ML20205S101
| ML20205S101 | |
| Person / Time | |
|---|---|
| Issue date: | 01/04/1998 |
| From: | Bradley Jones NRC COMMISSION (OCM) |
| To: | NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20205S086 | List: |
| References | |
| SECY-98-264-C, NUDOCS 9904260087 | |
| Download: ML20205S101 (23) | |
Text
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-[ #o, UNITED STATES
! * ' ' ,, 'g NUCLEAR REGULATORY COMMISSION g E WA SHINGTON, D.C. 20555 0001
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/ l OFFICE oF THE l COMMISSIONE R January 4,1998 TO: SECY
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FROM: Bradley Jones '
Executive Assistant, COM/GJD e ,/'. '# m I RE: SECY-98-264, Commissioner Dieus' Additional Comments 1
In her vote on SECY-98-264, Commissioner Dieus indicated that she would separately provide a line-in line-out version of the proposed FRN that contains additional recommended changes. ;
These are attached. I
Attachment:
As stated I 9904260087 990422 PDR COMMS NRCC s
.COR,R.ESPONDENCE PDR
y.
Insert 1
'When the Commission amended its emergency planning regulations on November 3,1980, it stated that 'any direct funding of State or local governments solely for emergency preparedness purposes by the Federal government would come through FEMA.' In its decision on June 30, 1997,"
Insert 2 "The Commission has determined that notwithstanding the June 30,1997 intention that "most likely the NRC" would fund the purchase State stockpiles of Kl, the continuing decreasing NRC budget offers little margin for the Commission to divert resources to new initiatives. Historically, funding for State and local emergency response planning has been the responsibility of those governments usually working with licensees. The Commission notes that the Petitioner has not requested the Federal funding of stockpiles of Kl. In the alternative" Insert 3 "NRC staff is preparing a technical report and an information brochure to enable State and local decision makers to make an informed decisions in this matter."
. Insert 4 "The Commission has considered the Kl policy question on numerous occasions since 1984.
The voting history cf the Commission shows that reaching consensus on this policy question has, been an elusive goal. An important reason for this historical lack of consensus is that this policy question is not a clear cut one. Individual Commissioners, past and present, have differed in their views with respect to the relative importance to be given to factors bearing on the Kl issue. These honest differences have led to divided Commission views on how to resolve the policy question. The Commission is unanimously agreed that its historical difficulty to reach consensus on the Ki policy question underscores the reality that this policy question is, contrary to what some may aver, not a simple one, is not one that is easily resolved and, as a result, has been the subject of protracted deliberation. With that relevant background, following are the Commission's views on specific issues raised by the Petition."
Insert 5 "In this light, the Commission agrees that the use of Kl may be determined by State and local emergency response planners to be a useful supplementary protective measure."
insert 6 "This situation has changed, partly because of the FDA approval of Kl as an over the counter drug. Some States have elected to incorporate Ki into the emergency response plans and have obtained adequate supplies for this purpose. The Federal govemment is stockpihng Ki with other medical supplies for NBC events.[Ther3 Commission is not aware of any factors that would constrain the availability of Kl for' stockpiling purposes.
Insert 7 i I
"The overall cost should not be a deterrent to stockpiling K1 for use by the general public should {
l State and local decision makers determine that the prophylatic use of Kl as a supplement to I evacuation and sheltering is appropriate."
Insert 8 "At that time it was believed that the NRC was the likely Federal agency to fund the stockpiling.
The continuing decreasing NRC budget offers little margin, however, to divert resources to new i initiatives. Historically, funding for State and local; emergency response planning has been the l 1 r esponsibility of those governments usually working with licensees and, absent Congressional funding specifically for this purpose, NRC is not prepared to fund stockpiling of Kl.- With respect to the use of Federal stockpiles for responses to NBC weapons or terrorist acts for responding to a nuclear power plant accident, the Commission believes that the better alternative is to establish robust, regional Federal stockpiles to enable States that have not established local
, stockpiles to use K1 in the event of such an accident.
Insert 9 "The Commission notes that when it amended its emergency planning regulations on November 3,1980, the regulatory standards for emergency planning were a restatement of basic joint NRC-FEMA guidance to licensees and to State and local governments incorporated in NUREG-0654; FEMA-REP-1," Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear power Plants for interim
, Use and Comment." This guidance was cited in the regulation and speaks to radioprotective drugs including their use by the general public including quantities, storage and means of distribution and State and local plans for decision making with respect to their use. The
- Commission removed the citations of the guidance from the regulation in 1987 but the guidance has continued in use for planning purposes and by the Federal agencies for evaluating emergency plans. As a result, it is believed that all of the affected States have considered the use of Kl. Some States have made the decision to stockpile Kl. Thus, in practical terms, the projected costs will occur only in those States that have not elected to stockpile Ki and choose
! to reconsider stockpiling in light of the NRC encouragement to consider doing so."
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ADDRESSES: Comments may be sent to the Secretary of the Commission. Attention:
Rulemaking and Adjudications Staff, U.S. Nuclear Regulatory Commission. Washington. DC 20555. or may be hand-delivered to One White Flint North,11555 Rockville Pike. Rockville MD 20852. between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be examined at the Commission's Public Document Room at 2120 L Street NW (Lower Level).
Washington, DC. l l
You may also provide comment via the NRC's interactive rulemaking web site on the _
j NRC home page (http://www.nrc. gov). This site provices the availability to' upload comments as files in any format that the NRC web browser supports. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG C nre. gov.
FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of Nuclear i
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001.
I Telephone: (301)415 3224. Internet: MTJ1 @ NRC. GOV.
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SUPPLEME NTARY INFORMATION:
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,,, g 7 By uncertaking this rulemaking, the Commission is proposing to grantAtwo petitions for rulemaktng (PRM 50 63 and 50-63A) from Mr. Peter Crane submitted on September 9,1995, and November 11,1997.
Considenng all public comments received, the information available in the literature.
20 years of exoerience gained in evaluating licensee emergency preparedness plans, and the
.. por d % Sky s (8 arguments presented t'y the petitioner, the Commission has decided to grantJhe petition]f or '
rulemaking and to proceed with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the et following sentence, after the first sentence: "In developing One range of actions. conom;;m 2
4 Cc ~,u.n sum e~, % kera s cc. , f.:n'au l lecd qtmu-& , 4 au.1,Lar
has bee gwcr to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate." In addition, the preamble for this proposed rule includes a statement to the effect that State and local decision makers, provided with proper information, may find tha se of Ki as a protective supplement is reasonable and prudent la w .t I for specific local conditions. The Commission also noted that, cer.e;;;e t w.ih ihe Cvmmuudo --
dec'E'0" en Junc 30,1007, the Federal govemment (most likely the NRC) is prepared to fund the purchase of a stockpile of Kl for the States, upon request.9 Th o NRC mu r,di ne iv j ensure '* '% piccers fx-States-te-obtain funding for-Ki is established. Jhe NRC staff will f:budjfrepedic&
Y -eise work with other relevant agencies to ensure that there are established piccecwe5 tc-ren mal l encb!c .c 70tonc! stockpile of KI, tei twiie..ei ech.t.ea, to be effectively and timely used by j inu l \
states that have not established local stockpiles and wish to make use of the _ tend stockpiles l l
in the event of a severe nuclear power plant accident. I On November 27,1995 (60 FR 58256), the Nuclear Regulatory Commission (NRC) published a Notice of Receipt of a petition for rulemaking (PRM-50-63) filed by Mr. Peter G. I Crane on his own behalf. The petitioner requested that the NRC amend its regulations I concerning emergency planning to include a requirement that emergency planning protective actions include the prophylactic use of potassium iodide (KI), which the petitioner notes prevents thyroid cancer after nuclear accidents.
On Novemoer 11,1997, the petitioner submitted a revision to his original petition (PRM-50-63A). The NRC published a Notice of Receipt of the amended petition on December 17, 1997 (62 FR 66038). In the amended petition, the petitioner requested that:
A statement [be made) clearly recommending stockpiling of KI as a " reasonable and prudent' measure, and; A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the j
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l first sentence: "In developing this range of actions, j I
consideration has been given to evacuation, sheltering, and the j prophylactic use of potassium iodide (KI), as appropriate."
I The petitioner also provided a marked-up version of the proposed Federal Radiological i i
Prepareoness Coordinating Committee (FRPCC) Federal Register notice concerning Federal j l
policy relating to the use of Kl for the general public.
g ,, 4 On June 26,1998 (SRM 98-061), the Commission decided to grant the petition for
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p e r adr. w o ale-a C.. To -
rulemaking PRM-50 63A by @e9g he .tl.
- c:;;cc:cd amendraent to 10 CFR 50.47(b)(10). The A
Commission also directed that the preamble for the proposed rule include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of K1 as a protective supplement is reasonable and prudent for specific local conditions.
va il ,:s 3 Petitioner's Basis for Requesting Potassium lodide The petitioner stated that potassium iodide (Kl) protects the thyroid gland, which is 1 highly sensitive to radiation from the radioactive iodine that would be released in extremely j senous nuclear accidents. By saturating the gland with iodine in a harmless form, Kl prevents any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead to thyroid cancer or other illnesses. The petitioner stated that the drug itself has a long shelf-life, at least 5 years, and causes negligible side effects.
The petitioner further stated that, in addition to preventing deaths from thyroid cancer, Kl prevents radiation caused illnesses. The petitioner notes that thyroid cancer generally means surgery, radiation treatment. and a lifetime of medication and monitoring. The petitioner asserted that the changes in medication that go with periodic scans put many patients on a physiological and psychological roller coaster. The petitioner stated that hypothyroidism can 4
1 general public should consult with the State to determine if these arrangements are appropriate. If local governments have the authority or secure the approval to incorporate K1 as a protective measure for the general public, they would need to include this i
measure in their emergency plans.
Analysis of issues Raised by Public Comments On November 27,1995 (60 FR 58256), a Notice of Receipt of the Petition for Rulemaking was published in the Federal Reaister requesting public comment. A total of 63 comment letters were received, of which 20 utilities,9 State govemmental agencies,2 utility l
interest organt:stions,1 letter signed by 12 health physicists,2 State universities and 1 member of the public were against the granting of the petition for rulemaking. Those letters in favor of granting the petition came from 5 environmental groups,22 members of the public (including 1 from the petitioner), and the American Thyroid Association.
l On December 17,1997 (62 FR 66038), the Commission published a request for public comment on the revised petition in the Federal Register. In response to several requests, the ;
comment penod was extended until February 17,1998, by a Federal Register notice published on January 21,1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 I a
utilities 3 State governmental agencies,1 utility interest association, and 1 member of the l public were against granting the petition for rulemaking. The letters in favor of granting the petition came from 8 public interest groups,46 members of the public (including 1 from the petitioner),3 physicians,2 U.S. Senators, anri 1 State Representative. The following issues were taised by the public commenters with an accompanying Commission response:
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lssue1 Nearly all nations with nuclear power protect their citizens by having Kl readily available and the logistics of distribution do not seem to pose any significantproblems. Would rh4nd ?
implementing a policy of using Ki for the general public be _yfCu 0 Qommission Resoonse At tr.; No 97, Commission meeting, senior NRG staff mem the
,ommission: "We recogrtze distribution, but they are not i Tsurmountable. ision is made by the State to do it [ stockpile and/or predistribut I
we can fioure out a wav to do it. It is the Commission's perception that if the State decides to include KI as a supplemental protective measure for the general public, O s cw & Ed W J--p rt!! method of^ implementation rM b: rd 7.; C' Z'
_ _ %make Kl readily avabablejou... J.;, ;^; r '""'^"a**' dr"a* "" h ""'+ rri The public could be informed of the drug's availability through the yearly emergency preparedness
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l information brochure that is mailed out to all residents throughout the 10 mile EPZ. It l would then be up to individual members of the public to obtain and store this supply of KI, which should then be available for use in the event of an emergenc'y. The 1 j
administration of the Kl could be at the direction of the State Medical Officer.
l issue 2 11 is " factual that the 1986 Chernobyl accident clearly demonstrated the benefit cf having Kl readily available. In Poland, where authorities expediently administered 18 million
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j World Health Organization (WHO) Guidance. The main points of the WHO Guidelines *
- regarding the use of stable iodine are as follows: l Near field: Stable iodine should be available for immediate distribution to all groups if the predicted thyroid dose is likely to exceed national reference levels. Close to nuclear installations iodine tablets should be stored or ,
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l predistnbuted to facilitate prompt utilization. .
Far field: Stable iodine should be available for distribution to pregnant women, neonates, infants, and children if the predicted dose is likely to exceed I reference levels, in Pd L Conclusicm from Polish Experience. (1) Small amounts of radioactive iodine were decosited LA As as a result of the Chernobyl accident, (2) no protective cctions were taken for the first 2 ch, of the accident, and (3) protective actions (except sheltering or evacuation) were taKen after the first 2 days of the accident. Because of the low iodine concentrations in Polanc anc the protective actions implemented, Poland has not detected excess cancers resutting from intaxe of racioiocines.
Overall Chernobyl Conclusion. The World Health Organization, almost every inaustr:al country in the world with nuclear power plants, and the American Thyroid Association, believe that the low iodine con:entrations, the banning of the consumption of fresh milk and the cistncution ano acministration of 90 million doses of Ki contributed to the observed lack of
' International Bas:c Safety Standards for Protection Against lonizing Radiation and for Safety of Raaiction Sources. Safety Senes No.115,IAEA,1996.
'"Metnod for the Development of Emergency Response Preparedness for Nuclear or Raoictogical Acc: dent." Te . doc-953. IAEA, July 1997.
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increase of childhood thyroid cancers in Poland. Most industrial nations with nuclear power plants have decided to stockpile Ki around nuclear power for use by the general public.
/a, c.c.al-aSf 1 Y$c C$nudx l erpt ut aa.
fin the event of an accident iri the United States, o,ur emergency planning calls for protective actions, tering, evacuation, and removal of conta 'nated food from
<tlqfwir*cA- ql upuau. -b ell mbetaubAth consumption / c;;uld significantly reduce the risk the public. ng KI available to the Sen.
public for use during evacuation could, under certain conditions, reduce the risk itmhe eff,me C cru 4teap he pubuc commcatef-artmuletecithe e nne h_tcion of the Chemnhyl epticn:: $ f.agg l e,j
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" Ear arguments against the stockpiling of Kl for use in such an event have focused on the iss es of possible toxicity from widespread use of potassium iodide, the difficult logistics f early distribution of KI and the question of cost / benefit ratio. Although all of those arg ents have some cogency, the recent Chemobyl experience has nullified their pertin ce. To date, over 1200 children in the Chemobyl area have developed papillary thyr cancer requiring major medicalintervention. Although the certainty of the fallout initia n of these cancers cannot be fully confirmed until current dose assessment studi are completed, the remarkable coincidence and extraordinarily high incidence of this rar tumor in the Chernobyl area is convincing enough to require some aCIlon."
"The concern about signi ant toxicity from potassium iodide in emergency blocking i doses has been made moo y the extensive Pclish experience where 18 million inoividuals received propnyla ic potassium iodide with c,verall toxicity of .2 percent (mostly nausea) but with only a raction of 1 percent having serious side-effects.
Current packaging of Klin Europ has appeared to resolve the problems about shelf hfe and the blister packing that is used n Sweden is certainly effective and inexpensive.
There are admittedly problems in eff tive and complete rapid early distribution and certainly in predistribution. However, s uld a reactor accident occur in the U.S.
reouinng Kl and it not be available becau e of an overly heavy emphasis on perceiver.i ditticulties, the resultant medical and politi I/ sociological impact will be disastrous."
"One cannot minimize the significance of a clu ter of 1200 children with this senous and fortunately rare cancer. Although with modern i ensive therapy results are good, such !
treatments often have very senous disrupting effe t upon the life of the individual and i such effect cannot be minimtzed."
l "The simplicity of having availacle a simple, inexpensiv agent that can greatly lower the l likelihood of this disease occurnng is a fact that cannot b overlooked. Indeed. K! will not c;ecrease whole body radiation and evacuation clearly i an optimalinmal response to an accident, but it is not always possible and supplementa ' n of evacuation with !
potassium iodide is undoubted!y useful. The Polish study sho d that potassium iodide
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aoministration decreased the potential thyroid radiation dose by s much as 40 percent l
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and this - n.jyggas late as 3 to 5 day: after th- Wosure to tallout from the cootinuino fira at the Chc;nagp pidm; a
Issue 3 1
" Stockpiling or predistnbution of potassium iodide (KI) as a protective action would not add any significant public health and safety benefit to the current level of protection provided by existing emergency plans for commercial nuclear power plants. Our emergency plans focus on evacuation as the key protective action to prevent exposure since it protects against exposure to all radionuclides, not just iodine. in addition, the potential for misadministration of K1 is present when predistributed to the general public, and ine: dents of misadministration have been informally reported at industry meetings by states whien predistnouted KI to the public."
Commission Aesconse The Commission agrees that it is the State's prerogative to decide to include stockpiling or crec:stnoution of KI as a protective action for the general public. The FDA concluded that risks f rom short term use of relatively low doses of Kl are out weighed by the radictog:cally induced thyroid modules or cancers at a projected dose to the thyroid glanci of 25 rem or greater. In so doing, the FDA approved Ki as an over the-counter drug. The Amencan Thyroid Association fully endorses the use of Ki and, as previously discussec. there were only 2 significant adverse reactions and 36,000 medically significant reactions (nausea) in 90 million doses of Kl after the Chernobyl accident.
1 The taking of Ki snould require precautions similar to those associated with any other over the counter drug, and, of course, the packaging instructions should be followed.
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i Issue 4 I
" Evacuation is more feasible and practicable. Stockpiling of Kl has logistical problems which we feel renders this idea impracticable and unmanageable."
Commission Resoonse: .
l The Commission agrees that evacuation is usually " feasible and practicable" and is most effective protective action. If the Stato decides to include Kl as a supplemental protective measure for the general public, one possible method of implementation could 4a u hing. i h a 4 0 <_.
be that the State could make Kl readily available ere ottf6r over the-counter drugs can be purchased. The public could be informed of the' drug's availability through the !
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. yearly emergency preparedness information brochure that is mailed out to all residents i
throughout the 10 mile EPZ. Individual members of the public would be responsible for obtaining and stonng this supply of Kl. which could then be available for use in the event llw#du k5 i of an emergency, hr approaches to predistribution oowid include stockpiling at j
' reception centers for distribution during an evacuation. Other countries have found ways to effectively distribute KI when needed and the distribution issue is certainly not unsurmountable. The administration of'the Ki should be at the direction of the 'State Medical Officer.
Issue 5 The Three Mile Island expenence has shown us that it is not easy to obtain an adequate suoply of Kiin an emergency.
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l l Commission Response:
The commenter is correct, in that it was difficult to obtain Kl after the Three Island acc: dent. H0=tiei, mth the ....;;ed ",do. ; .ive ;;er g; V' lgii .,ci;a:-even;5 &ad ii'e
- 'W";"9 E C Of "'O E Cdcral CCVeiGiLei,; ig g,vy;de & 3;ygkp;l, yl Kj lgr egy Cl;;;!b !
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, decidc; to use a a; ; ;upgl;m m:! p ;;;;gse megeu,, lv, 3;,, generel pub llc, ,,,a Commission believes that an adequate supply of KI could be obtained.
!ssue 6 Even thougn KI administration before any exposure is ideal,'the Chernobyl experience also nas shown that the exposure can continue for days. Is the institution of Kl blockade at any time in this period beneficial?
Commission Aesconse The scministration of K1 is most effective if done before or immediately after (within 2 to !
4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />) a release. Nonetheless, during a chronic exposure of several days, the l
. l acministration of Ki any time during the exposure period may block some uptake of l
l rac:cactive iodine. However, the benefit diminishes quickly over time and may be very j small .f acministered late. If a release is expected to continue for several days, the NRC i
antic::ates that the public would be evacuated or other protective action would be taken. l l oerencing on the level of release. Kl could nevertheless serve as a useful suceremental and complement to these primary protective actions. ,
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but not serious, reactions to this single dose of Kl was also very low (0.2 percent). In addition, no detectable long-term disturbance in children's thyroid function was detected as of 1989. Additionally, the FDA has approved Kl for over-the-counter distribution.
The Commission, therefore, agrees that the post-Chemoby! experience has shown that large-scale deployment of K1 is relatively safe.
Issue 10 Several comments raised the question of liability: "Is the NRC prepared to address the number of legalimplications should a member of t'he general public be given Kl at their directive or recommendation and the individual have an extreme allergic reaction, possibly death?;"'The Federal Register Notice does not address legalissues for states I
who decide to adopt KI and states who do not decide to adopt or administer Kl to the public."; . "The issue of legal liability should not be dismissed lightly, if the NRC decides siit' ockpiling of K1 for the general public, has NRC considered what liability may arise from any adverse health effects? No initiative such as this should be undertaken without resolution of this issue.'; "Who would assume liability if the Kl was used prior to the Governor ordering its use?"
i Commission Resoonse: '
The comments focus principally on concems that State and local governments involved in distnbution and administration of Kl may be liable in tort if an individual receiving the
) Ki has a significant adverse med: cal reaction to the Kl. To the extent that commenters are raising the potential for federal govemment liability for the promulgation of this l -
C o w osso m f proposed rule, the NRC believes that ;i;t;; 2; 0;.T.i. '::!r. may be subject to tort liability through the imple entation of a Kl program depends upon a number of factors. l
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l Mc/;c;ct, t ;cu!d :ppe;r th;!: Commission decisiorkto require State and local -
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> L/ han i emergency planning officials to consider stockpiling Kl for public distribution should be l A
subject to the "discrgtionary function" exception to the Federal Tort Claims Act,28 USC l Lm,& % m dua MdLwwik.wAw.6bx 2671, et seq.," wnich protects the Federal Govemment from liabilit/./ The question of 3
whether a State of locality might be liable for involvement with administration of Kl to the general public can only be answered by reference to the laws and precedents of particular States. The NRC presumes that this would be part of the " consideration" that States and localities will undertake if this rule is promulgated. The NRC has not undertaken this analysis.
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!ssue 11 _
j Gmo ss ens Does thel 4CC wii consider stockpiling and using Kl as a reasonable and prudent protect:ve measure for the general public?
l "This exce tion from waiver of sovereign immunity provides that:
1 Any claims Dasec upon an act or omission of an employee of the Government, exercising cue care. in the execution of a statute or regulation, whether or not such statute or regulation De valia. or based upon the exercise or performance or the failure to exercise or perform a ciscretionary function or duty on the part of a federal agency or an employee of the Government, wnether or not the discretion involved be abused.
28 USC 2680(a). United States v. Varig Airlines,467 U.S. 797,808 (*.984); Berkovitz v.
United States. 486 U.S. 531 (1988).
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l Commission Resoonue
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i The Commission do/m
^*" that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement to evacuatio sheltering is reasonable and prudent for specific local conditions.
e com 7,n7 meed c dera cecry nn ,,w nf Ki ne en e .Rgwocy prepafM,. -
meas for commercial nuclear power plant accidents is being develope yQe FRPCC.
AA plans to publish this policy in the Federal Registe n early 1999, ;
nonetheless, it c ently is proposed to state that:
The revised Federal p 'cy is that KI should be stockpiled and distributed to emer Workers and institutionah d persons for radiologi 1 emergencies, but leaves the cecision on whether to sto lie, distribute and se Kl for the general public to the c:scretion of State and,in so cases, local overnments. Any State or local government that selects the use + Kl as rotective measure for the general public may so notify the appropnate FEM sonal Director, and may request funding for the puroose of purenasing a supply, deral offer to fund purchases of KI for the States represents an explicit rec nition t t this medicine can, under certain concitions, supplement other tection me ures and thereby enhance protection of the cuote State ano local vernments that o to include Kl as a protective measure for ine general ouclic wil e resoonsible for prep ng guidelines for its stockpiling, maintenance. crstnou n and use. State and local vemments may also contact FEMA wnen the sh hie of the drug has expired and t supply needs to be recien:snec. It ould also be noted that medical supplie 'ncluding Kl. will be stocxciiec in metropolitan areas and in three national sto piles across the country in sucoort State and local govemment response to emergen s caused by acts of terroris emer involving nuclear, enemical and biological agents. For r iological pt nc:es resulting from any cause, including accidents at comm cial nuclear power
.ts, this accitional stockoile can be acquired ad hoc by State or loca overnment
.am .. iney oetermine its use wouiu La LenaLea!.
Commission Decision tu f/d S hP On June 26.1998. the Commission decided to grant the petitionffor rulemaking.
A A Accercingly. the NRC statt was direc:e:: to proceed with rulemaking to change to CFR
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4-50.47(b)(10) by inserting the following sentence, after the first sentence "In deyeloping Ws-k k aw w as4es.,b Ausm,( S$<.//oul 7evauw k Y"UA-range of actions, con;;deret,ec, L.. c;n 9 ;;M:t evacuation, sheltenng, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate." in addition, the M n preamble for the proposed rule was to include a statement.to the effect that State and local decision makers, provided v ;:h proper informatio may find that the use of KI as a protective i
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i supplement is rea onable and prudent for specific local conditions.. The Commission alsodvb l y he11 luulal ll5 rw4ed that. con:::: n;;..:h :h: CSmmieeien's dpcision on June 30,1997, the Me,6F t.3 mfpcfoud 4 F.cinicmn;vipei L y-;S 4h NRCM fund the purchase of a stockpile of Ki for the States up
/.e & cr/how request.
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[he Commission !:: directedjhe NRC staff to work th other relevant agencies to rel>x T ensure that there are establisned ree prce:yheh oui stfa te . .u.. d . ii.Ju...i .tockpiles to be effectively and timely used by States that have not established local stockpiles and wish to make use of re 3mesd
'"; wre stockpiles in the event of a severe nuclear power plant eccident.
The Commission decision is implemented by publication of this proposed rule that would change 10 CFR 50.47(b)(10) with a 90-day public copment period. If the proposed rule is y y p r & d oreal ta/'M D accoteo in finai form, the petition would be granted and NRC action would be completed on PRM 50 63 and PRM 50-63A.
Commission Conclusions or Issues Raised by the Petitioner and Public Commenters f gj)/ef Y The Commission;;g:::: s'" ~2ny dthe issues raised by the petitioner and the public c n lusi ns:
GMj' Pf*'"/b""'d 1
commenters. ' The ;. ..c.T5m;kr has reached ic w dt/nuu.oel 0/sthe followi
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The Commission agrees that K yf administered in a timelyfashion, could l
orctect the thyroid gland from exposure to radioiodines inhaled or ingested following a maior rao:ciogical ace:oent. Th.e m m hm for stn4niHan a Sad d!:ttlng it to cc .;;gency wc&,cra -
aogEL%M.,.is c; ;6i;;.75 Ging 7:10!Og!C2! ?**'g0nC!? . 90 p ttienef-believes 4 hat-the -
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dihbution ni l(' *e? i ardew?? e"d Umi e!y i~ the Uki&L and Beiarus aum u,; Chem 4 accide in 1986 and that this accounts for the increased incidence of thyroid cancer in these-areas. He so argues that distribution of Kiin Poland was timely and effective and tha no
/
similar increase ' the incidence of thyroid cancer was seen. The Commission co 'dered all of the above informati in deciding to grant the petitioner's requested actions.
B. The Ke eny Commission criticized the failure to stockpil Ki and
. recommended that regional ekpiles be estab'.ished. The Kemeny ommission's report recognized that evacuation was t invariably the preferred resp se to an emergency and that even when evacuation was desirable, t'might not be feasible. The Commission believes that prompt evacuation and/or sheltering are t generally p red protective measures for severe reactor accidents. In developing the range of bli protective actions for severe accidents at commercial nuclear power plants, evacuation d place sheltering provide adequate protection for the general public. The Co ission be ves that K1 for the general public should nct replace evacuation and shelterin ut supplement th .
C. The Federal R togical Emergency Respon' Plan (FRERP) is the plan that would be used by the Fecor Govemment to support State and to I officials in responding to any peacetime radiologi 1 emergency. Such emergencies range fro transportati.on accidents involving r ioactive materials to terrorist events involving nucle materials. The FRERP includes range of protective actions commensurate with the risks as ciated with the range of em gencies for the general public and emergency workers. These prot tive actions include pvacuation. sheltering, and the prophylactic use of stable iodine. V/ith respe to prot tive actions for nuclear power plants, the NRC and FEMA have issued Draft upplement 3 to NUREG-0654/ FEMA REP 1, Rev.1, to provide updated guidance for the v
An'40Fm u protective action recommendations for severe reactor aLeicenu,. T;y3_
l t
% ca _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ . _ _ .
l doc it emphasizes that prompt evacettion is the preferred protective action for I alor projected severe e damage accidents.
D. The Commiss recognizes that in 199 Board of Govemors of the IAEA l
adepted new International Basic Safety rds. With respect to emergency planning, these standards provide, among othe ngs, " intervention for immediate protective action, incluoing sheltenng cuation, and iodine prophylaxis." It is imp t to note that each country b s its response plans on local and regional characteristics. For exa Italy and J nec. -g/k/LL me ha some coif 4inyemauonal K144/fb /w akustangards impipment and themguidelines,lk cinerev f \
E I. NhiiCommission agrees with the NRC staff estimate that the purchase of KI rddalg tablets isjnexpensive. Ki reb d costs increase when the cost of maintenance, cistribution, and public education are considered. 1 -
C, p. ,y,fw,t, & be '^ Y ' l The Commissi n be ieves that NSO m-M2! st ekpiles should p-^l;idc l To tubi't tw- & STts w t u k hrfbs t (c alc w/et f4H3U Wkt assu'ame .v 5tates anu iocai guvemmanm ui i . Un# .199N! etodp!! of "' i* "Vailabla if m u.V f, l[.I M et +
44/WFALknb4.jg1ptAfu.Y*sutAulY, denstx
-Commission e et to fund Ki- .
l
' 1 June 30.1997, the Commission voted to approve the NRC staff recommendation to encerse the FAPCC recommendations for the Federal Govemment to fund the purchase of potassium icoice (KI) for States at their request and endorsed the FRPCC recognition of the l
availacihty of tne Federal stockpile of Kl to State and local govemments for purposes of
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mitigating the consecuences of terronst use of nuclear, biological, or chemical (NBC) weapons.
6 _ y -
Unoer inis encorsement, the Federal Government would fund the purenase of KI, att ~
and local govern .. + would be responsible for maintenanc ution, and subsequent costs. As part of their emergency r anning, NRC licensees should discuss this matter with State ano foc ernments that make decisions on p e measures in planning for respon ergencies.
petitioners to submit a modification to his petition in order to address views he discu the meeting.
On November 11,1997, the petitioner submitted a revision to his petition PRM 50-63 which requested two things:
- 1. A statement clearly recommending stockpiling of Kl as a " reasonable and prudent" measure, and
- 2. A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions. consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (KI), as appropriate."
gm.Stltb Yj ed*Nadkf "'
On June 26.1998, the Commission dweeled the staff . . C~/ 00 001 te gara the petition for rulemaxing PRM 50-63A by revising 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in response to this directive.' l Alternatives were essentially considered in previous documents, in SECY 97124 (June 16.1997), on the " Proposed Federal Policy Reg trding Use of Potassium lodide after a Severe Acc: cent at a Nuclear Power Plant." The staff identified three options, one of which containec three suo-options, concerning a proposed change in the Federal policy regarding the use of potassium iocide (KI) as a protective measure for the general public during severe reactor accioents. Next, in an SRM dated June 30,1997, the Commission approved an option that encorsec the Federal offer to fund the purchase of Kl for States at their request and encorseo Feoeral Raciological Prepareaness Coordinating Committee (FRPCC) recognaion of the availacinty to State and local governments of the Federal stockpiling of Kl.
,e e
- 11. Need for Action I
in SECY-97-245, the staff proposed options for resolving the referenced petition for
( {
rulemaking. In SRM 98-06, the Commission directed the staff to proceed with the rulerr.aking.jI
.)
111.
EnvironmentalImpact of the Proposed Action - l The environmentalimpacts of the proposed action and its altemative are considered negligible by the NRC staff. Given the proppsed action would only add the sentence: "In a 4 M osin-e-au.arcoHeda w n/S4G (/ red porw wity tog w A A deveioping Ws range of actions, cend: afra has been ;b:r b evacuation, sheltering, and the prophylactic use of potassium iodide (KI), as appropriate." The staff is not aware of any environmentalimpact as a result of this proposed action.
I 1
I IV. Alternative to the Proposed Action I
5 0 The attemative to the proposed action at this time is to deny the petition and rents +m no action with respect to the use of Kl by the public. Should this no-action alternative be pursued, the staff is not aware of any resulting environmentalimpact.
V. Agencies and Persons Consulted Cognizant personnel from the Federal Emergency Management Agency were consulted, as was the petitioner as part of this rulemaking activity.
F.
On September 9,1995, a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl.
In SECY 97-245, dated October 23,1997, the staff provided three options for the I Commission's consideration in order to resolve PRM 50 63. .
On November 5,1997, the Commission was briefed by tile NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resolving the petition for rulemaking. During the meeting, the Commission invited the 4 petitioners to submit a modification to his petition in order to address views he discussed dunng the meeting.
On November 11,1997, the petitioner submitted a revision to his petition PRM 50-63A.
which requested two things:
A statement clearly recommending stockpiling of KI as a " reasonable and prudent" measure, and A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence:"In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic us of potassium iodide (KI), as~ appropriate."
On June 26,1998, the Commission directed the staff in SRM 98-061 to go,n J+- ,
eenJC.
p;tt - fer rh.:S ; oc" 50 S?A by rev; .,410 CFR Part 50.47 (b)(10). This proposed rulemaking is in response to this directive.
Alternatives were essentially considered in previous documents. In SECY-97124 (June 16,1997), on the " Proposed Federal Pokey Regarding Use of Potassium lodide after a Severe Accident at a Nuclear Power Plant." The staff identified three options, one of which contained 41 -
three sub options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (KI) as a protective measure for the general public during severe reactor accidents. Next, in an SRM dated June 30,1997, the Commission approved an option that encorsec the Federal offer to fund the purchase of KI for States at their request and endorsed l Feoeral Raciological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local govemments of the Federal stockpiling of Kl.
In SECY 97 245, the staff proposed options for resolving the referenced petition for rutemaking. In SRM 98-06, the Commission directed the staff to proceed with the rulemaking.
Given the Commission considered the options and directed the staff to grant the petition, the only alternatives considered here are the Commission approved option and the baseline. no-action alternative.
/, esa s , g,g/y,< w ""
The croposed rulempkin
%. " ram m of " ti ce w . aux. g does not " require" e ,e .4 -anything of licpnsees, but p p le w hr. 4 u w t Tc ^ States are to
have 20ve " := r ::cr ;f the use of Kl aiengeth evacuation and sheltering as protective actions. It is estimated that 30 States will need to make this consideration. Further, the staff estimates that the iacer - odec by the States could range from a staff week, to a half staff-year The 'atter ceing the case if a State decided to hold hearings on the issue.
If one assumes an average nourly salary of $70 (this estimate includes benefits, pro-ratec secretanal anc managenal assistance, but not overhead), the range of estimates would i
be frcm 52800 to 553.000. Again using a base of 30 States, the range is from S84,000 to S1.9 million. pegtf ,
it is cifficut to estimate the benefit of a State's consideration to stockpile Kl. However, we Deneve the ' enefit of sucn an act:on by the States is summed up by the petitioner who
'statec that the cec:sion to stocxcile Kl should tum on whether, given the enormous '
consecuences of being without K1 in a major accident, the drug is a prudent measure; not on wnetner :: wiil necessarity pay for itsett over time. As the petitioner further noted. Kl represents