power

Plant. In its SRM of June 30, 1997, the

Commission endorsed the Federal offer

to fund the purchase of KI for States. On

June 26, 1998, the Commission directed

that the FRPCC proposed Policy be

modified to include a statement to the

effect that State and local decision

makers, provided with proper

information, may find the use of KI as

a protective supplement is reasonable

and prudent for specific local

conditions. As noted above, the

Commission also reiterated its

endorsement of the Federal offer to fund

KI stockpiles for States. Subsequently,

on April 22, 1999, the Commission

directed the staff to amend the draft

FRN on the Federal KI Policy to

conform to the Commission decision on

the petitions for rulemaking, and the

decision not to fund State KI stockpiles.

On April 29, 1999, the Director of

FEMA, Mr. James Lee Witt, forwarded a

letter to the Commission commenting

on the issue of funding of stockpiles of

KI for States. The letter objected to the

Commission’s ‘‘unilateral’’ decision on

funding, and also noted ‘‘FEMA has

always opposed the notion that Federal

regional stockpiles of KI would be

effective [and believes that] regional

stockpiles would complicate, not

strengthen radiological emergency

preparedness.’’ FEMA believes that if a

State opts to use KI as a supplemental

protective measure, the NRC should

provide the funds for such a purchase.

The NRC responded to Mr. Witt’s

letter on June 15, 1999. This letter noted

the Commission’s decision not to fund

state stockpiles of KI as well as the

reasons underlying that decision. The

letter also referred to the Commission’s

direction to ‘‘the NRC staff to work with

FEMA staff to establish and maintain

regional KI stockpiles to be used in the

event that local stockpiles prove to be

insufficient, or when a state without a

stockpile elects to use KI on an ad hoc

basis in the case of a nuclear

emergency.’’ The letter expressed

confidence that the staffs, working

together would successfully resolve the

KI supply issue. The status of the

stockpile and funding issues are

discussed later in this notice. NRC is

working closely with the other Federal

agencies to determine appropriate

changes to the 1985 policy. A decision

regarding policy changes will be

reached after the conclusion of this

rulemaking.

In accordance with a Memorandum of

Understanding between NRC and

FEMA, NRC sent draft versions of this

Federal Register notice to FEMA for its

review and comment. FEMA responded

by letter dated January 12, 2000. That

letter reiterated their previous

comments opposing regional stockpiles

and instead favoring NRC funding of

State stockpiles. The letter also noted

that the development of regional

stockpiles of KI had not progressed.

As discussed in the public comment

evaluation, the Commission, as part of

its decision to grant in full the amended

rulemaking petition, has withdrawn its

support for the funding of regional KI

stockpiles and has reinstated its offer to

provide for NRC funding of State or, in

some cases, local stockpiles. The

Commission agrees to fund a State’s

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5429

2Two letters that were received in response to the

notice did not address the issues in the petition and

are not discussed further.

3Three of the letters (those from FEMA, the

senator and the congressional representative) were

not submitted during the comment period in

response to the notice, but are being treated as

comment letters for purposes of this discussion.

stockpile of KI, subject to various

restrictions and limitations (see Staff

Requirements Memorandum for the

Affirmation Session on December 22,

2000). NRC intends to work closely with

FEMA and the other Federal agencies in

FRPCC to finalize the draft Federal

Policy to replace the 1985 Federal

Policy. A decision regarding changes to

the draft policy will be reached after the

conclusion of this rulemaking. The

substance of the specific comments

attached to the FEMA letter is addressed

by the issues in the public comment

evaluation.

On September 30, 1998, the

Commission also directed the staff to

withdraw its guidance document,

NUREG–1633 and substantially revise

it, in a number of respects, including an

improved discussion on how the

practical problems in KI stockpiling,

distribution and use are handled by

States and other nations who use KI as

a supplement. To accomplish this task,

the NRC formed a KI Core Group,

consisting of representatives from those

States that have KI as a supplemental

protective action, the Conference of

Radiation Control Program Directors,

the National Emergency Management

Association, the U.S. Food and Drug

Administration (FDA), EPA and FEMA.

The revised draft guidance document,

NUREG–1633, ‘‘Assessment of the Use

of KI as a Supplemental Protective

Action During Severe Reactor

Accidents’’, Rev. 2 is expected to be

issued for comment following receipt of

the FDA’s draft revised position on

exposure action levels and proper

dosage of KI which was issued for

public comment on January 4, 2001 (66

FR 801).

In addition, the NRC plans to develop

a public information brochure

concerning the use of KI by the general

public following completion of the final

NUREG.

Public Comment Evaluation

On November 27, 1995 (60 FR 58256),

the NRC announced the receipt of the

original petition for rulemaking (PRM

50–63), and requested public comment

on the suggested rule amendment. A

total of 65 comment letters were

received.2 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.

Letters opposed to the petition came

from 20 utilities, 9 State governmental

agencies, 2 utility interest organizations,

a letter signed by 12 health physicists,

2 State university medical centers and 1

member of the public.

On December 17, 1997 (62 FR 66038),

the Commission published a request for

public comment on the amended

petition (PRM 50–63A) 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 86 comment

letters were received. The letters in

favor of granting the petition came from

8 public interest groups, 48 members of

the public (including 3 from the

petitioner), 3 physicians, 2 U.S.

Senators, one State Representative,

FEMA, the American Thyroid

Association, a KI manufacturer, and the

US Pharmacopeia Convention. Fourteen

utilities, 3 State government agencies, 1

utility interest association, and 2

members of the public opposed the

petition for rulemaking. A detailed

analysis of the issues raised by the

public comments with the response to

those issues was published in the June

14, 1999, proposed rule Federal

Register notice.

On June 14, 1999 (64 FR 31737), the

Commission published a proposed rule

in the Federal Register, based on the

revised petition for rulemaking (PRM

50–63A) and requested public comment

by September 14, 1999. A total of 77

comment letters were received.3 The

letters in favor of the proposed

rulemaking and the revised petition for

rulemaking originated from a United

States Senator; a member of the U.S.

House of Representatives; 3 State

agencies; 4 public interest groups; 10

members of the public (including two

from the petitioner); and one letter with

529 signatures. Letters that opposed the

proposed rulemaking came from 14

utilities; 13 State or local government

agencies; 1 utility interest association;

one letter from the Conference of

Radiation Control Program Directors

Standards committee representing 5

committee members; a letter from the

National Emergency Management

Association representing emergency

management directors in 50 states; a law

firm representing 15 utilities; and a

former Assistant Secretary of Nuclear

Energy at DOE. The FEMA letter of

April 29, 1999, was submitted before the

rule was published and discussed KI

stockpiles. Another 24 letters requested

the Commission to grant the original

petition (PRM 50–63) by requiring the

use of KI rather than the consideration

of KI in emergency planning. These

letters originated from members of the

public as well as public interest groups.

As part of the petitioner’s comment

letter dated August 17, 1999, on the

proposed rule the petitioner stated that,

in light of the Commission’s decision

not to fund state stockpiles of KI, the

Commission should consider his

original petition (PRM 50–63) to be

incorporated by reference and

resubmitted. He also requested the

Commission to grant the petition as

originally submitted.

The following discussion addresses

the significant comments and issues

raised in the three public comment

periods for the original and amended

petitions for rulemaking and the

proposed rule.

Issue A: Should KI Be Considered as a

Supplemental Protective Action to

Evacuation and Sheltering

Several commenters on the proposed

rule state that the rulemaking would not

add significant public health and safety

benefit beyond the current emergency

plans, because evacuation and

sheltering are the best means to protect

the public in the event of a radiological

emergency. According to these

commenters, evacuation and sheltering

are more effective at dose reduction

because they reduce dose to all organs,

not just to the thyroid.

Other comments express the view that

the Chernobyl experience (including use

of KI in Poland) shows that (1) thyroid

cancer is a major result of reactor

accidents, (2) the exposure can continue

for days and thus the institution of KI

blocking at any time is beneficial, (3)

deployment of KI is safe, and (4) shelf

life is extremely long. These

commenters note that EPA Manual

[Manual of Protective Action Guides

and Protective Actions for Nuclear

Incidents, EPA–400–R–92–001 (May

1992)] quotes the FDA as stating that

potassium iodide ‘‘will have substantial

benefit even if it is taken 3 or 4 hours

after acute exposure.’’ Thus, these

commenters believe that the advantage

of having a supply of KI on hand

outweighs moderate cost and that KI

should be a supplemental protective

action. Further, these commenters note

that just because there may be other

radionuclides to which people are

exposed is not a reason to deny them

the availability of KI.

Commenters who favor the use of KI

as a supplemental protective action

conclude that evacuation and sheltering

alone may not be sufficient safety

actions in the event that evacuation is

not feasible. They state that natural

5430 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

disasters could occur that would make

evacuation difficult and time consuming

at best, as for instance, earthquakes,

hurricanes, blizzards, and ice storms.

According to these commenters, a point

against strong reliance upon evacuation

is the evacuation routes themselves. As

an example, a commenter cites the area

around the Seabrook Nuclear Plant,

noting that during the summer tourist

season especially, it can be predicted

that evacuees will be forced to wait in

traffic for great lengths of time. This

commenter believes that if KI were

predistributed, instances of cancer,

hypothyroidism and other thyroid

disorders might be avoided.

Response. The Commission

recognizes evacuation to be the most

effective protective measure to be taken

in the event of a radiological emergency

because it protects the whole body

(including the thyroid and other organs)

from all radionuclides and all exposure

pathways. The Commission recognizes

that there may be situations when

evacuation is not feasible or is delayed.

In-place sheltering is an effective

protective action in such a situation.

However, it is important to note that the

issue is not evacuation or sheltering

versus KI. Rather, it is evacuation or

sheltering with KI versus evacuation or

sheltering without KI. The use of KI is

intended to supplement, not to replace,

other protective measures. This

amendment represents no change 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. Depending on the

circumstances, KI may offer additional

protection for one radiation-sensitive

organ, the thyroid, if used in

conjunction with evacuation and

sheltering. 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 but the use of KI

can be a reasonable and prudent

supplement. Therefore, it seems

reasonable, while continuing to

recognize the role of the State and local

governments in matters of emergency

planning, to require explicitly that

emergency planners consider the use of

KI.

Issue B: Is There a Need for New

Regulation

Commenters in favor of the proposed

rule note that 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 KI. These

commenters point to soaring rates of

thyroid cancer appearing in children in

the Soviet Union who were exposed to

the Chernobyl nuclear accident and who

received too little potassium iodide, and

too late. Thus, these commenters

support the view that there is new

information that suggests the need for

consideration by State and local

governments. In addition, many of these

commenters would go further than the

proposed rule language and require the

use of KI, not just its consideration.

In contrast to the above, letters from

some state and local governments, and

from utilities, say that the State and

local governments have already

considered the use of KI. They believe

that the petitioner has not provided any

compelling reasons why additional

Federal requirements are needed or how

they would benefit the health and safety

of the public. These State and local

government commenters reject the view

that the States have not had access to

sufficient technical information

regarding potassium iodide, and that

without accurate and current

information on KI—including the

Chernobyl experience and the

consensus of international experts—

States cannot make an informed

judgment. They conclude that this

assertion is without merit, as there has

been no shortage of information related

to the use of potassium iodide available

to State radiological emergency

planners, and oppose the implication

that State and local governments, absent

Federal actions, are incapable of making

informed decisions regarding the

protection of their citizens during a

radiological emergency. One commenter

stated that by issuing this rule, the

Commission is ignoring the views of

States where KI has been stockpiled or

pre-distributed, and where experience

shows the system is ineffective.

The commenters opposing the

proposed rule on this basis also note

that reliance on the Chernobyl

experience discounts the vast technical,

political, and socio-economic

differences between the United States

and Eastern European countries at the

time of the Chernobyl accident. The

efficacy of any protective measure will

depend on a large number of factors,

including but not limited to: the type of

reactor involved; accident sequences

and timing; source term; timeliness of

notification; the manner in which

protective action decisions are made

and transmitted to the public; the

mobility of the public; and the

receptiveness of the general public to

official instructions. These commenters

believe that the above factors have

already been considered by State and

local governments in the development

of existing emergency response plans.

Response. The Commission did not

intend to imply that States are not

capable of making informed decisions

regarding the protection of their citizens

during a radiological emergency. In fact,

the final rule calls on offsite authorities

to make their own decision on this

matter. Additionally, the Commission

recognizes that most State and local

governments have already considered

the use of KI in the event of an

emergency as part of their planning.

Nevertheless, the Commission believes

it appropriate to provide information

that may be of aid to offsite authorities

in their consideration of this matter.

Offsite authorities may, of course, use

this information as they see fit.

Several States have welcomed the

NRC’s efforts in developing information

relating to the benefits and risks

associated with using KI as a

supplemental protective measure for the

general public. This information is

intended to supplement and update

information already available on this

subject, including experience from State

and foreign governments that have made

KI available to the public. As noted

earlier, this information will be in a

revised NUREG–1633, which is

scheduled for publication for comment

after the FDA issues its draft guidance

and in an information brochure.

The Commission finds that KI is a

reasonable, prudent, and inexpensive

supplement to evacuation and

sheltering for specific local conditions.

Through its decision to require that the

use of KI be ‘‘considered’’ (rather than

being required), the Commission is

acknowledging that the efficacy of any

protective measure will depend upon a

number of factors, including those noted

by the commenter, that can vary not

only between countries but in

individual States. Thus, the

Commission concluded that decisions

on the use of KI need to be resolved on

a State-by-State basis. As part of this

consideration, State and local

governments can weigh all relevant

factors.

Issue C: The Importance of Information

in the Decisionmaking Process

Concerning the Public Use of KI

In the proposed rule, the Commission

noted that NUREG–1633 was being

revised to provide information about

experience in the United States and

abroad with distribution of KI, and that

an information brochure was also being

prepared. According to some

commenters, distribution of information

on the benefits and risks associated with

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5431

the use of KI should not be limited to

people living within nuclear power

plant emergency planning zones.

Further, commenters note that a

comprehensive public information

program outlining the potential range of

benefits and risks of using KI and how

to employ it most effectively in the

event of a radiological emergency would

be necessary to allow personal

decisionmaking. Making the

information and the KI itself available

directly to members of the public

provides them with the ability to decide

for themselves how best to take

advantage of the benefits associated

with the use of KI as supplementary

protection. One vehicle currently used

for disseminating regular preparedness

information which could be used to

provide information on KI is the public

information brochures and calendars

already required to be distributed

annually within each emergency

planning zone. In this commenter’s

view, making information and KI

available provides the greatest level of

protection for the greatest number of

people.

Some State government organizations

were concerned that making provisions

for KI might give the public a false sense

of security that they are fully protected,

and that the public might not evacuate.

Thus, these organizations believe that

there is a need for public information

concerning the supplemental role that

the use of KI could play.

Several of the commenters stated that

it is desirable that the NRC would work

with other appropriate Federal agencies

to develop and promulgate clear and

necessary guidance on the subject,

similar to the guidance on sheltering

and evacuation. These commenters also

believe that the final decision should lie

at the discretion of the State and local

governments. A few commenters

expressed the view that the rule puts the

burden of assessment on States who

have fewer technical resources than the

NRC, the EPA or the FDA.

One commenter thought that the

decisionmaking about stockpiling KI

must include rigorous assessments to

ensure sufficient quantities of KI will be

available for distribution to members of

the public, in both the plume exposure

pathway and the ingestion exposure

pathway.

Response. The Commission

recognizes that once a State decides to

include KI as a protective measure for

the general public, it would be up to the

State to decide how and when to

conduct an educational program on the

benefits and risks associated with using

KI and to supply KI for appropriate

distribution to the general public.

Additionally, the Commission agrees

that more detailed guidance on the use

of KI would be useful in assisting States

to assess the merits of stockpiling KI for

the general public, including logistics,

amounts and public information needs.

The Commission has formed a KI ‘‘Core

Group’’ consisting of representatives of

State, local, and Federal agencies whose

responsibility is to develop clear

guidance relating to the use of KI. This

guidance (NUREG–1633, Rev. 2) should

be published for comment after FDA

issues its draft guidance, which was

issued for public comment on January 4,

2001 (66 FR 801). The NRC is

continuing to work with other Federal

agencies through the FRPCC to

coordinate government policies

concerning radiation protection and

emergency planning. Further, a public

information brochure to be published

later will assist States and individuals

in making an informed decision on KI.

Issue D: Making KI Available to the

General Public

A range of comments were submitted

concerning ways by which KI could be

made available to the general public in

the event of a radiological emergency.

Many commenters simply asked NRC to

‘‘make KI available’’ without further

detail. In the proposed rule, the NRC

discussed Federal stockpiles of KI as

part of Federal response to terrorist acts.

One commenter indicated that

expanding this supply may be the best

approach. Another commenter stated

that the public is not interested in

stockpiles, but instead wants

information to make their own

decisions. Of those comments related to

specific methods of availability, these

can be generally grouped into

individual availability, State stockpiles

in the vicinity of nuclear power plants,

or regional stockpiles.

Individual Availability

One State submitted, as part of its

comments, a report that discussed a

plan they have developed that would

allow citizens to gain access to KI in

advance of an accident. The plan calls

for the State to secure agreements with

KI manufacturers to sell the medication

directly to individuals or retail outlets,

and to urge local pharmacies to stock KI

as an over-the-counter drug. Information

concerning KI availability and use

would be included in the annual

emergency information mailings

prepared by nuclear power plant staffs

and distributed to every property owner

within the emergency planning zones.

The State concluded that this method

would allow individuals to make their

own decisions about the use of KI. This

State noted that one can envision this

activity being conducted in conjunction

with existing programs designed to

remind and encourage family members

to periodically check home first aid kits,

smoke detectors, spare batteries for

flashlights and radios, and other items

that they might employ for their comfort

and protection in the event of any

emergency. In addition, one commenter

noted that KI is now available via the

Internet from at least two vendors at an

affordable price. (See also comments

above in issue C about decisionmaking.)

State Stockpiles

A number of commenters believe that

KI should be stockpiled in schools, fire

houses or reception centers near nuclear

power plants. These commenters state

that this is the advice of the experts, for

instance the World Health Organization

and Dr. Jean Temeck, from FDA. These

commenters believe that the young are

the most vulnerable; and, in the words

of Dr. Temeck, ‘‘in an emergency you

want to get it to the children as quickly

as possible and the teacher is right there

on the spot. * * * You do not need to

be medically trained to give KI. A

permission slip to administer KI can be

sent out by the school at the beginning

of each year.’’ Further, it makes sense to

these commenters that this time-critical

medicine be available nearby, such as in

a local school, hospital, or fire-station.

Thus, these commenters believe that

State stockpiles are appropriate because

regional stockpiles will not adequately

protect the public since KI must be

taken prior to exposure, or very shortly

thereafter (within about six hours), to be

an effective blocking agent.

Regional Stockpiles

A number of commenters, including

emergency preparedness and response

officials and FEMA, are concerned

about the regional stockpiling and

distribution process and its potential for

reducing the effectiveness of measures

which will provide much greater

protection to the public. In their view,

the complex logistics of storage and

distribution of regional stockpiles far

outweigh the usefulness of such a

stockpile and that regional stockpiles of

potassium iodide would complicate, not

strengthen radiological emergency

preparedness. These commenters

believe regional stockpiling has

disadvantages as compared to State

stockpiling. The administration of KI is

time-critical and regional stockpiling

means critical time will be spent

transporting the drug from a regional

stockpile to the area where it is needed.

For these reasons, they believe that

5432 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

regional stockpiles should supplement,

not substitute for State stockpiles.

Response. If a State decides to use KI

as a supplemental protective measure,

the Commission agrees that the State

should focus on the early administration

of KI to children. A decision to make KI

available to the general public will

require some planning by the State for

its own supplies of KI and methods of

distribution. Such planning (for

implementation of protective actions) is

a normal part of a State’s emergency

planning activities. As noted earlier, the

NRC plans to issue a guidance

document (NUREG–1633) to assist the

States. The Commission recognizes the

logistical challenges associated with the

distribution of KI to the general public.

For this reason, the staff intends to

include a discussion of experience with

KI distribution in the United States and

abroad in the guidance document

NUREG–1633.

There are different approaches that a

State can use in incorporating KI as a

supplemental protective measure for the

general public. One approach is that

mentioned by a commenter to distribute

information about the over-the-counter

availability of KI. Making KI available

over the counter would provide

members of the public with the

opportunity to decide for themselves if

they wanted to store and use KI. In fact,

some KI manufacturers have indicated

that they would make KI available to

any person who requests it, at a fee.

This approach would minimize the

need for State stockpiles or

predistribution and would put KI in the

hands of the public before an accident

occurs, rather than attempting to

distribute the KI from stockpiles after an

emergency is declared.

The concerns about the effectiveness

of regional stockpiles for rapid

deployment of KI to the public are also

acknowledged. FEMA has stated that in

its view, regional stockpiles will not

enhance local radiological emergency

preparedness because of complex

logistics. The Commission agrees. As

part of its decision on this final rule, the

Commission has decided to provide

funding for a supply of KI for States that

request such funding through FEMA

and to discontinue support of regional

stockpiles. The Commission believes

that in light of logistic difficulties, it is

doubtful that regional stockpiles of KI

could be effectively employed in the

unlikely event of a radiological

emergency at a commercial nuclear

power plant.

Issue E: Requiring versus Considering

Use of KI

Several commenters thought that the

proposed rule should be modified to

require the use of KI, not just the

consideration by State and local

officials. These commenters believe, for

instance, that the tragic comedy of

errors surrounding attempts to

distribute KI in the wake of the Three

Mile Island partial core melt accident

only serves to highlight the need for predistribution. The health of our children

is too important to leave their protection

to the consideration of states. These

commenters ask that if the U.S. system

is adequate, why do other industrialized

nations believe that sheltering and

evacuation alone are insufficient? Some

of these commenters want all

commercial reactor licensees to

distribute KI to all individuals within

the EPZ and to make KI available to

anyone within a 50-mile radius of the

reactor upon request. These commenters

believe that the prophylactic use of KI

for the general public should be a

mandatory emergency planning

requirement and should not be merely

an optional consideration, because, if

given the choice, many States may not

adequately protect their citizens.

Another reason cited for wanting NRC

to require KI is that ‘‘without a federal

mandate for stockpiling KI, the nuclear

industry will simply shift its fight

against the policy to the State and local

levels.’’

Response. Because the Commission

believes that current emergency

planning and protective measures—

evacuation and sheltering—are adequate

and protective of public health and

safety, the Commission will not require

use of KI by the general public. Rather,

the Commission recognizes the

supplemental value of KI and the

prerogative of the State to decide on the

appropriateness of the use of KI by its

citizens. The Commission believes the

final rule together with the

Commission’s decision to provide

funding for the purchase of a State’s

supply of KI strikes a proper balance

between encouraging (but not requiring)

the offsite authorities to take advantage

of the benefits of KI and acknowledging

the offsite authorities’ role in such

matters.

The use of KI 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. The Commission

recognizes that there may be situations

when evacuation is not feasible or is

delayed. In-place sheltering is an

effective protective action in such a

situation. Depending on the

circumstances, KI may offer additional

protection to one radiation-sensitive

organ, the thyroid, if used in

conjunction with evacuation and

sheltering. In addition, the Commission

notes that issues surrounding the

prophylactic use of KI following such

accidents do not lend themselves to

across-the-board solutions. Therefore,

the Commission has chosen to leave this

decision to State and local emergency

response planners, who may find that KI

should be a supplementary protective

measure, rather than to mandate its use.

Additionally, the Commission’s

amendment to require explicitly that

planners consider the use of KI, rather

than require the use of KI, recognizes

the important role of the States and

local governments in matters of

emergency planning and the use of

medicinal protective measures by their

citizens.

Issue F: Funding

Some commenters, including FEMA,

state that the recent decision of the

Commissioners not to fund the purchase

of KI is an unfortunate reversal to the

goal of providing supplementary

protection for the general public. Thus,

citing the Chernobyl accident, they urge

the Commission to reconsider its

position in light of the proven

usefulness of KI in preventing

childhood thyroid cancer. One State

commenter was concerned that after two

years of efforts made toward

implementing this supplementary

protection, the Commission’s recent

actions undermine that State’s effort.

While understanding the Commission’s

financial concerns leading to this

decision, this commenter proposed that

the Commission could approach

Congress for a supplemental

appropriation.

Another commenter stated that the

Commission’s withdrawal of the offer to

pay for State KI stockpiles sends a

message that KI preparedness is not

important, and that States who were

considering plans to establish stockpiles

have dropped such plans. Further, some

commenters believe that the NRC

reversal of position regarding funding of

KI for States that elect to stockpile it

adversely affects the implementation of

the policy proposed by the Federal

Radiological Preparedness Coordinating

Committee (FRPCC). [That draft policy

currently provides that if a State

chooses to add KI as a supplement to its

evacuation and sheltering protective

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5433

actions, the State will inform FEMA,

which will forward the request to the

NRC for payment.] Another commenter

noted that the Kemeny Commission

supported stockpiling KI, and that the

Commission should fulfill an earlier

NRC commitment to do so.

Several States expressed the view that

the requirement that use of KI be

considered is an unfunded State

mandate and is contrary to an Executive

Order of 8/5/99.

A number of commenters stated that

they thought the utilities should pay for

supplies of KI in the vicinity of the

power plants. Some utilities expressed

concern that the rulemaking might

result in requests to the utilities from

State and local organizations for such

funding.

Response. The Commission decision

not to fund State stockpiles has been

reversed as the result of public comment

on this rulemaking. Promulgation of this

final rule underscores the Commission’s

views on the importance of emergency

preparedness, including consideration

of the use of KI. The Commission has

decided to fund State and, in some

cases, local stockpiles of KI, subject to

certain restrictions and limitations (see

Staff Requirements Memorandum for

the Affirmation Session on December

22, 2000). The Commission believes that

in light of logistical difficulties, it is

doubtful that regional stockpiles of KI

could be effectively employed in the

unlikely event of a radiological

emergency at a commercial nuclear

power plant. The Commission’s offer to

fund the purchase of a supply of KI for

a State choosing to use KI prophylaxis

as a supplemental protective measure

retains the FRPCC’s proposal that the

State remain responsible for all other

funding connected with the

incorporation of KI, such as preparing

guidelines for its stockpiling,

maintenance, distribution and use, and

for all other ancillary costs.

The Commission agrees that, in the

past, licensees may have found it in

their own self interest to assist State and

local governments by providing

resources for emergency planning

needs. The Commission expects that

those States who decide to use KI for the

general public will make suitable

arrangements to fund costs other than

the initial purchase of a supply of KI.

After funding the initial purchases of KI,

the Commission may consider

extending the program to fund stockpile

replenishment, but has made no

commitments in this regard. As with

other aspects of offsite emergency

planning, the NRC will not require

licensees to fund State activities, but the

States can, of course, act in cooperation

and coordination with licensees.

As to the issues whether the rule

constitutes an ‘‘unfunded State

mandate’’ or is contrary to an Executive

Order of August 5, 1999, the Nuclear

Regulatory Commission, as an

independent regulatory agency, is not

subject to the requirements of Title II of

the Unfunded Mandates Reform Act of

1995 or Executive Order 13132,

‘‘Federalism,’’ August 5, 1999.

Issue G: Whether This Rulemaking Is a

Backfit

A commenter representing nuclear

utilities raised a concern that if

licensees would be required to expend

significant resources in considering the

use of KI in emergency plans, then the

proposed rule is clearly a backfit and a

backfitting analysis should be

performed. Thus, the commenter

requested that the NRC either limit the

specific actions which would be

required to be taken by licensees to

demonstrate that the adequate

consideration required by the proposed

rule has been implemented, or the

required backfitting analysis should be

conducted and a suitably revised

proposed rule should be published for

comment.

Response. This notice contains a

‘‘Backfit Analysis’’ section, which notes

that the Commission concludes that the

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 responsibility 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. The final rule

imposes no binding requirement for

State or local governments to alter

emergency 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 § 50.47(b)(10). Once again, the

rule does not impose new requirements

on nuclear power plant licensees who

are the intended beneficiaries of the

Backfit Rule provisions. Therefore, no

backfit is involved.

Issue H: State Liabilities in Providing KI

for the General Public

State and local government

organizations raised concerns about

legal implications should a member of

the general public be given KI at their

directive or recommendation and the

individual has an extreme allergic

reaction. Commenters note that the

Federal Register notice does not address

legal issues for States who decide to

adopt KI and for States who do not

decide to adopt or administer KI to the

public. Further, if the NRC decides to

require stockpiling of KI for the general

public, the commenters ask whether

NRC has considered what liability may

arise from any adverse health effects.

Another concern was about who would

assume liability if the KI was used prior

to a Governor ordering its use.

Response. These 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. As

stated in the proposed rule FR notice,

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 as a result of

promulgation of this rule. To the extent

that commenters are raising the

potential for Federal government

liability for the promulgation of this

proposed rule, the proposed rule FRN

notes NRC views 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

2671, et seq., which protects the Federal

Government from liability. The

Commission’s offer to fund State

stockpiles would similarly be subject to

the ‘‘discretionary function’’ exception.

The Commission has directed the staff

to ensure that NRC funding for KI is

accompanied by appropriate disclaimers

to ensure that the NRC and any of its

employees are not to be held

responsible for any activity connected

with transporting, storing, distributing,

administering, using, or determining

proper doses of KI for adults and

children.

Issue I: FDA Input on KI

A few commenters thought that the

dosage and intervention levels should

be lowered from the values in the

existing FDA guidance. For instance,

they conclude that NRC should require

using KI prophylaxis at one rem

projected dose exposure not at the

5434 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

current 25 rem. It was noted that Poland

uses a 5 rem intervention level. The

concern of these commenters is that

continued use of the old guidance

subjects children to greater risk than

necessary.

Response. The FDA is the Federal

agency responsible for decisions about

appropriate thresholds and dosages for

use of KI. Existing FDA guidance related

to the use of KI on dosage intervention

levels is contained in a June 29, 1982

notice (47 FR 28158). As stated therein,

‘‘FDA concludes in the final

recommendations that risks from the

short-term use of relatively low doses of

potassium iodide for thyroid blocking in

a radiation emergency are outweighed

by the risks of radioiodine-induced

thyroid nodules or cancer at a projected

dose to the thyroid gland of 25 rem.’’

That notice also provides recommended

dosages for adults and children. New

FDA guidance was published in the

Federal Register for public comment on

January 4, 2001 (66 FR 801). The

Commission will incorporate it into its

guidance documents.

Issue J: Original Petition Versus Revised

Petition

A few commenters state that in the

proposed rule, the Commission claims

to have granted the alternative

submitted in the amended petition, but

did not actually do so. In their view, the

amended petition contained the

combination of three elements— the

requirement to consider KI stockpiling,

the unequivocal recommendation that

States establish stockpiles, and the offer

of Federally-funded State stockpiles.

Since the promise of funding removed

a major impediment to States adopting

a pro-KI policy, the commenters believe

that the petitioner felt that amending his

petition to require only ‘‘consideration’’

of the use of KI would likely result in

State decisions favorable to using KI. In

their view, the amended PRM was

premised on the now-withdrawn NRC

offer of Federally-funded State

stockpiles of KI, and therefore it would

be entirely appropriate for the petitioner

to rescind his amendment to PRM 50–

63 and to insist that the NRC adopt what

was requested in his original petition.

Response. The Commission agrees

with this comment. Since the

Commission has decided to reinstate its

offer to fund a supply of KI for State or,

in some cases, local governments that

choose to incorporate KI prophylaxis in

their emergency plans, the Commission

believes that it is granting the amended

petition (PRM–50–63A) in all respects.

Issue K: Meaning of ‘‘Consideration’’

Several commenters stated that the

proposed rule is vague in that it did not

define ‘‘consideration.’’ They believe

that the rule should clarify that the KI

‘‘consideration’’ within the context of

radiological emergency planning and

preparedness needs to be performed

only once by the responsible State

agency, which would provide written

notice of the consideration to the

Commission. Thereafter, no further

‘‘consideration’’ should be required

unless the State determines there is

reason to reconsider its position and

that the ‘‘consideration’’ process is not

subject to continuing oversight or

recurring evaluation by the NRC, or any

other federal agency.

Another commenter questioned

whether a State that considered the

issue in the early 1980s, and rejected the

use of KI, could now claim that the

Commission’s current proposal has

already been fulfilled. Reliance upon

the earlier consideration would violate

the intent of the petitioner’s proposal.

Another commenter questioned

whether the following scenario would

be considered acceptable and in

compliance with the rule: a State

considered the use of KI, but found the

licensee unwilling to pay for it, so the

State decided that although use of KI

might be a good idea, it couldn’t afford

it.

Response. The Commission would

expect that a State’s ‘‘consideration’’

would involve at least an internal

review of this notice and brief

deliberation on the State’s position on

the use of KI by the general public. In

NRC’s experience, States periodically

review their emergency plans and

preparedness, typically on an exercise

frequency basis, to ensure that plans are

up to date and account for local changed

circumstances. For those States that

conduct such periodic reviews, the

Commission would expect the States to

undertake their ‘‘consideration’’ of the

use of KI during the first periodic

review conducted by the State of offsite

emergency plans and preparedness

following the effective date of this rule

amendment and issuance of revised

NUREG–1633 guidance. For those States

that do not routinely conduct periodic

reviews, the Commission would expect

the States to undertake their

‘‘consideration’’ of the use of KI on the

same frequency as periodic emergency

preparedness exercises following the

effective date of this rule amendment

and issuance of guidance. The rule does

not require States to provide written

notice of their ‘‘consideration.’’ The

Commission expects that States will

inform FEMA and the NRC of the results

of their consideration.

Additionally, the Commission agrees

that the ‘‘consideration’’ process is not

subject to continuing oversight or

recurring evaluation by the NRC or any

other Federal agency.

By issuing this rule, the Commission

is stating its conclusion that

consideration of the use of KI that might

have been performed many years ago,

needs to be reexamined in light of new

information. Thus reliance upon such

earlier evaluations would not be

consistent with the rule requirement.

Issue L: Federal Distribution of KI

One commenter noted that the

Commission’s proposed rule would

seem to support the same techniques

used for forced KI distribution that were

dictated by governments in Eastern

Europe during the Chernobyl accident.

The commenter urged the Commission

to consider whether this posture would

be endorsed by any government, be it

Federal, State, or local. This commenter

believes the NRC staff ignores the

testimony of those States where KI is

stockpiled or pre-distributed for the

public and where experience shows the

system is ineffective. Additionally, a

commenter thought that the proposed

rule is predicated on the false

assumption that even if States decide

not to stockpile KI for the general

public, they will have access to Federal

reserves of the drug. By the

Commission’s own admission, such

reserves have yet to be established nor

has the funding mechanism to support

such reserves been identified. The

proposal suggests that states ‘‘consider’’

the availability of resources that do not

exist.

Likewise, a commenter stated that the

proposed rule implies that even when a

State decides as a matter of public

policy against distribution of KI for the

general population, the Federal

government will develop plans to

override that decision. The purpose of

such plans is unclear in the context of

the proposed rule. Once a State has

given due consideration to the use of KI

stockpiling as a supplemental protective

action and determined it to be

unwarranted, the commenter seeks the

basis on which the Commission

proposes to develop a contingency plan.

Response. The Commission has never

endorsed ‘‘forced KI distribution.’’

Under this final rule the use of KI

continues to be a State option.

Moreover, revised NUREG–1633 will

discuss the benefits and risks associated

with using KI and the U.S. and foreign

experience with public distribution.

While the Commission has always

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5435

4Comment letter from the Massachusetts

Coalition To Stockpile KI dated September 10,

1999.

recognized that distribution at the time

of an accident will present difficulties if

there has been no advance planning, the

Commission believes that the States will

take the distribution matters into

account when they consider the use of

KI for the general public under this rule.

The Commission has decided to

withdraw its decision to provide

funding for regional Federal KI

stockpiles. However, it should be noted

that Commission efforts in this regard

were not intended to ‘‘override’’ a State

decision not to use KI during an

emergency; rather, they were intended

to make KI available in the event that a

particular State changed its views and

decided to use KI in an actual

emergency, and had nowhere else to go

for KI. The Commission believes that in

light of logistical difficulties, it is

doubtful that regional stockpiles of KI

could be effectively employed in the

unlikely event of a radiological

emergency at a commercial nuclear

power plant.

Issue M: Importance of Emergency

Planning

A few commenters feel that safe siting

and Design-Engineered features alone

do not optimize protection of the

public-health and safety and that the

Commission should not rely upon

probabilistic risk assessments to obviate

the need for stockpiling and

predistribution of KI. Another

commenter is concerned that the

premature aging of reactor components,

the economics of utility restructuring,

and the long-term storage of high-level

waste at reactor sites all contribute to

the need for KI stockpiling.

Response: The Commission agrees

with the importance of emergency

planning to complement site and design

features and stated so in the August 19,

1980, Federal Register Notice (45 FR

55402) which codified the NRC’s

emergency planning regulations

following the Three Mile Island

accident: ‘‘The Commission’s final rules

are based on the significance of

adequate emergency planning and

preparedness to ensure adequate

protection of the public health and

safety. It is clear * * * that onsite and

offsite emergency preparedness as well

as proper siting and engineered design

features are needed to protect the health

and safety of the public. As the

Commission reacted to the accident at

Three Mile Island, it became clear that

the protection provided by siting and

engineered design features must be

bolstered by the ability to take

protective measures during the course of

an accident.’’

The Commission did not rely upon

probabilistic risk assessments in

developing this final regulation on

consideration of the use of KI.

The Commission interprets the third

comment to relate to factors that the

commenter believes could increase the

likelihood of an accident and which, in

the commenter’s view, heighten the

importance of emergency planning. The

Commission’s regulations recognize the

importance of emergency planning by

requiring development of a range of

protective actions, which include

sheltering and evacuation and, by this

rulemaking, consideration of the use of

KI for the general public.

Issue N: Cost of KI and Shelf-Life

One commenter feels that the NRC

has exaggerated the estimated cost of KI,

ignoring comments that point to the

availability of inexpensive and longlasting KI. This commenter thinks that

market forces are likely to bring down

the cost of KI and that savings in the

NRC budget could be effected without

diminishing the safety of America’s

children.

The U.S. Pharmacopeia wrote in its

comment letter that the long-term

viability of the drug was tested and it

was found that 11 years after

manufacture and eight years after the

expiration date, the tablets were assayed

at 99.1% of the labeled content of KI.

The petitioner expressed the view that

since the U.S. is currently engaged in a

$15 million study of radiation-caused

thyroid disease in the Ukraine, it was

hard to understand why the government

was not willing to spend a fraction of

that amount to prevent radiation caused

thyroid disease at home.

Response. Cost estimates used in past

documents were based upon

information available at those times.

NRC presently estimates the cost of KI

to be about 18 to 20 cents per tablet if

purchased in bulk, with a shelf life of

7 to 10 years. As a result, the

Commission finds that KI is a

reasonable, prudent and inexpensive

supplement to evacuation and

sheltering for the general public for

specific local conditions.

As noted earlier, the Commission has

decided to offer to provide funding for

a supply of KI for State or, in some

cases, local governments that choose to

incorporate KI prophylaxis in their

emergency plans.

Issue O: Safety of KI

Commenters believe that there is new

information available from Poland and

Belarus regarding use of KI following a

radioactive release. They state that there

were no reported serious adverse

reactions. Specifically, 18 million

individuals received prophylactic KI

with overall toxicity of 2.5% (mostly

nausea) but with only a fraction of 1%

having serious side-effects.4

Commenters state that this experience

has been recognized by other countries

who are stockpiling KI for use by the

general public. This data has led some

commenters to say that 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. 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 KI seems relatively

minimal, and people absolutely should

have the choice of making an informed

decision and assuming possible risk.

Response. The Commission did

consider the experience with mass

distribution of KI during the Chernobyl

radiological emergency (although the

record on that distribution is not

complete). That experience is still being

investigated and evaluated by public

health authorities worldwide. When the

appropriate health agencies have

established the applicability of the

Polish experience to the United States,

the findings will be followed in NRC

guidance. The NRC acknowledges that

KI is a reasonable, prudent, and

inexpensive supplement to evacuation

and sheltering for specific local

conditions. The Commission guidance

on emergency planning has long taken

KI into consideration (see NUREG–

0654/FEMA–REP–1, ‘‘Criteria for

Preparation and Evaluation of

Radiological Emergency Response Plans

and Preparedness in Support of Nuclear

Power Plants,’’ Rev. 1, p. 63, items e and

f). The FDA has approved KI as an overthe-counter medication and has found it

effective and safe as discussed in the

response to issue I.

Commission Decision on the Petitions

for Rulemaking

Based on the foregoing, and as noted

herein, the action by the Commission to

approve this final rule grants in part and

denies in part the original petition (PRM

50–63) and grants in all respects the

amended petition (PRM 50–63A). The

rule change, which requires

‘‘consideration’’ of the use of KI, is

responsive to the amended petition.

Further, including in this Federal

Register notice for the final rule, a

5436 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

statement that ‘‘KI is a reasonable,

prudent, inexpensive supplement to

evacuation and sheltering for specific

local conditions,’’ is also responsive to

both petitions. This statement does not

use the petitioner’s exact language but is

responsive to the petitioner’s request.

The Commission’s final position on

funding of State stockpiles grants that

part of the original and amended

petition to include a statement of such

support in the Statement of

Considerations for the rule. However,

the final rulemaking would deny that

part of the original petition requesting

that the Commission amend 10 CFR

50.47(b)(10) to require that the range of

protective actions developed for the

plume exposure pathway EPZ include

sheltering, evacuation, and the

prophylactic use of iodine.

The Commission has found that ‘‘[I]n

developing the range of actions for

severe accidents at nuclear power

plants, evacuation and sheltering

provide adequate protection for the

general public.’’ (Proposed Rule, 64 FR

at 31745). In addition, the Commission

notes that issues surrounding the

prophylactic use of KI following such

accidents do not lend themselves to

across-the-board solutions. Therefore,

the Commission has chosen to leave

such decisions to State and local

emergency response planners to

determine whether their emergency

plans should include the use of KI as a

supplementary protective measure for

the general public. The Commission’s

decision is implemented through this

final rule that changes 10 CFR

50.47(b)(10). This final rule completes

NRC action on PRM 50–63 and PRM 50–

63A.

Rationale for the Commission Decision

The Commission has considered the

KI policy question on numerous

occasions since 1984. The history of the

Commission deliberations 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

agrees that its historical difficulty in

reaching 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.

After 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 amend 10

CFR 50.47(b)(10), by adding a sentence

similar to the one suggested in the

revised petition. Specifically the

following sentence is inserted in

§ 50.47(b)(10), 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.’’

The Commission finds that KI is a

reasonable, prudent and inexpensive

supplement to evacuation and

sheltering for specific local conditions.

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

an international 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 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 is

reasonable to take a further small step

and, continuing to recognize the

important role of the States and local

governments in matters of offsite

emergency planning, explicitly require

that planners consider the use of KI.

The amendment 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 significantly improved since

the current emergency planning

requirements were put in place after the

Three Mile Island-2 accident in 1979.

The use of KI is intended to

supplement, not to replace, other

protective measures. This amendment

does not change 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. The

Commission recognizes that there may

be situations when evacuation is not

feasible or is delayed. In-place

sheltering is an effective protective

action in such a situation. Depending on

the circumstances, KI may offer

additional protection to one radiationsensitive organ, the thyroid, if used in

conjunction with evacuation and

sheltering. 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. In appropriate

circumstances, KI can provide

additional protection. In addition, the

Commission notes that issues

surrounding the prophylactic use of KI

following such accidents do not lend

themselves to across-the-board

solutions. Therefore, the Commission

has chosen to leave such decisions to

State and local emergency response

planners, who may find that KI should

be a supplementary protective measure.

The NRC recognizes that any decision

to use KI as a supplemental protective

measure for the general public presents

issues of how best to position and

distribute the medicine, to ensure: (1)

That optimal distribution takes place in

an emergency, with first priority given

to protecting children; (2) that persons

with known allergies to iodine not take

it; and (3) that members of the public

understand that KI is not a substitute for

measures that protect the whole body.

To date, these issues have been

addressed in different ways in the

numerous countries that currently use

KI as a protective measure for their

citizens. The NRC is working with

States and other Federal agencies to

develop guidance on these and other

issues 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.

Commission Decision on Funding of

State Stockpiles or Supplies of KI

The Federal Register notice for the

proposed rule (64 FR 31737) stated the

Commission’s then-held position only

to support funding of regional stockpiles

or other supplies of KI as opposed to

funding of State stockpiling of KI. As

described above, in its deliberations on

this final rule, the Commission has

withdrawn its support for funding of

regional KI stockpiles and has reinstated

its offer to provide NRC funding of State

or, in some cases, local stockpiles,

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5437

subject to various restrictions and

limitations (see Staff Requirements

Memorandum for the Affirmation

Session on December 22, 2000).

In doing this, the Commission has

responded to comments from FEMA and

other commenters. The Commission is

supporting the 1996 FRPCC’s Ad Hoc

Subcommittee on Potassium Iodide

recommendation that the Federal

government (NRC through FEMA)

should fund the purchase of State, or in

some cases local, KI stockpiles. The

Commission recognizes that this policy

contradicts the Commission’s historical

policy that funding for State and local

emergency planning is the

responsibility of those governments

often working with licensees. The

Commission is making this exception to

the long-standing policy on the basis of

the FRPCC’s recommendation and

recent petitions received. The

Commission has determined that for a

State that has decided to stockpile KI,

NRC funding for purchase of KI for use

by that State during a radiological

emergency would directly contribute to

fulfilling NRC’s regulatory mission. The

Commission also recognizes that any

State choosing to incorporate KI

prophylaxis as a supplemental

protective action in its emergency

planning will face costs, other than the

cost of the purchase of KI. Consistent

with the long-standing policy, these

ancillary costs will remain the

responsibility of the State government.

Depending on how the State

incorporates KI prophylaxis in its

emergency plans, the ancillary costs

could significantly exceed the cost of

the purchase of the KI supply.

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.

National Technology Transfer and

Advancement Act

The National Technology Transfer

and Advancement Act of 1995, Pub. L.

104–113, requires that Federal agencies

use technical standards developed or

adopted by voluntary consensus

standards bodies unless the use of such

a standard is inconsistent with

applicable law or otherwise impractical.

In this final rule, the NRC is amending

its emergency planning regulations to

require that consideration be given to

including potassium iodide as a

protective measure for the general

public that would supplement

sheltering and evacuation in the event

of a severe reactor accident. This action

does not constitute the establishment of

a consensus standard that contains

generally applicable requirements to

which the provisions of the Act apply.

Environmental Assessment and Finding

of No Significant Impact for Completing

Action on the Petitions for Rulemaking

Relating to the Use of Potassium Iodide

(KI) for the General Public

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 NRC 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, that 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 NRC staff’s

recommendation in SECY–98–061 dated

March 31, 1998, ‘‘Staff Options for

Resolving a Petition for Rulemaking

(PRM 50–63 and 50–63A) Relating to a

Re-evaluation of the Policy Regarding

the use of Potassium Iodide (KI) by the

General Public after a Severe Accident

at a Nuclear Power Plant,’’ to deny the

revised petition for rulemaking (PRM

50–63A) and directed the NRC staff to

grant the petition by revising 10 CFR

50.47 (b)(10). This final rule responds to

this directive.

Alternatives were essentially

considered in previous documents. In

SECY–97–124 (June 16, 1997),

‘‘Proposed Federal Policy Regarding Use

of Potassium Iodide after a Severe

Accident at a Nuclear Power Plant,’’ the

NRC 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.

On April 22, 1999, the Commission

voted to approve publication in the

Federal Register of a proposed rule that

would grant the revised petition for

rulemaking (PRM 50–63A). The

proposed rule was published on June

14, 1999 (64 FR 31737). In the

petitioner’s comment letter on the

proposed rule, he stated that in light of

the Commission decision not to fund

State stockpiles of KI, the Commission

should consider his original petition

(PRM 50–63) to be incorporated by

reference and resubmitted in his

comment letter. He also requested the

Commission to grant the petition as

originally submitted. The Commission,

by undertaking this final rulemaking, is

denying in part the original petition for

rulemaking (PRM 50–63), which would

require the use of KI for the general

public. In so doing, the Commission has

decided to continue to recognize the

important role of the State by explicitly

requiring that planners consider (PRM

50–63A) the use of KI for the general

public. The Commission is granting in

all respects the amended petition,

including reinstating its support for

funding State stockpiles of KI.

II. Need for Action

In SECY–97–245, the NRC staff

proposed options for resolving the

original petition for rulemaking. In an

SRM on SECY–98–061, the Commission

directed the NRC staff to proceed with

the rulemaking. In so doing, the

Commission found that KI is a

reasonable, prudent, and inexpensive

supplement to evacuation and

sheltering for specific local conditions.

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

an international radiological emergency.

Although the record on that distribution

is not complete, the indications thus far

are that mass distribution is effective in

5438 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

preventing thyroid cancer and causes

few threatening side effects. Therefore,

in order to achieve greater assurance

that KI will receive due attention by

planners, it seems reasonable, while

continuing to recognize the important

role of the States in matters of offsite

emergency planning, to explicitly

require that planners consider the use of

KI. The rule is needed to ensure that the

States are aware of and take into

consideration the costs, risks, and

benefits of KI in their decision making

process in order to optimize emergency

planning for the public health and

safety.

III. Environmental Impact of the Final

Action

The environmental impacts of the

final action and its alternative (deny the

petitions in their entirety and take no

action) are considered negligible by the

NRC staff, given that the final 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 NRC staff is

not aware of any environmental impacts

as a result of this final action.

IV. Alternative to the Final Action

The alternative to the final 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 NRC staff is

not aware of any resulting

environmental impact.

V. Agencies and Persons Consulted

Cognizant personnel from the States,

FEMA, and FDA were consulted, as was

the petitioner, as part of this rulemaking

activity.

VI. Finding of No Significant

Environmental 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

significantly affecting the quality of

human environment and; therefore, an

environmental impact statement is not

required. This amendment will require

that consideration be given to

evacuation, sheltering, and as a

supplement to these, the prophylactic

use of KI. This action will not have a

significant impact upon the

environment.

Paperwork Reduction Act Statement

This final 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 (OMB) approval numbers

3150–0009 and 3150–0011.

Public Protection Notification

If a means used to impose 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 Final

Rulemaking Completing Action on

Petitions for Rulemaking (PRM 50–63)

and (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 NRC staff provided three

options for the Commission’s

consideration 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:

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.’’

In the petitioner’s comment letter on

the proposed rule, he stated that in light

of the Commission decision not to fund

State stockpiles of KI, the Commission

should consider his original petition

(PRM 50–63) to be incorporated by

reference and resubmitted in his

comment letter. He also requested the

Commission to grant the petition as

originally submitted. The Commission,

by undertaking this rulemaking, is

granting the amended petition and is

granting in part and denying in part the

original petition. The Commission is

denying that portion of the original

petition for rulemaking (PRM 50–63),

which would require the use of KI for

the general public. In so doing, the

Commission has decided to continue to

recognize the important role of the State

in matters of emergency planning by

explicitly requiring that planners

consider (PRM 50–63A) the use of KI for

the general public.

In SECY–97–245, the NRC staff

proposed options for resolving the

original petition for rulemaking. By

SRM dated June 26, 1998, on SECY–97–

245, ‘‘Staff Options for Resolving a

Petition for Rulemaking (PRM 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,’’ the Commission directed

the NRC staff to revise 10 CFR

50.47(b)(10). This final rule responds to

this directive.

Alternatives were essentially

considered in previous documents. In

SECY–97–124 dated June 16, 1997,

‘‘Proposed Federal Policy Regarding Use

of Potassium Iodide after a Severe

Accident at a Nuclear Power Plant,’’ the

NRC 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. Given that the

Commission considered the options and

directed the NRC staff to grant the

amended petition, the only alternatives

considered here are the Commissionapproved option and the baseline, noaction alternative.

The final rule does not ‘‘require’’ any

action of licensees. States are to

‘‘consider’’ the use of KI along with

evacuation and sheltering as protective

actions. It is estimated that no more

than 30 States will need to make this

consideration. The rule does not impose

any substantive requirements on States

to actually stockpile or plan for the use

of KI. Therefore, States would not

accrue the costs associated with such

actions. However, the Commission

recognizes that consideration of using

KI as a supplemental protective measure

may result in some State expenditures.

The NRC staff estimates that the labor

needed by the States could range from

a staff-week, to half of a staff-year. The

latter would be the case if a State

decided to hold hearings on the issue.

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 5439

If one assumes an average hourly salary

of $70 (this estimate includes benefits,

prorated secretarial and managerial

assistance, but not overhead), the range

of estimates would be from $2800 to

$63,000 per State. Using a base of 30

States, the range of impacts for the

States to make the KI consideration 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

addresses the use of radioprotective

drugs 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

by States and licensees and by the

Federal agencies for evaluating

emergency plans. As a result, it is

believed that all of the 30 affected States

have at some point considered the use

of KI. A few of the 30 affected States

have made the decision to stockpile KI.

Thus, in practical terms, the projected

costs will occur only in those States that

have not previously 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 use KI for the

general public. However, we believe the

benefit of such an action by the States

is summed up by the petitioner who

stated that the decision to use KI for the

general public should turn on whether,

given the 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 catastrophiccoverage 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.’’

Nonetheless, the Commission notes

that this rule will introduce another

element in the context of emergency

planning requirements for which

licensees are ultimately responsible.

Licensees have the obligation to confirm

that offsite authorities have considered

the use of KI as a supplemental

protective action for the general public.

While this ultimate responsibility could

have practical implications, with some

associated burdens, the extent is

considered minimal when viewed in the

overall licensee burden of complying

with all of the existing emergency

planning requirements.

Additionally, the rule does not

articulate any implementation date or

inspection criteria.

As stated above, this analysis focuses

on the rule being codified as the result

of petitions for rulemaking and on the

Commission direction to grant the

amended petition in all respects and to

grant in part the original petition.

This 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 will not have a significant

economic impact on a substantial

number of small entities. This final rule

would affect only States and indirectly

licensees of nuclear power plants. These

States and 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).

Compatibility of Agreement State

Regulations

Under the ‘‘Policy Statement on

Adequacy and Compatibility of

Agreement State Programs’’ that was

approved by the Commission on June

30, 1997, and published in the Federal

Register on September 3, 1997 (62 FR

46517), Part 50 is classified as

compatibility Category ‘‘NRC.’’ The NRC

program elements in this category are

those that relate directly to areas of

regulation reserved to the NRC by the

Atomic Energy Act or provisions of Title

10 of the Code of Federal Regulations.

Plain Language

The President’s Memorandum dated

June 1, 1998, entitled ‘‘Plain Language

in Government Writing,’’ directed that

the government’s writing be in plain

language. This memorandum was

published June 10, 1998 (63 FR 31883).

In complying with this directive,

editorial changes have been made in the

final revisions to improve the

organization and readability of the

existing language of the paragraphs

being revised. These types of changes

are not discussed further in this notice.

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 § 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 applicable to 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 final rule imposes no new

requirements on licensees, nor does it

alter procedures at nuclear facilities.

Rather, it is directed to State or local

governments, the entities with the

important role to determine the

appropriateness of the use of KI for their

citizens, calling on these governments to

5440 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

‘‘consider’’ KI as one of the elements of

their offsite emergency planning.

However, the rule imposes no binding

requirement to alter plans and

procedures on State or local

governments. 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 § 50.47(b)(10).

On this basis, the final rule does not

impose new substantive requirements

on anyone. After consideration of these

factors, no backfit is involved and no

backfit analysis as defined in § 50.109 is

required.

Commission precedent also makes

clear that the amendment 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; November 3, 1987). The

Commission’s final 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 42084). Likewise, when the

Commission altered its emergency

planning requirements in 1987 to

change the timing 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 final 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 final 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 is

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 final rule itself does not impose any

requirement or burden on the licensee.

Accordingly, the Commission concludes

that the final rule would not impose any

backfits as defined in 10 CFR 50.109.

Nonetheless, the Commission notes

that this rule will introduce another

element in the context of the emergency

planning requirements that licensees are

ultimately responsible for, whereby

licensees have the obligation to confirm

that offsite authorities have considered

the use of KI as a supplemental

protective action for the general public.

That ultimate responsibility could have

practical implications, with some

associated burdens, the extent of which

is considered minimal when viewed in

the overall licensee burden of

complying with all of the existing

emergency planning requirements.

Small Business Regulatory Enforcement

Fairness Act

In accordance with the Small

Business Regulatory Enforcement

Fairness Act of 1996, the NRC has

determined that this action is not a

major rule and has verified this

determination with the Office of

Information and Regulatory Affairs of

OMB.

List of Subjects in 10 CFR Part 50

Antitrust, Classified information,

Criminal penalties, Fire protection,

Intergovernmental relations, Nuclear

power plants and reactors, Radiation

protection, 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, and 5 U.S.C.

552 and 553, the NRC is adopting 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 Stat.

1242, as amended 1244, 1246, (42 U.S.C.

5841, 5842, 5846).

Section 50.7 also issued under Pub. Law

95–601, sec. 10, 92 Stat. 2951, as amended

by Pub. Law 102–486, sec. 2902, 106 Stat.

3123, (42 U.S.C. 5851). Sections 50.10 also

issued under secs. 101, 185, 68 Stat. 936, 955,

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

Pub. Law 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. Law 91–190, 83 Stat.

853 (42 U.S.C. 4332). Sections 50.34 and

50.54 also issued under Pub. Law 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 § 50.47, paragraph (b)(10) is

revised to read as follows:

§ 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 9th day

of January, 2001.

For the Nuclear Regulatory Commission.

Annette Vietti-Cook,

Secretary of the Commission.

[FR Doc. 01–1156 Filed 1–18–01; 8:45 am]

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