Consideration of Potassium Iodide in Emergency Plans
[Federal Register: June 14, 1999 (Volume 64, Number 113)]
[Proposed Rules]
[Page 31737-31749]
[DOCID:fr14jn99-13]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 50
RIN 3150-AG11
Consideration of Potassium Iodide in Emergency Plans
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing an
amendment to its emergency planning regulations governing the domestic
licensing of production and utilization facilities. The proposed rule
would amend the current regulations to require that consideration shall
be given to including potassium iodide (KI), as a protective measure
for the general public that would supplement sheltering and evacuation.
KI would help prevent thyroid cancers in the unlikely event of a major
release of radioactivity from a nuclear power plant. The proposed rule
responds to petitions for rulemaking submitted by Mr. Peter G. Crane
concerning the use of KI in emergency plans.
DATES: Submit comments by September 13, 1999. Comments received after
this date will be considered if practical to do so, but only those
comments received on or before this date can be assured of
consideration.
ADDRESSES: Comments may be sent to the Secretary of the Commission,
Attention: Rulemakings and Adjudications Staff, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, or may be hand-delivered to One White
Flint North, 11555 Rockville Pike, Rockville, MD 20852, between 7:30
a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be
examined at the Commission's Public Document Room at 2120 L Street NW
(Lower Level), Washington, DC.
You may also provide comment via the NRC's interactive rulemaking
web site on the NRC home page (http://www.nrc.gov). This site provides
the availability to upload comments as files in any format that the NRC
web browser supports. For information about the interactive rulemaking
site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG@nrc.gov.
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: By undertaking this rulemaking, the
Commission, while not adopting the exact language suggested by the
petitioner, is proposing to grant a petition for rulemaking (PRM-50-
63A) submitted by Mr. Peter Crane on November 11, 1997. That petition
is a revision of a petition (PRM-50-63) that he submitted on September
9, 1995.
Considering all public comments received, the information available
in the literature, 20 years of experience gained in evaluating licensee
emergency preparedness plans, and the arguments presented by the
petitioner, the Commission has decided to grant the petition for
rulemaking and to proceed
[[Page 31738]]
with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the following
sentence, after the first sentence: ``In developing this range of
actions, consideration has been given to evacuation, sheltering, and,
as a supplement to these, the prophylactic use of potassium iodide
(KI), as appropriate.'' In addition, the preamble for this proposed
rule includes a statement to the effect that State and local decision
makers, provided with proper information, may find that the use of KI
as a protective supplement is reasonable and prudent for specific local
conditions. When the Commission amended its emergency planning
regulations on November 3, 1980, it stated that ``any direct funding of
State or local governments solely for emergency preparedness purposes
by the Federal government would come through FEMA.'' In its decision on
June 30, 1997, the Commission also noted that, the Federal government
(most likely the NRC) is prepared to fund the purchase of a stockpile
of KI for the States, upon request. The Commission has determined that
notwithstanding the June 30, 1997, intention that ``most likely the
NRC'' would fund the purchase of State stockpiles of KI, the NRC budget
has continued to decrease and offers little margin for the Commission
to divert resources to new initiatives. Historically, funding for State
and local emergency response planning has been the responsibility of
those governments usually working with licensees. The Commission notes
that the Petitioner has not requested the Federal funding of stockpiles
of KI. In the alternative, the NRC will work with other relevant
agencies to ensure that there are established robust, pre-positioned
regional stockpiles of KI, to be effectively and timely used by states
that have not established local stockpiles and wish to make use of the
regional stockpiles in the event of a severe nuclear power plant
accident.
On November 27, 1995 (60 FR 58256), the Nuclear Regulatory
Commission (NRC) published a Notice of Receipt of a petition for
rulemaking (PRM-50-63) filed by Mr. Peter G. Crane on his own behalf.
The petitioner requested that the NRC amend its regulations concerning
emergency planning to include a requirement that emergency planning
protective actions include the prophylactic use of potassium iodide
(KI), which the petitioner notes prevents thyroid cancer after nuclear
accidents.
On November 11, 1997, the petitioner submitted a revision to his
original petition (PRM-50-63A). The NRC published a Notice of Receipt
of the amended petition on December 17, 1997 (62 FR 66038). In the
amended petition, the petitioner requested that:
A statement [be made] clearly recommending stockpiling of KI as
a ``reasonable and prudent'' measure, and;
A proposed rule change to 10 CFR 50.47(b)(10) which would be
accomplished by inserting the following sentence after the first
sentence: ``In developing this range of actions, consideration has
been given to evacuation, sheltering, and the prophylactic use of
potassium iodide (KI), as appropriate.''
The petitioner also provided a marked-up version of the NRC staff's
proposed Federal Radiological Preparedness Coordinating Committee
(FRPCC) Federal Register notice concerning Federal policy relating to
the use of KI for the general public.
On June 26, 1998 (SRM 98-061), the Commission decided to grant the
portion of the petition for rulemaking PRM-50-63A regarding the
requested amendment to 10 CFR 50.47(b)(10). The Commission also
directed that the preamble for the proposed rule include a statement to
the effect that State and local decision makers, provided with proper
information, may find that the use of KI as a protective supplement is
reasonable and prudent for specific local conditions. The NRC staff is
also preparing a technical report and an information brochure to enable
State and local decision makers to make an informed decision in this
matter.
Petitioner's Basis for Requesting Potassium Iodide
The petitioner stated that potassium iodide (KI) protects the
thyroid gland, which is highly sensitive to radiation from the
radioactive iodine that would be released in extremely serious nuclear
accidents. By saturating the gland with iodine in a harmless form, KI
prevents any inhaled or ingested radioactive iodine from lodging in the
thyroid gland, where it could lead to thyroid cancer or other
illnesses. The petitioner stated that the drug itself has a long shelf-
life, at least 5 years, and causes negligible side effects.
The petitioner further stated that, in addition to preventing
deaths from thyroid cancer, KI prevents radiation-caused illnesses. The
petitioner notes that thyroid cancer generally means surgery, radiation
treatment, and a lifetime of medication and monitoring. The petitioner
asserted that the changes in medication that go with periodic scans put
many patients on a physiological and psychological roller coaster. The
petitioner stated that hypothyroidism can cause permanent retardation
in children and, if undiagnosed, can condemn adults to a lifetime of
fatigue, weakness, and chills.
The Petitioner's Discussion of the Three Mile Island Accident (TMI)
The petitioner noted that in December 1978, the Food and Drug
Administration (FDA) announced that it had determined that KI was safe
and effective for thyroid protection in nuclear accidents. The
petitioner stated that the issue attracted little attention, that the
NRC and the Federal Government as a whole took no public position on
the drug, and that three months after the FDA announcement, on March
28, 1979, the TMI accident began to unfold. The petitioner stated that
Federal and State officials, searching for supplies of KI in case it
should be needed, discovered that none was to be had and that a supply
had to be manufactured, literally overnight. The petitioner indicated
that at 3:00 a.m. on Saturday, March 31, 1979, an FDA official arranged
with the Mallinckrodt Chemical Company for the immediate production of
250,000 doses of KI.
The petitioner also discussed the Report of the President's
Commission on the Accident at Three Mile Island (the Kemeny Commission
report), issued in October 1979, and stated that the report was
strongly critical of the failure to stockpile KI. The petitioner noted
that among the Kemeny Commission's major recommendations was that an
adequate supply of the radiation protective agent, KI for human use,
should be available regionally for distribution to the general
population and workers affected by a radiological emergency.
The Petitioner's Discussion of the Potassium Iodide Policy
The petitioner stated that in NUREG-0632, ``NRC Views and Analysis
of the Recommendations of the President's Commission on the Accident at
TMI,'' issued in November 1979, the NRC agreed with the findings of the
Kemeny Commission and planned to require nuclear power plant licensees
to have adequate supplies of KI available for nuclear power plant
workers and the general public as part of State emergency response
plans.
According to the petitioner, the three agencies most concerned, the
FDA, the NRC, and the Federal Emergency Management Agency (FEMA),
favored the stockpiling of KI for the next several years. The
petitioner stated that the Atomic Industrial Forum, a nuclear industry
trade association, declared itself against the stockpiling of KI in May
1982.
The petitioner indicated that the NRC staff was strongly in favor
of KI
[[Page 31739]]
stockpiling as late as September 27, 1982, when the NRC staff submitted
a memorandum to the Commissioners proposing that the Commission agree
with a draft interagency policy statement supporting KI stockpiling.
The petitioner further stated that on October 15, 1982, less than 3
weeks after sending the draft policy statement to the Commission for
approval, the NRC staff sent a supplementary memorandum withdrawing the
memorandum of September 27. The later memorandum informed the
Commissioners that NRC's Office of Nuclear Regulatory Research (RES)
could, by January 1, 1983, produce a paper showing that KI was
significantly less cost-beneficial than previously assumed. The NRC
staff proposed sending this document to the FDA and FEMA with the
recommendation not to stockpile and distribute KI. The petitioner
indicated that the NRC staff briefed the Commission in November 1983 on
the NRC staff's proposal to take a strong position against KI. A policy
statement was later issued that disposed of the Kemeny Commission's
recommendation which favored stockpiling KI. According to the
petitioner, only a year later, the Chernobyl accident would give
tangible proof of the value of the drug in radiological emergencies.
The Petitioner's Discussion of the Effects of Chernobyl
The petitioner stated that during the Chernobyl accident of 1986,
the damaged reactor spewed radioactive iodine over a wide area of what
was then the Soviet Union and Poland. The petitioner further stated
that in Russia, the Ukraine, and Belarus, where the distribution of KI
was inadequate and untimely, the population in these countries is now
experiencing extraordinarily high levels of childhood thyroid cancer.
However, in Poland, where KI was administered to 97 percent of the
nation's children, there has been no similar increase in thyroid
cancer. The petitioner noted that Poland is a proof-positive example of
the benefits of a well-prepared KI program.
The petitioner stated that the U.S. Government is spending money to
study radiation-caused thyroid cancer in the Ukraine and Belarus, and
the Department of Energy (DOE) announced a $15 million, 15-year program
that will follow 70,000 children in the Ukraine, to understand the
thyroid cancer risk of exposure to radio iodine. The petitioner further
stated that the U.S. Government has spent generously to bring Ukrainian
doctors to the United States for training in thyroid surgery because
mishandled operations can result in damaged nerves and larynxes,
rendering patients permanently mute.
The petitioner discussed post-Chernobyl developments on KI policy.
He stated that the Chernobyl accident demonstrated that KI worked and
that countries that failed to stockpile and distribute it are
experiencing serious public health problems.
The Petitioner's Discussion of the NRC's Reconsideration of
Potassium Iodide
The petitioner notes that in June 1989, the NRC reconsidered the KI
issue after the petitioner filed a Differing Professional Opinion
urging a change in policy. On November 27, 1989, the American Thyroid
Association wrote to the NRC urging KI stockpiling on a nationwide
basis and, in 1990, the NRC announced that it was reconsidering the
existing Federal policy. In April 1992, a contractor under the
sponsorship of the NRC Office of Nuclear Regulatory Research issued a
report that included a revised cost-benefit analysis of the use of KI.
The petitioner described the report as concluding that stockpiling KI
continued to be not cost-effective, but that the difference between
costs and benefits was narrower than had been calculated by the NRC
staff in the early 1980s. The petitioner further indicated that, in
December 1993, an industry trade group, the Nuclear Utility Management
and Resources Council, sent a report entitled ``Review of Federal
Policy on Use of Potassium Iodide,'' to the Commission arguing against
any change in current KI policy.
The petitioner noted that, in March 1994, the NRC staff declared
its support for KI stockpiling. However, the NRC staff proposal for a
change in policy was not adopted, the Commissioners having voted 2 to 2
on the staff's proposal in May 1994. (Under Commission procedures, a
tie vote means that a proposal fails.)
The Petitioner's Discussion of Additional Support for Granting the
Petition for Rulemaking
The petitioner described a September 1994, FEMA publication
proposing a ``Federal Radiological Emergency Response Plan'' that
envisioned the use of KI during radiological emergencies. Under the
plan, the NRC would be the lead Federal agency during emergencies at
nuclear power plants and would advise State and local governments
whether or not to distribute KI (based on advice received from an
interagency panel). The States and localities would then administer the
KI, if necessary.
The petitioner also indicated that the Board of Governors of the
International Atomic Energy Agency, with U.S. Government support,
adopted new International Basic Safety Standards in 1994. The
petitioner stated that these standards represented the consensus of the
world's experts on radiation safety and the standards provide, among
other things, that intervention levels of immediate protective actions,
including sheltering, evacuation, and iodine prophylaxis, shall be
specified in emergency plans. Thus, the petitioner stated, the
international radiation protection community, like the Kemeny
Commission in 1979 and the short-lived draft Federal policy statement
of 1982, recognized that effective preparedness for radiological
emergencies means having three actions to consider [evacuation,
sheltering and iodine prophylaxis].
The Petitioner's Discussion of the Merits of the Petition for
Rulemaking
The petitioner believes the NRC should implement the recommendation
of the Kemeny Commission and that the United States should maintain the
option of using the drug KI for public thyroid protection during
nuclear accidents. The petitioner requested that the Commission
definitively review and decide on the issue rather than simply having
the NRC staff decide not to propose it to the Commission.
The petitioner stated that evacuation is not necessarily the
protective measure of choice in every emergency, and even when it is
the preferred option, it is not always feasible. The Kemeny Commission
report explained that different types of accidents, and the particular
circumstances presented, may call for different protective measures.
The petitioner notes that maintaining a KI option ensures that
responsible authorities have the option of additional protection at
their disposal.
The petitioner indicated that NRC has made it clear that a finding
of adequate emergency planning does not translate into a guarantee that
the entire affected public can be evacuated, but that evacuation is
generally feasible.
The petitioner believes that sometimes, either by choice or
necessity, authorities may decide to shelter people or tell them to
remain indoors rather than evacuate them. The petitioner points out
that it may be desirable to administer KI any time people are sheltered
or told to stay indoors, when evacuation routes would take people
through areas of radiological contamination, and when there has been a
large airborne release of radioactive iodine to the atmosphere.
The petitioner believes that the decision on stockpiling KI should
turn on whether, given the enormous
[[Page 31740]]
consequences of being without it in a major accident, the drug is a
prudent measure; not on whether it will necessarily pay for itself over
time. The petitioner further believes that KI represents a kind of
catastrophic-coverage insurance policy offering protection for events
which, while they occur only rarely, have such enormous consequences
that it is sensible to take special precautions.
The petitioner stated that the estimates of KI's cost-effectiveness
depend on estimates that are no more than informed guesses about the
probability of severe accidents and that the NRC's cost-benefit
analysis of the early 1980s was based on the assumption that a severe
accident with a major release of radioactivity could occur in this
country only once every 1 or 2 thousand years.
The petitioner believes that if it were really true that serious
accidents with a release of radioactivity were so unlikely, there would
be good reason not only to reject stockpiling of KI but also to
dispense with all emergency planning. The petitioner also stated that
if KI is not cost-effective, then the rest of nuclear emergency
planning is probably not cost-effective either.
The petitioner believes that cost-benefit analysis is a technique
that should be applied with good sense, especially where public health
measures are concerned. According to the petitioner, the cost-benefit
analysis of KI proceeded from the assumption that there was no
difference in desirability between prevention of radiation-caused
thyroid disease and cure. Thus, the only factor to be considered in
evaluating KI was the cost. The petitioner also believes that the U.S.
Government determined that instead of spending money to prevent
radiation-caused thyroid disease, society should spend its money
treating the disease if and when it occurs.
The petitioner believes that the existing policy on KI was
defective from the start because it was based, in part, on inaccurate
information provided to the NRC Commissioners. He stated that the
information provided to the NRC Commissioners seriously understated the
significance of radiation-caused thyroid disease and thereby
understated to an equal degree the value of KI.
The petitioner also believes that it was not clear that the
Commission had any idea of the real nature of post-accident thyroid
disease at the time it adopted an anti-KI position.
The petitioner stated that existing policy left the judgment on
stockpiling KI to the States. The petitioner asserts that this policy
also ensures that the States do not have an adequate basis for making
informed decisions. He believes that the Federal Government, and NRC in
particular, has failed to provide the States with sound technical
advice on the subject. The petitioner also believes that without
accurate and current information on KI--including the Chernobyl
experience and the consensus of international experts--States cannot
make an informed judgment.
The petitioner believes that no State or local official or member
of the public could imagine that in a real emergency, there would be no
KI to administer. The petitioner raised the question: If KI stockpiling
is not worthwhile, why is the administration of the drug one of the
protective measures identified in the 1994 Federal Emergency Response
Plan? He also asked why, if KI is worthwhile, as the plan implies,
something is not being done to make sure that it is available.
The petitioner believes that the Federal Government should either
change the 1985 policy and make the use of KI a viable option in a real
emergency, or it should explain why the United States has decided that
KI will not be an option.
The Petitioner's Proposed Amendment to the NRC Regulations
In the original petition (PRM-50-63) that was submitted on
September 9, 1995, the petitioner requested that 10 CFR Part 50 be
amended to include language taken from FEMA's Federal Radiological
Emergency Response Plan of September 1994, and recommended the
following revision to the regulations.
The petitioner proposed that Section 50.47(b)(10) be amended to
read as follows:
(10) A range of protective actions including sheltering,
evacuation and prophylactic use of iodine have been developed for
the plume exposure pathway EPZ [emergency planning zone] for
emergency workers and the public. Guidelines for the choice of
protective actions during an emergency, consistent with Federal
guidelines, are developed and in place, and protective actions for
the ingestion exposure pathway EPZ appropriate to the locale have
been developed.
In the revised petition (PRM-50-63A) that was submitted on November
11, 1997, the petitioner requested that 10 CFR 50.47(b) (10) be revised
to read:
(10) A range of protective action have been developed for the
plume exposure EPZ for emergency workers and the public. In
developing this range of actions, consideration has been given to
evacuation, sheltering, and the prophylactic use of potassium iodide
(KI), as appropriate. Guidelines for the choice of protective
actions during an emergency, consistent with Federal guidelines, are
developed and in place, and protective actions for the ingestion
exposure pathway EPZ appropriate to the locale have been developed.
The petitioner believes that if this revised change is adopted, the
plan will become an accurate description of emergency preparedness for
radiological emergencies; the recommendation of the Kemeny Commission
will at last be implemented; and the United States will be in
compliance with the International Basic Safety Standards.
The petitioner suggested that the NRC, either on its own or jointly
with other agencies, issue a policy statement declaring that KI
stockpiling is a reasonable and prudent measure that is necessary to
ensure that the drug will be available in the event of a major
accident. The petitioner believes that this statement would clarify
that KI can be used in conjunction with evacuation and sheltering to
maximize protection to the public.
The petitioner also believes that the policy statement would show
the willingness of the NRC to provide a stockpile of the drug to States
and localities upon request, and would support the Kemeny Commission's
recommendation to create regional stockpiles of the drug as a backup
for emergencies.
Discussion
Stockpile of Medicinal Supplies for Nuclear, Biological, and Chemical
Agents (1995)
In June 1995, the President issued Presidential Decision Directive
39 (PDD-39) on U.S. Policy on Counter Terrorism. The PDD-39 directed
Federal agencies to take a number of measures to reduce vulnerability
to terrorism, to deter and respond to such acts, and to strengthen
capabilities to prevent and manage the consequences of terrorist use of
nuclear, biological, and chemical (NBC) weapons, including weapons of
mass destruction. The PDD-39 assigned to FEMA the task of ensuring that
the Federal Response Plan (FRP) was adequate to respond to the
consequences of terrorism.
FEMA, in coordination with the Catastrophic Disaster Response Group
(CDRG) \1\, developed a draft report to the President entitled, ``An
Assessment of Federal Consequence Management
[[Page 31741]]
Capabilities for Response to Nuclear, Biological or Chemical (NBC)
Terrorism,'' dated June 12, 1996. The report recommended, among other
things, that the Federal Government purchase and stockpile thyroid
blocking agents (KI) for the general public that could be used in the
event of a nuclear terrorist event. The NRC was a member of the Core
Group which generated the recommendations and was instrumental in
adding KI to the list of medical supplies to be stockpiled nationally.
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\1\ The CDRG is the headquarters senior-level coordinating group
which addressees policy issues regarding the Federal Response Plan
(FRP). The CDRG is chaired by FEMA and comprises of representatives
of Federal departments and agencies with responsibilities under the
FRP. The NRC is represented by the Incident Response Division
Director, AEOD.
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The Core Group concluded that as the result of recent events,
significant threats over the past few years, and the increased
availability and proliferation of NBC materials, there is an increasing
concern for the potential of terrorist incidents. NBC events, the
report continued, may occur as a local event with potentially profound
national implications. In responding to these events, the first
responders must be able to provide critical resources to the victims.
These include, but are not limited to, chemical nerve antidotes,
vaccines for anthrax, and antibiotics. The Core Group identified the
need to purchase and preposition stockpiles of adequate medical
supplies at the Federal, State, and local level. While KI was not
considered as vital as chemical nerve antidotes and vaccines, the NRC
staff was successful in getting KI included with other medical supplies
for NBC events because of the unusual characteristics of these events.
Because of the special characteristics of NBC events, the Core
Group recommended a broader range of protective actions. The NRC
concurred in the findings of the report in a letter dated September 25,
1996, from the Director of NRC's Office of Analysis and Evaluation of
Operational Data to FEMA's Director. The report was subsequently
presented to the President in February 1997, and approved for
distribution in May 1997. However, FEMA recently reported that the
federal stockpiles of KI are few and stocked only for first responders
to terrorist action. As things stand now, needs of members of the
public for KI on an ad hoc basis would have to be supplied from other
sources. As stated above, the Commission intends to work with FEMA to
assure that stockpiles contain adequate supplies of KI.
FRPCC Subcommittee on KI (1996)
Along with petitioning the NRC, Mr. Crane also requested that FEMA
review his petition and reconsider the Federal policy. In early 1996,
the FRPCC convened an Ad-Hoc Subcommittee on Potassium Iodide to
request and review new information on this matter from interested
parties. The subcommittee conducted a public meeting on June 27, 1996.
The subcommittee evaluated all comments from the June 27 public meeting
and made the following recommendation regarding the Federal KI policy:
1. Without changing the Federal policy by interceding in the
State's prerogative to make its own decisions on whether to use KI,
the Federal Government (NRC, or through FEMA) should fund the
purchase of a stockpile for a State that decides to incorporate KI
as a protective measure for the general public;
2. The Subcommittee believes the language in the 1985 policy
should be softened to be more flexible and balanced. For example,
the problem many interveners observe with the Federal policy is the
italicized statement ``The Federal position with * * * potassium
iodide for use by the general public is that it should not be
required.'' It would not be as negative if the last phrase were
reworded to state ``it [potassium iodide for use by the general
public] is not required, but may be selected as a protective measure
at the option of the State or, in some cases, local governments.''
3. The subcommittee recommends that local jurisdictions that
wish to incorporate KI as a protective action for the general public
should consult with the State to determine if these arrangements are
appropriate. If local governments have the authority or secure the
approval to incorporate KI as a protective measure for the general
public, they would need to include this measure in their emergency
plans.
Analysis of Issues Raised by Public Comments
The Commission has considered the KI policy question on numerous
occasions since 1984. The voting history of the Commission shows that
reaching consensus on this policy question has been an elusive goal. An
important reason for this historical lack of consensus is that this
policy question is not a clear cut one. Individual Commissioners, past
and present, have differed in their views with respect to the relative
importance to be given to factors bearing on the KI issue. These honest
differences have led to divided Commission views on how to resolve the
policy question. The Commission is agreed that its historical
difficulty to reach consensus on the KI policy question underscores the
reality that this policy question is not a simple one, is not one that
is easily resolved and, as a result, has been the subject of protracted
deliberation.
On November 5, 1997, the Commission held a public meeting with its
staff, FEMA representatives, and the author of the 1995 rulemaking
petition to consider the petition and proposed changes to the Federal
policy on the use of KI. In part as a result of the meeting, the
petitioner amended his petition to ask for a rule that would require
that consideration would be given in the formulation of emergency plans
to the use of KI as a supplement to evacuation or sheltering, and on
June 26, 1998, the Commission granted the amended petition, and
directed the NRC staff to initiate the requested rulemaking. The
Commissioners also decided that the FRPCC Federal Register notice on
Federal KI policy should include a statement to the effect that the
State and local decision makers, provided with proper information, may
find that the use of KI as a protective supplement is reasonable and
prudent for specific local conditions. On September 30, 1998, the
Commission approved a draft Federal Register notice and directed that
it be sent to the FRPCC.
On November 27, 1995 (60 FR 58256), a Notice of Receipt of the
Petition for Rulemaking was published in the Federal Register
requesting public comment. A total of 63 comment letters were received,
of which 20 utilities, 9 State governmental agencies, 2 utility
interest organizations, 1 letter signed by 12 health physicists, 2
State universities and 1 member of the public were against the granting
of the petition for rulemaking. Those letters in favor of granting the
petition came from 5 environmental groups, 22 members of the public
(including 1 from the petitioner), and the American Thyroid
Association.
On December 17, 1997 (62 FR 66038), the Commission published a
request for public comment on the revised petition in the Federal
Register. In response to several requests, the comment period was
extended until February 17, 1998, by a Federal Register notice
published on January 21, 1998 (63 FR 3052). A total of 82 comment
letters were received, of which 13 utilities, 3 State governmental
agencies, 1 utility interest association, and 1 member of the public
were against granting the petition for rulemaking. The letters in favor
of granting the petition came from 8 public interest groups, 46 members
of the public (including 1 from the petitioner), 3 physicians, 2 U.S.
Senators, and 1 State Representative. The following issues were raised
by the public commenters with an accompanying NRC staff response:
Issue 1: Nearly all nations with nuclear power protect their
citizens by having KI readily available and the logistics of
distribution do not seen to pose any significant problems. Would
implementing a policy of using KI for the general public be so
difficult?
Staff Response: At the November 5, 1997, Commission meeting, senior
NRC
[[Page 31742]]
staff members told the Commission: ``We recognize that there are
difficulties in distribution, but they are not insurmountable. If a
decision is made by the State to do it [stockpile and/or predistribute
KI] we can figure out a way to do it.'' It is the staff's perception
that if the State decides to include KI as a supplemental protective
measure for the general public, one possible method of implementation
could be that the State could make KI readily available where other
over-the-counter drugs can be purchased. The public could be informed
of the drug's availability through the yearly emergency preparedness
information brochure that is mailed out to all residents throughout the
10 mile EPZ. It would then be up to individual members of the public to
obtain and store this supply of KI, which should then be available for
use in the event of an emergency. The administration of the KI could be
at the direction of the State Medical Officer.
Issue 2: It is ``factual that the 1986 Chernobyl accident clearly
demonstrated the benefit of having KI readily available. In Poland,
where authorities expediently administered 18 million doses of KI, 97
percent of all Polish children were protected from thyroid disease. In
contrast, there are soaring rates of childhood thyroid cancer, 200
times pre-Chernobyl levels, in the former Soviet republics of Russia,
Belarus, and the Ukraine because very little KI was administered, too
long after exposure.''
Staff Response: The Chernobyl reactor (a RBMK-1000 design) is
located in the Ukraine close to Belarus. The accident occurred at 01:23
on Saturday, 26 April 1986, when explosions destroyed the reactor core
and reactor building. The explosions sent debris from the core flying
into the air and exposed the reactor core to the atmosphere. The
heavier debris from the plume was deposited close to the site. In
general, the initial release is thought to have risen to over 1 km in
altitude, thereby resulting in much lower doses close to the site than
those expected from a ground level release. The major release lasted 10
days, during which most of the noble gases and more than 40 percent of
the iodines are estimated to have been released. The varying
meteorological conditions, release rates, and release heights resulted
in very complex dose and ground deposition patterns.
It is often assumed that ingestion was the major source of thyroid
dose early in the accident. However, the contribution of inhalation
cannot be assessed because air sampling was not effectively conducted
early in the accident. As of 1996, except for thyroid cancer, there has
been no confirmed increase in the rates of other cancers, including
leukemia, among the first responders, liquidators,\2\ or the public,
that have been attributed to release from the accident.
---------------------------------------------------------------------------
\2\ Liquidators are a large number (about 200,000) of workers
and military personnel who performed cleanup, construction of the
sarcophagus, and other operations in the contaminated zones
following the accident.
---------------------------------------------------------------------------
Belarus Experience. With the Chernobyl plant located only 4 miles
(7 km) away, Belarus was heavily impacted by the accident. This impact
was heightened by the fact that protective actions were not implemented
in Belarus during the first six days after the accident. Several
authors have stated that KI was distributed to the population in
Belarus during the first week following the accident.\3\ However, there
is no confirmed published data on the dosage, coverage, or other
details concerning the implementation of the thyroid blocking in
Belarus.\4\ In addition, cows typically grazed in Belarus at the time
of year when the accident occurred, and yet no efforts were taken to
restrict the consumption of contaminated milk for the first 10 days
following the accident.
---------------------------------------------------------------------------
\3\ Personal communication, E. Buglova M.D., Head Laboratory of
Radiation Hygiene and Risk Analysis, Ministry of Health, Republic of
Belarus, December 1997.
\4\ ``Thyroid Cancer in Children Living Near Chernobyl, Expert
Panel Report on the Consequences of the Chernobyl Accident''--
Williams D. et al., K.H. ECSL-EAEC, Report EUR 15248 EN, Brussels-
Luxembourg, 1993, p. 108.
---------------------------------------------------------------------------
On May 2 (day 7 following the accident) the decision was made to
evacuate the areas of Belarus and Ukraine within 18 miles (30 km) of
the plant (30 km zone). The evacuation was completed on May 5, 1986.
Since 1990, a rapid increase has been observed in the incidence in
thyroid cancer among Belarus children who were 0 to 14 years old at the
time of the accident. Before the accident, the rate of thyroid cancer
among this cohort was about 0.4 per 100,000; by 1996, this rate had
risen to 3.9 per 100,000.5,6 This included
approximately 3,000 children, 0 to 18 years old, that were evacuated
from the 30-km zone within Belarus. Among this group, four thyroid
cancer cases have been detected since the accident. All of these cases
were registered after the end of the latent period for radiation-
induced thyroid cancer. Taking into account the spontaneous rate of
this disease in this age group and the number of evacuated persons, all
of these cases are considered accident-induced.
---------------------------------------------------------------------------
\5\ E. Buglova et al., ``Thyroid Cancer in Belarus After the
Chernobyl Accident; Incidence, Prognosis, Risk Assessment.'' Low
Doses of Ionizing Radiation: Biological Effects and Regulator
Control, Spain, November 1997, Contributed Paper, pp. 280-284.
\6\ ''Thyroid Cancer Incidence Rate in the Republic of
Belarus.'' Okeanov A. et al., Radiation and Risk Bulletin of
National Radio-Epidemiological Registry, Obninsk., 1995, Issue 6,
pp. 236, 239.
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The total number of excess thyroid cancers in Belarus children is
currently about 750, and is estimated to reach a maximum of more than
3500 over the lifetime of this cohort.3, 4, 6 The vast majority of the
thyroid cancers were diagnosed among those living more than 50 km (31
miles) from the site.
The increase in the rate of thyroid cancers in Belarus is
concentrated among those who were youngest at the time of the accident.
Fortunately, these cancers respond favorably to early treatment; to
date, two or three of the Belarus children diagnosed with thyroid
cancer have died as a result of that disease.\6\
Poland Experience. Poland detected increased levels of airborne
radioactive contamination on the night of April 27, 1986 (day 2).
Although there was no official notification of the accident by the
USSR, it was assumed, on the basis of Tass News Agency reports, that
the increases were attributable to the accident at Chernobyl. On April
28 (day 3), the country formed a governmental commission to recommend
protective actions. Among these actions, the commission recommended
intervention levels for taking protective actions on the morning of
April 29 (day 4).7
---------------------------------------------------------------------------
\7\ The Implementation of Short-term Countermeasures After a
Nuclear Accident, Proceeding of an NEA Workshop Stockholm,'' Sweden,
1-3 June 1994, OECD 1995.
---------------------------------------------------------------------------
On April 29, Poland's Minister of Health gave orders to prepare and
distribute KI to the 11 provinces most affected. KI was to be made
available through hospitals, public health centers, schools, and
kindergartens. The country used its mass media to announce the
protective action and to appeal for volunteers to assist in the
nationwide distribution.
The Commission then instituted the following additional protective
measures: 8
\8\ Manual on Public Health Actions in Radiation Emergencies,
WHO, European Center of Environmental and Health, Rome Division,
1995.
---------------------------------------------------------------------------
Feeding of cows on pastures or with fresh fodder was
banned countrywide until May 15, 1986.
Fresh milk with radioactivity concentration above 1,000
Bq/L was banned for consumption by children and pregnant or
lactating women.
All children under the age of 4 were given powdered
milk through numerous distribution centers.
Children and pregnant or lactating women were advised
to eat a minimum of fresh leafy vegetables (until May 16, 1986).
[[Page 31743]]
The distribution of KI was initiated on April 29 (day 4) and was
virtually completed by May 2 (day 7). This included the distribution of
KI to more than 90 percent of the children under the age of 16 and
about a quarter of the adults. A total of 10.5 million doses of KI were
given to children and 7 million doses were given to adults. Multiple
doses, although not recommended, were taken in a number of cases.
Because of diminishing air contamination, the KI prophylaxis was not
repeated. In the second phase of the response, powdered milk was made
available to all children less than 4 years of age. This program
effectively started on May 3 (day 8).
It is estimated that approximately a 40-45 percent reduction in
thyroid burden was achieved by thyroid blocking and milk restrictions
in the 11 provinces treated.\7\ Had the Russian authorities given
prompt warning, the 24- or 48-hour gain in time might have improved the
effectiveness of their response.
There were no reported serious adverse reactions except for two
adults with known iodide sensitivity. About 36,000 medically
significant reactions were also reported (mostly nausea).9
Because of the low iodine concentrations in Poland it is doubtful that
epidemiological studies could detect excess cancers resulting from
intake of radio iodine.\8\
---------------------------------------------------------------------------
\9\ A ``medically significant'' reaction was one for which the
person suffering the reaction consulted a physician more than once.
Nauman and Wolff, ``Iodide Prophylaxis in Poland After the Chernobyl
Reactor Accident: Benefits and Risks,'' The American Journal of
Medicine, Vol. 94, May 1993, p. 530. About .2% of the population
that received KI had ``medically significant'' adverse reactions to
KI. Id. However, ``[i]t should be pointed out that control values
for these side effects in a population not receiving KI are not
available.'' Id. That is, it is not known what the incidence of such
reactions would be in a population under similar stress, but not
receiving KI, and thus it is not known to what extent these adverse
reactions were the result of KI.
---------------------------------------------------------------------------
International Practices--During this assessment, the NRC staff
examined the current policies and practices regarding the use of
thyroid blocking during Nuclear Power Plant accidents for a number of
countries. The NRC staff accomplished this task primarily through
personal communication with colleagues in each country. In general, the
countries either are following or intend to implement systems that are
consistent with the guidance promulgated by the World Health
Organization (WHO). Specifically, the WHO recommends predistribution of
stable iodine close to the site and stockpiles further from the site.
These stocks should be strategically stored at points such as schools,
hospitals, pharmacies, fire stations, or police stations, thereby
allowing prompt distribution. A further description of the WHO guidance
is provided below, followed by a discussion of the guidance promulgated
by IAEA and a comparison between U.S. and international practice.
World Health Organization (WHO) Guidance. The main points of the
WHO Guidelines 10, 11 regarding the use of stable
iodine are as follows:
\10\ International Basic Safety Standards for Protection Against
Ionizing Radiation and for Safety of Radiation Sources, Safety
Series No. 115, IAEA, 1996.
\11\ ``Method for the Development of Emergency Response
Preparedness for Nuclear or Radiological Accident,'' Tecdoc-953,
IAEA, July 1997.
---------------------------------------------------------------------------
Near field: Stable iodine should be available for
immediate distribution to all groups if the predicted thyroid dose
is likely to exceed national reference levels. Close to nuclear
installations iodine tablets should be stored or predistributed to
facilitate prompt utilization.
Far field: Stable iodine should be available for
distribution to pregnant women, neonates, infants, and children if
the predicted dose is likely to exceed reference levels.
Conclusion from Polish Experience. In Poland (1) Small amounts of
radioactive iodine were deposited as a result of the Chernobyl
accident, (2) no protective actions were taken for the first 2 days of
the accident, and (3) protective actions (except sheltering or
evacuation) were taken after the first 2 days of the accident. Because
of the low iodine concentrations in Poland and the protective actions
implemented, Poland has not detected excess cancers resulting from
intake of radio iodines.
Overall Chernobyl Conclusion. The World Health Organization, almost
every industrial country in the world with nuclear power plants, and
the American Thyroid Association, believe that the low iodine
concentrations, the banning of the consumption of fresh milk and the
distribution and administration of 90 million doses of KI contributed
to the observed lack of increase of childhood thyroid cancers in
Poland. Most industrial nations with nuclear power plants have decided
to stockpile KI around nuclear power for use by the general public.
In contrast to the Chernobyl experience, in the event of an
accident in the United States, our emergency planning calls for
protective actions, sheltering, evacuation, and removal of contaminated
food from consumption all of which significantly reduce the risk of
exposure of the public to all radionuclides. Making KI available to the
public for use during evacuation or especially sheltering could, under
certain conditions, reduce the risk resulting from exposure to one
important group of radionuclides, the radioiodines. That is why current
NRC guidance discusses KI for plant personnel, emergency workers, and
institutionalized persons unlikely to be evacuated promptly.
In this light the Commission agrees that the use of KI may be
determined by State and local emergency response planners to be a
supplementary protective measure.
Issue 3: ``Stockpiling or predistribution of potassium iodide (KI)
as a protective action would not add any significant public health and
safety benefit to the current level of protection provided by existing
emergency plans for commercial nuclear power plants. Our emergency
plans focus on evacuation as the key protective action to prevent
exposure since it protects against exposure to all radionuclides, not
just iodine. In addition, the potential for misadministration of KI is
present when predistributed to the general public, and incidents of
misadministration have been informally reported at industry meetings by
states which predistributed KI to the public.''
Staff Response: The Commission agrees that it is the State's
prerogative to decide to include stockpiling or predistribution of KI
as a protective action for the general public. The FDA concluded that
risks from short term use of relatively low doses of KI are out weighed
by the radiologically induced thyroid nodules or cancers at a projected
dose to the thyroid gland of 25 rem or greater. In so doing, the FDA
approved KI as an over-the-counter drug. The American Thyroid
Association fully endorses the use of KI and, as previously discussed,
there were only 2 significant adverse reactions and 36,000 medically
significant reactions (nausea) in 90 million doses of KI after the
Chernobyl accident. The taking of KI should require precautions similar
to those associated with any other over-the counter drug, and, of
course, the packaging instructions should be followed.
Issue 4: ``Evacuation is more feasible and practicable. Stockpiling
of KI has logistical problems which we feel renders this idea
impracticable and unmanageable.''
Staff Response: The staff agrees that evacuation is usually
``feasible and practicable'' and is the most effective protective
action. If the State decides to include KI as a supplemental protective
measure for the general public, one possible method of implementation
could be that the State could make KI readily available such as by
making it available where other over-the-counter
[[Page 31744]]
drugs can be purchased. The public could be informed of the drug's
availability through the yearly emergency preparedness information
brochure that is mailed out to all residents throughout the 10 mile
EPZ. Individual members of the public would be responsible for
obtaining and storing this supply of KI, which could then be available
for use in the event of an emergency. Another approach to
predistribution is to include stockpiling at reception centers for
distribution during an evacuation. Other countries have found ways to
effectively distribute KI when needed and the distribution issue is
certainly not unsurmountable. The administration of the KI should be at
the direction of the State Medical Officer.
Issue 5: The Three Mile Island experience has shown us that it is
not easy to obtain an adequate supply of KI in an emergency.
Staff Response: The commenter is correct, in that it was difficult
to obtain KI after the Three Mile Island accident. That is one reason
why the Commission believes that planners should consider stockpiling
KI, and why the Commission supports Federal stockpiles, so that States
that have chosen not to stockpile KI could have access, albeit ad hoc
and delayed, to an adequate supply in a radiological emergency at a
nuclear power plant. As noted elsewhere in this notice, the Commission
will work with other agencies to assure that there are Federal regional
stockpiles that contain adequate supplies of KI. Moreover, the general
availability of KI is greater now than at the time of the TMI accident,
partly because of the FDA's approval of KI as an over the counter drug.
Some States have elected to incorporate KI into the emergency response
plans and have obtained adequate supplies for this purpose. The
Commission is not aware of any factors that would constrain the
availability of KI for stockpiling purposes. The Commission believes
that an adequate supply of KI could be obtained.
Issue 6: Even though KI administration before any exposure is
ideal, the Chernobyl experience also has shown that the exposure can
continue for days. Is the institution of KI blockade at any time in
this period beneficial?
Staff Response: The administration of KI is most effective if done
before or immediately after (within 2 to 4 hours) a release.
Nonetheless, during a chronic exposure of several days, the
administration of KI any time during the exposure period may block some
uptake of radioactive iodine. However, the benefit diminishes quickly
over time and may be very small if administered late. If a release is
expected to continue for several days, the NRC anticipates that the
public would be evacuated or other protective action would be taken,
depending on the level of release. KI could nevertheless serve as a
useful supplemental and complement to these primary protective actions.
Issue 7: KI is an effective thyroid blocking agent only when
administered immediately before or after an exposure to radioactive
iodine (that is, within one to two hours). Distribution of KI in a
timely fashion to the general public following an accident could
further complicate and decrease the effectiveness of implementing
evacuation or residential sheltering.
Staff Response: The staff disagrees with this position. If a State
chooses to include KI as an additional protective measure, it is
anticipated that the State could make KI readily available to the
public where other over-the-counter medicines are available or by other
distribution means and that the public be made aware of its (the KI)
availability, not at the time of an emergency, but KI could be made
available year round.
Issue 8: One of the major impediments to distribution of KI to
school children is coordination and administration of the program,
e.g., the actual decision making process to administer KI or evacuate,
parental approval and recordkeeping, identification and documenting
allergic reactions, and the availability of a qualified medical
professional to administer the potassium iodide.
Staff Response: The staff disagrees. Upon declaration of a general
emergency there should be NO decision ``to administer KI or evacuate.''
The preferred protective action for the close-in population should be
evacuation. The administration of KI should be treated in the same
fashion as any other over-the-counter medication that might be given to
children while away from home, after observing the instructions
provided with the KI packaging. Prior parental approval to administer
KI in the event of an emergency can and should be addressed in the
planning process for any State that decides to use KI. The individual
State may provide the appropriate guidance and establish a system for
obtaining parental approval before the taking of other protective
actions that are currently being followed in the EPZ around nuclear
power plants.
Issue 9: Does the post-Chernobyl Polish experience show that large-
scale deployment of KI is safe?
Staff Response: Approximately 18 million doses of KI were
distributed primarily, but not exclusively, to children. The bulk of
the distribution took about three days. There were no reported serious
adverse reactions except for two adults with known iodide sensitivity.
The rate of serious side effects (10-7) is consistent with
the frequency seen during routine use of KI for medical treatment of
respiratory disease. The incidence of medically significant, but not
serious, reactions to this single dose of KI was also very low (0.2
percent). In addition, no detectable long-term disturbance in
children's thyroid function was detected as of 1989. Additionally, the
FDA has approved KI for over-the-counter distribution. The staff,
therefore, agrees that the post-Chernobyl experience has shown that
large-scale deployment of KI is relatively safe.
Issue 10: Several comments raised the question of liability: ``Is
the NRC prepared to address the number of legal implications should a
member of the general public be given KI at their directive or
recommendation and the individual have an extreme allergic reaction,
possibly death?''; ``The Federal Register Notice does not address legal
issues for states who decide to adopt KI and states who do not decide
to adopt or administer KI to the public.''; ``The issue of legal
liability should not be dismissed lightly. If the NRC decides to
require stockpiling of KI for the general public, has NRC considered
what liability may arise from any adverse health effects? No initiative
such as this should be undertaken without resolution of this issue.'';
``Who would assume liability if the KI was used prior to the Governor
ordering its use?'
Staff Response: The comments focus principally on concerns that
State and local governments involved in distribution and administration
of KI may be liable in tort if an individual receiving the KI has a
significant adverse medical reaction to the KI. To the extent that
commenters are raising the potential for federal government liability
for the promulgation of this proposed rule, the NRC believes that
whether the Commission may be subject to tort liability through the
implementation of a KI program depends upon a number of factors.
However, it would appear that a Commission decision to require state
and local emergency planning officials to consider stockpiling KI for
public distribution should be subject to the ``discretionary function''
exception to the Federal Tort Claims Act, 28 USC
[[Page 31745]]
2671, et seq.,12 which protects the Federal Government from
liability. The question of whether a State or locality might be liable
for involvement with administration of KI to the general public can
only be answered by reference to the laws and precedents of particular
States. The NRC presumes that this would be part of the
``consideration'' that States and localities will undertake if this
rule is promulgated. The NRC has not undertaken this analysis.
---------------------------------------------------------------------------
\12\ This exception from waiver of sovereign immunity provides
that:
Any claims based upon an act or omission of an employee of the
Government, exercising due care, in the execution of a statute or
regulation, whether or not such statute or regulation be valid, or
based upon the exercise or performance or the failure to exercise or
perform a discretionary function or duty on the part of a federal
agency or an employee of the Government, whether or not the
discretion involved be abused.
28 USC 2680(a). United States v. Varig Airlines, 467 U.S. 797,
808 (1984); Berkovitz v. United States, 486 U.S. 531 (1988).
---------------------------------------------------------------------------
Issue 11: Does the Commission consider stockpiling and using KI as
a reasonable and prudent protective measure for the general public?
Staff Response: The Commission believes that State and local
decision makers, provided with proper information, may find that the
use of KI as a protective supplement to evacuation and sheltering is
reasonable and prudent for specific local conditions.
Commission Decision
KI is a reasonable, prudent, and inexpensive supplement to
evacuation and sheltering for specific local conditions. Therefore, the
Commission's guidance on emergency planning has long taken KI into
consideration (NUREG-0654/FEMA-REP-1, Rev. 1, p. 63, items e and f.).
However, since the last revision of that guidance, there has been
experience with the mass distribution of KI during a radiological
emergency, and though the record on that distribution is not complete,
the indications thus far are that mass distribution is effective in
preventing thyroid cancer and causes remarkable few threatening side
effects. Moreover, many nations in Europe and elsewhere, nations as
different in their circumstances, politics, and regulatory structures
as France, Canada, and Japan, have stockpiled KI and planned for its
use. So have some U.S. States. The World Health Organization and the
International Atomic Energy Agency recommend its use. Therefore, in
order to achieve greater assurance that KI will receive due attention
by planners, it seems reasonable to take a small further step and,
continuing to recognize the authority of the States in matters of
emergency planning, explicitly require that planners consider the use
of KI.
The proposed rule change should not be taken to imply that the NRC
believes that the present generation of nuclear power plants is any
less safe than previously thought. On the contrary, present indications
are that nuclear power plant safety has improved since the current
emergency planning requirements were put in place after the Three Mile
Island accident.
The use of potassium iodide is intended to supplement, not to
replace, other protective measures. This rule change thus represents no
alteration in the NRC's view that the primary and most desirable
protective action in a radiological emergency is evacuation of the
population before any exposure to radiation occurs, whenever that is
feasible. (Evacuation protects the whole body, whereas potassium iodide
protects only a single gland, the thyroid.) Depending on the
circumstances, KI may offer additional protection if used in
conjunction with evacuation and/or sheltering.
The NRC recognizes that the decision to stockpile KI presents
issues of how best to position and distribute the medicine, to ensure,
e.g., that optimal distribution takes place in an emergency, with first
priority given to protecting children; that persons with known
allergies to iodine not take it; that members of the public understand
that KI is not a substitute for measures that protect the whole body;
etc. To date, these issues have been addressed in different ways in the
numerous countries that currently stockpile KI. The NRC is working with
States and localities to develop guidance on these and other points
relating to the use of KI. The NRC believes that these implementation
issues can be solved, given the level of expertise in the relevant
Federal and State agencies, and the experience of numerous nations that
have built KI into their emergency plans.
It is expected that States will inform FEMA and the NRC of the
results of their consideration of whether to opt for stockpiling. This
will enable the Federal government to engage in better contingency
planning for States that decide against stockpiling KI.
The Commission decision is implemented by publication of this
proposed rule that would change 10 CFR 50.47(b)(10) with a 90-day
public comment period. If the proposed rule is adopted in final form,
the petition would be granted in part and denied in part and NRC action
would be completed on PRM 50-63 and PRM 50-63A.
Commission Conclusions or Issues Raised by the Petitioner and Public
Commenters
The Commission having reviewed the issues raised by the petitioner
and the public commenters, has reached the following conclusions:
A. The Commission agrees that KI, when determined by State and
local emergency response planners and if administered in a timely
fashion, could protect the thyroid gland from exposure to radioiodines
inhaled or ingested following a major radiological accident. This is
the basis for stockpiling it and distributing it to emergency workers
and institutionalized persons during radiological emergencies. The
petitioner believes that the distribution of KI was inadequate and
untimely in the Ukraine and Belarus after the Chernobyl accident in
1986 and that this accounts for the increased incidence of thyroid
cancer in these areas. He also argues that distribution of KI in Poland
was timely and effective and that no similar increase in the incidence
of thyroid cancer was seen. The Commission considered all of the above
information in deciding to grant the petitioner's requested actions.
B. The Kemeny Commission criticized the failure to stockpile KI and
recommended that regional stockpiles be established. The Kemeny
Commission's report recognized that evacuation was not invariably the
preferred response to an emergency and that even when evacuation was
desirable, it might not be feasible. The Commission believes that
prompt evacuation and/or sheltering are the generally preferred
protective measures for severe reactor accidents. In developing the
range of public protective actions for severe accidents at commercial
nuclear power plants, evacuation and in-place sheltering provide
adequate protection for the general public. The Commission believes
that KI for the general public should not replace evacuation and
sheltering, but supplement them.
C. The Federal Radiological Emergency Response Plan (FRERP) is the
plan that would be used by the Federal Government to support State and
local officials in responding to any peacetime radiological emergency.
Such emergencies range from transportation accidents involving
radioactive materials to terrorist events involving nuclear materials.
The FRERP includes a range of protective actions commensurate with the
risks associated with the range of emergencies for the
[[Page 31746]]
general public and emergency workers. These protective actions include
evacuation, sheltering, and the prophylactic use of stable iodine. With
respect to protective actions for nuclear power plants, the NRC and
FEMA have issued Draft Supplement 3 to NUREG-0654/FEMA-REP-1, Rev. 1,
to provide updated guidance for the development of protective action
recommendations for severe reactor accidents. This document emphasizes
that prompt evacuation is the preferred protective action for actual or
projected severe core damage accidents.
D. The Commission recognizes that in 1994 the Board of Governors of
the IAEA adopted new International Basic Safety Standards. With respect
to emergency planning, these standards provide, among other things,
``intervention levels for immediate protective action, including
sheltering, evacuation, and iodine prophylaxis.'' It is important to
note that each country bases its response plans on local and regional
characteristics. For example, Italy and France, using the same
international standards and guidelines, implement them differently.
E. Although the cost of KI tablets has doubled, the Commission
agrees with the NRC staff estimate and other nations' experience, that
the purchase of KI tablets is relatively inexpensive. KI-related costs
increase when the cost of maintenance, distribution, and public
education are considered. However, the overall cost is minimal when
placed in the context of emergency planning and should not be a
deterrent to stockpiling KI for use by the general public should State
and local decision makers determine that the prophylactic use of KI as
a supplement to evacuation and sheltering is appropriate.
F. The Commission believes that robust regional stockpiles should
be established to enable use by States that have not established local
stockpiles and wish to make use of KI in the event of a severe nuclear
power plant accident.
Commission Decision To Fund KI
On June 30, 1997, the Commission voted to approve the NRC staff
recommendation to endorse the FRPCC recommendations for the Federal
Government to fund the purchase of potassium iodide (KI) for States at
their request and endorsed the FRPCC recognition of the availability of
the Federal stockpile of KI to State and local governments for purposes
of mitigating the consequences of terrorist use of nuclear, biological,
or chemical (NBC) weapons. At that time it was believed that the NRC
was the likely Federal agency to fund the stockpiling. Historically,
funding for State and local; emergency response planning has been the
responsibility of those governments usually working with licensees and,
absent Congressional funding specifically for this purpose, NRC is not
prepared to fund stockpiling of KI.
Findings
Metric Policy
On October 7, 1992, the Commission published its final Policy
Statement on Metrication. According to that policy, after January 7,
1993, all new regulations and major amendments to existing regulations
were to be presented in dual units. The amendment to the regulations
contains no units.
Environmental Assessment and Finding of No Significant Impact for
Granting the Petition for Rulemaking Relating To the Use of Potassium
Iodide (KI)
I. Introduction
On September 9, 1995, a petition for rulemaking (PRM 50-63) was
filed with the NRC by Mr. Peter Crane. The petitioner requested that
the NRC amend its emergency planning regulations to require that
emergency plans specify a range of protective actions to include
sheltering, evacuation, and the prophylactic use of KI.
In SECY 97-245, dated October 23, 1997, the staff provided three
options for the Commission's consideration in order to resolve PRM 50-
63.
On November 5, 1997, the Commission was briefed by the NRC staff,
the Federal Emergency Management Agency (FEMA), and the petitioner
regarding the options available for resolving the petition for
rulemaking. During the meeting, the Commission invited the petitioner
to submit a modification to his petition in order to address views he
discussed during the meeting.
On November 11, 1997, the petitioner submitted a revision to his
petition PRM 50-63A, which requested two things:
1. A statement clearly recommending stockpiling of KI as a
``reasonable and prudent'' measure, and
2. A proposed rule change to 10 CFR 50.47(b)(10) which would be
accomplished by inserting the following sentence after the first
sentence: ``In developing this range of actions, consideration has
been given to evacuation, sheltering, and the prophylactic use of
potassium iodide (KI), as appropriate.''
On June 26, 1998, the Commission disagreed with the staff
recommendation to deny the petition for rulemaking PRM 50-63A by
revising 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in
response to this directive.
Alternatives were essentially considered in previous documents. In
SECY-97-124 (June 16, 1997), on the ``Proposed Federal Policy Regarding
Use of Potassium Iodide after a Severe Accident at a Nuclear Power
Plant.'' The staff identified three options, one of which contained
three sub-options, concerning a proposed change in the Federal policy
regarding the use of potassium iodide (KI) as a protective measure for
the general public during severe reactor accidents. Next, in an SRM
dated June 30, 1997, the Commission approved an option that endorsed
the Federal offer to fund the purchase of KI for States at their
request and endorsed the Federal Radiological Preparedness Coordinating
Committee (FRPCC) recognition of the availability to State and local
governments of the Federal stockpiling of KI.
II. Need for Action
In SECY-97-245, the staff proposed options for resolving the
referenced petition for rulemaking. In SRM 98-061, the Commission
directed the staff to proceed with the rulemaking.
III. Environmental Impact of the Proposed Action
The environmental impacts of the proposed action and its
alternative are considered negligible by the NRC staff. Given the
proposed action would only add the sentence: ``In developing this range
of actions, consideration has been given to evacuation, sheltering, and
the prophylactic use of potassium iodide (KI), as appropriate.'' The
staff is not aware of any environmental impact as a result of this
proposed action.
IV. Alternative to the Proposed Action
The alternative to the proposed action at this time is to deny the
petitions and take no action with respect to the use of KI by the
public. Should this no-action alternative be pursued, the staff is not
aware of any resulting environmental impact.
V. Agencies and Persons Consulted
Cognizant personnel from the Federal Emergency Management Agency
were consulted, as was the petitioner, as part of this rulemaking
activity.
VI. Finding of No Significant Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
Subpart A of 10 CFR Part 51, that the amendment is not a major Federal
action
[[Page 31747]]
significantly affecting the quality of human environment, and
therefore, an environmental impact statement is not required. This
amendment will require that emergency plans specify a range of
protective actions to include sheltering, evacuation, and the
prophylactic use of KI. This action will not have a significant impact
upon the environment.
Paperwork Reduction Act Statement
This proposal rule does not contain a new or amended information
collection requirement subject to the Paperwork Reduction Act of 1995
(44 U.S.C 3501 et seq.). Existing requirements were approved by the
Office of Management and Budget (OBM) approval numbers 3150-0009 and
3150-0011.
Public Protection Notification
If an information collection does not display a currently valid OMB
control number, the NRC may not conduct or sponsor, and a person is not
required to respond to, the information collection.
Regulatory Analysis of the Proposed Rulemaking Granting In Part A
Petition for Rulemaking (PRM 50-63A) Relating to the Use of
Potassium Iodide (KI)
On September 9, 1995, a petition for rulemaking (PRM 50-63) was
filed with the NRC by Mr. Peter Crane. The petitioner requested that
the NRC amend its emergency planning regulations to require that
emergency plans specify a range of protective actions to include
sheltering, evacuation, and the prophylactic use of KI.
In SECY 97-245, dated October 23, 1997, the staff provided three
options for the Commission's consideration in order to resolve PRM 50-
63.
On November 5, 1997, the Commission was briefed by the NRC staff,
the Federal Emergency Management Agency (FEMA), and the petitioner
regarding the options available for resolving the petition for
rulemaking. During the meeting, the Commission invited the petitioners
to submit a modification to his petition in order to address views he
discussed during the meeting.
On November 11, 1997, the petitioner submitted a revision to his
petition PRM 50-63A, which requested two things:
A statement clearly recommending stockpiling of KI as a
``reasonable and prudent'' measure, and
A proposed rule change to 10 CFR 50.47(b)(10) which would be
accomplished by inserting the following sentence after the first
sentence: ``In developing this range of actions, consideration has
been given to evacuation, sheltering, and the prophylactic use of
potassium iodide (KI), as appropriate.''
On June 26, 1998, the Commission directed the staff in SRM 98-061
to revise 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in
response to this directive.
Alternatives were essentially considered in previous documents. In
SECY-97-124 (June 16, 1997), titled ``Proposed Federal Policy Regarding
Use of Potassium Iodide after a Severe Accident at a Nuclear Power
Plant,'' the staff identified three options, one of which contained
three sub-options, concerning a proposed change in the Federal policy
regarding the use of potassium iodide (KI) as a protective measure for
the general public during severe reactor accidents. Next, in an SRM
dated June 30, 1997, the Commission approved an option that endorsed
the Federal offer to fund the purchase of KI for States at their
request and endorsed Federal Radiological Preparedness Coordinating
Committee (FRPCC) recognition of the availability to State and local
governments of the Federal stockpiling of KI.
In SECY-97-245, the staff proposed options for resolving the
referenced petition for rulemaking. In SRM 98-06, the Commission
directed the staff to proceed with the rulemaking.
Given that the Commission considered the options and directed the
staff to grant the petition, the only alternatives considered here are
the Commission approved option and the baseline, no-action alternative.
The proposed rulemaking does not ``require'' anything of licensees,
but States are to have shown ``consideration'' of the use of KI along
with evacuation and sheltering as protective actions. It is estimated
that 30 States will need to make this consideration. Further, the staff
estimates that the labor needed by the States could range from a staff-
week, to a half staff-year. The latter being the case if a State
decided to hold hearings on the issue.
If one assumes an average hourly salary of $70 (this estimate
includes benefits, pro-rated secretarial and managerial assistance, but
not overhead), the range of estimates would be from $2800 to $63,000.
Again using a base of 30 States, the range is from $84,000 to $1.9
million.
The Commission notes that when it amended its emergency planning
regulations on November 3, 1980, the regulatory standards for emergency
planning were a restatement of basic joint NRC-FEMA guidance to
licensees and to State and local governments incorporated in NUREG-
0654; FEMA-REP-1, ``Criteria for Preparation and Evaluation of
Radiological Emergency Response Plans and Preparedness in Support of
Nuclear Power Plants for Interim Use and Comment.'' This guidance was
cited in the regulation and speaks to radioprotective drugs including
their use by the general public including quantities, storage and means
of distribution and State and local plans for decision making with
respect to their use. The Commission removed the citations of the
guidance from the regulation in 1987 but the guidance has continued in
use for planning purposes and by the Federal agencies for evaluating
emergency plans. As a result, it is believed that all of the affected
States have at some point considered the use of KI. Some States have
made the decision to stockpile KI. Thus, in practical terms, the
projected costs will occur only in those States that have not elected
to stockpile KI and choose stockpiling in light of the Chernobyl
accident, recent international practice, and the NRC requirement to
consider the use of KI.
It is difficult to estimate the benefit of a State's consideration
to stockpile KI. However, we believe the benefit of such an action by
the States is summed up by the petitioner who stated that the decision
to stockpile KI should turn on whether, given the enormous consequences
of being without KI in a major accident, the drug is a prudent measure;
not on whether it will necessarily pay for itself over time. As the
petitioner further noted, KI represents a kind of catastrophic-coverage
insurance policy offering protection for events which, while they occur
only rarely, can have such enormous consequences that it is sensible to
take special precautions, especially where, as here, the cost of such
additional precautions is relatively low.
As stated above, this analysis focuses on the rule being proposed
as the result of a petition. Also, since the Commission has directed
the staff to pursue the FRPCC results with respect to KI and has
directed the staff to pursue the rulemaking, the regulatory analysis
presented here is for the edification of the decision makers so they
can make an informed decision on the proposed rule.
The above constitutes the regulatory analysis for this action.
Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission hereby certifies that this rule, if adopted,
will not have a significant economic impact on a substantial number of
small entities. This proposed rule would affect only
[[Page 31748]]
the licensees of nuclear power plants. These licensees, do not fall
within the scope of the definition of ``small entities'' set forth in
the Regulatory Flexibility Act. 5 U.S.C. 601, or the size standards
adopted by the NRC (10 CFR 2.810).
Backfit Analysis
The definition of backfit, as set forth in 10 CFR 50.109(a)(1), is
clearly directed at obligations imposed upon licensees (and applicants)
and their facilities and procedures. Section 50.109(a)(1) defines a
backfit as:
* * * the modification of or addition to systems, structures,
components, or design of a facility; or the design approval or
manufacturing license for a facility; or the procedures or
organization required to design, construct or operate a facility,
any of which may result from a new or amended provision in the
Commission rules or the imposition of a regulatory staff position
interpreting the Commission rules that is either new or different
from a previously applicable staff position * * *.
Section 50.109 is replete with references to ``facilities'' and
``licensees,'' which in their totality make clear that the rule is
intended to apply to actions taken with respect to nuclear power plant
licensees and the facilities they operate. See Section 50.109(a)(7),
``If there are two or more ways to achieve compliance with a license or
the rules or orders of the Commission, or with written licensee
commitments * * * then ordinarily the applicant or licensee is free to
choose the way that best suits its purposes [emphasis added].'' This
focus on licensees and their facilities is further confirmed by the
Statement of Considerations accompanying the backfit rule, 53 FR 20603
(June 6, 1988), where the Commission stated that backfitting ``means
measures which are intended to improve the safety of nuclear power
reactors * * *.'' 53 FR at 20604. The nine factors to be considered
under 10 CFR 50.109(c) further make clear that the rule is aimed at
requirements on licensees and facilities. These include: ``(2) General
description of the activity that would be required by the licensee or
applicant in order to complete the backfit; * * * (5) Installation and
continuing costs associated with the backfit, including the cost of
facility downtime or the cost of construction delay; [and] (6) The
potential safety impact of changes in plant or operational complexity.
* * * [emphasis added]''
The proposed rule imposes no new requirements on licensees, nor
does it alter procedures at nuclear facilities. Rather, it is directed
to States or local governments--the entities with the authority to
determine the appropriateness of the use of KI for their citizens--
calling upon the governments to ``consider'' KI as one of the elements
of their offsite emergency planning. Even as to states or local
governments, it imposes no binding requirement to alter plans and
procedures. Furthermore, the basic standard that emergency planning
must include consideration of a range of protective actions, is already
set forth in the existing wording of section 50.47(b)(10). On this
basis, the proposed rule in reality does not impose new requirements on
anyone. On a consideration of all of the above factors, no backfit is
involved and no backfit analysis is required.
Commission precedent also makes clear that the proposed rule change
does not constitute a backfit. The Commission's position was stated
explicitly in 1987, when the last major change took place in emergency
planning regulations. 52 FR 42078 (Nov. 3, 1987). The Commission's
final notice of rulemaking on this rule involving the ``Evaluation of
the Adequacy of Off-Site Emergency Planning for Nuclear Power Plants at
the Operating License Review Stage Where State and Local Governments
Decline to Participate in Off-Site Emergency Planning'' stated that the
emergency planning rule change in question ``does not impose any new
requirements on production or utilization facilities; it only provides
an alternative method to meet the Commission's emergency planning
regulations. The amendment therefore is not a backfit under 10 CFR
50.109 and a backfit analysis is not required.'' 52 FR at 42084.
Likewise, when the Commission altered its emergency planning
requirements in 1987 to change the timing requirements for full
participation emergency exercises (a change that, as a practical
matter, could be expected to result in licensees' modifying emergency
preparedness-related procedures to accommodate exercise frequency
changes), it stated: ``The final rule does not modify or add to
systems, structures, components or design of a facility; the design
approval or manufacturing license for a facility; or the procedures or
organization required to design, construct, or operate a facility.
Accordingly, no backfit analysis pursuant to 10 CFR 50.109 is required
for this final rule.'' 52 FR 16828 (May 6, 1987). The proposed
emergency planning rule change is of a similar nature and similarly
does not involve a backfit.
It has been argued by at least one commenter on the petition for
rulemaking that, although licensees are not directly burdened by the
proposed rule, they would be indirectly burdened because they would
feel called upon to explain the new policy to their customers. By this
logic, almost any Commission action that led an NRC licensee to issue a
press release could be considered a backfit. Such a position would
represent unsound law and policy. Here, the burden of public
information on licensees or applicants, if any, appears de minimis. It
plainly does not rise to the level of the type of concrete burden
contemplated by the Commission when it enacted the backfit rule. It
might also be argued that, if a State or local government were to
decide to stockpile and use KI for the general public, it would
undertake interactions with the affected licensee to coordinate offsite
emergency planning. Although this could result in some voluntary action
by the licensee to coordinate its planning, the proposed rule itself
does not impose any requirement or burden on the licensee. Accordingly,
the Commission concludes that the proposed rule, if adopted, would not
impose any backfits as defined in 10 CFR 50.109.
List of Subjects in 10 CFR Part 50
Antitrust, Classified Information, Criminal penalties, Fire
protection, Intergovernmental relations, Nuclear power plants and
reactors, Radiation protection, Reactor siting criteria, Reporting and
recordkeeping requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act for 1954, as amended, the Energy Reorganization
Act of 1974, as amended, the National Environmental Policy Act of 1969,
as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the
following amendment to 10 CFR Part 50.
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION
FACILITIES
1. The authority citation for 10 CFR Part 50 continues to read as
follows:
Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68
Stat. 936, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83
Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232,
2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stats. 1242,
as amended 1244, 1246, (42 U.S.C. 5841, 5842, 5846).
Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42
U.S.C. 5851). Sections 50.10 also issued under secs. 101, 185, 68
State. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102,
[[Page 31749]]
Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Section 50.13,
50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as
amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56
also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections
50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L.
91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also
issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section
50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).
Sections 50.80, 50.81 also issued under sec. 184, 68 Stat. 954, as
amended (42 U.S.C. 2234). Appendix F also issued under sec. 187, 68
Stat. 955 (42 U.S.C. 2237).
2. In Sec. 50.47, paragraph (b)(10) is revised to read as follows:
Sec. 50.47 Emergency plans.
* * * * *
(b) * * *
(10) A range of protective actions has been developed for the plume
exposure pathway EPZ for emergency workers and the public. In
developing this range of actions, consideration has been given to
evacuation, sheltering, and, as a supplement to these, the prophylactic
use of potassium iodide (KI), as appropriate. Guidelines for the choice
of protective actions during an emergency, consistent with Federal
guidance, are developed and in place, and protective actions for the
ingestion exposure pathway EPZ appropriate to the locale have been
developed.
* * * * *
Dated at Rockville, Maryland, this 3rd day of June, 1999.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-14584 Filed 6-11-99; 8:45 am]
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