[Federal Register Volume 66, Number 13 (Friday, January 19, 2001)]
[Rules and Regulations]
[Pages 5427-5440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1156]



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

[[Page 5427]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 50

RIN 3150-AG11


Consideration of Potassium Iodide in Emergency Plans

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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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: 
[email protected].

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, Sec. 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

[[Page 5428]]

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.
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    \1\ This 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).
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    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

[[Page 5429]]

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.
---------------------------------------------------------------------------

    \2\ Two letters that were received in response to the notice did 
not address the issues in the petition and are not discussed 
further.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ Three 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.
---------------------------------------------------------------------------

    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

[[Page 5430]]

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

[[Page 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

[[Page 5432]]

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 pre-distribution. 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

[[Page 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 Sec. 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

[[Page 5434]]

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

[[Page 5435]]

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 long-lasting 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.
---------------------------------------------------------------------------

    \4\ Comment letter from the Massachusetts Coalition To Stockpile 
KI dated September 10, 1999.
---------------------------------------------------------------------------

    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 over-the-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

[[Page 5436]]

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 
Sec. 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 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. 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,

[[Page 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

[[Page 5438]]

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

[[Page 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 catastrophic-coverage insurance policy 
offering protection for events which, while they occur only rarely, can 
have such enormous consequences that it is sensible to take special 
precautions, especially where, as here, the cost of such additional 
precautions is relatively low.''
    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 Sec. 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

[[Page 5440]]

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


Sec. 50.47  Emergency plans.

* * * * *
    (b) * * *
    (10) A range of protective actions has been developed for the plume 
exposure pathway EPZ for emergency workers and the public. In 
developing this range of actions, consideration has been given to 
evacuation, sheltering, and, as a supplement to these, the prophylactic 
use of potassium iodide (KI), as appropriate. Guidelines for the choice 
of protective actions during an emergency, consistent with Federal 
guidance, are developed and in place, and protective actions for the 
ingestion exposure pathway EPZ appropriate to the locale have been 
developed.
* * * * *

    Dated at Rockville, Maryland, this 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]
BILLING CODE 7590-01-P