ML20196B606
| ML20196B606 | |
| Person / Time | |
|---|---|
| Issue date: | 06/14/1999 |
| From: | NRC |
| To: | |
| References | |
| FRN-64FR31737, RULE-PR-50 NUDOCS 9906230235 | |
| Download: ML20196B606 (13) | |
Text
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. Federal Register /W1. 64, No.113/Mond2y, Juns 14,1999/ Proposed. Rules 31737
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facilities. The proposed rule would amend the current regulations to require j
that consideration shall be given to including potassium iodide (IG), as a i
4 protective measure for the general l
publicthat would supplement sheltering and evacuation. IG would i
i help prevent thyroid cancers in the unlikely event of a majorrelease of radioactivity from a nuclear power plant. The proposed rule responds to petitions for rulemaking submitted by MrcPeter G. Crane concerning the use ofIGin 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 Rockvdle Pike, Rockville, MD 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be eynmined at the Commission's Public Document Room at 2120 L Street NW (Lower Level), Washinaton, 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 infonnation about the interactive rulemaking site, contact Ms.
A} )
Carol Gallagher, (301) 415-6215: e-mail CA G@ntc. gov.
l FOR FURTHER pfFORt4ATION CONTACT:
Michael T.Jamgochian, Office of Nuclear Reactor Regulation, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001.
Telephone: (301) 415-3224. Internet:
MTJ19NRC. GOV.
I NUCLEAR REGULATORY Com under+akinF this rulamaking, the rn= mission, while not adopting the 10 CFR Part 50 exact language suggested by the petitioner,is proposing to grant a RIN 3150-AG11 petition for rulemaking (PRM-50-63A) submitted by Mr. Peter Crane on WPWasah M M Emergency Plans November 11,1997. That petition is a revision of a petition (PRM-50-63) that AGENCY: Nuclear Regulatory he submitted on September 9,1995.
Commission.
Considering all public comments f
ACTION: Proposed rule.
received, the information available in the literature. 20 years of experience
~
SuessaARY:The Nuclear Regulatory gained in evaluating licensee emergency
- c. n ; O g c)
Commission (NRC)is proposing an preparedness plans, and the arguments O
amendment to its emergency planning presented by the petitioner, the regulations governing tne domestic Commission has decided to grant the licensing of production and utilization petition for rulemaking and to proceed 9906230235 990614
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~31738-Federd Register /Vol. 64, No.113/ Monday, June 14,1999/ Proposed Rults with rula== king to amend 10 CFR (62 FR 66038). In thi amended petition, & Petitioner's Disen==lan nf the Three 50.47(b)(10) by inserting the following the petitioner requested that:
Mile Island Accident (TMI)
I g
the Erst,sen ence: "In A statement (be made] clearly The petitioner noted that in December sen a
9 conuderation has given to' bd
[h'm 1978, the Food and Drug Administration ree
, ind; evacuation, shelterin A proposed ru e$h" e to 20 m (FDA) announced that it had supplement to these,g, and, as a.' so.u(b)(10) which woufd be accomplished determined that KI was safe and.
use of potassium 1odido (b, phylactic the effective for thyroid nuclear accidents. _ protection in as.
by inserting the following sentence abr the ne petitioner stated rppropriate." In addition, the preamble first sentence: "In developing this range of
- for this proposed rule includes a actions, c nsideration has been given to that the issue attracted little attention,.
statement to the effect that State and evacuati n, sheltering, and the pmphylactic that the NRC and the Federal U88 Potassium lodide (KI), as appmpriate.
Government as a whole took no public local decision makars, provided with proper information, may find that the The tioner also provided a Position on the drug, and that three use of K! as a protective supplement is
-up version of the NRC staff's-months aAer the FDA announcement, reasonable and prudent for specific Proposed Federal Radiologica]
on March 28,1979, the TMI accident local conditions. When the Commission Preparedness Coordinating Committee began to unfold. b petitioner stated amended its emwegency planning (FRPCC) Federal Register notice that Federal and State officials, regulations on November 3,1980,it concerning Federal poli relating to the searching for supplies of KI in case it stated that "any direct fimding of State use of KI for the general ublic.
should be needed, discovered that none or local governments solely for On June 26,1998 (S98-061), the was to be had and that a supply had to
)
emergency preparedness purposes by Commission decided to grant the be manufactured, literally overnight.
b Federal government would come Portion of the petition for rulamaking The petitioner indicated that at 3:00 i
through FEMA." In its decision on June PRM-50-63A regarding the requated m.m. on Saturday, March 31,1979, an I
30,1997, the Commission also noted amendment to 10 CFR 50.47(b)(10). The FDA official
- arranged with the that, the Federal government (most Commisalon also directed that the Mallinckrodt Chemical Company for the
~
Preamble for the pro d rule include immediate production of 250,000 doses likely the NRC)is to fund th'e purchase of a st e of KI for the a statement to the that State and of KI.
States, upon request. b Commlasion local decision makers, provided with N petitioner also discussed the has determined that notwithstanding proper information, may find that the Report of the President's Commission ths June 30,1997, intention that "most use of KI as a protective supplement is on the Accident at Three Mile Island likely the NRC"would fund the reasonable and prudent for specific (the Kemeny Commission report),
purchase of State stockpiles of KI, the local conditions. The NRC staffis also issued in October 1979, and stated that NRC budget has continued to decrease preparing a technical report and an the report was strongly critical of the and offers little margin for the information brochure to enable State failure to stockpile Kl. The petitioner Co==laston to divert resources to new and local decision makers to make an noted that among the Kemeny initiatives Historically,fundingfor informed decisionin this matter.
c.ammi..lan's major recommendations was that an adequate supply of the St:te and local emergency response Petitlener's Basis for Requesting radiation protective agent, KI for human planning has been the responsibility of pmm those governments usually working use, should be available regionally for with licensees. The Commission notes The petitioner stated that potassium distribution to the general that the Petitioner has not requested the iodide (KI) rotects the thyroid gland, and workers affected by s populationadiolog Federal fimding of stockpiles of KL in which is hi y sensitive to radiation emergency.
tla alternative, the NRC will work with from the ra osctive iodine that would other relevant a ncies to ensure that be released in extremely serious nuclear h Petitioner's Discussion of the there are established robust, pr,.
accidents. By saturating the gland with Potassium Iodide Policy positioned regional stockpiles of KI,'to iodine in a hannless form, KI prevents The petitioner stated that in NUREG-be effectively and timely used by states any. inhaled or ingested radioactive 0632,"NRC Views and Analysis of the that have not established local iodine from lodgingin the thyroid Recommendations of the President's stockpiles and wish to make use of the gland, whereit could lead to thyroid Commission on the Accident at TMI,"
regional stockpiles in the event of a cancer or other illnesses. The petitioner issued in November 1979, the NRC severe nuclear pqyer plant accident.
stated that the drug itself has a long agreed with the findings of the Kemeny On November 27.1995 (60 FR 58256), shelf-life, at least 5 years, and causes Comadssion and planned to require ble side effects.
the Nuclear Regulatory th==lasian ngPetitioner further stated that, in nuclear power plant licensees to have (NRC) published a Notice of Receipt of adequate supplies of KI available for aption for rul==aking (PRM-50-es) addition to preventing deaths from nuclear power plant workers and the med by Mr. Peter G. Crane on his own thyroid cancer, KI prevents radiation-general public as part of State behalf. b petitioner requested that the caused illnesses. The petitioner notes emergency response plans.
NRC amend its regulations cancarning that thyroid cancer generally means According'to the petitioner, the three emergency planning to include a surgery, radiation treatment, and a agencies most concerned, the FDA, the requirement that emergency planning lifetime of medica *. ion and monitoring.
NRC, and the Federal Em.,sy protective actions include the.
The petitioner asserted that the changes Management Agency (FEMA), favored prophylactic use of potassium lodide in medication that go with periodic the stackpilia= of K1 for the next several
- (KI), which the petitioner notes prevents scans put many patients on a years.b petitioner stated that the thyroid cancer after s.uclear accidents.
physiological and psychological roller Atomic Industrial Forum, a nuclear un November 11,1997, the petitioner coaster.The petitioner stated that industry trade association, declared g
submitted a revision to his original hypothyroidism can cause permanent itself against the stockpiling of K1in T
petition (PRM-50-63A).The NRC retardationin children and,if May 1982.
published a Notice of Receipt of ths undlagnosed, can condemn adults to a h petitioner indicated that the NRC amended petition on December 17,1997 lifetime of fatigue, weakness, and chills, staff was strongly in favor of KI
Federal Register /Vol.' 64, No.113 / Monday, June 14,1999/Propos:d Ruhs 31739 stockpiling as 1:13 as Sept:mber 27, and larynxes, rend: ring piti:nts Govrrnm:nt support, adopted n:w 1982, when the NRC staff submitted a permanently mute.
International Basic Safety Standards in memorandum to the Commissioners -
The petitioner discussed post-1994. The petitioner stated that these l
proposing that the Commission agree Chernobyl developments on KI policy.
standards represented the consensus of f
with a draft interagency poli He stated that the Chernobyl accident the world's experts on radiation safety statement supporting KI st fling.
demonstrated that K! worked and that and the standards provide, among other i
The petitioner further stated ton countries that failed to stockpile and things, that intervention levels of i
October 15,1982,less thin 3 weeks after distribute it are experiencing serious immediate protective actions, including sending the draft policy statement to the public health problems.
sheltering, evacuation, and lodine Commission for approval, the NRC staff The Petitioner's Discussion of the NRC's prophylaxis, shall be specified in
. sent a supplementary memorandum Reconsideration of Potassiur T xlide emergency plans. Thus, the petitioner withdrawing the memorandum of stated, the international radiation tomber 27. The later memorandum The petitioner notes that in June 1989, l
Seformed the Commissioners that NRC's in the NRC reconsidered the KI issue after protection community, like the Kemen Commission in 1979 and the short-lived Office of Nuclear Regulatory Research the petitioner filed a Differing draft Federal policy statement of 1982, (Rf i) could, by January 1,1983, Professional Opinion urging a change in recognized that effective preparedness
. produce a paper showing that KI was policy. On November 27,1989, the forradiological emergencies means significantly less cost-beneficial than American Thyroid Association wrote to having three actions to consider previously assumed. The NRC a.taff
. the NRC urgin,KI stockpiling on a
[ evacuation, sheltering anel iodine proposed sending this document to the nationwide is and, in 1990, the NRC prophylaxis)
FDA and FEMA with the '
announced that it was reconsidering the recommendation not to stockpile and existing Federal policy.12 April 1992, a The Petitioner's Discussion of the i
distribute KI. The petitioner indicated contractor under the sponsorship of the Merits of the Petition for Rulemaking that the NRC staff briefed the NRC Office of Nuclear Regulatory The petitioner believes the NRC Commission in November 1983 on the Research issued a report that included should implement the recommendation NRC staff's proposal to tale a strong a revised cost-benefit analysis of the use of the Kemeny Commission and that the position against KI. A policy statement of KI. The petitioner described the United States should maintain the was later issued that disposed of the report as concluding that stockpiling KI option of using the drug KI for public Kemeny Commission's recommendation. continued to be not cost-effective, but
' thyroid protection during nuclear which favored stockpiling KI. According that the difference between costs and accidents. The petitioner requested that ~
to the petitioner, only a year later, the benefits was narrower than had been the Commission definitively review and Chernobyl accident would give tangible calculated by the NRC staffin the early decide on the issue rather than simply proof of the value of the drug in 1980s. The petitioner further indicated having the NRC stcff decide not to radiological emer8encies, that, in December 1993, an industry propose it to the Commission.
The Petitioner,s Discussion of the trade group, the Nuclear Utility The petitioner stated that evacuation Management and Resources Council, is not necessarily the protective measure ho hernobyl sent a report entitled " Review of Federal of choice in every emergency, and even
'The petitioner stated that duriog the Policy on Use of Potassium Iodide," to when it is the preferred option, it is not Chernobyl accident of 1986, the the Commission arguing against any always feasible. The Kemeny damaged reactor spewed radioactive change in current KI policy.
Commission report explained that iodine over a wide area of what was The petitioner noted that,in March different types of accidents, and the then the Soviet Union und Poland. The 1994, the NRC staff declared its support particular circumstances presented, may petitioner further stated that in Russia, for KI stockpiling. However, the NRC call for different protective measures.
the Ukraine, and Belarus, where the staff proposal for a change in policy was The petitioner notes that maintaining a distribution of KI was inadequate and not adopted, the Commissioners having KI option ensures that responsible 1mtimely, the population in these voted 2 to 2 on the staff's proposalin authorities have the option of additional countries is now experiencing May 1994. (Under Commission protection at their disposal.
extraordinarily high levels of c'didhood procedures, a tie vote means that a The petitioner indicated that NRC has thyroid cancer However,in Poland, proposal fails.)
made it clear that a finding of adequate where KI was administered to 97 emergency planning does not translate percent of the nation's children, there The Petitioner's Discussion of into a guarantee that the entire affected has been no similar increase in thyroid. Additional Sr.pport for Granting the public can be evacuated, but that cancer. The petitioner noted that Poland Petition for Rulemaking evacuation is generally feasible.
is a proof-positive example of the The petitioner described a September The petitioner believes that benefits of a well-prepared KI program.
1994, FEMA publication proposing a sometimes, either by choice or i
The petitioner stated that the U.S.
" Federal Radiological Emergency necessity, authorities may decide to i
Government is spending money to study Response Plan" tnat envisioned tb s use shelter people or tell them to remain radiation-caused thyroid cancer in the of KI during radiological emergen les.
indoors rather than evacuate them. The i
Ukraine and Belarus, and the
. Under the plan, the NRC would be the petitioner points out that it may be Department of Energy (DOE) announced lead Federal agency during emergencies desirable to administer KI any time a $15 million,15-year program that will at nuclear power plants and would people are sheltered or told to stay j
follow 70,000 children in the Ukraine, advise S. ate and local governments indoors, when evacuation routes would to understand the thyroid cancer risk of whether or not to distribute KI (based on take people through areas of radiological exposure to radio iodine. The petitioner advice received from an interagency contamination, and when there has been further stated that the U.S. Government panel). The States and localities would a large airborne release of radioactive
/
has spent generously to bring Ukrainian then administer the KI, af necessary, he iodine to the atmosphere.
i I
doctors to the' United States for training The petitioner also indicated that t The petitioner believes that the in thyroid surgery because mishandled Board of Governors of the International decision on stockpiling KI should turn operations can result in damaged nerves Atomic Energy Agency, with U.S.
on whether, given the enormous
i
-31740 Federal Register /Vol. 64, No.113 /Mondty, Juna 14,1999/ Proposed Rules consequences of being without it in a States do not have an adequate basis for actions during an emergency, consistent with major accident;the drug is a prudent making informed decisions. He believes Federal guidelines, are developed and in l
P ace and protective actions for the ingestion measure; not on whether it will that the Federal Government, and NRC
',xP,oy8 appropriate to the necessarily pay for itself over time. The in particular, has failed to provide the w
]
nd P8 -
petitioner further believes that KI States with sound technical advice on represents a kind of catastrop_ hic-the subject. The petitioner also believes The petitioner believes that if this e
coverage insurance policy offering that without accurate and current revised change is adopted, the plan will protection for events which, while they information on XI-including the become an accurate description of occur only rarely, have such enormous Chernobyl experience and the ernergency preparedness for radiological j
co ences that it is sensible to take consensus of international experts--
emergencies; the acommendation of the s
precautions.-
States cannot make aninformed Kemeny Commission will at last be q
The petitionerstated that the Judpnent.
Implemented; and the United States will estimates of K!'s cost-eNectiveness The tioner believes that no State be in compliance with the International depend on estimates that are no more or1 official or member of the public Basic Safety Standards than informed guesses about the could imagine that in a real emergency, The pe6 Hone suggested that the Probability of severe accidents and that there woufd be no KI to administer. The. NRC, enher on its own m joindy with the NRC's cost-benefit analysis of the petitioner raised the question:If KI ther agencies, issue a policy statement carly 1980s was based on the st iling is not worthwhile, why is declaring that KI stockpilingis a assumption that a severe accident with thep ministration of the drug one of the reasonable and prudentmeasure thatis a major release of radioactivity could protective measures identified in the necessary to ensure that the drug will be..
avaHable in die went d a snajw
. occurin this country only once every 1 1994 Federal Emergency Response Plan? accident. The petitioner believes that or 2 thousand years.
He also asked why, if KIis worthwhile, The petitioner believes that ifit we" as the lan. implies, something.is not this statement would clarig nacK1 can that really truethat serious accidents.with a.
3, tag [one to make sure that it is.
be used in conjunchn wi uation release of radia=cHvity were so unkkely, available.
and sheltering to maximize protection to there would be good reason not only to The tioner believes that the O'[**EC-reject stad=ma= of K! but also to Fed Govern = ant should either PMMoner also behens &at die -
dispense with aH emergency pl=nni"E
. The petitioner also stated that if KIis change the 1985 policy and make the Policy statement would show the l
don 6 a mal willingness f the NRC to provide a-use dKIa via a obld explain why the st ekpile of the drug to States and not cost-eNectise,.then the rest of
, or it sh nuclear emergency planning is probably. [ni%tes has decided that KIwill.
I calities uPon request, and would..
not cost-effective either...
not be an oP a support the Kemeny ra==i== ion's d
The petitioner believes that cost.
recommendation to create regional -
benefit analysis is a technique that The Petitioner's Propeeed Annendment stockpiles of the drug as a backup for should be applied with good sense, to the NRC *.
emergencies.
esPecially where public health measums in the original petition (PRM-50-63)
Discussier peti the ben t ysis of KI 5 e on r t that 50 NOCW8 of cinolSUPPliesfor proceeded.from the assumption that CFR 5' art 50 be amen 7ed to include Nuclear, Biological, and Chemical.
there was no difference in desirability e taken from FEMA's Federal Agents UpsS between prevention of radiation-caused-Ra ologicalEmerBen Response Plan in June 1995, the President issued thymid disease.and cure. Thus, the only. of September 1994, an7 recommended Presidential Decision Directive 39 factor to be considered in evaluating KI was the cost. The tioner also the following revision to the regulations. (PDD-39) on U.S. Policy on Counter The petitioner proposed that Section Terrorism. The PDD-39 directed Federal believes that the
.S. Government 50.47(b)(10) be amended to read as agencies to take a number of measures determined that instead of spending tomw,:
to reduce vulnerability to terrorism, to money to prevent radiation caused deter and respond to such acts, and to thyroid disease, society should spend its (to) A range of protective actions including stm@u g6Hhwed s t ac tion a d ph c
money treating the disease if and when.
b,,
go p1 manage the consequences of ferrorist -
H occurs.
exposure pathway EPZ femergency planning use of nuclear, biological, and chemical; The petitioner believes that the zonel for emergency workers and the public.
(NBC) weapons, including weapons of existing licy on KI was defective from Guidelines for the choice of protective mass destruction. The PDD-39 assigned -
the start use it was based,in part, actions during an emergency, consistent with to FEMA the task of ensuring that the on inaccurate information provided to Federal guidelines, are developed and in -
Federal Response Plan (FRP) was the NRC Co==l==ioners. He stated that, place, and protective actions for the ingestion adequate to respond to the the information provided to the NRC exposure pathway EPZ appropriate to the Com=Immioners seriously understated locale have been developed.
co"kuences of terrorism.
F k coordbanon wie 6e 1
the significance of radiation-caused in the revised petition (PRM-50-63A) Catastrophic Disaster Response Group thyroid disease and thereby understated that was submitted on November 11, (CDRG) 2, developd a draA report to the to an equal degree the value of KI.
1997, the petitioner requested that 10 President entitlea,"An Assessment of The petitioner also believes that it CFR 50.47(b)(10) be revised to read:
Federal Consequence Management w.s not clear that the Commission had
^
pro 1 e
elod'sdap any idea of the real nature of post-zr i The CDRC is the headquarters senior level 1
d accident thyroid disease at the time it emergency workers and the public. In co rdinatins sroup which addressues policy issues 5
adopted an anti-KI position.
d eloping thi f eti rosardins the Federal Response Plan (FRP). The b n sfven o evacuation,
,,,,,,[,, hederal de M anfasencies 0
The tiener stated that existing consideration policy eft the judgruent on stockpiling sheltering, and the prophylactic use of with responsibilities under the FRP. The NRC is K1 to the, States. The petitioner asserts potassium iodide (KI), as appropriate.
represented by the Incident Response Division that this policy also ensures that the Guidelines for the choice of protective Director. AEOD.
_ Federal Register /Vol,.64; No.11a/ Monday,.Jims 14,1999/Propos d Rul:s 31741 Capabilities for Response to Nuclear, i interested parties. Tha subcommittee ths petition:r amended his petition to Biological or Chemical (NBC) conducted a public meeting on June 27, ask for a rule that would require that Terrorism," dated June 12,1996. The 1996. The subcommittee evaluated all consideration would be given in the re ort recommended, among other comments from the June 27 public formulation of emergency plans to the s, that the Federal Government meeting and made the following use of KI as a supplement to evacuation p
e and stockpile thyroid blocking recommendation regarding the Federal or sheltering, and on June 26,1998, the agents (KI) for the general public that KI policy:
Commission granted the amended 6
could be used in the event of a nuclear
- 1. Without changing the Federal policy by petition, and directed the NRC staff to terrorist event.The NRC was a member interceding in the State's prerogative to make mitiate the requested rulemaking. The l
cf the Core Group which generated the its own decisions on whether to use KI, the Commissioners also decided that the recommendations and was instrumental Federal Government (NRC, or through FRPCC Federal Register notice on in adding KI to the. list of rpedical FDIA) should fund the purchase of a Federal KI policy should include a lies to be stockpiled nationally, stockpile for a State that decides to statement to the effect that the State and sube Core Group concluded that as the, incorporate KI as a protective measure for the ' local decision ma Bene p result of recent events, significant Proper information, may find that the mmittee beheves & lan e
threats over the past few years, and the in the 1985 poli should be softened to use of KI as a protective supplement is increased availability and proliferation ~ more flexible an7 balanced. For example, the reasonable and prudent for specific of NBC matarials, there is an increasing problem many interveners observe with the local conditions. On September 30, concern for the potential of terrorist Federal policy is the Itahcized statement 1998, the Commission approved a draft incidents. NBC events, the report "The Federal position with * *
- potassium Federal Register notice and directed continued, may occur as a local event iodide for use by the general public is that thatit be sent to the FRPCC.
with potentially profound national it should not be required." It would not be On November 27,1995 (60 FR 58256),
implications, la responding to these as negati,ve if the last phrase were reworded a Notice of Receipt of the Petition for Is qui d,bu Rulemaking was publishedin the svents, the firrt responders must be able
,o p bi n
to provide critical resources to the selected as a protective measure et the option Federal Register requesting public victims. These include, but are not of b state or. in some cases. local
. comment. A total of 63 comment letters limited to, chemical nerve antidotes, governments."
were received, of which 20 utilities,9 vaccines for anthrax, and antibiotics,
- 3. The subcommittee recommends that State governmental agencies,2 utility The Core Group identified the need to local Jurisdictions that wish to incorporate KI interest o anizations.1 letter signed by purchase and preposition stockpiles of as a protective action for the general public 12 health ysicists,2 State universities adequate medical supplies at the sh uld consult with the Stste to determine if and 1 mem r of the public were against Federal, State, and local level. While KI
-these " "8'
' P mp l te ve th augo {ty o,,
the granting of the tition for was not considered as vital as chemical go,rnm t approval to incorporate KI as a protective rulemaking. Those etters in favor of nerve antidotes and vaccines, the NRC measure for b general public, they would granting the petition came from 5 staff was successfulin getting KI need to include this measure in their environmental groups,22 members of included with other medical supplies emergency plans.
the public (including 2 from the for NBC events because of the unusual Analysis ofIssues animad by Public Petitioner), and the American Thyroid characteristics of these events.
Comments Association.
Eecause of the special characteristics On December 17,2007 (62 FR 66038),
of NBC events, the Core Group The Commission has considered the the Commission published a request for KI olicy question on numerous public comment on the revised petition rncommended a broader range of P
protective actions. The NRC concurred occasions since 1984. The voting history in the Federal Register. In response to in the findings of the report in a letter of the Commission shows that reaching several requests, the comment period dated September 25,1996, from the consensus on this policy question has was extended until February 17,1998, Director of NRC's Office of Analysis and been an elusive goal. An important by a Federal Register notice published Evaluation of Operational Data to reason for this historicallack of on January 21,1998 (63 FR 3052). A FEMA's Director.The report was consensus is that this policy question is total of 82 comment letters were subsequently presented to the President not a clear cut one. Individual received, of which 13 utilities 3 State in February 1997, and approved for Commissioners, past and present, have governmental agencies,1 utility interest distribution in May 1997. However, di3ered in their views with respect to association, and 1 member of the public FEMA recently reported that the federal the relatice importance to be given to were against granting the petition for stockpiles of KI are few and stocked factors bearing on the KIissue. These rulemaking.The letters in favor of only for first responders to terrorist honest differences have led to divided granting the petition came from 8 public action. As things stand now, needs of Commission views on how to resolve interest groups,46 members of the members of the public for KI on an ad the policy question. The Commission is public (including I from the petitioner),
hoc basis would have to be supplied agreed that its historical difficulty to 3 physicians,2 U.S. Senators, and i from other sources. As stated above, the reach consensus on the KI policy State Representative. The following Commission intends to work with questien underscores the reality that issues were raised by the public FEMA to assure that stockpiles contain this policy question is not a simple one, commenters with an accompanying adequate supplies of KI.
is not one that is easily resolved and, as NRC staff response:
a result,has been the subject of Issue 2:Nearly all nations with FRPCCSubconunittee on Kf(1996) protracted deliberation.
nuclear power protect their citizens by Along with petitioning the NRC, Mr.
On November 5,1997, the having KI readily available and the a
Crane also requested that FEMA review Commission held a public meeting with logistics of distribution do not seen to his petition and reconsider the Federal its staff, FEMA representatives, and the pose any significant problems. Would policy. In early 1996, the FRPCC author of the 1995 rulemaking petition implementing a policy of using KJ for convened an Ad-Hoc Subcommittee on to consider the petition and proposed the general public be so difficult?
Potassium lodide to request and review changes to the Federal policy on the use StoffResponse: At the November 5, new information on this matter from of KI. in part as a result of the meeting, 1997, Commission meeting, senior NRC
'31742 Federal Register /Vol. 64, No.113/ Monday, Juns 14,1999/ Proposed Rulu staff mamhers told the Commission:
cincer, there has been no confirmed cancer. Taking into account the "We recognize that there are difficulties increase in the rates of other cancers, spontaneous rate of this disease in this in distribution, but they are not including leukemia, among the first age group and the number of evacuated insurmountable. If a decision is made by responders, liquidators,2 or the public, persons, all of these cases are the State to doit [ stockpile and/or
. that have been attributed to release from considered accident-inducedc predistribute KI) we can out a the accident.
The total number of excess thyroid way to do it."It is the s perception Delarus Experience. With the cancers in Belarus children is currently that if the State decides to include KI as Chernobyl plant located only 4 miles (7 about 750, and is estimated to reach a a supplemental protective measure for km) away, Belarus was heavily maximum of more than 3500 over the the general public, one possible method impacted by the accident. This impact lifetime of this cohort.3,4,6 The vast ofimplementation could be that the was he%htened by the fact that majority of the thyroid cancers were State could make K1 readily available protective actions were not diagnosed among those living more than where other over-the-counter drugs can implemented in Belarus during the first 50 km (31 miles) from the site.
be purchased. The publiccould be six days after the accident. Several The inemase in the rate of thyroid informed of the drug's availability authors have stated that KI was cancers in Belarus is concentrated through the yearly emergency distributed to the population in Belarus among those who were youngest at the pre,,e='- information nrochure that during the first week following the time of the accident. Portunately, these la mailed out to all residents throughout accident.* However, there is no cancers respond favorably to early
)
the to mile EPZ. It would then be up to confirmed published data on the dosaae, treatment; to date, two or three of the 1
individualmembersof the ublic to coverage, or other details concerning the Belarus children diagnosed with thyroid
{
obtain and store this sup
- ofKI, implementation of the thyroid blocking cancer have died as a result of that
. which should then be a e for use in Belarus.4 In addition, cows typically disease.e in the event of an emergency.The grazed in Belarus at the time of year Poland Experience. Poland detected administration of the KI could be at the ~ when the accident occurred, and yet no increased levels of airborne radioactive direction of the State Medical Officer.
efforts were taken to restrict the contamination on the night of April 27, Issue 2:It is " factual that the 1986 consumption of contaminated milk for 1986 (day 2). Although thnre was no Chernobyl accident clearly the first to days following, the accident. official notification of the uccident by demanstrated the beneSt of having KI On May 2 (day 7 following the the USSR,it was assumed, on the basis readily available. In Poland, where accident) the decision was made to of Taas News Agency reports, that the authorities expediently ad=laistered 18 evacuate the areas of Belarus and increases wme attributable to the million doses of KI,97 percent of all Ukraine within 18 miles (30 km) of the accident at Chernobyl. On April 28 (day Polish children were protected from plant (30 km zone). The evacuation was 3), the country formed a governmental thyroid disease. In contrast, there are completed on May 5,1986.
commission to recommend protective soaring rates of childhood thyroid -
Since 1990, a rapid increase has been actions. Among these actions, the cancer,200 times pre-Chernobyllevels, observed in the incidence in thyroid commission recommended intervention in the former Soviet wpublics of Russia, cancer among Belarus children who levels for taking protective actions on Belarus, and the Ukraine because very were o to to years old at the time of the the morning of April 29 (day 4)J little KI was administered, too long after accident. Before the accident, the rate of On April 29, Poland's Minister of exposure."
thyroid cancer among this cohort was Health gave orders to prepare and I
9taff Response:The Chernobyl reactor about 0.4 per 100.000: by 1996, this rate distribute KI to the il provinces most (s RBMK-1000 design) is located in the had risen to 3.9 per 100,000.s,* This affected. K1 was to be made available Ukraine close to Belarus. The accident included approximately 3,000 children. through hospitals, public health centers, occurred at 01:23 on Saturday,26 April o to 18 years old, that were evacuated schools, and kindergartens. The country 1986, when explosions destroyed the from the 30-km zone within Belarus.
used its mass media to announce the reactor core and reactor building. The Among this group, four thyroid cancer protective action and to appeal for explosions sent debris from the core cases have been detected since the volunteers to assist in the nationwide flying into the air and exposed the accident. All of these cases wem distribution.
reactor core to the atmosphem. The registered after the end of the latent The Commlasion then instituted the heavier debris from the plume was period for radiation-induced thyroid f6110 wing additional protective deposited close to the site. In general, measures:s the initial release is thought to have 81.i
- f **quidatore are e Ierse numba (about 200.000)
. Feeding of cows on pastures or with risen to over 1 km in altitude, thereby
'kers and militarygonnel who perfonned fresh fodder was banned w=Mde until fuP caswum anmP e ua.and oth May 15,1986, h
resulting in much lower doses close to the site than those ed from a
.7 dent.
co e===Matad,o u 4,g h
- Fmsh milk with radioactivity 2
ys duringwhicha the L t
o theiyeand more than40 percent of nobl 3,,7
. All children under the age of 4 wm inam are estimated to have been e -ityroid cancer in Children IJving Near given powdered milk through numerous released. The varying meteorological Chernobyl, Expert Panel Report on the
, distribution centers.
conditions, release rates, and release of the Chernobyl Accident"-
e Children and pregnant orlactating F-h resulted in yery complex dose WHBanu D. gt al.. K.H. ECSleEABC, Report EUR women wm advised to eat a minimum of 1s24: EN. Bruhola-1.uxemhou:g.1993, p. los.
fresh leafy vegetables (until May 16,1986)..
It poften assumed thatund deposition pattoms
,g, go,io,,,,,3,. rhyroid Cancer in silarus on was After the Chernobyl Accident: Incidence, Prognosis, the major source of thyroid ose early Risk i
-=at."Iow Doses oflonizing Radiation:
,The implementation of Short term Coun: r After a Nuclear Accident, in the accident. However, the stological Effects and Regulator Control. Spain.
Proceeding of an NEA Workshop Stockholm,"
=
contribution ofinhalation cannot be No 199 on oper p 2
Sweden,1-3 June 1994, OECD 1995.
assessed because air sampling was not of Belarus." Oksanov A. et al., Radiation and Risk e Manuel on Public Health Actions in Radiation affectively conducted early in the suustin of National Radio-Epidemiological Emergencies. WHO. European Center of accident. As of 1996, except for thyroid Registry. Obninsk. 1995, lasue 6. pp. 236. 239.
Eovironmental and Health, Rome Division.1995.
I
Federal Register /Vol. 64, No.113/ Monday, Juns 14,1999/ Proposed Ruhs 31743
. The distributi:n of KI was initi:ted on stations, thereby allowing prompt resulting from exposure to one April 29 (day 4) and was virtually '
distribution. A further description of the important group of radionuclider, the 1
- completed by May 2 (day 7). This WHO guidance is provided below, radiolodines. That is why current NRC l
included the distribution of KI to more followed by a discussion of the guidance discusses KI for plant than'90 percent of the children under guidance promulgated by.IAEA'and a personnel, emergency workers, and the age of 16 and about a' quarter of the comparison between U.S. and institutionalized persons unbly to be adults. A total of 10.5 million doses of international practice.
evacuated promptly.
- KIwere given to children and 7 million WorldHealith Organization (WHO)
In this light theen-mi.. ion agrees doses were given to adults. Multiple Guidance. The main points of the WHO that the use of KImay be determined by doses, although not reca===nded, were. Guidelines to.11 regarding the use of State and local emergency response taken in a number of cases. Because of stable iodine are as follows:
plan'ters to be a sup protective measure. plementary d8=8ai hia= air contamination, the KI
- Nearfleid: stable iodine should be' iiin the available for immediate distribution to all Issue 3:"Staanitia= or prophylaxis was not m'ponse, powde ed aroups if the predicted thyroid dose is likelY predistribu second phase of the res
~
- exceed milk was made available to all children
,ci,,,ined m' as a protective action would not add any db less than 4 years of age.This program stored or predistributed to facilitate prompt signiacant public health and safety e5setively started on May 3 (day 8),
utilisation.
beneSt to the current level of protection It is estlmated that approximately a
. Farfield: stable lodine'should be Provided by exi emergency plans 40-45 percent reduction in thyroid available for distribution to pregnant women, for commercial n ear power plants, burdenwas~achievedbythyroid '
neonateL, infants, and children if the Our emergency plans focus on blocking and milk restrictions in the 11 Predicted done is likely to exceed referene, evacuation as the key protective action provinces treated.7 Had the Russian imls.
to prevent exposure since it protects authorities given prompt w
,the Conclusion from Polish Experience. In against exposure to all radionuclides, 24-or 48-hour in time have Poland (1) Small amounts of radioactive not }ust iodine. In addition, the improved the o veness of air iodine were deposited as a result of the potential for misad=lnistration of Ka is Chernobyl accident, (2) no protective present when predistributed to the resEusewere no reported serious actions were taken for the first 2 days of general public, and incidents of adverse reactions except for two adults the accident, and (3) protective actions misadministration have been informally with known todido sensitivity. About (except sheltering or evacuation) were reported at industry meetings by states 36,000==dic=11y ignificant reactions taken after the first 2 days of the which predistributed KI to the public."
were also (mostly nausea).'
accident. Because of the low 16 dine StaffResponse:The Commission Because of low iodine concentrations in Poland and the agrees that it is the State's prerogative to concentrations in Poland it is doubtful protective actions implemented, Poland decide toinclude stockpiling or that epidemiological studies could has not detected excess cancers Predistribution of KI as a protective detect excess cancers resulting from resul from intake of radio iodines.
action for the general public. The FDA intake of radio iodine."
Chernobyl Conclusion.The concluded that risks from short term use InternationalPractiare-During this World Health Organization, almost of relativel low doses of KI are out assessment, the NRC staff avamin=d the every industrial country in the world weighed b the radiologically induced current policies and rectices regarding with nuclear power plants, and the thyroid n ules or cancers at a the use of thyroid b during American Thyroid Association, believe projected dose to the thyroid gland of 25 Nuclear Power Plant acci ots for a that the low lodine concentrations, the rem or serester. In so doing, the FDA number of countries, The NRC staff hanninF of the consumption ofinsh approuiKI as an over-the-counter accomplished this task primarily milk and the distribution and drug. The American Thyroid through personal enmmunication with administration of 90 million doses of KI Association fully endorses the use of KI colleagues in each country. In general, contributed to the observedlack of and, as previously @=e-
-+ there were the countries either are following or facrease of childhood thyroid cannars in only 2 i==iamat adverse reactions and intend to implement systems that are Poland. Most industrial nations with 36,000 medically significant reactions consistent with the mad==a=
nuclear power plants have decided to (nausea) in 90 million doses of KI after T
promulgated by the World Health stockpile KI around nuclear power for the Chernobyl accident. The taki"F of KI Organisation (WHO). Sa=eineall, the use by the general public, should require pmcautions similar to y
WHO recommends predistribution of In contrast to the Chernobyl those associated with any other over-the stable iodine close to the site and experience,in the event of an accident counter drug, and, of course, the stockpiles further from the site. These in the United States, our emergency anA=Pg instructions should be stocks should be strategically stored at planning calls for protective actions, followed.
points such as schools, hospitals, sheltering, evacuation, and removal of Issue 4:" Evacuation is more feasible pharmacies, fire stations, or police contaminated food from consumption and practicable. Staantilng of KI has all of which significantly reduce the risk logistical problems wliich we feel
' A, m.ny.i,.m t,s etion wm one sor of exposure of the public to all renders this idea impracticable and which the puun suSwiss the medon consulud radionuclides. Making KI available to unmana ble."
' @ p, g " '"'*
memotorwa abnaxie tn7o"neAEtEcNyt the public for use during evacuation or Shrff ponse:The staff that soments and Risks."N especially sheltering could, under evacuation is usually "feasi d
Amerima Journal of u-Hei==. Vol. 84. May 19e3 certain conditions, reduce the risk practicable" and is the most effective g8sa,,g,ay,of g,,,that mce{nd protective action. If the State decides to
.~
3,
- n. Id. nowever,-itit should be pointed out that
" Inter- *- ' amic safety sesaderds for include KI as a supplemental protective ulauan Protection Assinat Ionizing Radiation and for Safety measure for the general public, one control, iues ser then side easets in a @t is,it not meiving n am not available.-Id. T of Radiation Sources. Safety Series No.115,IAEA, possible method ofimplementation L,
is not known what the inoidance of such asctions lees.
would be in a population under aind1=e stress, but H " Method for the Developawnt of Emergency could be that the State could make KI not receiving o. and thus it is not known to what Response Preparedness for Nuclear or Radaological readily available such as by rr.sking it extent these adverse reactions were the result of m.
Accident " Tecdoo-953,1AEA, July 1997 Svailable'Where other over-the-counter
31744 Federal Engister/Vol. 64, No.113/ Monday, June 14,1999/ Proposed Rults drugs can be purchased.The public benefit diminishes quickly over time StaffResponse: Approximately 18 could be informed of the drug's.
and may be very smallif administered million doses of KI were distributed availability through the yearly late. If a release is expected to continue primarily, but not exclusively, to anergency preparedness information for several days, the NRC anticipates children. The bulk of the distribution brochure that is mailed out to all that the public would be evacuated or took about three days. There were no residents throughout the 10 mile EPZ.
other protective action would be taken, reported serious adverse reactions Individual members of the public would depending on the level of release. KI except for two adults with known be responsible for obtaining and storing could nevertheless serve as a useful iodide sensitivity. The rate of serious this supply of KI, which could then be supplemental and complement to these side effects (10-7) is consistent with the available for use in the event of an primary protective actions.
frequency seen during routine use of KI emergency. Another approach to Issue 7:KIis an effective thyroid for medical treatment of respiratory predistribution is to include stockpiling blocking a8ent only when administered disease. The incidence of medically et reception centers for distribution immediately before or after an exposure significant, but not serious, reactions to during an evacuation. Other countries
' to radioactive iodine (that is, within one this single dose of KI was also very low have found ways to effectively to two hours). Distribution of KIin a (0.2 percent). In addition, no detectable distribute KI when needed and the timely fashion to the general public long-term disturbance in children's I
distribution issue is certainly not followingan accident could further thyroid function was detected as of unsurmountable. The adminieration of complicate and. decrease the 1989. Additionally, the FDA has the.KI shouhl be at the direction of the effectiveness ofimplementing approved KI for over-the-counter i
State Medical Officer.
evacuation or residential sheltering.
distribution. The staff, therefore, agrees
{
Issue 5:The Three Mile Island StaffResponse:The staff disagrees that the ost-Chernob 1e rience has
)
experience has shown us that it is not with this position. If a State chooses to shown tkat large. scale de yment of KI casy to obtain an adequate supply of KI include KI as an additional protective is relatinely safe.
in an emergency.
measure, it is anticipated that the State Issue 10: Several comments raised the StaffResponse:The commenter is could make KI readil available to the Y
correct,in that it was difficult to obtain question ofliability:"Is the NRC KI dter the Three Mile Island accident.
["[
here c b l
$r Prepared to address the number.oflegal a
li That is one reason why therammission imp cations should a member of the distribution means and that the public believes that planners should consider be made aware ofits (the KI) general public be given KI at their stnanning KI, and why the not at the time of an directive or recommandation and the Commissi n supports Federal availability'but KIcould be made individual have an extreme allergic stockpiles, so that States that have
,y,g];e round reacdon, possibly death?"; "The Federal i
chosen not to stockpile KI could have Issue 8 One of thEmajor Register Notice does not address legal access, albeit ad hoc and delayed, to an (dequate supply in a radiological impediments to estribude of M to issues for states who decide to adopt KI school children is coordination and and states who do not decide to adopt emhency at a nuclear power plant. As administradon of 6e program, e.g., the or administer KI to the public."; "The not elsewhere in this notice,the al decision making process t issue oflegalliability should not be a
Commission will work with other or ev cuate, parental dismissed lightly. If the NRC decides to a mini e agencies to assure that there are Federal rehuire star +ndino of KI for the general regi nal stockpiles that contain a prov recor eeping, gg i entificatio dd enting allergic { ability may arise fronrany adverse adequate supplies of KI. Moreover, the rea ns,an e av ity o a general availabili of KIls greater now health effects? No initiative such as this than at the time o the TMI accident, qua m
pro s on t should be undertaken without partly because of the FDA's approval of administer the potassium iodide.
d%
" "Who would KI as an over the counter drug. Some StaffResponse:The staff disagrees, g
g'was used prior St:tes have ' elected to incorporate KI Upon declaration of a general into the emergency response plans and emergency there should be NO decision to the Governor orderingits use?'
have obtained adequate supplies for this "to administer KI or evacuate." The StaffResponse:The comments focus ose. The Commissionis not aware Preferred protective action for the close. principally on concerns that State and o any factors that would constrain the in population should be evacuation. The local governments involved in availability of KI for star +ndin, administration of KI should be treated distribution and administration of KI purposes. The enmmissio' believes that in the same fashion as any other over.
may be liable in tort if an individual n
an adequate supply of KI could be the-counter medication that might be receh-ing the KI has a significant obtained.
given to children while away from adverse medical reaction to the KI. To Issue 6:Even though KI home, after observing the instructions the extent that commenters are raising administration before any exposure is Provided with the KI packaging. Prior the potential for federal government ideal, the Chernobyl experience also has Parental approval to administer KIin nability for.the promulgation of this shown that the exposure can continue '
the event of an emergency can and proposed rule, the NRC believes that.
for days. Is the institution of KI should be addressed in the planning whether the Commission may be subject l
blockade at any time in this period process for any State that decides to use to tort liability through the beneficial?
KI. The individual State may provide implementation of a KI program StaffResponse:The administration of the appropriate guid&nce and establish depends upon a number of factors.
K1is most effective if done before or a system for obtaining parental approval However,it would appear that a immediately after (withis 2 to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />) before the takin8 of other protective Commission decision to require state a release. Nonetheless, during a chronic actions that are currently being followed and local emergency planning of.ficials cxposure of several days, the in the EPZ around nuclear power plants. to consider stockpiling KI for,public administration of KI any time during the Issue 9:Does the post-Chernobyl distribution should be subject to the exposure period may block some uptake Polish experience show that large-scale
" discretionary function" exception to of radioactive lodine. However, the deployment of KIis safet the Federal Tort Claims Act,28 USC
l ped:r:J Register /Vol. 64, No.113/ Monday, June 14,1999/ Proposed Ruhs 31745 i
2671, et seq.,tswhich protects the aut$ority of the States in matters ofste and, continuing to recognize the completed on PRM 50-63 and PRM 50-Federal Government from liability. The l
63A.
question of whether a State or locality emer8ency plannirig, e licitly require might be liable forinvolvement with that planners considerhe use of KI.
Gaunini n Gndusions orissues administration of KI to the general The proposed rule change should not Ra2 sed by the Petitioner and Public public can only be answered by be taken to imply that the NRC believes O """#####8
{
reference to the laws and precedents of that the present generation of nuclear The Commission having reviewed the l
Particular States. The NRC presumes power plants is any less safe than issues raised by the petitioner and the that this would be part of the previously thought. On the contrary, public commenters, has reached the 4
" consideration" that States and present indications are that nuclear following conclusions:
localities will undertake if this rule is Power plant safety has improved since A. The Commission agrees that KI, promulgated. The NRC h'as not the current emergency planning when determined by State and local undertaken this analysis.
requirements were put in place after the emergency response planners and if Issue 22:Does the Cammidon Three Mile Island accident.
ariministered in a timely fashion, could consider stockpiling and using KI as a The use of potassium iodide is protect the thyroid gland from exposure reasonaMe and prudent rotective latended to supplement, not to replace, to radiolodines inhaled or ingested measureforthegeneral ublicf other protective measures. This rule following a major radiological accident.
StoffResponse:The mmission r'hange thus represents no alteration in This is the basis for stockpiling it and believes that State and local decision the NRC's view that the primary and distributing it to amergency workers and makars, provided with proper.
most desirable protective action in a institutionalized persons during information may find that the use of KI radiological emergency is evacuation of radiological emergencies. The petitioner as a protective supplement to the population before any exposure to
' believes that the distribution of KI was evacuation and sheltering is reasonable radiation occurs, whenever that is inadequate and untimely in the Ukraine and prudent for specific local feasible. (Evacuation protects the whole and Belarus after the Chernobyl conditions.
body, whereas potassium iodide accident in 1986 and that this accounts protects only a single gland,the for the increased incidence of thyroid Coen11ssm.n &dsfon thyroid.)Inpending on the cancer in these areas. He also argues KIis a reasonable, prudent, and circumstances, KI may offer additional that distribution of KIin Poland was inexpensive supplement to evacuation protection if used in conjunction with timely and effective and that no similar and sheltering for specific local evacuation and/or sheltering.
increase in the incidence of thyroid conditions. Therefore, the Commission's The NRC recognizes that the decision cancer was seen. The Commission guidance on emagency planning has to stockpile KI presents issues of how considered all of the above information long taken KIinto consideration best to position and distribute the in deciding to grant the petitioner's (NUREG-0654/ FEMA-REP-1, Rev.1, p.
medicine, to ensure, e.g., that optimal requested actions.
63, items e and f.). However, since the distribution takes place in an B. The Kemeny Commission criticized '
1:st revision of that guidance, there has emergency, with first priority given to the failure to stockpile KI and been experience with the mass protecting children; that persons with,
recommended that regional stockpiles distribution of KI during a radiological known allergies to iodine not take it; be established. The Kemeny emergency, and though the record on that members of the public understand Commission's report recognized that that ciistribution is not complete, the that KI is not a substitute for measures evacuation was not invariably the indications thus far are that mass that protect the whole body; etc. To preferred response to an emergency and distribution is effective in preventing date, these issues have been addressed that even when evacuation was thyroid cancer and causes remarkable in different ways in the numerous desirable, it might not be feasible. The few threatening side effects. Moreover, countries that currently stockpile KI.
Commission believes that prompt many nations in Europe and elsewhere, The NRC is working with States and evacuation.and/or sheltering are the nations as different in their localities to develop guidance on these-. generally preferred protective measures circumstances, politics, and regulatory and other palats relating to the use of for severe reactor accidents. In structures as France, Canada, and Japan, KI. The NRC believes that these developingthe range of public have stockpiled KI and planned for its implementation issues can be solved, protectiva actions fnt severe accidents at use. So have some U.S. States. The given the level of rtise in the commercial nucleurepower plants, World Health Organization and the relevant Federal State agencies, and evacuation and in-place sheltering International Atomic Energy Agency the experience-of numerous nations that provide adequate protection for the recommend its use. Therefore, in order have built KIinto their emergency general publIc. The Commission to achieve greater assurance that KI will plans.
believes that KI for the general public receive due attention by planners, it it is expected that States will inform should not replace evacuation and seems reasonable to take a small further FEMA and the NRC of the results of sneltering, but supplement them.
their consideration of whether to opt for C.The Federal Radiological mrtus excepuen from watvw of sove.wisa stockpiling. This will enable the Federal Emergency Response Plan (FRERP)is immunity provida that:
government to engage in better the plan that would be used by the Any claims bened upon an act or omission of an contingency plannin for States that Federal Government to support State omglora of the Covanment. uncisins due care, decide against st KI.
and local officials in responding to any Irno*"uNtute rMe"onDidIoD The Commission n is peacetime radiological emergency. Such upon the anci.e or puformance or the fanure to implemented by publication of this emergencies range from transportation pen:ise or perform a discretionary funcuon or duty proposed rule that would change 10 accidents involving radioactive on the part of a fedwal egency or en employee of CFR 50.47(b)(10) with a 90-day public materials to 16rrorist events involving heen a not &a &credon bYd comment period. If the proposed rule is nuclear materials. The FRERP includes to e as usc seao(a). i.inited states v. varts Airlina, adopted in final form, the petition a range of protective actions ser u.s. ro7, aos (1984); serkovier v. united states, would be granted in part and denied in commensurate with the risks associated 488 ns. sat (seest part and NRC action would be with the range of emergencies for the
31746 Federal Register /Vol. 64, No.113 / Monday, Juns 14,1999/Proposrd Rules general public and am workers.
agency to fund ths stockpiling.
rulemaking is in responsa to this These protective actions de Historically, funding for State and local: directive.
l ov-e==+1a=. sheltering,ble iodine. With emergency response planning has been Alternatives were essentially and the
. ophylactic use of sta the responsibility of those governments considered in previous documents. In l
respect to protective actions for nuclear. usually working with licensees and, SECY-97-124 Oune 16,1997), on the power plants, the NRC and FEMA have absent Congressional funding
" Proposed Federal Policy Regarding Use issued Draft Su lament 3 to NUREG-spartne=11y for this purpose. NRC is not of Potassium Iodide after a Severe l
0654/ FEMA
-1, Rev.1, to provide prepared to fund stockpiling of KI.
Accident at a Nuclear Power Plant." The e
upd:ted guidance for the development of protective action recommendations II"$"88 staffidentified three options, one of which contained three sub-options, for severe reactor accidents.This MetricPolicy concerning a proposed change in the document emphaaivaa that prompt On October 7,1992, the Commission Federal policy regarding the use of tvecuation is the preferred protective published its final Policy Statement on Potassium iodide (KI) as a protective action for actual or projected severe core Metrication. According to that policy, measure for the general public during damage accidents.
fter January 7,1993, all new severe reactor accidents. Next, in an a
D.Tnerammission recognizes that in 1994 the Board of Governe of ee regulations and major amendments to
. SRM dated June 30,1997, the IAEA adopted new International Basic existing regulations were to be Commission approved an option that Safdy Standards. With mpect to presented in dual units. The endorsed the Federal offer to fund the emergency planning, these standards amendment to the regulations contains Purchase of KI for States at their request no units' and endorsed the Federal Radiological Provide, among other things, Preparedness Coordinating Committee
" intervention levels for immediate Environmental Assessment and Finding of 8
h (FRPCC)
N & a@W Pmteedve acdon, inclueng sheharing, f,'gf,gf,%3*mgn ti o the Use to State an ocal governments of the evacuation, and iodine prophylaxis. It of PotassiumIodide (KI).
Federal stockpiling of KI.
is important to note that each country bases its response plans on local and I. Introduction II.Need for Action j
regional characteristics. For example, On September 9,1995, a petition for In SECY-97-245, the staff proposed Italy and France, the same rule==Hng (PRM 50-63) was filed with options for resolving the referenced international stan and guidelines, the NRC by Mr. Peter Crane. The petition for rulemaking. In SRM 98-061,
)
implement them differently, blets has petitioner requested that the NRC the Commission directed the staff to E. Although the cost of KI ta amendits emergency lanning proceed with the rulemaking.
doubled, therammission agrees with regulations to require t emergency III. EnvironmentalImpact of the b NRC staff m'imata and obr E
Propond Action n:tions' experience, that the purchase of cd clu h
KI tablets is relatively laexpensive. KI -
actic use of The environmentalimpacts of the '
{
related costs increase when the cost of evacuation, and the pr -
proposed action and its alternative are gy i
maintananae, distribution, and public jn SECY 97-245, dated October 23, considered negligible by the NRC staff.
education are considered. However, the 1997, the staff provided three options Given the proposed action would only overall cost is minimal when placed in for the Commission's consideration in add the sentence: "In developing this the context of emergency planniglii""
order to resolve PRM 50-63.
range of actions, consideration has been and should not be a deterrent to stae_
On November 5,1997, the given to evacuation, sheltering, and the KI for use by the general public sh,ould' Commission was briefed by the NRC prophylactic use of potassium iodide State and local decision==ka s staff, the Federal Emergency (KI), as appropriate." The staffis not cetermine that the prophylactic use of Management Agency (FEMA), and the aware of any environmentalimpact as a KIas a supplement to evacuation and petitioner regarding the options result of this proposed action.
Mas onhieves that IV, Alternative to the Proposed Action u
n m
robust regional stockpiles should be Comminaion invited the petitioner to The alternative to the proposed action established to enable use by States that submit a modification to his petition in at this time is to deny the petitions and have not established local stockpiles order to address views he discussed take no action with respect to the use of and wish to make use of KIin the event d the masting.
KI by the public. Should this no-action of a severe nuclear power plant On ovember 11,1997, the petitioner alternative be pursued, the staff is not accident.
submitted a revision to his petition PRM aware of any resulting environmental Commission Decision To Fund D 50-43A, which requested two things:
impact.
On June 30,1997, the Commission
- 1. A statement clearly recommending V. Agsacies aand Persons Consulted voted to approve the NRC staff PrQ%of KIasyreasonable and st g
recommendation to endorse the FRPCC
- 2. A posed rule to to CFR Emergency Management Agency were sera = mand =*ians for the Federal so.47(b$ol which wo accomplished consulted, as was the petitioner, as part Government to fund the purchase of by inserting the following sentence after the of this rulamalring activity.
Potassium iodide (KI) for States at their first sentence: "In developing this range of -
request and endorsed the FRPCC actions, consideration has been given to VI. Finding of $o Significant Impact:
recognition of the availability of the evacuation, sheltering, and the prophylactic Availability m of otassium iodide (K4 as appropriate."
The Commission has determined Federal stocyle of KI to State and local P
governments sor purposes of mitigatisg.
On June 26,1998, the Commission under the National Environmental the consequences of terrorist use of '
disagreed with the staff Policy Act of 1969, as amended, and the nnelaar, biological, or chemical (NBC) recommendation to deny the petition for Commission's regulations in Subpart A weapons At that time it was believed rulemaking PRM 50-63A by revising 10 of 10 CFR Part 51, that the amendment that the NRC was the likely Federal-CFR Part 50.47 (b)(10). This proposed is not a major Federal action l
Federal Register /Vol. 64, No.113/ Monday, June 14,1999/ Proposed Rules 31747 l
significantly affecting the quality of On june 26,1998, the Commission Response Plans and Preparedness in human environment, and therefore, an directed the staffin SRM 98-061 to Support of Nuclear Power Plants for environmental impact statement is not revise 10 CFR Part 50.47 (b)(10). This Interim Use and Comment." This required. This amendment will require proposed rulemaking is in response to guidance was. cited in the regulation and that emergency plans specify a range of this directive, speaks to radioprotective drugs protective actions to include sheltering, Alternatives were essentially including their use by the general public l
evacuation, and the prophylactic use of considered in previous documents. In including quantities, storage and means KI. This action will not have a SECY-97-124 (June 16,1997), titled of distribution and State and local plans significant impact upon the
" Proposed Federal Policy Regarding Use for decision making with respect to their environment.
of Potassium lodide after a Severe use. The Commission tenoved tea t
Accident at a Nuclear Power Plant," the citations of the guidance from the Paperwork Reduction Act Statement
. staff identified three options, one of regulation in 1987 but the guidance has l
This proposal rule does not contain a which contained three sub-options, continued in use for planning purposes l
new or amended information collection concerning a proposed change in the and by the Federal agencies for i
requirement subject to the Paperwork Federal policy regarding the use of evaluating emergency plans. As a result.
Reduction Act of 1995 (44 U.S.C 3501 potassium lodide (KI) as a protective it is believed that all of the affected et seq.). Existing requirements were measure for the general public during States have at some point considered approved by the Omce of Management severe reactor accidents. Next, in an the use of Kl. Some States have made l
and Budget (OBM) approval numbers
.SRM dated June 30,1997, the the decision to stockpile KI. Thus,in
.3150-0009 and 3150-0011.
. Commission. approved an option that practical terms, the projected costs will Public Protection Notification endorsed the Federal offer to fund the occar only in those Statesthat have not If an information collection does not purchase of KI for States at their request elected to stockpile KI.and choose and endorsed Federal Radiological stockpiling in light of.the Chernobyl display a currently valid OMB control Preparedness Coordinating Committee accident,:recent. international practice /
number, the NRC may not conduct or (FRPCC) recognition of the availability and the NRC requirement to consider sponsor, and a person is not required to to State and local governments of the the use of KL respond to, the information collection.
Federal stockpiling of KI.
It is difficult to estimate the. benefit of I
l atory Analysis of the Proposed In SECY-97-245, the staff proposed a State's consideration to stockpile KI.
minsking Granting In Part A Petition options for resolving the referenced -
However, we believe.the benefit of such
, 'for Rulemaking (PRM 50-63A) Relating petition for rulemaking. In SRM 98-06,
.an action by the States is summed up by
' to the Use ofPotassium Iodide (KI) the Commission directed the staff to the petitioner who stated that the proceed with the rulemaking.
decision to stockpile KI should tum on On September 9,1995, a petition for Given that the Commission whether, given the enormous l
' rulemaking (PRM 50-63) was filed with considered the options and directed the consequences of being without KIin a the NRC by Mr. Peter Crane. The staff to grant the petition, the only ma}or accident, the drug is a prudent
. petitionariaquested that the NRC
+ alternatives consldered.here are the measure; not on whether it will amend its emergency planning
- Commission approved option and the necessarily pay for itself over time. As regulations to require that emergency baseline, no-action alternative.
the petitioner.further noted,KI plans specify.a range of protective The proposed rulemaking does not represents.a kind of catastrophic-actions to. include sheltering,
" require" an oflicensees, but coverage insurance policy offering evacuationcand the prophylactic use of States are to ve shown protection for events which, while they KI.
" consideration" of the use of KI along occur only rarely, can have such hi SECY 97-245, dated October 23, with evacuation and sheltering as enormous consequences that it is 1997, the staff provided three options
. protective actions. It is estimated that 30 sensible to take special precautions, for the Commission's consideration in States will need to make this especially where, as here, the cost of order to resolve PRM 50-63.
consideration. Further, the staff such additional precautions is relatively
.0a November 5,2997, the estimates that the labor needed by the
- low,
. Commlasion was briefed by the NRC States could range from a staff-week, to As stated above, this analysis focuses i
staff, the Federal Emergency a half staff year. The latter being the on the rule being proposed as the result Management Agency (FEMA), and th' case if a State decided to hold hearings of a petition. Also, since the petitioner regarding the options on the issue.
Con mission has directed the staff to available foa resolving the petition for If one assumes an average hourly pursue the FRPCC results with respect rulemaking. During the meeting, the salary of 370 (this estimate includes to KI and has directed the staff to pursue Commission invited the petitioners to benefits, pro-rated secretarial and the rulemaking, the regulatory analysis submit a modifhation to his petition in.nanagerial assist mee, but not presented here is for the edification of order to address views he discussed oorhead), the reage of estimates would the decision makers so they can make during the meeting.
1:c from s2800 to $63,000. Again using an informed decision on the proposed On November 11,1997, the petitionet a base of 30 States, the range is from rule.
submitted a revision to his petition PRM $84,000 to $1.9 million.
The above constitutes the regulatory 50-63A, which requested two things:
The Commiasion notes that when it analysis for this action.
A statement clearly recommending amended its emergency planning l
stockpiling of KI as a "renonable and regulations on November 3,1980, the Regulatory F,lexibility Certification l
prudent" ru isure, and regulatory stac.iards for emegency In accordance with the Regulatory A proposed rule change to to CFR planning were a restatement of basic Flexibility Act of 1980,5 U.S.C. 605(b),
So.47(b)(10) which would be accomplished by inserting the following sentence after the joint NRG-FEMA guidance to licensees the Commission hereby certifies that first sentence: "In developi this range of and to State ancQocal governments this rule,if adopted, will not have a e
incorporated in NUREG-0654: FEMA-significant economic impact on a ai she og, and the p p ylactic REP-1, " Criteria for Preparation and substantial number of small entities.
use of potassium lodido (KI), as appropriate." Evaluation of Radiological Emergency This proposed rule would affect only
31748-Federal Register /Vol. 64, No.113/ Monday, June 14,1999/ Proposed Rules the licensees of nuclear power plants.
governmeme-4he(ntities with ths rulimaking that, altho licensees are These %==
, do not fall within thi cuthority to determins the not directly burdened ths roposed scope of the de8mition of"amall appropriateness of the use of Ki for the rule, they would be in burdened entitim" set forth in the Regulatory citizens-calling upon the governments because they would feel call upon to Flexibility Act. 5 U.S.C. 601, or the size to " consider" K1 as one of the elements explain the new policy to their standards adopted by the NRC (10 CFR of their offsite emergency planning customers. By thIs logic, almost any 2.810).
Even as to states or local governments, Commission action that led an NRC itimposes no binding requirement to licensee to issue a press release could be Bacidit Analysis alter plans and procedures.
considered a backfit. Such a position The deBaltion of backat, as set forth Furthermore, the basic standard that would represent unsound law and la 10 CFR 50.109(a)(1),is clearly emergency planning must include policy. Here, the burden of public directed at obligations imposed upon consideration of a range of protective information on licensees or applicants.
4 licensees (and applicants) and their actions,is already set forthin the if any, appears de mmimls. It plainly facilities and procedures. Section existing wording of section 50.47(b)(10). does not rise to the level of the t of 50.109(a)(1) dannaa a hacket as:
On this basis, the proposed rulein concrete burden contemplated the
- *
- the modification of or addition to reality does not impose new Commission when it enacted th backfit systems, structures, components, or design of requirements on anyone. On a rule. It might also be argued that, if e a facility; or the design approval or consideration of all of the above factors, State or local government were to
= ?: Janlicense for a facility; or the no backfit is involved and no backfit decide to stockpile and use KI for the procedures or organisation required to analysis is required.
general public,it would undertake design, construct or operate a facility, any of Commission precedent also makes interactions with the affected licensee to which may result from a new or amended clear that the proposed rule change does coordinate offsite emergency planning on in the Co===i== ion mies o he not constitute a backat. The Posi d
Although this could result in some Commission's position was stated voluntary action by the licensee to n
dther new or diSerent from a previously explicitly in 1987, when the last major coordinate its planninF. the proposed rppHcable starposition * * *.
changa took place in emergency rule itself does not impose any planning regulations 52 FR 42078 (Nov. requirement or burden on the licensee.
Section 50.100 is rep 3,1987). The Commission's final notice Accordingly, the Commission concludes
'khuatio of the Adeq
- consees, hich otality make
' b po any' of Off S e clear that the rule is intended to apply Emergency Planning for Nuclear Power defined in to CPR 50.109*
n to actions taken with respect to nuclas'
. Plants at the Operating License Review Power plant licensees and the facilities Stage Where State and Local List of Subjects in to CFR Part 50
" they operate. See Section 50.109(a)(7),
Governments Decline to Participate in Antitrust, Classified Information, "If there are two ormore we s to OK-Site Emergency PlanninF" stated Criminal penalties, Fire protection, achieve compliance with a conse or that the emergency planning rule Intergovernmental relations. Nuclear the rules or orders of the Commission, changein question "does notimpose power plants and reactors, Radiation or with written heense, enmmitments any new requirements on production or. proteeJon, Reactor siting criteria,
- *
- then ordinarily the applicant or utilization facilities; it only provides an Reporting and recordkeeping heenseeis free to choose the way that alternative method to meet the requirements, best suits its purposes [ emphasis Commission's emergency planning For the reasons set out in the tdded)." This focus onlicensees and regulations. The amendment therefore is th:ir facilities is further confirmed by not abackfit under 10 CFR 50.109 and preamble and under the authority cf the the Statement of Considerations a backfit analysis is not required." 52 FR Atomic f:nergy Act for 1954, as accompanying the hackAt rule,53 FR at 42084. Likewise, when the amended, the Energy Reo anization.
Act of 1974, as amended, e National 20603 Quae 6,1988), where the Commission altered its emergency Environmental Policy Act of 1969, as Commission stated that ackAtting planning requirements in 1987 t amended, and 5 U.S.C. 553, the NRC is h
" manna snessures which are intended to change tne timing requirements for full improve the safety of nuclear power participation emergency exercises (a Proposing to adopt the following amendmeat to 10 CFR Part 50*
reactors * * *." 53 FR at 20604. The change -that, as a practical matter, could nine factors to be considered under 10 be ed to result in licensees' PART So-DOMESTIC UCENSING OF
, CFR 50.109(c) further make clear that modi emergency preparedness-FYlODUCTION AND UTIUZATION the rule is aimed at requirements on relat procedures to accommodate FACluTIES
- lican-and facilities. These include:-
exercise frequency changes), it stated:
(2) General description of the activity "The final rule does not modify or add
- 1. The authority citation for 10 CFR that would be required by the boensee to systems, structures, components or Part 50 continues to read as follows:
or op in order to complete the design of a facility; the design approval Authority: Secs.102.103,104',105,181, t; * * * (5) Installation and or manufachwins license for a facility; 182,183,186,189,88 Stat. 936,938,948, enntinuing costs associated with the orthe roceduresororganization ;
953, 954, 555, 956, as amended, sec. 234. 83 backfit, including the cost of facihty to design, construct, or operate tLat. 444, as amended (42 U.S.C. 2132, 2133, downtime or the cost of construction a
. AWy,nobackfit.
2134,2135,2201,2232,2233,2239,2282h a
ed 202 8 St delay; [and] (6) The potential safety analysis pursuant to 10 CFR 50.109 is Q201 2
g impact of changes in plant or required for this final rule. 52 FR 5841,5842,5846).
cperational lexity, * *
- 16823 (May 6,1987). The proposed Section 50.7 also issued under Pub. L 95 -
[ emphasis
)"
emergency planning rule change is of a 801, sec.10,92 Stat. 2951, as amended by The proposed rule imposes no new similar nature and similarly does not Pub. L 102-4a6, sec. 2902,106 Stat. 3123 requirements on licensees, nor does it involve a backfit.
(42 U.S.C. 5851). Sections so.10 also issued alter procedures at nuclear facilities.
It has been argued by at least one under secs. 101,185,68 State 936,955, as Rather, it is directed to States or local commenter on the petition for amended (42 U.S.C. 2131,2235); sec.102,
F:
~
Federal Register /Vcl. 64, No.113/ Monday, Juno 14,1999/ Proposed Rules 31749 j
. 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 s
amended (42 U.S.C 2138). Sections 50.23, 50.35,50.55, and 50.58 also issued under sec. 185,68 Stat. 955 (42 U.S.C. 2235). Sections 60.33a,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 Stal
.3073 (42 U.S.C 2:39). Section 50.78 also I
issued under sec.122,68 Stat. 939 (42 U.S.C.
j 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 j
sec.187,88 Stat. 955 (42 U.S.C. 2237).
- 2. In 6 50.47, paragraph (b)(10)is revised to read as follows:
950.47 Emergency piene.
-(b) * * *
(10) A range of protective actions has i
been developed for theplume are
. pathway EPZ for emergency wo rs
. 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 theingestion exposure pathway EPZ appropriate to the locale have been developed.
Dated at Rockville, Maryland, this 3rd day ofJune,1999.
For the Nuclear Regulatory Commission.
Annette Vietti Cook,
,Secretaryofthe Commissloa.
(FR Doc. 99-14584 Filed 6-11-99; 8:45 am]
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