ML20054D937

Testimony of Jj Mauro Re Use of Potassium Iodide as Thyroid Blocking Agent,Contention 17/26(2).No Current Accepted Public Health Practice Exists Which Provides for Potassium Iodide Use by General Public.Prof Qualifications Encl

ML20054D937
Person / Time
Site:	Waterford
Issue date:	04/20/1982
From:	Maro J, Mauro J EBASCO SERVICES, INC., LOUISIANA POWER & LIGHT CO.
To:
Shared Package
ML20054D911	List: ML20054D910 ML20054D918 ML20054D925 ML20054D928 ML20054D931 ML20054D934 ML20054D937 ML20054D943 ML20054D947
References
NUDOCS 8204230524
Download: ML20054D937 (11)

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p1 :7] April 20, 1982 37 p, p j UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION Before the Atomic Safety and Licensing Board In the Matter of )

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LOUISIANA POWER & LIGHT )

COMPANY ) Docket No. 50-382

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(Waterford Steam Electric )

Station, Unit 3) )

APPLICANT'S TESTIMONY OF JOHN J. MA URO ON THE USE OF POTASSIUM IODIDE AS A THYROID BLOCKING AGENT My name is John J. Mauro. I am the manager of the Ebasco s

Services, Inc. Radiological Assessment Department. Since joining EBASCO Services in 1973, I have been a consultant to Louisiana Power & Light Company in areas related to radiation protection, nuclear licensing and emergency planning. I hold a doctorate degree in Biology / Health Physics from New York University - Institute of Environmental Medicine and I am certified by the American Board of Health Physics. A detailed 1

resume of my educational qualifications and professional i experience is attached. I The purpose of this testimony is to address the concern raised by the Joint Intervenors in their Contention 17/26(2),

which states:

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I Applicant han failed to adaquately make provision, I according to the Emergency Plan contained in i Chapter 13.3 of the FSAR, for distribution and/or storage of potassium iodide in accordance with accepted public health practice in locations which are readily accessible to affected individuals as protection against thyroid irradiation.

It has long been assumed that the principal radioactive isotope released in a reactor accident is Iodine-131 ("I-131"),

along with other radioiodines. When radioiodines are inhaled or ingested, they tend to accumulate in the thyroid and are metabolized into organic iodide compounds which may reside in the thyroid long enough to cause local radiation damage. In the event of a radiological accident, a radioprotective drug such as potassium iodide ("KI") can be administered to curtail the accumulation of radiodines by the thyroid. In effect, the iodide saturates the iodine transport system, deterring entry of radiciodine.(1)

The NRC and Federal Emergency Management Agency (" FEMA")

criteria for preparing and evaluating emergency response plans, set out in NUREG-0654,1/ specify that emergency plans are to include provisions for the use of radioprotective drugs, particularly for emergency workers and institutionalized persons in the plume exposure pathway Emergency Planning Zone

("EPZ"), and that state and local plans are to indicate the 1/ " Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants," U.S. Nuclear Regulatory Commission and Federal Emergency Management Agency, NUREG-0654/ FEMA-REP-1, Rev. 1, November 1980, Evaluation Criteria J.10.e and J.10.f.

method by which decisions on the distribution of such drugs to the general public will be made in an emergency. The distribu-tion of radioprotective drugs to the general public is not required or recommended by NUREG-0654.

The State Radiological Emergency Response Plans! (includ-ing Attachment 1, which contains the St. Charles and St. John the Baptist Parish Enclosures) reflects the policy of the State to make KI available for use by emergency workers and institutionalized persons (including persons residing in nursing homes or confined to hospitals or penal institutions) within the risk area in an emergency. This is consistent with the guidance of NUREG-0654.

The State Plan (including Attachment 1) does not provide for the administration of KI to the general public; thus, LNED will not rely on KI as a protective action option for the public, but will instead rely on other protective action options--such as sheltering or evacuation--for public protec-tion in the event of a serious radiological emergency. The State's decision not to provide KI to the general public is a reasonable one, considering a number of factors, particularly uncertainty in the incidence of side effects and allergic and adverse reactions to KI, the lack of control against improper use of the drug of both children and adultc, the logistical 2/ Louisiana Peacetime Radiological Response Plan, Annex J,

Appendix 7 to Louisiana Preparedness Plan for Emergency i Operations.

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problema of KI administration to the general public, the availability of KI, the availability of other protective action options (including the potential impact of KI use on those other options), and current Federal guidance on the subject.

Doses of KI which are higher than those which would be used for thyroid-blocking have been used widely for many years by physicians in the treatment of bronchial asthma and other pulmonary disorders. A variety of reactions have been reported in connection with this medically supervised use of KI. The incidence of reaction is considered, in general, to be directly proportional to the dose and duration of therapy.(1)

Accordingly, individuals are cautioned not to exceed the recommended dose for thyroid-blocking purposes, and not to take the drug for periods of time longer than instructed.(2)

Possible side effects of KI include skin rashes, swelling of the salivary glands, and iodism (metallic taste, burning mouth and throat, sore teeth and gums, head cold symptoms and occasional gastrointestinal symptoms).(2) A few people have allergic reactions with more serious symptoms. These symptoms include fever, joint pains, swelling of the face and body and at times severe shortness of breath requiring immediate medical attention. Taking iodide may also (rarely) cause overactivity or underactivity of the thyroid, or enlargement of the thyroid (goiter).(2)

The logistics of KI administration to the general public also militate against its use. Distribution to the public at i

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l the time of an accident would be very time-consuming, and might well involve radiological exposure to the public which would be required to leave shelter if the drug were dispensed from stockpiles. On the other hand, predistribution of KI would preclude responsible control of the storage of the drug. KI must be stored at controlled room temperature, between 59 and 85' F, and is sensitive to both moisture and light.(2)

Predistribution would involve the risk that the drug would be improperly stored, permitting decomposition and loss of potency.

Predistribution of KI to the general public would also prevent responsible control of the time and manner of adminis-tration of the drug. If the drug were predistributed (and thus readily available at all times), individuals might--on the basis of rumor or a misunderstanding of plant status--take the drug spontaneously, without being instructed to do so, thereby exposing themselves unnecessarily to the risk of allergic and adverse reactions and side effects from the drug. Similarly, predistribution would increase the chance that individuals would exceed the recommended dose (i.e., take several doses rather than just one). Predistribution of KI would also involve a danger that children would accidentally ingest the drug, in the absence of any need for the drug, and quite possibly in doses exceeding the recommended dosage, exposing themselves unnecessarily to risks (and, in the case of excessive doses, increased risks) of side effects and allergic and adverse reactions.

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.1 The availability of other protective action options --

including evacuation, sheltering, and respiratory protection --

as well as considerations of the effectiveness of KI, further contraindicate administration of KI (especially its predistri-bution) to the general public. In the event of a serious I radiological accident involving significant releases of radioiodines, KI could be effective in thyroid protection.

However, an accident resulting in significant releases of radiciodines would also involve significant releases of nobel gases and radiocesiums, which would cause whole body and lung exposures which are not mitigated by KI. A KI plan for the general public might instill a false sense of security, inhibiting effective evacuation or sheltering.

There is also a question of availability of large quanti-ties of KI for distribution to the public. Carter-Wallace Pharmaceuticals (which produces Thyro-Block, the only form of KI approved by the Food and Drug Administration for use as a thyroid-blocking agent in radiological emergencies) has ceased production of the drug, and now offers only Thyro-Block tablets with an expiration date of December, 1982.(3)

Present uncertainties as to the amount of radiciodine which might be released in an accident further support the State's policy. Recent research comparing consequence estimates used in risk assessment with actual results of accidents and large scale experiments has indicated that the radioactivity (including I-131) actually released to the

environment in an accident hac been substantially overestimated.(4) Similarly, there is an ongoing debate among experts as to the toxicity of radioiodine to the thyroid. Both these factors have great bearing on the need for KI for thyroid-blocking purposes in an emergency.

The multiple uncertainties associated with the KI issue are reflected in current Commission policy, pursuant to which the NRC Staff is to:

1. Continue to work with appropriate Federal agencies, i.e., FEMA, FDA and EPA, to address the uncertainties in the use of KI by the general public and possible alternative respiratory protection strategies.

2. Press on with source term technology studies

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• to a point where the Commission can adequately consider the potential impact on--among other regulatory matters--alter-native protective actions for public use in a nuclear plant emergency.

The Commission has expressly reserved judgment on the advisa-bility of recommending the stockpiling of KI for the general public.(5)

There are also significant costs associated with KI.

The cost of KI is approximately 75 cents per unit (14 tablets).(3) Using that figure, the cost of one unit of KI for each resident in the EPZ would be approximately $55,000.

Nor would the cost represent a one-time expenditure, since Thyro-Block has a shelf-life of only three years.(3) Thus, all KI would have to be replaced every three years, whether it had been used or not.

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Sinco the Stato does not rely on KI as a protective action option for the general public, the provisions in the State Plan (including Attachment 1) are consistent with Federal emergency planning guidance; that-is, the State has predetermined that KI will not be administered to the general public, and that complies with the NUREG-0654 planning standard.

While it is conceivable that comprehensive federal guidance, applicable to all operating reactors, may at some point in the future recommend the administration of KI to the general public in an emergency, there clearly is no current

" accepted public health practice" providing for KI use by the general public. Weighing factors such as the incidence of adverse and allergic reactions and side effects, the logistical problems of KI administration, and the availability of other protective action options, the State's public health policy decision not to provide KI to the general public is well-founded. However, KI will be provided to emergency workers and institutionalized persons, if appropriate, in the event of a serious radiological emergency.

t REFERENCES (1) FDA Notice; Request for Submission of New Drug Applications and Notice of Availability of Labeling Guidelines, Potassium Iodide As A Thyroid-Blocking Agent  !

In A Radiation Emergency, 43 Fed. Reg. 58798 (1978). ,

(2) Patient Package Insert for " Thyro-Block," Wallace I

Laboratories.

1 (3) Conversation with Linda Ivins, Carter-Wallace, March 5, 1982. l (4) Technical Basis For Estimating Fission Product Behavior  ;

During LWR Accidents, NUREG-0772 (Battelle Columbus Laboratories, Oak Ridge National Laboratory, Sandia ,

National Laboratory, Nuclear Regulatory Commission, March 1981).

(5) Memorandum from Samuel S. Chilk, Secretary to the Commission, to William J. Dircks, Executive Director for Operations (March 26, 1981), citing NRC documents {

SECY-80-257 (May 20, 1980) and SECY-80-257A (September 18,  ;

1980).

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JOHN J. MAURO Manager, Radiological Assessment Department Ebasco Services, Inc.

Education: B.S., Biology, Long Island University, 1967.

M.S., Biology / Health Physics, New York University, 1970.

Ph.D., Health Physics, New York University Institute of Environmental Medicine, 1973.

Experience: 1973 to Present: Dr. Mauro has been a member of Ebasco's Radiological Impact Assessment Department and is presently Manager of that department. In this capacity, Dr. Mauro is responsible for all offsite health physics and emergency planning consulting services offered by Ebasco. These services include:

(1) the analysis of radionuclide source .

terms and impacts associated with routine operations and hypothetical accidents at nuclear power plants; (2) the development of emergency plans; and, (3) the design of environmental radiological surveillance programs for Ebasco's nuclear power clients.

Dr. Mauro has provided these and additional services for 10 nuclear power facilities.

Dr. Mauro's involvement with the Waterford 3 project has included: (1) Preparation of those sections of the Safety Analysis Reports (both PSAR and FSAR) and Environmental Reports which deal with the analysis of radionuclide release rates and offsite doses due to routine operation of Waterford 3 and under hypothetical accident conditions; (2) Design of the environmental radiological surveillance program; (3) Preparation of the Radiological Environmental Technical Speci-fications and Offsite Dose Calculation Manual; and, (4) Preparation of portions of the Waterford 3 Emergency Plan.

1970-1973: Research Assistant, New York University. Performed research activities related to the ecology of the Hudson River.

Professional Affiliations: Certified by the American Board of Health Physics.

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F J. J. Mauro Page 2 Representative Publications: Mauro, J. J. and M. E. Wrenn." Reasons for the Absence of a Trophic Level Effect for Radiocesium in the Hudson River Estuary,"

IRPA Proceedings, Washington, D.C., October 1973.

Mauro, J. J., Michlewicz and A. Letizia.

' Evaluation of Environmental Dosimetry Models for Applicability to Possible Radioactive Waste Repository Discharges," Department of Energy, Y/OWI/SUB-77/45705, September, 1977.

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

Fellman. " Airborne Uranium, Its Concentration and Toxicity in Uranium Enrichment Facilities,"

Department of Energy, K/PO/SUB-79/31057/1, February, 1979.

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

Nuclear Safety, Vol. 20, No. 5, September-October, 1979.

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