ML20054F715

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Testimony of DB Davidoff & LB Czech on Commission Questions 3 & 4.NY State Radiological Emergency Preparedness Plan Discussed.Certificate of Svc Encl
ML20054F715
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Site: Dresden, Indian Point  Entergy icon.png
Issue date: 06/07/1982
From: Czech L, Davidoff D
NEW YORK, STATE OF
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Download: ML20054F715 (34)


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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION a

'52.. ' 10 9 44 BEFORE THE ATOMIC SAFETY AND LICENSING BOARD

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In the Matter of

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CONSOLIDATED EDISON COMPANY OF NEW YORK

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Docket Nos. 50-247 SP (Indian Point Unit 2)

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50-286 SP

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POWER AUTHORITY OF THE STATE OF NEW YORK

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June 7, 1982 (Indian Point Unit 3)

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TESTIMONY OF NEW YORK STATE'S WITNESSES ON COMMISSION QUESTIONS THREE AND FOUR DONALD B.

DAVIDOFF DIRECTOR RADIOLOGICAL EMERGENCY PREPAREDNESS GROUP LAWRENCE B.

CZECH CHIEF, NUCLEAR PROTECTION PLANNING i

RADIOLOGICAL EMERGENCY PREPAREDNESS GROUP i

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Juns 1982 DONALD B.

DAVIDOFF EDUCATION Dartmouth College,-B.A. (1956)

Albany Law School, Juris Doctor (1959)

Admitted to New York State Bar (1960)

EMPLOYMENT Commenced New York State employment as a Public Administration Intern assigned to the State Comptroller's Office.

(1959-60)

Promoted to Jr. Attorney and Legislative Secretary.

(1960-62)

Promoted to the position of Attorney.

(1962-64)

Promoted to the position of Senior Attorney.

(1964-66)

Promoted to the position of Ascociate Attorney - Office of Counsel - State Health Department.

(1966-67)

Promoted to Director, Bureau of Nursing Home Companies.

(1967-69)

Promoted to Associate Director, Division of Health Economics.

(1969-76)

Promoted to Assistant Commissioner - Division of Health Facility Standards.

In charge of full Division and substantial regional staff.

Responsible for licensure and inspection of health facilities including emergency plans.

(1976-77)

Reorganization.

Creation of Office of Health Systems Management within Health Department.

Appointed Assistant Director, Facility Surveillance Group.

(1977-78)

Appointed Assistant Director - Standards Group.

(1979-80)

Acting Director of Radiological Health -- Office of Public Health.

(Feb. 1980 - April 1980)

Director of Radiological Health and Manager of Nuclear Emergency Planning Group. (May 1980 - September 1981)

Director of Radiological Health and Director of Radiological Emergency Freparedness Group.

(October 1981 - December 1981)

Director of Radiological Emergency Preparedness Group.

(January 1982 -

)

ADDRESS New York State Department of Health Empire State Plaza - Tower Bldg., Room 1750 Albany, NY 12237 _ _

Junn 1982 LAWRENCE B. CZECH My name in Lawrence B. Czech and my business address is Empire State Plaza, Tower Building, Room 1750, Albany, New York 12237.

I am Chief of Nuclear Protection Planning, Radiological Emergency Preparedness Group (REPG).

I have a Bachelor of Science (1960) and a Master of Science (1961) both with a major in physics from the State University of New York at Albany.

I have attended numerous specialized training courses in radiological health including health physics training at the Oak Ridge As'sociated Universities.

I have been in my present position since January of 1981.

I have been assigned responsibilities in the area of radiological emergency preparedness including planning and response since 1972.

Prior to formally joining REPG, the radiological planning activities were part of my assigned responsibilities initially as an Associate Radiological Health Specialist (1972-1977) and Principal Radiological Health Specialist (1977-1981) in the Health Department's Bureau of Radiological Health.

From 1966 to 1970, I was a Senior Civil Defense Radiological Representr '.ive in the New York State Civil Defense Commission and had responsibility in radiological training and review of local (county and city) radiological annexes to their civi.1 defense emergency plans.

From 1961 to 1965 I was a Senior Biophysicist in the Radiological Sciences Laboratory in the State Health Department's Division of Laboratories and Research.

I was responsible for operating a calibration facility for radiation survey instruments.

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4 I have previously provided_ testimony on the' State's radiological emergency preparedness program at the Nuclear Regulatory Commission's operating license hearing for the James A. FitzPatrick nuclear power plant and the Public Service Commission's Article VIII siting hearings for the proposed Sterling and Jamesport reactors.

I am a member of.the-Health Physics Society'and the Conference of Radiation Control Program' Directors.

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,,1 Testimony on Questions 3 and 4 l

4' Preliminary Statement

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New York State established its first program for dealing with

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public health concerns related to radioactive materials in 1953, nine

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years before the operation of any nuclear power facilities in the State..

13 When the first commercial nuclear reactor for electric-' generation began r.

operations in New York State in 1962 (Indian Point #1)', aispecific nuclear" energency preparedness plan was established which called for coordinated Q, t

utility, State and local governmental activity.

This early plan'was 3

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o relatively minimal when compared with recent plans.

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With the advent of additional plants in New York and elsewhere, the Nuclear Regulatory Commission (NRC) in 1975 promulgated nationwide

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radiologic emergency preparedness regulations.

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J original New York State site plan were developed in response to iphe rten ~ "i n

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requirements and were concurred in by NRC.

As these plan' r'eris, ion's wen \\

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s being put in place, the March 28, 1979 accident at 3

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5 occurred, focusing worldwide attention on the emergency capabi@ities Dfff i sN all nuclear plants and governmental agencies responsible for public

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'k Following numerous legislative inquiries and cublic hearings into the TMI incident, NRC and the Federal Emergency Management Agency

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(FEMA) were directed by Executive Order to develop more comprehensive t

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emergency preparedness regulations.

The final federal regdlations we;e put in place in November 1980, requiring each nuclear power plant licensee to improve its onsite emergency preparedness.

The 4

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5 regulations in NUREG-0654 mandated new or expanded effort by licensees, t

local governments and the states on the 16 specific emergency planning s

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standards set forth in the NUREG.

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3 New Ydr,k began;the task of coordinating development of a s

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- new plan to meet the new federal requirements.

By December 1980, a draft Radiological Emergency Preparedness Plan, outlining State and loca'1" roles and responsib'ilities was submitted to NRC and FEMA for i

informal review.

During the first months of 1981, State, local and utility staff continued to refine and improve the draft plan.

On July 15, and August 17 and 19,.the Disaster Preparedness Commission forwarded to FEMA three formal plan submissions which together constitute a

the existing New York State Radiological Emergency Preparedness Plan.

On August 24, 1981, NRC advised its New York licensees, based on FEMA representations, that the plan was adequate for licensure purposes, subject to 'further findings and adjustments following required

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exercises to test plant, county and State preparedness, s

'New York's Plan was prepared as a requirement inherent in the responsibilities assigned to the State Disaster Preparedness Commission

,j '1 under.Edecutive Law, Article 2-B and is an integral element of the l%.

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' State"s Disaster Preparedness Plan.

The development of this Plan was 6

f, qs si mccr:*ded odt in accordance -with the federal guidelines contained in

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Cr iteria 'for Preparation and Evaluation of Radiological Emergency Response I !

'O Plans ' and Preparedness in Support of Nuclear Power Plants, NUREG-0654/

FEMA-REP-1, Rev. 1 issued jointly in November of 1980 by the United States Nuclear Regulatory Commission and the Federal Emergency Management Agency.

The Radiological Emergency Preparedness Plan relies upon the operatora of nuclear power plants to undertake appropriate action in l

the event of an incident involving the release or potential release of 4

radiation from the plant.

Federal regulations and guidelines mandate specific actions in the event of specified classes of incidents.

4 The purpose of the Plan is to provide the blueprint for training and equipping state and local response personnel, educating and notifying the public and conducting the drills, exercises and studies necessary to ensure that if an emergency response is called for, it be timely and effective.

The State should have the capacity to independently verify the responses of the utility, adjust them if needed and then carry out appropriate actions together with local government.

It is essential that the correct protective actions be identified, that governmental agencies take the steps necessary-to carry out those actions and that the affected public knows what actions are to be taken and how to take them.

The Radiological Emergency Preparedness Group (REPG) has been designated as the lead unit for administration of all aspects of the Plan, including liaison with other State agencies, affected local governments, other States, Federal agencies and the licensees.

We will address the contentions on Commission Questions Three and Four to the extent those contentions attack with any specificity the exercise of our emergency planning function. We have not addressed Contentions 3.2 and 4.3 in our prefiled testimony.

The New York State Radiological Emergency Preparedness Plan l

for Indian Point was prepared by the Radiological Emergency Preparedness Group and we are therefore sponsoring it in this proceeding as Exhibit (DD-LC-1)

The Plan for the Indian Point plants con-sists of a State portion prepared by the Radiological Emergency Pre-paredness Group and plans for each of the four counties, Orange, Putnam, Rockland and Westchester which we sponsored to the NRC.

3.1.

Emergency planning for Indian Point Units 2 and 3 is inadequate in that the present plans do not meet any of the sixteen manda-tory standards set forth in 10 CFR 50.47(b), nor do they meet the standards set forth in Appendix E to 10 CFR Part 50.

The New York State Radiological Emergency Prcparedness Plan (State portion, Site Specific portion and the Putnam, Orange, Rockland, and Westchester County portions) is in substantial compliance with each of the sixteen planning standards for offsite emergency preparedness set forth in 10 CFR 50.47(b), and Appendix E to 10'CFR Part 50.

Several specific items within some of the sixteen planning standards need further revision, as acknowledged by the State, and as indicated by FEMA in its comments on the Indian Point portions of the State Plan dated December 31, 1981.

However, none of the individual items found in need of revision, or otherwise out of compliance, is of sufficient weight to invalidate a planning standard.

Further, the total of all deficiencies combined does not support a non-compliance finding.

Experience with the FEMA review process and the regulations themselves indicates that an ongoing series of revisions is anticipated.

The review process is not a simple snap shot in time, but rather a series of reviews, meetings, revisions, and further reviews.

This process has been used since 1980.

The items referred to above are being corrected.

We have been working with the four counties and with FEMA.

We have negotiated changes in County plans with the counties and FEMA.

We have provided training to County employees and intend to provide funds where avail-able.

We have made changes where necessary in the State Plan.

All indications point to acceptable changes which would put the Plan even more in line with the Federal regulations.

3.3 The present estimates of evacuation times, based on NUREG-0654 and studies by CONSAD Research Corporation and by Parsons, Brinckerhoff, Quade and Douglas, Inc., are unreliable.

They are based on unproven assumptions, utilize unverified methodologies, and do not reflect to the actual emergency plans.

The evacuation time estimates employed by Parsons, Brinckerhoff, Quade and Douglas in the development of the Indian Point Plan have been tested by State personnel and have been found to be reasonable.

The CONSAD study was commissioned by the Power Authority of the State of New York and Consolidated Edison as part of the development of the first draft of local plan material.

The Parsons study was reviewed by State staff from the New York State Department of Transportation which has expertise in the area of traffic and evacuation estimating.

After i

thorough review, the Department of Transportation staff accepted the estimates and the basis for them as developed by Parsons.

REPG therefore j

incorporated the Parsons estimates into the emergency plans.

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3.4.

The Licensees cannot be depended upon to notify the proper authorities of an emergency promptly and accurately enough to assure effective response.

Since May of 1980, REPG has been charged with being the primary contact of utilities in the case of an accident that requires reporting.

The utilities are required to make use of the dedicated

" hotline," which connects both reactors with the four counties and the State of New York.

There was some confusion and some lack of reporting prior to the enactment of the new specific emergency classification system contained in the new planning criteria.

The former reporting system left considerable room for judgement on behalf of nuclear power plant operators.

The new classification system is much more explicit, and since its effective date, State experience with the reporting of incidents from both consolidated Edison and PASNY has been acceptable.

We continue to work with the utilities to improve the notification system, both in terms of procedures and in the communications system itself.

Each report of an unusual event or a higher classification from a company is recorded on the dedicated hotline, a:

REPG also makes a permanent record of the incident on a separately devised reporting document.

Tne report recently delivered by the Disaster Preparedness Commission to the Governor and the Legislature, which is already in the hands of the intervenors, recommends an increase in the amount of data which would automatically flow to the State.

This is the so-called independent verification concept, which would augment the present reporting system.

The call for an independent system is partially motivated by concern, in general terms, about reliance upon any utility

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to report incidents.

However, the record.of these two companies 1

over the past two years has shown a consistent improvement in the attempt to report necessary infor:natic.7 'co the State and the counties.

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3.6' The emergency plans and proposed protective action do not adequately take into account the full range of accident scenarios and meteorological conditions for Indian Point Units 2 and 3.

I The offsite emergency plans of the four counties and the State in relation to the Indian Point site are not predicated on any range or type of accident scenario or meteorological conditions.

Rather, we have developed these plans to respond to any accident that might occur, and to be prepared for a full range of activities within 10

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miles of each site for inhalation purposes, and within 50 miles of each site for ingestion purposes.

The plan provides various options for the responsible authorities in a radiological incident.

The authorities will be able to respond'in a variety of ways which will take into consideration precipitation, temperature inversion, meteorologggalandotherfactions.

The following State portions of the plan address the range of protective actions:

Part I Section IIIB, Part II Section IB, Part III Section I Procedures H and J.

The following portions of the County portion of the Plans also address the range of protective actions:

Part III C, D, F, G and H, Appendix J and Health Procedures.

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3.7.

The problems of evacuating children from threatened areas have not been adequately addressed in the present emergency plans.

The local plans and procedures do address the special problems of children in adequate fashion.

We recognize the necessity for much i

more work on ti.is important item, and can report that State and county staffs are spending many productive hours in dealing with all aspects of the children's evacuation process. The main problem exists when children are in school.

We are working with school districts an'd bus operators and examining ways to improve present procedures and the special problems of certain school districts.

One REPG staff member has been assigned to arrange and attend sessions in which a county and a district discuss what can be done to improve the treatment of children under an emergency plan.

These sessions have I

also been attended by parents' groups.

The results of this process will be reflected in the next revision of the emergency plan.

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3.9.

The road system in the vicinity of the Indian Point plant is inadequate for timely evacuation.

It is the position of New York State that evacuation of the EPZ for Indian Point is feasible based on the capability or the road network.

This opinion is based on the review completed by the Department of Transportation of the evacuation time estimates prepared by Parsons, Brinckerhoff, Quade & Douglas, Inc.

4.1..

The plume exposure-pathway EPZ should be expanded from its present 10-mile radius in order to meet local emergency.

response needs and capabilities.

The State has accepted the Federally recommended 10 mile plume exposure pathway emergency planning zone as appropriate for the Indian Point site.

We are not convinced by the arguments that a wider generic zone is appropriate than the one recommended by the Federal government.

We have not seen any evidence specific to this site that a wider zone is more appropriate than the Federal generic

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4.2.

The following specific feasible offsite procedures should be taken to protect the public:

a) Potassium iodide should be provided in an appropriate form for all residents in the EPZ.

b) Adequate sheltering capability should be provided for all residents in the EPZ.

c) License conditions should prohibit power operation of Units 2 and 3 when the roadway network becomes degraded because of adverse weather conditions.

d) The roadway network should be upgraded to permit successful evacuation of all residents in the EPZ before the plume arrival time, a) The position of the State of New York on the question of potassium iodide is set forth in detail in the previously referred to Report to the Governor and the Legislature by the Disaster Preparedness Commission.

The specific detailed response was extracted from the full report and was previously supplied to the parties.

The substance of our position is that the potential medical benefit of providing potassium iodide to all residents within the EPZ is outweighed by potential adverse effects.

The extract from the report is attached as Exhibit (DD-LC 2) b) Sheltering as a protective action refers to locating the population in structures, such as their homes, to provide protection from a gasecus radioactive release.

A sheltering directive would include recommendation for ventillation control, such as closing doors and windows, turning off air conditioners,etc. Thus, sheltering in this context does not require the civil defense / nuclear attack shelters with their blast and fallout protection.

County plans do make use of public fallout shelters to supplement sheltering in houses, places of work, schools, and similar facilities.

The State of New fork has not made a specific study of the sheltering capability of the EPZ.

We assume that the EPZ contains i

enough dwellings or other buildings to provide adequate protection for the population of the appropriate kind.

c)

It is the position of New York State that it is appropriate for the NRC to consider the capabilities of the road network in conditioning the granting of licenses, and plant operation should only be allowed if successful evacuation is possible.

Adverse uoather conditions are one of the considerations which the Federal i

planning regulations require to be considered in the development of the evacuation component of a radiological emergency plan.

The work performed by the Parsons firm as consultants, and as reviewed i

I by the Department of Transportation staff, is consistent with the Federal requirements and does indeed take into consideration the specific weather conditions as required by the Federal regulations.

i That work indicates successful evacuation in all conditions.

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Since successful evacuation is possible even with the existing roadway network, there is no need to upgrade the network.

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4.4.

The emergency plans should be upgraded by taking account of special groups with special needs in emergencies.

In particular, provision must be made for evacuating persons'who are. dependent upon others for their mobility.

The county and State portions of the Plan were developed with the needs of special populations very much in mind.

Upgrading is in process.

However, certain procedures and actions by the involved public responsible for evacuating dependent persons must flesh out the most appropriate method of handling specific cases.

l The Plan calls for development of public information material.

Such descriptive material has been prepared and mailed to a wide range of residences and businesses within the emergency planning zone.

The material discusses the problem of those with special needs, and invites the public to submit specific instances where special assistance is required.

Those requests are referred to the appropriate county Department of Social Services where follow-up contacts are to be made.

In many cases, such contacts have already been made, but we recognize that much more needs to be done in this important area.

In addition to government efforts, a major responsibility remains for families and friends of those with special problems.

Vulnerability is not a simple matter of relationship to a possible accident at a nuclear power plant.

Any emergency or disaster would affect this population in a similar fashion.

It remains a residual responsibility for relatives or friends to work out special problems with appropriate public agencies.

The relatives or friends should recognize that the total burden of protecting special populations cannot and should not be borne by government. I

4.5.

Specific'ntsps must be taken by NRC, State and local officials to promote a public awareness that nuclear power plant accidents with substantial offsite risks are possible at Indian Point.

It is essential that all concerned parties promote a public awareness as to the possibility of an accident at a nuclear power plant, and that there might be substantial risk to the population within the vicinity of such plants.

It is feasible for specific steps to be taken to promote the public awareness.

The' Federal planning criteria specific-ally require such public information activity.

There are two basic steps which the State is embarking upon.

First, we will develop a series of informational documents for various segments of our society dealing with the existence of nuclear power plants and the potential offsite risks to the public.

The Department of Health, which is a. major participant in the radiological emergency planning program, has a long history of public education programs in the area of health matters.

We will rely on the expertise which exists in DOH, and we will bring that into focus within the program responsibility of the Radiological Emergency Preparedness Group.

Probably the most effective way of advising the public about this problem is by direct contact.

Working with the counties, we have already participated in a series of meetings with a variety of organizations to discuss radiological emergency planning.

The work plan for the remainder of fiscal year 1982-83 for the Radiological Emergency Preparedness Group, places heavy emphasis on public contacts.

4 4.6 A maximum acceptable level of_ radiation exposure for the public must be established before any objective basis will exist for adequate emergency planning.

The State has not developed an independent standard for

" acceptable radiation dose."

The State has adopted the protective action guides developed by the Environmental Protection Agency as guidelines for making decisions on when to take protective actions.

Adoption of the Federal protective action guides is set forth in the State Plan.

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d 4.7.

The present emergency planning brochures and present means of alerting and. informing the population of an emergency do not give adequate attention to problems associated with persons who are deaf, blind, too young to understand the instructions, or who do not' speak English.

See testimony on contention 4.4 and 4.5.

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Exhibit (r;-LC 2)

(Excerpt From Chapter 708 Report to the Governor and Legislature of the State of New York prepared by the New York State Disaster Preparedness Commission distributed March 25, 1982)

Medical Aspects - Potassium Iodide In addition to the other planning and response activities necessary to respo,.d to radiological emergencies the issue of the thyroid prophylaxis is discussed in detail below.

Medical opinion differs concerning the appropriatene ss of using a chemical agent to prevent the uptake of radioactive iodine by the human thyroid in the case of a nuclear power plant accident.

Howeve r, at least one substance, po ta ssium iodide (KI), has proven e ffec tive.

There are unanswered questions related to use of KI involving uncertain risk / benefit evaluations. the identification of the segments of the population for which its use is

intended, and, provisions fo r its storage and timely distribution.

In the United

Kingdom, authorities have recommended potassium iodate (KIO )

fo r prophylaxis; however KIO4 has not been 4

approved for human use in the United States.

New York State recommendations on KI usage have been a rrived at through considerations of actual and theoretical nuclear incidents, pa thways through which the thyroid gland can be exposed to radioac tive iodine s pecie s, the natural history of populations exposed to such risks, the nechanism of KI action and the potentially harmful side e f fec t s known to have occurred with its use.

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1957, there have been five accidents wo rldwide involving airborne radioactive iodine releases from a nuclear facility (FDA, 1981; Levenson, 1980).

Expe rience indicates that when radioisotopes of the common chemical iodine are inhaled or ingested they course through the bloodstream and are gradually inco rporated into the thyroid gland where they accumulate ra pidly.

The thyroid gland uses iodine to manufacture hormones necessary to maintain a normal adult life and to provide for normal growth and development of a fetus or child.

Depending on the quantity of radioiodine, the iodiosotopic composition and the duration of residence in the gland, 9assing or permanent damage to the thyroid can Other experiences with radioiodines have implicated them in causing occur.

benign thyroid tumors (nodules) and/or cancer ten to twenty years after exposure (Maxon, 1980) (Dobyns, 1974).

The implications of a causative relationship to cancer, however, are somewhat tenuous, having been derived primarily from studies of limited populations living on the Marshall Islands who were subjected to fallout from nuclear weapons tests.

There are more than 20 radioactive lostopes of iodiae which are generated in the process of nuclear fission (NCRD, 1980).

The predominant exposure following a reactor incident will be from 1311 but short-lived 132,

133,

134,

and 135I also contribute radioisotopes such as I

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significantly to health risks (NCRP, 1977).

Approximately one-half of the 1311 inco rpo ra t ed into the thyroid will still be found within the body eight days after exposure; the other radiciodines have half-lives from minutes to several hours, and therefore pose a lesser problem.

Because of the volatile nature of 131,

I reactor containments are designed to retain such vapors.

Dry air-cooled reactors have little ca pability to retain such isotopes; but all New York State reactors are water-cooled,131thereby minimizing the volatility of the se isotopes.

The quantity of 1 emitted in the TMI incident was found to be only one millionth of the anticipated quantity of vaporized 1311 which could have been available (Levenson, 1980).

Inhaled iodine reaches equilibrium in body fluids in about 30 minutes. Within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, from 10 to 20 percent of the total dose will be found in thyroids of older children and adults.

Newborns, within the first t

day of li fe, retain more iodine than do older infants, thereby placing their thyroids at greater risk during exposure.

Since an infant's thyroid gla nd is also smaller, size s pecific radiation exposure is proportionately greater for infants.

131I can be transferred to the fo rage of grazing cows, then on to milk and thus to man.

As milk intake is greatest in infants, in some cases being the only source of nutrients, the milk pathway places infants at 131I (NCRP, 1980)

Drinking water and other vegetation greater risk to also may become contaminated, thereby adding to the thyroid burden through ingestion (Comar, 1978).

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1.

Thyroid Nodules and Cancer: The most extensive studies of human ex pe rience with radiation induced thyroid abnormalities resulted from the 1954 Bikini Atoll Incident (Conrad, 1980).

These studies indicated that the Rongelap and Ailingnae peoples on the Marshall Islands have developed a significantly increased number of benign thyroid nodules.

The risk, for develo pment of nodules in children appears to be two to three times the risk of maglignancies in adults, but the number of patients of each type is so small that no statistical significance can be ascribed to the data (Maxon, 1977). These same findings appear to have been demonstrated in the Ja pane se, years after the bombing of Hiroshima and Nagasaki but here, as with the Marshalese, external whole body radiation contributed significantly to the thyroid dose (Conrad, 1980).

The principal 131,

but the e f fects of external radioisotope was identified as I

radiation, which is far more effective in inducing thyroid tumors than is internal 1311 irradiation, obscure the data and produce equivocal conclusions (Rallison, 1974).

It has been calculated that radioactive isotopes of iodine are only one twentieth to one-seventieth as effective as x-ray irradiation in this regard (Maxon, 1977).

Deaths due to these 1311 induced thyroid abnormalities are rare and "such abnormalities are amenable both to protective measures and to treatment with hormones and surgery"

( Conrad, 1980).

Because of these observations, which can be interpreted as demonstrating an increased sensitivity of childhood end adolescent thyroids to radioiodine, large populations of school children in Utah, Nevada and Arizona (Rallison, 1974),

(Weiss, 1971) were studied extensively to determine whether exposure to fallout from nuclear weapons testing in Nevada had increased their risk of thyroid tumors.

Considering the numerous limitations in the interpretation of the data, there was no evidence that exposed persons suffered an increased risk of developing thyroid tumors.

The di f ference in tumor incidence between this group and those previously described may be due to differences in the dose to which each was exposed.

Calculated estimates of thyroid doses in the Nevada experience vary by a factor of ten because of a lack of interest in these particular isotopes at the time of the weapons test.

The Marshall Islands residents received thyroid doses of some three to ten times that of the Nevada population and suffered a significantly greater dose from external gamma radiation.

Patients with hyperactive thyroid glands (thyrotoxicosis) can be treated for this condition by drugs, surgical removal of the gland

( thyroidectomy) or with 131 There has been some past resistance to the I

use of 1311 in children with this condition, because of their presumed predilection to develop thyroid tumors when exposed to large doses of this agent.

Careful analysis by the Coope rative Thyrotoxicosis Therapy Follow-Up Study (Dobyns, 1974) of 998 adults and children treated by various means for this disorder showed that the rate of post-occurring malignant neoplasms (cancer) in the group treated with drugs was approximately four times greater than that of patients treated initially by 1311 and nine times greater t han that for patients treated by thyroidectomy.

Even though the incidence was low, this study supports the notion that children and young adults treated with 1311 (which may not totally destroy their gland and cause hypothyroidism) are more 85

susceptible to benign tumors than older persons.

The risk of death from malignant thyroid neoplasms in these children and adults with thyrotoxicosis is small and is the same whether treated by 131I or surgery.

Since the development of thyroid tumors after irradiation may require a latency period of from 10 to 20 years after exposure, continued observation of the younger patients so identified is mandatory.

As a result, it has been suggested "that evidence negates the basis for the cancerophobia that has, until now, denied children with this disease the simplest, least expensive, and most e f fective treatment: 131I thera py (Crawford, 1981).

2.

Thyroid Neoplasms and Dose of Radiation:

As stated above, irradiation of the thyroid is much less potent in its ability to induce thyroid abnormalities than is external irradiation received from x-rays.

To date, most case studies include patients who have received radiation dosas from both sources, either concomitantly or sequentially, and this lessens the validity of derived cancer risk data.

The first observations of an association between radiation to the thyroid gland and the development of thyroid cancer were reported in 1950 (Pilch, 1973).

The evidence for the association is based on the development of thyroid cancer years after receiving external irradiation to the head, neck and upper chest regions for various conditions.

Hazen (Hazen, 1966) reported three thyroid carcinomas which developed in 170 children who received an average dose of 585 rads to the face; analysis of the field size, and there fore the radiation dose absorbed by the thyroid, was critical in the induction of the neoplastic process.

Others reported one carcinoma and three adenomas among 2,111 children who received x-ray treatments to their upper chest regions for enlargement of their thymus glands.

Maxon (Maxon, 1980) evaluated 1,266 persons who received external irradiation for benign diseases in childhood.

The mean elapsed time between irradiation and operation for thyroid cancer was 16 years (range six to 28 years); the mean estimated total radiation dose was 524 rads (range 210 1,130 rads).

The prevalence of benign thyroid nodules was approximately equal to that of thyroid cancer. Modan reported 12 cases of thyroid malignancy in 10,902 children who received x-ray therapy for fungal infections of the scalp; the absorbed calculated dose was only 6.5 rads, however, and there fo re carelessness during irradiation has been proposed as an explanation.

Combining the reports of Sa fa ( Sa fa,

1975) and the Coo pe rative Thyrotoxicosis Follow-Up Study, there were two cases of thyroid cancer and 17 cases of benign nodules in a population of 304 treated with 131I for overactive thyroids (thyrotoxicosis).

The mean thyroid dose to this internal exposure to radiation was 9,000 rads, with a mean follow up of 11 years.

These cases were treated between the ages of one and 20 years.

Rallison surveyed 5,179 children, of whom 1,378 had been exposed to a maximum of 120 rads from fallout in the we ste rn United States wea pons testing program.

He found no di f fe rence between the irradiated a nd nonirradiated subjects in the prevalence of thyroid tumors.

The mean dose to the thyroid in this case was 46 rads.

86

It appears therefore, that high doses of irradiation to the thyroid are not associated with the developnent of thyroid cancer.

The apparent protective mechanism at doses greater than 2,000 rads of external irradiation may be due to destruction of all thyroid cells, leavint no cells within the gland capable of undergoing tumor formation.

With 131,

I more than 60,000 rads to the thyroid appears to cause total thyroid ablation, with no subsequent risk of thyroid tumors in either children or adults. (Maxon, 1977).

Studies of the Marshallese people accidentally exposed to radioactive fallout following detonation of a nuclear device at Bikini in 1954 have been extensive (Conrad, 1980).

Their exposure was mixed, consisting primarily of strontium, barium and iodine._ The Rongelap adults received an estimated dose of 335 rads of radioiodine, doses to children under 10 years old ranged from 700 to 1,000 rads.

In 117 subjects under 18 at the time of exposure, thyroid nodules developed in 22, two of these were malignant.

In 122 persons, 18 years of age or older at ex posure, nodules occurred in 12, two of these were malignant.

From the above, it is obvious that the risk of developing thyroid nodules, benign or malignant, from 131I is not accurately known: however, there is sufficient reason to sus pect that at some level such radiation will be carcinogenic.

The observations support the contention that infants, children and young adults are at greatest risk.

The NCRP, the EPA, FEMA, the FDA and the NRC recommend KI as a protective action to 131 1 exposure.

KI protects the thyroid from the potentially harmful effects of 131I through two mechanisms:

first by loading the exposed gland with large amounts of stable iodide so the proportion of radioactive iodine present in the circulating blood is diminished (dilution effect); second (as the blood level of stable iodide increases) by serving as an auto-regulatory mechanism in the thyroid, limiting the rate at which further iodide can be accumulated by the gland.

The degree of protection is directly related to the dose of stable iodide given and the time of administration in relation to exposure to 131,

1 If the blocking dose is given immediately prior to exposure, or within 30 minutes, blocking of radioactive iodine uptake will be more than 90 percent e f fective.

Only 50 percent of the uptake is blocked if administration is delayed 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />.

Essentially no e f fect is achieved if the delay is more than 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.

Initial administration after 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> may actually increase the 131I uptake since stable iodide also suppresses the release of thyroid hormone.

After the initial dose additional daily doses of KI must be administered to prevent the small amount of radioiodine that leaves the gland from being recycled through it.

Prophylaxis with KI, however, keeps the 131I in the blood stream for a relatively long time, thus exposing the blood-forming organs to an increased dose of radiation. As a result, the risk of premature death due to bone marrow suppression or leukemia could be significantly increased.

87 1

This issue should be considered before a medical decision on the use of KI is made in a particular incident.

Potassium iodide has been used to treat a number of medical conditions, such as asthma and bronchitis.

Because of s_uch use, reports of isolated reactions to iodides have been published.

But since more than 100,000,000 KI tablets are used each year in the United States, and there is massive use of providone iodine as a surgical wound cleanser, it is reasonable to assume that iodide reac tions are quite rare (ATA, 1981; Sosman, 1979).

De pending on the dose and duration of treatment, the use of KI has been known to cause thyroid enlargement, and to cause both increased and decreased gland activity.

If a pregnant woman is treated, tne newborn can suffer dangerous thyroid enlargement and decreased glandular activity.

If very high doses of iodine are given for prolonged periods, inflammation of the thyroid also can occur. Risk / Benefit evaluation, however, does dictate the need for KI for young age g roups at lcw dose exposure and with controlled administration to prevent total destruction of the thyroid by radionuclides.

Adverse reactions, independent of thyroid effects, are documented and include fever, swollen salivary glands, nasal polyps, generalized swelling, skin eruptions and inflammation of blood vessels.

With very high doses, gastric disturbances are not uncommon.

The very significant reported side e f fects from the use of KI occur only af ter chronic administration of daily doses far in excess of those necessary for the thyroid blocking proposed in a radiation emergency.

_I_f,f general distribution of iodine is contemplated, care fully prepared public information materials should be distributed and individuals potentially at risk from its side e f fects (and previously known to have iodide sensitivities) must be identified and alerted and be given alternatives to its use.

In recommending limited use of KI, it is to be noted that the use of the chemical is only one potential protective action to be considered together with other safety measures in a radiation emergency.

Potassium iodide should be most useful to populations for whom evacuation is not recommended or not feasible and for whom the potential absorbed thyroid dose is projected to exceed the pre-established level which would warrant its use.

Care must be taken to assure that KI is administered early enough to be effective, rather than harmful.

Care also must be exercised to consider the e f fects of possible increased radiation exposure to the blood-fo rming organs.

With these caveats, the measures recommended are:

1.

Potassium iodide should be manu factured in 130 mg scored water soluble tablets in sufficient quantity to meet nuclear emergency preparedness needs.

88

l i

2.

Despite its relatively short shelf life (three years) the d rug should be kept onsite at nuclear powe r plants in su f ficient quantity to provide protection for 10 days for all plant personnel; dose and duration to be prescribed by a medically qualified individual in consultation with health physics trained personnel in the case of an anticipated or actual power pinnt accident.

3.

Because of instability of KI in certain atmosphere conditions (i.e.,

light sensitivity),

s torage should confonn with manufacturers guidelines.

4.

An adequate supply of the drug should be guaranteed for populations of special concern when the projected absorbed thyroid dose of I exceeds the recommended threshold above which iodine blockade is indicated.

This high risk group encompasses pregnant women, the fetus (via the mother), neonate, in fant and young child, and captive populations for whom evacuation is not possible or would not provide adequate protection (i.e., emergency medical services personnel, hospital and nursing home personnel and patients, prison personnel and inmates, etc.).

5.

Pre-distribution of KI to the general population is not recommended but it is advisable that advance planning fo r rapid KI distribution be arranged (ATA, 1981).

6.

Based on available data ( ATA,1981), a protective action guide of 50 rads to the thyroid is suggested as a threshold above which iodine blockade is indicated for pregnant women, infants and children to provide an added measurement of protection to these high risk groups who by the nature of their particular thyroid function are most susceptible to the effects of radioactive iodine. Despite the previously noted sensitivity of KI for these age

gruups, its care ful use will mitigate the po tential development of mental retardation due to total destruction of the thyroid gland by radionuclides.

7.

The American Thyroid Association states that "it would seem unlikely that clinically significant thyroid disease would result from individual exposure of less than 100 rads" ( ATA,1981).

l 8.

The protective action guide of 25 rads should be the threshold dose for use of KI for nuclear power workers because of their risk of chronic multiple exposure.

9.

The de fini tive decision to administer KI to any New York State resident because of an impending or actual nuclear powe r plant accident should remain with the Commissioner of Health.

10.

For those over one year of age, KI should be administered once daily at a dose of 130 mg per day; for those less than one year I

89

of age, the dose should be 65 mg per day, or one-half of a tablet; for those requiring a liquid or powered fo rm o f KI, the tablet should be crushed and/or solubilized in water (4 oz.) and administered as such; for plant

workers, the decision to administer this compound should be made by medically quali fied professionals in consultation with health physics personnel.

11.

Potassium iodide should not be administered for more than 10 days without medical consultation; administration should begin as long be fore the projected ex posure as is necessary to maximize its e f fec ts.

12.

Educational material is needed for both medical professionals and for the public to inform them about KI and its limitations in providing protection and its potential side effects.

13.

A treatment and side effects registry is desirable to more adequately document the toxic effect of KI.

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Re ferences American Thyroid Association, 1981. The Use of Iodine as a Thyroidal Blocking Agent in the Event of a Reactor Accident: Recommendations of the American Thyroid Association. Worchester, Massachusets, Sept. 19,.1981.

Comar, C.L., and Thompson, J.C., 1978 Radioactivity in Foods; in Modern Nutrition in Health and Disease, Goodhart, R.S. and Shils, M.E. (eds. ):

New York, Lea and Febiger,1978, pp. 520-534.

Conrad, R. A.,

1980. The 1954 Bikini Atoll Incident: An Update of the Findings in the Marshallese People; in Hubner, K.F. and Fry, S. A.,

(eds.): The Medical Basis for Radiation Accident Preparedness, New York, Elsevier/ North-Holland, 1980, pp.55-58.

Crawford, J.D., 1981. Marginal Comments: Hyperthyroidism in Children: A Reevaluation of Treatment.

Am. J. Dis. Child. 135: 109-110.

Dobyns, B.M., Sheline, C.E., Workman, J.G., et al,1974. Malignant and Benign Neoplasms of the Thyroid in Patients Treated for Hyperthyroidism. A Report of the Cooperative Thyrotoxicosis Therapy Follow up Study.

J.

Clin. Endocrinol. Metab. 38:976-998.

Food and Drug Administration,1981. Background Material for the Development of the Food and Drug Administration's Recommendations on Thyroid-Blocking with Potassium Iodide. Publication FDA 81-8158.

U.S. Department of Health and Human Services, Washington D.C.

Hazen, R.W.,

Pifer, J.W., Toyooka, E.T., et al, 1966. Neoplasms Following Irradiation of the Health.

Cancer Research 26:305-311.

Levenson, M. and Rahn, F., 1980. Realistic Estimates of the Consequences of Nuclear Accidents. Address delivered at ANS Annual Meeting, Washington, D.C., November 10-20, 1980.

Maxon, H.R., Thomas, S.R., Saenger, E.L., et al, 1977.

Ionizing Irradiation and the Induction of Clinically Significant Disease in the Human Thyroid.

Am. J. Med. 63:967-978.

i Maxon, H.R., Saenger, E.L., Thomas, S.R., et al,1980. Clinically Important i

l Radiation-Associated Thyroid Disease. JAMA 244:1802-1805.

l Modan, B., Baidatz, D., Mart, H., et al,197 4.

Radiation -Induced Head and Neck Tumors. The Lancet 1:277-279.

[

National Council on Radiation Protection, 1977. Protection of the Thyroid I

Gland in the Event of Release of Radioiodine. NCRP Report No. 55.

National Council on Radiation Protection and Measurements, Washington, D.C.

20014 i

National Council on Radiation Protection, 1980. Management of Persons Accidentally Conaminated with Radionuclides. NCRP Report No. 65.

National Council on Radiation Protection and Measurements, Washington, D.C. 20014.

91

Pilch, B.Z., Kahn, C.R., Ketcham, A.S.,

et al, 1973. Thyroid Cancer Af ter Radioactive Diagnostic Procedures in Childhood. Pediatrics 51:898-902.

Rallison, M.L., Dobyns, B.M., Keating, J.R., et al, 197 4.

Thyroid Diseases in Children--A Survey of Subjects Potentially Exposed to Fallout Radiation.

Am. J. Med. 56 : 457.

Sa fa, A.M., Schmuacher, D.P., Rodriguez-Autunez, A., 1975. Long-term Follow up Results in Children and Adolescents Treated with Radioactive Iodine (1-131) for Hyperthyroidism.

N. Engl. J. Med. 292:167.

Sosman, H. (CarterHiallace, Inc.), 1979. Personal Communication to D. Axelrod, Comnissioner, N.Y State Department of Health, Nov. 12, 1979.

U.S. Department of Energy,1979 " Environmental Aspects of Commercial Radioactive Waste Mangement". Report No. DOE /ET-0029, UC-70.

National Technical Information Service, Virginia 22161.

U.S. Federal Emergency Management Agency, 1980. Guidance on Offsite Emergency Radiation Measurement Systems: Phase 1 - Airborne Release. Report No.

FEMA-REP-2.

Federal Emergency Management Agency, Washington D.C.

20472.

U.S. Nuclear Regulatory Commission,1975. Guide and Checklist for the Development and Evaluation of State and Local Government Radiological Emergency Response Plans in Support of Fixed Nuclear Facilities. Report No. NUREG-75/lli (Revision 1 of WASH-1293). National Technical Information Service, Springfield, Virginia 22161.

U.S. Nuclear Regulatory Commission,1980. Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants. National Technical Information Service, Virginia 22161.

Wahlen, M., Kunz, C.O., Matuszek, J.M., Mahoney, W.E.,

and Thompson, R.C.,

1980. Radioactive Plume from the Three Mile Island Accident: Xenon-133 in Air at a Distance of 375 Kilometers.

Science 207:639--640.

Weiss, E.S., Rallison, M.L., London, W.T., et al, 1971. Thyroid Nodularity in Southwestern Utah School Children Exposed to Fallout Radiation.

A. J. P.H. 61 : 2 41-2 49.

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