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Consideration of Potassium Iodide in Emergency Plans
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 19, 2001 (Volume 66, Number 13)]
[Rules and Regulations]
[Page 5427-5440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ja01-1]
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Rules and Regulations
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[[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:
MTJ1@nrc.gov.
SUPPLEMENTARY INFORMATION: Section 50.47 of the Commission's
regulations establishes requirements for emergency plans for nuclear
power reactors to provide reasonable assurance that adequate protective
measures can and will be taken in the event of a radiological
emergency. Section 50.47(b) contains 16 planning standards, and in
particular, 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.
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\2\ Two letters that were received in response to the notice did
not address the issues in the petition and are not discussed
further.
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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.
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\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.
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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