[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 

[[Page 58257]]
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 AXD[email protected].

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. 

[[Page 58258]]

    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 

[[Page 58259]]
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]
BILLING CODE 7590-01-P