ML20106A279

Affidavit of Jj Mauro Re Contention G Concerning Inclusion of Availability of Potassium Iodide for Emergency Workers & Public in Emergency Plans

ML20106A279
Person / Time
Site:	Perry
Issue date:	02/01/1985
From:	Mauro J CLEVELAND ELECTRIC ILLUMINATING CO., ENVIROSPHERE CO.
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ML20106A256	List: ML20106A254 ML20106A269 ML20106A279 ML20106A287
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION 00'KTED Before the Atomic Safety and Licensing Boacd, p 4 p.q g In the Matter of )

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THE CLEVELAND ELECTRIC ) Docket Nos'. 50-440 ILLUMINATING COMPANY, _ET _AL. ) 50-441

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(Perry Nuclear Power Plant, )

Units 1 and 2) )

AFFIDAVIT OF JOHN J. MAUR0 City of New York )

ss:

State of New York )

John J. Mauro, being duly sworn, deposes and says as follows:

. 1. My name is John J. Mauro. I am the Director of the Radiological Assessment and Health Physics Department of Envirosphere Company, a division of Ebasco Services Incorporated. My business address is Two World Trade Center, New York, New York 10048. Since joining Ebasco in 1973, I have been a consultant to several nuclear utilities and state agencies in the area of emergency planning and radiation protection. I hold a doctorate degree in Biology / Health Physics from New York

' University Medical Center - Institute of Environmental Medicine. I am certified by the American Board of Health Physics and the Board of _ Hazard Control Managers. A complete statement of my professional qualifications and experience is attached hereto as Exhibit A. I have personal knowledge of the matters set forth herein and believe them to be true and correct.

INTRODUCTION

2. .The purpose of this affidavit is to respond to Sunflower Alliance, Inc., el al.'s (" Sunflower's") Contention G, which states:

Emergency plans should include the availability of potassium iodide (KI) for emergency workers and the public.

This affidavit demonstrates that the use of KI for offsite emergency workers and the general public is not required by current Federal regulations, and that it is reasonable and appropriate that the Ohio 1

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• Department of Health has decided not to provide KI for emergency workers

or residents of.the plume exposure pathway EPZ for the Perry Nuclear Power

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Plant.*

3; This ~ affidavit is divided into four main sections. The first

. .section presents a brief overview of the history of the KI issue and is

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.provided in order to establish the historical perspective for the sections which follow. The second section describes the current Federal regulatory guidance regarding the use.of KI. The primary purpose of this section is t to demonstrate that there are no Federal regulations regarding the use of

.K I offsite1'and that all Federal agencies defer to State authorities

._F regarding the use of K! offsite. The third section describes the benefits and limitations 'of KI. This section demonstrates that the benefi.ts associated with the offsite use of.KI are marginal and offset by its g , -deficiencies. The last section specifically addresses KI as a protective

- F  ? measure for offsite emergency wcekers.

HISTORICAL OVERVIEW 0F KI ISSUE

4. Potassium iodide (KI) and other compounds of iodine have been

-used extensively in the treatment and diagnosis of a variety of illnesses.

It hasi been used as an antibiotic in the treatment of bacterial

--infections (Stone, 1971) .an expectorant in the treatment of asthma (PDR, 1980)~ and as a thyroid blocking agent to protect the thyroid' from u ' radiation during the. I-125 fibrinogen test which is used for the detection of venous thrombosis..(Denham, 1974). Accordingly, K! and other compounds

-of. iodine have~ widespread medical use and have long been recognized as _an effective means. to block the uptake of iodine by the thyroid gland.

Because of this medical experience with KI, discussions on the use of- KI

, .for protection -_of the public from radiation accidents'are cited in the

~ literature as early as 1963 (Pochin,1963).

! 5.- With the: publication of the Reactor. Safety Study (WASH-1400) in 1975, which identified radioactive iodine as a potentially. significant icontributor' to: health consequences following a core melt accident, and

.the. growing concern at that time regarding the adequacy of emergency. plan.s (RED-76-73), it was thought that greater attention should be given to the a :possible use of ' thyroid blocking agents. .In order to. provide more M  : complete guidance on this Tsubject, the National Council ; on ' Radiation Protection and Measurements-(NCRP) published NCRP Report No. 55. In this

report, the'NCRP reviewed the literature on the effects of exposure of the

< thyroid gland to I-131 and - the effectiveness of various blocking agents r

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• _. : Institutionalized persons'are. considered members of the general public:

for the purpose of this affidavit; since'the County: Emergency Plans

, provide for. evacuation _of such persons-along with the rest of the general population. (SEE " Lake County Emergency Response Plan for 'the Perry 1 Nuclear Power Plant" (Rev.3,' October, 1984), ' Section J-06; '"Ashtabula County Radiological Emergency Preparedness Plan" (May 10, 1984), Section J.4.1; '"Geauga County Radiological Emergency Response Plan" (Change No. 2

. dated July,1984), Section $4.)

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4 for protection of the thyroid gland. The NCRP concluded and recommended that KI should be considered for use by emergency workers and the general public. It should be noted, however, that the NCRP did not recommend predistribution to individual members of the general public. In addition, it emphasized that the responsible physician for the nuclear facility or state and local officials should make the decisions regarding the administration of the drug (NCRP-55,1977).

' 6. At the time this recommendation was made, KI was only available through prescription. Accordingly, no pharmaceutical company would produce it in large quantities 5,ince only very limited quantities could be sold via prescription. To remedy this situation, the Food and Drug Administration requested in the Federal Register (43 FR 58798) that new drug applications (NDA) for over the counter (0TC) sale of K! be submitted to FDA, In response to this notice, Carter-Wallace I.aboratories submitted an NDA (18-307, May 9, 1979) and received a license for the sale of KI.

However, its use was limited to emergency situations and only under the direction of-the State and local health authorities.

7. The next milestone in the evolution of the status of K! as a protective agent.was the accident at Three Mile Island (TMI). During the accident, the FDA made extensive efforts to obtain large supplies of KI in the event'that'it was needed. Because of the difficulty encountered by FDA in rapidly obtaining KI, one of the findings of the various TMI study groups was that preplanning for the use of KI is appropriate (Kemeny,-

1979).

_8. After the TMI findings were issued, the NRC published many

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. regulations and regulatory guidelines pertaining to . emergency planning.

The most important of these guidelines which address the use of KI as a protective response are contained in NUREG-0654 and state the following:

" Criteria J.6.c Each licensee shall, for individuals remaining or arriving onsite during the emergency make provisions for: ,

- Use of radioprotective drugs, (e.g., individual thyroid protection).

Section J.10 4

The organization's plans to implement protective measures for the plume exposure pathway shall include:

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-- 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 distribution.

- State and local organizations' plans should include the methodology by which decisions by the State N 3 4

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6-Health Department for administering radioprotective drugs to the general population are made during an emergency and the pre-determined conditions under which such drugs may be used by offsite emergency workers;"

9. In March 1980 the NRC published a study which attempted to further evaluate the merits of K! (Aldrich,1980). The study concluded that KI is not cost-effective because of the extremely low probability of a large release of radiciodine. Partly as a result of this study, the nuclear industry began to seriously re-evaluate the use of KI. It was also at this time that several other reports were published which revealed that the yrobability of a release of large quantities of radioiodine following a core melt accident is much less than previously believed (Levenson, 1980; NUREG-0772). In light of these findings, and the general lack of a clear Federal policy on KI, the Nuclear Safety Oversight Committee wrote to President Carter "that Federal policy should recommend against the use of potassium iodine for the general public until such time as: (1) research has been carried out to clarify the source term for iodine releases thereby demonstrating the need and (2) clear and convincing plans have been formulated to demonstrate how potassium iodide can be effectively distributed and made available for use when needed. We recognize that while potassium iodide is a highly effective thyroid blocking agent, our concern is its misuse by our uninformed public in inappropriate circumstances."

10. In addition, the medical community began to reassess the conclusions of NCRP-55 and the FDA with respect to the safety of Kl.

This reassessment took the form of position papers by the New York Academy of Medicine (N.Y. Acad. Med, 1981), the American Thyroid Association (Am. Thy. Assoc., 1981) and papers by Nobel Laureate in Medicine Dr R.S. Yalow -(Yalow,1980). In all :ases, the primary enncern was the uncertain nature of the side effects of Kl.

11.- Complementing the studies on the side effects and cost-effectiveness of K! were studies performed by the Harvard School of Public Health (Cooper, 1981) on the effectiveness of various expedient methods of respiratory protection. The studies showed that common household it .s such as wetted towels or sheeting offered a protection factor of 10 or greater for iodine and particulate matter. James Martin of the NRC's Reactor Risk Branch, Division of Risk Analysis, Office of Nuclear Regulatory Research (Martin,1981) concluded that "these studies demonstrate that application by the public of ad hoc shelter and respiratory protection could provide inhalation pathway protection factors (PFs) of ten or more and ad hoc respiratory protection providing an additional PF of three to twenty or so. These PFs are very competitive with that of potassium iodide (K!) for the thyroid but the former would protect other organs as well ...."

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-4 CURRENT REGULATORY FRAMEWORK 4

12. Tnere are currently no Federal regulations which require the use )

of KI as a thyroid blocking agent for offsite emergency workers or members l of the general public. As stated by D. McLoughlin, Acting Associate  ;

Director State and Local Programs and Support of FEMA:

"Each State has responsibility for formulating guidance to to define if and when potassium iodide is used as a thyroid I blocking agent for emergency workers, institutionalized i persons and the general public" (FEMA, 1982) I

13. Though the responsibility for decisions regarding the use of K1 i offsite clearly lies with the State, numerous statements and guidelines l have been issued by several r ederal agencies.

The statements and guidelines have resulted jn some confusion as to whether there is a Federal policy on KI, and which agency has the authority to define Federal policy related to Kl. In this section, a description is provided of the  !

current position or guidance of the Nuclear Regulatory Commission (NRC),

the Federal Emergenc and the Food and Drug l Administration (FDA) ony the Managtment tse of Kl. Agency (FEMA), j NRC Guidance I

14. The position of the NRC Staff regarding the use of K! offsite has-evolved from ~ being supportive of offsite use of K! (NUREG-0654) to recommending against requiring tne predistribution or stockpiling of K1 as a preplanned emergency protective measure for use by the general public (SECY-83-362).

15. The Staff's position is that there is currently enough information on hand regarding the radiciodine source term .~oll owi ng a severe reactor accident to make a definitive statement against the stockpiling or predistribution of K! for general public use. The Staff recommends against stockpiling or predistribution of K! offsite as a condition of an operating license primarily because of the extremely high cost / benefit associated with such programs ( Aldrich , 1980). The cost / benefit uncertainty analysis performed by the Staff " conclusively shows that K1 offers extremely small benefit in relation to its costs and is not cost-ef fective'as a preplanned emergency protective measure for the general public" (SECY-83-362).

FEMA Guidance

16. As was the case with the NRC, FEMA was originally supportive of K! and recommended its use by offsite emergency workers and institutionalized persons (NUREG-0654). FEMA is currently reviewing its K!

guidance in light of its recognition that State health officers have the ultimate responsibility for the health of their citizens, and each State has a responsibility for formulating guidance to define if and when the public and offsite emergency workers should be given potassium iodide and instructed to use it. (Krimm 1982; FEMA, 1982) 5

17. FEMA has reverseu its position regardin.g the need for Federal stockpiling of KI. In April 1981 and in March 1982, FEMA testified that it was preparing to purchase K1 for a national stockpile. However, FEMA subsequently stated that it will no longer have any involvement in the stockpiling of Kl. (Krimm,1982).

18. It is clear that FEMA's position has evolved from very active support for the offsite use of K1 to delegating full responsibility for decisions regarding the offsite use of K1 to State authorities. FEMA's current role is to review the preparedness planning of State and local governments who wish to exercise the option of K1 stockpiling as part of the normal review of State and local preparedness under 44 CFR 350. The reasons for the change in FEMA's positon are the many uncertainties associated with the use of K1 and the fact that there are many other methods for protecting the public and emergency workers which could be more effective. (Krimm, 1982; FEMA, 1982)

FDA Guidance

19. Under 44 CFR 351, FDA, as delegated by DHHS, is responsible for assisting State and local authorities in. developing plans for preventing adverse effects from exposure to radiation in the event that radioactivity is released. These plans include the prophylactic use of drugs that could reduce the radiation dose to specific organs from the sudden release into the environment of large quantities of radioactivity.

20. In fulfilling these responsibilities, the FDA issued a position paper (47 FR28158) which stated that K! can be safe and effective as a thyroid blocking agent if used as prescribed and under the conditions specified by the FDA. This position, however is worded in a way that has resulted in considerable controversy and some confusion as to whether K1 is required for offsite use. Clarification regarding this matter was provided by Dr. G. C. Johnson of FDA. Dr. Johnson emphasized that "the FDA has not recommended the use of Kl. rather it has stated that the drug is safe and effective for use in accordance with the labelling instructions." (Johnson,1982)

21. The FDA has provided this clarification because it recognizes that "each State is responsible for formulating guidance on when, if at all, the public should be supplied with K! along with instructions on how to use it" (47FR28158). The role of FDA in this matter is to provide guidance on its proper use, should State officials elect to use it.

22. Based on the above regulatory overview it is clear that differences of opinion exist between the NRC and FEMA regarding the desirability of K! as a protective measure and that the merits of its use at any site are debatable. It is for these reasons that the Federal agencies have left decisions regarding the use of K! to the individual State authorities.

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6 TECHNICAL OVERVIEW

23. The difficulties encountered by Federal agencies in finalizing treir policy on K! are due in large part to the complex technical issues issociated with its use. In this section, an overview is provided of the rechnical issues. It is intended to demonstrate that the use of K! has many real and potential limitations which, when viewed in their entirety, support the reasonableness of the State of Ohio's position in deciding against the offsite use of KI.

24. Any decision regarding the use of K! offsite must be based on a balancing of the costs and benefits of such a program. In this section it is shown that the potential benefits of K! are marginal while the real and potential costs are considerable. This observation becomes even more compel, ling in light of the fact that there are other protective actions which can provide comparable protection to the thyroid gland to KI.

(Cooper,,1981)

Benefits

25. On the benefit side of the equation, there is little disagreement that KI, if properly used, would significantly reduce the internal dose to the thyroid gland from Inhaled or inqested radioiodine. Specifically, following a severe accident, the use i- K! would reduce the dose to the thyroid gland by about a factor of 5 and reduce the number of cancer fatalities about 5% (NUREG-0771). The benefit is only marginal because the exposure of the thyroid gland is not the critical pathway of exposure in terms of cancer fatalities. The critical exposures are to the - whole body by radiciodine and other radionuclides. As stated by the NRC Staff in Enclosure A of SECY-83-362, for severe core melt accidents, exposure to the thyroid would be the least of the health problems of concern, especially within about 10 miles, and therefore K1 should be given the least consideration as a protective measure.

Costs

26. The costs of the program include both economic costs and potential costs to the public health and safety.

Economic:

27. The economic costs of implementing a K! program include the purchase price of the KI, periodic replacement costs (the K! must be replaced every threeyears), costs for stockpiling, distributing and monitoring the status of the drug, and administrative expenses associated with the program. Aldrich (1982) has estimated the annual 12ed cost for purchasing K! to be $0.10 per person per year. Even though this is probably an underestimate, it is clear that from a purely economic perspective, even if stockpiling and administrative costs are included, the costs per person are relatively small and are not a critical factor in the decision making process. However, Aldrich has also shown that due to the extremely low probability of a large release of radiolodines, the cost benefit ratio of the offsite use of K1 is in excess of 9 million dollars per theoretical death averted. This estimate is based on extremely 7

conservative assumptions regarding the probability of a large release of radiciodine and conservative assumptions regarding the carcinogenicity of radiation exposure to the thyroid gland. A more realistic estimate is about 200 million dollars per thyroid cancer fatality averted (SECY-83-382). In addition, these estimates do not include any possible adverse health effects associated with the use of Kl.

Public Health and Safety:

28. The greatest controversy associated with the use of KI as a blocking agent centers around its possible side effects and its potential for interfering with effective emergency response.

29. Dr. Roslyn S. Yalow has taken a strong position against the administration of K! to the general public without medical supervision, and advocates reliance upon shelter and evacuation. 'Dr. Yalow agrees with FDA that the side effects are infrequent and generally minor. However, she cites publications which reveal that individuals with rheumatoid arthritis, lupus or hypocomplementic vasculitis could suffer severe, and possibly fatal, side effects from KI administration. (Yalow, 1981).

30. The American Thyroid Association has published a summary of the side effects of K! (Am Thy Assoc, 1981). The paper cites numerous references in the medical literature describing: thyrotoxicosis, edema, nasal polyps, dermatitis and hypocomplementic vasculitis and recommends that a more systematic evaluation of side effects be performed in order to obtain reliable information on the actual risks of K! administration. On March 2, 1981 the Committee on Public Health of the New York Academy of Medicine passed a resolution opposing the stockpiling, at the present time, of K1 for the purpose of potentially protecting the population of New York City against an accidental exposure to radioiodine. Among the several reasons for this position were potential adverse side effects and cost-benefit considerations. (NY Acad, 1981).

31. Based on the above studies, FDA acknowledges that uncertainties exist about the incidence and severity of side effects of Kl. The side -

effects cited by the FDA include iodine gotter, hyperthyroidism, hypothyroidism, dermatologic and mucous membrance reactions and allergic reactions. The FDA supports its position by stating that though significant side effects from K! have been reported, they have occurred following chronic administration of daily doses far in excess of those necessary for thyroid blocking in a radiation emergency, and these problems are not expected to occur from the short term use of relatively low doses of potassium iodide. However, the FDA also states that exceptions to this may include persons with unusual sensitivity to iodine, newborn children, the elderly, pregnant women, and the developing fetus.

(FDA, 1982). Further, FDA does not consider persons taking more than the.

recommended dose, either by accident or on the assumption that larger doses would provide greater protection.

32. The FDA also states that KI is not a panacea and that it does not reduce the uptake of other radioactive material, does not provide protection against external radiation and needs to be balanced against other protective measures such as sheltering, evacuation or respi ratory 8

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protection.- In addition, FDA recomends that, if used, a system of medical reporting and assistance is needed in the event of side effects.

(FOA, 1982). Under emergency conditions, medical assistance may be di f ficult to provide and efforts to provide such assistance could interfere with other protective actions, such as shelter and evacuation.

33. -In addition to possible adverse side effects, the use of K1 in an emergency can also have detrimental effects on the implementation of other, more effective, protective measures. Since the greatest projected health impacts on the population as the result of passage of a plume would be due to whole body exposures, as opposed to exposure to the thyroid (ACRS 1983), the effectiveness of other, potentially more effective, protective actions could be reduced due to 1) the time taken to locate and take the drug. 2) a false sense of security by the public regarding the effectiveness of the drug, 3) overdoses, (SECY-83-362) and 4) misuse.

34. From another perspective, Malinauskas (1982) calculated that severe reactor accidentswithIgrgere1asesofradioiodine occur with frequencies in the range of 10- to10~9 per year. With 100 reactors operating in this country, Malinauskas questions the logic of maintaining a continuous supply of K! doses to contend with an event which will occur at a rate of perhaps once every ten centuries. In addition, Malinauskas raises the question whether the number of fatalities projected to occur over this pe'riod would be greater due solely to transportation accidents associated with the distribution of Kl.

35. In response to tnis question I,tjave peyormed the calculation suggested by Malinauskas. Using 10 to 10 accidents per reactor per year as the probability of a serious core melt ' accident, it is-estimated that it will take 100,000 to 10,000,000 years before any one reactor will have a serious core melt accident. Assuming that such an-accident occurs, the total number of damaged thyroids within 10 miles of the plant 'is about 500, (Aldrich,1980) with an estimated maximum of about 15 fatalities due to thyroid cancer. Assuming that 100 vehicle miles must be. traveled per year per plant in order to support a K1 program, a total of ten million to one billion vehicle ~ miles would be traveled before the K Using a transportation risk coefficient of 10 f would 9eed to be used. fatalities per vehicle mile (WASH-1238 to 10~

1 to 1000 fatalities are projected to occur from road accidents required to support the program. Clearly, the potential benefits for K! use are so small that the transportation risks, attendent to its management, may, alone be sufficient to offset any benefi+.s.

KI FOR OFFSITE EMERGENCY WORKERS

36. The concerns about side effects and the inability of K! to protect against much more important whole body exposures are equally.

applicable to offsite emergency. workers. In addition, the cost / benefit analysis performed by Aldrich is also applicable to emergency workers because the results of the analysis are independent of the number of people by a given location. These concerns, coupled with increasing evidence that the radiciodine source terms have been grossly overestimated

- in the past (10COR,1984), provide compelling reasons to look toward other more effective methods for protecting offsite radiation workers. In 9

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t addition, given the relatively small number of radiation workers, should conditions exist where significant exposures to radioiodine are likely, procurement and distribution of KI to offsite workers who may receive such exposures can be implemented on an ad hoc basis. For example, all nuclear utilities store relatively large quantities of KI. It is therefore reasonable to assume that these sources of KI could be made available on short notice if needed.

37. As a final point, one may reasonably question why KI is required, and appropriate, for use by on-site emergency workers but not- for offsite emergency workers. The primary reason is the very close proximity of the onsite. workers to the source of exposure. The onsite response team may need to enter buildings where the levels of radiciodine are elevated, even though the radioiodine source term to the environment is very low.

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.38. For.the reasons stated-above, requiring the use of K1 for the Perry ; Nuclear Power Plant, either for offsite emergency workers or the

- public, would not significantly enhance the public health or safety. The decision by .the State of Ohio and the Counties of Lake, Ashtabula and

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lGeauga not to use KI is a reasonable one. Sunflower's Contention G is without inerit..

John J. Mauro

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" Subscribed and sworn to before me e, # -day of j, /u /uu ,1985 thisL ..-

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a REFERENCES ACRS 1983 Comments of the Use of Potassium Iodide (KI) As a Thyroid Blocking Agent.

Prepared by Subcommittee on Reactor Radiological Effects. Advisory Committee on Reactor Safeguards. April 30th, 1983.

Aldrich,1980

. Aldrich, D.C. and R.M. Blond. Examination of the Use of Potassium Iodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents.

NUREG/CR-1433. SAND 80-0981.

Am. Thy. Assoc.,1981 American Thyroid Association. The Use of Iodine as a Blocking Agent in the Event of a Reactor Accident. September 1981.

Cooper,1981 Cooper, D. W.; W.C. Hinds and J M Price. Expedient Methods of Respiratory Protection. NUREG/CR-2272. SAND 81-7143. November, 1981.

Denham, 1974 Denham, M .J . and R. L. Himsworth. Hyperthyroidism Induced by Potassium Iodide Given in the Course of I-125 Fibrinogen Test. Age and Aging, 3, 221. ~1974.

FDA, 1982

' Final Recommendations. Potassium Iodide As a Thyroid Blacking Agent In a

' Radiation Emergency: Recommendations on Use (April 1982). Prepared by the Bureau of-Radiological Health and Bureau of Drugs FDA, DHHS.

FEMA, 1982 Letter from D. McLoughlin to Regional Directors on Interim Policy Guidance ion Potassium Iodide. Decembe r.1, .1982.

IDCOR, 1984 Nuclear Power Plant Response to Severe Accidents by Technology for Energy Corporation. Industrial Degraded Core Rulemaking Program. November, 1984.

Johnson, 1982 L Johnson G.C. FDA Guidance on Potassium Iodide. In "Use of Potassium Iodide in Emergency Planning for Nuclear Power Plants." A compilation of technical ~ papers from the Atomic Industrial Forum 'Conferenc~e " Radiation Issues for the Nuclear Industry". ' October 3-6, 1982. November,- 1982.

'Kemeny, 1979- . .

' Report to the President's Commission on the Accident at Three Mile Island.

~0ctober, 1979.

Krimm,.1982 Krimm, Richard. -Potassium Iodide Stockpiling in'"Use of Potassium-Iodide in. Emergency Planning for_. Nuclear Power Plants. A complilation of technical papers from the Atomic Industrial Forum Conference " Radiation-Issues ~for the Nuclear Industry." October 3-6, 1982. New Orleans, La.

November ,1982.

12 T

Levenson, 1980 Levenson, M. and F. Rah,. Realistic Estimates of the Consesquences of Nuclear Accidents. The Electric Power Research Institute. November, 1980.

~ Malinauskas, 1981 Malinauskas, A.P. The Radioiodine Source Term and Its Potential Impact on 1the Use of Potassium Iodide. In "Use of Potassium Iodide in Emergency Planning for Nuclear Power Plants. A compilation of . papers from the Atomic' Industrial Forum Conference " Radiation Issues for the Nuclear Industry". October 3-6, 1982, New Orleans, La. November, 1982.

Martin,1981 Martin, .J.A. On the Efficacy of Ad Hoc Respiratory Protection During A Radiological Emergency. Presented at the 26th Annual Meeting of the Health Physics Society. ' June 21-25, 1981.

NCRP 55 NRCP Report No. 55. Protection of the Thyroid Gland in the Event of Releases of Radiciodine. National Council on Radiation Protection and Measurement. August 1, 1977.

NUREG-0654 ~

Criteria for Preparation and Evaluation of Radiological Emergency Response Plans. and Preparedness in Support of Nuclear Power Plants. NUREG-0654 FEMA-REP-1, Rev 1. November 1980.

NUREG-0771 Regulatory Impact of Nuclear Reactor Accident Source Term Assumptions.

June 1981.

NUREG-0772 Technical Basis for Estimating Fission Product Behavior During LWR Accidents. . Prepared by Battelle~ Columbus Laboratories.- Oak Ridge

. National Laboratory, Sandia National Laboratory and the Nuclear Regulatory Commission. March 6,1981.

NY Acad Med,1981 .

1New York Academy of Medicine. Resolution concerning the- stockpiling of potassium iodide in New York City in the event of a ' nuclear accident.

March 2, 1981.

PDR,1980 .

. Physicians Desk Reference.. 1980, _ 34th Edition. Publisher . Charles E Baker, Jr.

Pochin,.1963 .

Pochin, ; E. E. ' Public: Health and Medical- Measures: Their Practicability.

and Associated Problems. ~ In Proceedings of a seminar jointly sponsored by

. the . Food and Agriculture Vrganization of -the UK, IAEA and WH0. Geneva,

> November 18-22,'1963.

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RED-76-73

- Report to the Congress by the Comptroller General of the US. Stronger Federal . Assistance to States Needed for Radiation Emergency Response

- Planning. . March 18,1976.

SECY-83-362 Emergency Planning Predistribution/ Stockpiling of Potassium Iodide for the General Public. ~ Policy Issue for the Commissioners from W J Dircks.

August 30, 1983.

Stone, 1971-Stone 0.J . - What Are the Non Endocrine Biologic Effects of Iodides.

Medical Times 99 (12), 143. December, 1971.

^

WASH-1238 Environmental Survey of the Transportation of Radioactive Materials to and

-fran Nucl ear Power Pl ants. WASH-1238. US Nuclear Regulatory Commission.

WASH-1400 Reactor Safety Study. An Assessment of Accident Risks in US Commercial Nuclear Power Plants. WASH-1400. NUREG-75/014. October 1975.

Yalow, 1980

' Yalow, R.S. Risk in. Mass Distribution of KI President at a Symposium Sponsored by the Endocrine Society, " Iodine: Good or Evil After Nuclear Accidents. June 19, 1980.

Yalow,1981 Letter.from-R.S. Yalow to A.H. Hayes, Jr. of FDA. July 1981..

47FR28158 Potassium Iodide as a Thyroid Blocking Agent in a Radiation Emergency:

Final Recommendations on Use. Federal Register Vol 47, No. 125, Page 28158. Tuesday, June 29, 1982.

45FR11912-

' Potassium . Iodide Efor. Thyroid Blocking in a Radiation Emergency Only; approval and availability..

. 43FR58798 Potassium Iodide as a Thyroid Blocking Agent in a Radiation Emergency.

Federal Register Vol 43, No. 242, Page 58798. Friday, December 15, 1978.-

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-e EXHIBIT A

.- Resume JOHN J MAURO Education: BS - Long Island University 1967 MS - New York University 1970 PhD - New York University Medical Center - Institute of Environmental Medicine 1973

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Awards: - Alvin Gruder Memorial Award for Excellence in Biological i Sciences

- Member of the Optimates Society for Academic Achievement

- Founder's Day Award for Doctoral Dissertation Societies: - Health Physics Society

- American National Standards Committee on Emergency Planning Certifications: Certified by the American Board of Health Physics Certified by the Board of Certified Hazard Control Managers Current Position: . Director of the Radiological Assessment and Health Physics.

Department of Envirosphere Company in New York City.

. Suninary of While a graduate student at the Institute of Environmental Professional Medicine of New York University, I was also a full-time Experience: Research Assistant from 1970 to 1973. In this position I assisted Principal Investigators on numerous research -

projects on the ecology and radioecology of the lower

, Hudson River Estuary. - ,

In addition to my responsibilities as Research Assistant, I was a full-time graduate student, studying environmental-g health,' health physics and radioecology. My doctoral research was on the radioecological behavior of Cs-137 in

. -the lower Hudson River Estuary.

- After receiving my doctoral degree in 1973, I joined Ebasco Services as a Radiological Assessment Engineer.' .Ebasco Services is a major architect-engineer-constructor for power generating facilities. My. initial responsibilities at Ebasco were to evaluate the radionuclide release rates from proposed and operating nuclear power facilities under ,

normal plant operation and following postulated accidents, and to determine.the radiation exposures and health risks to workers and members of the nearby general population.  ;

In this capacity'I developed several models for performing radiological-impact assessment, and have prepared the

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radiological impact assessment sections of license

. applications..

Since joining Ebasco I have held positions of increasing.

responsibility, and am currently Director.of the

-Radiological Assessment and Health Physics Department in I Envirosphere Company, the Nuclear Licensing and

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• - - 2-Environmental Health Division of Ebasco Services. In this position, I-am_ responsible for all radiological health and emergency planning services provided by Envirosphere Company.- I manage a technical staff of 10 senior level consultants with advanced degrees in nuclear and biological sciences, with a combined 150 years of professional experience in technological risk management.

Icolitinuetopersonallyp'ovideconsultingservices. r These services include the analysis of radiological source tems, environmental transport, radioecology, internal and external dosimetry, health risk assessment, radiological surveillance, emergency planning, regulatory analysis and the preparation and defense of expert testimony on these subjects. Recently I have also become involved in the evaluation of toxic chemical hazards at industrial sites and low-level radioactive waste management. These services have been provided for a large number of clients representing the nuclear power industry and federal and state agencies and their subcontractors.

I have also managed several consulting contracts in the areas of radiological and chemical toxicology, health physics,' and emergency planning. Most of these projects X have been of a multidisciplined nature and included

- participation of: specialists in the areas.of toxicology,.

nuclear engineering, mathematical modelling, raeteorology, hydrology and computer sciences.

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- Publications and Mauro, J J and M E Wrenn 1972. A review of Radiocesium in Presentations: - Aquatic Biota. Presented at the Health Physics Society Annual Meeting, Las Vegas, Nevada, June 12-16,.1972.

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Mauro, J J and M E Wrenn 1973. Reasons for the Absence of-P ,

a Trophic Level Effect.for Radiocesium in the Hudson River Estuary. Presented at-the IRPA meeting held'in Washington,

- D C in October. -Published in the proceedings of.that' R -

. meeting.,

Mauro, J J and-J Porrovechio 1976. Numerical Criteria for-

- In-plant as Low as is Reasonably Achievable. In

- " Operational Health Physics.">1 Proceedings of the 9th Mid-Year Topical Symposium of the Health Physics Society.

Mauro,- J J, D Michlewicz and A Letizia 1977. Evaluation of.

" ' Environmental Dosimetry Models for Applicability to

Possible Radioactive. Waste Repository Discharges, ~ '

'Y/0WI/SUB-77/45705.

g Mauro, J J 1978. -Comparison of Gaseous Effluent Standards for Nuclear 'and Fossil Fuel Power Production Facilities.

_' f Proceedings of the December 1979 Annual Meeting of the

' American Ntriear Society.

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o s ,

J Thomas, J J Mauro, J Ryniker and R Fellman 1979.

Airborne Uranium, Its Concentration and Toxicity in Uranium Enrichment Facilities, K/P0/SUB -79/31057/1, February.

Lind K E, Mauro, J J, J D Levine, L Yemin, H J Howe, Jr and C W Pierce 1979. Safety Related Research Required to Support Future Fusion Research Reactors. Presented at the Annual Meeting of the American Nuclear Society-San Francisco, November,1979.

O'Donnell E P, and Mauro J J 1979. A Cost-Benefit Comparison of Nuclear and Nonnuclear Health and Safety Protective Measures and Regulations. Nuclear Safety, Vol.

20 No. 5, September-October, 1979.

Mauro, J J 1980. A Real Time Computer Program for Offsite Radiological Impact Assessment. Presented at the 1980 Annual Meeting of the American Nuclear Society. TANSAO 34 1-889.

Bhatia R, Mauro, J J and G Martin 1980. Effects of Containment Purge on the Consequences of a Loss of Coolant Accident. Presented at the 1980 Annual Meeting of the American Nuclear Society. TANSAO 34 1-899.

Marschke S, and Mauro, J J 1980. Radiocesium Transport Into Reservoir Bottom Sediments - A Licensing Approach.

Presented at the 1980 Annual Meeting of the ANS. TANSAO 34 1-899.

Mauro, J J and D Michlewicz 1981. Deployment Concepts for Real Time Environmental Dosimetry Systems. Presented at the 1981 Annual Meeting of the Health Physics Society.

Mauro,-J J and E P 0'Donnell 1982. The Role of the Architect / Engineer in the Emergency Planning Process.

Presented at the Annual Meeting of the American Nuclear Society. June 6-10, 1982.

Mauro, J J and W R Rish 1982. Dealing-with Uncertainties in Examining Safety Goals for Nuclear Power Plants. In

.NUREG/CP-0027. Proceedings of the International Meeting on Thermal Reactor Safety. l l

Mauro, J J, S Schaf fer, J Ryniker, and J Roetzer. Survey I of Chemical and Radiological Indices Evaluating Toxicity.

National Low-Level Radioactive Waste Management Program.  ;

DOE /LLW-17T. March, 1983. j 0153G a

f. "h; q, . .

Vold E, J J Mauro and D Michlewicz 1984. Dose Projection for Nuclear Emergency Response on a Microcomputer.

. Published in " Computer Applications in Health Physics."

Proceedings of the Health Physics Midyear Topical Meeting, Pasco, Washington. February 5-9, 1984.

Mauro, J J, S Schaffer, W Rish and J Parry. Application of Probabilistic Techniques to Dose and Risk Assessment Performed by EPA in Support of 40 CFR 191. Submitted for Publication.

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