ML20081C303
| ML20081C303 | |
| Person / Time | |
|---|---|
| Site: | Callaway  |
| Issue date: | 10/27/1983 |
| From: | Baxter T SHAW, PITTMAN, POTTS & TROWBRIDGE, UNION ELECTRIC CO. |
| To: | |
| References | |
| ISSUANCES-OL, NUDOCS 8310310200 | |
| Download: ML20081C303 (13) | |
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.s JNC October.27, 1983 23 OCT 28 Hg:3; UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION fCCdW
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. ,r;n BEFORE THE ATOMIC SAFETY AND LICENSING BOARD In the Matter of )
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UNION ELECTRIC COMPANY ) Docket No. STN 50-483 OL
)
l (Callaway Plant, Unit 1) )
APPLICANT'S REPLY TO THE PROPOSED FINDINGS OF FACT AND CONCLUSIONS OF LAW FILED BY INTERVENOR REED Pursuant to the schedule established by the. Board at the hearing held on September 13, 1983,1/ Applicant herein submits its reply to Intervenor Reed's " Findings of Fact and Conclu-sions of Law," dated October 6,* 1983.2/ In addressing Mr.
l Reed's proposed findings of fact and conclusions of law, Appli-cant's reply will not attempt to restate its position on all of the issues raised by Mr. Reed on which Applicant disagrees, nor
- 1/ See Tr. 2402; Memorandum and Order (Leave to Withdraw Tes-timony and Scheduling for Filing Proposed Findings and Conclu-sions of Law), October 4, 1983.
2/ The NRC Staff has filed " Proposed Findings of Fact and Conclusions of Law," dated October 21, 1983. Applicant has no-response to the Staff's proposed findings, which accurately reflect the evidentiary record.
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. 's remarshal all the relevant facts which support its case.
Rather, Applicant continues to rely upon " Applicant's Proposed Findings of Fact and Conclusions of Law in the Form of a Pro-posed Initial Decision," dated September 23, 1983.
The main regulatory argument made by Mr. Reed in support of his contention 3/ that the State of Missouri should predistribute potassium iodide ("KI") to the general public residing within the plume exposure pathway emergency planning zone ("EPZ") is that the Food and Drug Administration ("FDA")
has concluded 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). Applicant contends that in his proposed findings of fact and conclusions of law Mr. Reed has mischaracterized both the substance and scope of the FDA recommendation, as well as the position of Applicant and the State of Missouri regarding federal guidance on the provision of KI.
In his proposed findings of fact and conclusions of law Mr. Reed cites the FDA recommendation's conclusion 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 3/ Mr. Reed only pursues Contention 6 in his proposed find-ings of fact and conclusions of law. In fact, he proposes a Board conclusion of law that "[w]ith respect to matters placed in controversy by Reed Contention 16, there is reasonable as-surance that adequate protective measures can and will be taken to properly inform the public of defensive actions needed to protect the public health and safety." Reed Proposed Findings at 8-9.
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risks of.radioiodine-induced thyroid nodules or cancer at a projected dose to the thyroid gland of 25 rem, and that doses recommended for use are 130 milligrams (mg) a day for adults and children about one yecr of age and 65 mg per day for infants below one year of age. Mr. Reed, however, states that the FDA recommendation recommends that these doses "be adminis-tered in a radiation emergency," rather than accurately quoting the recommendation -- which quite differently recommends that these doses "be considered for thyroid blocking in radiation emergencies in those persons who are likely to receive a
. projected radiation dose of 25 rem ar greater to the thyroid gland from radiciodines released into the environment." 47 Fed. Reg. 28158 (emphasis added); Reed Proposed Findings at 2.
Mr. Reed then accuses Applicant of making a " radical" attack on the FDA findings "with testimony relating to ' risks', 'use for non-intended purposes,' ' inducing a false sense of security in the public,' uncontrolled admi'nistration of KI without medical supervision,' 'a greater risk of the likelihood of, and a di-minished ability to respond to adverse reactions,'" citing 10 C.F.R. $ 2.758(a) for the proposition that such an " attack" is impermissible.4/
4/ This citation is, of course, clearly inappropriate.
Section 2.758 by its plain terms applies only to rules and reg-ulations of the Nuclear Regulatory Commission. The pronounce-ments of another agency clearly are not encompassed by section 2.758. Thus, the FDA recommendations, even if they stood for the proposition Mr. Reed contends, which they do not, are not in any way binding on the NRC's own adjudicatory decisions.
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.i Mr. Reed has misconstrued the FDA recommendation on the use of potassium iodide as standing for the propositions that KI should be predistributed and that it has been deemed risk free, and then accuses Applicant (ignoring the fact that a State public health policy decision is at issue) of attacking such guidance. Contrary to Mr. Reed':s assertion, the FDA rec-ommendation, as previously noted, recommends that the use of KI only "be considered for thyroid blocking in radiation emergencies . . .". Id. The FDA recommendation is not, as Mr.
Reed suggests, a blanket federal recommendation for the provision of KI. Rather, it is recommended that each State consider the use of KI in the context of emergency planning needs for particular nuclear power plant sites. Furthermore, not only does FDA recommend that KI only be considered for use, but it only recommends such consideration for use "in those persons who are likely to receive a projected radiation dose of 25 rem or greater to the thyroi'd gland from radioiodines released into the environment." Id. Mr. Reed has disregarded the uncontroverted testimony of Mr. Kenneth V. Miller of the State of Missouri's Bureau of Radiological that at a projected off-site dose rate to the thyroid of 25 rem (the point at which the FDA has recommended KI be considered for use as a thyroid blocking agent in case of a nuclear accident) the State PAG's prescribe an immediate evacuation. See Tr. 2274, 2319-20 a
.i (Miller).5/ In addition, there is no evidence in the record suggesting any impediments to evacuation. Contrary to Mr.
Reed's suggestion that the FDA recommendation stands for the proposition that the use of KI is risk free, the recommendation notes that persisting "[u]ncertainties still exist about the dose response for radioiodine-induced thyroid cancers and the incidence and severity of side effects from potassium iodide."
As discussed in Applicant's proposed findings of fact and conclusions of law, the FDA recommendation notes that "[e]ach State is responsible for formulating guidance on when, if at all, the public should be supplied with potassium iodide along With instructions on how to use it," and that "[t]he cost and effectiveness of other protective measures such as seeking shelter, evacuation, or respiratory protection also need to be considered." 47 Fed. Reg. 28159. Among the factors responsi-ble for the State's policy _deci'sion are concerns for the possi-bility of adverse reactions, the possibility of the drug's misuse, the potential KI might have for inducing a false sense of security, logistical difficulties surrounding its stock-piling and distribution, and the limited protective benefit KI would actually afford.in a radiation emergency. See S/ Mr. Reed states in his proposed findings that Applicant's witness Dr. Linnemann testified that medically-confined but non-institutionalized individuals should be given KI. The record reveals that Dr. Linnemann was only responding to a hypothetical in which it was postulated such people could not be evacuated. Tr. 2309-14.
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Applicant's Proposed Findings of Fact 5, 6, 7 and 10. Instead of addressing these disadvantages on their merits, Mr. Reed tries to blanket them as Applicant " attacks" on FDA findings, disregarding that these same concerns were raised at the hear-ing by the NRC Staff. Reed Proposed Findings at 2. The record amply reveals that, fully in line with the FDA recommendation's guidance, the State of Missouri has undergone a careful balanc-ing of factors and emergency planning needs in its decision to provide KI for emergency workers and institutionalized persons but not for the general public.
Not only has Mr. Reed misconstrued the regulatory consequences of the FDA recommendation, but, importantly, he has entirely disregarded the record with respect to federal guidance on KI from the Federal Emergency Management Agency
(" FEMA") and the NRC, neither of which has recommended the ad-ministration of KI to the general public located within the 10-mile plume exposure EPZ. In'short, Mr. Reed both mis-characterizes the FDA recommendation on KI in suggesting that it represents a federal requ irement for predistribution, and entirely disregards the ample record demonstrating that there I
is no current federal recommendation that KI be distributed to the general public.
! It has been a recurring argument of Mr. Reed in this pro-ceeding that the predistribution of KI is necessary because prolonged sheltering will be likely. As evidence for this con-tention, Mr. Reed has cited NUREG/CR-0388, SAND 78-0269 i
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.i accident release scenarios.p/ In particular, in his proposed findings of fact and conclusions of law, Mr. Reed references the Accident I scenario of NUREG/CR-0388 with a containment failure occurring after 16 minutes. Mr. Reed goes on to state that "[b]ecause of the rapidity of this release, and all as-sumed realistic descriptions of circumstances and radioactive material release progression, it is reasonable to assume that prolonged shelter would be the only option possible for those caught within the PEP EPZ," and that "[a]ccident descriptions III, IV and VI present similar data." Reed Proposed Findings at 4.
Mr. Reed has again flatly disregarded the evidence of the record with such bald statements. Uncontroverted testimony on behalf of Applicant indicated that Accident I of NUREG/CR-0388 was an extraordinary scenario with a per year frequency of
-11 Contrary to Mr. Reed's 10 . Paddleford Testimony at 9.
assertion, the record indicates'that most serious accident sce-narios would evolve over a significant period of time, and that this fact, combined with Callaway's advanced diagnostic instru-l mentation and facilities, will allow adequate time for evacua-tion under most accident scenarios. Mr. Reed has left untreated the evidence of record that in the event of a rapid p/ Once again Mr. Reed cites 10 C.F.R. 5 2.758(a) for the proposition that this document is above " attack." Even though Applicant has not, in fact, attacked any of the findings of NUREG/CR-0388, it is clear that a Staff published technical paper is not a rule or regulation within the meaning of section 2.758. See n.4, supra.
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_offsite release the'public.will be instructed to shelter temporarily until evacuation can be effectuated. If necessary, I the assistance of the National Guard can be called upon to assist in an evacuation. Applicant's Proposed Finding of Fact 1,2 . Similarly uncontroverted is testimony that in the event of
. a quick release the use of shelter combined with ad hoc respi-ratory protection provides comparable thyroid protection to the use of.KI, in addition to protecting other organs as well. Ap-plicant's Proposed Finding of Fact 15. In short' Mr. Reed has based his case on the need for KI on an event of extremely remote probability, has disregarded the evidence of adequate compensating protective actions in the event of such an unlike-ly scenario, and has failed to address the key point that even under the worst of hypothetical accident scenarios the provision of KI provides no unique protection to the public.
With regard to the use of ad hoc respiratory protection, Mr. Reed suggests that "to assume that laboratory test results for ad hoc devices will apply under actual residential usage is a false assumption." Reed Proposed Findings at 4. For defense of this proposition, Mr. Reed cites an impromptu exhibition at the hearing in which he asked Applicant witness Slaten to dem-l l 'onstrate the use of a handkerchief, and Mr. Reed's own nonevidentiary observation that there was a failure to seal.
What Mr. Reed has mistaken is that the efficiencies of ad hoc techniques presented with Mr. Slaten's testimony were, in fact, j
performed with human subjects. Tr. 2355-6 (Slaten). They are
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. i thus not laboratory controlled hypothetical results, but results obtained using human subjects and realistic conditions.
To be sure, insuring a seal is a key to an ad hoc technique's effectiveness, but this is true with any respiratory technique, and no attempt of tieing or taping the handkerchief was conducted during Mr. Reed's impromptu exhibition. See Tr.
2344-5 (Slaten). Such an uncontrolled, improperly administered and undocumented exhibition by Mr. Reed is no substitute for the substantiated and uncontroverted evidence of the record indicating the effectiveness of ad hoc respiratory protection.
The final point Applicant wishes to address with respect to Mr. Reed's proposed findings of fact and conclusions of law i.s his suggestion that from a cost / benefit standpoint KI is relatively cheap (although no evidence on this matter was presented into the record), and that provision of KI "is not hindered by medical or logistical reasons." Reed Proposed Findings at 7. The reason for"not providing KI to the public, Mr. Reed contends, is a political one growing out of a desire not to tarnish nuclear power's public relations image. Mr.
! Reed here is engaged in a gross mischaracterization of the l
issues, first in waving away and leaving unaddressed and
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l uncontroverted the record's substantial evidence of medical and logistical reasons for not initiating a mass, uncontrolled dis-tribution of KI, and then in suggesting that Applicant is at-tempting to circumvent federal guidance in order to protect its public image. Instead of treating the factors involved in the i n
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.5 State of Missouri's decision on their merits, Mr. Reed has consistently represented that the policy decision made on KI has been a decision of Applicant grounded in pecuniary or public image interests, rather than a health policy decision by the State of Missouri based on the medical and logistical reasons which Mr. Reed has entirely failed to address. Con-trary to Mr. Reed's suggestion, the uncontroverted evidence of the record reveals that the State of Missouri's decision to provide KI for emergency workers and institutionalized persons, but not for the general public, has been based on a careful review of federal guidance, taking into consideration the advantages of KI, the costs and disadvantages of providing KI, and the likelihood of the need for KI in the context of emer-gency planning for the Callaway site.
Respectfully submitted, 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: October 27, 1983 a
i4' l , UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE ATOMIC SAFETY AND LICENSING BOARD In the Matter of )
)
UNION ELECTRIC COMPANY ) Docket No. STN 50-483 OL
)
(Callaway Plant, Unit 1) )
CERTIFICATE OF SERVICE I hereby certify that copies of " Applicant's Reply To The i
Proposed Findings Of Fact And Conclusions Of Law Filed By Intervenor Reed" were served this 27th day of October, 1983 by deposit in the U.S. mail, first class, postage prepaid, to the parties on the attached Service List.
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Thomas A. Baxter Dated: October 27, 1983
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. UNITED STATES OF AMERICA
.k NUCLEAR REGULATORY COMMISSION BEFORE THE ATOMIC SAFETY AND LICENSING BOARD-In the Matter of )
l )
l l
UNION ELECTRIC COMPANY ) Docket No. STN 50-483 OL
)
(Callaway Plant, Unit 1) )
SERVICE LIST James P. Gleason, Esquire IEenneth M. discices, Esquire Q1mirman Chackes and Hoare l Atcznic Safety and Licensing Board 314 N. Broadumy l 513 Gilmours Drive St. Iouis, Missouri 63102 Silver Mg, Maryland 20901 Mr. John G. Reed l Mr. Glenn O. Bright Routa 1 l Atcznic Safety and M - 47 & City, Missouri 65262 Board ,
s U.S. Nuclear Regulatory ownianion Mr. Howard, Steffen Washington, D.C. 20555 Chanois, Missouri 65024 Dr. Jerry R. Kline Mr. Harold Icttmann Atcznic Safety and Licensing Route 1 .
Board -
Owensville, Missouri 65066 U.S. Nuclear Regulatsary Cbumission
==h 45 tat, D.C. 20555 Mr. Fred Iiuology
. Rural Route Robert G. Perlis, W4m ]hineland, Missouri 65069 Office of the Executive Iagal Director U.S. Nuclear Regulatory owniemias Mr. mumm 1 J. Birk ,
l *-h 45tru, D.C. 20555 P.O. Box 243 Marrison, Missouri 65061 D% and Service Sectica Office of the h i.-sy Mr. Itsbert G. Wright l- .
U.S. Nuclear Beip'1% ownieminri Boute 1
- 4shingtcm, D.C. 20555 Fulten, Missouri 65251
, M ? E. Birk, M i m -
Eric A. Eisen, Esquire Assistant to the General osunsel Birch, Hortzm, Bittner & Monroe Obien Electric Ozqsany 1140 Cr .rdcut Avenue, N.W. , #1100 P.O. Bdx 149 Washingten, D.C. 20036 -
St. Iouis, Missouri 63166 Steve Ferris A. Scott Caugar, Esquire '
FIma, Region VII l Assistant General Q:nzasel 911 Walnue l Missouri Puinlic Service ownimmim Roan 300 P.O. Box 360 Kansas City, M4 ==ri 64106 Jefferson City, Missouri 65102 i
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- 2 Atmic Safety and Licansirs; Appeal Board Panel U.S. Nuclear Wslery tw=n4 = mien Washington, D.C. 20555 e
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