ML20078B815
| ML20078B815 | |
| Person / Time | |
|---|---|
| Site: | Callaway  |
| Issue date: | 09/23/1983 |
| From: | Baxter T SHAW, PITTMAN, POTTS & TROWBRIDGE, UNION ELECTRIC CO. |
| To: | |
| Shared Package | |
| ML20078B817 | List: |
| References | |
| ISSUANCES-OL, NUDOCS 8309270264 | |
| Download: ML20078B815 (41) | |
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DOCKETED USNRC 1
N SEP 26 P452 I
UNITED STATES OF AMERICA Crn:r OF Si ,': ~
NUCLEAR REGULATORY COMMISSION 00CKUf;g(~-
- BEFORE THE ATOMIC SAFETY AND LICENSING BOARD In the Matter of )
)
UNION ELECTRIC COMPANY ) Docket No. STN 50-483 OL
)
(Callaway Plant, Unit 1) )
APPLICANT'S PROPOSED FINDINGS OF 4
FACT AND CONCLUSIONS OF LAW IN THE FORM OF A PROPOSED INITIAL DECISION Thomas A. Baxter, P.C.
Deborah B. Bauser SHAW, PITTMAN, POTTS & TROWBRIDGE Joseph E. Birk UNION ELECTRIC COMPANY Counsel for Applicant September 23, 1983 8309270264 830923 2D}
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TABLE OF CONTENTS l
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I. INTRODUCTION............................................. 1 II. OPINION.................................................. 2.
A. Reed Contentions 6 and 16........................... 3 B. The State of Missouri's Policy on the Provision of KI................................. 4 C. Potassium Iodide as a Thyroid Blocking Agent in a Radiation Emergency...................... 6 D. Federal Guidance on Potassium Iodide 8 E. Medical Benefits and Disadvantages of Potassium Iodide Administration to the General Public..................................... 15 F. Logistical Difficulties Surrounding Public Distribution................................. 17 G. The Likelihood of the Need for KI in the Context of. Emergency Planning for Callaway.......... 17 H. Conclusions......................................... 24 III. FINDINGS OF FACT......................................... 25 IV. CONCLUSIONS OF LAW......... ............................ 31 V. ORDER.................................................... 32 Appendix 1 INTERVENOR'S CONTENTIONS 1
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Septcmbor 23, 1983 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE ATOMIC SAFETY AND LICENSING BOARD In the Matter )
)
! UNION ELECTRIC COMPANY ) Docket No. STN 50-483 OL
)
(Callaway Plant, Unit 1) )
APPLICANT'S PROPOSED FINDINGS OF FACT AND CONCLUSIONS OF LAM IN THE FORM A PROPOSED INITIAL DECISION I. INTRODUCTION On December 13, 1982, this Atomic Safety and Licensing Board issued,a Partial Initial Decision (Operating License) on the ap-plication of Union Electric Company for a license to operate the Callaway Plant. Union Electric Company (Callaway Plant, Unit 1),
LBP-82-109, 16 N.R.C. 1826 (1982), aff'd, ALAB-740, 18 N.R.C.
(Sept. 14, 1983).1/ In this decision, the Board resolves the remaining contested issues in this proceeding.
1/ The Partial Initial Decision, which summarizes the relevant history of the proceeding up to the time of its issuance, re-solved the contentions of the Joint Intervenors (Coalition for the Environment, Missourians for Safe Energy and Crawdad Alli-ance) with respect to the performance of Applicant's quality as-surance programs for design and construction of the Callaway Plant. The Board decided those contentions in favor of authoriz-ing operation of the facility, but withheld authority to issue the license until it resolved the outstanding matters in contro-versy.
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The matters in controvaray Eddronsad in this dscision are the contentions of intervenor John G. Reed of Kingdom City, Missouri, with respect to the adequacy of off-site emergency preparedness for the Callaway Plant. In its Special Prehearing Conference Order of April 21, 1981, the Board deferred specifica-tion of Mr. Reed's emergency planning contentions pending the de-velopment of the off-site plans. Following the schedule adopted at a prehearing conference held on September 8, 1982, Mr. Reed filed twenty proposed contentions on October 1, 1982. In Memoranda and Orders dated December 7, 1982 and February 25, 1983, the Board admitted all but Contentions 12 and 15.B of those proposed.
Subsequently, in Orders dated June 23 and July 27, 1983, the Board approved settlement agreements executed by Applicant, Mr.
Reed and the NRC Staff, and dismissed Reed Contentions 1 through 5, 7 through 11, 13 through 15, and 17 through 20. The issues remaining for hearing, then, were Reed Contentions 6 and 16.
Pursuant to the Board's Order of August 11, 1983, the hear-ing was held on September 13, 1983, in Fulton, Missouri. Limited appearance statements by interested members of the public were received pursuant to 10 C.F.R. $ 2.715(a). Appearing as parties were Applicant, intervenor Reed, and the NRC Staff. The Public Service Commission of Missouri appeared as a representative of an interested ' state pursuant to 10 C.F.R. 5 2.715(c). The record of the hearing includes the written and oral testimony of witnesses P
presented by Applicant and the NRC Staff, and of the witnans from the Missouri Bureau of Radiological Health, who testified volun-tarily. No witnesses were offered by intervenor Reed.
II. OPINION A. Reed's Contentions 6 and 16 The contentions addressed in this decision are printed in full in Appendix 1. In summary, in Contention 6 intervenor Reed contends that potassium iodide ("KI") should be administered to emergency workers and the general public residing within the plume exposure pathway emergency planning zone ("EPZ"). The main concern expressed in Centention 6 is that residents within the EPZ may be directed to remain sheltered for a protracted period of time during a radiological release without sufficient respira-tory protection from the inhalation of radiciodines. Mr. Reed 2
argues that the protection offered by sheltering is limited and that reliance on ad hoc respiratory protective devices absent the provision of KI places the public health and safety in jeopardy.
Mr. Reed claims that federal guidance from the Food and Drug Ad-ministration ("FDA") and NUREG-0654 supports the provision of KI for such purpose.2/
2/ NUREG-0654/ FEMA-REP-1 (Rev. 1), " Criteria for Preparation and Evaluation'of Radiological Emergency Response Plans and Preparedness in< Support of Nuclear Power Plants," (Nov. 1980).
NUREG-0654 represents guidance which is not legally binding. See (Continued Next Page) s .
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4 Contention 16 faults tha cmsrgsncy plano in that they do not contain message instructions regarding respiratory protection in the case of prolonged sheltering. Although Contention 16 specif-ically faults the lack of message instructions regarding respira-tory protection, the contention as written criticizes reliance on ad hoc respiratory protection and argues that the public will be
- left unprotected and uninformed of.how to protect themselves in the event of prolonged sheltering. As Mr. Reed stated himself in his deposition on August 18, 1982 (See pp. 245-247), the concern l expressed in Contention 16 is essentially the same as that of T
Contention 6, namely that without KI the public will be caught unprotected from the inhalation of radioiodines during protracted sheltering.
B. The State of Missouri's Policy on the Provision of KI The policy of the State of Missouri with respect to the ad-ministration of KI was presented by Mr. Kenneth V. Miller, Admin-t istrator of the Missouri Bureau of Radiological Health ("BRH"),
which is that part of the Division of Health within the Missouri Department of Social Services charged with the overall (Continued)
Metropolitan Edison Company (Three Mile Island Nuclear Station, Unit No. 1), LBP-81-59, 14 N.R.C. 1211, 1460 (1981), aff'd, ALAB-698, 16 N.R.C. 1290, 1298-99 (1982), rev' d in part on other grounds, CLI-83-22, 18 N.R.C. (Sept. 8,_1983).
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responsibility of directing operations relating to nuclear I
radiation affecting the environment outside the Callaway Plant l exclusion area. Included under this State responsibility is determining the need for implementing protective actions,3/ among which are the provision and use of radioprotective drugs. Miller at 1. The State's policy on the administration of KI is set forth in Annex B of the Missouri Nuclear Accident Plan -
Callaway. Miller at 6. The policy is to make KI available in an emergency for use by emergency workers and institutionalized persons within the risk area for whom evacuation would be infeasible or very difficult.4/ The State of Missouri does not, however, plan to administer KI to the general public; instead, the State will rely on other protective options -- such as shel-tering or evacuation -- in the event of a serious emergency.
Miller, Attachment 1; Tr.-1270, 2274 (Miller). This policy deci-sion is based upon the available federal guidance on KI, as well 3/ A protective action is an action taken to avoid or reduce projected doses when the benefits derived from such action are sufficient to offset any undesirable effects of the protective action. Testimony of Missouri Bureau of Radiological Health by Kenneth V. Miller in Response to Reed Contention 6 (Protective Actions Against Radioiodines), ff. Tr. 2268 (hereafter " Miller"),
Attachment 1 at Bl.
4/ Consequently, that portion of Reed Contention 6 which addresses emergency workers has been satisfied by revisions to the State Plan adopted after Contention 6 was proposed and admit-ted for adjudication. Tha basis for this change was the FDA guidance, which we discuss below. See Tr. 2316-17 (Miller).
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Os en tho Stcto'o undsrctending of tha cdventegas end disadvantages of KI distribution. Miller at 2; Board Finding 1.
In addition, this decision is based upon the uncontroverted State
- assessment that evacuation is a more feasible logistical response for protection of the general public against radioiodine than is issuance of KI to a large population of people. Miller, Attach-ment 1 at B15.
C. Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency The purpose of administering KI would be for use as a thyroid-blocking agent in a radiological emergency. When an individual takes KI, radioiodine which might be released from the power plant and inhaled or ingested by the individual is prevented from accumulating in the thyroid. Miller at 2; Linnemann 5/ at 3. Essentially, the thyroid will absorb the sta-ble iodine in the form of KI so that radioactive iodine will not be absorbed by the saturated thyroid. The " blocked" radioactive iodine is then eliminated in the urine. If taken in a timely I fashion, KI can be highly effective in reducing radioactive io-dine exposures to the thyroid gir d; conversely, if taken at the .
wrong time, it can have little or no effect. Linnemann at 3 and 5/ Applicant's Testimony of Roger E. Linnemann, M.D. in Re- j sponse to Reed Contentions 6 and 16 (Protective Actions Against l Radiciodines and Messages with Instructions for Long-term Shel-tering), ff. Tr. 2268 (hereafter "Linnemann").
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I 4; Tr. 2275 (Linnemnnn); Board Finding 2. Tha FDA hno concludsd that potassium iodide is safe and effective for use as a thyroid-blocking agent in a radiation emergency under certain specified conditions of use. 47 Fed. Reg. 28158 (1982).
The FDA recommendation, however, goes on to note that:
[t]he use of potassium iodide in a radiation emer-gency is not a panacea. It does not reduce the uptake of the body of other radioactive materials nor provide protection against external radiation, and needs to be balanced against the cost and ef-fectiveness of other protective measures such as seeking shelter, evacuation or respiratory protection.
Id. at 28159. Importantly in this regard, the FDA recommende-tion recognizes that "[e]ach State has the responsibility for formulating guidance to define if and when the public should be given potassium iodide and instructed.to use it." Id. The FDA recommendation then indicates that the decision to provide for the administration of potassium iodide is a State public health policy decision and should involve a balancing of factors such as its effectiveness as a thyroid-blocker, the possibility of adverse effects or misuse, logistical difficulties and costs, and the likelihood of its need in the context of emergency l I
planning as a whole. We find that the State of Missouri has undergone a careful balancing of such factors, factors which the Board will now review with respect to emergency planning for the Callaway site.
D. Fadorni Guidenco on Potannium Iodida Among the factors cited by Mr. Miller of the State of Missouri's Bureau of Radiological Health as responsible for its decision to provide for the use of KI by emergency workers and institutionalized persons, but not for the general public, is the current state of available federal guidance. Miller at 2-5; Tr. 2273-74 (Miller).
10 C.F.R. 5 50.47(b) requires that on-site and off-site emergency response plans for nuclear power plants meet sixteen standards, including the following:
(10) A range of protective actions have been developed for the plume exposure pathway EPZ for emergency workers and the public. Guide-lines for the choice of protective actions during an emergency, consistent with Federal guidance, are developed and in place . . . , .
Among the recommended evaluation criteria set forth in NUREG-0654 as means of satisfying the section 50.47(b)(10) planning standard is that plans to implement protective measures for the plume exposure pathway include provisions for the use of radioprotective drugs. NUREG-0654,Section II.J.10.e. This criterion is deemed to be of particular impor-tance for emergency workers and institutionalized persons with-in the plume exposure EPZ whose immediate evacuation may be infeasible or very difficult. Id.
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1 Policy guidance on the administration of KI in tha svant of a radiological emergency has been provided by a number of federal agencies. Specifically, the FDA, the Federal Emergency l Management Agency (" FEMA"), the NRC and the Environmental Protection Agency (" EPA") have issued statements on this subject. In addition, a policy statement on KI has been pro-posed by the Federal Radiological Preparedness Coordinating Committee ("FRPCC").
In June, 1982, FDA announced in the Federal Register the availability of its final recommendations concerning the admin-istration of KI to the public in a radiation emergency. 47 Fed. Reg. 28150 (1982). FDA's recommendations stem from the f
responsibility of the Department of Health and Human Services, of which FDA is a part, for providing guidance to State and
- local governments on the use of radioprotective substances (e.g., KI) to reduce'the radiation dose to specific organs, including dosage and projected radiation exposures at which J such drugs should be used. See 44 C.F.R. 5 351.23(f),
published in 47 Fed. Reg 10758, 10761 (1982) (FEMA final regu-lations on allocation of responsibilities among various federal The agencies for radiological emergency response planning).
purpose of FDA's final recommendations on KI is to facilitate a national consensus on the use of KI during a radiation emergen-cy and to provide information and guidance to State and local i
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public health agencies and other persono rosponsible for formulating emergency response plans for radiation accidents.
FDA concludes in its final KI recommendations that the risks from the short-term use of relatively low doses of KI for j thyroid blocking in a radiation emergency are outweighed by the risks of radioiodine-induced thyroid nodules or cancer at a projected dose to the thyroid gland of 25 rem. EDA therefore recommends that KI in doses of 130 milligrams ("mg") per day for adults and children above 1 year of age, and 65 mg per day for children below 1 year of age, be considered for thyroid blocking in radiation emergencies, but only in those persons who are likely to receive a projected radiation dose of 25 rem or greater to the thyroid gland from radioiodines released into the environment. 47 Fed. Reg. 28158; Board Finding 3.
FEMA is the organization with primary responsibility in the Federal Government for establishing policies, coordinating federal assistance, and providing guidance to State and local governments on developing, reviewing, assessing, and testing State and local radiological emergency plans. 44' C. F. R. 9 351.2O(a). The NRC is responsible for reviewing FEMA's find-ings and determinations regarding the adequacy of State and local plans and taking into account the overall state of emer-gency preparedness in making decisions to issue nuclear power ;
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$ 351.21(c) cnd (d). NRC plant operating licenses. 44 C.F.R.
also specifically is assigned the responsibility of assisting FEMA in providing guidance and assistance to State and local governments concerning the storage and distribution of radioprotective substances and prcphylactic use of drugs (e.g.,
KI) to reduce the radiation dose to specific organs as a result of radiological emergencies. 44 C.F.R. 5 351.21(n).
Both the FEMA and NRC staffs have recommended that nuclear power plant licensees as well as State and local governments provide radioprotective drugs for thyroid protection in the event of a nuclear power plant accident for (i) emergency workers and other individuals remaining or arriving on-site during the emergency; (ii) emergency workers within the plume exposure EPZ; and (iii) institutionalized persons within the plume exposure EPZ whose immediate evacuation may be infeasible Carroll 6/ at 3-5; Board Finding 4. 'In its or very difficult.
December 1, 1982 Interim Policy Guidance on Potassium Iodide, FEMA stated that, since the ultimate responsibility for the health of citizens rests with each state, and since some states do not plan to include KI in their emergency preparedness plan-ning, FEMA is reviewing its guidance, set forth in NUREG-0654, 6/ NRC Staff Testimony of Marlee Carroll on Reed Contentions 6 and 16, ff. Tr. 2366 (hereafter " Carroll").
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which requires provisions for the use of radioprotective drugs, with the belief that demonstration of an appropriate alterna-tive for institutionalized persons could be acceptable.
Nevertheless, FEMA continues to support the use of KI for this purpose. Carroll at 2-3.
The FEMA and NRC guidance on KI contained in evaluation criterion J of NUREG-0654, recommending that KI be particularly considered for use by emergency workers and institutionalized persons, was influenced by the following considerations: (i) the recommended populations to be administered KI are limited in size and would require quantities of KI which could be read-ily maintained, distributed, administered and controlled; (ii) these populations have a relatively high probability of being exposed to radioactive airborne releases should an accident occur; '(iii) the medical history of the populations could be
> established readily, thus avoiding possible side effects to sensitive persons by taking other measures for such persons; and (iv) these individuals can be readily monitored for adverse effects by medical personnel. Carroll at 4. None of these considerations applies to the population at large. To date, neither the NRC nor FEMA has recommended the administration of KI to the general public located within the 10-mile plume expo-sure EPZ. Rohrer7/ at 2; Carroll at 2-3, Tr. 2367 (Rohrer),
7/ NRC Staff Testimony of David M. Rohrer Regarding Emergency l Planning (Contentions 6 and 160, ff. Tr. 2366 (hereafter "Rohrer").
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2368 (Carroll); Board Finding 4.
EPA is responsible for the establishment of Protective Action Guides ("PAGs") for all aspects of radiological emergen-
, cy response planning, in coordination with appropriate federal t
agencies. 44 C.F.R. 6 351.22(a). EPA also prepares guidance for State and local governments on implementing PAGs, including recommendations on protective actions which can be taken to mitigate the potential radiation dose to the population. 44 C.F.R. $ 351.22(b). In its Manual for Protective Action Guides
. and Protective Actions for Nuclear Incidents, EPA-520/1-75-001, Sept., 1975 (Revised June 1980), at pages 1.41-1.42, EPA recommends the use of KI as a prophylaxis for emergency workers located in areas possibly involving radioiodine contamination, in accordance with State health laws and under the direction of State medical officials. 'With respect to the efficacy of ad-ministering KI to the general population, EPA notes that this option is still under consideration by government agencies but should not be construed to be the policy of EPA at this time.
Miller at 4-5.
The FRPCC consists of FEMA (which chairs the Committee),
the NRC, the EPA, the Department of Health and Human Services, the Department of Energy, the Department of Transportation, the Department of Defense, the Department of Agriculture, the Department of Commerce, and any other federal agencies or i
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departments as appropriate. 10 C.F.R. $ 351.10(a). The FRPCC assists FEMA by (i) providing policy direction for the program of federal assistance to State and local governments in their radiological emergency planning and preparedness activities; and (ii) resolving issues relating to the granting of final FEMA approval of a State plan. 10 C.F.R. $ 351.11(a).
In an October 7, 1982 proposed federal policy statement on potassium iodide, the FRPCC endorsed the NRC/ FEMA guidance on KI distribution for emergency workers and institutionalized
. individuals. The policy statement reiterates that KI distribu-tion is the responsibility of state authorities, stresses that KI provides merely thyroid protection and is thus a limited protective method to be used in conjunction with sheltering, evacuation or other protective methods, and concludes that in deciding whether or not to use KI, " State and local authorities. . .should csrefully evaluate advantages and possi-ble problems in implementing this program for the specific nu-clear power plant (s) within their jurisdiction." Carroll at 4-5.
In summary, current federal guidance on the administration of KI favors administration of the drug to emergency workers and institutionalized persons within the EPZ for whom immediate evacuation may be infeasible or very difficult for use as a thyroid-blocking agent in radiological emergency. This
guidance is consistent with the concern expressed in NUREG-0654, evaluation criterion J.10.e about these vulnerable groups. There is no current federal recommendation that KI be distributed to the general public.
E. Medical Benefits and Disadvantages of Potassium Iodide Administration to the General Public The Board considered a survey of the medical benefits and disadvantages supporting the State of Missouri's decision to make KI available for use by emergency workers and institution-alized persons for whom evacuation may be very difficult or infeasible, but not for the general public.8/ If taken at the proper time, the administration of stable iodine in the form of KI can substantially reduce the thyroid's uptake of radiciodines. Conversely, if not taken at the proper time, KI may have little or no effect. Linnemann at 3-4; Tr. 2275, 2303-05 (Linnemann). Given KI's potential effectiveness as a thyroid blocking agent, Dr. Linnemann supports its controlled administration to high risk persons such as emergency workers and institutionalized persons for whom evacuation may be very difficult or infeasible. Linnemann at 4-5, Tr. 2308-09 (Linnemann).
8/ Testimony from Applicant on the medical benefits and disadvantages of KI distribution was given by Dr. Roger E.
Linnemann, a medical doctor with particular expertise in the area of radiological health.
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There are, however, numerous medical concerns which counsel against an uncontrolled, widespread distribution of KI to the general public in the context of a radiation emergency.
The FDA final recommendations recognized that " uncertainties still exist about the dose response for radioiodine induced thyroid cancers and the incidence and severity of side effects from potassium iodide," uncertainties which "are unlikely to be resolved soon." 47 Fed. Reg. 28158. Although there is substantial experience with an individualized, medically contrciled administration of the drug for treatment of bronchi-al asthma and other pulmonary diseases, there has been no expe-rience with the risks of allergic reactions associated with a general distribution of KI to the public. Without such experi-ence, it is difficult to quantify the risks of adverse reactions in sensitive groups in the population. Those risks, however, should be considered potentially significant.
Linnemann at 4; Tr. 2276, 2283-94, 2300 (Linnemann); Board Finding 5.
Another and related type of medical concern besides the potential for adverse reactions is the potential for misuse and abuse of the drug attendant on its uncontrolled distribution by the governmant. For example, there is the difficulty of insuring that the drug is taken properly and in a timely fashion when needed, especially during crisis conditions.
There is the possibility, associated with any drug, of its uso for non-intended purposes. There is also the danger that KI has the potential for inducing a false sense of security in the I
i public with regard to protection from radiation, when it only protects the thyroid. Furthermore, under such uncontrolled ad-ministration of KI without medical supervision there would be a greater risk of the likelihood of, and a diminished ability to respond to, adverse reactions. Linnemann at 5; Rohrer at 3; Tr. 2281-83, 2292-93, 2305-06 (Linnemann); Tr. 2370-74 (Rohrer); Board Finding 6.
F. Logistical Difficulties Surrounding Public Distribution Another set of factors raised against the policy of providing KI to the general public involves logistical problems such as the costs of stockpiling, a timely distribution of the
! drug, and the drug's . limited shelf life (2 to 3 years). Rohrer at 3-5; Linneman at 5; Tr. 2378-81 (Rohrer); Tr. 2307 (Linnemann); Board Finding 7.
G. The Likelihood of the Need for KI in the Context of Emergency Planning for Callaway The main issue of controversy in deciding whether or not to provide KI to the general public surrounds the actual need for KI in order to provide reasonable assurance that adequate respiratory protection can and will be provided in the event of an accident at the Callaway Plant. An important fact l
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apparently overlooked by Mr. Reed is that at the point at which KI would be considered as a protective action according to the FDA recommendation, namely when there is a projected offsite dose to the thyroid of 25 rem, the State PAGs preceribe an evacuation of threatened off-site populations.9/ Tr. 2274, 2319-20 (Miller); Board Finding 8. In the event of a low dos-age airborne release or a rapid release preventing an immediate evacuation, the public will be instructed to take shelter and instructed in the use of ad hoc respiratory protection until conditions. warrant a relaxation of protective actions, or until the passage of the plume allows for a safe evacuation.
Slaten10/ at 4-5; Tr. 2322 (Miller); Board Finding 9.
To challenge this policy, Mr. Reed argues: (1) that rapid off-site releases may prevent an evacuation when the 25 rem PAG level is exceeded, forcing the EPZ population to rely on immediate and protracted sheltering; (2) that sheltering is ef-fective for a limited duration; and, (3) that ad hoc 9/ The State Protective Action Guide (PAG) is the projected dose to individuals in the populA; ion which warrants taking pro-tective actions. PAG's have been developed to reduce to manage-able levels the decisions that must be made to protect the public in the event of a nuclear incident. See Miller, Attachment 1 at Bl.
Slaten in Response to Reed 10/ Applicant's Contentions Testimony of Neal G.
6 and 16 (Protective Actions Against Radioiodine and Messages with Instructions for Long-Term Sheltering), ff. Tr.
2268 (hereafter "Slaten").
respiratory measures do not offer adequate protection. Under i such conditions, the public, the Intervenor contends, assumes the same status as institutionalized persons for whom evacua-tion may be infeasible or very difficult, and thus should have recourse to identical protective measures. .
To begin with, we must reject the Intervenor's attempt to draw an analogy for planning purposes between the off-site public instructed to take shelter and institutionalized persons for whom evacuation may be infeasible or very difficult. NRC guidance is very clear in distinguishing for planning and pro-tective response purposes the difference between these two sets of population groups. See Carroll at 3. The recommendations for the provision of KI to the institutionalized -- such as those in prisons, mental hospitals, or hospitals -- is clearly predicated on the anticipated limited ability to safely move these populations from the institutions in which they reside.
Tr. 2389 (Carroll); 2308-09 (Linnemann). The intervenor's at-tempt to claim that the general population may similarly be an-ticipated to be constricted in emergency response alternatives finds no basis in federal guidance, which precisely differenti-ates these groups, and is easily refuted. As Applicant's witnesses testified, for the great range of potential accident scenarios evacuation is a real and feasible alternative. Pad-1 dieford11/ at 8-9; Slaten at 15-16; Tr. 2277-2278, 2331 11/ Applicant's Testimony of Donald F. Paddleford in Response to Reed Contentions 6 and 16 (Protective Actions Against i 1
(Continued Next Page)
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I Much of the testimony was, in fact, directed at challenging the likelihood of the need for KI in the context of emergency planning for the Callaway site. In the event of a rapid off-site release, the meterological conditions which would carry such a plume off-site rapidly would likely remove it rapidly. Slaten at 15.
Another consideration to take into account is the limited protective benefit KI actually offers compared to the effec-tiveness of other protective action measures which would be im-plemented according to the State Protective Action Guides. In the context of these other planned protective actions, the risk of thyroid exposure is not necessarily the paramount concern.
Studies conducted by both the FDA and NRC indicate that the fatal carcinogenic risk is greater from the whole body dose than from the thyroid dose using the airborne plume from various accidents in WASH-1400, " Reactor Safety Study." The studies indicated that for a rad io of 20 to 1 thyroid to whole body dose, the resulting risk of cancer death is three-times greater for the whole body dose. This difference in risk is a (Continued)
Radioiodines and Messages with Instructions for Long-Term Shel-tering), ff. Tr. 2268 (hereafter "Paddleford").
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result of the low percentage of deaths for thyroid cancor ao compared to a higher percentage of deaths for many other types of cancer. This makes the value of administering KI to the general public questionable as other protecti~e measures (e.g.,
evacuation or shelter) would be instituted based on the more critical effects, which would also reduce the thyroid dose.12/
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Rohrer at 2-3; Tr. 2367 (Rohrer); Board Finding 10. As we have noted, the State of Missouri will evacuate at a projected off-site dose to the thyroid of 25 rem, the point at which according- to the FDA recommendations KI would become a consid-ered protective action. Thus, in the context of emergency planning for the general public as a whole, it appears that KI offers no unique protective advantage.
W The FRPCC also remarks in this regard that "[o]ne of the considerations in deciding whether to implement the use and dis-tribution of KI for the general population is that KI blocking only effectively reduces the radiation exposure of the thyroid gland. While this is an important ontribution to the health and safety of the individual, it is not nearly as effective as measures which protect the total body of the individual from radioactivity. Both in-place sheltering and precautionary evacu-ations can reduce the exposure to the total body." Carroll at 5.
Similarly, the Board takes notice of the observation in the FDA ~
Final Recommendations (30-31) that "[i]f public health authorities choose to evacuate people from the accident site, and if those people are moved promptly, the use of potassium iodide may not be necessary. Evacuation, when it is a logistically fea-sible option, is a more effective method of reducing (or eliminating) thyroid exposure to radiation and may be a more de-sirable protective measure, especially for the population at high risk from such exposure (e.g., infants, children, and pregnant '
women)."
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The final question which concerns us in this regard, thsn, is the ability to provide respiratory protection when postulating the need for protracted sheltering. To put the need in perspective, the Board finds that for most potential accident scenarios there would be more than sufficient time to initiate an evacuation,13/ and that the probability of an accident requiring both immediate and protracted sheltering exists at the remote spectrum of low probability events. Pad-dieford at 2-10, 12-13; Tr. 2277-78, 2328-32 (Paddleford);
Board Finding 11. If faced with a situation requiring immediate and protracted sheltering, protective measures such as the clearing of roads and the use of National Guard helicop-l ters can be utilized to evacuate stranded persons. Slaten at 15 and Attachment 2; Tr. 2269 (Slaten); Board Finding 12.
No evidence suggests'any difficulty or impediments to evacuation.14/ Furthermore, the combination of sheltering and the use of ad hoc respiratory protection measures can offer 13/ In addition to the time of accident evolution, one must consider the. advanced diagnostic instrumentation and facilities installed at the Callaway plant, allowing for prompt assessment of the present and future state of the plant during an accident sequence. This will serve to minimize the time lag between a developing threat to the general public and notification of the ,
public. Paddleford at 11-13; Tr. 2278 (Paddleford).
14/ Mr. Reed voluntarily withdrew his Contention 19 on the ade-quacy of plans to deal with potential impediments to evacuation.
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comparable respiratory protection to KI, in addition to protecting other organs. Slaten at 15; Tr. 2271-73, 2333-50 (Slaten); Board Findings 13, 14 and 15. Neither the NRC nor FEMA requires compensating measures absent provision of KI to the general public. The emphasis for protection of the general public is that they be educated to tune to their local Emergen-cy Broadcasting Station (EBS) and follow any instructions con-cerning shelter, protective actions, and if necessary, evacua-Rohrer at 5; Carroll at 5-6. Board Finding 16. EBS tion.
instructions will advise the public in appropriate protective actions, including when and how to initiate ad hoc respiratory protection, and in measures to increase the effectiveness of a shelter. Slaten at 14; Tr. 2391-94 (Carroll); Board Finding 17.
We are reminded in this instance of NUREG-0654's admoni-tion that:
[t]he overall objective of emergency response plans is to provide dose savings (and in some cases immediate life saving) for a spectrum of accidents that could produce off-site doses in excess of Protective Action Guides (PAGs). No single specific accident sequence should be iso-lated as the one for which to plan because each accident could have different consequences, both in nature and degree.
NUREG-0654, p.6. See also Slaten at 16; Tr. 2272-73, 2351 (Slaten). We find, consequently, that there is no justifica-tion for gearing emergency planning to the low probability 1
l l
potential of immediate and long-term sheltering, and furthermore, that even in the event of such accident conditions the State of Missouri has developed sound protective action al-ternatives to the use of KI, consistent with federal guidance, which can adequately protect the public.
H. Conclusions l Federal guidance indicates that the decision on whether or not to provide for the administration of potassium iodide for use in the event of a nuclear power plant accident is a state public health policy decision. The State of Missouri's deci-sion to make KI available for use by emergency workers and in-stitutionalized persons but not for the general public is con-sistent with the current federal posture on the issue, and has involved a careful balancing of the advantages, risks, costs and liNely need for KI in.the context of emergency planning for Callaway. In similar NRC proceedings where this issue has been litigated, licensing boards have addressed this issue and have found acceptable state policies which are consistent with the federal guidance.15/ Consequent /, we find no basis for Reed i
15/ See Metropolitan Edison Company (Three Mile Island Nuclear Station, Unit No. 1), LBP-81-59, 14 N.R.C. 1211, 1664-70 (1981),
aff'd, ALAB-697, 16 N.R.C. 1265 (1982); Southern California Edison Company et al. (San Onofre Nuclear Generating Stations, Units 2 and 3), LBP-82-39, 15 N.R.C. 1163, 1186, 1230-31, 1242 (1982), aff'd, ALAB-717, 17 N.R.C. (March 4, 1983);
t
. Louisiana Power and Light Company (Waterford Steam Electric Station, Unit 3), LBP-82-100, 16 N.R.C. 1550, 1567 (1982), aff'd, ALAB-732, 17 N.R.C. , slip op. at 27 (June 30, 1983). )
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- Contentions 6 and 16.
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III. FINDINGS OF FACT
- 1. The policy of the State of Missouri as developed by the Bureau of Radiological Health is to provide for the admin-istration of KI to the emergency workers and institutional 1 zed pirsons for whom evacuation would be infeasible or very difficult, but not for the general public. Instead of providing KI to the general public, the State plans to rely on the protective measures of evacuation, sheltering, and the use of ad hoc respiratory techniques. This policy decision is based upon the availablo federal guidance on KI, the State's understanding of the advantages and disadvantages of KI distri-bution, and the State's determination that for the Callaway Plant evacuation is a more feasible logistical response for the protection of the general public. Miller at 2; Miller, Attach-ment 1; Tr.2270, 2274 (Miller).
- 2. In the event of a radiological accident, a radioprotective drug such as potassium iodide ("KI") can be ad-ministered to curtail the accumulation of radioiodines by the thyroid. If taken in a timely fashion, KI can be highly effec-tive in reducing radioactive iodine exposures to the thyroid gland; conversely, if taken at the wrong time it can have lit-tle or no effect. Linnemann at 3 - 4; Tr. 2275, 2303-05 (Linnemann).
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- 3. The FDA's Final Recommendations on the use of KI conclude that the risks from the short-term use of relatively low doses of KI for thyroid blocking in a radiation emergency are outweighed by the risks of radiciodine-induced thyroid nod-ules or cancer at a projected dose to the thyroid gland of 25 rem. FDA therefore recommends that KI in doses of 130 milli-grams ("mg") per day for adults and children above 1 year of age, and 65 mg per day for children below 1 year of age be con-sidered for thyroid blocking in radiation emergencies, but only in those persons who are likely to receive a projected radia-tion dose of 25 rem or greater to the thyroid gland from radiciodines released into the environment. 47 Fed. Reg. 28158 l
(1982). l
- 4. Both the FEMA and NRC staffs have recommended that nu-clear power plant licensees as well as State and local governments provide radioprotective drugs for thyroid protection in the event of a nuclear power plant accident for (i) emergency workers and other individualc remaining or arriv-ing on-site during the emergency; (ii) emergency workers within the plume exposure EPZ; and (iii) institutionalized persons within the plume exposure EPZ whose immediate evacuation may be infeasible or very difficult. Carroll at 3-5. To date, nei-ther the NRC nor FEMA has recommended the administration of KI to the general public located within the lO-mile plume exposure
EPZ. Rohrer at 2; Carroll at 2 and 3; Tr. 2367 (Rohrer); 2368 (Carroll). Current federal guidance indicates that the deci-sion of whether to provide KI is a state public health policy decision. Carroll at 2, 3, and 5; Tr. 2368 (Carroll).
- 5. The FDA has recognized that uncertainties exist regarding the dose response for radioiodine induced thyroi'd cancers and the incidence and severity of side effects from KI.
47 Fed. Reg. 28158. There has been no experience with the risks of allergic reactions associated with a general distribu-tion of KI to the public. Without such experience, it is difficult to quantify the risks of adverse reactions in sensi-tive groups in the population. Those risks, however, should be considered potentially significant. Linnemann at 4; Tr. 2276, 2283-94, 2560 (Linnemann).
- 6. Numerous medical
- problems surround the uncontrolled distribution of a drug cu h as KI to the general public. These include inspring that the drug is taken properly and in a time-ly fashion when needed, the possibility of its use for non-intended purposes, and the potential KI has for inducing a false sense of security from radiation. Furthermore, under such uncontrolled administration of KI without medical supervi-sion there would be a greater risk of the likelihood of, and a diminished ability to respond to, adverse reactions. Linnemann at 5; Rohrer at 3; Tr. 2281-83, 2292-93, 2305-06 (Linnemann);
2370-74 (Rohrer).
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- 7. Among the logistical difficulties surrounding a public distribution of KI are the costs of stockpiling, a timely dis-l tribution of the drug, and the drug's limited shelf life (2 to 3 years). Rohrer at 3-5; Linnemann at 6; Tr. 2378-81 (Rohrer);
2307 (Linnemann).
- 8. At a projected off-site dose rate to the thyroid of 25 rem (the point a which the FDA has recommended KI be considered for use as a thyroid blocking agent in case of a nuclear accident) the State plan calls for an immediate evacuation.
Evacuation is the most effective protection against radioiodines. Tr. 2274, 2319-20 (Miller).
- 9. Should an accident result either in a low dosage air-borne release or a rapid release preventing an immediate evacu-ation, the public will be instructed to take shelter and will be instructed in the use of ad hoc respiratory protection until
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conditions warrant a relaxation of protective actions or permit a safe evacuation. Slaten at 4-6; Tr. 2322 (Miller).
- 10. KI offers a limited protective benefit in that it only protects the thyroid gland. Staff studies conducted by the FDA and NRC indicate that fatal carcinogenic risk is
, greater from the whole body dose than from the thyroid dose ,
using the airborne plume from various accidents in WASH-1400,
" Reactor Safety Study." The studies indicated that for a ratio of 20 to 1 thyroid to whole body dose, the resulting risk of 1
cancer death is three times greater for the whole body dose.
This difference in risk is a result of the low percentage of deaths for thyroid cancer as compared to a higher percentage of deaths for many other types of cancer. This makes the value of administering KI to the general public questionable as other protective meacures (e.g., evacuation or shelter) would be in-stituted based on the more critical effects, which would also reduce the thyroid dose. Rohrer at 2-3; Tr. 2367 (Rohrer).
- 11. For most potential accident scenarios there will be sufficient time to initiate an evacuation. The probability of an accident requiring both immediate and protracted sheltering exists at the remote spectrum of low probability events. Pad-dieford; Tr. 2277-78, 2328-32 (Paddleford).
- 12. If faced with a situation requiring immediate and protracted sheltering, protective measures such as the clearing of roads and the use of National Guard helicopters can be uti-lized to evacuate stranded persons. Slaten at 15 and' Attach-ment 2.
- 13. The use of sheltering as a viable protective action is supported by data on the ability of structures to shield individuals from exposure to radiation. The effectiveness of inherent structural shielding can be auamented by the use of ventilation strategies. Slaten at 3-8; Tr. 2272, 2334-39 (Slaten).
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- 14. The use of ad hoc respiratory protection as a vicble protective action is supported by data on the effectiveness of using common household materials as inhalation filtering de- ,
I vices to minimize internal exposure to radioactive material.
Slaten at 8-14; Tr. 2272, 2342-49 (Slaten).
- 15. The combination of sheltering and ad hoc respiratory protection provides comparable thyroid protection to the use of KI, in addition to protecting other organs as well. Slaten at 13, 15; Tr. 2272, 2349 (Slaten).
- 16. Neither NRC nor FEMA requires compensating measures absent provision of KI to the general public. The emphasis for protection of the general public is that they be educated to tune to their local Emergency Broadcasting Station (EBS) and follow any instructions concerning shelter, protective actions, and if'necessary, evacuation. Rohrer at 5; Carroll at 5-6.
j 17. EBS instructions will advise the public in appropriate prctective actions, including when and how to ini-tiate ad hoc respiratory protection, and in measures to in-crease the_ effectiiveness of a shelter. Slaten at 14; Tr.
2391-94 (Carroll).
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IV. CONCLUSIONS OF LAW f i
y The Board has considered all the evidence submitted on Reed Contentions 6 and 16, as well as the proposed findings of fact and conclusions of law filed by the parties. Those pro-posed' findings and conclusions not adopted or otherwise addressed in this decision have been found to be without merit or utinecessary to the Board's decision. Based upon a review of the entire record in this proceeding and the foregoing opinion and findings of. fact, the Board enters the following conclu-sions of law.
With respect to the matters placed in controversy by Reed Contentions 6 and 16, there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the Callaway Plant. Further-more, as to the matters placed in controversy by Reed Conten-tions 6 and 16, the off-site emergency response plans meet the standards of 10 C.F.R. 5 50.47(b)(5) and (10).
This is a contested proceeding on an application for an operating license for a utilization facility, and the Board has made findings of fact and conclusions of law on all of the mat-ters in controversy. The Board has not determined that a ,
serious safety, environmental, or common defense and security matter-exists. See 10 C.F.R. 5 2.760a. Other findings
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required to be made prior to the issuance of an operating license are to be made by the Director of Nuclear Reactor Regu-lation. See id. and 10 C.F.R. 5 50.57.
Having decided all matters in cont.oversy in favor of au-thorizing operation of the facility, the Board concludes that l
as to the matters decided in the Partial Initial Decision and this Initial Decision, the Director of Nuclear Reactor Regula-I tion is authorized to issue to Applicant Union Electric Company a license to operate the Callaway Plant, Unit 1.
V. ORDER WHEREFORE, IT IS ORDERED, in accordance with 10 C.F.R. $$
2.760a and 50.57, that upon making the requisite findings with respect to matters not embraced in the Partial Initial Decision and this Initial Decision, the Director of Nuclear Reactor Reg-ulation is authorized to issue to Applicant Union Electric Com-pany a license to operate the Callaway Plant, Unit 1.
! IT IS FURTHER ORDERED, in accordance with 10 C.F.R. EL 2.760(a), 2.762 and 2.764, that this Initial Decision is effec-l tive immediately insofar as it authorizes operation up to five percent of the facility's rated power and shall otherwise be-come effective pursuant to 10 C.F.R. 5 2.764(f)(2). This Ini-tial Decision shall constitute the final action of the Commission forty-five (45) days after the date of issuance f
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hereof, unless exceptions are taken in accordance with section 2.762 or the Commission directs that the record be certified to it for final decision. Any exceptions to this Initial Decision or designated portions thereof must be filed within ten (10) j days after service of the decision. A brief in support of the exceptions must be filed within thirty (30) days thereafter (forty (40) days in the case of the NRC Staff). Within the thirty (30) days of the filing and service of the brief of the appellant (forty (40) days in the case of the NRC Staff), any other party may file a brief in support of, or in opposition to, the exceptions.
Respectfully submitted, hau- - -- - - --- ---
Thomas A. Baxter, P.C.
Deborah B. Bauser SHAW, PITTMAN, POTTS & TROWBRIDGE 1800 M Street, N.W.
Washington, D.C. 20036 (202) 822-1000 Joseph E. Birk UNION ELECTRIC COMPANY P.O. Box 149 St. Louis, Missouri 63166 (314) 554-2096 Counsel for Applicant Dated: September 23, 1983
Appendix 1 INTERVENOR'S CONTENTIONS
- 6. Protective Actions Against Radiciodine (Drugs And Equipment)
A range of protection actions have not been developed for the plume exposure pathway EPZ for local emergency workers or the public which protect against direct or ingested radiation as is required by 10 CFR, Part 50, Section 50.47(b)(10) and NUREG 0654, II, J, which includes provisions for the use of radioprotective drugs, particularly for emergency workers and institutionalized persons whose immediate evacuation may be infeasible or very difficult. Such provisions must include quantities, storage, and means of distribution (See NUREG 0654, II, J, e).
A. Evacuation is considered the most protective action for members of the public in a radiological accident (SOP, pg.
8-4) but constraints and disadvantages may make it inappropri-ate, such as arrival of the plume in mid-evacuation, etc.
Evacuation is a last resort (SOP, pg. 8-3).
B. Shelter is, therefore, the primary protective action but good protection in a dwelling is limited (EPA-520/1-75-OO1, 1.6.3.2):
"- , shelter provided by dwellings with windows and doors closed and ventilation turned off would provide good protection from inhalation of gases and vapors for a short period (i.e. one hour or less) but would be
-- ineffective after about two hours - ."
No effective course of action is proposed for sheltering after that period. Use of ad hoc repiratory devices in lieu of other effective methods of preventing inhalation or ingestion of nuclides such as rad'ioactive iodines for extended periods of time places public health and safety in jeopardy.
(1) Use of potassium-iodide as a protective option by residents in the plume exposure pathway EPZ is rejected in the proposed Off-site Plan, page 9-5, item I. l (2) Potassium-iodide is not provided for optional use by local emergency workers, nor is respiratory protection that meets NRC standards for use in a radiological environment.
(3) Local. governments' proposed SOPS state t?-t be-cause of safety, economic and .'egal considerations, the deci-sion to evacuate should be the protective action of last resort (See SOPS, Proc. No. 8, 4.3). Of the two options discussed in the SOPS, shelter and evacuation, the State has decided to evacuate rather than issue KI; however, shelter without the benefit of KI is the primary protective action to be considered l
)
in an accident involving a release of nuclides from the plant.
Pre-school children, pregnant women and all females of
l child-bearing age who are advised to stay indoors (shelter I mode) without KI or respiratory protection are subject to thy-roid damage or its destruction in themselves and/or the chil-dren in utero.
C. The State of Missouri has refused to provide radioprotective drugs, e.g. prophylactic iodine, for either emergency workers or the general public. The Bureau of Radiological Health has decided that evacuation is a more fea-sible logistical response for protection against radioiodine than is issue of potassium iodide (KI) (See State of Missouri RERP, page Bil, H.).
(1) Radioiodines contribute significant exposure modes to whole body exposures, thyroid exposure and lung expo-sure (See NUREG 0654, page 18, Table 3).
(2) The principle inhalation dose will be from io-dines and particulate material in the plume. Due to the abili-l ty of the thyroid to concentrate iodine, the thyroid dose re-sulting from inhalation of radioiodines may be several times greater than the corresponding wPile body external gamma dose that would be received (State RERP, Annex B, C.2).
D. Selection of two options as a range of protective actions without including suitable protective support equipment or chemical prophylaxis to enhance the effectiveness of a selected option over time renders said option to be ineffective
.i . i., .
under the definition of the two options contained in the SOP, pages 8-3, 8-4, and 8-5.
E. The U.S. Food and Drug Administration has found the use of potassium-iodide (KI) to be safe and effective as a thy-roid blocking agent to prevent the uptake of radioactive io-dines by the thyroid glands. Since said Federal agency has publically rendered such judgment on the use of KI, it is felt I
that said KI should be made an optional defensive measure that
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the general public can take in a sustained shelter situation to protect against thyroid damage or loss, especially in chil-dren/ infants. Public warnings on packages / bottles can advise of possible reactions to use of this drcq by persons who are allergic to KI (similar to the warnings on migarettes and patent medicines), if officials are concerned chout ingestion 2
of KI by allergenic residents of the EPZ.
F. NUREG 0654, page 63, J. Protective Response, e, states:
" Provisions for the use of radioprotective drugs, particularly for emergency workers and institutionalized persons within the plume exposure EPZ whose immediate evacuation may be infeasible or very difficult, including quantities, storage, and means'of distribu-tion."
Such evaluation criteria is applicable to State and local governments and indicates that use of KI or similar drugs is a required criteria for a satisfactory plan (see NUREG 0654, page l
4, lines 13-15): 1
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" FEMA and NRC regard all of the planning standards identified herein as essential for an adequate radiological emergency plan."
G. Common sense and reason indicates that a situation such as this is not in the best interest of providing protection for the public health and safety. If a situation precluding evacuation is possible, and shelter phases may exceed two hours (the effective limit of homes -- see SOP, Pro-cedure No. 8, 5.1.1) and the public is to be afforded protection from radiciodines, KI or some other thyroid protec-tive drug or device must be made available to shelterees.
- 16. Messages With Instructions For Long-Term Sheltering State and local governments shall provide written messages intended for the public which shall include the appropriate as-pects of sheltering,.ad hoc respiratory protection, thyroid blocking or evacuation (see NUREG 0654, II, E.7.). Messages contained in the proposed Offsite Plan does not provide for instructions relating to thyroid blocking or respiratory protection if prolonged sheltering is necessitated.
A. Ad hoc respiratory protective devices (handkerchief or towel over mouth and nose, etc.) are known to be less effec-I tive than filter-type respirators whose effective lifetime under use is from 2 to 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> (see EPA-520/1-75-001, Chapter l
1 .
E 1, 1.6.3.4, page 1.40, lines 13 & 14) and shelter in buildings suitable for winter habitation (see SOP, Procedure No. 8, 5.1.1) will provide reasonably good protection for about two hours. Given these facts, reasonably adequate respiratory and thyroid protection is provided if shelter is restricted to two or three hours. In cases of flooding, snow and/or ice on area roads; travel in rural areas of all counties have been cur-tailed for days. In the event of an accident / release of nuclides, shelter must be considered necessary for as long as two to four days. In such circumstances, residents are placed in a situation wherein they cannot move out of the area and do not have protective options which insure their safety if they stay. This situation clearly places public health and safety at risk.
B. Instructions in the Offsite Plan and SOPS must be rewritten to include instructions for the provision of long term shelter instructions which are available to residents who will be advised to take shelter versus evacuation in the event of an accident / release of nuclides at the plant.
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