ML19210D526
| ML19210D526 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/1979 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Grasso E CONNECTICUT, STATE OF |
| Shared Package | |
| ML19210D527 | List: |
| References | |
| NUDOCS 7911270253 | |
| Download: ML19210D526 (7) | |
Text
d It U'ilTED STATES
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NUCLEAR REGULATORY COMMISSION COMM 7; 's E
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October 29, 1979 OFF? E OF THE OHIIRMAN The Honorable Ella T. Grasso Governor of Connecticut Hartford, Connecticut 06115
Dear Governor Grasso:
Thank you for your letter of July 19, 1979, expressing your concerns on radiological emergency response planning activities. We at the Commission are also concerned about this and we are now reviewing all aspects of the program.
Tnis review will no doubt result in recomendations for improvements.
Let me specifically address the n:rnbered questions and points in your letter:
1.
You asked about actions to make a thyroid blocking drug available for institutionalized citizens, emergency workers and the general public.
The recent letter concerning thyroid blocking sent to Mr. Alan Hekking of your Office of Civil Preparedness staff by Mr. Jerome Halperin of the U.S. Food and Drug Administration (enclosed) partially answers this question.
In addition, we also believe that all involved agencies (State, Federal, local) must resolve the issue of stockpiling a thyroid blocking agent and associated funding shortly. At a recent meeting between FDA and flRC staff, this was one of the topics of discussion.
Whatever policy does result will probably be developed under the auspices of the several Federal agencies involved in radiological emergency response planning with State and local governments.
Mr. Frank Mancuso, the Cirector of your Office of Civil Preparedness will be kept abreast of developments through an Interorganizational Advisory Comittee of State and local government emergency prepared-ness officials of which he is a member.
2.
You proposed that I recomend to the Secretary of Transpt.vtation that his Departent work with Commissioner Powers of the Connecticut Department of Transportation to provide highway signs showing evacuation routes and contaminated areas.
I have written a letter to Secretary Goldschmidt of the Department of Transportaticn.asking that he honor your request. A copy of the letter is enclosed.
1396 159 7911270 S b
The Hor.orable Ella T. Gaasso 0
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_a 3.
You asked when refresher training will be available for State emercency res:onse perconnel.
I am pleased that Connecticut has taken advantage of the training provided by t.1e NRC. The training programs are still available and we will entertain additional requests for training of those personnel who have not received the training.
As a matter of fact, a_s a result of a recent request from some of the other New England States, we are contemplating scheduling two of the courses in New England within the next several months.
These would be the Radiological Emergency Response Planning Course and the Radiological Emergency Response Coordinators Course.
If you have perscanel whc would benefit by attendance, please infonn Robert G. P.yan, Director of the Office of State Programs. He can te reached at (301) 492-8170.
We de not as yet have any fonnal programs for refresher training since the job of initial training has absorbed available training resources.
We do expect to be in a posi+. ion to work on refresher trair.ing during the next calendar year. dessrs. Frank Mancuso and Arthur T. Heubner, your Radiation Control Director, will be advised when -efresher training is available..
4.
You expressed concern about nuclear reactors in other States close tc the borders o' Connecticut and the need for sharing resources to respend to an accident at one of these reactors.
We share your concerns about contiguous State planning.
As a matter of fac:, section II.C of our Emergency Planning Guide and Checklist NUREG-75/lli (which was published in 1974) contains the elements of this planning which we believe should be addressed in State and local Radiological Emergency Response Plans.
Contiguous State / local planning is necessary before we will concur in a State plan.
Specifically vich regard to New England, we have recently been in conta:t with earesentatives of Vemont, New Hampshire, Massachuse:ts and Maine to discuss the development of their plans for concurrence.
Contiguous State planning and accident classifications and notifications have been covered in these discussions.
At the most recer.: meetin;, in which representatives of three of those States parti:f oated, Vemont agreed to write an emergency plan annex which coulc be used by all four States to describe mutual support and assistance du-ing an accident.
We have infonned Vemont of your conce ns in tiis area and you will receive a copy of the draft anc.ex wnen it is ready.
1396 160
The honoratie Ella T. Grasso.
ke are aware of the New England Radiological Health Campact to w1i:h all hew England States belong and which allows each State ta :all upon its neighbors in time of need in responding to nciological emergencies. We believe this is essential, especially in New England, because of the relatively small geographical area covered by each State. We are also pleased by the passage on May 15,1979 of Resolution Number 206 by the New England Regional Cxnission which expresses the Governors' desire to w:rk together as a region in planning for nuclear emergencies. We look forward to the reports which each State will be preparing this fall to cetermine if there is any help we can provide.
5.
Y3u asked how we propose to handle the media during an' accident at a nuclear powrt-plant, particularly in light of the lessons lea ned at Threc Mile Island.
In egard to communicating with the news media during an accident, t e NRC Office of Public Affairs will be working with the NRC C#fice of Nuclear Reactor Regulation to provide facilities for t e news aedia as part of an Emergency Operations Center to be established in the vicinity of all nuclear power plants.
Establish-ten; of such a center is one element of an action plan developed b/ the NR Office of Nuclear Reactor Regulation to improve emergency p eoaredness at all of these facilities and is intended to accom-m:date Federal, State and local personnel as well as rews media rep esentatives. Coordination with State and local officials is a key part of this overall plan. Moreover, there are a number of c going investigations into the Three Mile Island accident which ray provide some additional recommendations for working with the radia to provide accerate reporting in cases of future nuclear a:cidents.
The Commission will be giving all recommer,dations in t;is area careful attention.
5.
Y:u expressed concern about Connecticut's ability to handle a
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n.c. ear crisis.
Y:u have a good radiological emergency response plan. This paper p:an is of limited value, however, unless it is annually tested a-d supported by appropriate preparedness resources. This is the main reason we have a requirement for an annual exercise as a c:nciition to maintaining NRC concurrence in the State plan.
T is, we believe, is the best way to identify deficiencies and c:r ect them.
I: this connection, we are in the process of developing accident s:enarios for exercising State plans. Our initial effort is to p c vide this scenario for those States, such as Connecticut, w-i:h already have a concurred plan. For the long tern, we have a c:ntract for 'the development of a series of 10-12 scenarios w.i:h we noce will provide a spectrum of postulated accidents w i:n can be used to exercise either part of a plan or tne entire pa.
1396 161
The Honorable Ella T. Grasso.
Monitoring will play a big part in response and we realize that help is needed in this area.
You can be sure that the Federal government will respond with assistance as was the case during the Three Mile Island accident.
Related to monitoring of airborne radiological releases is an identified need to be able to measure a dominant radioisotope, i.e., radioiodine.
Under contract to us, Brookhaven National Laboratory has developed a relatively inexpensive radiciodine monitoring instrument which is currently undergoing independent evaluation by the Idaho National Engineering Laboratory (INEL).
We also have another research program with INEL to develop a series of guidance documents for the use of Federal, State and local agencies in responding to radiological emergencies.
This guidance will provide information on measuring certain critical isotopes such as radiciodine, radiostrontium and radiocesium which might be components of any serious radiological release.
These documents are scheduled for completion by about the end of 1980.
Finally, you should be aware that the Congress is also concerned about responses to radiological emergencies and the coordination of responses by all parties.
In S.562, the Senate version of the NRC 1980 Authorization Bill, there is a requirement that the NRC develop an agency plan for response to nucleae emergencies and another requirement that the Federal government develop a Federal response plan over and above the existing Interagency Radiological Assistance Plan which is being reevaluated.
Please be assured that we do share your concerns and that we will continue to work with you to be better prepar,ed to respond to nuclear emergencies.
\\Sincerely, C.A.,b y,
Jose M. Hendrie Chairman
Enclosures:
As stated 1396 162
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August 21, 1970 t
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f Mr. Alan M. lfckking i
Operations Officer State of Connecticut i
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Dear Mr. liekking:
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Your letter of July 24, 1970 regtests that the Cureau of Drugs issue general guidance on use of pctessiu a hG.ide for thyroid blocking and encourege r
l production of the drug for use t7 state groups in conjunction with the state
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Radiological Emergency 2csporse ric_n. It also suggests that the Food und Dru; i
l Adtninistration make funds evrila-lc for regional stockpiles of the dru.,.
in the opening paragraph of your 'etter you cito a letter which I wrote to Mr.
Robert G. Ryan, Directer of th: Office of State Programs of the Nuclear Regulatcry Commissicn, on May 22, 1978. You appear to be aware of the fact i
that the Food and Drug Admirst ation published a notice in the Federal i
Register on December 15, 1975 inviting applicants to submit new drug I
applications for manufacttre of patassium iodide in tablet or liquid forms fo:-
thyroid blocking in nuclear cmegencies.
The notice also announced the availability of guideline labeling fr such products.
I am enclosing copics of these documents for your use.
- n addition, the Federal Register of l'riday,
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August 17, 1970, contair.s a noti:e of availability of an amended guideline r
labeling (also enclosed). I arn encb: ring a copy of this now labeling for your use.
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t You will note that the announce aent inviting applications was in 'the public domain more than threc tonths b:.'cre the accident at Three Mile Island. During this time no pharmaceutical raandacturcrs expressed an interest in making the drug. Since the Three i!ile 1sinne accident, new drug applications for potassium iodido tablets and satt. nted s:.ution ucre submitted by the Mallinekrodt
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Company of St. Louis. liliacis '.in a reccat acquistion, that part. of the b
Mallinekrodt or;;anization has bec: purchared by Carter '.Vallace Inc., Cranbury.
j New Jersey). We expect that thesr applicctions will be approved shortly and that I
the products will 1;c niilable ice uarketi".g.
If the State of Connecticut is I
interested in purcha-in: a s gly :f p:.t:reium indide to stocicpile around nuclear I
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gk sites in Connecticut, you may wish to contact the Carter-Wallace firm and inquire about price and availability. In that regard, you may wish to contact
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Joseph S. Ilarun, M.D., Corporate Vice President, Medical and Scientific.
Services, Carter-Wallr.cc, Inc.,11alf Acre Road, Cranbury,14cw Jersey, 03512, 4
phone, G09-G55-G000.
r The l'ood and Drug Administrt. tion has long cdvocated the desirebility of stockpiling potassium iodido products for thyroid blocking in response to i
radiological cmergencies. We worked closely with the Ad lioc Committee on B.
Thyroid Blocking of the National Council on Radiation Protcetion and Measure-ments (NCRP) in the develop:nent of its Report No. 55. That report was an important clement in the process through which we established the safety and 4
Y cffectiveness of potassium iodide for this purpose and thereby were able to g{
G waive the requirement fcr cli-ical tricts and pre-clinical (animals) tests to 1
determine the crc ~'s safety a-d effectiveness as a condition of grant!n:; a new drug application. I cm p'.cnsed that the applications will be approved at shortly and that the~ drug will finally be availabic for stockpiling.
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Mf Spenking of stoci:pUirg, the Fcod cnd Drug Administration is not a drug supplier.
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With the exception of the Three Mile Island accident, where we had a supply of potassium iodido solution manufcetured and transported te lictrisburg, Pennsyl-vania, we have not been a cu,tplier of drugs before and we do not intend to do so in the future. In fact, the supply that was stockpiled in llarrisburg has since f
been retricycd by PDA nd is now beir; stored in en FDA facility in Arkansas.
Our job is to evaluate the sa'cty and effectiveness of drugs for marketing but not to act as a supplier. Therefore, your request for funding is not possible to grant.
We believe that supplic:s of the drug can be made available either by State emergency response agencies purchasing and stockpiline; it or by Fedcen1 d
(NRC) or state cgencies requi-ing that utilities operating nuclear power plants 6
ns a condition of their op:ratitc; licenses or permits, be required to purchase adequate supplies of the d ag: for use by states in conjuncticn with emergency
.m radiolo;;ical response plans.
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la terms of guidance for use of the drug, the only guidance currently available is that contnined in ilc MCRP Report No. 55. My colleagues and I cre preparin; c paper which we hopo 'to sub tit to the literature shortly which may be helpful in terms of emplifyir.3 some of that guidance. From the experienec at Three Mlle Island, it wcs fcund that in addition to the requirement for a stockpile of the drug, it was rlso necessc y to have a detailed plan for its distribution.
The State of Pennsylvania pre;cred such a plan c:. ! you may wish to centnet Dr.
Gordon ?lr.c! cod, Sec cicry of the Commonwenith Depcrtment of Public lienith in licrric'.~ rg, to rcquest a copj of the Per.nsylvania plan as u examp!c of what one state hns done. In cdditic: to the distribution plan, it is also impcrtcnt that f
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n Alan I.1. IIckking the state develop a decision rule and document what conditions would have to r
provnil for the det:g to be used and to determine who would be the official g'g responsibic for directing its use and how that decision would be communicated jI to the general public and environs of the plant. These are elements of state L
emergency respense plan which can be done well in advanec of actually securing I'
a stockpile of the drug.
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i I hope that I have boon able to clear up any misconceptions you had about the status of potassium idodide for thyroid blocking and FDA's role in terms of
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making it available for use. If I can be of further assistance, please 'fccl free i
to contcet me.
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Sincerely yours, 9
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Jerome A. llalperin g t Deputy Director j
i Bureau of Drugs p
Enclosu es:
December 15, 1970 Federal Register M
Guideline Labeling August 17, 1979 Federal Register y f d l (
Amended Guideline Labeling i
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