[Federal Register Volume 60, Number 227 (Monday, November 27, 1995)]
[Proposed Rules]
[Pages 58256-58259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28832]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 50
[Docket No. PRM-50-63]
Peter G. Crane, Receipt of Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; Notice of receipt.
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SUMMARY: The Nuclear Regulatory Commission (NRC) has received and
requests public comment on a petition for rulemaking filed by Mr. Peter
G. Crane. The petition has been docketed by the Commission and has been
assigned Docket No. PRM-50-63. The petitioner requests that the NRC
amend its regulations concerning emergency planning to include a
requirement that emergency planning protective actions include
sheltering, evacuation, and the prophylactic use of potassium iodide,
which prevents thyroid cancer after nuclear accidents. The request
would amend one of the 16 planning standards in 10 CFR 50.47 by which
licensee emergency plans are evaluated in order to assure that the
option of using potassium iodide is included in emergency planning.
DATES: Submit comments by February 12, 1996. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given except to those comments received on
or before this date.
ADDRESSES: Submit comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001. Attention: Docketing and
Services Branch.
Deliver comments to 11555 Rockville Pike, Rockville, Maryland,
between 7:45 am and 4:15 pm on Federal workdays.
For a copy of the petition, write: Rules Review Section, Rules
Review and Directives Branch, Division of Freedom of Information and
Publications Services, Office of Administration, U.S. Nuclear
Regulatory Commission, Washington, DC 20555. For information on
submitting comments electronically, see ``Electronic Access'' under
Supplementary Information.
FOR FURTHER INFORMATION CONTACT: Michael Jamgochian, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555. Telephone: 301-415-6534, or Michael T. Lesar, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555. Telephone: 301-415-7163 or Toll Free: 800-368-5642.
SUPPLEMENTARY INFORMATION:
Electronic Access
Comments may be submitted electronically, in either ASCII text or
WordPerfect format (version 5.1 or later), by calling the NRC
Electronic Bulletin Board (BBS) on FedWorld. The bulletin board may be
accessed using a personal computer, a modem, and one of the commonly
available communications software packages, or
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directly via Internet. Background documents on this rulemaking also are
available for downloading and viewing on the bulletin board.
If using a personal computer and modem, the NRC rulemaking
subsystem on FedWorld can be accessed directly by dialing the toll-free
number 800-303-9672. Communication software parameters should be set as
follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1).
Using the ANSI or VT-100 terminal emulation, the NRC rulemaking
subsystem can then be accessed by selecting the ``rules menu'' option
from the ``NRC main menu.'' Users will find the ``FedWorld On-line
User's Guides'' particularly helpful. Many NRC subsystems and data
bases also have a ``Help/Information Center'' option that is tailored
to the particular subsystem.
The NRC subsystem on FedWorld also can be accessed by a direct-dial
telephone number for the main FedWorld BBS, 703-321-3339, or by using
Telnet via Internet: fedworld.gov. If using 703-321-3339 to contact
FedWorld, the NRC subsystem will be accessed from the main FedWorld
menu by selecting the ``Regulatory, Government Administration and State
Systems,'' then selecting ``Regulatory Information Mall.'' At that
point, a menu will be displayed that has an option ``U.S. Nuclear
Regulatory Commission'' that will take you to the NRC on-line main
menu. The NRC on-line area also can be accessed directly by typing ``/
go nrc'' at a FedWorld command line. If you access NRC from FedWorld's
main menu, you may return to FedWorld by selecting the ``Return to
FedWorld'' option from the NRC on-line main menu. However, if you
access NRC at FedWorld by using NRC's toll-free number, although you
will not have access to the main FedWorld system, you will have full
access to all NRC systems.
If you contact FedWorld using Telnet, you will see the NRC area and
menus, including the rules menu. Although you will be able to download
documents and leave messages, you will not be able to write comments or
upload files (comments). If you contact FedWorld using FTP, all files
can be accessed and downloaded but uploading files is not allowed; you
will only see a list of files without descriptions (normal gopher
look). An index file listing all files within a subdirectory and
descriptions of those files, is available. There is a 15-minute time
limit for FTP access.
Although FedWorld also can be accessed through the Worldwide Web,
like FTP, that mode only provides access for downloading files and does
not display the NRC Rules Menu.
For more information on NRC bulletin boards call Mr. Arthur Davis,
Systems Integration and Development Branch, NRC, Washington, DC 20555,
telephone (301) 415-5780; e-mail AXD3@nrc.gov.
Background
The NRC received a petition for rulemaking dated September 9, 1995,
submitted by Mr. Peter G. Crane on his own behalf. The petition was
docketed as PRM-50-63 on September 12, 1995. The petitioner requests
that the NRC amend its regulations in 10 CFR Part 50 that govern
emergency planning. Specifically, the petitioner is seeking to amend
one of the 16 planning standards in 10 CFR 50.47 to include the use of
potassium iodide (KI) as one action to be considered in emergency
situations under licensee emergency plans.
Potassium Iodide
The petitioner discusses KI and its uses. Specifically, 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 drug itself has a long shelf life--at least five years--
and causes negligible side effects.
The petitioner further states that, in addition to preventing
deaths from thyroid cancer, KI prevents radiation-caused illnesses. The
petitioner indicates that thyroid cancer, curable in 90-95 percent of
cases, generally means surgery, radiation treatment, and a lifetime of
medication and monitoring. The petitioner asserts that the changes in
medication that go with periodic scans put many patients on a
physiological and psychological rollercoaster. The petitioner states
that hypothyroidism can cause permanent retardation in children and, if
undiagnosed, can condemn adults to a lifetime of fatigue, weakness, and
chills.
Three Mile Island
The petitioner discusses the U.S. policy with regard to KI before
the Three Mile Island (TMI) accident. In December 1978, the Food and
Drug Administration (FDA) announced that it had determined that
potassium iodide was safe and effective for thyroid protection in
nuclear accidents. The issue attracted little attention and the NRC and
the Federal Government as a whole took no public position on the drug.
Three months after the FDA announcement, on March 28, 1979, the TMI
accident began to unfold. After two days of unsuccessful efforts to
bring the reactor under control, it was still uncertain whether a major
release of radioactivity could be averted. The petitioner states that
Federal and State officials, searching for supplies of KI in case it
should be needed, discovered that there was none to be had. A supply
had to be manufactured, literally overnight. The petitioner indicates
that at 3 am on Saturday, March 31, an FDA official arranged with the
Mallinckrodt Chemical Company for the immediate production of 250,000
doses of KI. Without a written contract or a purchase order, the
company began production and the first shipment of the drug arrived in
Pennsylvania 24 hours later.
The petitioner also discusses that after the accident, President
Carter appointed John Kemeny to head a commission to investigate the
accident. The Kemeny Commission report, issued in October 1979, was
strongly critical of the failure to stockpile KI. Among the Kemeny
Commission's major recommendations was that an adequate supply of the
radiation protective agent, potassium iodide for human use, should be
available regionally for distribution to the general population and
workers affected by a radiological emergency. The report also explained
that different types of accidents might require different kinds of
emergency response, particularly that in some accident situations,
evacuation may not be the emergency planning measure of choice.
Potassium Iodide Policy
The petitioner states that Federal agencies initially supported the
Kemeny Commission recommendation. 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 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 a State emergency
response plan.
According to the petitioner, the three agencies most concerned, the
FDA, NRC, and Federal Emergency Management Agency (FEMA), all favored
the stockpiling KI for the next several years. The petitioner states
that the Atomic Industrial Forum, a nuclear industry trade association,
declared itself against the stockpiling of KI in May 1982.
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The petitioner indicates that the NRC staff was strongly in favor
of KI stockpiling as late as September 27, 1982, when the staff issued
a memorandum to the Commissioners proposing that the NRC agree with a
draft interagency policy statement supporting KI stockpiling. The
petitioner further states that on October 15, 1982, less than three
weeks after sending the draft policy statement to the Commission for
approval, the staff sent a supplementary paper withdrawing the
memorandum of September 27. The later memorandum informed the
Commissioners that NRC's Office of Nuclear Regulatory Research could,
by January 1, 1983, produce a paper showing that KI was significantly
less cost beneficial than previously assumed. The staff proposed
sending this document to the FDA and FEMA with the recommendation not
to stockpile and distribute KI.
The petitioner indicates that the NRC staff briefed the
Commissioners on the staff's proposal to take a strong position against
KI in November 1983. A policy statement was later issued that disposed
of, once and for all, the Kemeny Commission's recommendation in favor
of 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.
Effects of Chernobyl
The petitioner states 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 states
that in Russia and the Ukraine, and also in Belarus, where the
distribution of KI was inadequate and untimely, they are 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 believes that Poland is a proof-positive example
of the benefits of a well-prepared KI program.
The petitioner describes the U.S. Government spending to study
radiation-caused thyroid cancer in Ukraine and Belarus. Announcing a
$15 million 15-year program that will follow 70,000 children in
Ukraine, the Department of Energy (DOE) declared in a press release
that the studies provide a unique opportunity to understand the thyroid
cancer risk of exposure to radioiodine. The DOE press release
explained: ``The release of radioiodine is likely to figure prominently
in any nuclear power plant disaster and knowledge of its carcinogen
potency is inadequate, especially in children.'' In addition, the
petitioner further states 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, and children rendered permanently mute.
The petitioner discusses post-Chernobyl developments on KI policy.
He states that the Chernobyl accident demonstrated that KI worked and
that countries that failed to stockpile and distribute it are finding
themselves with serious public health problems.
Potassium Iodide Reconsidered
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 Commission 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
describes the report as concluding that stockpiling continued not to be
cost-effective, but that the difference between costs and benefits was
narrower than had been calculated by the NRC staff in the early 1980s.
Then the petitioner indicates that, in December 1993, an industry trade
group, the Nuclear 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 states that in March 1994, the NRC staff declared
its support for KI stockpiling. However, the NRC staff proposal for a
change in policy was blocked when the Commissioners voted 2 to 2 in May
1994. Under NRC procedures, a tie vote on a proposal means that it
fails.
Additional Support
The petitioner describes a September 1994 FEMA publication
proposing a ``Federal Radiological Emergency Response Plan'' that
envisions the use of KI during radiological emergencies. According to
the petitioner, this implies that the authors of the plan recognize the
drug's usefulness. Under the plan, the NRC would be the lead Federal
agency during emergencies at nuclear power plants and would advise
State and local governments (based on advise received from an
interagency panel); the States and localities would then administer the
KI, if necessary.
The petitioner also indicates that in 1994, the Board of Governors
of the International Atomic Energy Agency, with U.S. Government
support, adopted new ``International Basic Safety Standards.'' These
standards represent the consensus of the world's experts on radiation
safety. With regard to emergency planning, they provide, among other
things: ``Intervention levels of immediate protective actions,
including sheltering, evacuation, and iodine prophylaxis, shall be
specified in emergency plans * * *'' thus the international radiation
protection, like the Kemeny Commission in 1979 and the short-lived
draft Federal policy statement of 1982, recognize that effective
preparedness for radiological emergencies meant having three items to
consider.
Discussion of the Petition
The NRC is soliciting public comment on Mr. Cranes's petition,
which requests the changes to the regulations in 10 CFR part 50.
The petitioner has submitted this petition for rulemaking because
he believes the NRC should implement the recommendation of the
President's Commission on the Accident at Three Mile Island, known as
the Kemeny Commission, that the United States maintain the option of
using the drug potassium iodide for thyroid protection during nuclear
accidents. The petitioner requests that the Commission definitively
review and decide on the issue rather than simply have the NRC staff
decide not to propose it to the Commission.
The petitioner states 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 measure. The
petitioner believes maintaining a KI option ensures that responsible
authorities have an additional type of protection at their disposal.
The petitioner indicates 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 necessarily, but that
evacuation is generally feasible. The petitioner believes that
sometimes, either by choice or necessity, authorities may be sheltering
people or telling them to remain indoors rather than
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evacuating them. The petitioner believes that it may be desirable to
administer KI any time people are sheltered or told to stay indoors,
when evacuation routes take people through areas of radiological
contamination and when there is a large airborne release high in the
atmosphere.
The petitioner believes that the decision on stockpiling KI should
turn on whether, given the enormous 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 states that the estimates of KI's cost-effectiveness
depend on estimates that are no more than informed guesses about the
probability of severe accidents. The NRC's cost-benefit analysis of the
early 1980's was based on the assumption that a severe accident with a
major release of radioactivity could occur in this country only once
every thousand years.
The petitioner believes that if it were really true that serious
accident 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 the rest of emergency planning. The petitioner also
states that if KI is not cost-effective, then the rest of nuclear
emergency planning is probably not cost-effective either. If serious
accidents are really possible only every one or two thousand years, it
is unlikely that any element of current nuclear emergency planning
could be found cost-effective.
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 difference in 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 states 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 they adopted an anti-KI position.
The petitioner states that existing policy purports to leave the
judgment on stockpiling KI to the States; however 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 mentions a letter to the Commissioners from Senators
Simpson and Lieberman sent in April 1994. This letter stated that the
Federal Government has a moral responsibility to provide the public
with complete and accurate information regarding the risks from
Federally-licensed activities and ways in which those risks may be
reduced. The petitioner also mentions FEMA's Federal Emergency Response
Plan of September 1994. The plan provides that, in an emergency at a
nuclear power plant, an interagency advisory team will provide guidance
on KI to the NRC, and the NRC will provide advice to State and local
governments on measures that they should take to avoid or reduce
exposure to the public, including sheltering, evacuation, and
prophylactic use of iodine.
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
iodine to administer. The petitioner raises the question: If KI
stockpiling is not worthwhile, why is administration of the drug one of
the protective measures identified in the plan? He also questions that
if KI is worthwhile, as the plan implies, then why isn't something
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
The petitioner requests that 10 CFR Part 50 be amended to include
language taken from FEMA's Federal Radiological Emergency Response Plan
of September 1994 and recommends the following revision to the
regulations:
The petitioner proposes that Sec. 50.47 be amended by revising
paragraph (10) to read as follows:
Sec. 50.47 Emergency plans.
(a) * * *
(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.
* * * * *
The petitioner believes that if this 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 suggests 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 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 state
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 for the creation of regional stockpiles of the drug as a
backup for emergencies.
Dated at Rockville, Maryland, this 20th day of November, 1995.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 95-28832 Filed 11-24-95; 8:45 am]
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